Key result
The BASILICA procedure was technically successful in 86.7% of patients at high risk for TAVI-induced coronary obstruction, with no all-cause deaths or strokes at 30 days.
Why the study?
Clinical outcomes of the BASILICA technique required evaluation in patients considered at high or prohibitive risk of TAVI-induced coronary obstruction.
Does the BASILICA technique safely prevent iatrogenic coronary obstruction in high-risk patients undergoing TAVI?
Observational (n=15)
No
Does the BASILICA technique safely prevent iatrogenic coronary obstruction in high-risk patients undergoing TAVI?
The BASILICA technique is a feasible and safe approach to prevent iatrogenic coronary obstruction during TAVI in patients at high risk.
Supports BASILICA feasibility in high-risk TAVI; hypothesis-generating pending larger prospective validation.
OBJECTIVES: This study aimed to assess the clinical outcome of the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary obstruction (BASILICA) technique in a single-center patient cohort considered at high or prohibitive risk of transcatheter aortic valve implantation (TAVI)-induced coronary obstruction. METHODS: Between October 2019 and January 2021, a total of 15 consecutive patients (age 81.0 [78.1, 84.4] years; 53.3% female; EuroSCORE II 10.6 [6.3, 14.8] %) underwent BASILICA procedure prior to TAVI at our institution. Indications for TAVI were degeneration of stented (n = 12, 80.0%) or stentless (n = 1, 6.7%) bioprosthetic aortic valves, or calcific stenosis of native aortic valves (n = 2, 13.3%), respectively. Individual risk of TAVI-induced coronary obstruction was assessed by pre-procedural computed tomography analysis. Procedural and 30-day outcomes were documented in accordance with Valve Academic Research Consortium (VARC)-2 criteria. RESULTS: BASILICA was attempted for single left coronary cusp in 12 patients (80.0%), for single right coronary cusp in 2 patients (13.3%), and for both cusps in 1 patient (6.7%), respectively. The procedure was feasible in 13 patients (86.7%) resulting in effective prevention of coronary obstruction, whilst TAVI was performed without prior successful bioprosthetic leaflet laceration in two patients (13.3%). In one of these patients (6.7%), additional chimney stenting immediately after TAVI was performed. No all-cause deaths or strokes were documented after 30 days. CONCLUSION: The BASILICA technique appears to be a feasible, safe and effective concept to avoid iatrogenic coronary artery obstruction during TAVI in both native and bioprosthetic valves of patients at high or prohibitive risk. ClinicalTrials.gov Identifier: NCT04227002 (Hamburg AoRtic Valve cOhoRt).
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Westermann et al. (2021) conducted an observational in Aortic valve disease at high risk of TAVI-induced coronary obstruction (n=15). BASILICA procedure was evaluated on Technical success (successful leaflet traversal and laceration). The BASILICA procedure was technically successful in 86.7% of patients at high risk for TAVI-induced coronary obstruction, with no all-cause deaths or strokes at 30 days.
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