Outcomes of Prosthesis-Patient Mismatch Following Supra-Annular Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry
Gilbert H L Tang, Aditya Sengupta, Sophia L Alexis, Vinayak N Bapat, David H Adams, Samin K Sharma, Annapoorna S Kini, Susheel K Kodali, Basel Ramlawi, Hemal Gada, Amit N Vora, John K Forrest, Ryan K Kaple, Fang Liu, Michael J Reardon, Gilbert H L Tang, Aditya Sengupta, Sophia L Alexis, Vinayak N Bapat, David H Adams, Samin K Sharma, Annapoorna S Kini, Susheel K Kodali, Basel Ramlawi, Hemal Gada, Amit N Vora, John K Forrest, Ryan K Kaple, Fang Liu, Michael J Reardon
Abstract
Objectives: The aim of this study was to assess the outcomes of severe prosthesis-patient mismatch (PPM) in the TVT (Transcatheter Valve Therapy) Registry in patients undergoing supra-annular transcatheter aortic valve replacement (TAVR) for de novo stenosis or failed surgical bioprostheses (transcatheter aortic valve [TAV]-in-surgical aortic valve [SAV]).
Background: Severe PPM has been associated with adverse outcomes following TAVR, yet the clinical outcome of severe PPM after supra-annular TAVR is largely unknown.
Methods: Supra-annular TAVR was performed in patients enrolled in the TVT Registry with de novo stenosis (n = 42,174) or TAV-in-SAV (n = 5,446). Valve Academic Research Consortium-3 criteria were used to define severe PPM. The clinical impact of severe PPM on 1-year mortality and valve-related readmission was assessed using multivariate regression. A generalized linear mixed model was used to evaluate predictors of severe PPM.
Results: Severe PPM was found in 5.3% of patients undergoing de novo TAVR and 27.0% of patients undergoing TAV-in-SAV. The presence of severe PPM was not significantly associated with 1-year mortality or valve-related readmissions in both groups. Mean aortic gradients were higher in patients with severe PPM than in those without severe PPM at 1 month (9.7 ± 5.7 mm Hg vs. 7.3 ± 4.0 mm Hg; p < 0.001) and 1 year (10.2 ± 6.4 mm Hg vs. 8.0 ± 4.3 mm Hg; p < 0.001). Pre-procedural factors, including a <20-mm aortic annulus, were positive predictors of severe PPM in patients undergoing de novo TAVR (area under the curve = 0.795) and TAV-in-SAV (area under the curve = 0.764).
Conclusions: Severe PPM after supra-annular TAVR was not associated with increased 1-year mortality or valve-related readmissions. Longer-term follow-up is needed to determine if higher residual gradients in patients with severe PPM predict long-term outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).
Keywords: aortic valve stenosis; patient-prosthesis mismatch; supra-annular; transcatheter aortic valve replacement.
Conflict of interest statement
Funding Support and Author Disclosures Medtronic obtained the data from the TVT Registry and funded the analyses for this report. Dr. Tang is a physician proctor for Medtronic; and is a consultant for Medtronic, Abbott Structural Heart, and W. L. Gore & Associates. Dr. Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C, and Boston Scientific. Dr. Adams has received other support from Medtronic during the conduct of the study; other support from NeoChord and Medtronic outside the submitted work; and receives patent royalties from Edwards Lifesciences (US9526615 B2 and US9011529 B2) and Medtronic (US8764821 B2). Dr. Sharma has served on the Speakers Bureau for Abbott Vascular, Boston Scientific, TriReme, and Cardiovascular Systems. Dr. Kodali has received grants and research support from Medtronic, Boston Scientific, Claret Medical, and Edwards Lifesciences; has served on steering committees for Claret Medical, Edwards Lifesciences, and Meril; has held equity in Thubrikar Aortic Valve; and has received honoraria from Claret Medical and St. Jude Medical. Dr. Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr. Gada has served as a consultant to Abbott, Bard Medical, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Vora serves as a consultant to Medtronic. Dr. Forrest has received grant support and research contracts and consultant fees, honoraria, and Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr. Kaple is a speaker for Abbott and has received honoraria from Edwards Lifesciences. Dr. Liu is an employee and shareholder of Medtronic. Dr. Reardon has received fees to his institution from Medtronic for consulting and providing educational services. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed