Early and late effects of aortic root enlargement: Results from the Pericardial Surgical Aortic Valve Replacement Pivotal Trial: A multicenter, prospective clinical trial

Abstract

ObjectiveDuring surgical aortic valve replacement, prosthesis–patient mismatch is avoided by implanting the largest possible valve, which sometimes requires annular enlargement (ARE). The effects of ARE on mortality remain controversial. We reviewed data from a multinational clinical trial evaluating a novel pericardial bioprosthesis to determine the influence of ARE 5 years postimplant. MethodsPatients with aortic valve disease requiring surgical aortic valve replacement were prospectively enrolled at 25 centers in North America and 13 centers in Europe. Standardized follow-up was prescribed, including serial echocardiography assessed by a core lab. A composite 30-day end point of major morbidity or mortality was defined as death, reoperation for any cause, stroke, deep sternal wound infection, and acute kidney injury. ResultsAmong 602 patients with detailed intraoperative data, 90 (15%) underwent ARE with similar rates in North America (17%) and Europe (12%; P = .11). Implanted valve size was similar in both groups (P = .18). The prevalence of moderate or severe prosthesis–patient mismatch at 12 months and at 5 years was comparable between groups, as was the average indexed effective orifice area (P = .3). Five-year survival (ARE, 91% vs no ARE, 89%) and freedom from 30-day major morbidity and mortality (ARE, 87% vs no ARE, 89%) were also similar. ConclusionsIn this analysis of a prospective, observational clinical trial, we observed that the performance of an aortic root enlargement procedure did not increase morbidity or mortality at 30 days. We found that survival at 5 years was similar between groups, suggesting that the performance of an ARE procedure restored survival to that observed in patients who did not require an ARE.