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

S. Chris Malaisrie, Alan Zajarias, Martin B. Leon, Michael J. Mack, Philippe Pibarot, Rebecca T. Hahn, David Brown, S. Chiu Wong, J. Bradley Oldemeyer, Kan Shang, Jonathon Leipsic, Philipp Blanke, Mayra Guerrero

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1 Scopus citations

Abstract

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.

Original languageEnglish
Article number100077
JournalStructural Heart
DOIs
StateAccepted/In press - 2022

Keywords

  • Aortic valve replacement
  • Bioprosthesis
  • Regurgitation
  • Stenosis
  • Transcatheter

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