Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure: Placement of Aortic Transcatheter Valves 3 Aortic Valve-in-Valve Study.

Background

Transcatheter aortic valve implantation is safe and effective for high-risk patients with bioprosthetic valve failure (BVF) but has not been studied in low- and intermediate-risk patients. One year outcomes of the PARTNER 3 Aortic Valve-in-valve (AViV) Study were evaluated.

Methods

This prospective, single-arm, multicenter study enrolled 100 patients from 29 sites with surgical BVF. The primary endpoint was a composite of all-cause mortality and stroke at 1 year. The key secondary outcomes included mean gradient, functional capacity, and rehospitalization (valve-related, procedure-related, or heart failure related).

Results

A total of 97 patients underwent AViV with a balloon-expandable valve from 2017 to 2019. Patients were 79.4% male with a mean age of 67.1 years and Society of Thoracic Surgeons score of 2.9%. The primary endpoint occurred in 2 patients (2.1%) who had strokes; there was no mortality at 1 year. Five patients (5.2%) had valve thrombosis events, and 9 patients (9.3%) had rehospitalizations, including 2 (2.1%) for strokes, 1 (1.0%) for heart failure, and 6 (6.2%) for aortic valve reinterventions (3 explants, 3 balloon dilations, and 1 percutaneous paravalvular regurgitation closure). From baseline to 1 year, New York Heart Association class III/IV decreased from 43.3% to 4.5%, mean gradient from 39.1 ± 18.2 mm Hg to 19.7 ± 7.6 mm Hg, and ≥moderate aortic regurgitation from 41.1% to 1.1%.

Conclusions

AViV with a balloon-expandable valve improved hemodynamic and functional status at 1 year and can provide an additional therapeutic option in selected low- or intermediate-risk patients with surgical BVF, although longer term follow-up is necessary.

Informations de copyright

© 2022 The Authors.

Déclaration de conflit d'intérêts

Dr Malaisrie discloses a financial relationship with Edwards Lifesciences, Medtronic, Abbott, Terumo, Cryolife, and Baxter. Dr Zajarias discloses a financial relationship with Edwards Lifesciences, Medtronic, Boston Scientific, and Admedus. Dr Leon discloses a financial relationship with Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Gore & Associates, and Meril Lifescience. Dr Mack discloses a financial relationship with Edwards Lifesciences, Abbott, and Medtronic. Dr Pibarot discloses a financial relationship with institutional Echocardiography Core Lab agreements with Edwards Lifesciences. Dr Hahn discloses a financial relationship with Edwards Lifesciences, Philips Healthcare, Abbott Structural, Boston Scientific, Gore & Associates, Medtronic, and Navigate. Dr Wong discloses a financial relationship with Medtronic, Boston Scientific, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Oldemeyer has no financial relationships to disclose. Dr Shang is an employee of Edwards Lifesciences. Dr Leipsic is a consultant and holds stocks options in CIRCLE CVI and holds institutional core laboratory agreements with Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, MVRX, and Pi Cardia. Dr Blanke discloses a financial relationship with CIRCLE CVI, Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and Gore & Associates. Dr Guerrero discloses a financial relationship with Edwards Lifesciences and Abbott. Dr Brown has nothing to disclose.