Preventing Coronary Obstruction During TAVR: BASILICA Registry Results
Quick Takes
- This registry study reports that the BASILICA procedure is safe, with low rates of mortality and stroke.
- BASILICA appears feasible in the real-world setting, with successful traversal and laceration of all intended leaflets in 94.4% of patients.
- Of note, these data are retrospective and site-reported without independent monitoring and data verification, and need additional prospective validation.
Study Questions:
What is the real-world safety of the BASILICA (Bioprosthetic or native aortic scallop intentional laceration to prevent Iatrogenic Coronary Artery obstruction) procedure in a multicenter international registry?
Methods:
The investigators conducted the International BASILICA Registry, a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement (TAVR). Valve Academic Research Consortium (VARC-2) definitions were used to adjudicate events. Baseline subject and procedural characteristics were summarized as means and standard deviations for continuous variables and counts and percentages for categorical variables.
Results:
Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. VARC-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, native and bioprosthetic valves, and with the use of cerebral embolic protection.
Conclusions:
The authors concluded that BASILICA is safe, with low reported rates of stroke and death.
Perspective:
This registry study reports that the BASILICA procedure is safe, with low rates of mortality and stroke. Furthermore, the study suggests BASILICA is feasible in the real-world setting, with successful traversal and laceration of all intended leaflets in 94.4% of patients. Of note, these data are retrospective and site-reported without independent monitoring and data verification. Overall, these data should be considered reassuring but need additional prospective validation in other high-volume centers in a larger number of patients.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Cardiac Surgical Procedures, Coronary Occlusion, Coronary Vessels, Embolic Protection Devices, Heart Valve Diseases, Heart Valve Prosthesis, Iatrogenic Disease, Lacerations, Secondary Prevention, Stroke, Transcatheter Aortic Valve Replacement
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