Surgical aortic valve replacement with different generations of biological prostheses: haemodynamic valve performance and clinical outcome

Background and Objectives: Structural valve degeneration and the need for reintervention remain the primary challenges associated with biological tissue valves. In recent years, advancements in technology have led to the development of new generations of tissue-preserving valves available for aortic implantation. This study aims to evaluate the long-term outcomes of the Perimount Magna Ease (PME) valve (the latest generation utilizing the Therma Fix preservation process) and the mid-term outcomes of the recently introduced Inspiris Resilia (IR) valve, which is designed to minimize calcification and extend the period free from structural valve degeneration. Methods: The study started with a retrospective analysis. The first part of the study involved analysing 689 PME valves implanted in the aortic position at the AOUI of Verona between 2010 and 2012. We evaluated ten-year outcomes in terms of freedom from major cardiovascular and valve-related events, as well as the hemodynamic performance of the valve, stratified by valve size and age group using a competing risk analysis. The second part of the study was a prospective collection and analysis of all IR valves implanted in the aortic position (tot 451) from 2017 to 2023 at the AOUI of Verona.The third part, focused on a comparative analysis of patients who underwent isolated or combined aortic valve replacement with either IR or PME valves during the same timeframe (2017-2023). A propensity score-matched study was performed to compare the two patient populations regarding five-year outcome.In the fourth part, we involved other six European Cardiac Surgery Centers collecting data on all IR valves implanted in the aortic position from 2017 to 2023, thereby establishing the first multicenter, real-world registry of IR valves. Results: For the PME prostheses,the overall cumulative incidence reported for SVD ≥2 and reoperation were 3.6% and 1.9% at 10 years, respectively. Patients younger than 65 years showed higher cumulative incidence of SVD ≥2 at 10 years compared with patients aged 65 to 75 and older than 75 years (9.7% vs 2.6% vs 2.7%; P= .013), as well as of redo AVR (7.8% vs 3.3% vs 0.4%; P= .002).For the IR valves implanted at AOUI of Verona, freedom from cardiovascular mortality was 97.9%. Five-year freedom from reintervention was 95.2%, while freedom from endocarditis was 92.6%. Freedom from moderate-to-severe and to severe SVD was 94.1% and 98.8% at five years, respectively. The PSM analysis of a younger population (mean age 65 years old) shows no differences in cardiovascular mortality at five years of follow-up (96.5% in PME vs 98.0% in IR ; p 0.41 ) A total of 8 (3.6%). Freedom from prosthesis explant, from endocarditis, from rehospitalization and from stroke were comparable at five-years. Finally, the analysis of the European Resilia Multicentre Registry showed five-year freedom from SVD Stages 1, 2 and 3 of 95.7%, 98.6%, and 99.3%, respectively. The estimated 5-year overall survival was 93.2%, while freedom from cardiovascular mortality was 97.2%. Event-free probabilities at 5 years for endocarditis, stroke and reintervention were 98.6%, 98.1%, and 98.2%, respectively. Mean aortic valve pressure gradient was stable compared to discharge (median 11.0 mmHg at discharge vs 12.0 mmHg at 5 years). Conclusion: PME valve generation demonstrated good long-term clinical and hemodynamic outcomes, however, patients younger than 65 years old had higher incidence of SVD and reintervention. IR valves demonstrated excellent five-year outcome in patients younger than 65 years in single, multicenter analysis, and PSM analysis, with a very low incidence of moderate -to severe SVD. Long-term follow-ups are required to assess and compare long-term outcome with previous generations of prostheses.