Early hemodynamic performance of the complete supraannular Trifecta aortic valve bioprosthesis - a single-center experience in a series of 608 patients

Objectives: The St. Jude Medical Trifecta bioprosthesis is a new stented tri-leaflet pericardial valve designed for supra-annular aortic valve replacement (AVR) incorporating several design features including a true supra-annular sewing cuff and a stent designed to maximize valve hemodynamics. The aim of the study was to evaluate the early clinical outcome and the hemodynamic performance in patients undergoing AVR with the Trifecta bioprosthesis at our institution.

Methods: A total of 608 consecutive patients with severe symptomatic aortic valve disease (mean NYHA class 2.9 ± 0.9) underwent AVR between January 2009 and March 2013 with the implantation of the Trifecta aortic valve prosthesis. Mean age was 69.5 ± 9.3 (range 18-88 years). 387 patients were male and 221 were female (63.7/36.3%). Mean EuroSCORE was 6.8 ± 2.9%. Procedures were as follows: Isolated AVR (n = 210/34.5%), with a partial upper mini-sternotomy used in 70% of cases. AVR with one or more concomitant procedures (n = 398/65.5%): CABG (n = 219/55%), mitral valve repair/replacement (n = 55/13.8%), tricuspid valve repair/replacement (n = 34/8.5%). All intra- and postoperative data were collected prospectively. At discharge, hemodynamic evaluation was performed by means of transthoracic echocardiography in all patients.

Results: Mean cross-clamp and CPB times were 85.6 ± 32.8 and 119.8 ± 47.1 min. There were no intraoperative deaths. Mean hospital stay was 11 days. The 30-day in-hospital mortality was 3.2%. Adjusted mean systolic pressure gradients (MPG) for valve sizes 19 (n = 28/4.6%), 21 (n = 147/24.2%), 23 (n = 199/32.7%), 25 (n = 140/23.0%), 27 (n = 63/10.4%) and 29 mm (n = 30/4.9%), were 9.2 ± 5.8, 10.8 ± 4.2, 9.5 ± 3.7, 8.4 ± 2.8, 7.9 ± 2.6 and 5.4 ± 1.6 mmHg, respectively. Mean effective orifice area (EOA) for valve sizes 19, 21, 23, 25, 27 and 29 mm were 1.6 ± 0.4, 1.7 ± 0.4, 1.9 ± 0.4, 2.0 ± 0.3, 2.3 ± 0.4 and 2.8 ± 0.6 cm², respectively. Severe patient-prosthesis mismatch (EOAI < 0.65 cm²/m²) occurred in 4.8% of patients, mild mismatch (EOAI < 0.85 cm²/m²) was observed in 21.9% of patients. No prosthesis dislocation, endocarditis, valve thrombosis or relevant aortic regurgitation was observed until discharge.

Conclusions: The initial experience with the Trifecta valve bioprosthesis shows good clinical outcomes with excellent early hemodynamic performance. Further studies with longer follow-up are needed to confirm these promising preliminary results.