The BASILICA Trial: Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction.
The BASILICA Trial: Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction.
- 2019
Available online through MWHC library: 2008 - present
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. 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. Copyright Published by Elsevier Inc. 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. 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. 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.
English
1936-8798
10.1016/j.jcin.2019.03.035 [doi] S1936-8798(19)30832-5 [pii]
*Aortic Valve Stenosis/su [Surgery]
*Aortic Valve/su [Surgery]
*Bioprosthesis
*Coronary Stenosis/pc [Prevention & Control]
*Heart Valve Prosthesis
*Heart Valve Prosthesis Implantation/is [Instrumentation]
*Iatrogenic Disease/pc [Prevention & Control]
*Prosthesis Failure
*Transcatheter Aortic Valve Replacement/is [Instrumentation]
Aged
Aged, 80 and over
Aortic Valve Stenosis/dg [Diagnostic Imaging]
Aortic Valve Stenosis/pp [Physiopathology]
Aortic Valve/dg [Diagnostic Imaging]
Aortic Valve/pp [Physiopathology]
Coronary Stenosis/dg [Diagnostic Imaging]
Coronary Stenosis/et [Etiology]
Coronary Stenosis/pp [Physiopathology]
Feasibility Studies
Female
Heart Valve Prosthesis Implantation/ae [Adverse Effects]
Hemodynamics
Humans
Male
Prospective Studies
Prosthesis Design
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Treatment Outcome
United States
MedStar Heart & Vascular Institute
Journal Article
Available online through MWHC library: 2008 - present
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. 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. Copyright Published by Elsevier Inc. 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. 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. 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.
English
1936-8798
10.1016/j.jcin.2019.03.035 [doi] S1936-8798(19)30832-5 [pii]
*Aortic Valve Stenosis/su [Surgery]
*Aortic Valve/su [Surgery]
*Bioprosthesis
*Coronary Stenosis/pc [Prevention & Control]
*Heart Valve Prosthesis
*Heart Valve Prosthesis Implantation/is [Instrumentation]
*Iatrogenic Disease/pc [Prevention & Control]
*Prosthesis Failure
*Transcatheter Aortic Valve Replacement/is [Instrumentation]
Aged
Aged, 80 and over
Aortic Valve Stenosis/dg [Diagnostic Imaging]
Aortic Valve Stenosis/pp [Physiopathology]
Aortic Valve/dg [Diagnostic Imaging]
Aortic Valve/pp [Physiopathology]
Coronary Stenosis/dg [Diagnostic Imaging]
Coronary Stenosis/et [Etiology]
Coronary Stenosis/pp [Physiopathology]
Feasibility Studies
Female
Heart Valve Prosthesis Implantation/ae [Adverse Effects]
Hemodynamics
Humans
Male
Prospective Studies
Prosthesis Design
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Treatment Outcome
United States
MedStar Heart & Vascular Institute
Journal Article