Aims: The aim of this study was to evaluate the feasibility, efficacy and safety of the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) technique during transcatheter aortic valve implantation (TAVI) in an initial cohort at a single European centre.
Methods and results: Between August 2018 and March 2020, BASILICA was attempted in 23 leaflets in 21 consecutive patients undergoing TAVI (age 78±6 years, 52% female). The index procedure was performed for 21 degenerated bioprosthetic leaflets (90%, 9.2±2.6 years after implantation) and two native leaflets (10%). BASILICA was performed for a single leaflet in 19 (90%) patients and for both leaflets in two (10%) patients. The median total procedure time was 82 (interquartile range [IQR] 70-131) minutes, and BASILICA time (sheath-in to laceration) was 45 (IQR 35-67) minutes. A cerebral embolic protection device was used in 20 (95%) patients. BASILICA was feasible in all but one patient (95%) and resulted in effective prevention of coronary obstruction in 19 patients (90%). One patient developed a non-flow-limiting ostial lesion after BASILICA and TAVI, and was treated by additional coronary stenting. No mortality or stroke was observed up to 30 days.
Conclusions: The feasibility, efficacy and safety of BASILICA in this early single-centre experience were consistent with the initial proof-of-concept reports. Further validation by ongoing multicentre registries remains warranted.