St. Jude Medical Trifecta aortic valve: Results from a prospective regional multicentre registry

Abstract

Background: The Trifecta aortic bioprosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) is a stented pericardial heart valve with excellent preliminary results. Aim of the study was to evaluate its early clinical and hemodynamic performances in a multicenter regional registry. Methods: Between January 2011 and June 2012, 178 consecutive patients undergoing aortic valve replacement with the Trifecta bioprosthesis were prospectively enrolled at 9 Italian centers. Clinical and echocardiographic data were collectedat discharge, 6-months and at 1-year postoperatively. Results: The average age was 75.4 ± 7.7years,and 95 (53%) were men. Indication for valve replacement included stenosis in 123 patients (69%), mixed lesions in 25 (14%), and regurgitation in 30 (17%). Ninety-three (52%) patients were in NYHA functional class III/ IV. Hospital mortality accounted for 5 (2.8%) patients. No valve-related perioperative complications were encountered. Median follow-up was 20.5months (range: 1-34). Early (≤6months) complications included one thromboembolic event, one major bleeding, and 3 endocarditis (2 explants). Two late (>6months) thromboembolic events and two endocarditis (1 explant) were registered. No valve thrombosis or structural deterioration were observed after discharge. At 30-months, freedom from all-cause mortality was 87%, freedom from valve-related mortality 99.4%, freedom from endocarditis 97.5%, and freedom from valve explants 98%. At 1-year, mean gradients ranged from 8 to 16mmHg, and effective orifice area indexes from 1.0 to 1.2cm2/m2 for valve sizes from 19 to27 mm, respectively. No patients had severe prosthesis-patient mismatch. Conclusions: Trifecta bioprosthesis provided favourable clinical and hemodynamic results over time.