Fischlein Theodor, Meuris Bart, Hakim-Meibodi Kavous, Misfeld Martin, Carrel Thierry, Zembala Marian, Gaggianesi Sara, Madonna Francesco, Laborde François, Asch Federico, Haverich Axel
Department of Cardiac Surgery, Paracelsus Medical University, Klinikum Nürnberg, Nuremberg, Germany.
Department of Cardiac Surgery, U.Z. Gasthuisberg, Leuven, Belgium.
J Thorac Cardiovasc Surg. 2016 Jun;151(6):1617-1626.e4. doi: 10.1016/j.jtcvs.2015.12.064. Epub 2016 Jan 22.
Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year.
From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%.
One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up.
The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.
在主动脉瓣狭窄患者中，无缝合主动脉瓣置换术（AVR）为标准AVR提供了一种替代方案。这项前瞻性单臂研究旨在证明一种牛心包无缝合主动脉瓣在1年时的安全性和有效性。
2010年2月至2013年9月，658例患者（平均年龄78.3±5.6岁；40.0%为80岁及以上老人；64.4%为女性；胸外科医师协会平均评分7.2±7.4）在25个欧洲中心接受了无缝合AVR。29.5%的患者同时进行了心脏手术，33.3%的患者接受了微创心脏手术。
1年时各中心报告的全因死亡率为8.1%，心脏死亡率为4.5%，中风发生率为3.0%，瓣膜相关再次手术率为1.9%，心内膜炎发生率为1.4%，严重瓣周漏发生率为0.6%。未发生瓣膜血栓形成、移位或瓣膜结构恶化。纽约心脏协会心功能分级至少改善1级的患者占77.5%，且保持稳定（1年时70.4%为纽约心脏协会I级或II级）。平均有效瓣口面积为1.5±0.4cm²；压力阶差为9.2±5.0mmHg。左心室质量从术前的138.5g/m²降至1年时的115.3g/m²（P<0.001）。超声心动图核心实验室检查结果证实，瓣周漏很少见，且在随访期间保持稳定。
Perceval无缝合瓣膜使接受AVR的中危患者1年事件发生率较低。超过四分之三的患者纽约心脏协会心功能分级得到改善且保持稳定。这些数据支持了Perceval无缝合瓣膜在这一中危人群中至1年时的安全性和有效性。
