The BASILICA Trial Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction

被引：185

作者：

Khan, Jaffar M. ^{[1
]}

Greenbaum, Adam B. ^{[2
,3
,4
]}

Babaliaros, Vasilis C. ^{[4
]}

Rogers, Toby ^{[1
,5
]}

Eng, Marvin H. ^{[2
,3
]}

Paone, Gaetano ^{[2
,3
]}

Leshnower, Bradley G. ^{[4
]}

Reisman, Mark ^{[6
]}

Satler, Lowell ^{[5
]}

Waksman, Ron ^{[5
]}

Chen, Marcus Y. ^{[1
]}

Stine, Annette M. ^{[1
]}

Tian, Xin ^{[1
]}

Dvir, Danny ^{[2
,3
]}

Lederman, Robert J. ^{[1
]}

机构：

[1] NHLBI, Cardiovasc Branch, Div Intramural Res, NIH, Bldg 10,Room 2C713,MSC 1538, Bethesda, MD 20892 USA

[2] Henry Ford Hlth Syst, Ctr Struct Heart Dis, Div Cardiol, Detroit, MI USA

[3] Henry Ford Hlth Syst, Div Cardiac Surg, Detroit, MI USA

[4] Emory Univ Hosp, Struct Heart & Valve Ctr, 1364 Clifton Rd NE, Atlanta, GA 30322 USA

[5] Medstar Washington Hosp Ctr, Washington, DC USA

[6] Univ Washington, Seattle, WA 98195 USA

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2019年 / 12卷 / 13期

基金：

美国国家卫生研究院;

关键词：

bioprosthetic heart valve failure; coronary artery obstruction; structural heart disease; transcatheter aortic valve replacement; transcatheter electrosurgery; TRANSCATHETER AORTIC-VALVE; CLINICAL-OUTCOMES; TRANSCAVAL ACCESS; REPLACEMENT; IMPLANTATION; THROMBOSIS; RISK; PROTECTION; INSIGHTS;

D O I：

10.1016/j.jcin.2019.03.035

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVES The BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study. BACKGROUND Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction. METHODS Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images. RESULTS Between February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR. CONCLUSIONS BASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk. Published by Elsevier on behalf of the American College of Cardiology Foundation.

引用

页码：1240 / 1252

页数：13

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