Department of Surgery, University Hospitals, Case Western Reserve University School of Medicine, Cleveland, Ohio.
Toronto General Hospital, Toronto, Ontario, Canada.
J Thorac Cardiovasc Surg. 2018 Oct;156(4):1368-1377.e5. doi: 10.1016/j.jtcvs.2018.03.171. Epub 2018 Apr 18.
The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve.
This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration-specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis.
The primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P < .0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P < .0001).
This analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.
本研究旨在评估一种新型带支架牛心包主动脉瓣的安全性、有效性和血流动力学性能。
该试验纳入了有症状的中度或重度主动脉瓣狭窄或慢性重度主动脉瓣反流的患者。我们评估了死亡率、与瓣膜相关的不良事件、功能恢复以及美国食品和药物管理局要求的出院时、3-6 个月和 1 年的血流动力学性能，以获得监管批准。主要分析比较了植入后与食品和药物管理局规定的客观性能标准相关的晚期线性化瓣膜相关不良事件发生率，以确定与瓣膜相关的不良事件发生率是否在可接受范围内。不良事件包括血栓栓塞、血栓形成、所有和主要出血、所有和主要瓣周漏以及心内膜炎。
主要分析纳入了 864 例接受植入治疗和 904.1 个瓣膜年随访的患者。共有 577 例患者完成了 1 年评估。主要终点在死亡、血栓栓塞、血栓形成、所有和主要瓣周漏以及心内膜炎方面得到满足，但在所有和主要出血方面未得到满足。1 年时，无全因死亡和瓣膜相关死亡的生存率分别为 96.4%和 99.7%。从基线到 1 年，纽约心脏协会（NYHA）心功能分级变化如下：I 级 10.8%至 73.7%；II 级 48.9%至 22.6%；III 级 38.0%至 3.5%；IV 级 2.3%至 0.2%。有效瓣口面积从 0.9±0.5cm²增加到 1.5±0.4cm²（P<0.0001），平均主动脉梯度从 42.7±16.5mmHg 降低到 12.5±4.3mmHg（P<0.0001）。
对一种新型带支架牛心包主动脉瓣的分析显示，其总体死亡率和与瓣膜相关的不良事件较低，血流动力学性能可与其他外科主动脉瓣相媲美。
