The Sorin Freedom SOLO stentless tissue valve: early outcomes after aortic valve replacement

• Published in: Texas Heart Institute journal 2013, Vol.40 (1), p.50-55
• Main Authors: Altintas, Garip, Diken, Adem Ilkay, Hanedan, Onur, Yurdakok, Okan, Ozyalcin, Sertan, Kucuker, Seref Alp, Ozatik, Mehmet Ali
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aortic Valve Stenosis - diagnosis; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Bioprosthesis; Clinical Investigation; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - mortality; Hemodynamics; Humans; Male; Middle Aged; Multiple Organ Failure - mortality; Prospective Studies; Prosthesis Design; Severity of Illness Index; Thrombocytopenia - etiology; Time Factors; Treatment Outcome
• ISSN: 0730-2347; 1526-6702

We prospectively evaluated the hemodynamic performance of the SORIN Freedom SOLO aortic bioprosthesis, a stentless bovine pericardial valve designed for supra-annular implantation. Forty patients (mean age, 71.68 ± 5.25 yr; 29 men) with severe aortic stenosis underwent aortic valve replacement from January 2008 through August 2009. Patients were evaluated by transthoracic echocardiography and clinical examination, both preoperatively and again at 6 and 24 postoperative months. Peak and mean transvalvular gradients, end-diastolic and end-systolic diameters, interventricular septal and posterior wall thicknesses, indexed volumes of ventricular mass, degrees of aortic regurgitation, and left ventricular ejection fractions were calculated echocardiographically. The valves were implanted with single polypropylene sutures. In the early postoperative period, 1 patient (2.5%) died of multiorgan failure. The mean aortic cross-clamp time was 86.05 ± 34.2 min. Echocardiographic peak gradients were 84.54 ± 16.85 mmHg (preoperative), 29.59 ± 6.27 mmHg (6 mo postoperative), and 24.33 ± 4.67 mmHg (24 mo postoperative) (P < 0.001); left ventricular mass indices were 176.26 ± 39.98 g/m(2) (preoperative), 139.21 ± 30.1 (6 mo postoperative), and 120.51 ± 23.88 g/m(2) (24 mo postoperative) (P < 0.001). During follow-up, the maximum aortic insufficiency recorded was trace, and no valve dysfunctions were observed. Temporary thrombocytopenia was documented in all patients during early postoperative follow-up (lowest level at day 3); recovery to preoperative levels occurred by day 10. The Freedom SOLO aortic bioprosthesis is an easy-to-implant valve with excellent hemodynamic performance. The thrombocytopenia appears to be a transient laboratory finding.