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Archive for the ‘Cardiac and Cardiovascular Surgical Procedures’ Category


Are TAVR volume requirements limiting rural and minority access to this life-saving procedure, or are they still necessary for patient safety?

Reporter: Aviva Lev-Ari, PhD, RN

 

CMS Considers Changing TAVR Volume Requirements

Debate over transcatheter aortic valve replacement (TAVR) procedures continues as the Centers for Medicare and Medicaid Services (CMS) considers changing the status quo. Are TAVR volume requirements limiting rural and minority access to this life-saving procedure, or are they still necessary for patient safety?

In June 2018, cardiology news sources widely reported that CMS opened public comment on established volume requirements for hospitals and heart teams to perform TAVR. The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) then met on July 25 to discuss the issue. A report in Cardiovascular Business suggested that the committee appeared split on the subject—especially in weighing the potential harms of limiting TAVR to only high volume hospitals.

Cases for and against TAVR volume requirements

The Case for TAVR Volume Requirements

For those on the side of maintaining TAVR volume requirements, the benefits are obvious—volume is associated with positive outcomes and lower rates of complications. In fact, a 2018 expert consensus document from four major cardiology societies actually supported increasing volume requirements to maintain a TAVR program, to ensure adequate data collection for statistically reliable quality metrics and quality assurance.

A new study published in September in JACC: Cardiovascular Interventions seems to add new weight to this argument—data collected from hospitals participating in the international TAVR registry showed volume to have a significant effect on patient safety. The findings suggested that a learning curve of at least 225 procedures was required for hospitals to perform TAVRs with the lowest mortality rates, and that low annual volume hospitals were associated with decreased procedural safety and higher patient mortality.

John D. Carroll, MD, of the University of Colorado School of Medicine wrote an editorial in the same publication arguing that there is a “danger of lowering TAVR quality of care” by relaxing or eliminating TAVR volume requirements. “This would create many new centers starting a new learning curve, result in more low-volume centers, and potentially diluting the case volume and advanced skills of established and high-volume centers,” he writes.

The Case Against TAVR Volume Requirements

While the case for TAVR volume requirements is strong, it does little to answer the central question of the opposing viewpoint—does the benefit of expanding TAVR access to rural areas outweigh the cost of allowing the procedure to be conducted in relatively inexperienced or low-volume centers?

It is difficult to capture data depicting how many patients with aortic stenosis go without valve replacement due to TAVR volume requirements, but the concern seems genuine. We continue to learn more about TAVR, but experts have already established the procedure as the “treatment of choice in the extreme-risk patient who cannot have surgery,” said Martin B. Leon, MD, FACC at a 2017 American College of Cardiology conference.

In this population, where surgical valve replacement is not an option, median life expectancy is increased from 11 months to almost 30 months with TAVR, according to Leon. Indeed, some experts like Deepak L. Bhatt, MD, MPH, FACC, believe that, regardless of surgical risk scores, patients over 80 should undergo TAVR rather than surgical valve replacements.

If TAVR volume requirements limit access to the procedure for this growing elderly population, the negative effects would be obvious. An Edwards Lifesciences resource about aortic stenosis states, “After the onset of symptoms, patients with severe aortic stenosis have a survival rate as low as 50% at 2 years.”

SOURCE

https://acp-online.org/tavr-volume-requirements-debate/

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Top 100 of 415 articles published on PubMed in 2018 on TAVR

Reporter: Aviva Lev-Ari, PhD, RN

 

SOURCE

https://www.ncbi.nlm.nih.gov/pubmed  [2018 TAVR]

Select item 301029701.

Ninety-Day Readmissions of Bundled Valve Patients: Implications for Healthcare Policy.

Koeckert MS, Grossi EA, Vining PF, Abdallah R, Williams MR, Kalkut G, Loulmet DF, Zias EA, Querijero M, Galloway AC.

Semin Thorac Cardiovasc Surg2018 Aug 10. pii: S1043-0679(18)30168-0. doi: 10.1053/j.semtcvs.2018.07.017. [Epub ahead of print]

PMID:
30102970
Select item 300946422.

TAVR Vs. SAVR in Intermediate-Risk Patients: What Influences Our Choice of Therapy.

Still S, Szerlip M, Mack M.

Curr Cardiol Rep2018 Aug 9;20(10):82. doi: 10.1007/s11886-018-1026-3. Review.

PMID:
30094642
Select item 300945323.

Transcatheter aortic valve replacement in patients with severe aortic stenosis and heart failure.

Bavishi C, Kolte D, Gordon PC, Abbott JD.

Heart Fail Rev2018 Aug 9. doi: 10.1007/s10741-018-9726-8. [Epub ahead of print] Review.

PMID:
30094532
Select item 300930574.

Disarming the Ticking Time Bomb: Post-Procedure Electrocardiography Predictors of High-Degree Conduction Disturbances After Transcatheter Aortic Valve Replacement.

Nazif TM, Chen S, Kodali SK.

JACC Cardiovasc Interv2018 Aug 13;11(15):1527-1530. doi: 10.1016/j.jcin.2018.07.003. No abstract available.

PMID:
30093057
Select item 300930565.

Predictors of Advanced Conduction Disturbances Requiring a Late (≥48 H) Permanent Pacemaker Following Transcatheter Aortic Valve Replacement.

Mangieri A, Lanzillo G, Bertoldi L, Jabbour RJ, Regazzoli D, Ancona MB, Tanaka A, Mitomo S, Garducci S, Montalto C, Pagnesi M, Giannini F, Giglio M, Montorfano M, Chieffo A, Rodès-Cabau J, Monaco F, Paglino G, Della Bella P, Colombo A, Latib A.

JACC Cardiovasc Interv2018 Aug 13;11(15):1519-1526. doi: 10.1016/j.jcin.2018.06.014.

PMID:
30093056
Select item 300930556.

Immediate Post-Procedural 12-Lead Electrocardiography as Predictor of Late Conduction Defects After Transcatheter Aortic Valve Replacement.

Jørgensen TH, De Backer O, Gerds TA, Bieliauskas G, Svendsen JH, Søndergaard L.

JACC Cardiovasc Interv2018 Aug 13;11(15):1509-1518. doi: 10.1016/j.jcin.2018.04.011.

PMID:
30093055
Select item 300925577.

Von Willebrand factor and the aortic valve: Concepts that are important in the transcatheter aortic valve replacement era.

Ibrahim H, Rondina MT, Kleiman NS.

Thromb Res2018 Jul 30;170:20-27. doi: 10.1016/j.thromres.2018.07.028. [Epub ahead of print] Review.

PMID:
30092557
Select item 300893298.

Antiplatelet Treatment for Catheter-Based Interventions in High-Risk Patients: Current Guidelines and Expert Opinion.

Rath D, Gawaz M.

Hamostaseologie2018 Aug 8. doi: 10.1055/s-0038-1668165. [Epub ahead of print]

PMID:
30089329
Select item 300870259.

The Evolution of Echocardiographic Type and Anesthetic Technique for Transcatheter Aortic Valve Replacement at a High-Volume Transcatheter Aortic Valve Replacement Center.

Marino M, Lilie CJ, Culp WC Jr, Schepel SR, Tippett JC.

J Cardiothorac Vasc Anesth2018 Jun 30. pii: S1053-0770(18)30468-3. doi: 10.1053/j.jvca.2018.06.022. [Epub ahead of print]

PMID:
30087025
Select item 3007961110.

Propensity matched comparison of in-hospital outcomes of TAVR vs. SAVR in patients with previous history of CABG: Insights from the Nationwide inpatient sample.

Nalluri N, Atti V, Patel NJ, Kumar V, Arora S, Nalluri S, Nelluri BK, Maniatis GA, Kandov R, Kliger C.

Catheter Cardiovasc Interv2018 Aug 5. doi: 10.1002/ccd.27708. [Epub ahead of print]

PMID:
30079611
Select item 3007956111.

Permanent pacemaker implantation after transcatheter aortic valve replacement in bicuspid aortic valve patients.

Xiong TY, Liao YB, Li YJ, Zhao ZG, Wei X, Tsauo JY, Xu YN, Feng Y, Chen M.

J Interv Cardiol2018 Aug 5. doi: 10.1111/joic.12546. [Epub ahead of print]

PMID:
30079561
Select item 3007952212.

Effect of transcatheter aortic valve replacement on left atrial function.

Truong VT, Chung E, Nagueh S, Kereiakes D, Schaaf J, Volz B, Ngo TNM, Mazur W.

Echocardiography2018 Aug 5. doi: 10.1111/echo.14109. [Epub ahead of print]

PMID:
30079522
Select item 3007679413.

TAVR 2.0: Collaborating to Measure, Assure, and Advance Quality.

Shahian DM, Gleason TG, Shemin RJ, Carroll JD, Mack MJ.

Ann Thorac Surg2018 Aug 1. pii: S0003-4975(18)31034-8. doi: 10.1016/j.athoracsur.2018.07.004. [Epub ahead of print] No abstract available.

PMID:
30076794
Select item 3007608114.

Low Iodine Contrast Injection for CT Acquisition Prior to Transcatheter Aortic Valve Replacement: Aorta Assessment and Screening for Coronary Artery Disease.

Hachulla AL, Noble S, Ronot M, Guglielmi G, de Perrot T, Montet X, Vallée JP.

Acad Radiol2018 Aug 1. pii: S1076-6332(18)30330-1. doi: 10.1016/j.acra.2018.06.016. [Epub ahead of print]

PMID:
30076081
Select item 3007532615.

Variation in post-TAVR antiplatelet therapy utilization and associated outcomes: Insights from the STS/ACC TVT Registry.

Sherwood MW, Vemulapalli S, Harrison JK, Dai D, Vora AN, Mack MJ, Holmes DR, Rumsfeld JS, Cohen DJ, Thourani VH, Kirtane A, Peterson ED.

Am Heart J2018 Jul 9;204:9-16. doi: 10.1016/j.ahj.2018.06.006. [Epub ahead of print]

PMID:
30075326
Select item 3006878516.

State of Transcatheter Aortic Valve Implantation in Spain Versus Europe and Non-European Countries.

Biagioni C, Tirado-Conte G, Rodés-Cabau J, Ryan N, Cerrato E, Nazif TM, Eltchaninoff H, Sondergaard L, Ribeiro HB, Barbanti M, Nietlispach F, De Jaegere P, Agostoni P, Trillo R, Jiménez-Quevedo P, D’Ascenzo F, Wendler O, Maluenda G, Chen M, Tamburino C, Macaya C, Leon MB, Nombela-Franco L.

J Invasive Cardiol2018 Aug;30(8):301-309.

Select item 3006493717.

Accuracy of predicted orthogonal projection angles for valve deployment during transcatheter aortic valve replacement.

Steinvil A, Weissman G, Ertel AW, Weigold G, Rogers T, Koifman E, Buchanan KD, Shults C, Torguson R, Okubagzi PG, Satler LF, Ben-Dor I, Waksman R.

J Cardiovasc Comput Tomogr2018 May 26. pii: S1934-5925(18)30130-8. doi: 10.1016/j.jcct.2018.05.017. [Epub ahead of print]

PMID:
30064937
Select item 3006277818.

Absence of Electrocardiographic Left Ventricular Hypertrophy is Associated with Increased Mortality After Transcatheter Aortic Valve Replacement.

Kampaktsis PN, Ullal AV, Swaminathan RV, Minutello RM, Kim L, Bergman GS, Feldman DN, Singh H, Chiu Wong S, Okin PM.

Clin Cardiol2018 Jul 30. doi: 10.1002/clc.23034. [Epub ahead of print]

Select item 3005825919.

Early and midterm outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valves.

Aalaei-Andabili SH, Beaver TM, Petersen JW, Anderson RD, Karimi A, Thoburn E, Kabir A, Bavry AA, Arnaoutakis GJ.

J Card Surg2018 Jul 29. doi: 10.1111/jocs.13775. [Epub ahead of print]

PMID:
30058259
Select item 3005725220.

The Incidence of Dysphagia Among Patients Undergoing TAVR With Either General Anesthesia or Moderate Sedation.

Mukdad L, Kashani R, Mantha A, Sareh S, Mendelsohn A, Benharash P.

J Cardiothorac Vasc Anesth2018 May 26. pii: S1053-0770(18)30373-2. doi: 10.1053/j.jvca.2018.05.040. [Epub ahead of print]

PMID:
30057252
Select item 3005685121.

Sex-Specific Differences in Outcome of Transcatheter or Surgical Aortic Valve Replacement.

Kaier K, von Zur Mühlen C, Zirlik A, Schmoor C, Roth K, Bothe W, Hehn P, Reinöhl J, Zehender M, Bode C, Stachon P.

Can J Cardiol2018 Aug;34(8):992-998. doi: 10.1016/j.cjca.2018.04.009. Epub 2018Apr 12.

PMID:
30056851
Select item 3005602322.

Hemodynamic monitoring by pulse contour analysis during trans-catheter aortic valve replacement: A fast and easy method to optimize procedure results.

Ristalli F, Romano SM, Stolcova M, Meucci F, Squillantini G, Valente S, Di Mario C.

Cardiovasc Revasc Med2018 Jul 19. pii: S1553-8389(18)30314-2. doi: 10.1016/j.carrev.2018.07.015. [Epub ahead of print]

PMID:
30056023
Select item 3005418823.

TAVR Versus SAVR in the Era of NSQIP.

Vadlamudi R, Duggan M.

J Cardiothorac Vasc Anesth2018 May 26. pii: S1053-0770(18)30370-7. doi: 10.1053/j.jvca.2018.05.037. [Epub ahead of print] No abstract available.

PMID:
30054188
Select item 3005090924.

Expanding TAVI to Low and Intermediate Risk Patients.

Voigtländer L, Seiffert M.

Front Cardiovasc Med2018 Jul 12;5:92. doi: 10.3389/fcvm.2018.00092. eCollection 2018. Review.

Select item 3004863225.

Albumin Is Predictive of 1-Year Mortality After Transcatheter Aortic Valve Replacement.

Hebeler KR, Baumgarten H, Squiers JJ, Wooley J, Pollock BD, Mahoney C, Filardo G, Lima B, DiMaio JM.

Ann Thorac Surg2018 Jul 23. pii: S0003-4975(18)31022-1. doi: 10.1016/j.athoracsur.2018.06.024. [Epub ahead of print]

PMID:
30048632
Select item 3004178326.

Bioprosthetic structural valve deterioration: How do TAVR and SAVR prostheses compare?

Aldalati O, Kaura A, Khan H, Dworakowski R, Byrne J, Eskandari M, Deshpande R, Monaghan M, Wendler O, MacCarthy P.

Int J Cardiol2018 Oct 1;268:170-175. doi: 10.1016/j.ijcard.2018.04.091.

PMID:
30041783
Select item 3003771727.

Exposure to glucocorticoids prior to transcatheter aortic valve replacement is associated with reduced incidence of high-degree AV block and pacemaker.

Oestreich B, Gurevich S, Adabag S, Kelly R, Helmer G, Raveendran G, Yannopoulos D, Biring T, Garcia S.

Cardiovasc Revasc Med2018 Jul 18. pii: S1553-8389(18)30311-7. doi: 10.1016/j.carrev.2018.07.012. [Epub ahead of print]

PMID:
30037717
Select item 3003742428.

Comparison of Hospital Outcomes of Transcatheter Aortic Valve Implantation With Versus Without Hypothyroidism.

Subahi A, Yassin AS, Adegbala O, Akintoye E, Abubakar H, Elmoghrabi A, Ibrahim W, Ajam M, Pahuja M, Weinberger JJ, Levine D, Afonso L.

Am J Cardiol2018 Jun 5. pii: S0002-9149(18)31197-4. doi: 10.1016/j.amjcard.2018.05.025. [Epub ahead of print]

PMID:
30037424
Select item 3003171929.

Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study.

Rodés-Cabau J, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre JM, Asmarats L, Pelletier-Beaumont E, Philippon F.

JACC Cardiovasc Interv2018 Aug 13;11(15):1495-1505. doi: 10.1016/j.jcin.2018.04.016. Epub 2018 Jul 18.

PMID:
30031719
Select item 3003171830.

Arrhythmias and Conduction Disturbances Following Transcatheter Aortic Valve Replacement: Out of Sight, Out of Mind?

Pighi M, Piazza N.

JACC Cardiovasc Interv2018 Aug 13;11(15):1506-1508. doi: 10.1016/j.jcin.2018.05.038. Epub 2018 Jul 18. No abstract available.

PMID:
30031718
Select item 3002924731.

Numerical Parametric Study of Paravalvular Leak Following a Transcatheter Aortic Valve Deployment Into a Patient-Specific Aortic Root.

Mao W, Wang Q, Kodali S, Sun W.

J Biomech Eng2018 Oct 1;140(10). doi: 10.1115/1.4040457.

PMID:
30029247
Select item 3002920732.

Comparative Fluid-Structure Interaction Analysis of Polymeric Transcatheter and Surgical Aortic Valves’ Hemodynamics and Structural Mechanics.

Ghosh R, Marom G, Rotman O, Slepian MJ, Prabhakar S, Horner M, Bluestein D.

J Biomech Eng2018 Jun 25. doi: 10.1115/1.4040600. [Epub ahead of print]

PMID:
30029207
Select item 3002830433.

Extended benefits of TAVR in young patients with low-intermediate risk score: proceed with care.

Doshi R.

EuroIntervention2018 Jul 20;14(4):e485. doi: 10.4244/EIJ-D-18-00236L. No abstract available.

Select item 3002830034.

Valve-in-valve TAVR using the SAPIEN 3 transcatheter heart valve: still plagued by patient-prosthesis mismatch.

Saxon JT, Cohen DJ, Feldman T.

EuroIntervention2018 Jul 20;14(4):e377-e379. doi: 10.4244/EIJV14I4A66. No abstract available.

Select item 3002573135.

The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients.

Kim WK, Hengstenberg C, Hilker M, Kerber S, Schäfer U, Rudolph T, Linke A, Franz N, Kuntze T, Nef H, Kappert U, Zembala MO, Toggweiler S, Walther T, Möllmann H.

JACC Cardiovasc Interv2018 Jul 23;11(14):1368-1374. doi: 10.1016/j.jcin.2018.03.023.

Select item 3002557236.

Transcatheter Aortic Valve Replacement of Failed Surgically Implanted Bioprostheses: The STS/ACC Registry.

Tuzcu EM, Kapadia SR, Vemulapalli S, Carroll JD, Holmes DR Jr, Mack MJ, Thourani VH, Grover FL, Brennan JM, Suri RM, Dai D, Svensson LG.

J Am Coll Cardiol2018 Jul 24;72(4):370-382. doi: 10.1016/j.jacc.2018.04.074.

PMID:
30025572
Select item 3002410237.

Transcatheter valve-in-valve versus redo surgical aortic valve replacement for the treatment of degenerated bioprosthetic aortic valve: A systematic review and meta-analysis.

Tam DY, Vo TX, Wijeysundera HC, Dvir D, Friedrich JO, Fremes SE.

Catheter Cardiovasc Interv2018 Jul 19. doi: 10.1002/ccd.27686. [Epub ahead of print]

PMID:
30024102
Select item 3001983938.

Predicted magnitude of alternate access in the contemporary transcatheter aortic valve replacement era.

Rogers T, Gai J, Torguson R, Okubagzi PG, Shults C, Ben-Dor I, Satler LF, Waksman R.

Catheter Cardiovasc Interv2018 Jul 18. doi: 10.1002/ccd.27668. [Epub ahead of print]

PMID:
30019839
Select item 3001982839.

Slope of left ventricular filling as an index of valvular and paravalvular regurgitation in native and prosthetic aortic valves.

Makki N, Ghao X, Whitson B, Shreenivas S, Crestanello J, Lilly S.

Catheter Cardiovasc Interv2018 Jul 18. doi: 10.1002/ccd.27684. [Epub ahead of print]

PMID:
30019828
Select item 3001982240.

Is two better than one? Re-evaluating the surgical approval process for TAVR.

Shreenivas S, Lilly S, Reardon M, Answini GA, Kereiakes DJ.

Catheter Cardiovasc Interv2018 Jul 18. doi: 10.1002/ccd.27666. [Epub ahead of print] No abstract available.

PMID:
30019822
Select item 3001816741.

Improving the Diagnostic Performance of 18F-FDG PET/CT in Prosthetic Heart Valve Endocarditis.

Swart LE, Gomes A, Scholtens AM, Sinha B, Tanis W, Lam MGEH, van der Vlugt MJ, Streukens SAF, Aarntzen EHJG, Bucerius J, van Assen S, Bleeker-Rovers CP, van Geel PP, Krestin GP, van Melle JP, Roos-Hesselink JW, Slart RHJA, Glaudemans AWJM, Budde RPJ.

Circulation2018 Jul 17. pii: CIRCULATIONAHA.118.035032. doi: 10.1161/CIRCULATIONAHA.118.035032. [Epub ahead of print]

PMID:
30018167
Select item 3001752042.

Software-automated multidetector computed tomography-based prosthesis-sizing in transcatheter aortic valve replacement: Inter-vendor comparison and relation to patient outcome.

Baeßler B, Mauri V, Bunck AC, Pinto Dos Santos D, Friedrichs K, Maintz D, Rudolph T.

Int J Cardiol2018 Jul 9. pii: S0167-5273(18)32256-3. doi: 10.1016/j.ijcard.2018.07.008. [Epub ahead of print] No abstract available.

PMID:
30017520
Select item 3001751843.

Inflammation in aortic stenosis: Shaping the biomarkers network.

Schiattarella GG, Perrino C.

Int J Cardiol2018 Jul 6. pii: S0167-5273(18)33669-6. doi: 10.1016/j.ijcard.2018.07.026. [Epub ahead of print] No abstract available.

PMID:
30017518
Select item 3001728244.

Inter- and intra-observer repeatability of aortic annulus measurements on screening CT for transcatheter aortic valve replacement (TAVR): Implications for appropriate device sizing.

Knobloch G, Sweetman S, Bartels C, Raval A, Gimelli G, Jacobson K, Lozonschi L, Kohmoto T, Osaki S, François C, Nagle S.

Eur J Radiol2018 Aug;105:209-215. doi: 10.1016/j.ejrad.2018.06.003. Epub 2018 Jun 15.

PMID:
30017282
Select item 3001614745.

Atherosclerosis on CT Angiogram Predicts Acute Kidney Injury After Transcatheter Aortic Valve Replacement.

Kandathil A, Abbara S, Hanna M, Minhajuddin A, Wehrmann L, Merchant AM, Mills R, Fox AA.

AJR Am J Roentgenol2018 Jul 17:1-7. doi: 10.2214/AJR.17.19340. [Epub ahead of print]

PMID:
30016147
Select item 3001289046.

Transfemoral Implantation of the Acurate neo for the Treatment of Aortic Regurgitation.

Toggweiler S, Cerillo AG, Kim WK, Biaggi P, Lloyd C, Hilker M, Almagor Y, Cuculi F, Brinkert M, Kobza R, Muller O, Rück A, Corti R.

J Invasive Cardiol2018 Jul 15. pii: JIC2018715-3. [Epub ahead of print]

Select item 3000980047.

Suprasternal and Left Axillary Transcatheter Aortic Valve Replacement in Morbidly Obese Patients.

Olds A, Eudailey K, Nazif T, Vahl T, Khalique O, Lewis C, Hahn R, Leon M, Bapat V, Ahmed M, Kodali S, George I.

Ann Thorac Surg2018 Jul 13. pii: S0003-4975(18)30978-0. doi: 10.1016/j.athoracsur.2018.05.095. [Epub ahead of print]

PMID:
30009800
Select item 3000336648.

Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves.

Wernly B, Zappe AK, Unbehaun A, Sinning JM, Jung C, Kim WK, Fichtlscherer S, Lichtenauer M, Hoppe UC, Alushi B, Beckhoff F, Wewetzer C, Franz M, Kretzschmar D, Navarese E, Landmesser U, Falk V, Lauten A.

Clin Res Cardiol2018 Jul 12. doi: 10.1007/s00392-018-1326-z. [Epub ahead of print]

PMID:
30003366
Select item 3000209949.

Myocardial Scar and Mortality in Severe Aortic Stenosis: Data from the BSCMR Valve Consortium.

Musa TA, Treibel TA, Vassiliou VS, Captur G, Singh A, Chin C, Dobson LE, Pica S, Loudon M, Malley T, Rigolli M, Foley JRJ, Bijsterveld P, Law GR, Dweck MR, Myerson SG, McCann GP, Prasad SK, Moon JC, Greenwood JP.

Circulation2018 Jul 12. pii: CIRCULATIONAHA.117.032839. doi: 10.1161/CIRCULATIONAHA.117.032839. [Epub ahead of print]

PMID:
30002099
Select item 2999613850.

Aortic Angulation and TAVR.

Gandotra P.

Cardiology2018 Jul 11;140(3):141-142. doi: 10.1159/000490094. [Epub ahead of print] No abstract available.

Select item 2998906851.

Endovascular repair of severe aortic coarctation, transcatheter aortic valve replacement for severe aortic stenosis, and percutaneous coronary intervention in an elderly patient with long term follow-up.

Fallatah R, Elasfar A, Amoudi O, Ajaz M, AlHarbi I, Abuelatta R.

J Saudi Heart Assoc2018 Jul;30(3):271-275. doi: 10.1016/j.jsha.2018.01.003. Epub 2018 Feb 9.

Select item 2998711952.

Impact of Rapid Ventricular Pacing on Outcome After Transcatheter Aortic Valve Replacement.

Fefer P, Bogdan A, Grossman Y, Berkovitch A, Brodov Y, Kuperstein R, Segev A, Guetta V, Barbash IM.

J Am Heart Assoc2018 Jul 9;7(14). pii: e009038. doi: 10.1161/JAHA.118.009038.

Select item 2998314253.

Imaging Evaluation for the Detection of Leaflet Thrombosis After Transcatheter Aortic Valve Replacement.

Zhao ZG, Wang MY, Jilaihawi H.

Interv Cardiol Clin2018 Jul;7(3):293-299. doi: 10.1016/j.iccl.2018.03.007. Epub 2018Jun 29. Review.

PMID:
29983142
Select item 2998314154.

Imaging Evaluation and Interpretation for Vascular Access for Transcatheter Aortic Valve Replacement.

Foley TR, Stinis CT.

Interv Cardiol Clin2018 Jul;7(3):285-291. doi: 10.1016/j.iccl.2018.03.006. Epub 2018Jun 29. Review.

PMID:
29983141
Select item 2998121455.

Echocardiography in transcatheter aortic (Core)Valve implantation: Part 2-Transesophageal echocardiography.

Naqvi TZ.

Echocardiography2018 Jul;35(7):1020-1041. doi: 10.1111/echo.14034. Review.

PMID:
29981214
Select item 2998029956.

Impact of patient-specific morphologies on sinus flow stasis in transcatheter aortic valve replacement: An in vitro study.

Hatoum H, Dollery J, Lilly SM, Crestanello J, Dasi LP.

J Thorac Cardiovasc Surg2018 Jun 7. pii: S0022-5223(18)31521-6. doi: 10.1016/j.jtcvs.2018.05.086. [Epub ahead of print]

PMID:
29980299
Select item 2997656857.

Malnutrition and Mortality in Frail and Non-Frail Older Adults Undergoing Aortic Valve Replacement.

Goldfarb M, Lauck S, Webb JG, Asgar AW, Perrault LP, Piazza N, Martucci G, Lachapelle K, Noiseux N, Kim DH, Popma JJ, Lefèvre T, Labinaz M, Lamy A, Peterson MD, Arora RC, Morais JA, Morin JF, Rudski L, Afilalo J; FRAILTY-AVR Investigators .

Circulation2018 Jul 5. pii: CIRCULATIONAHA.118.033887. doi: 10.1161/CIRCULATIONAHA.118.033887. [Epub ahead of print]

PMID:
29976568
Select item 2997636358.

Debris Heterogeneity Across Different Valve Types Captured by a Cerebral Protection System During Transcatheter Aortic Valve Replacement.

Schmidt T, Leon MB, Mehran R, Kuck KH, Alu MC, Braumann RE, Kodali S, Kapadia SR, Linke A, Makkar R, Naber C, Romero ME, Virmani R, Frerker C.

JACC Cardiovasc Interv2018 Jul 9;11(13):1262-1273. doi: 10.1016/j.jcin.2018.03.001.

PMID:
29976363
Select item 2997426459.

A Review of Alternative Access for Transcatheter Aortic Valve Replacement.

Young MN, Singh V, Sakhuja R.

Curr Treat Options Cardiovasc Med2018 Jul 4;20(7):62. doi: 10.1007/s11936-018-0648-5. Review.

PMID:
29974264
Select item 2997123860.

Transcatheter Aortic Valve Replacement and Concomitant Mitral Regurgitation.

Stähli BE, Reinthaler M, Leistner DM, Landmesser U, Lauten A.

Front Cardiovasc Med2018 Jun 19;5:74. doi: 10.3389/fcvm.2018.00074. eCollection 2018. Review.

Select item 2996942761.

Propensity matched comparison of clinical outcomes after transaortic versus transfemoral aortic valve replacement.

Chollet T, Marcheix B, Boudou N, Elbaz M, Campelo-Parada F, Bataille V, Bouisset F, Lairez O, Porterie J, Galinier M, Carrie D, Lhermusier T.

EuroIntervention2018 Jul 3. pii: EIJ-D-18-00168. doi: 10.4244/EIJ-D-18-00168. [Epub ahead of print]

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Alternative access for transcatheter aortic valve replacement in older adults: A collaborative study from France and United States.

Damluji AA, Murman M, Byun S, Moscucci M, Resar JR, Hasan RK, Alfonso CE, Carrillo RG, Williams DB, Kwon CC, Cho PW, Dijos M, Peltan J, Heldman AW, Cohen MG, Leroux L.

Catheter Cardiovasc Interv2018 Jul 3. doi: 10.1002/ccd.27690. [Epub ahead of print]

PMID:
29968273
Select item 2996613163.

Does Aortic Angulation Impact Outcomes in TAVR.

Czarny MJ, Resar JR.

Cardiology2018;140(2):103-105. doi: 10.1159/000489697. Epub 2018 Jul 2. No abstract available.

PMID:
29966131
Select item 2996339164.

Transcaval transcatheter aortic valve replacement: a visual case review.

Muhammad KI, Tokarchik GC.

J Vis Surg2018 May 14;4:102. doi: 10.21037/jovs.2018.04.02. eCollection 2018.

Select item 2996107265.

Aortic Angulation Does Not Impact Outcomes in Self-Expandable or Balloon-Expandable Transcatheter Aortic Valve Replacement.

Elmously A, Gray KD, Truong QA, Burshtein A, Wong SC, de Biasi AR, Worku B, Salemi A.

Cardiology2018;140(2):96-102. doi: 10.1159/000488933. Epub 2018 Jun 29.

PMID:
29961072
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Transcatheter Aortic Valve Replacement in Extremely Large Annuli: (Over)expanding Bioprosthetic Technology to the Limits?

Mehilli J, Jochheim D.

JACC Cardiovasc Interv2018 Jul 23;11(14):1388-1389. doi: 10.1016/j.jcin.2018.05.007. Epub 2018 Jun 27. No abstract available.

PMID:
29960756
Select item 2996075567.

Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve.

Tang GHL, Zaid S, George I, Khalique OK, Abramowitz Y, Maeno Y, Makkar RR, Jilaihawi H, Kamioka N, Thourani VH, Babaliaros V, Webb JG, Htun NM, Attinger-Toller A, Ahmad H, Kaple R, Sharma K, Kozina JA, Kaneko T, Shah P, Hirji SA, Desai ND, Anwaruddin S, Jagasia D, Herrmann HC, Basra SS, Szerlip MA, Mack MJ, Mathur M, Tan CW, Don CW, Sharma R, Gafoor S, Zhang M, Kapadia SR, Mick SL, Krishnaswamy A, Amoroso N, Salemi A, Wong SC, Kini AS, Rodés-Cabau J, Leon MB, Kodali SK.

JACC Cardiovasc Interv2018 Jul 23;11(14):1377-1387. doi: 10.1016/j.jcin.2018.03.034. Epub 2018 Jun 27.

PMID:
29960755
Select item 2995818268.
Select item 2995225269.

Stent fractures after common femoral artery bail-out stenting due to suture device failure in TAVR.

Veulemans V, Afzal S, Ledwig P, Heiss C, Busch L, Sansone R, Soetemann DB, Maier O, Kleinebrecht L, Kelm M, Zeus T, Hellhammer K.

Vasa2018 Jun 28:1-9. doi: 10.1024/0301-1526/a000712. [Epub ahead of print]

PMID:
29952252
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Transcatheter Mitral Valve Replacement: Functional Requirements for Device Design, Bench-Top, and Pre-Clinical Evaluation.

Iyer R, Chalekian A, Lane R, Evans M, Yi S, Morris J.

Cardiovasc Eng Technol2018 Jun 27. doi: 10.1007/s13239-018-0364-z. [Epub ahead of print]

PMID:
29951830
Select item 2994327371.

Gender-dependent association of diabetes mellitus with mortality in patients undergoing transcatheter aortic valve replacement.

Linke A, Schlotter F, Haussig S, Woitek FJ, Stachel G, Adam J, Höllriegel R, Lindner A, Mohr FW, Schuler G, Kiefer P, Leontyev S, Thiele H, Borger MA, Holzhey D, Mangner N.

Clin Res Cardiol2018 Jun 25. doi: 10.1007/s00392-018-1309-0. [Epub ahead of print]

PMID:
29943273
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Transcatheter aortic valve replacement with the 34 mm Medtronic Evolut valve : Early results of single institution experience.

D’Ancona G, Dißmann M, Heinze H, Zohlnhöfer-Momm D, Ince H, Kische S.

Neth Heart J2018 Aug;26(7-8):401-408. doi: 10.1007/s12471-018-1122-4.

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Midterm Outcomes With the Self-Expanding ACURATE neo Aortic Bioprosthesis: The “Bumblebee Paradox” in Transcatheter Aortic Valve Replacement.

Barbanti M, Todaro D.

JACC Cardiovasc Interv2018 Jul 23;11(14):1375-1376. doi: 10.1016/j.jcin.2018.06.004. Epub 2018 Jun 22. No abstract available.

PMID:
29941369
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Atrioventricular and intraventricular block after transcatheter aortic valve implantation.

Lee JJ, Goldschlager N, Mahadevan VS.

J Interv Card Electrophysiol2018 Jun 24. doi: 10.1007/s10840-018-0391-6. [Epub ahead of print]

PMID:
29936634
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Recurrent Unilateral Transudative Pleural Effusion Due to Low Flow, Low Gradient Severe Aortic Stenosis.

Al-Khafaji JF, Taha M, Abdalla AO, Rowan C.

Am J Case Rep2018 Jun 23;19:739-743. doi: 10.12659/AJCR.909448.

Select item 2992964276.

Whose Urgency Is it, Anyway?

Brener SJ.

JACC Cardiovasc Interv2018 Jun 25;11(12):1186-1187. doi: 10.1016/j.jcin.2018.03.035. No abstract available.

PMID:
29929642
Select item 2992964177.

Outcomes Following Urgent/Emergent Transcatheter Aortic Valve Replacement: Insights From the STS/ACC TVT Registry.

Kolte D, Khera S, Vemulapalli S, Dai D, Heo S, Goldsweig AM, Aronow HD, Elmariah S, Inglessis I, Palacios IF, Thourani VH, Sharaf BL, Gordon PC, Abbott JD.

JACC Cardiovasc Interv2018 Jun 25;11(12):1175-1185. doi: 10.1016/j.jcin.2018.03.002. Epub 2018 Mar 11.

PMID:
29929641
Select item 2992963978.

Medium-Term Follow-Up of Early Leaflet Thrombosis After Transcatheter Aortic Valve Replacement.

Ruile P, Minners J, Breitbart P, Schoechlin S, Gick M, Pache G, Neumann FJ, Hein M.

JACC Cardiovasc Interv2018 Jun 25;11(12):1164-1171. doi: 10.1016/j.jcin.2018.04.006.

PMID:
29929639
Select item 2992775879.

Left Subclavian Transcatheter Aortic Valve Replacement Under Combined Interscalene and Pectoralis Nerve Blocks: A Case Series.

Block M, Pitchon DN, Schwenk ES, Ruggiero N, Entwistle J, Goldhammer JE.

A A Pract2018 Jun 18. doi: 10.1213/XAA.0000000000000819. [Epub ahead of print]

PMID:
29927758
Select item 2992620680.

Optimal pre-TAVR annulus sizing in patients with bicuspid aortic valve: area-derived perimeter by CT is the best-correlated measure with intraoperative sizing.

Wang Y, Wang M, Song G, Wang W, Lv B, Wang H, Wu Y.

Eur Radiol2018 Jun 20. doi: 10.1007/s00330-018-5592-y. [Epub ahead of print]

PMID:
29926206
Select item 2992437681.

Immediate improvement of left ventricular mechanics following transcatheter aortic valve replacement.

Lozano Granero VC, Fernández Santos S, Fernández-Golfín C, Plaza Martín M, de la Hera Galarza JM, Faletra FF, Swaans MJ, López-Fernández T, Mesa D, La Canna G, Echeverría García T, Habib G, Martíne Monzonís A, Zamorano Gómez JL.

Cardiol J2018 Jun 20. doi: 10.5603/CJ.a2018.0066. [Epub ahead of print]

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Sex-Specific Considerations in Women with Aortic Stenosis and Outcomes After Transcatheter Aortic Valve Replacement.

Mihos CG, Klassen SL, Yucel E.

Curr Treat Options Cardiovasc Med2018 Jun 19;20(7):52. doi: 10.1007/s11936-018-0651-x. Review.

PMID:
29923126
Select item 2992253583.
Select item 2991587884.

Less pronounced reverse left ventricular remodeling in patients with bicuspid aortic stenosis treated with transcatheter aortic valve replacement compared to tricuspid aortic stenosis.

Xiong TY, Wang X, Li YJ, Liao YB, Zhao ZG, Wei X, Xu YN, Zheng MX, Zhou X, Peng Y, Wei JF, Feng Y, Chen M.

Int J Cardiovasc Imaging2018 Jun 18. doi: 10.1007/s10554-018-1401-6. [Epub ahead of print]

PMID:
29915878
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Predictors of Persistent Tricuspid Regurgitation After Transcatheter Aortic Valve Replacement in Patients With Baseline Tricuspid Regurgitation.

Worku B, Valovska MT, Elmously A, Kampaktsis P, Castillo C, Wong SC, Salemi A.

Innovations (Phila)2018 May/Jun;13(3):190-199. doi: 10.1097/IMI.0000000000000504.

PMID:
29912741
Select item 2991243286.

Transcatheter aortic valve replacement in the setting of left atrial appendage thrombus.

Salemi A, De Micheli A, Aftab A, Elmously A, Chang R, Wong SC, Worku BM.

Interact Cardiovasc Thorac Surg2018 Jun 14. doi: 10.1093/icvts/ivy189. [Epub ahead of print]

PMID:
29912432
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TAVR versus SAVR: Who determines the risk?

Lazar HL.

J Card Surg2018 Jun 17. doi: 10.1111/jocs.13744. [Epub ahead of print] No abstract available.

PMID:
29911336
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Evolving trends in aortic valve replacement: A statewide experience.

Kim KM, Shannon F, Paone G, Lall S, Batra S, Boeve T, DeLucia A, Patel HJ, Theurer PF, He C, Clark MJ, Sultan I, Deeb GM, Prager RL.

J Card Surg2018 Jun 17. doi: 10.1111/jocs.13740. [Epub ahead of print]

PMID:
29911307
Select item 2990896989.

Transcatheter Aortic Valve Replacement on an Aortic Mechanical Valve.

Arzamendi D, Ruiz V, Ramallal R, Alcasena MS, Beunza MT, Larman M.

JACC Cardiovasc Interv2018 Jul 9;11(13):e107-e108. doi: 10.1016/j.jcin.2018.04.046. Epub 2018 Jun 13. No abstract available.

PMID:
29908969
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Transcatheter or surgical treatment of severe aortic stenosis and coronary artery disease: A comparative analysis from the Italian OBSERVANT study.

Barbanti M, Buccheri S, Capodanno D, D’Errigo P, Ranucci M, Rosato S, Santoro G, Fusco D, Tamburino C, Biancari F, Seccareccia F; OBSERVANT Research Group.

Int J Cardiol2018 Jun 7. pii: S0167-5273(17)36915-2. doi: 10.1016/j.ijcard.2018.06.011. [Epub ahead of print]

PMID:
29903519
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Oral anti-Xa anticoagulation after trans-aortic valve implantation for aortic stenosis: The randomized ATLANTIS trial.

Collet JP, Berti S, Cequier A, Van Belle E, Lefevre T, Leprince P, Neumann FJ, Vicaut E, Montalescot G.

Am Heart J2018 Jun;200:44-50. doi: 10.1016/j.ahj.2018.03.008. Epub 2018 Mar 10.

PMID:
29898848
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Utility of an additive frailty tests index score for mortality risk assessment following transcatheter aortic valve replacement.

Steinvil A, Buchanan KD, Kiramijyan S, Bond E, Rogers T, Koifman E, Shults C, Xu L, Torguson R, Okubagzi PG, Pichard AD, Satler LF, Ben-Dor I, Waksman R.

Am Heart J2018 Jun;200:11-16. doi: 10.1016/j.ahj.2018.01.007. Epub 2018 Jan 31.

PMID:
29898837
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Advanced chronic kidney disease: Relationship to outcomes post-TAVR, a meta-analysis.

Makki N, Lilly SM.

Clin Cardiol2018 Jun 12. doi: 10.1002/clc.22993. [Epub ahead of print] Review.

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Comparing outcomes after transcatheter aortic valve replacement in patients with stenotic bicuspid and tricuspid aortic valve: A systematic review and meta-analysis.

Kanjanahattakij N, Horn B, Vutthikraivit W, Biso SM, Ziccardi MR, Lu MLR, Rattanawong P.

Clin Cardiol2018 Jun 12. doi: 10.1002/clc.22992. [Epub ahead of print]

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Stroke and Cardiovascular Outcomes in Patients With Carotid Disease Undergoing Transcatheter Aortic Valve Replacement.

Kochar A, Li Z, Harrison JK, Hughes GC, Thourani VH, Mack MJ, Matsouaka RA, Cohen DJ, Peterson ED, Jones WS, Vemulapalli S.

Circ Cardiovasc Interv2018 Jun;11(6):e006322. doi: 10.1161/CIRCINTERVENTIONS.117.006322.

PMID:
29895600
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Percutaneous access versus surgical cut down for TAVR: Where do we go from here?

Ates I, Cilingiroglu M.

Catheter Cardiovasc Interv2018 Jun;91(7):1363-1364. doi: 10.1002/ccd.27653.

PMID:
29894594
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Inadvertent pacemaker lead dislodgement.

Eulert-Grehn JJ, Schmidt G, Kempfert J, Starck C.

Pacing Clin Electrophysiol2018 Jun 12. doi: 10.1111/pace.13412. [Epub ahead of print]

PMID:
29893417
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Successful Coronary Protection during TAVI in Heavily Calcified Aortic Leaflets in Patient with Short and Low Left Coronary System.

Kabach M, Alrifai A, Lovitz L, Rothenberg M, Faber C, Nores M.

Case Rep Cardiol2018 May 14;2018:2758170. doi: 10.1155/2018/2758170. eCollection 2018.

Select item 2988746499.

Role of T2 mapping in left ventricular reverse remodeling after TAVR.

Gastl M, Behm P, Haberkorn S, Holzbach L, Veulemans V, Jacoby C, Schnackenburg B, Zeus T, Kelm M, Bönner F.

Int J Cardiol2018 Sep 1;266:262-268. doi: 10.1016/j.ijcard.2018.02.029.

PMID:
29887464
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Early changes in N-terminal pro-B-type natriuretic peptide levels after transcatheter aortic valve replacement and its impact on long-term mortality.

Liebetrau C, Gaede L, Kim WK, Arsalan M, Blumenstein JM, Fischer-Rasokat U, Wolter JS, Kriechbaum S, Huber MT, van Linden A, Berkowitsch A, Dörr O, Nef H, Hamm CW, Walther T, Möllmann H.

Int J Cardiol2018 Aug 15;265:40-46. doi: 10.1016/j.ijcard.2018.02.037.

PMID:
29885699

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Aortic Stenosis (AS): Managed Surgically by Transcatheter Aortic Valve Replacement (TAVR) – Search Results for “TAVR” on NIH.GOV website, Top 16 pages

Reporter: Aviva Lev-Ari, PhD, RN

 

The concept of transcatheter balloon expandable valves was first introduced in the 1980s by a Danish researcher by the name of H. R. Anderson who began testing this idea on pigs. In 2002, Dr. Alain Cribier performed the first successful percutaneous aortic valve replacement on an inoperable patient. The first approval of TAVR for the indication of severe AS in prohibitive risk patients came in 2011. In 2012, the FDA approved TAVR in patients at high surgical risk. In 2015 the indication was expanded to include “valve-in-valve” procedure for failed surgical bioprosthetic valves. Most recently, in 2016 the FDA approved the SAPIEN valve for use in patients with severe AS at intermediate risk.

SOURCE

https://www.ncbi.nlm.nih.gov/pubmed/28613729

 

Critical care management of patients following …

Transcatheter aortic valve replacement (TAVR) is rapidly gaining popularity as a technique to surgically manage aortic stenosis (AS) in high risk …

Imaging in Transcatheter Aortic Valve Replacement (TAVR …

Transcatheter aortic valve replacement (TAVR) is a novel technique developed in the last decade to treat severe aortic stenosis in patients who are …

TAVR and SAVR: Current Treatment of Aortic Stenosis

Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011, providing a critically needed alternative therapy for …

Transcatheter Aortic Valve Replacement: Design, Clinical …

Transcatheter aortic valve replacement (TAVR) is a new technology that recently has been shown to improve survival and quality of life in patients …

Cost-Effectiveness Analysis of TAVR

Transcather aortic valve replacement (TAVR) has rapidly gained worldwide acceptance for treating very high-risk patients with symptomatic severe …

Clinical Studies Assessing Transcatheter Aortic Valve …

Extreme-Risk or Inoperable Patients for sAVR. Early clinical evaluation of TAVR included patients deemed unsuitable for sAVR. The logistic Euroscore …

Mitral Valve Surgery: Current Minimally Invasive and …

Minimally Invasive Mitral Valve Repair or Replacement. Most MV pathology can be treated with minimally invasive, … As we learned from the TAVR …

Transcatheter (TAVR) versus surgical (AVR) aortic valve …

The risk in the early phase was higher after TAVR than AVR, and in the TAVR arm in patients with a smaller aortic valve area index. In the late risk …

Procedure makes heart valve replacement safer for high-risk patients

4 months ago – Scientists developed a novel technique that prevents a rare but often fatal complication that can arise during a heart valve procedure called …

Sedation or general anesthesia for transcatheter aortic …

Transfemoral transcatheter aortic valve implantation (TAVI) is nowadays a routine therapy for elderly patients with severe aortic stenosis (AS) and …

Transcatheter aortic valve replacement: outcomes of …

Transcatheter aortic valve replacement: outcomes of patients with moderate or severe mitral regurgitation. Toggweiler S(1), … One year after TAVR …

Outcomes in Transcatheter Aortic Valve Replacement for …

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS).

New method for performing aortic valve replacement proves …

Researchers at the National Institutes of Health have developed a new, less invasive way to perform transcatheter aortic valve replacement (TAVR), a …

Acquired Aorto-Right Ventricular Fistula following …

Transcatheter aortic valve replacement (TAVR) techniques are rapidly evolving, and results of published trials suggest that TAVR is emerging as the …

Post Transapical Aortic Valve Replacement (TAVR …

A 63-year-old female presented to the emergency department with complaints of her “heart beating out of my chest,” palpitations, and shortness of …

Surgical or Transcatheter Aortic-Valve Replacement in …

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. … Although transcatheter aortic-valve replacement (TAVR) …

Transcatheter aortic valve replacement versus surgical …

Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Thourani VH(1) …

Transcatheter aortic valve replacement (TAVR): access …

Ramlawi B(1), Anaya-Ayala JE, Reardon MJ. Author information: (1)Methodist DeBakey Heart & Vascular Center, The Methodist Hospital, Houston, Texas …

Simulation of Transcatheter Aortic Valve Replacement in …

Simulation of Transcatheter Aortic Valve Replacement in patient-specific aortic roots: … Transcatheter aortic valve replacement (TAVR), …

Simulation of Transcatheter Aortic Valve Replacement in …

Simulation of Transcatheter Aortic Valve Replacement in patient-specific aortic roots: … Transcatheter aortic valve replacement (TAVR), …

Transcatheter Aortic Valve Replacement Versus Surgery in …

The objective of this study was to compare outcomes in women after surgical aortic valve replacement … transcatheter aortic valve replacement (TAVR) …

Lederman Lab – NHLBI Cardiovascular Intervention Program

ledermanlab.nhlbi.nih.gov/

Transcaval TAVR was developed at the NHLBI Cardiovascular Intervention Program and applied to patient care in collaboration with Dr. Adam Greenbaum at …

Functional status and quality of life after transcatheter …

Kim CA, Rasania SP, Afilalo J, Popma JJ, Lipsitz LA, Kim DH. BACKGROUND: The functional and quality-of-life benefits of transcatheter aortic valve …

One-Year Outcomes of Transcatheter Aortic Valve …

1. Ann Thorac Surg. 2017 May;103(5):1392-1398. doi: 10.1016/j.athoracsur.2016.11.061. Epub 2017 Feb 24. One-Year Outcomes of Transcatheter Aortic …

Local versus general anesthesia for transcatheter aortic …

Now randomized trials are needed for further evaluation of MAC in the setting of TAVR. PMCID: PMC4022332 PMID: 24612945 [PubMed – indexed for MEDLINE]

Predictors and clinical outcomes of permanent pacemaker …

CONCLUSIONS: PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and …

Transcatheter aortic valve replacement program development …

TAVR programs require data management strategies to facilitate and monitor program growth, support program evaluation, and meet the requirements for …

New technique makes heart valve replacement safer for some …

Lederman explained that during TAVR, the surgeon places a catheter inside the heart and uses a balloon to open a new valve inside the aortic valve.

Minimally invasive aortic valve replacement using the …

The term “sutureless aortic valve” (su-AV) describes a type of valve which facilitates anchoring of bioprostheses in the aortic position without use …

Use of extracorporeal membrane oxygenation in complicated …

1. Gen Thorac Cardiovasc Surg. 2017 Feb 24. doi: 10.1007/s11748-017-0757-1. [Epub ahead of print] Use of extracorporeal membrane oxygenation in …

Reoperative aortic valve replacement through upper …

Reoperative aortic valve replacement (AVR) has become increasingly common . … but who may not be considered eligible for TAVR procedure.

MRI evaluation prior to Transcatheter Aortic Valve …

MRI evaluation prior to Transcatheter Aortic Valve Implantation … Transcatheter Aortic Valve Implantation (TAVI) … imaging for TAVR assessment in …

Impact of New-Onset Left Bundle Branch Block and …

New-onset LBBB post-TAVR was associated with a higher risk of PPI (risk ratio [RR], 2.18; 95% confidence interval [CI], 1.28-3.70) and cardiac death …

Migration of the transcatheter valve into the left ventricle

Transcatheter valves can embolize into the aorta if the valve is malpositioned too high or, less commonly, migrate into the left ventricle when the …

Transcarotid Transcatheter Aortic Valve Replacement …

All patients were unsuitable for transfemoral TAVR due to severe peripheral vascular disease. An MIS was undertaken in 29.8% (n = 52) …

The transaortic approach for transcatheter aortic valve …

The transaortic approach for transcatheter aortic valve replacement: initial clinical experience in the United States. Lardizabal JA(1), O’Neill BP …

Transcatheter Aortic Valve Replacement: The New Standard …

Transcatheter Aortic Valve Replacement: The … The aim of this study was to assess how the introduction of transcatheter aortic valve replacement (TA …

Minimally invasive aortic valve surgery: state of the art …

Minimally invasive aortic valve replacement (MIAVR) is defined as an aortic valve replacement (AVR) procedure that involves a small chest wall …

Prognostic impact of pulmonary artery systolic pressure in …

Prognostic impact of pulmonary artery systolic pressure in patients undergoing transcatheter aortic valve … TAVR was associated with a decrease in …

Transcatheter Aortic Valve Replacement is Associated with …

This meta-analysis aims to assess the differential outcomes of TAVR and SAVR in patients enrolled in published randomised controlled trials (RCTs).

Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic …

There were no differences between groups in valve hemodynamic status post-TAVR. CONCLUSIONS: This small trial showed that SAPT (vs. DAPT) …

Upper gastrointestinal bleeding following transcatheter …

Upper gastrointestinal bleeding following transcatheter aortic valve replacement: A retrospective analysis. Stanger DE(1), … (TAVR). BACKGROUND: …

Computed tomography-based sizing recommendations for …

Consecutive patients (n = 120) underwent CT before TAVR with balloon-expandable valves sized by transesophageal echocardiography (TEE) …

European experience and perspectives on transcatheter …

European experience and perspectives on transcatheter aortic valve replacement. Davies WR(1), Thomas MR(2).

[PDF] Mandatory Reporting of Clinical Trial Identifier Numbers …

accrualnet.cancer.gov/sites/accrualnet.cancer.gov/files/Mandatory%20Reporting%20of%20Clinical%20Trial%20Identifier%20FAQs.pdf

Mandatory Reporting of Clinical Trial Identifier Numbers on Claims . Q: Do organizations bill Medicare for all services related to the clinical trial …

Transcatheter Aortic Valve Replacement: Imaging Techniques …

Transcatheter Aortic Valve Replacement: Imaging Techniques for Aortic Root Sizing. Wichmann JL(1), Varga-Szemes A, Suranyi P, Bayer RR 2nd, Litwin SE …

Transcatheter Aortic Valve Thrombosis: Incidence …

METHODS: Among 460 consecutive patients who underwent TAVR with the Edwards Sapien XT or Sapien 3 (Edwards Lifesciences, Irvine, California) THV, …

Sutureless aortic valve replacement – PubMed Central (PMC)

Given its recent developments, the majority of evidence regarding sutureless aortic valve replacement (SU-AVR) is limited to observational studies …

Comparison of balloon-expandable vs self-expandable valves …

Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valvereplacement: … (TAVR) is an effective …

Geometric changes in ventriculoaortic complex after …

Geometric changes in ventriculoaortic complex after transcatheter aortic valve replacement and its association … The post-TAVR AoA area/pre-TAVR AoA …

Acute and 30-Day Outcomes in Women After TAVR: Results …

Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy.

Should We Perform Carotid Doppler Screening Before …

Should We Perform Carotid Doppler Screening Before Surgical or Transcatheter Aortic Valve Replacement? … (TAVR) between January 2007 and August …

Transcatheter Versus Surgical Aortic Valve Replacement in …

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an option in certain high-risk surgical patients with severe aortic valve stenosis.

Risk stratification and clinical pathways to optimize …

Risk stratification and clinical pathways to optimize length of stay after … We evaluated standardized TAVRoutcomes and length of stay according to …

Use of imaging for procedural guidance during …

1. Curr Opin Cardiol. 2013 Sep;28(5):512-7. doi: 10.1097/HCO.0b013e3283632b5e. Use of imaging for procedural guidance during transcatheter aortic …

Serial Changes in Cognitive Function Following …

Serial Changes in Cognitive Function Following Transcatheter Aortic Valve Replacement. Auffret V(1), Campelo-Parada F(1), Regueiro A(1), …

Acute kidney injury after transcatheter aortic valve …

Acute kidney injury after transcatheter aortic valve replacement: a systematic review and meta-analysis. Thongprayoon C(1), Cheungpasitporn W, Srivali …

Aortic valve replacement – PubMed Health

Transcatheter aortic valve replacement (TAVR), sometimes called transcatheter aortic valve implantation (TAVI), was developed as an alternative for …

Costs of periprocedural complications in patients treated …

Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: … Renal failure and the need for repeat TAVR …

Trial design: Rivaroxaban for the prevention of major …

The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. DESIGN: GALILEO …

Expandable sheath for transfemoral transcatheter aortic …

Expandable sheath for transfemoral transcatheter aortic valve replacement: procedural outcomes and complications. Borz B(1), Durand E, Tron C, …

Direct Aortic Access Transcatheter Aortic Valve …

Direct Aortic Access Transcatheter Aortic Valve Replacement: Three-Dimensional Computed Tomography Planning and Real … was selected for DA-TAVR …

The impact of frailty on outcomes after cardiac surgery: a …

1. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3110-7. doi: 10.1016/j.jtcvs.2014.07.087. Epub 2014 Aug 7. The impact of frailty on outcomes after …

Establishment of a transcatheter aortic valve program and …

Establishment of a transcatheter aortic valve program and heart valve team at a Veterans Affairs facility. … (TAVR) program.

Echocardiographic determinants of LV functional …

Echocardiographic determinants of LV functional improvement after transcatheter aortic valve replacement. … Transcatheter aortic valve replacement ( …

CT in transcatheter aortic valve replacement.

CT in transcatheter aortic valve replacement. … the rapidly emerging role of CT in the context of transcatheter aortic valve replacement will be …

Transcatheter Aortic Valve Replacement for the Treatment …

Transcatheter Aortic Valve Replacement for the … This study sought to summarize available evidence on transcatheter aortic valve replacement (TAVR) …

Valvular performance and aortic regurgitation following …

End points were post-TAVR moderate to severe AR and paravalvular AR, effective orifice area (EOA), mean trans-aortic pressure gradient (MPG), …

Annual Outcomes With Transcatheter Valve Therapy: From the …

Annual Outcomes With Transcatheter Valve Therapy: From the STS/ACC TVT Registry. Holmes DR Jr, Nishimura RA, Grover FL, Brindis RG, Carroll JD …

The impact of live case transmission on patient outcomes …

The impact of live case transmission on patient outcomes during transcatheter aortic valve replacement: … Data support the notion that live …

Review of Major Registries and Clinical Trials of Late …

Review of Major Registries and Clinical Trials of Late Outcomes After Transcatheter … Final studies were selected irrespective of the type of TAVR …

Trans-subclavian aortic valve replacement with various …

Trans-subclavian aortic valve replacement with various bioprosthetic valves: Single-center experience. Kasapkara HA(1), Aslan AN(2), Ayhan H(1), …

Vascular complications post-transcatheter aortic valve …

Vascular complications post-transcatheter aortic valve procedures. Mangla A(1), Gupta S(2). Author information: (1)Division of Cardiology, Department …

[Monitoring of haemodynamics and function of the aortic …

[Monitoring of haemodynamics and function of the aortic prosthesis during transcatheter aortic valve replacement]. [Article in Russian]

Midregional Proadrenomedullin Improves Risk Stratification …

Midregional Proadrenomedullin Improves Risk Stratification beyond Surgical Risk Scores in Patients Undergoing Transcatheter Aortic Valve … (TAVR …

Midregional Proadrenomedullin Improves Risk Stratification …

Midregional Proadrenomedullin Improves Risk Stratification beyond Surgical Risk Scores in Patients Undergoing Transcatheter Aortic Valve … (TAVR …

Dual Versus Single Antiplatelet Regimen With or Without …

Dual Versus Single Antiplatelet Regimen With or Without Anticoagulation in Transcatheter Aortic Valve … (TAVR), with dual antiplatelet therapy …

Impact of baseline mitral regurgitation on short- and long …

Impact of baseline mitral regurgitation on short- and long-term outcomes following transcatheter aortic … before the index TAVR procedure was …

TAVRassociated prosthetic valve infective endocarditis …

TAVRassociated prosthetic valve infective endocarditis: results of a large, multicenter registry. Latib A, Naim C, De Bonis M, Sinning JM, …

Mechanisms of Heart Block after Transcatheter Aortic Valve …

Consequently, patients undergoing TAVR are prone to peri-procedural complications including cardiac conduction disturbances, which is the focus of …

JACC. Cardiovascular Imaging – Journals – NCBI

JACC. Cardiovascular Imaging journal page at PubMed Journals. Published by Elsevier

Short-Term Outcomes with Direct Aortic Access for …

Short-Term Outcomes with Direct Aortic Access for Transcatheter Aortic Valve Replacement. Ramlawi B, Abu Saleh WK, Jabbari OA, Barker C, Lin C, … (T …

Impact of patient-prosthesis mismatch after transcatheter …

Impact of patient-prosthesis mismatch after transcatheter aortic valve-in-valve implantation in degenerated bioprostheses. Seiffert M(1), Conradi L …

Extent and distribution of calcification of both the …

AR grade 2 to 4 assessed by the method of Sellers immediately after TAVR device implantation was observed in 55 patients (31%). Multivariate …

Safety, Feasibility, and Hemodynamic Effects of Mild …

Safety, Feasibility, and Hemodynamic Effects of Mild Hypothermia in Transcatheter Aortic Valve Replacement: The TAVR … feasibility, and hemodynamic …

Transcatheter aortic valve implantation: anesthetic …

Transcatheter aortic valve implantation: anesthetic considerations. Billings FT 4th(1), Kodali SK, Shanewise JS. Author information: (1)Departments of …

RFA-HL-19-009: Cardiothoracic Surgical Trials Network …

grants.nih.gov/grants/guide/rfa-files/RFA-HL-19-009.html

Bicuspid aortic valve disease has been excluded from TAVR pivotal trials, but TAVR is increasingly used in this population, despite …

www.ncbi.nlm.nih.gov

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Outcome comparison of African-American and Caucasian …

METHODS: Consecutive patients who underwent TAVR were included in this analysis. Patients’ baseline characteristics, procedural data, …

Incidence and predictors of permanent pacemaker …

Incidence and predictors of permanent pacemaker implantation following treatment with the repositionable Lotus™ transcatheter aortic valve.

Effect of Hospital Volume on Outcomes of Transcatheter …

Effect of Hospital Volume on Outcomes of Transcatheter Aortic Valve Implantation. Badheka AO(1), Patel NJ(2), Panaich SS(3), Patel SV(4), …

Aortic valve sizer for TAVR | NIH 3D Print Exchange

3dprint.nih.gov/discover/3dpx-007958

This sizer is designed to simulate the insertion of heart valve prosthetics into 3d printed patient phantoms. It is loosely based on the size …

Health Topics | National Heart, Lung, and Blood Institute …

Materials for patients and health professionals on health topics related to overweight and obesity, heart, lung, blood, and sleep disorders.

DailyMed – ASPIRIN 81MG ADULT LOW DOSE- aspirin tablet …

dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14d010fb-c4a1-4c3d-942f-58719727bfc0

ASPIRIN 81MG ADULT LOW DOSE- aspirin tablet, delayed release . To receive this label RSS feed. Copy the URL below and paste it into your RSS Reader …

Incidence and predictors of permanent pacemaker …

Incidence and predictors of permanent pacemaker implantation following treatment with the repositionable Lotus™ transcatheter aortic valve.

Aortic valve sizer for TAVR | NIH 3D Print Exchange

3dprint.nih.gov/discover/3dpx-007958

This sizer is designed to simulate the insertion of heart valve prosthetics into 3d printed patient phantoms. It is loosely based on the size …

Transcatheter Aortic Valve Replacement in Severe Aortic …

1. Transcatheter Aortic Valve Replacement in Severe Aortic Stenosis: A Review of Comparative Durability and Clinical Effectiveness Beyond 12 Months …

Sigmoid Septum and Balloon-Expandable Transcatheter Aortic …

de Biasi AR, Worku B, Skubas NJ, Salemi A. Transcatheter aortic valve replacement (TAVR) continues to garner considerable attention, especially as the …

Intra- and Inter-Observer Reproducibility of Transcatheter …

Intra- and Inter-Observer Reproducibility of Transcatheter Aortic Valve Replacement Planning Measurements by Multidetector … of the pre-TAVR …

www.ncbi.nlm.nih.gov

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Transthoracic Echocardiography to Assess Aortic …

Transthoracic Echocardiography to Assess Aortic Regurgitation after TAVRA Comparison with Periprocedural Transesophageal Echocardiography.

Procedural Experience for Transcatheter Aortic Valve …

Procedural Experience for Transcatheter Aortic Valve Replacement and Relation to Outcomes: The STS/ACC TVT Registry. Carroll JD(1), Vemulapalli S(2) …

A comprehensive review of the PARTNER trial.

Svensson LG(1), Tuzcu M, Kapadia S, Blackstone EH, Roselli EE, Gillinov AM, Sabik JF 3rd, Lytle BW. Author information: (1)Department of Thoracic and …

TCT-697 Comparison of Outcomes of Transcatheter Aortic …

TCT-697 Comparison of Outcomes of Transcatheter Aortic Valve Replacement plus Percutaneous Coronary Intervention versus Transcatheter Aortic Valve …

Combined rotational atherectomy and aortic balloon …

Combined rotational atherectomy and aortic balloon valvuloplasty as a bridge to transcatheter aortic valve replacement. Ali O(1), Marmagkiolis K(2) …

Updated standardized endpoint definitions for …

1. Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1. Updated standardized endpoint definitions for …

Clinical outcomes after transcatheter aortic valve …

CONCLUSIONS: VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical …

2012 ACCF/AATS/SCAI/STS expert consensus document on …

2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. Holmes DR Jr, Mack MJ, Kaul S, Agnihotri A, Alexander KP …

Combined rotational atherectomy and aortic balloon …

Combined rotational atherectomy and aortic balloon valvuloplasty as a bridge to transcatheter aortic valve replacement. Ali O(1), Marmagkiolis K(2) …

Clinical outcomes after transcatheter aortic valve …

CONCLUSIONS: VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical …

TAVR MVR – PubMed Result – ncbi.nlm.nih.gov

1: Grover FL, Vemulapalli S, Carroll JD, Edwards FH, Mack MJ, Thourani VH, Brindis RG, Shahian DM, Ruiz CE, Jacobs JP, Hanzel G, Bavaria JE, Tuzcu EM …

Aortic valve calcium scoring is a predictor of …

Aortic valve calcium scoring is a predictor of paravalvular aortic regurgitation after transcatheter aortic valve implantation

Transcatheter Aortic Valve-in-Valve Replacement Instead of …

Díez JG, Schechter M, Dougherty KG, Preventza O, Coselli JS. Transcatheter aortic valve replacement (TAVR) is a well-established method for replacing …

Coronary Calcium Scan | National Heart, Lung, and Blood …

Buildup of calcium, or calcifications, are a sign of atherosclerosis, coronary heart disease, or coronary microvascular disease. A coronary calcium …

An update on transcatheter aortic valve replacement.

An update on transcatheter aortic valve replacement. … Before the development of transcatheter aortic valve replacement (TAVR … and noninferiority …

The Iowa Model of Evidence-Based Practice to Promote …

The Iowa Model of Evidence-Based Practice to Promote Quality Care: an illustrated example in oncology nursing. Brown CG(1). Author information: …

Two-Year Outcomes in Patients With Severe Aortic Valve …

There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality …

Home – PubMed – NCBI

PubMed comprises more than 28 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include …

Integrated 3D Echo-X-Ray navigation to predict optimal …

Integrated 3D Echo-X-Ray navigation to predict optimal angiographic deployment projections for TAVR. Kim MS, Bracken J, Nijhof N, Salcedo EE, Quaife …

Cardiac rehabilitation after transcatheter aortic valve …

Cardiac rehabilitation after transcatheter aortic valve implantation compared to patients after valve replacement. Tarro Genta F(1), Tidu M, Bouslenko …

TAVR | NIH 3D Print Exchange

3dprint.nih.gov/discover/tavr

TAVR. Discover > TAVR. 3DPX-007958 Aortic valve sizer for TAVR ahmedhosny. TAVR, aortic valve, sapienXT, heart valve, sizer, Prosthetic. Discover 3D …

www.ncbi.nlm.nih.gov

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Imaging Pandora’s Box: incidental findings in elderly …

Imaging Pandora’s Box: incidental findings in elderly patients evaluated for transcatheter aortic valve replacement. Orme NM(1), Wright TC(2), Harmon …

fascia iliaca compartment block – PubMed – NCBI

TCT-753 Fascia Iliaca Compartment Block (FICB) and None to Light Sedation as an Alternative Minimalist Approach to Sedation for Patients Undergoing …

Stents | National Heart, Lung, and Blood Institute (NHLBI)

For the Coronary Arteries. Doctors may use stents to treat coronary heart disease (CHD). CHD is a disease in which a waxy substance called plaque …

TAVR | NIH 3D Print Exchange

3dprint.nih.gov/discover/tavr

TAVR. Discover > TAVR. 3DPX-007958 Aortic valve sizer for TAVR ahmedhosny. TAVR, aortic valve, sapienXT, heart valve, sizer, Prosthetic. Discover 3D …

Imaging Pandora’s Box: incidental findings in elderly …

Imaging Pandora’s Box: incidental findings in elderly patients evaluated for transcatheter aortic valve replacement. Orme NM(1), Wright TC(2), Harmon …

Transcatheter Aortic Valve Implantation Within Degenerated …

Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. Webb JG(1), Mack MJ(2) …

[PDF] Transmural” catheter interventions for congenital and …

demystifyingmedicine.od.nih.gov/dm16/m03d22/DM-LedermanRJ.pdf

Transmural” catheter interventions for congenital and structural heart disease … For TAVR, TEVAR, pVAD, etc, when 6-9 mm femoral artery sheaths …

Leaflet Thrombosis in Surgically Explanted or Post-Mortem …

1. JACC Cardiovasc Imaging. 2017 Jan;10(1):82-85. doi: 10.1016/j.jcmg.2016.11.009. Leaflet Thrombosis in Surgically Explanted or Post-Mortem TAVR Valv …

Diagnostic accuracy of multidetector computed tomography …

Diagnostic accuracy of multidetector computed tomography coronary angiography in 325 consecutive patients referred for transcatheter aortic valve …

Transcatheter aortic valve implantation in bicuspid anatomy.

Zhao ZG(1), Jilaihawi H(2), Feng Y(1), Chen M(1). Author information: (1)Department of Cardiology, West China Hospital, Sichuan University, 37 Guoxue …

www.ncbi.nlm.nih.gov

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Platelet activation is less enhanced in the new balloon …

Stroke and thromboembolic events after transfemoral aortic valve replacement (TAVR) continue to be a problem. The aim of our study was to compare …

Discover 3D Models | NIH 3D Print Exchange

3dprint.nih.gov/discover?terms=&field_model_category_tag_tid%5B0%5D=93&field_model_license_nid=All&sort_by=created&sort_order=DESC&items_per_page=24&page=2

Discover 3D Models . Back To Top. Search . Enter terms, … 3DPX-007958 Aortic valve sizer for TAVR. ahmedhosny. 3DPX-007884 Fly Pad. Joyner Cruz …

Beyond PARTNER: appraising the evolving trends and …

Beyond PARTNER: appraising the evolving trends and outcomes in transcatheter aortic valve replacement. … TAVR may become an alternative to surgical …

1-Year Outcomes With the Fully Repositionable and …

1. JACC Cardiovasc Interv. 2016 Feb 22;9(4):376-384. doi: 10.1016/j.jcin.2015.10.024. 1-Year Outcomes With the Fully Repositionable and Retrievable …

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Beyond PARTNER: appraising the evolving trends and …

Beyond PARTNER: appraising the evolving trends and outcomes in transcatheter aortic valve replacement. … TAVR may become an alternative to surgical …

Echocardiographic imaging of procedural complications …

Echocardiographic imaging of procedural complications during self-expandable transcatheter aortic valve replacement. Hahn RT(1), Gillam LD(2), Little …

Digest – The NIH Record – November 18, 2016

nihrecord.nih.gov/newsletters/2016/11_18_2016/digest.htm

For about 85 percent of patients with this condition, doctors typically perform TAVR through the femoral artery in the leg. But for the other 15 …

Electrocardiographic changes and clinical outcomes after …

Gutiérrez M(1), Rodés-Cabau J, Bagur R, Doyle D, DeLarochellière R, Bergeron S, Lemieux J, Villeneuve J, Côté M, Bertrand OF, Poirier P, Clavel MA …

Coronary Artery Bypass Grafting | National Heart, Lung …

Coronary artery bypass grafting (CABG) is a type of surgery that improves blood flow to the heart. Surgeons use CABG to treat people who have severe …

Heart Surgery | National Heart, Lung, and Blood Institute …

Heart surgery is done to correct problems with the heart. Many heart surgeries are done each year in the United States for various heart problems. The …

Aspirin-clopidogrel no better than aspirin alone for …

NIH study also shows that overall stroke risk is down from 10 years ago. Aspirin combined with the antiplatelet drug clopidogrel is no better than asp …

Heart Valve Disease | National Heart, Lung, and Blood …

Heart valve disease occurs if one or more of your heart valves don’t work well. The heart has four valves: the tricuspid, … (TAVR). For this …

The Odyssey of TAVR from concept to clinical reality.

1. Tex Heart Inst J. 2014 Apr 1;41(2):125-30. doi: 10.14503/THIJ-14-4137. eCollection 2014. The Odyssey of TAVR from concept to clinical reality.

Echo Doppler Estimation of Pulmonary Capillary Wedge …

Echo Doppler Estimation of Pulmonary Capillary Wedge Pressure in Patients with … (TAVR) has become a … Noninvasive quantification of pulmonary …

Aspirin-clopidogrel no better than aspirin alone for …

NIH study also shows that overall stroke risk is down from 10 years ago. Aspirin combined with the antiplatelet drug clopidogrel is no better than asp …

Could late enhancement and need for permanent pacemaker …

Could late enhancement and need for permanent pacemaker implantation in patients undergoing TAVR be explained by undiagnosed transthyretin cardiac …

Diabetes mellitus is associated with increased acute …

However, there are conflicting data on the impact of DM on outcomes of transcatheter aortic valve replacement (TAVR). HYPOTHESIS: …

Cardiac Catheterization | National Heart, Lung, and Blood …

Cardiac catheterization (KATH-eh-ter-ih-ZA-shun) is a medical procedure used to diagnose and treat some heart conditions. A long, thin, flexible tube …

The National Institutes of Health (NIH) Consensus …

consensus.nih.gov/1984/1984FrozenPlasma045html.htm

Fresh Frozen Plasma: Indications and Risks. National Institutes of Health Consensus Development Conference Statement September 24-26, 1984

Successful repair of aortic annulus rupture during …

Successful repair of aortic annulus rupture during transcatheter aortic valve replacement using extracorporeal membrane oxygenation support. Negi …

Pathology of balloon-expandable and self-expanding stents …

1. J Heart Valve Dis. 2015 Mar;24(2):139-47. Pathology of balloon-expandable and self-expandingstents following MRI-guided transapical aortic valve …

Fluoroscopy-guided aortic root imaging for TAVR: “follow …

Fluoroscopy-guided aortic root imaging for TAVR: “follow the right cusp” rule. Kasel AM, Cassese S, Leber AW, von Scheidt W, Kastrati A.

Reply: Aortic Stiffness: Complex Evaluation But Major …

Reply: Aortic Stiffness: Complex Evaluation But Major Prognostic Significance Before TAVR. Yotti R, Bermejo J, Gutiérrez-Ibañes E, …

Ventricular Assist Device | National Heart, Lung, and …

ventricular assist device (VAD) is a mechanical pump that supports heart function and blood flow in people who have weakened hearts.

Severe Symptomatic Aortic Stenosis in Older Adults …

Severe Symptomatic Aortic Stenosis in Older Adults: Pathophysiology, Clinical Manifestations, Treatment Guidelines, and Transcatheter Aortic Valve …

Aortic Stiffness: Complex Evaluation But Major Prognostic …

Aortic Stiffness: Complex Evaluation But Major Prognostic Significance Before TAVR. Harbaoui B, Courand PY, Girerd N, Lantelme P.

www.ncbi.nlm.nih.gov

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Home – MeSH – NCBI

MeSH (Medical Subject Headings) is the NLM controlled vocabulary thesaurus used for indexing articles for PubMed.

Cohen M[author] – PubMed – NCBI

TCT-712 “Cusp Overlap” View Facilitates Accurate Fluoro-Guided Implantation of Self-Expanding Valve in TAVR. Zaid S, Raza A, Michev I, Ahmad H, Kaple …

Incidence and risk factors of hemolysis after …

1. Am J Cardiol. 2015 Jun 1;115(11):1574-9. doi: 10.1016/j.amjcard.2015.02.059. Epub 2015 Mar 12. Incidence and risk factors of hemolysis after …

Insurance Coverage and Clinical Trials – National Cancer …

Insurance Coverage and Clinical Trials. Federal law requires most health insurance plans to cover routine patient care costs in clinical … National …

www.ncbi.nlm.nih.gov

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PARTNER trial data showing superior outcomes from TAVI …

openi.nlm.nih.gov/detailedresult.php?img=PMC3431975_cmc-6-2012-125f4&req=4

PARTNER trial data showing superior outcomes from TAVI vs. standard therapy for death at 1 and 2 years for: (A) death from any cause, and (B) death …

Transthoracic echocardiography guidance for TAVR under …

Transthoracic echocardiography guidance for TAVR under monitored anesthesia care. Sengupta PP, Wiley BM, Basnet S, Rajamanickman A, Kovacic JC …

Incidence and risk factors of hemolysis after …

1. Am J Cardiol. 2015 Jun 1;115(11):1574-9. doi: 10.1016/j.amjcard.2015.02.059. Epub 2015 Mar 12. Incidence and risk factors of hemolysis after …

A year in the life of a cardiologist: an interview with Dr …

Dr Manoharan is the clinical lead for the TAVR programme in Northern Ireland and functions as a Clinical Proctor for the Medtronic CoreValve and the …

Insurance Coverage and Clinical Trials – National Cancer …

Insurance Coverage and Clinical Trials. Federal law requires most health insurance plans to cover routine patient care costs in clinical … National …

Transcatheter aortic valve replacement (TAVR) in patients …

Transcatheter aortic valve replacement (TAVR) in patients with systemic autoimmune diseases. Fuentes-Alexandro S(1), Escarcega R, Garcia-Carrasco M …

Transcatheter versus surgical aortic-valve replacement in …

Transcatheter versus surgical aortic-valve replacement in high-risk patients. Smith CR(1), Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, …

Transapical Transcatheter Valve-in-Valve Implantation for …

Transapical Transcatheter Valve-in-Valve Implantation for Failed Mitral Valve Bioprosthesis. … Transcatheter valve-in- valve implantation has been …

Echocardiography – Journals – NCBI

Echocardiography journal page at PubMed Journals. Published by Wiley-Blackwell

Transapical Transcatheter Valve-in-Valve Implantation for …

Transapical Transcatheter Valve-in-Valve Implantation for Failed Mitral Valve Bioprosthesis. … Transcatheter valve-in- valve implantation has been …

Impact of Interaction of Diabetes Mellitus and Impaired …

Impact of Interaction of Diabetes Mellitus and Impaired Renal Function on Prognosis and the Incidence of Acute Kidney Injury in Patients Undergoing …

Frequency of and Prognostic Significance of Atrial …

Frequency of and Prognostic Significance of Atrial Fibrillation in Patients Undergoing Transcatheter Aortic Valve Implantation. Sannino A(1), …

Timing, predictive factors, and prognostic value of …

1. Circulation. 2012 Dec 18;126(25):3041-53. doi: 10.1161/CIRCULATIONAHA.112.110981. Epub 2012 Nov 13. Timing, predictive factors, and prognostic …

www.ncbi.nlm.nih.gov

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AccessGUDID – DEVICE: NA (00643169368873)

accessgudid.nlm.nih.gov/devices/00643169368873

accessgudid – na (00643169368873)- custom pack cb8a42r 2pk tavr pack

Balloon expandable sheath for transfemoral aortic valve …

Balloon expandable sheath for transfemoral aortic valve implantation: a viable option for patients with challenging access. Dimitriadis Z(1), Scholtz …

Staged High-Risk Percutaneous Coronary Intervention with …

The management of concomitant obstructive coronary artery disease and severe aortic stenosis in poor surgical candidates is an evolving topic …

TAVR BMI – PubMed Result

1: Arsalan M, Filardo G, Kim WK, Squiers JJ, Pollock B, Liebetrau C, Blumenstein J, Kempfert J, Van Linden A, Arsalan-Werner A, Hamm C, Mack MJ …

Aortic valve replacement: is porcine or bovine valve better?

Comment in Interact Cardiovasc Thorac Surg. 2013 Mar;16(3):373-4. Interact Cardiovasc Thorac Surg. 2013 Mar;16(3):374. A best evidence topic in …

Can TAVR Make Me Smarter?

Author information: (1)Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada; Morristown Medical Center, Morristown, New Jersey; Cardiovascular …

www.ncbi.nlm.nih.gov

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Transthoracic echocardiography guidance for TAVR under …

Transthoracic echocardiography guidance for TAVR under monitored anesthesia care. Sengupta PP, Wiley BM, Basnet S, Rajamanickman A, Kovacic JC …

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Coronary Artery Interventions: Balloon, Stent, Drug-eluting Stent and Antiplatelet Demand

Curator: Justin D. Pearlman, MD, PhD, FACC

Italicized text represents the voice of Dr. Pearlman

Coronary Artery Disease (CAD), causing impeded blood supply to the heart, constitutes a major cause of disability and death, amounting to triple all forms of cancer combined. The warning symptoms may include a decline in exertion tolerance, usually accompanied by additional symptoms known as “chest pain.” However, “chest pain” is an inaccurate term because it may not be in the chest and it may not include pain (commonly, “chest pain” may occur in the neck, jaw, anterior chest and/or left arm, and may just felt as a light pressure, squeezing, ache, or sense of doom, sometimes with sweating, nausea and/or palpitations, the sensation of abnormal heart beats).

Dr. Heberden is credited with establishing the diagnostic malady called “angina pectoris.” Angina Pectoris corresponds to obstruction in a coronary artery resulting in  exertion-limiting symptoms related to effort (cardiac demand), typically in the chest, neck, jaw and/or arm. The term “angina pectoris” literally means sore throat in the chest. Classic angina is a pressure in the chest that moves to the left arm, reproducible at a particular degree of exertion, such as climbing 1 flight of stairs, that is relieved withing 5 minutes of rest or sublingual nitroglycerin. Other patterns of pain are called “atypical” either because they represent a different expression of the same disease, or because they are not cardiac in etiology. Many studies report that women with CAD are more often “atypical,” which can lead to missed diagnosis.

The first right heart catheterization in a human was performed by Werner Forssmann on himself in 1929. Diagnostic cardiac catheterization was introduced by André Cournand and Dickinson Richards in the early 1940s. Dr. Palin and others identified focal partial blockages in patients with angina by injecting the aorta with iodinated contrast agents followed by x-ray imaging. Selective coronary angiography was described by Mason Sones in the early 1960s, based on an accidental engagement of a catheter into a coronary origin during aortography. 

The facts that coronary angiography generally leads to intervention, and has some risk of damaging an artery and possibly triggering a heart attack, has promoted widespread use of “stress tests” to screen for risk level prior to consummating a decision to perform angiography for elevated coronary risk findings. Coronary revascularization has proven beneficial for classic “ST elevation” heart attacks or the equivalent presenting as a new left bundle block, within the first 6-12 hours of onset, preferably within 1 hour, and also for blockages with poor “flow reserve” involving all tree coronary territories or the left main coronary artery.  Also, revascularization provides a means to relieve angina as an alternative to medications for patients with lesser disease, even though that has not been shown to be reliable in prevention of future heart attacks. Some patients, particularly those with diffuse coronary disease not suitable for stents or bypass, undergo a repeated challenge of compression to the legs and buttocks called “EECP” (enhanced external couterpulsation) to stimulate natural remodeling of the blood supply to the heart, some, after severe damage substantially weakens the heart, take on the cancer and infection risks of a immunosuppression heart transplant, and some receive a mechanical heart or a left ventricular assist pump.

Whereas some “stress tests” check for “rush hour traffic jams” by checking status at baseline and then when speeding up the heart with an exercise challenge, other forms of “stress testing” use chemicals either to speed up the heart rate, to stimulate higher workload conditions, or just to increase blood flow in the coronary arteries (increase traffic by arterial dilation without stress).  Thus, just as “chest pain” does not have to include chest or pain, stress tests do not have to include stress.

Keywords: In-stent restenosis (ISR), stent thrombosis (ST), bare metal stents (BMS), drug-eluting stent (DES), drug-coated balloon (DCB), paclitaxel-eluting balloon (PEB)

The history of cardiac catheterization. – NCBI

Can J Cardiol. 2005 Oct;21(12):1011-4.

The history of cardiac catheterization.

Abstract

The evolution of cardiac catheterization has occurred over at least four centuries. One of the first major steps was the description of the circulation of the blood by William Harvey in 1628. The next milestone was the measurement of arterial pressure by Stephen Hales, one century later. The 19th century represented the golden age of cardiovascular physiology, highlighted by the achievements of Carl Ludwig (physiology of blood pressure), Etienne-Jules Marey (pulse and blood pressure measurement) and Claude Bernard (vasomotor control of blood supply), among others. Human cardiac catheterization developed during the 20th century. The first right heart catheterization in a human was performed by Werner Forssmann on himself in 1929. Diagnostic cardiac catheterization was introduced by André Cournand and Dickinson Richards in the early 1940s, and selective coronary angiography was described by Mason Sones in the early 1960s. More recently, with the advent of catheter-based interventions, pioneered by Andreas Gruentzig in the late 1970s, there has been considerable progress in the refinement and expansion of these techniques. Currently, the Sones technique (direct cannulation of a coronary artery) substantially replaced the previously indirect aortography coronary angiography. Both selective coronary angiography and percutaneous coronary intervention rely mainly on percutaneous femoral and percutaneous radial artery entry routs.

On the occasion of the 50th anniversary of the Montreal Heart Institute, we will highlight the contributions of that institution on selective coronary angiography and percutaneous coronary interventions.

PMID:
16234881

https://www.uptodate.com/contents/intracoronary-stent-restenosis

 

Etiopathogenesis

Restenosis is a progressive phenomenon that begins in the early hours after the barotrauma from PCI (Table 1).

Table 1

Time-related assessment of in-stent restenosis (ISR)
Early (within days)
   Elastic return (recoil) (ER)
   Relocation of axially transmitted plaque
Late (weeks to months)
   Reorganization of thrombus
   Neointima formation
      Cell proliferation
      Cell migration
      Cell matrix synthesis
   Remodelling
   Resolution of inflammation

ISR, in-stent restenosis; ER, elastic recoil.

The three major pathogenic mechanisms that underlie restenosis are:

  1. Early elastic return (recoil) (ER);
  2. Vascular remodeling;
  3. Neointimal hyperplasia.

The first and the second mechanisms are typical of “old-style” or “plain old balloon” angioplasty (POBA) before the stent era. The presence of metallic struts from stents promotes a new mechanism called neointimal hyperplasia.

Myointimal trauma induced by PCI affects the atherosclerotic process and changes its course from the natural evolution of atherosclerotic plaque to a more aggressive local response to the treatment. Atherosclerosis is characterized by a sequence of processes which induce vasoconstriction and the initial endothelial dysfunction resulting in the mechanism of endoplasmic reticulum (ER and vascular remodelling, enhanced by an inflammatory process triggered by vessel injury, as evidenced by the increase in C-reactive protein or MCP-1 in patients at increased risk of restenosis (20).

SOURCES

 

 

The following articles review the benefits of stents to keep coronary arteries propped open after balloon expansion of a focal area of blockage. These articles establish the motivation for drug-eluting stents to address the problem that stents introduced of stimulating a tissue reaction which causes early in-stent re-stenosis (tissue in-growth obstructing the desired blood channel).

Research findings which support the widespread use of drug-eluting stents and uninterrupted use of strong antiplatelet agents

  • TI In-stent restenosis in the drug-eluting stent era.
  • AU Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R
  • SO J Am Coll Cardiol. 2010;56(23):1897.
The introduction of the drug-eluting stent (DES) proved to be an important step forward in reducing rates of restenosis and target lesion revascularization after percutaneous coronary intervention. However, the rapid implementation of DES in standard practice and expansion of the indications for percutaneous coronary intervention to high-risk patients and complex lesions also introduced a new problem: DES in-stent restenosis (ISR), which occurs in 3% to 20% of patients, depending on patient and lesion characteristics and DES type. The clinical presentation of DES ISR is usually recurrent angina, but some patients present with acute coronary syndrome. Mechanisms of DES ISR can be biological, mechanical, and technical, and its pattern is predominantly focal. Intravascular imaging can assist in defining the mechanism and selecting treatment modalities. Based upon the current available evidence, an algorithm for the treatment approaches to DES restenosis is proposed.AD
Cardiovascular Institute, Mount Sinai Medical Center, New York, New York 10029, USA. george.dangas@mssm.eduPMID
This is an early report on advantages of stent placement over the prior “plain old balloon angioplasty” (POBA). 
BACKGROUND: Coronary-stent placement is a new technique in which a balloon-expandable, stainless-steel, slotted tube is implanted at the site of a coronary stenosis. The purpose of this study was to compare the effects of stent placement and standard balloon angioplasty on angiographically detected restenosis and clinical outcomes.
METHODS: We randomly assigned 410 patients with symptomatic coronary disease to elective placement of a Palmaz-Schatz stent or to standard balloon angioplasty. Coronary angiography was performed at base line, immediately after the procedure, and six months later.
RESULTS: The patients who underwent stenting had a higher rate of procedural success than those who underwent standard balloon angioplasty (96.1 percent vs. 89.6 percent, P = 0.011), a larger immediate increase in the diameter of the lumen (1.72 +/- 0.46 vs. 1.23 +/- 0.48 mm, P<0.001), and a larger luminal diameter immediately after the procedure (2.49 +/- 0.43 vs. 1.99 +/- 0.47 mm, Por = 50 percent) of 22 and 32 percent, respectively (P = 0.02). Peripheral vascular complications necessitating surgery, blood transfusion, or both were more frequent after stenting than after balloon angioplasty (13.5 vs. 3.1 percent, P<0.001). The mean hospital stay was significantly longer in the stent group than in the angioplasty group (8.5 vs. 3.1 days, Por =50% follow-up diameter stenosis [DS]) in 419 of 1,437 (29%) patients undergoing routine angiographic follow-up correlated directly with the likelihood of TLR (73% vs. 26% for>70% DS compared with<60% DS). Smaller pretreatment minimum lumen diameter (MLD), smaller final MLD, longer stent length, diabetes mellitus, unstable angina, and hypertension were independent predictors of TLR. Prior MI and current smoking were negative predictors.
CONCLUSIONS: At one year after stenting, most clinical restenosis reflected TLR, which was predicted by the same variables previously associated with an increased risk of angiographic restenosis. The lower absolute rate of clinical restenosis relative to angiographic restenosis was due to infrequent TLR in lesions with less severe (28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization.
CONCLUSION: Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.

The following reports clarified the basis for early stent re-stenosis, first by intravascular miniaturized ultrasound imaging of the problem, then by animal models.

BACKGROUND: Studies have suggested that restenosis within Palmaz-Schatz stents results from neointimal hyperplasia or chronic stent recoil and occurs more frequently at the articulation.
METHODS AND RESULTS: Serial intravascular ultrasound (IVUS) was performed after intervention and at follow-up in 142 stents in 115 lesions. IVUS measurements (external elastic membrane [EEM], stent, and lumen cross-sectional areas [CSAs]and diameters) were performed, and plaque CSA (EEM lumen in reference segments and stent lumen in stented segments), late lumen loss (delta lumen), remodeling (delta EEM in reference segments and delta stent in stented segments), and tissue growth (delta plaque) were calculated. After intervention, the lumen tended to be smallest at the articulation because of tissue prolapse. At follow-up, tissue growth was uniformly distributed throughout the stent; the tendency for greater neointimal tissue accumulation at the central articulation reached statistical significance only when normalized for the smaller postintervention lumen CSA. In stented segments, late lumen area loss correlated strongly with tissue growth but only weakly with remodeling. Stents affected adjacent vessel segments; remodelingprogressively increased and tissue growth progressively decreased at distances from the edge of the stent. These findings were similar in native arteries and saphenous vein grafts and in lesions treated with one or two stents. There was no difference in the postintervention or follow-up lumen (at the junction of the two stents) when overlapped were compared with nonoverlapped stents.
CONCLUSIONS: Late lumen loss and in-stent restenosis were the result of neointimal tissue proliferation, which tended to be uniformly distributed over the length of the stent.

Animal modeling as well as human sample histology showed biochemical basis for stent tissue in-growth which lead to effective choices for drug-eluting stents to release chemicals slowly over a long time to counteract that issue. However, the treatment may be too effective, as it also blocks protective endothelial lining of the stents, so blood products in circulation passing through a stent remain exposed to trauma that can promote thrombosis.

OBJECTIVES: We examined the relative contributions of inflammation and arterial injury to neointimal formation in a porcine coronary overstretch restenosis model.
BACKGROUND: Previous studies established that stents cause neointimal proliferation proportional to injury. Although inflammation has been postulated to be a major contributor to restenosis after angioplasty, there is a paucity of data on the relation between inflammation and subsequent neointimal formation.
METHODS: Twenty-one pigs underwent balloon injury followed by implantation of oversized, tubular, slotted stents (stent/artery ratio 1.2:1) in the left anterior descending coronary artery. Morphometric analysis of the extent of injury (graded as injury score 0 to 3) and inflammation (graded as inflammation score 0 to 3) 1 month later was assessed and correlated with neointimal formation.
RESULTS: An inflammatory reaction was observed in 20 of 21 pigs, and significant positive correlations were found between the degree of arterial injury and the extent of the inflammatory reaction (r = 0.80, p<0.01) and between the extent of inflammatory reaction and the neointimal thickness (r = 0.75, p<0.01), neointimal area (r = 0.53, p = 0.01) and percent area stenosis (r = 0.66, p<0.01) within the stents. Importantly, there were areas with inflammation only in the absence of injury, and vice versa, that were also associated with neointimal hyperplasia.
CONCLUSIONS: These data suggest that the inflammatory reaction plays an equally important role as arterial injury in neointimal formation after coronary stenting, and that anti-inflammatory approaches may be of value to reduce in-stent restenosis.

BACKGROUND: Experimental animal studies have shown that coronary stenting induces neointimal proliferation. However, the histopathological events after coronary stenting in humans have not been studied systematically.
METHODS AND RESULTS: We investigated 11 stented coronary arteries (9 Palmaz-Schatz stents, 1 Wiktor stent, and 1 ACS Multi-Link stent) obtained from 11 patients who had died 2 days to 21 months after stenting. We focused on gross, histological, and immunohistochemical aspects of the repair processes. Two patients developed symptoms of restenosis. Serial sections were stained with antibodies against smooth muscle cells (SMCs), macrophages, and endothelial cells. At 9 and 12 days after stenting, the stent sites showed thrombus formation with early formation of neointima composed of abundant macrophages and alpha-actin-negative spindle cells. From 64 days on, all sites with stenting showed a distinct layer of neointima, albeit to varying degrees. In nonrestenotic lesions, neointimal thickening was markedly less than in restenotic lesions but without qualitative differences; the neointima contained macrophages but was composed predominantly of alpha-actin-positive SMCs.
CONCLUSIONS: These observations strongly support the concept that neointimal proliferation in humans is a process of staged redifferentiation of SMCs, which may cause in-stent stenosis. Moreover, the exuberant neointimal proliferation with accumulation of macrophages and extensive neovascularization at sites of stent restenosis suggests a role for organization of mural thrombus.

BACKGROUND: Despite the increasing use of stents, few reports have described human coronary artery morphology early and late after stenting.

METHODS AND RESULTS: Histology was performed on 55 stents in 35 coronary vessels (32 native arteries and 3 vein grafts) from 32 patients. The mean duration of stent placement was 39+/-82 days. Fibrin, platelets, and neutrophils were associated with stent struts</=11 days after deployment. In stents implanted for20 associated inflammatory cells compared with 44% of struts embedded in a lipid core and 36% of struts in contact with damaged media (P<0.001). Neointimal growth determined late histological success, and increased neointimal growth correlated with increased stent size relative to the proximal reference lumen area. Neointimal thickness was greater for struts associated with medial damage than struts in contact with plaque (P<0.0001) or intact media (P<0.0001). When matched for time since treatment, neointimal cell density in stented arteries was similar to that in unstented arteries that had undergone balloon angioplasty and showed similar proteoglycan deposition.

CONCLUSIONS: Morphology after coronary stenting demonstrates early thrombus formation and acute inflammation followed by neointimal growth. Medial injury and lipid core penetration by struts result in increased inflammation. Neointima increases as the ratio of stent area to reference lumen area increases. Deployment strategies that reduce medial damage and avoid stent oversizing may lower the frequency of in-stent restenosis.

OBJECTIVES: The goal of this study was to evaluate the cellular and extracellular composition of human coronary arterial in-stent restenosis after various periods of time following stent deployment.

BACKGROUND: Neointimal in-growth rather than stent recoil is thought to be important for coronary arterial in-stent restenosis. There is only limited data on the cellular and extracellular composition changes with time after stent deployment.

METHODS: We analyzed 29 coronary arterial in-stent restenotic tissue samples (14 left anterior descending coronary artery, 10 right coronary artery, and 5 left circumflex artery) retrieved by using directional coronary atherectomy from 25 patients at 0.5 to 23 (mean, 5.7) months after deployment of Palmaz-Schatz stents employing histochemical and immunocytochemical techniques.

RESULTS: Cell proliferation was low (0% to 4%). Myxoid tissue containing extracellular matrix (ECM) enriched with proteoglycans was found in 69% of cases and decreased over time after stenting. Cell-depleted areas were found in 57% of cases and increased with time after stenting. Versican, biglycan, perlecan, and hyaluronan were present with varying individual distributions in all samples. Positive transforming growth factor-beta1 staining was found in 80% of cases. Immunostaining with alpha-smooth muscle actin identified the majority of cells as smooth muscle cells with occasional macrophages present (<or =12 cells per section).

CONCLUSIONS: These data suggest that enhanced ECM accumulation rather than cell proliferation contribute to later stages of in-stent restenosis. Balloon angioplasty of in-stent restenosis may, therefore, fail due to ECM changes during: 1) additional stent expansion, 2) tissue extrusion out of the stent, or 3) tissue compression.

BACKGROUND: Coronary-artery stents are known to reduce rates of restenosis after coronary angioplasty, but it is uncertain how long this benefit is maintained.

METHODS: We evaluated clinical and angiographic follow-up information for up to three years after the implantation of Palmaz-Schatz metallic coronary-artery stents in 143 patients with 147 lesions of native coronary arteries.

RESULTS: The rate of survival free of myocardial infarction, bypass surgery, and repeated coronary angioplasty for stented lesions was 74.6 percent at three years. After 14 months, revascularization of the stented lesion was necessary in only three patients (2.1 percent). In contrast, coronary angioplasty for a new lesion was required in 11 patients (7.7 percent). Follow-up coronary angiography of 137 lesions at six months, 114 lesions at one year, and 72 lesions at three years revealed a decrease in minimal luminal diameter from 2.54 +/- 0.44 mm immediately after stent implantation to 1.87 +/- 0.56 mm at six months, but no further decrease in diameter at one year (in patients with paired angiograms, 1.95 +/- 0.49 mm at both six months and one year). Significant late improvement in luminal diameter was observed at three years (in patients with paired angiograms, 1.94 +/- 0.48 mm at six months and 2.09 +/- 0.48 mm at three years; P<0.001).

CONCLUSIONS: Clinical and angiographic outcomes up to three years after coronary-artery stenting were favorable, with a low rate of revascularization of the stented lesions. Late improvement in luminal diameter appears to occur between six months and three years.

BACKGROUND: Recently, it has been reported that the luminal diameter shows phasic changes after stenting: the progression of luminal narrowing followed by its regression. To elucidate the mechanisms involved in the phasic changes in luminal diameter after stenting, we examined the changes in neointimal thickness and the appearance of neointima by a series of angiographic and angioscopic observations for 3 years after stent implantation.

METHODS AND RESULTS: In 12 patients who received a Wiktor coronary stent, serial angiographic and angioscopic examinations were performed immediately, 2 to 4 weeks, 3 months, 6 months, and 3 years after the stenting without repetition of angioplasty. Neointimal thickness was determined by angiography as the difference between stent and luminal diameters. The angioscopic appearance of neointima over the stent was classified as transparent or nontransparent according to the visibility of the majority of the stent. Neointimal thickness increased significantly at 3 months (0.75+/-0.32 mm) without further changes at 6 months (0.74+/-0.32 mm). Thereafter, however, it decreased significantly over 3 years (0.51+/-0.26 mm). The angioscopic appearance was classified as transparent in 8 patients (100) immediately after stenting, 6 patients (100%) at 2 to 4 weeks, 2 patients (17%) at 3 months, 2 patients (20%) at 6 months, and 7 patients (58%) at 3 years.

CONCLUSIONS: The neointima became thick and nontransparent until 6 months and then became thin and transparent by 3 years. We conclude that neointimal remodeling exists after stenting and plays a major role in the alteration of coronary luminal diameter after stenting.

Although previous randomized trials 1-2 have demonstrated lower restenosis rates in selected lesions with coronary stents than with conventional balloon angioplasty. in-stent restenosis remains an important clinical problem.(3,4) Previous serial angiographic studies(5,6) showed that lumen loss after stenting occurred within 6 months. On the other hand, improvements in lumen dimensions between 6 months and 2 to 3 years have been demonstrated by angiography.(6-9) Serial (postintervention and at 6-month follow-up) intravascular ultrasound (IVUS) studies(10,11) have demonstrated that coronary stenting eliminates negative arterial remodeling, and thus intimal hyperplasia is solely responsible for in-stent restenosis. However, little has been reported about changes in intimal hyperplasia that occur beyond this 6-month period. This serial IVUS study evaluated the changes in intimal hyperplasia between 6 and 12 months after stent placement.

BACKGROUND: The angiographic presentation of in-stent restenosis (ISR) may convey prognostic information on subsequent target vessel revascularizations (TLR).

METHODS AND RESULTS: We developed an angiographic classification of ISR according to the geographic distribution of intimal hyperplasia in reference to the implanted stent. Pattern I includes focal (10 mm within the stent, pattern III includes ISR>10 mm extending outside the stent, and pattern IV is totally occluded ISR. We classified a total of 288 ISR lesions in 245 patients and verified the angiographic accuracy of the classification by intravascular ultrasound. Pattern I was found in 42% of patients, pattern II in 21%, pattern III in 30%, and pattern IV in 7%. Previously recurrent ISR was more frequent with increasing grades of classification (9%, 20%, 34%, and 50% for classes I to IV, respectively; P=0.0001), as was diabetes (28%, 32%, 39%, and 48% in classes I to IV, respectively; P<0.01). Angioplasty and stenting were used predominantly in classes I and II, whereas classes III and IV were treated with atheroablation. Final diameter stenosis ranged between 21% and 28% (P=NS among ISR patterns). TLR increased with increasing ISR class; it was 19%, 35%, 50%, and 83% in classes I to IV, respectively (Por =50%, late lumen loss as lumen diameter reduction and target lesion revascularization (TLR) as any repeat PTCA or coronary artery bypass surgery involving the stented lesion.

RESULTS: Multivariate analysis demonstrated that diabetes mellitus, placement of multiple stents and minimal lumen diameter (MLD) immediately after stenting were the strongest predictors of restenosis. Diabetes increased the risk of binary restenosis with an odds ratio (OR) [95% confidence interval]of 1.86 [1.56 to 2.16]and the risk of TLR with an OR of 1.45 [1.11 to 1.80]. Multiple stents increased the risk of binary restenosis with an OR of 1.81 [1.55 to 2.06]and that of TLR with an OR of 1.94 [1.66 to 2.22]. An MLDor = 50% diameter stenosis at follow-up angiography, diffuse restenosis as a follow-up lesion length>or = 10 mm and aggressive restenosis as either an increase in lesion length from the original lesion or a restenotic narrowing tighter than the original. Clinical, anatomic and procedural characteristics were evaluated for lesions associated with these types of restenosis.

RESULTS: Diffuse restenosis was associated with a smaller reference artery diameter, longer lesionlength, female gender, longer stent length and the use of coil stents. Aggressive restenosis was more common in women, with the use of Wallstents and with long stent to lesion length ratios. Aggressive restenosis occurred earlier and was more closely associated with symptoms and myocardial infarctions than nonaggressive restenotic lesions.

CONCLUSIONS: Markers for diffuse restenosis were also important markers for the presence of any restenosis. A long stent to lesion length ratio is an important marker for aggressive restenosis. When severe forms of in-stent restenosis occur, they tend to present earlier and with more symptoms, including myocardial infarction. More careful consideration of the type of in-stent restenosis may aid in identifying when alternative strategies may be useful.

OBJECTIVES: We sought to assess whether coronary stents have modified the predictive value of demographic, clinical and quantitative coronary angiographic (QCA) predictors of coronary restenosis.

BACKGROUND: A systematic analysis in a large cohort of registries and randomized trials of the percutaneous transluminal coronary angioplasty (PTCA) and stent era has never been performed.

METHODS: A total of 9,120 treated lesions in 8,156 patients included in nine randomized trials and 10 registries, with baseline, post-procedural and six-month follow-up QCA analyses, were included in this study. Predictors of restenosis were identified with univariate and multivariate logistic regression analyses. Interaction terms were introduced in the regression equation to evaluate whether the predictors of restenosis were common to both eras or specific for either one of the revascularization techniques.

RESULTS: The restenosis rate was 35% after PTCA and 19% after angioplasty with additional stenting. In the univariate analysis, favorable predictors were previous coronary artery bypass graft surgery (CABG), stent use, stent length and a large pre-procedural minimal lumen diameter (pre-MLD); unfavorable predictors were weight, body mass index, diabetes mellitus, multi-vessel disease, lesion length and a high residual post-procedural diameter stenosis (post-DS). Predictors specific for the PTCA population were a large post-procedural MLD (post-MLD) as favorable and a severe pre-procedural DS (pre-DS) as unfavorable. Favorable predictors specific for the stent population were a large post-MLD and a large pre-procedural reference diameter (pre-RD). In the multivariate analysis, the best model included the following favorable predictors: stent use, a large post-MLD, previous CABG and the interaction term between stent use and a large post-MLD; unfavorable predictors were lesion length and diabetes mellitus.

CONCLUSIONS: There are no major differences in demographic and clinical predictors of coronary restenosis between PTCA and stent populations. In the modern (stent) era, a severe pre-DS is no longer an unfavorable predictor of restenosis. Still important, but more so in the stent population, is a large post-MLD (optimal result). Finally, a larger pre-RD became a favorable predictor with the advent of stenting.

OBJECTIVES: We sought to evaluate the relation between stented segment length and restenosis.

BACKGROUND: Multiple or long coronary stents are now being implanted in long lesions or in tandem lesions. A longer stented segment might result in a higher probability of restenosis. However, there is little information available on the relation between stented segment length and restenosis.

METHODS: Between April 1995 and December 1996, 725 patients with 1,090 lesions underwent stenting. Lesions were divided into three groups according to the length of the stented segment: 1) group I (n = 565): stented segment length20 but35 mm.

RESULTS: There was no significant difference in the incidence of subacute stent thrombosis among the three groups (0.4% in group I, 0.4% in group II, 1.2% in group III; p = NS). The minimal lumen diameter (MLD) after stenting was greater in group I than in group III (3.04 +/- 0.60 mm in group I, 3.01 +/- 0.54 mm in group II, 2.91 +/- 0.58 mm in group III; p<0.05). At follow up, a smaller MLD was observed in group III as compared with group I and group II (2.04 +/- 0.93 mm in group I, 1.92 +/- 1.00 mm in group II, 1.47 +/- 0.97 mm in group III; p<0.01). The restenosis rates were 23.9% in group I, 34.6% in group II and 47.2% in group III (p36 mm, and (7) bifurcation stenting. The present study population was composed of 238 patients (441 lesions) for whom 6-month angiographic follow-up data were obtained (70% of eligible patients). Significant clinical, angiographic, and procedural predictors of post-SES restenosis were evaluated. Binary in-segment restenosis was diagnosed in 7.9% of lesions (6.3% in-stent, 0.9% at the proximal edge, 0.7% at the distal edge). The following characteristics were identified as independent multivariate predictors: treatment of in-stent restenosis (OR 4.16, 95% CI 1.63 to11.01; P<0.01), ostial location (OR 4.84, 95% CI 1.81 to 12.07; P<0.01), diabetes (OR 2.63, 95% CI 1.14 to 6.31; P=0.02), total stented length (per 10-mm increase; OR 1.42, 95% CI 1.21 to 1.68; P<0.01), reference diameter (per 1.0-mm increase; OR 0.46, 95% CI 0.24 to 0.87; P=0.03), and left anterior descending artery (OR 0.30, 95% CI 0.10 to 0.69; P<0.01).

CONCLUSIONS: Angiographic restenosis after SES implantation in complex patients is an infrequent event, occurring mainly in association with lesion-based characteristics and diabetes mellitus.

BACKGROUND: The aim of this study was to evaluate the relationship between residual plaque burden after coronary stent implantation and the development of late in-stent neointimal proliferation.

METHODS AND RESULTS: Between January 1996 and May 1997, 50 patients underwent intravascular ultrasound (IVUS) interrogation at 6+/-1.2 months after coronary stent implantation in native coronary arteries. IVUS images were acquired with a motorized pullback, and cross-sectional measurements were performed within the stents at 1-mm intervals. The following measurements were obtained: (1) lumen area (LA), (2) stent area (SA), (3) area delimited by the external elastic membrane (EEMA), (4) percent neointimal area calculated as (SA-LA/SA)x100, and (5) percent residual plaque area calculated as (EEMA-SA)/EEMAx100. Volume measurements within the stented segments were calculated by applying Simpson’s rule. In the pooled data analysis of 876 cross sections, linear regression showed a significant positive correlation between percent residual plaque area and percent neointimal area (r=0.50, y= 45.03+0.29x, P<0.01). There was significant incremental increase in mean percent neointimal area for stepwise increase in percent residual plaque area. Mean percent neointimalarea was 16.3+/-10.3% for lesions with a percent residual plaque area of/=50% (P<0.001). The volumetric analysis showed that the percent residual plaque volume was significantly greater in restenotic lesions compared with nonrestenotic lesions (58.7+/-4.3% versus 51.4+/-5.7%, respectively; Por = 50% diameter stenosis at follow-up, follow-up percent diameter stenosis [DS]and follow-up minimal lumen diameter [MLD]) were determined.

RESULTS: Three variables were the most consistent predictors of the follow-up angiographic findings: ostial lesion location, IVUS preinterventional lesion site plaque burden (plaque/total arterial area) and IVUS assessment of final lumen dimensions (whether final lumen area or final MLD). All three variables predicted both the primary (binary restenosis) and secondary (follow-up MLD and follow-up DS) end points. In addition, a number of variables predicted one or more but not all the end points: 1) restenosis (IVUS preinterventional lumen and arterial area); 2) follow-up DS (QCA lesion length); and 3) follow-up MLD (QCA lesion length and preinterventional MLD and DS and IVUS preinterventional lumen and arterial area).

CONCLUSIONS: Ostial lesion location and IVUS preinterventional plaque burden and postinterventional lumen dimensions were the most consistent predictors of angiographic in-stent restenosis.

OBJECTIVES: We aimed to identify periprocedural quantitative coronary angiographic (QCA) variables that have predictive value on long-term angiographic results and to construct multivariate models using these variables for postprocedural prognosis.

BACKGROUND: Coronary stent implantation has reduced the restenosis rate significantly as compared with balloon angioplasty in short de novo lesions in coronary arteries>3 mm in size. Although the postprocedural minimal luminal diameter (MLD) is known to have significant bearing on long-term angiographic results, no practically useful model exists for prediction of angiographic outcome based on the periprocedural QCA variables.

METHODS: The QCA data from patients who underwent Palmaz-Schatz stent implantation for short (3 mm and completed six months of angiographic follow-up in the four prospective clinical trials (BENESTENT I, BENESTENT II pilot, BENESTENT II and MUSIC) were pooled. Multiple models were constructed using multivariate analysis. The Hosmer-Lemeshow goodness-of-fit test was used to identify the model of best fit, and this model was used to construct a reference chart for prediction of angiographic outcome on the basis of periprocedural QCA variables.

RESULTS: Univariate analysis performed using QCA variables revealed that vessel size, MLD before and after the procedure, reference area before and after the procedure, minimal luminal cross-sectional area before and after the procedure, diameter stenosis after the procedure, area of plaque after the procedure and area stenosis after the procedure were significant predictors of angiographic outcome. Using multivariate analysis, the Hosmer-Lemeshow goodness-of-fit test showed that the model containing percent diameter stenosis after the procedure and vessel size best fit the data. A reference chart was then developed to calculate the expected restenosis rate.

CONCLUSIONS: Restenosis rate after stent implantation for short lesions can be predicted using the variables percent diameter stenosis after the procedure and vessel size. This meta-analysis indicates that the concept of “the bigger the better” holds true for coronary stent implantation. Applicability of the model beyond short lesions should be tested.

BACKGROUND: Restenosis prediction from published studies is hampered by inadequate sample size and incomplete angiographic follow-up. The prediction of restenosis with the existing variables is poor. The aim of the present study was to include the clinical and angiographic variables commonly associated with angiographic restenosis and develop a prediction model for restenosis from the PRESTO database.

METHODS AND RESULTS: This study included 1312 patients with a single lesion enrolled in the angiographic substudy of the PRESTO trial. We constructed 2 risk scores. The first used preprocedural variables (female gender, vessel size [4 mm], lesion length>20 mm, diabetes, smoking status, type C lesion, any previous percutaneous coronary intervention [PCI], and unstable angina) derived from previous studies. Estimated restenosis rates and corresponding variability for each possible level of the resultant risk score were obtained via bootstrapping techniques. The area under the receiver-operator characteristic (ROC) curve was 0.63, indicating modest discriminatory abilityto predict restenosis. The second approach constructed a multiple logistic regression model considering significant univariate clinical and angiographic predictors of restenosis identified from the PRESTO database (treated diabetes mellitus, nonsmoker, vessel size, lesion length, American College of Cardiology/American Heart Association type C lesion, ostial location, and previous PCI). The area under the ROC curve for this risk score was also 0.63.

CONCLUSIONS: The preprocedural clinical and angiographic variables from available studies and from the PRESTO trial have only modest predictive ability for restenosis after PCI.

  • AD Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic and Mayo Foundation, Rochester, Minn 55905, USA.
  • PMID 15173022
  • TI Effects of stent length and lesion length on coronary restenosis.
  • AU Mauri L, O’Malley AJ, Cutlip DE, Ho KK, Popma JJ, Chauhan MS, Baim DS, Cohen DJ, Kuntz RE
  • SO Am J Cardiol. 2004;93(11):1340.

The choice of drug-eluting versus bare metal stents is based on costs and expectations of restenosis and thrombosis risk. Approaches to stent placement vary from covering just the zone of maximal obstruction to stenting well beyond the lesion boundaries (normal-to-normal vessel). The independent effects of stented lesion length, nonstented lesion length, and excess stent length, on coronary restenosis have not been evaluated for bare metal or drug-eluting stents. We analyzed the angiographic follow-up cohort (1,181 patients) from 6 recent bare metal stent trials of de novo lesions in native coronary arteries. Stent length exceeded lesion length in 87% of lesions (mean lesion length 12.4 +/- 6.3 mm, mean stent length 20.0 +/- 7.9 mm, mean difference 7.6 +/- 7.9 mm). At 6- to 9-month follow-up, the mean percent diameter stenosis was 39.1 +/- 20.1%. In an adjusted multivariable model of percent diameter stenosis, each 10 mm of stented lesion length was associated with an absolute increase in percent diameter stenosis of 7.7% (p<0.0001), whereas each 10 mm of excess stent length independently increased percent diameter stenosis by 4.0% (p<0.0001) and increased target lesion revascularization at 9 months (odds ratio 1.12, 95% confidence interval 1.02 to 1.24). Significant nonstented lesion length was uncommon (12.5% of cases). In summary, stent length exceeded lesion length in most stented lesions, and the amount of excess stent length increased the risk of restenosis independent of the stented lesion length. This analysis supports a conservative approach of matching stent length to lesion length to reduce the risk of restenosis with bare metal stents.

BACKGROUND: Observed rates of restenosis after drug-eluting stenting are low (or =32% relative increase in power,>or =24% absolute increase for late loss between 0.2 and 0.6 mm).

CONCLUSIONS: Late loss is monotonically related to restenosis risk in published stent trials. It is a generalizable and powerful angiographic end point in early or small trials of new drug-eluting stents.

BACKGROUND: Binary angiographic and clinical restenosis rates can vary widely between clinical studies, even for the same stent, influenced heavily by case-mix covariates that differ among observational and randomized trials intended to assess a given stent system. We hypothesized that mean in-stent late loss might be a more stable estimator of restenosis propensity across such studies.

METHODS AND RESULTS: In 46 trials of drug-eluting and bare-metal stenting, increasing mean late loss was associated with higher target lesion revascularization (TLR) rates (P<0.001). When the class of bare-metal stents was compared with the class of effective drug-eluting stents, late loss was more discriminating than TLR as measured by the high intraclass correlation coefficient (rho) (late loss, rho=0.71 versus TLR, rho=0.22; 95% CI of difference=0.33, 0.65). When the individual drug-eluting stents and bare-metal stents were compared, late loss was a better discriminator than TLR (0.68 versus 0.19; 95% CI of difference=0.24, 0.60). Greater adjustments of study covariates are needed to stabilize assessments of TLR compared with late loss because of greater influence of reference vessel diameter on TLR than on in-stent late loss. Optimization of late loss with the use of a novel method ofstandardization according to diabetes prevalence and mean lesion length resulted in minor adjustments in late loss (<0.08 mm for 90% of reported trials) and an ordered array of mean late loss values for the stent systems studied.

CONCLUSIONS: Late loss is more reliable than restenosis rates for discriminating restenosis propensity between new drug-eluting stent platforms across studies and might be the optimum end point for evaluating drug-eluting stents in early, nonrandomized studies.

BACKGROUND: Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization.

METHODS: We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days.

RESULTS: The rate of failure of the target vessel was reduced from 21.0 percent with a standard stentto 8.6 percent with a sirolimus-eluting stent (P<0.001)–a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion (16.6 percent in the standard-stent group vs. 4.1 percent in the sirolimus-stent group, P<0.001). The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined.

CONCLUSIONS: In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed.

  • AD Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute of New York, New York 10021, USA. jmoses@lenoxhill.net
  • PMID 14523139
  • TI A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.
  • AU Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME, TAXUS-IV Investigators
  • SO N Engl J Med. 2004;350(3):221.

BACKGROUND: Restenosis after coronary stenting necessitates repeated percutaneous or surgical revascularization procedures. The delivery of paclitaxel to the site of vascular injury may reduce the incidence of neointimal hyperplasia and restenosis.

METHODS: At 73 U.S. centers, we enrolled 1314 patients who were receiving a stent in a single, previously untreated coronary-artery stenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10 to 28 mm) in a prospective, randomized, double-blind study. A total of 652 patients were randomly assigned to receive a bare-metal stent, and 662 to receive an identical-appearing, slow-release, polymer-based, paclitaxel-eluting stent. Angiographic follow-up was prespecified at nine months in 732 patients.

RESULTS: In terms of base-line characteristics, the two groups were well matched. Diabetes mellitus was present in 24.2 percent of patients; the mean reference-vessel diameter was 2.75 mm, and the mean lesion length was 13.4 mm. A mean of 1.08 stents (length, 21.8 mm) were implantedper patient. The rate of ischemia-driven target-vessel revascularization at nine months was reduced from 12.0 percent with the implantation of a bare-metal stent to 4.7 percent with the implantation of a paclitaxel-eluting stent (relative risk, 0.39; 95 percent confidence interval, 0.26 to 0.59; P<0.001). Target-lesion revascularization was required in 3.0 percent of the group that received a paclitaxel-eluting stent, as compared with 11.3 percent of the group that received a bare-metal stent (relative risk, 0.27; 95 percent confidence interval, 0.16 to 0.43; P<0.001). The rate of angiographic restenosis was reduced from 26.6 percent to 7.9 percent with the paclitaxel-eluting stent (relative risk, 0.30; 95 percent confidence interval, 0.19 to 0.46; P<0.001). The nine-month composite rates of death from cardiac causes or myocardial infarction (4.7 percent and 4.3 percent, respectively) and stent thrombosis (0.6 percent and 0.8 percent, respectively) were similar in the group that received a paclitaxel-eluting stent and the group that received a bare-metal stent.

CONCLUSIONS: As compared with bare-metal stents, the slow-release, polymer-based, paclitaxel-eluting stent is safe and markedly reduces the rates of clinical and angiographic restenosis at nine months.

BACKGROUND: Recent studies have suggested that smokers may require less frequent repeated revascularization after percutaneous coronary intervention (PCI) compared with nonsmokers. However, the mechanism of this phenomenon is unknown.

METHODS AND RESULTS: We examined the association between smoking and restenosis using pooled data from 8671 patients treated with PCI in 9 multicenter clinical trials. Clinical restenosis was examined in the cohort of 5682 patients who were assigned to clinical follow-up only. Angiographic restenosis was evaluated in the subset of 2989 patients who were assigned to mandatory angiographic restudy. Among those patients assigned to clinical follow-up only, target lesion revascularization (TLR) occurred in 6.6% of smokers and 10.1% of nonsmokers (P<0.001). After adjustment for baseline clinical and angiographic differences, the rate of TLR remained significantly lower in smokers with an adjusted relative risk of 0.69 (95% CI, 0.54 to 0.88). Among the angiographic cohort, there were no differences in the rates of angiographic restenosis or follow-up diameter stenosis in either univariate or multivariate analyses. This dissociation between clinical and angiographic restenosis was explained in part by reduced sensitivity to restenosis on the part of smokers and by the greater reluctance of smokers to seek medical attention despite recurrent angina.

CONCLUSIONS: In patients undergoing contemporary PCI, cigarette smoking is associated with a lower rate of subsequent TLR without affecting angiographic restenosis. These findings have important implications for the follow-up of smokers after PCI and suggest that cross-study comparisons of rates of clinical restenosis must account for the potential confounding effect of smoking.

  • AU Violaris AG, Thury A, Regar E, Melkert R, Serruys PW
  • SO Heart. 2000;84(3):299.

OBJECTIVES: To assess the influence of smoking on restenosis after coronary angioplasty.

DESIGN AND PATIENTS: The incidence of smoking on restenosis was investigated in 2948 patients. They were prospectively enrolled in four major restenosis trials in which quantitative angiography was used before and immediately after successful angioplasty and again at six months.

RESULTS: Within the study population there were 530 current smokers, 1690 ex-smokers, and 728 non-smokers. Smokers were more likely to be men (85.9% v 87. 5% v 65.3%, current v ex- v non-, p<0.001), to be younger (54.0 (9. 0) v 57.0 (9.1) v 59.9 (9.4) years, p<0.001), to have peripheral vascular disease (7.2% v 5.5% v 2.3%, p<0.001), and have sustained a previous myocardial infarction (42.9% v 43.9% v 37.9%, p = 0.022), but were less likely to be diabetic (9.1% v 9.5% v 12.6%, p = 0.043) or hypertensive (24.9% v 29.3% v 37.2, p50% diameter stenosis) at six months (35.28% v 35.33% v 37.09%, current v ex- v non-), or the absolute loss (0.29 (0.54) v 0.33 (0.52) v 0. 35(0.55) mm, respectively; p = 0.172).

CONCLUSIONS: Although smokers have a lower incidence of known predisposing risk factors for atherosclerosis, they require coronary intervention almost six years earlier than non-smokers and three years earlier than ex-smokers. Once they undergo successful coronary angioplasty, there appears to be no evidence that smoking influences their short term (six month) outcome, but because of the known long term effects of smoking, patients should still be encouraged to discontinue the habit.

  • AU Pache J, Kastrati A, Mehilli J, Schühlen H, Dotzer F, Hausleiter J, Fleckenstein M, Neumann FJ, Sattelberger U, Schmitt C, Müller M, Dirschinger J, Schömig A
  • SO J Am Coll Cardiol. 2003;41(8):1283.

OBJECTIVES: We tested the hypothesis that thinner-strut stents are associated with a reduced rate of restenosis when comparing two stents with different design.

BACKGROUND: We have previously shown that, for two stents with similar design, the risk for restenosis is dependent on the strut thickness. It is unknown whether strut thickness preserves its relevance as a determinant of restenosis even in the presence of different stent designs.

METHODS: A total of 611 patients with symptomatic coronary artery disease were randomly assigned to receive either the thin-strut ACS RX Multilink stent (Guidant, Advanced Cardiovascular Systems, Santa Clara, California) (strut thickness 50 microm, interconnected ring design; n = 309) or the thick-strut BX Velocity stent (Cordis Corp., Miami, Florida) (strut thickness 140 microm, closed cell design; n = 302). The primary end point was angiographic restenosis (>or =50% diameter stenosis at follow-up angiography). Secondary end points were the incidence of target-vessel revascularization (TVR) and the combined rate of death and myocardial infarction (MI) at one year.

RESULTS: The incidence of angiographic restenosis was 17.9% in the thin-strut group and 31.4% in the thick-strut group, relative risk, 0.57 (95% confidence interval, 0.39 to 0.84), p<0.001. A TVR due to restenosis was required in 12.3% of the thin-strut group and 21.9% of the thick-strut group, relative risk, 0.56 (95% confidence interval, 0.38 to 0.84), p = 0.002. No significant difference was observed in the combined incidence of death and MI at one year.

CONCLUSIONS: When two stents with different design are compared, the stent with thinner struts elicits less angiographic and clinical restenosis than the thicker-strut stent.

  • AU Yoshitomi Y, Kojima S, Yano M, Sugi T, Matsumoto Y, Saotome M, Tanaka K, Endo M, Kuramochi M
  • SO Am Heart J. 2001;142(3):445.

BACKGROUND: Experimental studies have revealed that stent configuration influences intimal hyperplasia. The purpose of this study was to evaluate clinical outcomes for 2 stent designs in a randomized trial with quantitative coronary angiography (QCA) and intravascular ultrasonography (IVUS).

METHODS: We randomly assigned 100 patients with 107 lesions and symptomatic coronary artery disease to deployment of a Multilink stent (Advanced Cardiovascular Systems, Guidant, Santa Clara, Calif) or a GFX stent (Applied Vascular Engineering, Santa Rosa, Calif) with IVUS guidance. QCA and IVUS studies were performed before and after intervention and at follow-up (4.2 +/- 1.0 months).

RESULTS: There were no significant differences in baseline characteristics and QCA and IVUS parameters before and after intervention between the 2 groups. However, minimal lumen diameter at follow-up was significantly larger in the Multilink group (2.46 +/- 0.59 vs 2.08 +/- 0.79 mm, P<.05). Maximal in-stent intimal hyperplasia was significantly larger in the GFX group (2.9 +/- 1.7 vs 1.8 +/- 1.2 mm(2), P<.01). The restenosis rate differed between the 2 groups (Multilink 4% vs GFX 26%, P =.003). In multiple stepwise logistic regression analysis, the only predictor that significantly correlated with restenosis was stent type (P<.01). The odds ratio for the GFX stent-treated vessels was 18.65 (95% confidence interval 2.10-165.45).

CONCLUSIONS: With deployment of the GFX stent, a thicker neointima develops within the stent. Stent configuration may affect clinical outcomes.

  • AU Castagna MT, Mintz GS, Leiboff BO, Ahmed JM, Mehran R, Satler LF, Kent KM, Pichard AD, Weissman NJ
  • SO Am Heart J. 2001;142(6):970.

OBJECTIVES: Serial intravascular ultrasonographic (IVUS) studies have shown that in-stent restenosis is the result of intimal hyperplasia (IH). However, routine preintervention IVUS imaging has suggested that many restenotic stents were inadequately deployed. The purpose of this IVUS study was to determine the incidence of mechanical problems contributing to in-stent restenosis (ISR).

METHODS: Between April 1994 and June 2000, 1090 patients with ISR were treated at the Washington Hospital Center. All underwent preintervention IVUS imaging. IVUS measurements included proximal and distal reference lumen areas and diameters; stent, minimum lumen, and IH (stent minus lumen) areas; and IH burden (IH/stent area).

RESULTS: In 49 ISR lesions (4.5%), there were morphologic findings that contributed to the restenosis. These were termed mechanical complications. Examples include (1) missing the lesion (eg, an aorto-ostial stenosis), (2) stent “crush,” and (3) havingthe stent stripped off the balloon during the implantation procedure. Excluding mechanical complications, stent underexpansion was common. In 20% of the ISR cases the stents had a cross-sectional area (CSA) at the site of the lesion<80% of the average reference lumen area. Twenty percent of lesions had a minimum stent area<5.0 mm(2) and an additional 18% had a minimum stent area of 5.0 to 6.0 mm(2). Twenty-four percent of lesions had an IH burden<60%.

CONCLUSION: Mechanical problems related to stent deployment procedures contribute to a significant minority of ISR lesions (approximately 25%).

  • AU Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U, Topol EJ, Bulle TM
  • SO Circulation. 1990;82(4):1193.

To assess the likelihood of procedural success in patients with multivessel coronary disease undergoing percutaneous coronary angioplasty, 350 consecutive patients (1,100 stenoses) from four clinical sites were evaluated. Eighteen variables characterizing the severity and morphology of each stenosis and 18 patient-related variables were assessed at a core angiographic laboratory and at the clinical sites. Most patients had Canadian Cardiovascular Society class III or IV angina (72%) and two-vessel coronary disease (78%). Left ventricular function was generally well preserved (mean ejection fraction, 58 +/- 12%; range, 18-85%) and 1.9 +/- 1.0 stenoses per patient had attempted percutaneous coronary angioplasty. Procedural success (less than or equal to 50% final diameter stenosis in one or more stenoses and no major ischemic complications) was achieved in 290 patients (82.8%), and an additional nine patients (2.6%) had a reduction in diameter stenosis by 20% or more with a final diameter stenosis 51-60% and were without major complications. Major ischemic complications (death, myocardial infarction, or emergency bypass surgery) occurred in 30 patients (8.6%). In-hospital mortality was 1.1%. Stepwise regression analysis determined that a modified American College of Cardiology/American Heart Association Task Force (ACC/AHA) classification of the primary target stenosis (with type B prospectively divided into type B1 [one type B characteristic]and type B2 [greater than or equal to two type B characteristics]) and the presence of diabetes mellitus were the only variables independently predictive of procedural outcome (target stenosis modified ACC/AHA score; p less than 0.001 for both success and complications; diabetes mellitus: p = 0.003 for success and p = 0.016 for complications). Analysis of success and complications on a per stenosis dilated basis showed, for type A stenoses, a 92% success and a 2% complication rate; for type B1 stenoses, an 84% success and a 4% complication rate; for type B2 stenoses, a 76% success and a 10% complication rate; and for type C stenoses, a 61% success and a 21% complication rate. The subdivision into types B1 and B2 provided significantly more information in this clinically important intermediate risk group than did the standard ACC/AHA scheme. The stenosis characteristics of chronic total occlusion, high grade (80-99% diameter) stenosis, stenosis bend of more than 60 degrees, and excessive tortuosity were particularly predictive of adverse procedural outcome. This improved scheme may improve clinical decision making and provide a framework on which to base meaningful subgroup analysis in randomized trials assessing the efficacy of percutaneous coronary angioplasty.

  • AU Kastrati A, Schömig A, Elezi S, Dirschinger J, Mehilli J, Schühlen H, Blasini R, Neumann FJ
  • SO Circulation. 1999;100(12):1285.

Background-The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology criteria are predictive of early outcome after various coronary catheter interventions. Their potential prognostic value after stent implantation and, in particular, for restenosis and long-term clinical outcome has not been studied. We assessed the prognostic value of the modified ACC/AHA criteria for the long-term angiographic and clinical outcome of patients after coronary stenting. Methods and Results-This study includes 2944 consecutive patients with symptomatic coronary artery disease treated with coronary stent placement. Modified ACC/AHA lesion morphology criteria were used to qualitatively assess the angiograms; type A and B1 lesions were categorized as simple, and type B2 and C lesions were designated complex. Primary end points were angiographic restenosis and 1-year event-free survival. Restenosis rate was 33.2% in complex lesions and 24.9% in simple lesions (P<0.001). It was 21. 7% for type A, 26.3% for type B1, 33.7% for type B2, and 32.6% for type C lesions. One-year event-free survival was 75.6% for patients with complex lesions and 81.1% for patients with simplelesions (P50% by QCA. IVUS predictors were minimum and mean in-stent area, stent length, and in-stent diameter. Multiple models were constructed with multivariate logistic regression analysis. The model containing minimum in-stent area and stent length best fit the Hosmer-Lemeshow goodness-of-fit test. This model was used to construct a reference chart to calculate the expected 6-month restenosis rate.

CONCLUSIONS: The expected 6-month in-stent restenosis rate after stent implantation for short lesions in relatively large vessels can be predicted by use of in-stent minimal area (which is inversely related to restenosis) and stent length (which is directly related to restenosis), both of which can be read from a simple reference chart.

  • AU Kastrati A, Schömig A, Elezi S, Schühlen H, Wilhelm M, Dirschinger J
  • SO Circulation. 1998;97(24):2396.

BACKGROUND: Little is known about the behavior with regard to restenosis of multiple lesions within the same patient treated with intracoronary stenting. Our objective was to test the hypothesis that there is an intrapatient dependence of restenosis between lesions.

METHODS AND RESULTS: Quantitative analysis was carried out on angiograms obtained before, immediately after, and at 6 months after coronary stent placement in 1734 lesions in 1244 patients. We used a specialized logistic regression that not only accounts for intraclass correlation but also quantifies it in the form of odds ratio (OR) as the change in risk of a lesion to develop restenosis if another companion lesion had restenosis. The model was based on 23 patient- and lesion-related variables with binary restenosis (diameter stenosis>or =50%) as end point. The overall restenosis rate was 27.5%: 24.4% for single-lesion, 28.6% for double-lesion, and 33.8% for>or =3-lesion interventions. After adjustment for the influence of significant factors (hypercholesterolemia, systemic arterial hypertension, diabetes mellitus, previous PTCA, ostial lesion, location in left anterior descending coronary artery, number of stents placed, vessel size, stenosis severity, balloon-to-vessel ratio, and final result), the analysis found a significant intrapatient correlation, OR 2.5 (1.8 to 3.6). This means that in patients with multilesion interventions, the risk of a lesion to develop restenosis is 2.5 times higher if a companion lesion has restenosis, independently of the presence or absence of analyzed patient risk factors (eg, diabetes).

CONCLUSIONS: This study demonstrates that there is a dependence of restenosis between coronary lesions in patients who undergo a multilesion intervention. The likelihood of restenosis for a lesion is higher when another companion lesion has also developed restenosis. Other, as yet unidentified patient factors may be the source of this intrapatient correlation of restenosis.

  • AU Best PJ, Lennon R, Ting HH, Bell MR, Rihal CS, Holmes DR, Berger PB
  • SO J Am Coll Cardiol. 2002;39(7):1113.

OBJECTIVES: We sought to determine the effect of varying degrees of renal insufficiency on death and cardiac events during and after a percutaneous coronary intervention (PCI).

BACKGROUND: Patients with end-stage renal disease have a high mortality from coronary artery disease. Little is known about the impact of mild and moderate renal insufficiency on clinical outcomes after PCI.

METHODS: Cardiac mortality and all-cause mortality were determined for 5,327 patients undergoing PCI from January 1, 1994, to August 31, 1999, at the Mayo Clinic, based on the estimated creatinine clearance or whether the patient was on dialysis.

RESULTS: In-hospital mortality was significantly associated with renal insufficiency (p = 0.001). Even after successful PCI, one-year mortality was 1.5% when the creatinine clearance was>or =70 ml/min (n = 2,558), 3.6% when it was 50 to 69 ml/min (n = 1,458), 7.8% when it was 30 to 49ml/min (n = 828) and 18.3% when it was<30 ml/min (n = 141). The 18.3% mortality rate for the group with<30 ml/min creatinine clearance was similar to the 19.9% mortality rate in patients on dialysis (n = 46). The mortality risk was largely independent of all other factors.

CONCLUSIONS: Renal insufficiency is a strong predictor of death and subsequent cardiac events in a dose-dependent fashion during and after PCI. Patients with renal insufficiency have more baseline cardiovascular risk factors, but renal insufficiency is associated with an increased risk of death and other adverse cardiovascular events, independent of all other measured variables.

Recent studies have shown that patients with mild chronic renal insufficiency (CRI) have a high prevalence of cardiovascular disease and cardiac death. Furthermore, patients with CRI undergoing percutaneous coronary intervention have a higher rate of in-hospital and long-term morbidity and mortality. A recent retrospective subgroup analysis of  patients with CRI undergoing percutaneous intervention suggests that the use of stents may improve their in-hospital and long-term outcomes.

OBJECTIVE: To investigate 4-year outcomes and predictors of repeat revascularization in patients treated with Resolute™zotarolimus-eluting stent (R-ZES) and XIENCE V™everolimus-eluting stent (EES) in the RESOLUTE All Comers trial.

BACKGROUND: Data on long-term outcomes of new generation drug-eluting stents are limited, and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown.

METHODS: Patients were randomly assigned to treatment with R-ZES (n=1,140) or EES (n=1,152). We assessed pre-specified safety and efficacy outcomes at 4 years including target-lesion failure (TLF) and stent thrombosis (ST). Predictors of revascularization at 4 years were identified by Cox regression analysis.

RESULTS: At 4 years, rates of TLF (15.2% vs. 14.6%, p=0.68), cardiac death (5.4% vs. 4.7%, p=0.44), target-vessel myocardial infarction (MI) (5.3% vs. 5.4%, p=1.00), clinically-indicated target-lesion revascularization (TLR) (7.0% vs. 6.5%, p=0.62), and definite/probable ST (2.3% vs. 1.6%, p=0.23) were similar with R-ZES and EES. Independent predictors of TLR were: age, insulin-treated diabetes, SYNTAX score, treatment of saphenous vein grafts, ostial lesions, and instent restenosis. Independent predictors of any revascularization were: age, diabetes, previous PCI, ST-elevation MI, smaller reference vessel diameter, SYNTAX score, and treatment of left anterior descending, right coronary artery, saphenous vein grafts, ostial lesions, or instent restenosis.

CONCLUSIONS: R-ZES and EES demonstrated similar safety and efficacy throughout 4 years. TLR represented less than half of all repeat revascularization procedures. Patient and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap.

CLINICAL TRIAL INFO: RESOLUTE All Comers; NCT00617084.

BACKGROUND: Restenosis after percutaneous coronary intervention (PCI) has been thought to present in a stable manner as exertional angina. However, the presentation of in-stent restenosis (ISR) is not well-studied. We hypothesized that a substantial proportion of bare metal ISR presents as acute coronary syndromes. We aimed to characterize the severity of the clinical presentation of ISR.

METHODS: We searched our PCI database for all cases of PCI for bare metal ISR occurring between May 1999 and September 2003. Multivessel interventions were excluded. In-stent restenosis presentation was classified into three categories: (1) myocardial infarction (MI), (2) unstable angina requiring hospitalization before angiography, and (3) exertional angina. Routine angiographic screening after initial stent placement was not performed, so ISR episodes were clinical, rather than angiographic, ISR.

RESULTS: We identified 1186 cases of bare metal ISR in 984 patients. Median age was 63, 72% were male, and 36% had diabetes. Of the ISR episodes, 9.5% presented as acute MI (7.3% as non-ST-segment elevation MI and 2.2% as ST-segment elevation MI), 26.4% as unstable angina requiring hospitalization before angiography, and 64.1% as exertional angina.

CONCLUSIONS: More than one third of bare metal ISR episodes presented as MI or unstable angina requiring hospitalization. The acuity of the clinical presentation of bare metal ISR appears to be more severe than has been previously thought. Aggressive efforts, such as drug-eluting stents to decrease the incidence of unstable angina due to bare metal ISR, are warranted.

 

OBJECTIVES: We sought to evaluate the long-term clinical outcome of patients undergoing successful balloon angioplasty for in-stent restenosis, and to determine correlates of the need for subsequent target lesion revascularization (TLR).

BACKGROUND: In-stent restenosis can be safely treated by repeat percutaneous intervention. Reported subsequent TLR rates have varied from 20% to 80% and seem related to the type of restenotic lesion.

METHODS: The study population comprised 234 patients with follow-up data who were successfully treated with repeat balloon angioplasty for in-stent restenosis in 257 lesions between May 1995 and January 1998 at our institution.

RESULTS: Clinical follow-up was available at 459 (286 to 693) days after the repeat procedure. Event-free survival was 78.5% and 74.6% at 12 and 24 months, respectively. Recurrent events occurred in 58patients (24.8%), including 6 deaths (2.6%), 4 myocardial infarction (1.7%) and repeat target vessel revascularization in 50 patients (21.4%). Independent predictors of repeat TLR were time to in-stent restenosis<90 days (Hazard ratio 4.67, p<0.001), minimal luminal diameter after repeat procedure (Hazard ratio 0.38, p = 0.034) and the angiographic pattern of in-stent restenosis (Hazard ratio 1.65, p = 0.036).

CONCLUSIONS: Balloon angioplasty is an effective means of treating in-stent restenosis. The long-term results are acceptable particularly for focal restenotic lesions. Further restenosis is more common in patients with early initial recurrence, more proliferative lesions and a poorer angiographic result from repeat angioplasty.

 

Coronary stents have been the major advancement in percutaneous coronary intervention in the last decade and are used in 60% to 80% of patients. However, in-stent restenosis continues to be a problem, occurring in 20% to 30% of cases. The clinical presentation of patients who develop restenosis after stenting has not been well characterized. In this study we compared the clinical presentation of in-stent restenosis with that of restenosis without stenting. Of 739 patients who underwent percutaneous coronary intervention and had repeat catheterization between October 1, 1997, and June 30, 2000, 262 consecutive patients with recurrent ischemia and restenosis were identified: 191 patients with (group A) and 71 without (Group B) stenting. Patients who underwent interventions in bypass grafts and those who developed early acute stent thrombosis were excluded from the study. Recurrent clinical ischemia occurred at a mean of 5.5 months in group A and 6.5 months in group B (p = 0.24). Rest angina (Braunwald class II and III) was more frequent in group A (48% vs 32%, p = 0.032). Acute coronary syndromes, the combination of rest angina, and acute myocardial infarction were also more frequent in group A (68% vs 46%, p = 0.03). Patients in group A were more likely to have angiographically visible thrombus than those in group B (9% vs 0%, p = 0.02). Thus, acute coronary syndromes are a common clinical presentation of restenosis among patients whose follow-up angiogram is obtained for clinical reasons, and occur more frequently in patients with in-stent restenosis than in those with restenosis without stenting.

 

OBJECTIVES: The purpose of this study was to examine the outcomes of patients who developed coronary in-stent restenosis (ISR) or stent thrombosis (STH) inside drug-eluting stents (DES).

BACKGROUND: Drug-eluting stents have markedly reduced the incidence of restenosis. However, when restenosis occurs within a DES, its optimal management remains unclear.

METHODS: We retrospectively analyzed clinical and angiographic data from 92 patients who underwent revascularization for ISR (n = 84) or STH (n = 8) within a DES at our institution. Regular follow-ups were available up to 2 years. We recorded the occurrence of major adverse cardiac events (MACE), defined as deaths from all causes, myocardial infarction (MI), or target lesion revascularization (TLR), among patients treated by the “DES sandwich” technique or by other treatment methods.

RESULTS: In-hospital MACE included 1 periprocedural MI and 2 deaths. Over a mean follow-up of 15 +/- 6 months, the overall rates of death, MI, and TLR were 8.7%, 2.2%, and 30.6%, respectively. By actuarial analysis, the 12-month TLR and MACE rates were 28.2% and 42.9%, respectively.

CONCLUSIONS: Current treatments of ISR or STH in DES are associated with a high long-term rate of MACE.

 

BACKGROUND: Limited information is available regarding restenosis after implantation of a sirolimus-eluting stent (SES).

OBJECTIVE: To report on angiographic characteristics, clinical presentation and treatment of this particularly complex type of coronary lesion.

METHODS AND RESULTS: A total of 1424 SES were implanted in 1159 patients (average 1.2 per patient) for chronic or acute coronary syndromes in the University Hospital of Siena (Siena, Italy), which is a tertiary centre. Symptomatic in-SES restenosis was observed in 26 patients (2.2%) at 10+/-5 months (median eight months, range four to 23 months) following the initial intervention. In-SES restenosis was associated with stable angina in 16 patients, acute myocardial infarction in three patients and unstable angina in seven patients. Two patients had restenosis in two separate SES. Conditions often associated with in-SES restenosis included treatment of chronic total occlusion, geographic miss or in-stent restenosis during the index procedure. Among the first 20 patients, those with focal, in-body SES (type Ic) restenosisreceived balloon-only angioplasty, and patients with other patterns received repeat SES implantation. Clinical and angiographic follow-up (average 16+/-7 months) recorded one death (noncardiac) in the balloon-only group and four cases of unstable angina (three due to relapsing in-SES restenosis in the balloon-only group and the fourth due to a de novo lesion). Follow-up quantitative angiography showed a higher incidence of binary restenosis after balloon-only treatment (57% versus 17%; P<0.05), as well as higher lumen loss and loss index (Por =10 mm) inside the stent (71%) or focal (29%). Mean stent length was 16+/-7 mm. Balloon diameter of2.98+/-0.37 mm and maximal inflation pressure of 10+/-3 atm were used for balloon angioplasty. Angiographic success rate was 100% without any complication. Acute gain was lower after balloon angioplasty for in-stent restenosis than after stent implantation: 1.19+/-0.60 mm vs. 1.75+/-0.68 mm (p=0.0002). At 6-month follow-up, 60% of patients were asymptomatic and no patient died. Eighteen patients (35%) had repeat target vessel revascularization. Angiographic restenosis rate was 54%. Recurrent restenosis rate was higher when in-stent restenosis was diffuse: 63% vs. 31% when focal, p=0.046.

CONCLUSIONS: Although balloon angioplasty for in-stent restenosis can be safely and successfully performed, it leads to less immediate stenosis improvement than at time of stent implantation and carries a high recurrent angiographic restenosis rate at 6 months, in particular in diffuse in-stent restenosis lesions.

 

BACKGROUND: In-stent restenosis is an increasing clinical problem. Discordant results have been published regarding the risk of recurrent restenosis after repeat angioplasty for the treatment of in-stent restenosis.

METHODS AND RESULTS: One hundred three consecutive patients (107 vessels) underwent repeat percutaneous intervention for the treatment of in-stent restenosis and were entered in a prospective angiographic follow-up program. Repeat balloon angioplasty was performed at 93 lesions (87%) and additional stenting at 14 lesions (13%). The primary success rate was 98%. Six-month angiographic follow-up was performed in 85% of eligible patients. Restenosis was determined by quantitative angiography. Restenosis defined as a>50% diameter stenosis at follow-up was observed at 22% of lesions. The rate of target-lesion revascularization at 6 months was 17%. Repeat intervention for diffuse in-stent restenosis and severe stenosis before repeat intervention were associated with significantly higher rates of recurrent restenosis.

CONCLUSIONS: The overall restenosis rate after repeat intervention for in-stent restenosis is low. Thesubgroup of patients with diffuse and/or severe in-stent restenosis, however, is at higher risk of recurrent restenosis and may benefit from alternative therapeutic strategies.

 

OBJECTIVES: This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR).

BACKGROUND: Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high.

METHODS: We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events.

RESULTS: Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, por =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting.

CONCLUSIONS: In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.

 

OBJECTIVES: We sought to analyze the very late outcomes of patients treated for in-stent restenosis (ISR) according to treatment allocation and 10 prespecified variables.

BACKGROUND: Long-term results (>2 years) of patients with ISR undergoing repeat coronary interventions are not well established.

METHODS: The Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study compared these two strategies in 450 patients with ISR. A detailed systematic protocol was used for late clinical follow-up.

RESULTS: At one-year follow-up (100% of patients), the event-free survival was similar in the two groups (77% stent implantation [ST]arm, 71% balloon angioplasty [BA]arm, log-rank p = 0.19). Additional long-term clinical follow-up (median 4.3 years, range 3 to5 years) was obtained in 98.6% of patients. During this time 22 additional patients died (9 ST arm, 13 BA arm), 7 suffered a myocardial infarction (3 ST arm, 4 BA arm), 23 required coronary surgery (11 ST arm, 12 BA arm), and 9 underwent repeat coronary interventions (4 ST arm, 5 BA arm) (nonexclusive events). At four years the event-free survival was 69% in the ST arm and 64% in the BA arm (log-rank p = 0.21). Among the 10 prespecified variables, vessel size>or = 3 mm had a major influence on the clinical outcome at four years, with better results in the ST group (hazard ratio 0.51, 95% confidence interval 0.3 to 0.89, p = 0.016).

CONCLUSIONS: Patients with ISR undergoing repeat interventions have a significant event rate at late follow-up. Continued medical surveillance should be continued after one year. Patients with large vessels have a better outcome after repeat stenting.

 

BACKGROUND: Although both percutaneous transluminal coronary angioplasty (PTCA) and additional stenting can be used for the treatment for focal in-stent restenosis (ISR), no large-scale comparative data on the clinical outcomes after these interventional procedures have been reported.

METHODS: In the current study we compared the in-hospital and long-term clinical results of PTCA alone (n = 266 patients, n = 364 lesions) versus stenting (n = 135 patients, n = 161 lesions) for the treatment of focal ISR, defined as a lesion length less than or equal to 10 mm.

RESULTS: There were significantly more diabetic patients in the PTCA group than in the stent group (36% vs 26%, P =.04), but other baseline characteristics were similar. Lesion length and preprocedure minimal lumen diameter (MLD) were also similar in the two groups, but the stent group had a larger reference vessel diameter (3.40 +/- 0.73 mm vs 2.99 +/- 0.68 mm, P<.001). Stenting achieved a larger postprocedure MLD than PTCA did (2.95 +/- 0.95 mm vs 2.23 +/- 0.60 mm, P5 times normal was more frequent with stent (18.5% vs 9.7%, P =.05). At 1 year the two interventional strategies had similar cumulative mortality (4.6% PTCA vs 5.1% stent, P not significant) and target lesion revascularization rate (24.6% PTCA vs 26.5% stent, P not significant). By multivariate analysis, the sole predictor of target lesion revascularization was diabetes (odds ratio 2.4, 95% confidence intervals 1.2-4.7, P =.01).

CONCLUSION: Repeat stenting for the treatment of focal ISR had a higher postprocedure creatine kinase myocardial band elevation rate and similar long-term clinical results compared with PTCA alone.

 

BACKGROUND: We have previously reported the safety and effectiveness of sirolimus-eluting stents for the treatment of de novo coronary lesions. The present investigation explored the potential of this technology to treat in-stent restenosis.

METHODS AND RESULTS: Twenty-five patients with in-stent restenosis were successfully treated with the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo, Brazil. Nine patients received 2 stents (1.4 stents per lesion). Angiographic and volumetric intravascular ultrasound (IVUS) images were obtained after the procedure and at 4 and 12 months. All vessels were patent at the time of 12-month angiography. Angiographic late loss averaged 0.07+/-0.2 mm in-stent and -0.05+/-0.3 mm in-lesion at 4 months, and 0.36+/-0.46 mm in-stent and 0.16+/-0.42 mm in-lesion after 12 months. No patient had in-stent or stent margin restenosis at 4 months, and only one patient developed in-stent restenosis at 1-year follow-up. Intimal hyperplasia by 3-dimensional IVUS was 0.92+/-1.9 mm(3) at 4 months and 2.55+/-4.9 mm(3) after 1 year. Percent volume obstruction was 0.81+/-1.7% and 1.76+/-3.4% at the 4- and 12-month follow-up, respectively. There was no evidence of stent malapposition either acutely or in the follow-up IVUS images, and there were no deaths, stent thromboses, or repeat revascularizations.

CONCLUSION: This study demonstrates the safety and the potential utility of sirolimus-eluting Bx VELOCITY stents for the treatment of in-stent restenosis.

 

OBJECTIVES: In this study, we assess the value of sirolimus eluting stent (SES) implantation in patients with complex in-stent restenosis (ISR).

BACKGROUND: The treatment of ISR remains a therapeutic challenge, since many pharmacological and mechanical approaches have shown disappointing results. The SESs have been reported to be effective in de-novo coronary lesions.

METHODS: Sixteen patients with severe, recurrent ISR in a native coronary artery (average lesion length 18.4 mm) and objective evidence of ischemia were included. They received one or more 18 mm Bx VELOCITY SESs (Cordis Waterloo, Belgium). Quantitative angiographic and three-dimensional intravascular ultrasound (IVUS) follow-up was performed at four months, and clinical follow-up at nine months.

RESULTS: The SES implantation (n = 26) was successful in all 16 patients. Four patients had recurrent restenosis following brachytherapy, and three patients had totally occluded vessels preprocedure. At four months follow-up, one patient had died and three patients had angiographic evidence of restenosis (one in-stent and two in-lesion). In-stent late lumen loss averaged 0.21 mm and the volume obstruction of the stent by IVUS was 1.1%. At nine months clinical follow-up, three patients had experienced four major adverse cardiac events (two deaths and one acute myocardial infarction necessitating repeat target vessel angioplasty).

CONCLUSIONS: The SES implantation in patients with severe ISR lesions effectively prevents neointima formation and recurrent restenosis at four months angiographic follow-up.

 

BACKGROUND: The first clinical study of paclitaxel-eluting stent for de novo lesions showed promising results. We performed the TAXUS III trial to evaluate the feasibility and safety of paclitaxel-eluting stent for the treatment of in-stent restenosis (ISR).

METHODS AND RESULTS: The TAXUS III trial was a single-arm, 2-center study that enrolled 28 patients with ISR meeting the criteria of lesion lengthor =50%) at 6-month follow-up angiography based on “in-segment” analysis. Primary analysis was comparison between stent groups and balloon angioplasty groups; a secondary analysis compared sirolimus and paclitaxel stents.

RESULTS: Follow-up angiography was performed in 275 (92%) of 300 patients. The incidence of angiographic restenosis was 44.6% (41/92) in the balloon angioplasty group, 14.3% (13/91) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 21.7% (20/92) in the paclitaxel stent group (P = .001 vs balloon angioplasty). When compared with balloon angioplasty, receiving a sirolimus stent had a relative risk (RR) of angiographic restenosis of 0.32 (95% confidence interval [CI], 0.18-0.56); a paclitaxel stent had an RR of 0.49 (95% CI, 0.31-0.76). The incidence of target vessel revascularization was 33.0% (33/100) in the balloon angioplasty group, 8.0% (8/100) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 19.0% (19/100) in the paclitaxel stent group (P = .02 vs balloon angioplasty). The secondary analysis showed a trend toward a lower rate of angiographic restenosis (P = .19) and a significantly lower rate of target vessel revascularization (P = .02) among sirolimus stent patients compared with paclitaxel stent patients.

CONCLUSIONS: In patients with in-stent restenosis, a strategy based on sirolimus- or paclitaxel-eluting stents is superior to conventional balloon angioplasty for the prevention of recurrent restenosis. Sirolimus-eluting stents may be superior to paclitaxel-eluting stents for treatment of this disorder.

 

OBJECTIVES: We sought to assess the effectiveness of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR).

BACKGROUND: Treatment of patients with ISR remains a challenge.

METHODS: The Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) study is a multicenter randomized trial conducted in 150 patients with ISR (76 allocated to SES and 74 to balloon angioplasty [BA]). The primary end point was recurrent restenosis rate at nine months. Secondary end points included prespecified subgroup analysis, lumen volume on intravascular ultrasound (IVUS), and a composite of major clinical events at one year.

RESULTS: Angiographic success was obtained in all patients. At 9-month angiographic follow-up (96% of eligible patients) minimal lumen diameter was larger (2.52 mm [interquartile range (IQR) 2.09 to 2.81]vs. 1.54 mm [IQR 0.91 to 2.05]; p<0.001) and recurrent restenosis rate was lower (11% vs. 39%; p<0.001) in the SES group. Prespecified subgroup analyses were consistent with the main outcome measure. Lumen volume on IVUS at 9 months was also larger (279 mm3 [IQR 227 to 300]vs. 197 mm3 [IQR 177 to 230]; p<0.001) in the SES group. At one-year clinical follow-up (100% of patients), the event-free survival (freedom from death, myocardial infarction, and target vessel revascularization) was significantly improved in the SES group (88% vs. 69%; p<0.004) as the result of a lower requirement for target vessel revascularization (11% vs. 30%; p<0.003).

CONCLUSIONS: In patients with ISR, the use of SES provides superior long-term clinical, angiographic, and IVUS outcome than BA treatment.

 

Few data are available on the effectiveness of sirolimus-eluting stent implantation for the treatment of in-stent restenosis, and no data exist about the predictors of outcome after sirolimus-eluting stent implantation for complex in-stent restenosis (diffuse, proliferative, or total occlusion). From April 2002 to May 2004, 136 patients with 161 complex in-stent restenoses underwent sirolimus-eluting stent implantation. At 9 months, 5 patients had died (3 of cardiac and 2 of noncardiac causes), no reinfarctions had occurred, and 11 target vessel revascularization procedures had been performed. The target vessel revascularization rate was 8%, and the in-segment binary restenosis rate was 17%. The predictors of the risk of recurrence were unstable angina as the clinical presentation of in-stent restenosis, an ostial location of the target lesion, lesion length, and sirolimus-eluting stent diameter<or =2.5 mm.

OBJECTIVES: The aim of this study was to evaluate the long-term clinical outcome of the efficacy and safety of sirolimus-eluting stents (SES) for in-stent restenosis (ISR) in the TRUE (Tuscany Registry of Unselected In-Stent Restenosis) database.

BACKGROUND: The TRUE registry demonstrated that SES in the treatment of bare-metal stent ISR is efficacious (5% of target lesion revascularization [TLR]) and safe (stent thrombosis<1%) at 9 months. Clinical outcome at 4 years is reported.

METHODS: A total of 244 patients with ISR who were treated with SES implantation represent the study population. The incidence of major adverse cardiac events was collected at 4 years.

RESULTS: At 4-year follow-up, overall mortality was 9.8% (24 patients). Cardiac death occurred in 11 (4.5%), nonfatal myocardial infarction in 8 (3.2%), and TLR in 27 (11.1%) patients for a cumulative event-free survival rate of 80.3%. Definite stent thrombosis occurred in 5 (2%) patients and possible stent thrombosis in 2 (0.8%). Diabetes remained an independent negative predictor of freedom from TLR (odds ratio [OR]: 0.38; 95% confidence interval [CI]: 0.20 to 0.71, p = 0.002) and major adverse cardiac events (OR: 0.38; 95% CI: 0.20 to 0.71, p = 0.002).

CONCLUSIONS: The clinical benefit of SES implantation for bare-metal stent ISR is maintained at 4 years with a low TLR rate and an overall incidence of stent thrombosis of 0.7% per year.

 

In patients with stable CAD, PCI can be considered a valuable initial mode of revascularization in all patients with objective large ischaemia in the presence of almost every lesion subset, with only one exception: chronic total occlusions that cannot be crossed. In early studies, there was a small survival advantage with CABG surgery compared with PCI without stenting. The addition of stents and newer adjunctive medications improved the outcome for PCI. The decision to recommend PCI or CABG surgery will be guided by technical improvements in cardiology or surgery, local expertise, and patients’ preference. However, until proved otherwise, PCI should be used only with reservation in diabetics with multi-vessel disease and in patients with unprotected left main stenosis. The use of drug-eluting stents might change this situation. Patients presenting with NSTE-ACS (UA or NSTEMI) have to be stratified first for their risk of acute thrombotic complications. A clear benefit from early angiography (<48 h) and, when needed, PCI or CABG surgery has been reported only in the high-risk groups. Deferral of intervention does not improve outcome. Routine stenting is recommended on the basis of the predictability of the result and its immediate safety. In patients with STEMI, primary PCI should be the treatment of choice in patients presenting in a hospital with PCI facility and an experienced team. Patients with contra-indications to thrombolysis should be immediately transferred for primary PCI, because this might be their only chance for quickly opening the coronary artery. In cardiogenic shock, emergency PCI for complete revascularization may be life-saving and should be considered at an early stage. Compared with thrombolysis, randomized trials that transferred the patients for primary PCI to a ‘heart attack centre’ observed a better clinical outcome, despite transport times leading to a significantly longer delay between randomization and start of the treatment. The superiority of primary PCI over thrombolysis seems to be especially clinically relevant for the time interval between 3 and 12 h after onset of chest pain or other symptoms on the basis of its superior preservation of myocardium. Furthermore, with increasing time to presentation, major-adverse-cardiac-event rates increase after thrombolysis, but appear to remain relatively stable after primary PCI. Within the first 3 h after onset of chest pain or other symptoms, both reperfusion strategies seem equally effective in reducing infarct size and mortality. Therefore, thrombolysis is still a viable alternative to primary PCI, if it can be delivered within 3 h after onset of chest pain or other symptoms. Primary PCI compared with thrombolysis significantly reduced stroke. Overall, we prefer primary PCI over thrombolysis in the first 3 h of chest pain to prevent stroke, and in patients presenting 3-12 h after the onset of chest pain, to salvage myocardium and also to prevent stroke. At the moment, there is no evidence to recommend facilitated PCI. Rescue PCI is recommended, if thrombolysis failed within 45-60 min after starting the administration. After successful thrombolysis, the use of routine coronary angiography within 24 h and PCI, if applicable, is recommended even in asymptomatic patients without demonstrable ischaemia to improve patients’ outcome. If a PCI centre is not available within 24 h, patients who have received successful thrombolysis with evidence of spontaneous or inducible ischaemia before discharge should be referred to coronary angiography and revascularized accordingly–independent of ‘maximal’ medical therapy.

CONTEXT: Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy (VBT) affording the best results. The effectiveness of drug-eluting stents in this setting has not been established.

OBJECTIVE: To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in patients with restenotic lesions after prior stent implantation in native coronary arteries.

DESIGN, SETTING, AND PATIENTS: Prospective, multicenter, randomized trial conducted between June 6, 2003, and July 16, 2004, at 37 North American academic and community-based institutions in 396 patients with in-stent restenosis of a previously implanted bare-metal coronary stent (vessel diameter, 2.5-3.75 mm; lesion length,<or =46 mm).

INTERVENTIONS: Patients were randomly assigned to undergo angioplasty followed by VBT with a beta source (n = 201) or paclitaxel-eluting stent implantation (n = 195). Clinical and angiographic follow-up at 9 months was scheduled in all patients.

MAIN OUTCOME MEASURE: Ischemia-driven target vessel revascularization at 9 months.

RESULTS: Diabetes mellitus was present in 139 patients (35.1%). Median reference vessel diameter was 2.65 mm and median lesion length was 15.3 mm. In the VBT group, new stents were implanted in 22 patients (10.9%) and in the paclitaxel-eluting stent group, multiple stents were required in 57 patients (29.2%), with median stent length of 24 mm. Follow-up at 9 months was complete in 194 patients in the VBT group and 191 patients in the paclitaxel-eluting stent group (96.5% and 97.9%, respectively). For VBT and paclitaxel-eluting stents, respectively, the number of events and 9-month rates for ischemic target lesion revascularization were 27 (13.9%) vs 12 (6.3%) (relative risk [RR], 0.45; 95% confidence interval [CI], 0.24-0.86; P = .01); for ischemic target vessel revascularization, 34 (17.5%) vs 20 (10.5%) (RR, 0.60; 95% CI, 0.36-1.00; P = .046); and for overall major adverse cardiac events, 39 (20.1%) vs 22 (11.5%) (RR, 0.57; 95% CI, 0.35-0.93; P = .02), with similar rates of cardiac death or myocardial infarction (10 [5.2%]vs 7 [3.7%]; RR, 0.71; 95% CI, 0.28-1.83; P = .48) and target vessel thrombosis (5 [2.6%]vs 3 [1.6%]; RR, 0.61; 95% CI, 0.15-2.50; P = .72). Angiographic restenosis at 9 months was 31.2% (53 of 170 patients) with VBT and 14.5% (25 of 172 patients) with paclitaxel-eluting stents (RR, 0.47; 95% CI, 0.30-0.71; P<.001).

CONCLUSION: Treatment of bare-metal in-stent restenotic lesions with paclitaxel-eluting stents rather than angioplasty followed by VBT reduces clinical and angiographic restenosis at 9 months and improves event-free survival.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00287573.

 

AIMS: This study sought to investigate the 2-year outcomes of patients treated with the paclitaxel-eluting TAXUS((R)) stent (PES) or vascular brachytherapy (VBT), the previous ‘gold standard therapy’, for bare metal stent in-stent restenosis (ISR).

METHODS AND RESULTS: In the TAXUS V-ISR trial, 396 patients with bare metal stent ISR referred for percutaneous coronary intervention were prospectively randomized to either PES or beta source VBT. The present analysis reports 24-month clinical outcomes from that study. Between 9 and 24 months, ischaemia-driven target lesion revascularization tended to be required less frequently with assignment to PES compared to VBT (5.3 vs. 10.3%, P = .07). As a result, ischaemia-driven target lesion revascularization at 24 months was significantly reduced with PES compared with VBT (10.1 vs. 21.6%, P = 0.003), as was ischaemia-driven target vessel revascularization (18.1 vs. 27.5%, P = .03). There were no significant differences between the two groups with regard to death, myocardial infarction, or target vessel thrombosis either between 12 and 24 months, or cumulative to 24 months.

CONCLUSION: Freedom from clinical restenosis at 2 years is significantly enhanced after PES placement compared with VBT for bare metal stent ISR, with similar rates of death, myocardial infarction, and target vessel thrombosis.

 

CONTEXT: Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited.

OBJECTIVE: To determine the safety and efficacy of the sirolimus-eluting stent compared with vascular brachytherapy for the treatment of patients with restenosis within a bare-metal stent.

DESIGN, SETTING, AND PATIENTS: Prospective, multicenter, randomized trial of 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community medical centers. Data presented represent all follow-up as of June 30, 2005.

INTERVENTIONS: Vascular brachytherapy (n = 125) or the sirolimus-eluting stent (n = 259).

MAIN OUTCOME MEASURE: Target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months postprocedure.

RESULTS: Baseline patient characteristics were well matched. Lesion length was similar between vascular brachytherapy and sirolimus-eluting stent patients (mean [SD], 16.76 [8.55]mm vs 17.22 [7.97]mm, respectively; P = .61). Procedural success was 99.2% (124/125) in the vascular brachytherapy group and 97.3% (250/257) in the sirolimus-eluting stent group (P = .28). The rate of target vessel failure was 21.6% (27/125) with vascular brachytherapy and 12.4% (32/259) with the sirolimus-eluting stent (relative risk [RR], 1.7; 95% confidence interval [CI], 1.1-2.8; P = .02). Target lesion revascularization was required in 19.2% (24/125) of the vascular brachytherapy group and 8.5% (22/259) of the sirolimus-eluting stent group (RR, 2.3 [95% CI, 1.3-3.9]; P = .004). At follow-up angiography, the rate of binary angiographic restenosis for the analysis segment was 29.5% (31/105) for the vascular brachytherapy group and 19.8% (45/227) for the sirolimus-eluting stent group (RR, 1.5 [95% CI, 1.0-2.2]; P = .07). Compared with the vascular brachytherapy group, minimal lumen diameter was larger in the sirolimus-eluting stent group at 6-month follow-up (mean [SD], 1.52 [0.63]mm vs 1.80 [0.63]mm; P<.001), reflecting greater net lumen gain in the analysis segment (0.68 [0.60]vs 1.0 [0.61]mm; P<.001) due to stenting and no edge restenosis.

CONCLUSION: Sirolimus-eluting stents result in superior clinical and angiographic outcomes compared with vascular brachytherapy for the treatment of restenosis within a bare-metal stent.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00231257.

 

The greatest recent mechanical advance in percutaneous coronary revascularization (PCR) has been the development of bare-metal stents, which compared with traditional balloon angioplasty substantially reduce angiographic restenosis and the need for repeat target vessel revascularization (TVR). Stents provide a larger arterial lumen diameter immediately postprocedure (acute gain), although their drawback is an increased reparative response of neointimal formation (late loss). Fortunately, the net gain remains greatest with stents compared with other PCR devices. In less complex lesions, the rate of TVR with bare-metal stents is approximately 10% to 15%, although this rate has been reported to be 2- to 3-fold higher in more complex lesions and unique patient subsets.1,2 In 2003, at a time when the use of bare-metal stents peaked, approximately 1 million coronary stents were placed in patients hospitalized in the United States.3 Even with a conservative estimate, this means at least 100 000 in-stent restenotic lesions occurred, making this an important clinical problem.

BACKGROUND: We evaluated the clinical and angiographic outcomes of patients presenting with restenosis after sirolimus-eluting stent (SES) implantation treated with repeated percutaneous intervention.

METHODS AND RESULTS: A total of 24 consecutive patients have undergone repeated percutaneous intervention to treat post-SES restenosis (27 lesions). The restenosis was located within the stent in 93% of lesions. From the 27 lesions, 1 (4%) was re-treated with a bare stent, 3 (11%) were treated with balloon dilatation, and the remaining 23 lesions (85%) were treated with repeated drug-eluting stent implantation (SES in 12 lesions [44%], paclitaxel-eluting stents in 11 lesions [41%]). The event-free survival rate was 70.8% after a median follow-up of 279 days from the post-SES treatment. The overall recurrent restenosis rate was 42.9%. The risk of recurrent restenosis was increased for patients with hypercholesterolemia, previous angioplasty, failed brachytherapy, post-SES restenosis needing early (<6 months) treatment, and post-SES restenosis treated with balloon dilatation. The recurrent restenosis rate of originally de novo lesions re-treated with drug-eluting stents was 18.2%.

CONCLUSIONS: Even though de novo lesions treated with SES at baseline and re-treated with drug-eluting stents had reasonably better outcomes than other lesion types and strategies, our study shows that the treatment of post-SES restenosis is currently suboptimal and warrants further investigation.

 

Although clinical outcomes after sirolimus-eluting stents (SESs) have been previously described (“primary” success rates), the fate of patients whose SES implantation fail and who require ischemia-driven target lesion revascularization is poorly understood. The SIRIUS trial is a prospective, randomized, clinical trial that includes 533 evaluable patients with SESs. Twenty-two of these patients had adjudicated ischemia-driven target lesion revascularization (4.1%) within the first year of follow-up and comprised the study population of this analysis. Of these patients, 11 (50%) had diabetes, and restenotic lesions were focal and located at the proximal stent edge in 91% and 73% of patients, respectively. Restenosis was treated with bare metal stent implantation, balloon dilatation, or intravascular brachytherapy in 82%, 13.5%, and 4.5% of patients, respectively. At 1-year follow-up after the first recurrence (2-year follow-up after the index procedure), only 5 of these patients (23%) required a second repeat revascularization procedure. Risk factors for a second recurrence after treatment of SES restenosis were female gender, long lesions that required long stents at the index procedure, and an early first recurrence. In conclusion, SES failure treated with traditional percutaneous coronary intervention yielded good outcome at 1-year follow-up (secondary failure rate only 23%), perhaps due to the focal nature of the SES restenotic lesion. Future studies should evaluate other methods, including drug-eluting stents, to further optimize the outcome of treatment of SES failures.

 

  • AD Columbia University Medical Center-New York Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York, USA. imoussa@crf.org
  • PMID 16728218
  • TI Drug-eluting stent restenosis: the pattern predicts the outcome.
  • AU Cosgrave J, Melzi G, Biondi-Zoccai GG, Airoldi F, Chieffo A, Sangiorgi GM, Montorfano M, Michev I, Carlino M, Bonizzoni E, Colombo A
  • SO J Am Coll Cardiol. 2006;47(12):2399.

OBJECTIVES: We sought to determine if the angiographic pattern of in-stent restenosis in drug-eluting stents (DES) maintains its prognostic importance.

BACKGROUND: The pattern of restenosis in the bare-metal stent era had a significant impact on therapeutic outcomes.

METHODS: We identified a total of 250 consecutive restenotic lesions in 203 patients (66.4% sirolimus-eluting stents and 33.6% paclitaxel-eluting stents). We divided these lesions into two groups: focal, defined as<or =10 mm, 163 lesions (65.2%); and nonfocal, which were diffuse, proliferative, or obstructive, 87 lesions (34.8%). The end points analyzed were angiographic restenosis and target lesion revascularization (TLR).

RESULTS: Diabetes was the only clinical variable associated with the pattern of restenosis (28.8% focal compared with 52.9% diffuse; p = 0.0001). Angiographic follow-up of the treatment of restenosis was available in 61.2% of the lesions and was similar between the two groups. The rate of angiographic restenosis was 17.8% in the focal group and 51.1% in the nonfocal group (p = 0.0001). The incidence of TLR also increased with the type of restenosis treated (9.8% and 23%, respectively; p = 0.007). An adjusted multivariate analysis revealed that the pattern of restenosis remained associated with both the occurrence of restenosis and TLR (odds ratio [OR]5.1 [95% confidence interval (CI) 1.1 to 23], p = 0.03; and OR 3.61 [95% CI 1.2 to 10.9], p = 0.02; respectively).

CONCLUSIONS: Similar to bare-metal stent data, the angiographic pattern of restenosis following DES implantation is prognostically important. Diabetes is a significant predictor of the pattern of restenosis in the DES era.

 

OBJECTIVE: The authors aimed to compare the clinical outcomes with repeat drug-eluting stent (DES) implantation utilizing the same type versus an alternate DES type for in-stent restenosis (ISR) of DES.
BACKGROUND: : DES are proven as an effective treatment for bare metal ISR.
METHODS: A cohort of 116 patients previously treated with a sirolimus-eluting stent (SES) or a paclitaxel-eluting stent (PES) who presented with angiographic ISR were treated with repeat DES. Of these, 62 (53.4%) were treated with different DES and 54 (46.6%) were treated with the same DES. This cohort was followed for clinical events at 30 days, 6 months, and 1 year.
RESULTS: Baseline characteristics were similar except for more diabetes among patients receiving the different type of DES. Of the 116, overall 16.4% of the DES were implanted for previous ISR and 2.6% had previously received brachytherapy. At 6 months, the overall target vessel revascularization (TVR) rate was 12.2% for the entire cohort. The TVR-major adverse cardiac event (MACE) rate for the patients treated with different DES was 14.5% and 16.7% for the same DES (P = 0.750). Overall TVR rate at 1 year was 28.8%. The TVR-MACE was 32.6% for different DES and 35.0% for the same DES (P = 0.814).
CONCLUSIONS: Reimplantation of DES for the treatment of DES ISR (same or different) is safe but associated with a high rate of recurrences at 1 year regardless of the initial DES type. Other treatment modalities for ISR of DES should be considered to further improve the overall TVR-MACE.

 

BACKGROUND: Optimal treatment strategies for restenosis of sirolimus-eluting stents (SES) have not been adequately addressed yet.
METHODS AND RESULTS: During the 3-year follow-up of 12 824 patients enrolled in the j-Cypher registry, 1456 lesions in 1298 patients underwent target-lesion revascularization (TLR). Excluding 362 lesions undergoing TLR for stent thrombosis or TLR using treatment modalities other than SES or balloon angioplasty (BA), 1094 lesions with SES-associated restenosis in 990 patients treated with either SES (537 lesions) or BA (557 lesions) constituted the study population for the analysis of recurrent TLR and stent thrombosis after the first TLR. Excluding 24 patients with both SES- and BA-treated lesions, 966 patients constituted the analysis set for the mortality outcome. Cumulative incidence of recurrent TLR in the SES-treated restenosis lesions was significantly lower than that in the BA-treated restenosis lesions (23.8% versus 37.7% at 2 years after the first TLR; P<0.0001). Among 33 baseline variables evaluated, only hemodialysis was identified to be the independent risk factor for recurrent TLR by a multivariable logistic regression analysis. After adjusting for confounders, repeated SES implantation was associated with a strong treatment effect in preventing recurrent TLR over BA (odds ratio, 0.44; 95% confidence interval, 0.32 to 0.61; P50%) at 6- to 8-month follow-up, target lesion revascularization, the composite of death or myocardial infarction, and definite stent thrombosis at 12 months.
RESULTS: Regarding anti-restenotic efficacy, there were no differences between SES and PES in late loss (0.40 +/- 0.65 mm vs. 0.38 +/- 0.59 mm; p = 0.85), binary restenosis (19.6% vs. 20.6%; p = 0.69), or target lesion revascularization (16.6% vs. 14.6%; p = 0.52). In terms of safety outcomes, the rates of death/myocardial infarction (6.1% vs. 5.8%; p = 0.86) and stent thrombosis (0.4% vs. 0.4%; p>0.99) were also similar.
CONCLUSIONS: In cases of SES restenosis, treatment with either repeat SES or switch to PES was associated with a comparable degree of efficacy and safety. Drug resistance at an individual patient level may play a contributory role to the somewhat higher than expected late loss observed with the SES in the current study. (Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for In-Stent Restenosis 2 [ISAR-DESIRE 2]; NCT00598715).

 

BACKGROUND: Treatment of coronary in-stent restenosis is hampered by a high incidence of recurrent in-stent restenosis. We assessed the efficacy and safety of a paclitaxel-coated balloon in this setting.
METHODS: We enrolled 52 patients with in-stent restenosis in a randomized, double-blind, multicenter trial to compare the effects of a balloon catheter coated with paclitaxel (3 microg per square millimeter of balloon surface area) with those of an uncoated balloon catheter in coronary angioplasty. The primary end point was late luminal loss as seen on angiography. Secondary end points included the rates of restenosis (a binary variable) and major adverse cardiac events.
RESULTS: Multivessel disease was present in 80% of patients in both groups. Quantitative coronary angiography revealed no significant differences in baseline measures. At 6 months, angiography showed that the mean (+/-SD) in-segment late luminal loss was 0.74+/-0.86 mm in the uncoated-balloon group versus 0.03+/-0.48 mm in the coated-balloon group (P=0.002). A total of 10 of 23 patients (43%) in the uncoated-balloon group had restenosis, as compared with 1 of 22 patients (5%) in the coated-balloon group (P=0.002). At 12 months, the rate of major adverse cardiac events was 31% in the uncoated-balloon group and 4% in the coated-balloon group (P=0.01). This difference was primarily due to the need for target-lesion revascularization in six patients in the uncoated-balloon group (P=0.02).
CONCLUSIONS: Treatment of coronary in-stent restenosis with paclitaxel-coated balloon catheters significantly reduced the incidence of restenosis. These data suggest that the inhibition of restenosis by local drug delivery may not require stent implantation and sustained drug release at the site of injury. (ClinicalTrials.gov number, NCT00106587 [ClinicalTrials.gov].).

 

BACKGROUND: Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care.
METHODS AND RESULTS: One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 microg/mm2) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of>or =70% and<or =22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38+/-0.61 mm in the drug-eluting stent group versus 0.17+/-0.42 mm (P=0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; P=0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively (P=0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (P=0.15).
CONCLUSIONS: Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent. For the treatment of in-stent restenosis, inhibition of re-restenosis does not require a second stent implantation.

 

OBJECTIVE: We sought to compare the efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with bare-metal stent (BMS) in-stent restenosis (ISR).
BACKGROUND: Treatment of patients with ISR remains a challenge.
METHODS: This was a prospective, multicenter, randomized trial comparing DEB and EES in patients with BMS-ISR. The primary end-point was minimal lumen diameter at 9-month follow-up.
RESULTS: 189 patients with BMS-ISR from 25 Spanish sites were included (95 allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days, 92% of eligible patients) patients in the EES arm had a significantly larger minimal lumen diameter (2.36+0.6 vs 2.01+0.6 mm, p<0.001; absolute mean difference 0.35 mm 95%CI 0.16-0.53) and a lower % diameter stenosis (13+17% vs 25+20%, p<0.001). However, late loss (0.04+0.5 vs 0.14+0.5 mm, p=0.14) and binary restenosis rate (4.7 vs 9.5%, p=0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. The occurrence of the combined clinical outcome measure (cardiac death, myocardial infarction and target vessel revascularization) (6 vs 8%; HR:0.76;95%CI:0.26-2.18, p=0.6) and the need for target vessel revascularization (2 vs 6%; HR:0.32:0.07-1.59, p=0.17) were similar in the 2 groups.
CONCLUSIONS: In patients with BMS-ISR both DEB and EES provide excellent clinical results with a very low rate of clinical and angiographic recurrences. However, as compared with DEB, EES provide superior late angiographic findings.
CLINICAL TRIAL INFO: NCT01239953.

BACKGROUND: The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. We investigated the efficacy of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES), and balloon angioplasty in these patients.
METHODS: In this randomised, open-label trial, we enrolled patients older than 18 years with restenosis of at least 50% after implantation of any limus-eluting stent at three centres in Germany between Aug 3, 2009, and Oct 27, 2011. Patients were randomly assigned (1:1:1; stratified according to centre) to receive PEB, PES, or balloon angioplasty alone by means of sealed, opaque envelopes containing a computer-generated sequence. Patients and investigators were not masked to treatment allocation, but events and angiograms were assessed by individuals who were masked. The primary endpoint was diameter stenosis at follow-up angiography at 6-8 months. Primary analysis was done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00987324.
FINDINGS: We enrolled 402 patients, of whom 137 (34%) were assigned to PEB, 131 (33%) to PES, and 134 (33%) to balloon angioplasty. Follow-up angiography at 6-8 months was available for 338 (84%) patients. PEB was non-inferior to PES in terms of diameter stenosis (38·0% [SD 21·5]vs 37·4% [21·8]; difference 0·6%, one-sided 95% CI 4·9%; p(non-inferiority)=0·007; non-inferiority margin of 7%). Findings were consistent in per-protocol analysis (p(non-inferiority)=0·011). PEB and PES were superior to balloon angioplasty alone (54·1% [25·0]; p(superiority)<0·0001 for both comparisons). Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups.
INTERPRETATION: By obviating the need for additional stent implantation, PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent.
FUNDING: Deutsches Herzzentrum.

 

OBJECTIVE: To evaluate the clinical and angiographic outcome in patients with in-stent restenosis in small coronary arteries and repeat target lesion revascularisation.
DESIGN: Patients with in-stent restenosis in coronary arteries<or = 2.85 mm were eligible for the study and underwent target lesion revascularisation. Clinical and angiographic variables were assessed during a six month follow up period.
RESULTS: 73 patients with 79 lesions were treated by percutaneous transluminal coronary angioplasty (47%), excimer laser angioplasty (25%), or restenting (28%). The mean (SD) reference diameter before target lesion revascularisation was 2.12 (0.5) mm. Procedural success was achieved in all cases, but 57% of the patients had restenosis after six months. The rate of further restenosis was higher with laser angioplasty (78%) than with restenting (47%) or balloon angioplasty alone (49%, p<0.05).
CONCLUSIONS: Treatment for in-stent restenosis in small coronary arteries is feasible and safe, with a second restenosis rate comparable to large coronary artery series. The strategy of target lesion revascularisation influences further in-stent restenosis, with an increased rate with laser angioplasty compared with restenting and repeat dilatation alone.

 

OBJECTIVE: We examined long-term outcomes of patients with in-stent restenosis (ISR) who underwent different percutaneous interventions at the discretion of individual operators: balloon angioplasty (BA), repeat stent or rotational atherectomy (RA). We also examined long-term outcomes of patients with ISR who underwent coronary artery bypass surgery (CABG).
BACKGROUND: In-stent restenosis remains a challenging problem, and its optimal management is still unknown.
METHODS: Symptomatic patients (n = 510) with ISR were identified using cardiac catheterization laboratory data. Management for ISR included BA (169 patients), repeat stenting (117 patients), RA (107 patients) or CABG (117 patients). Clinical outcome events of interest included death, myocardial infarction, target vessel revascularization (TVR) and a combined end point of these major adverse cardiovascular events (MACE). Mean follow-up was 19+/-12 months (range = 6 to 61 months).
RESULTS: Patients with ISR treated with repeat stent had significantly larger average post-procedure minimal lumen diameter compared with BA or RA (3.3+/-0.4 mm vs. 3.0+/-0.4 vs. 2.9+/-0.5, respectively, p<0.05). Incidence of TVR and MACE were similar in the BA, stent and RA groups (39%, 40%, 33% for TVR and 43%, 40%, 33% for MACE, p = NS). Patients with diabetes who underwent RA had similar outcomes as patients without diabetes, while patients with diabetes who underwent BA or stent had worse outcomes than patients without diabetes. Patients who underwent CABG for ISR, mainly because of the presence of multivessel disease, had significantly better outcomes than any percutaneous treatment (8% for TVR and 23% for MACE).
CONCLUSIONS: In this large cohort of patients with ISR and in the subset of patients without diabetes, long-term outcomes were similar in the BA, repeat stent and RA groups. Tissue debulking with RA yielded better results only in diabetic patients. Bypass surgery for patients with multivessel disease and ISR provided the best outcomes.

 

BACKGROUND: In patients who develop in-stent restenosis, successful revascularization can be difficult to achieve using percutaneous methods. This study was designed to verify the surgical results in this setting and to evaluate the potential beneficial role of arterial bypass conduits.
METHODS AND RESULTS: Sixty consecutive coronary artery bypass patients with previous in-stent restenosis and 60 control cases were randomly assigned to receive an arterial conduit (either right internal thoracic or radial artery; study group) or a great saphenous vein graft (control group) on the first obtuse marginal artery to complete the surgical revascularization procedure. At a mean follow-up of 52+/-11 months, patients were reassessed clinically and by angiography. Freedom from clinical and instrumental evidence of ischemia recurrence was found in 19 of 60 subjects in the study group versus 45 of 60 in the control series (P=0.01). The results of the arterial grafts were excellent in both the study and control groups (right internal thoracic artery patency rate, 19 of 20 for both, and radial artery patency rate, 20 of 20 versus 19 of 20; P=0.99). Saphenous vein grafts showed lower patency rate than arterial grafts in both series and had extremely high failure rate in the study group (patency rate, 10 of 20 in the study group versus 18 of 20 in the control group; P=0.001). Use of venous graft was an independent predictor of failure in the study group, whereas hypercholesterolemia was associated with graft failure in both series.
CONCLUSIONS: Venous grafts have an high incidence of failure among cases who previously developed in-stent restenosis, whereas the use of arterial conduits can improve the angiographic and clinical results. Arterial grafts should probably be the first surgical choice in this patient population.

Background It is still unclear if patients treated for ISR may benefit from a long DAPT regimen.

Methods For the present purpose, we selected 224 patients undergoing the PCI procedure for ISR enrolled in the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial and randomized to short (6 months) versus long (24 months) DAPT regimen. The primary objective was the cumulative incidence of death, nonfatal myocardial infarction (MI), or cerebrovascular accident at 24 months. Safety endpoints were moderate and major bleeding complications.

  • AD PMID 24161321
  • TI Prasugrel versus clopidogrel in patients with acute coronary syndromes.
  • AU Wiviott SD1, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators.
  • SO N Engl J Med. 2007 Nov 15;357(20):2001-15. Epub 2007 Nov 4.

BACKGROUND:

Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention.

METHODS:

To compare prasugrel, a new thienopyridine, with clopidogrel, we randomly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel (a 60-mg loading dose and a 10-mg daily maintenance dose) or clopidogrel (a 300-mg loading dose and a 75-mg daily maintenance dose), for 6 to 15 months. The primary efficacy end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The key safety end point was major bleeding.

RESULTS:

The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81; 95% confidence interval [CI], 0.73 to 0.90; P<0.001). We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent target-vessel revascularization (3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs. 1.1%; P<0.001). Major bleeding was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients receiving clopidogrel (hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P=0.03). Also greater in the prasugrel group was the rate of life-threatening bleeding (1.4% vs. 0.9%; P=0.01), including nonfatal bleeding (1.1% vs. 0.9%; hazard ratio, 1.25; P=0.23) and fatal bleeding (0.4% vs. 0.1%; P=0.002).

CONCLUSIONS:

In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding. Overall mortality did not differ significantly between treatment groups. (ClinicalTrials.gov number, NCT00097591 [ClinicalTrials.gov].)

The lumen diameter reduction after percutaneous coronary intervention (PCI) is well known as “restenosis”. This phenomenon is due to vessel remodeling/recoil in case of no-stent strategy or, in case of stent employ, “neointimal proliferation” that consists in an excessive tissue proliferation in the luminal surface of the stent otherwise by a further new-occurring atherosclerotic process called “neoatherosclerosis”. The exact incidence of in-stent restenosis (ISR) is not easy to determine caused by different clinical, angiographic and operative factors. In the pre-stent era the occurrence of restenosis ranged between 32-55% of all angioplasties, and drop to successively 17-41% in the bare metal stents (BMS) era. The advent of drug eluting stent (DES), especially 2nd generation, and drug-coated balloon (DCB) further reduce restenosis rate until <10%. We here review the main characteristics of this common complication of coronary interventions, from its pathogenesis to the most appropriate treatment strategy.

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Left ventricular outflow tract (LVOT) obstruction (LVOTO): The Role of CT in TAVR and in TMVR

Reporter: Aviva Lev-Ari, PhD, RN

 

Left ventricular outflow tract obstruction (LVOTO) is a recognised feature of this condition which arises when blood leaving the outflow tract is impeded by systolic anterior motion of the mitral valve. LVOT obstruction was defined as a resting LVOT gradient of ≥30 mm Hg, with severe obstruction defined as ≥50 mm Hg (15).

Left ventricular outflow tract (LVOT) obstruction can occur at the valvular, subvalvular, or supravalvular level. In general, there is an obstruction to forward flow which increases afterload, and if untreated, can result in hypertrophy, dilatation, and eventual failure of the left ventricle. In the United States, most cases of LVOT obstruction are congenital in individuals younger than 50 years of age.

Jonathon Leipsic, M.D., FSCCT, professor of radiology and cardiology at the University of British Columbia, Vancouver, Canada, and an expert in transcatheter valve imaging. He spoke about his experiences with TAVR and TMVR trials and devices planning at the the Society of Cardiovascular Computed Tomography (SCCT) 2018 meeting.

Watch the VIDEO “What to Look for in CT Structural Heart Planning Software.”

Issues of Concern

Common Causes of Left Ventricular Outflow Tract Obstruction

Subaortic Stenosis (SAS)

Subaortic stenosis is narrowing at the level of the aortic valve. It may be due to a discrete ridge or fibrous ring encircling the LVOT. This fibrous membrane may extend onto the aortic valve cusps and make contact with the ventricular side of the anterior mitral leaflet. The obstruction may be focal or more diffuse, resulting in a tunnel leading out of the left ventricle. The discrete form is most common. Complex subaortic stenosis can also be seen which leads to abnormal adherence to the anterior leaflet of the mitral valve to the septum and the presence of endocardial tissue in the LVOT. These type of obstructions are commonly seen in patients with ventral septal defects (VSDs).

Clinical Significance

Left ventricular outflow tract obstructions involve stenotic lesions starting in the anatomic left ventricular outflow tract and stretching to the descending portion of the aortic arch.

Obstruction can be valvar, subvalvar, or supravalvar. Obstructions to forward flow can present alone or in concert. All of these lesions result in increased afterload on the left ventricle and if severe, result in hypertrophy and eventual dilatation and failure of the left ventricle. These lesions are usually congenital in the vast majority of individuals younger than 50 years. All patients with left ventricular outflow tract obstruction at a high risk for developing infective endocarditis and prophylaxis should be instituted.

Bicuspid Aortic Valve (BAV)

Bicuspid aortic valve is one of the most common congenital cardiovascular malformations, present in about 1% to 2% of the population and more common in males. BAV can be inherited, and family clusters have been documented. In those cases, inheritance patterns are usually autosomal dominant with variable penetrance. A mutation in the NOTCH1 gene has also been described.

BAVs arise from abnormal vasculogenesis and cusp formation, resulting in the formation of 1 smaller cusp and one larger cusp. More commonly, the right and left coronary cusps are fused. BAV is usually progressive, and most valves function normally until later in life. The abnormal valve formation leads to increased leaflet stress, more turbulent flow and restricted motion which leads to accelerated valve changes including scarring, calcification, aortic stenosis, and regurgitation. BAV is associated with dilation of the ascending aorta and increased risk of aortic dissection.

Clinical Features

The most common complication of BAV is aortic stenosis.

SOURCE

Left Ventricular Outflow Tract Obstruction

Viliane Vilcant; Ofek Hai.

https://www.ncbi.nlm.nih.gov/books/NBK470446/

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CABG: a Superior Revascularization Modality to PCI in Patients with poor LVF, Multivessel disease and Diabetes, Similar Risk of Stroke between 31 days and 5 years, post intervention

Reporter: Aviva Lev-Ari, PhD, RN

 

Lancet Study, 2/2018

Interpretation

CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies.

JACC Study, 7/2018

CONCLUSIONS

This individual patient-data pooled analysis demonstrates that 5-year stroke rates are significantly lower after PCI compared with CABG, driven by a reduced risk of stroke in the 30-day post-procedural period but a similar risk of stroke between 31 days and 5 years. The greater risk of stroke after CABG compared with PCI was confined to patients with multivessel disease and diabetes. Five-year mortality was markedly higher for patients experiencing a stroke within 30 days after revascularization.

European Journal of Cardiothoracic Surgery Study, 6/2018

CONCLUSIONS

Despite a longer length of hospital stay, patients with impaired LVF requiring intervention for coronary artery disease experienced a greater post-procedural survival benefit if they received CABG compared to PCI. We have demonstrated this at 30 days, 90 days, 1 year, 3 years, 5 years and 8 years following revascularization. At present, CABG remains a superior revascularization modality to PCI in patients with poor LVF.

 

New Studies on Clinical Outcomes from two Revascularization Strategies: CABG and PCI

 

J Am Coll Cardiol. 2018 Jul 24;72(4):386-398. doi: 10.1016/j.jacc.2018.04.071.

Stroke Rates Following Surgical Versus Percutaneous Coronary Revascularization.

Abstract

BACKGROUND:

Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are used for coronary revascularization in patients with multivessel and left main coronary artery disease. Stroke is among the most feared complications of revascularization. Due to its infrequency, studies with large numbers of patients are required to detect differences in stroke rates between CABG and PCI.

OBJECTIVES:

This study sought to compare rates of stroke after CABG and PCI and the impact of procedural stroke on long-term mortality.

METHODS:

We performed a collaborative individual patient-data pooled analysis of 11 randomized clinical trials comparing CABG with PCI using stents; ERACI II (Argentine Randomized Study: Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Patients With Multiple Vessel Disease) (n = 450), ARTS (Arterial Revascularization Therapy Study) (n = 1,205), MASS II (Medicine, Angioplasty, or Surgery Study) (n = 408), SoS (Stent or Surgery) trial (n = 988), SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial (n = 1,800), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) trial (n = 600), FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial (n = 1,900), VA CARDS (Coronary Artery Revascularization in Diabetes) (n = 198), BEST (Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease) (n = 880), NOBLE (Percutaneous Coronary Angioplasty Versus Coronary Artery Bypass Grafting in Treatment of Unprotected Left Main Stenosis) trial (n = 1,184), and EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial (n = 1,905). The 30-day and 5-year stroke rates were compared between CABG and PCI using a random effects Cox proportional hazards model, stratified by trial. The impact of stroke on 5-year mortality was explored.

RESULTS:

The analysis included 11,518 patients randomly assigned to PCI (n = 5,753) or CABG (n = 5,765) with a mean follow-up of 3.8 ± 1.4 years during which a total of 293 strokes occurred. At 30 days, the rate of stroke was 0.4% after PCI and 1.1% after CABG (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.20 to 0.53; p < 0.001). At 5-year follow-up, stroke remained significantly lower after PCI than after CABG (2.6% vs. 3.2%; HR: 0.77; 95% CI: 0.61 to 0.97; p = 0.027). Rates of stroke between 31 days and 5 years were comparable: 2.2% after PCI versus 2.1% after CABG (HR: 1.05; 95% CI: 0.80 to 1.38; p = 0.72). No significant interactions between treatment and baseline clinical or angiographic variables for the 5-year rate of stroke were present, except for diabetic patients (PCI: 2.6% vs. CABG: 4.9%) and nondiabetic patients (PCI: 2.6% vs. CABG: 2.4%) (p for interaction = 0.004). Patients who experienced a stroke within 30 days of the procedure had significantly higher 5-year mortality versus those without a stroke, both after PCI (45.7% vs. 11.1%, p < 0.001) and CABG (41.5% vs. 8.9%, p < 0.001).

CONCLUSIONS:

This individual patient-data pooled analysis demonstrates that 5-year stroke rates are significantly lower after PCI compared with CABG, driven by a reduced risk of stroke in the 30-day post-procedural period but a similar risk of stroke between 31 days and 5 years. The greater risk of stroke after CABG compared with PCI was confined to patients with multivessel disease and diabetes. Five-year mortality was markedly higher for patients experiencing a stroke within 30 days after revascularization.

KEYWORDS:

coronary artery bypass graft; left main; mortality; multivessel; percutaneous coronary intervention; stenting; stroke

PMID:
30025574
DOI:
10.1016/j.jacc.2018.04.071

 

Lancet Study

Head SJ, Milojevic M, Daemen J, Ahn JM, Boersma E, Christiansen EH, Domanski MJ, Farkouh ME, Flather M, Fuster V, Hlatky MA, Holm NR, Hueb WA, Kamalesh M, Kim YH, Mäkikallio T, Mohr FW, Papageorgiou G, Park SJ, Rodriguez AE, Sabik JF, Stables RH, Stone GW, Serruys PW, Kappetein AP. Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. Lancet. 2018 Feb 22 [Epub ahead of print]. doi: 10.1016/S0140-6736(18)30423-9. PMID: 29478841

Summary

Background

Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies.

Methods

We did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics.

Findings

We included 11 randomised trials involving 11 518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06–1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09–1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19–1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86–1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87–1·33; p=0·52), regardless of diabetes status and SYNTAX score.

Interpretation

CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies.

SOURCE

European Journal of Cardiothoracic Surgery Study, 6/2018

 

Eur J Cardiothorac Surg. 2018 Jun 22. doi: 10.1093/ejcts/ezy236. [Epub ahead of print]

Comparison of the survival between coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with poor left ventricular function (ejection fraction <30%): a propensity-matched analysis.

Abstract

OBJECTIVES:

Existing evidence comparing the outcomes of coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in patients with poor left ventricular function (LVF) is sparse and flawed. This is largely due to patients with poor LVF being underrepresented in major research trials and the outdated nature of some studies that do not consider drug-eluting stent PCI.

METHODS:

Following strict inclusion criteria, 717 patients who underwent revascularization by CABG or PCI between 2002 and 2015 were enrolled. All patients had poor LVF (defined by ejection fraction <30%). By employing a propensity score analysis, 134 suitable matches (67 CABG and 67 PCI) were identified. Several outcomes were evaluated, in the matched population, using data extracted from national registry databases.

RESULTS:

CABG patients required a longer length of hospital stay post-revascularization compared to PCI in the propensity-matched population, 7 days (lower-upper quartile; 6-12) and 2 days (lower-upper quartile; 1-6), respectively (Mood’s median test, P = 0.001). Stratified Cox-regression proportional-hazards analysis of the propensity-matched population found that PCI patients experienced a higher adjusted 8-year mortality rate (hazard ratio 3.291, 95% confidence interval 1.776-6.101; P < 0.001). This trend was consistent amongst urgent cases of revascularization: patients with 3 or more vessels with coronary artery disease and patients where complete revascularization was achieved. Although sub-analyses found no difference between survival distributions of on-pump versus off-pump CABG (log-rank P = 0.726), both modes of CABG were superior to PCI (stratified log-rank P = 0.002).

CONCLUSIONS:

Despite a longer length of hospital stay, patients with impaired LVF requiring intervention for coronary artery disease experienced a greater post-procedural survival benefit if they received CABG compared to PCI. We have demonstrated this at 30 days, 90 days, 1 year, 3 years, 5 years and 8 years following revascularization. At present, CABG remains a superior revascularization modality to PCI in patients with poor LVF.

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An Overview of the Heart Surgery Specialty: heart transplant, lung transplant, heart-lung transplantation, aortic valve surgery, bypass surgery, minimally invasive cardiac surgery, heart valve surgery, removal of cardiac tumors, reoperation valve surgery

Reporter: Aviva Lev-Ari, PhD, RN

Heart Transplant Surgeons at Cleveland Clinic:

http://my.clevelandclinic.org/transplant/services/heart/team.aspx

Cleveland Clinic: Change at the Top, Tomislav “Tom” Mihaljevic, M.D., as its next CEO and President to succeed Toby Cosgrove, M.D., effective Jan. 1, 2018

https://newsroom.clevelandclinic.org/2017/09/01/tomislav-mihaljevic-m-d-named-cleveland-clinic-ceo-president/

Treatment & Services

Specialty in Diseases and Conditions

 

 

One heart in 3 patients.

Source

Heart and Vascular Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.

Abstract

In this report, we present a successful reuse of a transplanted heart under complex clinical conditions. Our patient was the second recipient, a 63-year-old man with end-stage heart failure due to amyloid-induced cardiomyopathy. After an uneventful postoperative course, he was diagnosed with acute myelogenous leukemia 6 months after transplantation and died 10 months after transplantation. This outcome was determined by a malignancy in an immunosuppressed patient. Reuse of a transplanted heart in carefully selected patients is a possible alternative in an era of donor organ shortage.

Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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