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

Abstract

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