St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry
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RESEARCH ARTICLE
Open Access
St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry Giovanni Mariscalco1*, Silvia Mariani2, Samuele Bichi3, Andrea Biondi4, Andrea Blasio5, Paolo Borsani1, Fabrizio Corti2, Benedetta De Chiara6, Riccardo Gherli1, Cristian Leva7, Claudio Francesco Russo6, Giordano Tasca8, Paolo Vanelli9, Ottavio Alfieri5, Carlo Antona9, Germano Di Credico7, Giampiero Esposito3, Amando Gamba8, Luigi Martinelli6, Lorenzo Menicanti4, Giovanni Paolini2 and Cesare Beghi1
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. Keywords: Aortic valve replacement, Biomaterials, Heart valve bioprosthesis, Heart valve replacement
Background The Trifecta aortic bioprosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) is atri-leaflet stented pericardial valve designed for the aortic supra-annular placement [1]. Preliminary and early results about the performances of the Trifecta valve are encouraging [1–5]. Outstanding transvalvular gradients, excellent effective orifice area (EOA) data, low incidence of prosthesis-patient mismatch * Correspondence: [email protected] 1 Department of Cardiovascular sciences, Clinical Science Wing, University of Leicester, Glenfield Hospital, Leicester, United Kingdom Full list of author information is available at the end
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