Objective: The objective of our study is to evaluate safety, hemodynamic performance and durability of the new generation aortic bioprosthesis with Resilia Tissue.
Methods: RES-ITA Registry is the Italian multicenter registry created in 2017, enrolling patients who underwent isolated or combined AVR with Resilia tissue valve. The Registry was recently recognized by SICCH as the official national registry of Resilia tissue valve implantations, with Potenza’s Cardiac Surgery Unit as its coordinating center. Isolated AVR (50%) was performed predominantly through an upper J mini-sternotomy or a right anterior mini-thoracotomy, while combined procedures (50%) were performed in full sternotomy and included associated CABG, ascending aorta surgery, mitral valve repair or replacement, aortic annulus enlargement. For all patients, clinical and echocardiographic assessment were evaluated at discharge, 30 days, 6 months and every year after surgery.
Results: Between June 2017 and March 2022, about 1000 patients were included, coming from 13 Italian cardiac surgery centers. During last year, 6 more Italian centers have asked to join the Registry. Mean age was 57±11 years. Mean Euroscore II was 2.24±3.01%. Redo surgery was performed in 11%. Most frequently implanted valve sizes were 23 mm (30%), 25 mm (27.7%) and 27 mm (19%). Two-year freedom from all-cause mortality for isolated AVR and for all patients was 97.4±1.3% and 95.7±1.1%, respectively. Two-year freedom from major paravalvular leaks (≥2+/4) was 98.4±0.8; freedom from prosthesis thrombosis was 96.7±2 and freedom from prosthesis dysfunction (according to VARC-2 criteria) was 96.7±1.7. Mean gradient was 13.3±8.3 mmHg and maximum gradient was 23.2±16.2 mmHg at 2-year follow-up.
Conclusions: The new generation aortic prosthesis with RESILIA tissue demonstrates versatility of use, safety, good early and mid-term outcomes and hemodynamic performance. Further investigations and longer follow-up are needed to evaluate long-term durability.