Introduction: Bioprosthesis are increasingly used for aortic valve replacement (AVR), as a result of increasing elderly patients, as well as, continuous improvements in durability and hemodynamic performance of pericardial prosthesis. The Trifecta aortic prosthesis is a latest-generation trileaflet stented pericardial valve designed for supra-annular placement in the aortic position. This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve.
Methods: We retrospectively analyzed the data of 373 consecutive patients that underwent surgical implantation of the pericardial stented aortic prosthesis (Trifecta valve; St Jude Medical, St Paul, Minn) at our institution from March 2014 (first implant) to March 2017 (3 years). Pre-operative, operative and post-operative parameters and clinical outcomes, as well as, echocardiography data were evaluated.
Results: The mean age was 73,96 years ± 51, 176 (47,18%) patients were male, mean body mass index of 28,14 ± 12 and 75 (20,11%) were 380-years old. Concomitant procedures were performed in 123 (32,98%) patients. Isolated AVR was undertaken through conventional sternotomy (62,5%), partial sternotomy (35%) or anterior right minithoracotomy (2,5%). Prosthesis sizes implanted were: 19 mm (n=37), 21 mm (n=138), 23 mm (n=196) and 25 mm (n=2). The overall follow-up included 669 late patient-years. Early (≤ 30 day) mortality occurred in 20 patients (5.36%), and there were 4 (1.07%) late (≥ 31 days) deaths yielding a linearized mortality rate of 2.98% per late patient-year. For isolated AVR, mortality occurred in 12 (3.22%) patients. The incidence of new onset atrial fibrillation/flutter was of 28.95% (n=108). Five patients had necessity for implantation of postoperative permanent pacemaker (1,34%), and four mediastinitis/ sternal dehiscence (1.07%) and thirty nine cases of major bleeding required surgery (10.46%). There were 2 early thromboembolic events, including 1 (0,27%) stroke and 1 (0,27%) systemic embolic event. There were no instances of early valve thrombosis, endocarditis, or clinically significant haemolysis. There were no late thromboembolic events or valve structural deterioration. In total, there was 1 late valve explant due to an endocarditis. Overall, freedom from valve explant was 99,77% per late patient- -year. At postoperative echocardiography, average mean gradients across all valve sizes was 10.63mmHg. Mean follow-up was 4± 2 months. No severe aortic regurgitation was observed.
Conclusion: The present systematic review demonstrated that AVR with this prosthesis provided excellent early safety and hemodynamic outcomes with acceptable mean gradients; nevertheless, their timing, pathological characteristics, and clinical presentation mandate continued follow-up.