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

• Published in: JACC. Cardiovascular interventions Vol. 12; no. 13; pp. 1240 - 1252
• Main Authors: Khan, Jaffar M, Greenbaum, Adam B, Babaliaros, Vasilis C, Rogers, Toby, Eng, Marvin H, Paone, Gaetano, Leshnower, Bradley G, Reisman, Mark, Satler, Lowell, Waksman, Ron, Chen, Marcus Y, Stine, Annette M, Tian, Xin, Dvir, Danny, Lederman, Robert J
• Format: Journal Article
• Language: English
• Published: United States 08.07.2019
• Subjects: Aged; Aged, 80 and over; Aortic Valve - diagnostic imaging; Aortic Valve - physiopathology; Aortic Valve - surgery; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Bioprosthesis; Coronary Stenosis - diagnostic imaging; Coronary Stenosis - etiology; Coronary Stenosis - physiopathology; Coronary Stenosis - prevention & control; Feasibility Studies; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Hemodynamics; Humans; Iatrogenic Disease - prevention & control; Male; Prospective Studies; Prosthesis Design; Prosthesis Failure; Risk Factors; Time Factors; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - instrumentation; Treatment Outcome; United States; United States; coronary artery obstruction; transcatheter aortic valve replacement; transcatheter electrosurgery; bioprosthetic heart valve failure; structural heart disease
• DOI: 10.1016/j.jcin.2019.03.035
• ISSN: 1876-7605; 1936-8798

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. 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. 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. 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. 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.