Grubitzsch Herko, Wang Shaohua, Matschke Klaus, Glauber Mattia, Heimansohn David, Tan Erwin, Francois Katrien, Thalmann Markus
Department of Cardiovascular Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany
Division of Cardiac Surgery, University of Alberta Hospital Edmonton, Edmonton, Canada.
Eur J Cardiothorac Surg. 2015 Mar;47(3):e97-104. doi: 10.1093/ejcts/ezu471. Epub 2014 Dec 13.
The Freedom SOLO™ valve (Sorin Group, Italy) is a stentless aortic bioprosthesis designed for simplified implantation. The present multicentre study is the largest prospective evaluation of this prosthesis. Herein, we report on outcomes at 3-year follow-up.
From March 2009 to February 2013, a total of 804 consecutive patients (mean age 74.9 ± 6.3 years; 45.1% females) underwent aortic valve replacement with the Freedom SOLO™ valve at 33 centres. Concomitant procedures (70.2% coronary artery bypass grafting) were performed in 376 patients. The cumulative follow-up included 1100 patient-years (mean 16.5 ± 10.8 months; range: 0-40.5 months).
Sixty-four patients died (14 early, 50 late); 12 deaths (1 early, 11 late) were valve-related. Operative mortality (30 days) was 1.7%. At 3 years, overall survival was 82.6% [95% confidence interval (CI) 75.5-87.8%] and freedom from valve-related death was 95.5% (95% CI 89.2-98.2%). Linearized late event rates were 0.82%/patient-years for non-structural valve dysfunction, 0.55%/patient-years for structural valve deterioration, 1.55%/patient-years for endocarditis, 3.64%/patient-years for thromboembolism and 3.18%/patient-years for bleeding. In total, there were 22 reinterventions [19 valve explants, 2 refixations, 1 transcatheter aortic valve intervention (TAVI)] for endocarditis (11), non-structural dysfunction (9) and structural valve deterioration (2). Freedom from reintervention was 95.2% (95% CI 91.2-97.4%) at 3 years. There were no instances of valve thrombosis or haemolysis. At 1, 2 and 3 years, 97.0, 95.5 and 91.4% of patients were in NYHA class I or II. Between discharge and 3 years after surgery, mean transvalvular gradients exhibited a non-significant increase (6.5 ± 4.3 vs 8.7 ± 6.5 mmHg), whereas effective orifice area index remained stable (0.9 ± 0.2 vs 0.8 ± 0.3 cm(2)/m(2)). At 3 years, no patient presented with more than mild aortic regurgitation. Left ventricular mass index decreased significantly between discharge and 1 year after surgery (139.4 ± 40.9 vs 122.4 ± 35.3 g/m(2), P < 0.001) and remained unchanged thereafter. Left ventricular size and function did not change over time.
The Freedom SOLO™ valve is a unique stentless pericardial bioprosthesis whose design favours haemodynamic performance and thus facilitates left ventricular reverse remodelling. In terms of survival, morbidity and functional status, it is associated with beneficial outcomes up to 3 years after surgery. Ongoing follow-up will assess the valve at the long-term course.
Freedom SOLO™瓣膜（意大利索林集团）是一种无支架主动脉生物假体，旨在简化植入过程。本多中心研究是对该假体最大规模的前瞻性评估。在此，我们报告3年随访结果。
从2009年3月至2013年2月，共有804例连续患者（平均年龄74.9±6.3岁；45.1%为女性）在33个中心接受了Freedom SOLO™瓣膜主动脉瓣置换术。376例患者同时进行了其他手术（70.2%为冠状动脉旁路移植术）。累计随访时间为1100患者年（平均16.5±10.8个月；范围：0 - 40.5个月）。
64例患者死亡（14例早期死亡，50例晚期死亡）；12例死亡（1例早期死亡，11例晚期死亡）与瓣膜相关。手术死亡率（30天）为1.7%。3年时，总体生存率为82.6%[95%置信区间（CI）75.5 - 87.8%]，无瓣膜相关死亡的比例为95.5%（95% CI 89.2 - 98.2%）。非结构性瓣膜功能障碍的线性化晚期事件发生率为0.82%/患者年，结构性瓣膜退变的发生率为0.55%/患者年，心内膜炎的发生率为1.55%/患者年，血栓栓塞的发生率为3.64%/患者年，出血的发生率为3.18%/患者年。总共进行了22次再次干预[19次瓣膜取出、2次重新固定、1次经导管主动脉瓣介入治疗（TAVI）]，原因包括心内膜炎（11例）、非结构性功能障碍（9例）和结构性瓣膜退变（2例）。3年时无再次干预的比例为95.2%（95% CI 91.2 - 97.4%）。未发生瓣膜血栓形成或溶血情况。1年、2年和3年时，分别有97.0%、95.5%和91.4%的患者纽约心脏协会（NYHA）心功能分级为I级或II级。出院至术后3年期间，平均跨瓣压差呈非显著性增加（6.5±4.3 vs 8.7±6.5 mmHg），而有效瓣口面积指数保持稳定（0.9±0.2 vs 0.8±0.3 cm²/m²）。3年时，无患者出现超过轻度的主动脉瓣反流。出院至术后1年期间，左心室质量指数显著下降（139.4±40.9 vs 122.4±35.3 g/m²，P < 0.001），此后保持不变。左心室大小和功能随时间未发生变化。
Freedom SOLO™瓣膜是一种独特的无支架心包生物假体，其设计有利于血流动力学性能，从而促进左心室逆向重构。在生存、发病率和功能状态方面，术后3年内其结果良好。持续随访将评估该瓣膜的长期情况。
