Scientists develop novel technique that prevents coronary obstruction from TAVR: JACC

Scientists from the National Institute of Health (NIH) have developed a novel technique called Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR (BASILICA) that may prevent coronary obstruction from trans catheter aortic valve replacement (TAVR). The findings were published in the Journal of the American College of Cardiology: Cardiovascular Interventions (JACC).

A team of scientists led by Jaffar M. Khan from Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, conducted a prospective, multicenter, single-arm safety and feasibility study to ascertain the effectiveness and safety of the procedure.

This bioprosthetic valve was developed in NIH by weaving an electrified wire the size of a sewing thread through a catheter and using it to split the original leaflet in two so that it cannot block the coronary artery once it has been pushed aside by the new transcatheter heart valve. The procedure can be used on both the native valve leaflet or bioprosthetic valve leaflets in valve-in-valve (VIV) procedures.

An illustration of the BASILICA procedure

Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included in the study. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images.

Key Findings

• Primary success was met in 93% of the subjects.


• BASILICA traversal and laceration was successful in 95% of the attempted leaflets.


• There was 100% freedom from coronary obstruction and reintervention.


• Primary safety was met in 70%, driven by 20% of the major vascular complications related to TAVR but not BASILICA.


• There was 1 death at 30 days.


• There was 3% disabling stroke and 7% non-disabling strokes.


• The transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR.

Based on their findings, the authors concluded that BASILICA was feasible in both native and bioprosthetic valves. A hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk.

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