Background: Structural valve deterioration (SVD) is a major obstacle to lifetime durability for bioprosthetic heart valves. A bio­prosthetic valve created with RESILIA™ tissue was designed to produce long-term resistance to SVD.

Aim: The objective of this study was to evaluate the safety and performance of this new class of RESILIA™ tissue aortic bio­prosthesis.

Methods: A nonrandomised, prospective, multi-centre, single-arm, observational study was performed in 133 patients who underwent surgical aortic valve replacement between July 2011 and February 2013. Patients were assessed at 3–6 months and one year for haemodynamic performance, clinical outcomes, and functional improvement.

Results: The mean age was 65.3 ± 13.5 years, with 34 (25.6%) of patients < 60 years of age. Early (≤ 30 day) and late (> 30 day) all-cause mortality rates were 2.3% (n = 3) and 4.5% (n = 6), respectively. Early events included thromboembolism in three (2.3%) patients and major bleeding events requiring transfusion in six (4.5%) patients. Late events included one endocarditis leading to explant. Mean gradients were reduced across all valve sizes and were maintained at one year of follow-up. The mean effective orifice area and effective orifice area index increased across all valve sizes postoperatively and were maintained at one year. The rates of paravalvular leak (> 2+) at 3–6 months and one-year follow-up were 0.7% and 0.7%, respectively.

Conclusions: The new generation RESILIA™ tissue aortic valve bioprosthesis demonstrated excellent haemodynamic per­formance and safety outcomes at one year of follow-up. Longer follow-up of these patients will provide further insight on long-term durability.