St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry
Mariscalco et al. Journal of Cardiothoracic Surgery
St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry
Giovanni Mariscalco 0
Silvia Mariani 2
Samuele Bichi 1
Andrea Biondi 6
Andrea Blasio 5
Paolo Borsani 0
Fabrizio Corti 2
Benedetta De Chiara 4
Riccardo Gherli 0
Cristian Leva 3
Claudio Francesco Russo 4
Giordano Tasca 8
Paolo Vanelli 7
Ottavio Alfieri 5
Carlo Antona 7
Germano Di Credico 3
Giampiero Esposito 1
Amando Gamba 8
Luigi Martinelli 4
Lorenzo Menicanti 6
Giovanni Paolini 2
Cesare Beghi 0
0 Department of Cardiovascular sciences, Clinical Science Wing, University of Leicester, Glenfield Hospital , Leicester , United Kingdom
1 Section of Cardiac Surgery, Department of Cardiovascular Disease, Cliniche Humanitas Gavazzeni , Bergamo , Italy
2 Cardiac Surgery Clinic, University of Milano-Bicocca, San Gerardo Hospital , Monza , Italy
3 Department of Cardiac Surgery, Ospedale Civile di Legnano , Legnano , Italy
4 Cardiac Surgery Unit, Cardio-Thoraco-Vascular Department, Niguarda Cà Granda Hospital , Milan , Italy
5 Department of Cardio-Thoracic and Vascular Surgery, Università Vita-Salute San Raffaele , Milan , Italy
6 Department of Cardiac Surgery, IRCCS Policlinico San Donato , Milan , Italy
7 Cardio-Cerebro-Vascular Department, 'L. Sacco' University General Hospital , Milan , Italy
8 Cardiac Surgery Unit, Alessandro Manzoni Hospital of Lecco , Lecco , Italy
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.
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
(PPM), also in patients with a small aortic annulus relative
to body size or during exercise and recovery, have been
reported [
1–13
]. On the other hand, given the fact that the
Trifecta valve has been introduced in the routine surgery
quite recently, large trials and long-term follow up data
are still lacking, especially concerning the structural
deterioration and the hemodynamic performance of the
valve over time [
14–16
].
Therefore, the present study aims to evaluate early
clinical and hemodynamic performance of the Trifecta
bioprosthesis in a prospective regional Italian
multicenter registry.
Methods
Patient selection
Between 1st January 2011 and 30th June 2012, all
consecutive patients who received a St. Jude Trifecta valve
in aortic position were enrolled at nine Italian centres
located in the Lombardia region (Italy). Inclusion criteria
considered all the patients undergoing primary aortic
valve replacement (AVR) as isolated procedure or in
combination with other cardiac surgical procedures.
Ethic approval was granted by local Institutional Review
Boards, and the informed consent was collected from all
participants.
Surgical technique
Preoperative, anesthetic and postoperative management
followed each institutional policy and remained (...truncated)