Kevin Phan1, Hakeem Ha2, Steven Phan3, Martin Misfeld4, Marco Di Eusanio5, Tristan D Yan6. 1. The Collaborative Research (CORE) Group, Macquarie University, Sydney, Australia; Westmead Clinical School, Sydney Medical School, The University of Sydney, Sydney, Australia; St Vincent's Clinical School, The University of New South Wales, Sydney, Australia. 2. St Vincent's Clinical School, The University of New South Wales, Sydney, Australia. 3. The Collaborative Research (CORE) Group, Macquarie University, Sydney, Australia. 4. University of Leipzig, Heart Center, Leipzig, Germany. 5. The Collaborative Research (CORE) Group, Macquarie University, Sydney, Australia; Cardiovascular Surgery Department, Sant'Orsola-Malpighi Hospital, Bologna University, Bologna, Italy. 6. The Collaborative Research (CORE) Group, Macquarie University, Sydney, Australia; Department of Cardiothoracic Surgery, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia. Electronic address: tristanyan@annalscts.com.
Abstract
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.
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.
Authors: Paolo Nardi; Calogera Pisano; Fabio Bertoldo; Sara Rita Vacirca; Monica Greci; Carlo Bassano; Antonio Scafuri; Antonio Pellegrino; Giovanni Ruvolo Journal: J Thorac Dis Date: 2019-04 Impact factor: 2.895