Balloon-Expandable Valve Geometry After Transcatheter Aortic Valve Replacement in Low-Risk Patients With Bicuspid Versus Tricuspid Aortic Stenosis.


Journal

Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551

Informations de publication

Date de publication:
12 2021
Historique:
received: 26 03 2021
accepted: 31 03 2021
pubmed: 4 6 2021
medline: 1 1 2022
entrez: 3 6 2021
Statut: ppublish

Résumé

Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS). The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS. A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year. Despite challenging bicuspid anatomy of the aortic valve, our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies. NCT02628899, https://clinicaltrials.gov/ct2/show/NCT02628899.

Sections du résumé

BACKGROUND
Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS).
METHODS
The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS.
RESULTS
A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year.
CONCLUSION
Despite challenging bicuspid anatomy of the aortic valve, our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies.
TRIAL REGISTRY
NCT02628899, https://clinicaltrials.gov/ct2/show/NCT02628899.

Identifiants

pubmed: 34078581
pii: S1553-8389(21)00187-1
doi: 10.1016/j.carrev.2021.03.027
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT02628899']

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

7-12

Informations de copyright

Copyright © 2021. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. Puja Parikh – Consultant: Medtronic, Inc. Federico Asch – No personal disclosures. Director of the MedStar Health Academic Echocardiography Core Laboratory which has institutional contracts with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, Biotronik and LivaNova. Gaby Weissman – No personal disclosures. Director of an academic cardiac computed tomography core lab with institutional contracts with Ancora Heart and LivaNova. Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Auteurs

Giorgio A Medranda (GA)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Toby Rogers (T)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America.

Brian J Forrestal (BJ)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Brian C Case (BC)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Charan Yerasi (C)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Chava Chezar-Azerrad (C)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Christian C Shults (CC)

Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC, United States of America.

Rebecca Torguson (R)

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.

Corey Shea (C)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Puja Parikh (P)

Department of Medicine, Stony Brook Hospital, Stony Brook, NY, United States of America.

Thomas Bilfinger (T)

Department of Surgery, Stony Brook Hospital, Stony Brook, NY, United States of America.

Thomas Cocke (T)

Department of Cardiology, The Valley Hospital, Ridgewood, NJ, United States of America.

Mariano E Brizzio (ME)

Department of Cardiothoracic Surgery, The Valley Hospital, Ridgewood, NJ, United States of America.

Robert Levitt (R)

Department of Cardiology, HCA Virginia Health System, Richmond, VA, United States of America.

Chiwon Hahn (C)

Department of Cardiothoracic Surgery, HCA Virginia Health System, Richmond, VA, United States of America.

Nicholas Hanna (N)

St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK, United States of America.

George Comas (G)

Department of Cardiothoracic Surgery, St. John Health System, Tulsa, OK, United States of America.

Paul Mahoney (P)

Department of Cardiology, Sentara Norfolk General Hospital, Norfolk, VA, United States of America.

Joseph Newton (J)

Department of Cardiothoracic Surgery, Sentara Norfolk General Hospital, Norfolk, VA, United States of America.

Maurice Buchbinder (M)

Department of Cardiology, Foundation for Cardiovascular Medicine, San Diego, CA.

Cheng Zhang (C)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Paige E Craig (PE)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

W Guy Weigold (WG)

Department of Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Federico M Asch (FM)

MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC, United States of America.

Gaby Weissman (G)

Department of Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Hector M Garcia-Garcia (HM)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Itsik Ben-Dor (I)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Lowell F Satler (LF)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.

Ron Waksman (R)

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America. Electronic address: ron.waksman@medstar.net.

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