Objective: The Trifecta aortic prosthesis is a latest-generation trileaflet stented pericardial valve designed for supra-annular placement in the aortic position. Robust clinical evidence and long-term follow-up data for this new prosthesis are lacking; a systematic review was conducted to assess current evidence.
Methods: A comprehensive search from 6 electronic databases was performed, with time period parameters dating from database inception to January 2014. Results utilizing Trifecta prosthesis for aortic valve replacement (AVR) were identified.
Results: A total of 13 studies with 2549 patients undergoing AVR with this prosthesis were included in this review. The mean proportion of patients with aortic stenosis was 82.4%, with a mean gradient of 47.4 mm Hg, and a pooled effective orifice area (EOA) of 0.74 cm(2). Valve sizes of 21 mm and 23 mm were implanted in 71.3% of patients. The pooled rates of 30-day mortality, cerebrovascular accidents, and acute kidney injuries were 2.7%, 1.9%, and 2.6%, respectively. After implantation, the pooled mean gradient decreased to 9.2 mm Hg, whereas discharge EOA increased to 1.8 cm(2), compared with preoperative parameters. Among included studies with significant heterogeneity detected, most patients had satisfactory patient-prosthesis mismatch, with 2.7% having severe mismatch.
Conclusions: The present systematic review demonstrated that short-term AVR with this prosthesis provided excellent early safety and hemodynamic outcomes with acceptable mean gradients and EOA. Long-term follow-up and randomized controlled trials are warranted to confirm the early results.
Keywords: Aortic valve; outcomes; replacement.
Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.