Thorac Cardiovasc Surg 2012; 60 - V211
DOI: 10.1055/s-0031-1297601

Hemodynamic performance and first clinical experience with the TrifectaTM valve in a prospective single-center study

M Thielmann 1, D Wendt 1, J Aßmann 1, J Böhm 1, S Pasa 1, K Tsagakis 1, H Kälsch 2, T Buck 2, R Erbel 2, H Jakob 1
  • 1Klinik für Thorax- und Kardiovaskuläre Chirurgie, Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Essen, Germany
  • 2Klinik für Kardiologie, Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Essen, Germany

Aims: The TrifectaTM valve (St. Jude Medical, St. Paul, MN) is a tri-leaflet stented pericardial valve designed for supra-annular placement in aortic position. We sought to determine the hemodynamic performance of the Trifecta valve in a prospective, non-randomized, observational, single-center study.

Methods: A total of 128 consecutive patients with aortic valve disease undergoing aortic valve replacement (AVR) using the Trifecta bioprosthesis were studied from an interim analysis (07/2010 to 08/2011). Clinical and hemodynamic data were prospectively recorded. Hemodynamic performance was evaluated by transthoracic echocardiography including mean aortic pressure gradients and effective orifice areas (EOA) and indices (EOAI) at baseline, discharge, 3 and 6 months after surgery.

Results: Patients mean age was 72±7years (mean±SD) and 38% were female. Ninety (70%) of the patients were in NYHA-class III-IV. Logistic EuroSCORE was 14.4±12.2% and STS-score 4.8±6.0% on average. Fifty-two (41%) patients underwent isolated AVR, whereas 76 patients (59%) had concomitant cardiac surgery (21% additional valves, 52% CABG and 11% aortic surgery) and 7 patients as a redo procedure. A total of 11 patients (8.6%) underwent aortic annular root enlargement avoiding any patient prosthesis mismatch. Operative and 30-day mortality was 1/128 (0.8%) and 6/128 (4.7%). Mean aortic pressure gradients, EOAs, and EOAIs were 48.8±17.4mmHg, 0.8±0.3cm2 and 0.43±0.2cm2/m2 at baseline, 9.3±4.7mmHg, 1.9±0.4cm2, and 1.0±0.3cm2/m2 at discharge, 10.9±5.1mmHg, 1.9±0.5cm2, and 1.0±0.4cm2/m2 at 3 months and 8.5±3.4mmHg, 2.1±0.5cm2, and 1.1±0.5cm2/m2 at 6 months follow-up.

Conclusions: This prospective, observational study is the first to demonstrate promising clinical and hemodynamic results of the Trifecta valve within the first 6-months follow-up.