Registry Findings Support Safety of BASILICA to Prevent Coronary Obstruction in TAVR

March 22, 2021—Jaffar M. Khan, BM, BCh, PhD, et al published findings from a study evaluating the safety of bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA), which is a procedure to prevent coronary obstruction in patients undergoing transcatheter aortic valve replacement (TAVR). The findings are from the international BASILICA registry, a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and TAVR.

Simultaneous with the online publication on March 6 in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Dr. Khan presented the study at Cardiovascular Research Technologies’ CRT Virtual 2021 conference, which is being held on Saturdays from February 13 to April 24.

The investigators noted that the background of the study is that TAVR causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality, and that data from a large patient cohort to support the safety and feasibility of BASILICA are lacking.

As summarized in JACC: Cardiovascular Interventions, the study was composed of 214 patients enrolled at 25 centers in North America and Europe between June 2017 and December 2020. Of these patients, 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%. Valve Academic Research Consortium (VARC)-2 definitions were used to adjudicate events.

The investigators found that procedural success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was 86.9%. Thirty-day mortality was 2.8%. The rate of stroke was 2.8%, with 0.5% disabling stroke; 30-day death and disabling stroke occurred in 3.4%.

VARC-2 composite safety was achieved in 82.8%, and 1-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.

The investigators concluded that BASILICA is safe, with low reported rates of stroke and death. Additionally, BASILICA is feasible in the real-world setting, with a high procedural success rate and low rates of coronary artery obstruction, reported the investigators in JACC: Cardiovascular Interventions.