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

Giovanni Mariscalco, Silvia Mariani, Samuele Bichi, Andrea Biondi, Andrea Blasio, Paolo Borsani, Fabrizio Corti, Benedetta De Chiara, Riccardo Gherli, Cristian Leva, Claudio Francesco Russo, Giordano Tasca, Paolo Vanelli, Ottavio Alfieri, Carlo Antona, Germano Di Credico, Giampiero Esposito, Amando Gamba, Luigi Martinelli, Lorenzo Menicanti, Giovanni Paolini, Cesare Beghi

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. 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. The average age was 75.4 ± 7.7 years,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 20.5 months (range: 1-34). Early (≤6 months) complications included one thromboembolic event, one major bleeding, and 3 endocarditis (2 explants). Two late (>6 months) 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 16 mmHg, and effective orifice area indexes from 1.0 to 1.2 cm(2)/m(2) for valve sizes from 19 to27 mm, respectively. No patients had severe prosthesis-patient mismatch. Trifecta bioprosthesis provided favourable clinical and hemodynamic results over time.