Department of Cardiology, Bichat Hospital, AP-HP, Inserm U 1148, University of Paris, 75018 Paris, France.
Department of Cardiology, Bichat Hospital, AP-HP, Inserm U 1148, University of Paris, 75018 Paris, France.
Arch Cardiovasc Dis. 2023 Feb;116(2):98-105. doi: 10.1016/j.acvd.2022.12.003. Epub 2023 Jan 9.
Transcatheter aortic valve implantation now has a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation.
We sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves.
We conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve.
A total of 37 patients (male sex, 73%) with a median age of 81years (interquartile range 69-85years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n=31) had dyspnoea New York Heart Association class≥III. The device success rate was 94.6% (n=35). At 30days, the all-cause mortality rate was 8.1% (n=3) and valve migration occurred in 10.8% of cases (n=4). Dyspnoea New York Heart Association class≤II was seen in 86.5% of patients (n=32), and all survivors had aortic regurgitation grade≤1. At 1-year follow-up, all-cause mortality was 16.2% (n=6), 89.7% (n=26/29) of survivors were in New York Heart Association class≤II and all had aortic regurgitation grade≤2.
Transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.
经导管主动脉瓣植入术现在在治疗严重主动脉瓣狭窄患者方面发挥着重要作用。然而，关于其在治疗单纯主动脉瓣反流患者方面的可行性和安全性的证据很少。
我们旨在评估使用球囊扩张的 SAPIEN 3 经导管心脏瓣膜（爱德华兹生命科学公司，加利福尼亚州欧文，美国）治疗有原发性非钙化瓣膜单纯主动脉瓣反流患者的结果。
我们进行了一项回顾性和前瞻性的法国多中心观察性研究。我们纳入了所有有症状的严重原发性非钙化瓣膜单纯主动脉瓣反流且外科主动脉瓣置换术禁忌或高危的患者，这些患者接受了 SAPIEN 3 经导管心脏瓣膜的经导管主动脉瓣植入术。
共筛选了 37 名（男性占 73%）年龄中位数为 81 岁（四分位距 69-85 岁）的患者，这些患者接受了经胸超声心动图和计算机断层扫描检查，并在法国的 8 个中心进行了检查。基线时，83.8%（n=31）的患者有呼吸困难纽约心脏协会（NYHA）分级≥III 级。器械成功率为 94.6%（n=35）。术后 30 天，全因死亡率为 8.1%（n=3），瓣膜迁移发生率为 10.8%（n=4）。86.5%（n=32）的患者呼吸困难 NYHA 分级≤II 级，所有存活患者的主动脉瓣反流程度均为≤1 级。术后 1 年随访时，全因死亡率为 16.2%（n=6），89.7%（n=26/29）的存活患者 NYHA 分级≤II 级，且所有患者的主动脉瓣反流程度均为≤2 级。
对于外科主动脉瓣置换术禁忌的原发性非钙化瓣膜单纯主动脉瓣反流高危患者，使用 SAPIEN 3 经导管心脏瓣膜的经导管主动脉瓣植入术似乎是一种有前途的治疗方法。
