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Archive for the ‘Prosthesis-Patient Mismatch (PPM) in TAVI vs SAVR’ Category

W. Gerald “Jerry” Austen, MD influential in the design and creation of a cardiopulmonary (heart-lung) bypass machine and the intra-aortic balloon pump at MGH as renowned cardiac surgeon

Curator and reporter: Aviva Lev-Ari, PhD, RN

 

This article is classified in the ontology of LPBI Group’s Journal PharmaceuticalIntelligence.com under the Category of Research

  • Interviews with Scientific Leaders

This category includes 300 articles. LPBI Group’s will publish in July 2023 its Library of Audio Podcasts on “Interviews with Scientific Leaders.”

The presentations in the video below, about W. Gerald “Jerry” Austen, MD contributions to cardiac surgery are considered to be testimonials as well as qualify as  “Interviews with a Scientific Leader” in the domains of cardiac surgery and cardiac repair medical devices with a special focus on: 

  • cardiopulmonary (heart-lung) bypass machine, and
  • the intra-aortic balloon pump

On these two domains, LPBI Group had published extensively as the sources cited, below: Articles, e-Books in English and Spanish and Chapters in these book on the very specialty of Dr. Austen as included in the title of this article.

Image source: https://giving.massgeneral.org/stories/in-memoriam-w-gerald-austen-md?re_appeal=2210IMGENEWSLETTER

 

Watch the video

Celebration of Life for Dr. Jerry Austen 2023, May 6, 2023, at Boston Symphony Hall.

https://players.brightcove.net/pages/v1/index.html?accountId=21720773001&playerId=default&videoId=6327214637112&autoplay=true

 

In Memoriam: W. Gerald Austen, MD

Recently, Mass General celebrated the life and legacy of W. Gerald “Jerry” Austen, MD — a renowned cardiac surgeon, beloved family man and visionary leader.

SOURCE

In Memoriam: W. Gerald Austen, MD – Mass General Giving

https://giving.massgeneral.org/stories/in-memoriam-w-gerald-austen-md?re_appeal=2210IMGENEWSLETTER

For 70 years, Dr. Austen was part of the Mass General community, having completed his residency at the hospital and continuing to become one of the most distinguished and well-regarded physicians in the hospital’s more than 200-year history. At 39 years old, he was named Mass General’s chief of surgical services — a position he held for nearly 29 years. Under his leadership, the Department of Surgery became one of the greatest academic departments of surgery in the country. Among his many contributions, he was influential in the design and creation of a cardiopulmonary (heart-lung) bypass machine and the intra-aortic balloon pump.

Hundreds of Dr. Austen’s closest friends, colleagues and family members gathered at Boston Symphony Hall to commemorate his legacy. A variety of speakers — from current Mass General President David F. M. Brown, MD, to former hospital President Peter Slavin, MD, and retired Chairman, President and CEO of Abiomed Mike Minogue — shared fond memories of Dr. Austen, further illustrating his unmatched and lasting impact on others.

The Mass General community will continue to mourn the loss of such a giant in the medical world and will carry on Dr. Austen’s legacy through compassionate care and an unparalleled commitment to all patients.

Susan Hockfield, ex-President of MIT delivered a speech about mechanical engineering and biomedicine, medical devices and cardiac repair devices. How proud Dr. Austen was about his MIT education and functions he fulfilled for this institutions and others.

Other related contributions on the specialty of Dr.W. Gerald “Jerry” Austen, MD – cardiac surgery are covered in e-books and articles on this Open Access Online Scientific Journal, include the following:

Articles

319 articles in the Cardiac and Cardiovascular Surgical Procedures Category

98 articles in the Aortic Valve Category

Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement

https://pharmaceuticalintelligence.com/2020/02/04/among-patients-with-aortic-stenosis-who-were-at-intermediate-surgical-risk-there-was-no-significant-difference-in-the-incidence-of-death-or-disabling-stroke-at-5-years-after-tavr-as-compared-with-sur/

46 articles in the CABG Category

Call for the abandonment of the Off-pump CABG surgery (OPCAB) in the On-pump / Off-pump Debate, +100 Research Studies

https://pharmaceuticalintelligence.com/2013/07/31/call-for-the-abandonment-of-the-off-pump-cabg-surgery-opcab-in-the-on-pump-off-pump-debate-100-research-studies/

19 articles in the Artificial Heart Category

64 articles in the Valves and Tools Category

207 articles in the medical devices R&D & Inventions Category

e-Books:

English-language Edition:

  • Series A, Volume Six:

Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment2018

(English Edition) Kindle Edition

https://www.amazon.com/dp/B07MKHDBHF

$100

Spanish-language Edition:

  • Serie A, Volumen 6:

Cardiología intervencionista para el diagnóstico de enfermedades y cirugía cardíaca para el tratamiento de afecciones

(Spanish Edition) Kindle Edition. 2022

https://www.amazon.com/dp/B0BPRDLFNH

$75

Chapters in our e-Books on

Dr. Austen’s contributions to inventions

Team Collaborations on this book include:

https://pharmaceuticalintelligence.com/founder/medtech-medical-devices-for-cardiovascular-repair-curations/

Chapter 13:  Valve Replacement, Valve Implantation and Valve Repair

13.2   Aortic Valve

13.2.1 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/

13.2.2 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/

13.2.3 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/

13.2.4 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

https://pharmaceuticalintelligence.com/2018/10/09/surgical-aortic-valve-replacement-savr-vs-transcatheter-aortic-valve-implantation-tavi-results-comparison-for-prosthesis-patient-mismatch-ppm-adjusted-outcomes-including-mortality-heart-fai/

13.2.5 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/

13.2.6 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/

13.2.7 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/

13.2.8 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/

13.2.9 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/

13.2.10 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/

13.2.11 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/

13.2.12 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/

13.2.13 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/

13.2.14 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/

13.2.15 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/

13.2.16 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/

13.2.17 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/

13.2.18 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/

 

Chapter 4: Coronary Arteries Disease and Interventions

4.4     Milestones in CAD Therapy: Vascular Repair and Devices

4.4.1 Endovascular Aortic Repair: A New Tool for Procedure Planning

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/25/endovascular-aortic-repair-a-new-tool-for-procedure-planning/

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

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

https://pharmaceuticalintelligence.com/2013/05/05/bioengineering-of-vascular-and-tissue-models/

 

Chapter 7: Ventricular Failure: Assist Devices, Surgical and Non-Surgical

7.1     Trends in the Industry

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

In addition to minimally invasive treatments for coronary disease and valve disease, there are minimally invasive alternatives to heart transplant for the dangerously weak heart (extreme heart failure) which can otherwise result in Cardiogenic Shock. These involve various means to augment or complement the pumping function of the heart, such as a Ventricular Assist Device (VAD) .

With respect to the performance of Mitral Valve Replacement, the current practice favors bioprosthetic valves over mechanical valve replacement for most patients, initially just used for elderly to avoid need for coumadin, but now used at younger ages due to improvements in longevity of the bioprosthetic valves, plus less damage to red cells.

7.1.2 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

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

Reporter: Aviva Lev-Ari, PhD, RN

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

7.2     Left Ventricular Failure

7.2.1 Entire Family of Impella Abiomed Impella® Therapy Left Side Heart Pumps: FDA Approved To Enable Heart Recovery

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/06/entire-family-of-impella-abiomed-impella-therapy-left-side-heart-pumps-fda-approved-to-enable-heart-recovery/

7.2.2 Treatment Options for Left Ventricular Failure – Temporary Circulatory Support: Intra-aortic balloon pump (IABP) – Impella Recover LD/LP 5.0 and 2.5, Pump Catheters (Non-surgical) vs Bridge Therapy: Percutaneous Left Ventricular Assist Devices (pLVADs) and LVADs (Surgical)

Author: Larry H Bernstein, MD, FCAP And Curator: Justin D Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2013/07/17/treatment-options-for-left-ventricular-failure-temporary-circulatory-support-intra-aortic-balloon-pump-iabp-impella-recover-ldlp-5-0-and-2-5-pump-catheters-non-surgical-vs-bridge-therapy/

7.2.3 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock

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

https://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-of-intractable-cardiogenic-shock/

7.2.4 Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction

Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/05/09/experimental-therapy-left-inter-atrial-shunt-implant-device-for-heart-failure-expert-opinion-on-a-preliminary-study-on-heart-failure-with-preserved-ejection-fraction/

7.3     Right Ventricular Failure

7.3.1 Dilated Cardiomyopathy: Decisions on implantable cardioverter-defibrillators (ICDs) using left ventricular ejection fraction (LVEF) and Midwall Fibrosis: Decisions on Replacement using late gadolinium enhancement cardiovascular MR (LGE-CMR)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/03/10/dilated-cardiomyopathy-decisions-on-implantable-cardioverter-defibrillators-icds-using-left-ventricular-ejection-fraction-lvef-and-midwall-fibrosis-decisions-on-replacement-using-late-gadolinium/

 

Chapter 11: Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

11.1   Hybrid Cath Lab/OR Suite

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

In an uncommon reversal of opinion, the combined forces of the American Heart Association (AHA) and the American College of Cardiology (ACC) reviewed compelling data and reversed a prior assessment on the need for an on-site cardiovascular surgery support for sites offering interventional cardiac catheterization. The data show that sites offering the intervention without a surgeon achieve better results that sites that ship patients out for the interventions, and that the risk without on-site thoracic surgery backup is negligible.

AHA, ACC Change in requirement for surgical support:  Class IIb -> Class IIa Level of Evidence A: Supports Nonemergent PCI without Surgical Backup (Change of class IIb, level of Evidence B).

Larry H Bernstein, MD, FCAP and Justin D Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2013/07/17/aha-acc-change-in-requirement-for-surgical-support-class-iib-class-iia-level-of-evidence-a-support-nonemergent-pci-without-surgical-backup-change-of-class-iib-level-of-evidence-b/

11.1.1  3D Cardiovascular Theater – Hybrid Cath Lab/OR Suite, Hybrid Surgery, Complications Post PCI and Repeat Sternotomy

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/3d-cardiovascular-theater-hybrid-cath-labor-suite-hybrid-surgery-complications-post-pci-and-repeat-sternotomy/

11.1.2 Coronary Reperfusion Therapies: CABG vs PCI – Mayo Clinic preprocedure Risk Score (MCRS) for Prediction of in-Hospital Mortality after CABG or PCI

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

https://pharmaceuticalintelligence.com/2013/06/30/mayo-risk-score-for-percutaneous-coronary-intervention/

11.1.3 Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

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

https://pharmaceuticalintelligence.com/2013/06/23/comparison-of-cardiothoracic-bypass-and-percutaneous-interventional-catheterization-survivals/

11.1.4 Left Main Coronary Artery Disease (LMCAD): Stents vs CABG – The less-invasive option is Equally Safe and Effective

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/left-main-coronary-artery-disease-lmcad-stents-vs-cabg-the-less-invasive-option-is-equally-safe-and-effective/

11.1.5 Revascularization: PCI, Prior History of PCI vs CABG

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/25/revascularization-pci-prior-history-of-pci-vs-cabg/

11.1.6 Patients with Heart Failure & Left Ventricular Dysfunction: Life Expectancy Increased by coronary artery bypass graft (CABG) surgery: Medical Therapy alone and had Poor Outcomes

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/04/patients-with-heart-failure-left-ventricular-dysfunction-life-expectancy-increased-by-coronary-artery-bypass-graft-cabg-surgery/

11.2.6 CABG Survival in Multivessel Disease Patients: Comparison of Arterial Bypass Grafts vs Saphenous Venous Grafts

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

https://pharmaceuticalintelligence.com/2013/06/30/multiple-arterial-grafts-improve-late-survival-of-patients-with-multivessel-disease/

11.2.7 CABG or PCI: Patients with Diabetes – CABG Rein Supreme

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/11/05/cabg-or-pci-patients-with-diabetes-cabg-rein-supreme/

11.2.8 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

https://pharmaceuticalintelligence.com/2018/07/25/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/

11.2.9 Expected New Trends in Cardiology and Cardiovascular Medical Devices

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/17/expected-new-trends-in-cardiology-and-cardiovascular-medical-devices/

11.2.10 Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/09/patient-access-to-medical-devices-a-comparison-of-u-s-and-european-review-processes/

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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 4/13/2023

TAVR vs. SAVR in patients with pure aortic regurgitation: Key insights from a new Cleveland Clinic study
Michael Walter | April 11, 2023 | TAVR

Overall, TAVR and SAVR patients were linked to comparable in-hospital mortality, 30-day mortality and 30-day stroke rates. After a median follow-up period of 31 months, however, TAVR patients were associated with a higher mortality rate and higher risk of redo aortic valve replacement.

“The poorer intermediate-term outcomes with TAVR in our study could potentially be due to residual unmeasured differences and surgical risk between the two groups, but could also be related to the anatomical differences between pure severe AR and aortic stenosis,” the authors wrote. “The increased prevalence of bicuspid leaflets and annular/aortic root dilation in AR patients, with relatively less leaflet and annular calcification, pose a challenge with transcatheter heart valve anchoring and adequate positioning and increase the risk of paravalvular leak and device embolization. Abnormal hemodynamics across prosthetic valves and paravalvular leakage, whether mild or moderate/severe, are known predictors of poor outcomes, including death. The recommendation to oversize the THV during implantation is also associated with increased risk of aortic rupture and conversion to open heart surgery, a complication that was observed in 1% of TAVR patients in our study.”

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/

 

 

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