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Updated: Dec 9, 2025
Transcatheter Pulmonary Valve Replacement from Autologous Pericardium with a Self-Expandable Nitinol Stent in an Adult Sheep Model
Published on: June 8, 2022
Double transcatheter balloon-expandable valve implantation for severe valve dysfunction in high-risk patients:
João Bosco Breckenfeld Bastos Filho1, Roney Orismar Sampaio1, Felipe Reale Cividanes1
1Heart Institute of São Paulo (InCor), University of São Paulo, São Paulo, Brazil.
Objectives:
Concomitant valvular heart valve disease is a frequent finding, with higher morbidity and mortality among patients undergoing redo surgical procedures. Our goal was to report our initial experience with combined transcatheter Inovare bioprosthesis implants for severe valve dysfunction.
Methods:
Among 300 transcatheter procedures, a total of 6 patients had concurrent simultaneous transcatheter bioprosthesis implants for severe mitral bioprosthesis failure (valve-in-valve), with a second valve procedure that included native aortic (n = 2) or degenerated bioprostheses in the aortic position (n = 4). During the procedures, all patients were treated with a balloon-expandable Inovare transcatheter valve, using the transapical approach.
Results:
Patients were highly symptomatic [New York Heart Association (NYHA) functional class IV: 100%], with a mean age of 62 ± 5 years, yielding a mean European System for Cardiac Operative Risk II (EuroSCORE II) of 24.0 ± 10.1%. There was a mean of 1.6 ± 0.4 prior valve operations/patient, with a median time from prior mitral bioprosthesis surgery of 13.0 (9.2-20.0) years. Device success was 100% according to the Mitral Valve Academic Research Consortium and the Valve Academic Research Consortium-2 criteria. During the hospital stay, only 1 patient required dialysis, and the median intensive care unit and hospital lengths of stay were 5.0 (3.2-6.7) days and 16.0 (12.2-21.2) days, respectively. No deaths occurred at 30 days; at a median follow-up of 287 (194-437) days, 1 patient died of a non-cardiac cause and the rest of patients were in NYHA functional class I or II, with normofunctioning bioprostheses.
Conclusions:
Transcatheter double valve interventions using the Inovare bioprosthesis in this initial series were shown to be a reasonable alternative to redo surgical operations. The short- and mid-term clinical and echocardiographic outcomes demonstrate promising results, although future studies with a larger number of patients and longer follow-up are warranted.
