Christ Torsten, Claus Benjamin, Zielinski Christina, Falk Volkmar, Grubitzsch Herko
Department of Cardiovascular Surgery, Charité - Universitätsmedizin Berlin, Berlin, Germany. Electronic correspondence:
Department of Cardiovascular Surgery, Charité - Universitätsmedizin Berlin, Berlin, Germany.
J Heart Valve Dis. 2016 Nov;25(6):679-684.
The Sorin Freedom SOLO valve is a third-generation stentless aortic valve which shows beneficial hemodynamic performance compared to stented bioprostheses. Long-term results regarding hemodynamics, the durability of the valve, and patient outcome are scarce, and their acquisition was the aim of this single-center study.
Between 2005 and 2006, a total of 68 consecutive patients (30 males, 38 females; mean age at surgery 76.1 ± 6.3 years) underwent aortic valve replacement with a Sorin Freedom SOLO prosthesis. Indications were aortic stenosis (n = 50), aortic regurgitation (n = 1) and mixed lesions (n = 17). Associated procedures were performed in 31 patients (45.6%), most of which were coronary artery bypass grafting (68.8 %). The follow up was performed by telephone interviews, and clinical and echocardiographic examinations. Morbidity, mortality and echocardiographic data were analyzed.
The total follow up was 501.1 patient-years, with a mean follow up of 7.4 ± 3.4 years (maximum 11.2 years). The follow up was 100% complete. Hospital mortality was 4.4% (n = 3). Actuarial survival at five and 10 years was 76.5 ± 5.1% and 41.5 ± 6.5%, respectively. Reinterventions were performed in eight patients; these included three reoperations due to endocarditis, four transcatheter aortic valve implantations, and one reoperation due to structural valve deterioration (SVD). The overall freedom from valve reintervention due to SVD at five and 10 years was 97.8 ± 2.2% and 82.9 ± 7.5%, respectively. After eight years, echocardiography demonstrated peak and mean transvalvular gradients of 18 ± 11 and 10 ± 7 mmHg, respectively. The overall effective and indexed aortic valve orifice areas were 1.73 ± 0.58 cm2 and 0.92 ± 0.33 cm2/m2, respectively.
At long-term follow up the Sorin Freedom SOLO bioprosthesis was associated with favourable hemodynamic results and survival. Freedom from SVD was not superior to that occurring with stented bioprostheses.
索林自由SOLO瓣膜是第三代无支架主动脉瓣膜，与有支架生物瓣膜相比，其血流动力学性能更佳。关于血流动力学、瓣膜耐久性及患者预后的长期结果较少，本单中心研究旨在获取相关数据。
2005年至2006年期间，共有68例连续患者（男性30例，女性38例；手术时平均年龄76.1±6.3岁）接受了索林自由SOLO人工瓣膜主动脉瓣置换术。适应证为主动脉瓣狭窄（n = 50）、主动脉瓣关闭不全（n = 1）和混合性病变（n = 17）。31例患者（45.6%）进行了相关手术，其中大部分为冠状动脉旁路移植术（68.8%）。通过电话访谈、临床及超声心动图检查进行随访。分析发病率、死亡率及超声心动图数据。
总随访时间为501.1患者年，平均随访7.4±3.4年（最长11.2年）。随访完成率为100%。住院死亡率为4.4%（n = 3）。5年和10年的精算生存率分别为76.5±5.1%和41.5±6.5%。8例患者进行了再次干预；其中包括3例因心内膜炎进行的再次手术、4例经导管主动脉瓣植入术以及1例因结构性瓣膜退变（SVD）进行的再次手术。5年和10年因SVD导致瓣膜再次干预的总体免于率分别为97.8±2.2%和82.9±7.5%。8年后，超声心动图显示跨瓣膜峰值压差和平均压差分别为18±11 mmHg和10±7 mmHg。总体有效主动脉瓣口面积和指数化主动脉瓣口面积分别为1.73±0.58 cm²和0.92±0.33 cm²/m²。
长期随访显示，索林自由SOLO生物瓣膜具有良好的血流动力学结果及生存率。免于SVD的情况并不优于有支架生物瓣膜。
