Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study.

The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance. Despite the advanced age of the study population, with an intermediate risk profile, mortality and morbidity rates at 5 years compare with those reported in both arms of recent trials that have compared transcatheter and surgical valves in similar risk populations. CAVALIER , Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark; DSMB , Data Safety Monitoring Board; CEC , Clinical Event Committee; Echo , echocardiography; SD , standard deviation; STS , Society of Thoracic Surgeons; CI , confidence interval; AVR , aortic valve replacement. [Display omitted] [ABSTRACT FROM AUTHOR]