Results of aortic valve replacement with a new supra-annular pericardial stented bioprosthesis.

BACKGROUND: The stented Soprano valve (Sorin Biomedica S.pA., Saluggia, Italy) is a pericardial tissue valve designed for a totally supra-annular implant with the aim of improving hemodynamic performance, particularly in patients with a reduced aortic annulus. However, its hemodynamics and early clinical outcome are poorly understood.

METHODS: Seventy-seven patients (mean age 76 +/- 5 years, 56% males) underwent aortic valve replacement with the Soprano valve. All patients were monitored with clinical examination and serial echocardiography at 1, 6, and 12 months and yearly afterward.

RESULTS: At preoperative echocardiography, average left ventricular outflow tract diameter was 2.1 +/- 0.2 cm. At operation, 35% of patients received a 20-mm valve, 54% a 22-mm valve, and 11% a 24-mm valve. At 6-month follow-up, peak and mean transprosthetic gradients were 18 +/- 8 and 9 +/- 4 mm Hg, respectively; effective orifice area (EOA) and EOA index were 1.84 +/- 0.6 cm2 and 0.9 +/- 0.2 cm2/m2, respectively. Incidence of patient-prosthesis mismatch (ie, EOA index < 0.85 cm2/m2) was 23%, with no case of severe mismatch (ie, EOA index < 0.6 cm2/m2). In addition, left ventricular hypertrophy showed a significant regression (mass index from 214 +/- 98 g to 129 +/- 41 g; p = 0.001), and ejection fraction increased (from 58% +/- 17% to 67% +/- 8%; p = 0.001). Cumulative follow-up was 7.9 months per patient. Thirty-day mortality rate was 2.6% (2 of 77). Cumulative survival at 6, 12, and 24 months was 92% +/- 3.7%, 85% +/- 5.7%, and 85% +/- 5.7%, respectively. Two patients experienced embolic episodes. One case of anticoagulant-related bleeding occurred.

CONCLUSIONS: In our series, the Soprano bioprosthesis showed a good hemodynamic performance, low incidence of patient-prosthesis mismatch, and favorable early clinical results.