Advertisements
Feeds:
Posts
Comments

Archive for the ‘Valve-in-Valve Procedure’ Category


Surgical Aortic Valve Replacement (SAVR) vs Transcatheter Aortic Valve Implantation (TAVI): Results Comparison for Prosthesis-Patient Mismatch (PPM) – adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year

 

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 11/27/2018

Journal of the American College of Cardiology

5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients

Abstract

Background The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality–risk patients.

Objectives The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability.

Methods Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned.

Results A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years.

Conclusions This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)

SOURCE

http://www.onlinejacc.org/content/72/22/2687

J Am Coll Cardiol. 2018 Sep 18. pii: S0735-1097(18)38287-1. doi: 10.1016/j.jacc.2018.09.001. [Epub ahead of print]

Prosthesis-Patient Mismatch in 62,125 Patients Following Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry.

Abstract

BACKGROUND:

Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (AVR) for aortic stenosis is generally associated with worse outcomes. Transcatheter AVR (TAVR) can achieve a larger valve orifice and the effects of PPM after TAVR are less well studied.

OBJECTIVES:

The authors utilized the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry to examine the frequency, predictors, and association with outcomes of PPM after TAVR in 62,125 patients enrolled between 2014 and 2017.

METHODS:

On the basis of the discharge echocardiographic effective valve area indexed to body surface area, PPM was classified as severe (<0.65 cm2/m2), moderate (0.65 to 0.85 cm2/m2), or none (>0.85 cm2/m2). Multivariable regression models were utilized to examine predictors of severe PPM as well as adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year in 37,470 Medicare patients with claims linkage.

RESULTS:

  • Severe and moderate PPM were present following TAVR in 12% and 25% of patients, respectively. Predictors of severe PPM included small (≤23-mm diameter) valve prosthesis, valve-in-valve procedure, larger body surface area, female sex, younger age, non-white/Hispanic race, lower ejection fraction, atrial fibrillation, and severe mitral or tricuspid regurgitation.
  • At 1 year, mortality was 17.2%, 15.6%, and 15.9% in severe, moderate, and no PPM patients, respectively (p = 0.02).
  • HF rehospitalization had occurred in 14.7%, 12.8%, and 11.9% of patients with severe, moderate, and no PPM, respectively (p < 0.0001).
  • There was no association of severe PPM with stroke or quality of life score at 1 year.

CONCLUSIONS:

Severe PPM after TAVR was present in 12% of patients and was associated with higher mortality and HF rehospitalization at 1 year. Further investigation is warranted into the prevention of severe PPM in patients undergoing TAVR.

KEYWORDS:

aortic stenosis; prosthesis–patient mismatch; transcatheter aortic valve replacement

PMID:
30257798
DOI:
10.1016/j.jacc.2018.09.001

SOURCE

https://www.ncbi.nlm.nih.gov/pubmed/30257798

 

Prior Meta Analysis Study

Ann Thorac Surg. 2016 Mar;101(3):872-80

 

Ann Thorac Surg. 2016 Mar;101(3):872-80. doi: 10.1016/j.athoracsur.2015.11.048. Epub 2016 Jan 29.

Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Implantation.

Abstract

BACKGROUND:

We reviewed currently available studies that investigated prosthesis-patient mismatch (PPM) in transcatheter aortic valve implantation (TAVI) with a systematic literature search and meta-analytic estimates.

METHODS:

To identify all studies that investigated PPM in TAVI, MEDLINE and EMBASE were searched through August 2015. Studies considered for inclusion met the following criteria: the study population included patients undergoing TAVI and outcomes included at least post-procedural PPM prevalence. We performed three quantitative meta-analyses about (1) PPM prevalence after TAVI, (2) PPM prevalence after TAVI versus surgical aortic valve replacement (SAVR), and (3) late all-cause mortality after TAVI in patients with PPM versus patients without PPM.

RESULTS:

We identified 21 eligible studies that included data on a total of 4,000 patients undergoing TAVI. The first meta-analyses found moderate PPM prevalence of 26.7%, severe PPM prevalence of 8.0%, and overall PPM prevalence of 35.1%. The second meta-analyses of six studies, including 745 patients, found statistically significant reductions in moderate (p = 0.03), severe (p = 0.0003), and overall (p = 0.02) PPM prevalence after TAVI relative to SAVR. The third meta-analyses of five studies, including 2,654 patients, found no statistically significant differences in late mortality between patients with severe PPM and patients without PPM (p = 0.44) and between patients with overall PPM and patients without PPM (p = 0.97).

CONCLUSIONS:

Overall, moderate, and severe PPM prevalence after TAVI was 35%, 27%, and 8%, respectively, which may be less than that after SAVR. In contrast to PPM after SAVR, PPM after TAVI may not impair late survival.

Comment in

 

Other related studies published on TAVR, TAVI in this Open Access Online Scientific Journal include the following:

 

  • New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/31/new-method-for-performing-aortic-valve-replacement-transmural-catheter-procedure-developed-at-nih-minimally-invasive-tissue-crossing-transcaval-access-abdominal-aorta-and-the-inferior-vena-cava/

 

  • Second in the United States to implant Edwards Newly FDA-Approved Aortic Valve “Intuity Elite” Sutureless Valve at Northwestern Medicine

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/13/second-in-the-united-states-to-implant-edwards-newly-fda-approved-aortic-valve-intuity-elite-sutureless-valve-at-northwestern-medicine/

 

  • Medtronic’s CoreValve System Sustains Positive Outcomes Through Two Years in Extreme Risk Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/15/medtronics-corevalve-system-sustains-positive-outcomes-through-two-years-in-extreme-risk-patients/

 

  • One year Post-Intervention Mortality Rate: TAVR and AVR – Aortic Valve Procedures 6.7% in AVR, 11.0% in AVR with CABG, 20.7 in Transvascular (TV-TAVR) and 28.0% in Transapical (TA-TAVR) Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/08/04/one-year-post-intervention-mortality-rate-tavr-and-avr-aortic-valve-procedures-6-7-in-avr-11-0-in-avr-with-cabg-20-7-in-transvascular-tv-tavt-and-28-0-in-transapical-ta-tavr-patients/

 

  • Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

 

  • Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/06/22/off-label-tavr-procedures-1-in-10-associated-with-higher-in-hospital-30-day-mortality-1-year-mortality-was-similar-in-the-off-lavel-and-the-on-label-groups/

 

  • First U.S. TAVR Patients Treated With Temporary Pacing Lead (Tempo Lead)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/21/first-u-s-tavr-patients-treated-with-temporary-pacing-lead-tempo-lead/

 

  • SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis: One-Year Clinical Outcomes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/14/sapien-3-transcatheter-aortic-valve-replacement-in-high-risk-and-inoperable-patients-with-severe-aortic-stenosis-one-year-clinical-outcomes/

 

  • TAVR with Sapien 3: combined all-cause death & disabling stroke rate was 8.4% and 16.6% for the surgery arm

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/05/tavr-with-sapien-3-combined-all-cause-death-disabling-stroke-rate-was-8-4-and-16-6-for-the-surgery-arm/

 

  • Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/hadassah-opens-israels-first-heart-valve-disease-clinic/

  • Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/

 

  • Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/

 

  • Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis


Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/03/transcatheter-aortic-valve-replacement-for-inoperable-severe-aortic-stenosis/

 

  • Updated Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

Reporter: Aviva Lev-Ari, PhD,RN

https://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

 

  • The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

 

  • Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/

 

  • Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/04/investigational-devices-edwards-sapien-transcatheter-heart-valve/

 

 

Advertisements

Read Full Post »


First case in the US: Valve-in-Valve (Aortic and  Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices

Writer: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 9/24/2018

TCT: Long-Term Data Reassuring for Valve-in-Valve TAVR

New valve performs well through 3 years

by Nicole Lou, Contributing Writer, MedPage Today

Transcatheter valve-in-valve replacement had lasting benefits in a high-risk patient population requiring valve reintervention, registry data showed.

Starting with 365 patients who got valve-in-valve transcatheter aortic valve replacement (TAVR), death took its toll in 12.1%, 22.2%, and 32.7% by 12, 24, and 36 months, respectively. Stroke and repeat valve replacement had plateaued to 5.1% and 0.6% over 24 months, rising to 6.2% and 1.9% at the 36-month mark.

Valve performance was sustained the whole time, as effective orifice area had a significant boost from baseline to discharge, staying stable thereafter out to 3 years; mean gradient dropped after the procedure and similarly stayed unchanged over time, according to John Webb, MD, of St. Paul’s Hospital in Vancouver, at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

Among survivors, early improvements in functional status were also maintained over the 3-year period, Webb said. Most patients started off in New York Heart Association class 3 and 4 and were reclassified as class 1 and 2 after TAVR. Quality of life also was better, as shown in improved Kansas City Cardiomyopathy Questionnaire overall summary scores: 43.1 at baseline to 70.8 at 30 days (P<0.0001), and staying stable out to 3 years.

The results were not influenced by surgical valve size, failure mode, approach, or residual gradient.

These data are “certainly reassuring out 2-3 years” but the concern lies in anticipation of lower-risk and younger patients who are expected to start getting TAVR in the future, commented Stephan Windecker, MD, of the University of Bern in Switzerland, who was a panelist at the TCT late-breaker trial session.

There are some concerns regarding coronary obstruction, Webb acknowledged. “This is true in surgical valves and it would be every bit as true in transcatheter valves, if not more so.”

Primary Source

Transcatheter Cardiovascular Therapeutics

Source Reference: Webb JG “Late follow-up from the PARTNER aortic valve-in-valve registry” TCT 2018.

SOURCE

https://www.medpagetoday.com/meetingcoverage/tct/75261?xid=nl_mpt_ACC_Reporter_2018-09-23&eun=g5099207d2r

 

UPDATED on 4/13/2014

Replacement of the Mitral Valve: Using the Edwards’ Sapien Aortic Valve Device

https://pharmaceuticalintelligence.com/2014/04/10/replacement-of-the-mitral-valve-using-the-edwards-sapien-aortic-valve-device/

 

 

June 23, 2013

The following is a report of the first case in the US of both aortic and mitral valve transcatheter replacements using transfemoral devices via the transapical approach. 

It is part of a series on the cardiovascular team at the Columbia Univarsity Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation in the Partner trial.

Concomitant Transcatheter Aortic and  Mitral Valve-in-Valve Replacements Using Transfemoral Devices Via the Transapical Approach

Paradis J-M, Kodali SK, Hahn RT, George I, Daneault B, et al.
ColumbiaUniversityMedicalCenter/NewYork-Presbyterian Hospital, New York, NY fJACC:CARDIOVASCULARINTERVENTIONS  2013;6(1):94-96
http://dx.doi.org/10.1016/j.jcin.2012.07.018

Case Presentation

This is an 85 year old man with congestive heart failure (CHF) NYHA class III/IV and hemolytic anemia. He had a previous history of S. viridans bacterial endocarditis that caused severe aortic and mitral regurgitations. Both aortic and mitral valves were replaced in 2002.  A recenttTransesophageal echocardiogram (TEE) showed the left ventricular ejection fraction (LVEF) was 55%.    This was related to severe mitral regurgitation caused by a flail leaflet, and its internal diameters measured 21-23.8 mm.  There was, in addition, severe stenosis of the Carpentir-Edwards valve in the aortic position with an aortic valve area (AVA) of only 0.9 cm, which was 24 mm internal diameter measured by 3-D TEE.

Action Taken

The patient was felt to require reoperative aortic and mitral valve replacements, but he was deemed inoperable by 2 cardiothoracic surgeons.  Therefore they decided to proceed with transapical transcatheter double valve-in-valve implantation using 2 commercially available RetroFlex 3 transfemoral devices (Edwards Lifesciences, Irvine, CA).  A 26-mm Edwards SAPIEN transcatheter heart valve (THV) was placed within the Carpentier-Edwards valve in the aortic position without pre-dilatation under rapid ventricular pacing.  An Edwards SAPIEN 26-mm THV was then deployed within the Hancock modified bioprosthesis in the mitral position with a 2-step inflation technique.  TEE after deplonment of both valves showed excellent function.  The new aortic prosthetic valve had an AVA of 2.08 cm, peak and mean gradients of 12 and 6 mm Hg, respectively, and no aortic insufficiency.  The mitral valve area was 1.65 cm, and there was only trace mitral regurgitation.

Figure 1.TEE Showing the Mitral Bioprosthetic Valve

Transesophageal echocardiogram (TEE) demonstrating (A) color Doppler through the mitral bioprosthetic  valve. Severe intraprosthetic  mitral regurgitation caused by a flail leaflet generates an eccentric regurgitant jet (see Online Video1).The effective regurgitant orifice was calculated  to be 0.42cm. (B) Measurements of the internal dimensions of the mitral bioprosthesis using 3-dimensional reconstruction imaging.

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

Figure 2.TEE Showing  the Aortic Bioprosthetic Valve.

Transesophageal echocardiogram (TEE) showing (A) planimetry of the orifice and (B) measurement of the internal diameter of the aortic bioprosthesis.

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

Figure 3.The 4 Prosthetic Heart Valves.

Final fluoroscopic images showing the 4 prosthetic heart valves (Hancock modified,Carpentier-Edwards, and 2 Edwards SAPIEN transcatheter heart valves) in different angulations

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

Related articles in Pharma Intelligence

Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony

Aviva Lev-Ari, PhD, RN, 7/11/2012

https://pharmaceuticalintelligence.com/2012/07/11/implantable-synchronized-cardiac-assist-device-designed-for-heart-remodeling-abiomeds-symphony/

Biomaterials Technology: Models of Tissue Engineering for Reperfusion and Implantable Devices for Revascularization

Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/5_04_2013/bernstein_lev-ari/Bioengineering_of_Vascular_and_Tissue_Models

Foreseen changes in Guideline of Treatment of Cardiogenic Shock with Intra-aortic Balloon counterPulsation (IABP)

Evidence for Overturning the Guidelines in Cardiogenic Shock

Clinical Indications for Use of Inhaled Nitric Oxide (iNO) in the Adult Patient Market: Clinical Outcomes after Use, Therapy Demand and Cost of Care

Aviva Lev-Ari, PhD, RN, 6/3/2013

Aviral Vatsa PhD MBBS, 1/4/2013

Clinical Trials Results for Endothelin System: Pathophysiological role in Chronic Heart Failure, Acute Coronary Syndromes and MI – Marker of Disease Severity or Genetic Determination?

Aviva Lev-Ari, PhD, RN, 10/19/2013

https://pharmaceuticalintelligence.com/2012/10/19/clinical-trials-results-for-endothelin-system-pathophysiological-role-in-chronic-heart-failure-acute-coronary-syndromes-and-mi-marker-of-disease-severity-or-genetic-determination/

Diagnosis of Cardiovascular Disease, Treatment and Prevention: Current & Predicted Cost of Care and the Promise of Individualized Medicine Using Clinical Decision Support Systems

Justin Pearlman MD ME PhD MA FACC, Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/15/diagnosis-of-cardiovascular-disease-treatment-and-prevention-current-predicted-cost-of-care-and-the-promise-of-individualized-medicine-using-clinical-decision-support-systems-2/

This image was selected as a picture of the we...

This image was selected as a picture of the week on the Farsi Wikipedia for the 46th week, 2010. (Photo credit: Wikipedia)

legend for transesophageal echocardiogram of m...

legend for transesophageal echocardiogram of mitral valve prolapse (Photo credit: Wikipedia)

Diagram of the human heart 1. Superior Vena Ca...

Diagram of the human heart 1. Superior Vena Cava 2. Pulmonary Artery 3. Pulmonary Vein 4. Mitral Valve 5. Aortic Valve 6. Left Ventricle 7. Right Ventricle 8. Left Atrium 9. Right Atrium 10. Aorta 11. Pulmonary Valve 12. Tricuspid Valve 13. Inferior Vena Cava (Photo credit: Wikipedia)

An artificial heart valve may be used to surgi...

An artificial heart valve may be used to surgically replace a patient’s damaged valve. (Photo credit: Wikipedia)

Mitral valve prolapse 2

Mitral valve prolapse 2 (Photo credit: Wikipedia)

Read Full Post »