St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry. Issue 1 (December 2015)

• Record Type: Journal Article
• Authors: Mariscalco, Giovanni; Mariani, Silvia; Bichi, Samuele; Biondi, Andrea; Blasio, Andrea; Borsani, Paolo; Corti, Fabrizio; De Chiara, Benedetta; Gherli, Riccardo; Leva, Cristian; Russo, Claudio; Tasca, Giordano; Vanelli, Paolo; Alfieri, Ottavio; Antona, Carlo; Di Credico, Germano; Esposito, Giampiero; Gamba, Amando; Martinelli, Luigi; Menicanti, Lorenzo; Paolini, Giovanni; Beghi, Cesare
• Is Part Of: Journal of cardiothoracic surgery. Volume 10:Issue 1(2015)
• Page Start: 1
• Page End: 8
• Publication Date: 2015-12
• Subjects: Aortic valve replacement -- Biomaterials -- Heart valve bioprosthesis -- Heart valve replacement; Chest -- Surgery -- Periodicals; Heart -- Surgery -- Periodicals; 617.54005
• DOI: 10.1186/s13019-015-0379-6
• Languages: English
• ISSNs: 1749-8090

Abstract

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 ± 7.7 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 cm2 /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.