Five-year Outcomes Of Aortic Valve Replacement Using A Bioprosthetic Valve With The Novel Resilia Tissue: Final Study Results
Krysztof Bartus1, Agata Bilewska2, Maciej Bochenek1, Maciej Stapor3, Radoslaw Litwinowicz3, Jacek Rozanski2, Jerzy Sadowski1, Boguslaw Kapelak1, Mariusz Kusmierczyk1.
1Jagiellonian University, John Paul II Hospital, Krakow, Poland, 2Institute of Cardiology, Warsaw, Poland, 3John Paul II Hospital, Krakow, Poland.
Objective: Increased life expectancy highlights the need for extended longevity of bioprosthetic tissue in aortic valve replacement (AVR). We here report the outcomes through 5 year follow up of the EU RESILIA feasibility study, investigating the safety and performance in AVR patients of a bioprosthesis with the novel RESILIA tissue, made of bovine pericardium and incorporating integrity preservation technology. Methods: In this prospective, multicenter, single-arm EU RESILIA trial, an independent clinical events committee adjudicated safety events, and an independent echocardiographic core laboratory evaluated hemodynamic performance. Final results from a 5-year follow-up study, through April 20, 2018, are reported here. Results: Between July 2011 and February 2013, 133 patients requiring surgical AVR were implanted with the study valve. Average patient age at implant was 65.3 ± 13.5 years; 26% were ≤60 years old. A 19 or 21 mm valve was implanted in 43.6% of the patients. Study valve implantation was 100% successful. Average and total follow-up was 4.2 ± 1.5 years and 565.2 patient-years, respectively. There were 3 (2.3%) cases of all-cause death during the early (≤30 days) period and 18 (3.2%/554.4 late patient-years) during the late (>30 days) period. The incidence of major bleeding was 6.8% (9 patients) in the early period and 0.4%/late patient-years (2 events) in the late period. There were 0 early and 1 late event (0.2%/late patient-years) of each of valve thrombosis, endocarditis, explant, and non-structural valve dysfunction. There were no events of major paravalvular leak, hemolysis, or structural valve deterioration. The mean effective orifice area and transvalvular gradient at 5 years were 1.4 ± 0.5 cm2 and 14.8 ± 7.6 mm Hg, respectively. Conclusions: This longest-running evaluation of the RESILIA tissue demonstrated excellent safety outcomes and hemodynamic performance over 5 years of follow-up. We eagerly await the investigation of RESILIA™ tissue in the real-world setting.
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