• João Pedro Monteiro, Diogo Rijo, Sara Simões Costa, Rodolfo Pereira, Ricardo Ferraz, and Miguel Guerra.
• Centro Hospitalar Vila Nova de Gaia/Espinho, Portugal.
• Rev Port Cir Cardiotorac Vasc. 2017 Jul 1; 24 (3-4): 157.

IntroductionBioprosthesis 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.MethodsWe 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.ResultsThe 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.ConclusionThe 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.

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