Department of Cardiology, Shaare Zedek Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, P.O. Box 3235, Shmuel Bait 12 Street, Jerusalem 9103102, Israel.
Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
Eur Heart J. 2024 Sep 1;45(33):3031-3041. doi: 10.1093/eurheartj/ehae303.
This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction.
This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board.
Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%-100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%-100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%-99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%-99.0%)], without any cardiovascular deaths.
Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.
本试验旨在评估 ShortCut（首款专用瓣叶修饰装置）在有冠状动脉阻塞风险的行经导管主动脉瓣置换术（TAVI）患者中的安全性和疗效。
这是一项关键的前瞻性研究，共纳入了计划接受 TAVI 且有冠状动脉阻塞风险的生物瓣衰败患者。主要安全性终点为出院或 7 天时与操作相关的死亡率或卒中和主要疗效终点为每位患者瓣叶分离成功率。独立的血管造影、超声心动图和计算机断层扫描核心实验室评估所有图像。临床事件委员会和数据安全监测委员会对安全性事件进行裁决。
22 个临床中心共治疗了 60 名符合条件的患者（77.0±9.6 岁，70%为女性，96.7%为生物瓣手术失败，63.3%为单瓣叶分离，36.7%为双瓣叶分离）。所有患者均成功实现瓣叶分离[100%；95%置信区间（CI）94%-100.0%，P<.001]。包括瓣叶分离影像学确认在内的手术时间为 30.6±17.9min。59 例患者（98.3%；95%CI（91.1%-100%））达到主要安全性终点，无死亡病例，1 例（1.7%）为致残性卒中。30 天时，无冠状动脉阻塞的比例为 95%（95%CI 86.1%-99.0%）。90 天内，死亡率为 95%[95%CI（86.1%-99.0%）]，无心血管死亡病例。
使用 ShortCut 对生物瓣衰败的主动脉瓣瓣叶进行修饰是安全的，所有患者均成功实现瓣叶分离，在有冠状动脉阻塞风险的 TAVI 患者中获得了有利的临床结局。
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