Early hemodynamic performance of the third generation St Jude Trifecta aortic prosthesis: A systematic review and meta-analysis

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 cm². 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 cm², 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.