Stanger Olaf, Bleuel Irina, Reineke Sylvia, Banz Yara, Erdoes Gabor, Tevaearai Hendrik, Göber Volkhard, Carrel Thierry, Englberger Lars
Clinic for Cardiovascular Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
Clinic for Cardiovascular Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Eur J Cardiothorac Surg. 2015 Oct;48(4):562-70. doi: 10.1093/ejcts/ezu473. Epub 2014 Dec 27.
This study reports a series of pitfalls, premature failures and explantation of the third-generation Freedom SOLO (FS) bovine pericardial stentless valve.
A total of 149 patients underwent aortic valve replacement using the FS. Follow-up was 100% complete with an average observation time of 5.5 ± 2.3 years (maximum 8.7 years) and a total of 825 patient-years. Following intraoperative documentation, all explanted valve prostheses underwent histological examination.
Freedom from structural valve deterioration (SVD) at 5, 6, 7, 8 and 9 years was 92, 88, 80, 70 and 62%, respectively. Fourteen prostheses required explantation due to valve-independent dysfunction (n = 5; i.e. thrombus formation, oversizing, aortic dilatation, endocarditis and suture dehiscence) or valve-dependent failure (acute leaflet tears, n = 4 and severe stenosis, n = 5). Thus, freedom from explantation at 5, 6, 7, 8 and 9 years was 95, 94, 91, 81 and 72%, respectively. An acute vertical tear along the non-coronary/right coronary commissure to the base occurred at a mean of 6.0 years (range 4.3-7.3 years) and affected size 25 and 27 prostheses exclusively. Four FS required explantation after a mean of 7.5 years (range 7.0-8.3 years) due to severe functional stenosis and gross calcification that included the entire aortic root.
The FS stentless valve is safe to implant and shows satisfying mid-term results in our single institution experience. Freedom from SVD and explantation decreased markedly after only 6-7 years, so that patients with FS require close observation and follow-up. Exact sizing, symmetric positioning and observing patient limitations are crucial for optimal outcome.
本研究报告了第三代Freedom SOLO（FS）牛心包无支架瓣膜的一系列缺陷、早期失败及瓣膜取出情况。
共有149例患者使用FS进行了主动脉瓣置换。随访完全率为100%，平均观察时间为5.5±2.3年（最长8.7年），总计825患者年。术中记录后，所有取出的瓣膜假体均进行了组织学检查。
5、6、7、8和9年时无结构性瓣膜退变（SVD）的比例分别为92%、88%、80%、70%和62%。14个假体因瓣膜非依赖性功能障碍（n = 5；即血栓形成、尺寸过大、主动脉扩张、心内膜炎和缝线裂开）或瓣膜依赖性失败（急性瓣叶撕裂，n = 4和严重狭窄，n = 5）而需要取出。因此，5、6、7、8和9年时无瓣膜取出的比例分别为95%、94%、91%、81%和72%。沿非冠状动脉/右冠状动脉交界至基部的急性垂直撕裂平均发生在6.0年（范围4.3 - 7.3年），仅影响尺寸25和27的假体。4个FS因严重功能性狭窄和累及整个主动脉根部的严重钙化，平均7.5年（范围7.0 - 8.3年）后需要取出。
在我们单机构的经验中，FS无支架瓣膜植入安全且中期结果令人满意。仅6 - 7年后无SVD和无瓣膜取出的比例就显著下降，因此植入FS的患者需要密切观察和随访。精确的尺寸选择、对称定位以及注意患者的局限性对于获得最佳结果至关重要。
