Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic Abu Dhabi and Cleveland Clinic Foundation, Cleveland, Ohio.
Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic Abu Dhabi and Cleveland Clinic Foundation, Cleveland, Ohio.
J Thorac Cardiovasc Surg. 2019 May;157(5):1773-1782.e3. doi: 10.1016/j.jtcvs.2018.08.121. Epub 2018 Oct 23.
We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.
From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients.
Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m at discharge to 95.8 ± 27.1 g/m (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001).
These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.
我们进行了一项前瞻性、单臂临床试验，该试验获得了美国食品和药物管理局的研究性器械豁免批准，以评估 Perceval 缝线生物瓣的安全性和疗效，这是在美国的首次应用。
从 2013 年 6 月至 2015 年 1 月，在美国 18 个中心，共有 300 名患者（平均年龄 76.7±7.7 岁，54.3%为男性，37.3%≥80 岁，中位胸外科医师学会预测死亡率为 2.8%）接受了 Perceval 瓣膜植入术。20 名患者（6.7%）为二叶式主动脉瓣，5 名患者（1.7%）曾接受过主动脉瓣置换术。80 名患者（26.7%）采用微创入路，113 名患者（37.8%）同时进行了其他手术。
289 名患者（96.3%）成功植入。手术死亡率（30 天内）为 1.3%（n=4）（观察到的与预期的比值为 0.40）。1 年结果包括全因死亡率为 5.2%（n=15），卒中 1%（n=3），感染性心内膜炎 1.7%（n=5）。新的永久性围手术期起搏器使用率为 10.7%（n=30/281）；2.5%（n=7/281）因三度房室传导阻滞而使用。1 年时瓣膜相关再次手术率为 2.1%（n=6）。1 年随访时，98%的患者心功能纽约分级为Ⅰ/Ⅱ级，左心室质量指数从出院时的 103.5±30.1g/m 降至 95.8±27.1g/m（P=0.001），3 例（1.3%）存在中度瓣周漏。健康相关生活质量评分从术前的 62.7±21.8 提高到 1 年时的 85.5±17.8（P<0.001）。
这些结果证实了 Perceval 无缝线主动脉瓣置换术在研究患者中的安全性和有效性，其死亡率低于风险预测模型的预期。1 年时持续的血液动力学获益和生活质量的改善支持该器械在主动脉瓣疾病管理中的重要性。
