Johnston Douglas R, Griffith Bartley P, Puskas John D, Bavaria Joseph E, Svensson Lars G
Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio.
Department of Surgery, University of Maryland Medical Center, Baltimore, Md.
J Thorac Cardiovasc Surg. 2021 Nov;162(5):1478-1485. doi: 10.1016/j.jtcvs.2020.01.095. Epub 2020 Feb 21.
The COMMENCE trial was conducted to evaluate the safety and effectiveness of an aortic bioprosthesis with novel RESILIA tissue (Edwards Lifesciences, Irvine, Calif). Reports of early noncalcific valve failure resulting from thrombosis or leaflet tears in other valves warrant careful evaluation of early valve performance.
Patients underwent clinically indicated surgical aortic valve replacement with the Edwards Pericardial Aortic Bioprosthesis, Model 11000A (Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), single-arm, Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee; echocardiograms were analyzed by an independent core laboratory.
Between January 2013 and March 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years. Mean Society of Thoracic Surgeons predicted risk of mortality was 2.0% ± 1.8%. Follow-up duration was 3.7 ± 1.2 years, with a total of 2533 patient years of follow-up and a median follow-up of 4 years. Early all-cause mortality was 1.2%, thromboembolism 2.3%, all bleeding 1.0%, and major paravalvular leak 0.1%. One- and 4-year actuarial freedom from all-cause mortality was 97.7% (95% confidence interval, 96.5%-98.8%) and 91.9% (95% confidence interval, 89.7%-94.1%), respectively. At 4 years, New York Heart Association functional class improved compared with baseline in 63.0%, effective orifice area was 1.5 ± 0.5 cm, and mean gradient was 11.0 ± 5.6 mm Hg. Freedom from moderate or greater transvalvular insufficiency was 99.7%. There were no events of structural valve deterioration.
Safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue at 4 years are favorable. This novel tissue does not appear to result in unexpected early thrombosis events or noncalcific structural valve deterioration.
开展COMMENCE试验以评估采用新型RESILIA组织（爱德华生命科学公司，加利福尼亚州尔湾）的主动脉生物瓣膜的安全性和有效性。其他瓣膜因血栓形成或瓣叶撕裂导致早期非钙化性瓣膜功能障碍的报告，需要对早期瓣膜性能进行仔细评估。
在一项前瞻性、跨国、多中心（n = 27）、单臂、美国食品药品监督管理局医疗器械研究豁免试验中，患者接受了具有临床指征的采用11000A型号爱德华心包主动脉生物瓣膜（爱德华生命科学公司）的主动脉瓣置换术。事件由独立的临床事件委员会判定；超声心动图由独立的核心实验室分析。
2013年1月至2016年3月期间，689例患者接受了研究瓣膜。平均年龄为67.0±11.6岁。胸外科医师协会预测的平均死亡率风险为2.0%±1.8%。随访时间为3.7±1.2年，总计2533患者年的随访，中位随访时间为4年。早期全因死亡率为1.2%，血栓栓塞为2.3%，全因出血为1.0%，主要瓣周漏为0.1%。全因死亡率的1年和4年精算无事件生存率分别为97.7%（95%置信区间，96.5%-98.8%）和91.9%（95%置信区间，89.7%-94.1%）。在4年时，纽约心脏协会心功能分级较基线改善的患者占63.0%，有效瓣口面积为1.5±0.5 cm，平均跨瓣压差为11.0±5.6 mmHg。无中度或更严重的瓣膜反流事件。无瓣膜结构恶化事件。
这种采用RESILIA组织的主动脉生物瓣膜在4年时的安全性和血流动力学性能良好。这种新型组织似乎不会导致意外的早期血栓形成事件或非钙化性瓣膜结构恶化。
