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Updated: Aug 5, 2026
Transcatheter Pulmonary Valve Replacement from Autologous Pericardium with a Self-Expandable Nitinol Stent in an Adult Sheep Model
Published on: June 8, 2022
Valve-Related Outcomes up to Six Years of a Next-Generation Bovine Pericardial Bioprosthesis Compared with Its
Alessandra Francica1, Fabiola Perrone1, Irene Maffei1
1Division of Cardiac Surgery, Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona, 37126 Verona, Italy.
Abstract:
Background: Current ESC/EACTS guidelines recommend bioprosthetic valves for aortic valve replacement (AVR) in patients > 65 years, yet their use is increasing among younger individuals. The INSPIRIS Resilia (IR) valve, a next-generation bioprosthesis, was designed to improve durability and reduce structural valve degeneration (SVD). This study compares clinical and valve-related outcomes up to six years in patients undergoing AVR with either the IR or its predecessor, the Perimount Magna Ease (PME) valve. Methods: Between January 2017 and December 2023, 2053 patients underwent isolated or combined AVR at a single institution (1602 PME; 451 IR). Propensity-score matching identified 224 patient pairs with comparable baseline characteristics. Outcomes were assessed over follow-up extending up to six years, focusing on cardiovascular and valve-related adverse events. Transvalvular gradients were also assessed at follow-up. Results: After matching, mean age was 64.2 ± 7.7 years in both groups. Freedom from cardiovascular mortality at six years was similar between PME and IR (96.6% vs. 98.2%; p = 0.34), as were rates of stroke, rehospitalization, prosthetic valve endocarditis, and reintervention. A total of 12 PME (5.4%) and six IR valves (2.5%) were explanted during follow-up (p = 0.15), with prosthetic endocarditis representing the leading cause of reintervention. Only one case of severe SVD was observed in both groups. Conclusions: In patients undergoing AVR with comparable baseline risk profiles, IR and PME valves demonstrated similar clinical, valve-related, and hemodynamic outcomes up to six years of follow-up. Prosthetic valve endocarditis represented the leading cause of valve failure, whereas structural valve deterioration remained rare. Longer follow-up and a greater number of valve-related events will be necessary to determine whether differences in bioprosthetic valve degeneration emerge over time.
