Mid-term outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study

Abstract Objective To report mid-term clinical outcomes with a self-expandable sutureless aortic valve. Methods Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve. Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. Results Mean age of the population was 78.3±5.6 years and 40.0% (n=263) were ≥80 years; mean Society of Thoracic Surgery−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 min and aortic cross-clamping time was 40.7±18.1 min. 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 mmHg and 9.0±6.3 mmHg, respectively, at 5 years. Preoperatively, 33.4% implanted patients (n=210) were in New York Heart Association functional class I or II versus 93.1% patients (n=242) at 5 years. Conclusions This series, representing the longest follow-up with sutureless technology in a prospective, multicenter study, demonstrates that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.