Freedom SOLO valve: early- and intermediate-term results of a single centre's first 100 cases

Abstract

Objective: The Freedom SOLO aortic valve is a bovine pericardial stentless valve, which requires only one suture line. The aim of our single-centre retrospective study was to assess postoperative and intermediate-term haemodynamic results of the first 100 consecutively implanted valves.

Methods: One hundred patients (39 male and 61 female) underwent aortic valve replacement with a Freedom SOLO from November 2006 to January 2008. Their clinical, operative, platelet levels, echocardiography and follow-up data were prospectively recorded. All but two patients were available for follow-up (98% completeness), which averaged 12.6 ± 5.06 months.

Results: Associated procedures were performed in 38 patients (38%): 27 coronary artery bypass grafting (CABG), 11 mitral valve replacement, 11 septal myectomy and one ablation for atrial fibrillation. The mean age at the time of surgery was 77.2 ± 6.43 years. The mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 8.05 ± 2.07. Mean cross-clamp time of isolated valve replacements was 51.27 ± 4.7 min and 63.18 ± 21.7 min with associated procedures. The mean implanted valve size was 23.5 ± 1.9 mm. One patient was re-operated for bleeding, two for pericardial effusion and 39 were transfused. The overall hospital mortality was 3%. One patient died suddenly postoperatively, and a second due to a fatal atrio-ventricular block. A third patient died following a subdural bleed. Three patients required a pacemaker before hospital discharge. The overall patient survival was 97 ± 2.26% at 1 year. Echocardiographic results preoperative, 8 days postoperative and 12 months after surgery showed mean transvalvular gradients of 50.6 ± 15.3, 15.6 ± 5.2 and 11.5 ± 3.8 mm Hg, respectively, and mean left ventricular ejection fractions of 37.9 ± 10.2%, 44 ± 15.2% and 53.6 ± 10.4%. Effective orifice area index for valve sizes 19, 21, 23, 25 and 27 were 0.91 ± 0.08, 0.97 ± 0.1, 1.08 ± 0.07, 1.53 ± 0.12 and 1.57 ± 0.1cm(2)m(-2), respectively. There were three early non-structural dysfunctions (grade 1) of regurgitation, which remained stable at 12 months.

Conclusions: Freedom SOLO valve has very good early- and intermediate-term results. Short implantation times and its haemodynamic performances, particularly in small diameters, allow us to use it by first intention in older and often sicker patients. These results must be confirmed by long-term outcomes.