Background and aim of the study: The bileaflet Sorin Bicarbon Overline (Sorin Biomedica Cardio S.p.A., Saluggia, Italy) is a mechanical valve designed for total supra-annular implantation. However, the hemodynamics performance and early clinical outcome of the valve have not been well described.
Methods: A total of 168 patients (104 males, 64 females; mean age 62 +/- 9.9 years) underwent aortic valve replacement (AVR) with the Bicarbon Overline valve between September 2004 and June 2010. All patients were monitored by means of clinical examination and serial echocardiography before, and at nine to 12 months after, the procedure.
Results: During surgery, 27% of the patients received an 18 mm valve, 55% a 20 mm valve, and 18% a 22 mm valve. At the 12-month follow up, peak and mean transprosthetic gradients were 23.6 +/- 8.1 mmHg and 12.9 +/- 4.9 mmHg, respectively. Preoperatively, the average effective orifice area (EOA) was 0.80 +/- 0.41 cm2, while the postoperative average EOA was 2.01 +/- 0.26 cm2. No prosthesis-patient mismatch (PPM) was observed. The interventricular septum thickness (12.1 +/- 2.6 mm versus 11.2 +/- 2.0 mm; p = 0.05) and left ventricular end-systolic diameter (52 +/- 28 mm versus 41 +/- 23 mm; p = 0.05) were each reduced after surgery. The mean follow up period was 2.3 years, and the 30-day mortality rate 2.4% (n = 4). Cumulative survival at three, 12, and 24 months was 96%, 94%, and 92%, respectively. Freedom from any valve-related event at three, 12 and 24 months was 98.6%, 97.8% and 93.3%, respectively.
Conclusion: In the present series, the Bicarbon Overline prosthesis showed good hemodynamic performance, with no incidence of PPM, and favorable early clinical results.