Key result
Small Trifecta bioprostheses yield excellent hemodynamics with under ~11% moderate-to-severe prosthesis-patient mismatch at one year.
Why the study?
The haemodynamic performance and risk of prosthesis-patient mismatch of the small 19- and 21-mm St Jude Medical Trifecta bioprosthesis in patients with small aortic annulus diameters were not well reported.
Does the 19- and 21-mm St Jude Medical Trifecta bioprosthesis provide good haemodynamic performance and a low risk of prosthesis-patient mismatch in patients with small aortic annulus diameters?
Cohort (n=354)
Yes
Does the 19- and 21-mm St Jude Medical Trifecta bioprosthesis provide good haemodynamic performance and a low risk of prosthesis-patient mismatch in patients with small aortic annulus diameters?
The 19- and 21-mm St Jude Medical Trifecta bioprostheses provide excellent haemodynamic performance with a low rate of prosthesis-patient mismatch in patients with small aortic annuli.
Supports small-annulus use; observational data leave open need for randomized confirmation of outcomes.
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.
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Fouquet et al. (2016) conducted a cohort in Small aortic annulus diameters requiring aortic valve replacement (n=354). St Jude Medical Trifecta bioprosthesis (19- and 21-mm) was evaluated on Haemodynamic performance and prosthesis-patient mismatch. The 19- and 21-mm St Jude Medical Trifecta bioprostheses provided excellent haemodynamic performance with low rates of moderate or severe prosthesis-patient mismatch at 1 year (11% and 8.1%).
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