Haemodynamic performance of the small supra-annular Trifecta bioprosthesis: results from a French multicentre study.

OBJECTIVES: The St Jude Medical Trifecta bioprosthesis incorporates a single pericardial sheet externally mounted on a titanium stent that provides excellent haemodynamic results. The purpose of this multicentre study was to report on the haemodynamic performance and the expected lower risk of prosthesis-patient mismatch in patient with small aortic annulus diameters.

METHODS: The 19- and 21-mm Trifecta valves were implanted in 88 and 266 eligible patients, respectively between 2011 and 2013 at three centres in France (Angers, Rennes and Amiens). The mean age of the population was 78 ± 7 and 76 ± 6 years for 19- and 21-mm valve sizes of which 96.6 and 68% were female, respectively. The aortic valve replacement was associated with another surgery in 18.2 and 21.8% in each group, respectively.

RESULTS: The mean follow-up was 20.3 ± 11.9 and 24 ± 11.4 months for 19- and 21-mm valves, respectively. Early all-cause mortality was 2.5% and late mortality occurred in 5.8% of patients. The mean pressure gradient and the effective orifice area at discharge and at 1 year were respectively 12.4 ± 4.6 and 14.7 ± 5.8 mmHg (P = 0.003), 1.5 ± 0.3 and 1.4 ± 0.9 cm(2) (P = 0.06) in the 19-mm valve group; 10.4 ± 3.8 and 11.7 ± 4.5 mmHg (P = 0.001), 1.8 ± 0.3 and 1.5 ± 0.4 cm(2) (P = 0.1) in the 21-mm valve group. At 1 year, only 38 (11%) and 28 (8.1%) patients presented a moderate or severe prosthesis-patient mismatch for the two groups. After univariate analysis, no risk factor of mismatch was found.

CONCLUSIONS: The 19- and 21-mm St Jude Medical Trifecta provide excellent haemodynamic performance and the rate of moderate and severe prosthesis-patient mismatch is low.