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

Journal of Cardiothoracic Surgery

Cesare Beghi⁴  Giovanni Paolini⁹  Lorenzo Menicanti⁷  Luigi Martinelli³  Amando Gamba²  Giampiero Esposito⁶  Germano Di Credico⁸  Carlo Antona¹  Ottavio Alfieri⁵  Paolo Vanelli¹  Giordano Tasca²  Claudio Francesco Russo³  Cristian Leva⁸  Riccardo Gherli⁴  Benedetta De Chiara³  Fabrizio Corti⁹  Paolo Borsani⁴  Andrea Blasio⁵  Andrea Biondi⁷  Samuele Bichi⁶  Silvia Mariani⁹  Giovanni Mariscalco⁴ 

[1]Cardio-Cerebro-Vascular Department, ‘L. Sacco’ University General Hospital, Milan, Italy

[2]Cardiac Surgery Unit, Alessandro Manzoni Hospital of Lecco, Lecco, Italy

[3]Cardiac Surgery Unit, Cardio-Thoraco-Vascular Department, Niguarda Cà Granda Hospital, Milan, Italy

[4]Department of Cardiovascular sciences, Clinical Science Wing, University of Leicester, Glenfield Hospital, Leicester, United Kingdom

[5]Department of Cardio-Thoracic and Vascular Surgery, Università Vita-Salute San Raffaele, Milan, Italy

[6]Section of Cardiac Surgery, Department of Cardiovascular Disease, Cliniche Humanitas Gavazzeni, Bergamo, Italy

[7]Department of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy

[8]Department of Cardiac Surgery, Ospedale Civile di Legnano, Legnano, Italy

[9]Cardiac Surgery Clinic, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy

关键词: Heart valve replacement;    Heart valve bioprosthesis;    Biomaterials;    Aortic valve replacement;   

Others  :  1235114
DOI  :  10.1186/s13019-015-0379-6

 received in 2015-09-04, accepted in 2015-11-12,  发布年份 2015

【 摘 要 】

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 cm ² /m ²for 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.

【 授权许可】

   
2015 Mariscalco et al.

【 图 表 】

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