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

• Published in: Journal of cardiothoracic surgery 2015-11, Vol.10 (169), p.169-169, Article 169
• Main Authors: Mariscalco, Giovanni, Mariani, Silvia, Bichi, Samuele, Biondi, Andrea, Blasio, Andrea, Borsani, Paolo, Corti, Fabrizio, De Chiara, Benedetta, Gherli, Riccardo, Leva, Cristian, Russo, Claudio Francesco, Tasca, Giordano, Vanelli, Paolo, Alfieri, Ottavio, Antona, Carlo, Di Credico, Germano, Esposito, Giampiero, Gamba, Amando, Martinelli, Luigi, Menicanti, Lorenzo, Paolini, Giovanni, Beghi, Cesare
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Aortic Valve - surgery; Aortic Valve Insufficiency - surgery; Aortic Valve Stenosis - surgery; Bioprosthesis; Cardiovascular instruments, Implanted; Complications and side effects; Development and progression; Endocarditis; Female; Follow-Up Studies; Heart Valve Prosthesis; Humans; Male; Middle Aged; Patient outcomes; Prospective Studies; Prosthesis Design; Time Factors
• ISSN: 1749-8090; 1749-8090
• DOI: 10.1186/s13019-015-0379-6

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 to 27 mm, respectively. No patients had severe prosthesis-patient mismatch. Trifecta bioprosthesis provided favourable clinical and hemodynamic results over time.