BASILICA Trial: One-Year Outcomes of Transcatheter Electrosurgical Leaflet Laceration to Prevent TAVR Coronary Obstruction.
BASILICA Trial: One-Year Outcomes of Transcatheter Electrosurgical Leaflet Laceration to Prevent TAVR Coronary Obstruction.
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DOI：
10.1161/circinterventions.120.010238
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发表时间：
2021-05
期刊：
影响因子：
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通讯作者：
Lederman RJ
中科院分区：
文献类型：
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作者：
Khan JM;Greenbaum AB;Babaliaros VC;Dvir D;Reisman M;McCabe JM;Satler L;Waksman R;Eng MH;Paone G;Chen MY;Bruce CG;Stine AM;Tian X;Rogers T;Lederman RJ
冠状动脉阻塞是经导管主动脉瓣置换术(TAVR)中一种罕见的破坏性并发症。经导管电外科主动脉瓣撕裂是一种预防冠状动脉阻塞的新技术。我们报告了大教堂试验的1年结果。之前已经报道过30天成功和安全的主要终点。大殿试验是一项前瞻性、多中心、单臂的安全性和可行性研究。研究对象包括严重的本土或生物瓣膜疾病患者，手术风险高或极高，冠状动脉阻塞风险高。1年的终点包括死亡、中风和心肌梗死。源数据被独立验证，终端被独立判定。30名受试者在2018年2月至2018年7月之间登记。术后30d，BASICE成功28例(93.3%)，卒中3例(10%)，其中致残性卒中1例(3.3%)，死亡1例(3.3%)，围手术期心肌梗死1例(3.3%)。在30天到1年期间，没有额外的中风，没有心肌梗死，以及2例死亡(1年死亡率10%)。没有受试者需要对主动脉瓣或冠状动脉疾病进行重复干预。两名受试者有感染性心内膜炎(6.7%)，但均未与主动脉瓣隔离。没有人因心力衰竭而入院。14例(46.7%)因其他原因需要再次入院。超声心动图上的主动脉瓣压差、NYHA功能分级和KCCQ评分从基线改善到30d，并维持在1年。在这些接受TAVR治疗的合并多种并发症和限制性解剖的受试者中，没有晚期中风、心肌梗死或与BASIO相关的死亡。冠状动脉阻塞的缓解在1年内保持完好，与再入院无关。对于希望避免与呼吸管支架置入术相关的长期并发症的患者和医生来说，这些结果令人放心。Www.Clinicaltrials.gov NCT03381989
Coronary artery obstruction is a rare, devastating complication of transcatheter aortic valve replacement (TAVR). Transcatheter electrosurgical aortic leaflet laceration (BASILICA) is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial. Primary endpoints of 30-day success and safety have been reported previously. The BASILICA trial was a prospective, multicenter, single-arm safety and feasibility study. Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and high risk of coronary artery obstruction, were included. Endpoints at 1 year included death, stroke, and myocardial infarction. Source-data was independently verified, and endpoints independently adjudicated. 30 subjects were enrolled between February 2018 and July 2018. At 30 days, BASILICA was successful in 28 subjects (93.3%), there were 3 strokes (10%), including 1 disabling stroke (3.3%), 1 death (3.3%), and 1 periprocedural myocardial infarction (3.3%). Between 30-days and 1 year, there were no additional strokes, no myocardial infarction, and two deaths (10% 1-year mortality). No subject needed repeat intervention for aortic valve or coronary disease. Two subjects had infective endocarditis (6.7%) but neither was isolated to the aortic valve. There were no hospital admissions for heart failure. 14 (46.7%) subjects required repeat hospital admission for other causes. Aortic valve gradients on echocardiography, NYHA functional class and KCCQ scores improved from baseline to 30-days and were maintained at 1 year. In these subjects with multiple comorbidities and restrictive anatomy that underwent TAVR, there was no late stroke, myocardial infarction, or death related to BASILICA. Mitigation of coronary obstruction remained intact at 1 year and was not related to recurrent readmission . These results are reassuring for patients and physicians who wish to avoid the long term complications related to snorkel stenting. www.clinicaltrials.gov NCT03381989