The BASILICA technique uses percutaneous electrocautery to lacerate the diseased aortic valve leaflet prior to transcatheter valve implantation to prevent subsequent coronary obstruction. Expert operators at 25 high-volume centers contributed to a multi-center registry of 214 patients (1 to 59 patients/center) deemed at high risk for coronary obstruction who underwent TAVR after applying BASILICA. 67% of patients were high or extreme surgical risk. 73% of patients had bioprosthetic valve failure, and 27% had native valve stenosis. TAVR was performed using a balloon expandable valve in 60% and self-expanding valve in 40%. Cerebral protection was used in 48% of patients at the operator’s discretion.
Technical success (successful leaflet laceration) occurred in 94.4% of patients. Procedural success (successful BASILICA technique with survival free from culprit coronary obstruction, emergency surgery or intervention) occurred in 87% of patients. 4.7% of patients had coronary obstruction despite BASILICA, all of whom were bailed out with stenting, balloon angioplasty, or in the case of TAVR valve skirt induced obstruction, valve removal, and replacement.
There were no procedural deaths. 30-day outcomes included death in 2.8%, stroke in 2.8% (0.5% disabling), for a total death or disabling stroke of 3.4%. One year survival was 84%. There was no difference in outcomes in those patients undergoing valve in valve vs. native valve BASILICA/TAVR, in patients undergoing single leaflet vs double leaflet BASILICA, or in those patients with or without cerebral embolic protection. However, these subgroups analyses were limited by small numbers of patients and/or selection bias.
The 30-day outcomes in this registry compare favorably to those undergoing TAVR not specifically at risk for coronary obstruction and are superior to those reported for “snorkel” or “chimney” stenting. While the patients in this registry were deemed at high risk of coronary obstruction by their treating physicians, their risk features were not described, and their risk of obstruction is unknown. The BASILICA technique is also relatively complex and likely requires proctoring and experience to optimize results.
In conclusion, despite some limitations, this real-world multi-center registry shows BASILICA is a safe and likely effective technique for preventing coronary obstruction in selected patients undergoing TAVR and may be appropriate for high or extreme surgical risk patients.