5-Year Follow-Up From the PARTNER 2 Aortic Valve-in-Valve Registry for Degenerated Aortic Surgical Bioprostheses

Abstract

Objectives: The aim of this study was to report the outcomes of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) at 5 years.

Background: TAVR for degenerated surgical bioprostheses in patients at high risk for reoperative surgery is an important treatment option that may delay or obviate the need for surgical intervention; however, long-term outcomes of this procedure are unknown.

Methods: The PARTNER (Placement of Aortic Transcatheter Valves) 2 ViV and continued access registries prospectively enrolled patients with failed surgical bioprostheses at high risk for reoperation. Five-year clinical and echocardiographic follow-up data were obtained in 95.9% of patients.

Results: In 365 (96 registry and 269 continued access) patients, the mean age was 78.9 ± 10.2 years, the mean Society of Thoracic Surgeons predicted risk of surgical mortality score was 9.1 ± 4.7%, and New York Heart Association functional class was III or IV in 90.4%. At 5 years, the Kaplan-Meier rates of all-cause mortality and any stroke were 50.6% and 10.5%, respectively. Using Valve Academic Research Consortium 3 definitions, the incidence of structural valve deterioration, related hemodynamic valve deterioration, or bioprosthetic valve failure at 5 years was 6.6%. Aortic valve re-replacement was performed in 6.3% (n = 14), the majority of which was due to stenosis (n = 6) and combined aortic insufficiency/paravalvular regurgitation (n = 3). The mean gradient, Doppler velocity index, paravalvular regurgitation, and quality of life measured by Kansas City Cardiomyopathy Questionnaire scores in survivors remained stable from 30 days postprocedure through 5 years.

Conclusions: At the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvement in clinical and echocardiographic outcomes.

Keywords: aortic valve replacement; surgical transcatheter; valve-in-valve.

Conflict of interest statement

Funding Support and Author Disclosures Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, and Edwards Lifesciences; has received institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic and Novartis, Equity with Navigate; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Webb has received consulting fees from Edwards Lifesciences. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. Dr Herrmann has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, WL Gore; has received consulting fees/speaking honoraria from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and has equity in Microinterventional Devices. Dr Leipsic has served as a consultant for and owns stock options in Circle Cardiovascular Imaging. Drs Leipsic and Blanke have received funding from Edwards Lifesciences for computed tomography core laboratory analyses in the context of transcatheter valve therapy trials with no direct compensation. Dr Blanke has served as a consultant for Tendyne, Neovasc, and Circle Cardiovascular Imaging. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has received equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; is a national PI for Portico (Abbott) and Acurate (Boston Scientific) US IDE trials; has received personal proctoring fee from Edwards Lifesciences, and has received travel support from Edwards, Abbott and Boston Scientific. Dr Thourani does research and is a consultant for Abbott Vascular, Allergen, Boston Scientific, Cryolife, Edwards Lifesciences, Gore Vascular, and Jenavalve. Dr Xu is an employee of Edwards Lifesciences. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and consulting/advisory board participation for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott. Dr Mack has served as coprimary investigator for the PARTNER Trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic; he received no direct compensation for any of these activities. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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