Englberger Lars, Carrel Thierry P, Doss Mirko, Sadowski Jerzy, Bartus Krzysztof, Eckstein Friedrich F, Asch Federico M, Martens Sven
Department of Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland.
Department of Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland.
J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.
Sutureless valves are designed to facilitate surgical implantation, including less-invasive techniques in aortic valve replacement, by maintaining surgical precision of implantation compared with transcatheter techniques. Long-term clinical experience with sutureless valves is lacking. We report the 5-year follow-up results of an international, prospective, multicenter study evaluating the clinical performance and safety of the 3f Enable valve (Medtronic Inc, Minneapolis, Minn).
Between March 2007 and December 2009, 141 patients (54 male; mean age, 76.1±5.7 years) undergoing aortic valve replacement with the 3f Enable valve were enrolled in 10 European sites. The mean follow-up was 2.76 years (range, 2 days to 5.1 years; total, 388.7 patient-years). Echocardiographic valvular hemodynamic and morphologic analyses were performed by an independent core laboratory.
The mean systolic gradient was 10.4±4.4 mm Hg at discharge and 7.7±4.1 mm Hg at 5 years. The mean effective orifice area was 1.7±0.5 cm2 at discharge and 1.6±0.2 cm2 at 5 years. Freedom from all-cause and valve-related mortality was 87.6%±2.9% and 96.8%±1.6% at 1 year (113 patients at risk) and 77.0%±7.5% and 93.8%±4.8% at 5 years (24 patients at risk), respectively. Six patients underwent reoperation (4 because of major paravalvular leakage and 2 because of endocarditis). Freedom from reoperation was 95.4%±1.9% at 1 year and 95.4%±6.1% at 5 years. No structural valve deterioration occurred during the follow-up period.
The sutureless 3f Enable valve represents a safe and effective treatment for aortic valve stenosis, providing an excellent hemodynamic profile. This study represents the longest follow-up study for a sutureless bioprosthesis. Sutureless valves may become an option for all patients with indicated biological aortic valve replacement.
无缝合瓣膜旨在通过与经导管技术相比保持植入手术的精确性，促进手术植入，包括主动脉瓣置换术中的微创技术。目前缺乏无缝合瓣膜的长期临床经验。我们报告一项国际、前瞻性、多中心研究的5年随访结果，该研究评估了3f Enable瓣膜（美敦力公司，明尼阿波利斯，明尼苏达州）的临床性能和安全性。
2007年3月至2009年12月期间，141例接受3f Enable瓣膜主动脉瓣置换术的患者（54例男性；平均年龄76.1±5.7岁）在10个欧洲地点入组。平均随访时间为2.76年（范围2天至5.1年；总计388.7患者年）。由独立的核心实验室进行超声心动图瓣膜血流动力学和形态学分析。
出院时平均收缩期压差为10.4±4.4 mmHg，5年时为7.7±4.1 mmHg。出院时平均有效瓣口面积为1.7±0.5 cm²，5年时为1.6±0.2 cm²。1年时全因死亡率和瓣膜相关死亡率分别为87.6%±2.9%和96.8%±%，5年时分别为77.0%±7.5%和93.8%±4.8%（1年时113例有风险患者，5年时24例有风险患者）。6例患者接受了再次手术（4例因严重瓣周漏，2例因心内膜炎）。1年时再次手术率为95.4%±1.9%，5年时为95.4%±6.1%。随访期间未发生结构性瓣膜退变。
无缝合的3 f Enable瓣膜是治疗主动脉瓣狭窄的一种安全有效的方法，具有良好的血流动力学特征。本研究是对无缝合生物假体进行的最长随访研究。无缝合瓣膜可能成为所有有适应证的生物主动脉瓣置换患者的一种选择。
