The BASILICA Trial: Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction

Abstract

Objectives: The BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study.

Background: Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction.

Methods: 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. 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.

Results: Between February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR.

Conclusions: BASILICA was feasible in both native and bioprosthetic valves. 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.

Keywords: bioprosthetic heart valve failure; coronary artery obstruction; structural heart disease; transcatheter aortic valve replacement; transcatheter electrosurgery.

FIGURE 1. Trial Enrollment

Sixty patients were screened and 30 were enrolled. All patients completed follow-up. One patient declined 30-day computed tomography (CT) and 1 died before 30 days. BASILICA = bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR; STJ = sinotubular junction; TAVR = transcatheter aortic valve replacement; VTC = virtual transcatheter heart valve to coronary distance.

FIGURE 2. Correlation Between Predicted and Observed Valve-to-Coronary Distance

(A) The overall correlation coefficient was 0.58, with (C) good correlation across left and right cusps. Observed virtual transcatheter heart valve to coronary distance (VTC) was smaller than predicted (B) for SAPIEN 3 valves and (D) in native aortic stenosis. (B, D) There were few outliers when using Evolut valves in surgical bioprostheses in which prediction underestimated VTC. The Bland-Altman plot demonstrates no systematic difference (bias) between predicted and observed VTC. LCA = left coronary artery; RCA = right coronary artery.

FIGURE 3. Three-dimensional CT Reconstruction After Doppio Native BASILICA

Native leaflets (LCC in red, RCC in green) and coronary arteries (blue) are manually segmented and colorized on a CT acquired after BASILICA and TAVR. Both left and right coronary leaflets are seen split and parted away from the coronary ostia. (Online Video 2) The leaflet configuration suggests that both coronary ostia would have obstructed without BASILICA. Abbreviations as in Figures 1 and 2.

FIGURE 4. Symptom and Quality of Life Improvement

There was an improvement in New York Heart Association (NYHA) functional class and Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 30 days compared with baseline. Error bars represent the interquartile range.

CENTRAL ILLUSTRATION. BASILICA Representative Example and Trial Results

Khan, J.M. et al. J Am Coll Cardiol Intv. 2019;12(13):1240–52. A representative subject with failed Mitroflow valve and at high risk of coronary obstruction who underwent doppio bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) and transcatheter aortic valve replacement (TAVR) (Online Video 1). (A) The guidewire traverses the right coronary cusp (RCC). (B) The guidewire traverses the left coronary cusp (LCC) into a snare in the left ventricular outflow tract. (C) BASILICA guidewire loops are formed through the base of both right and left cusps, ready for radiofrequency-assisted laceration. (D) Aortic root angiography demonstrates flow to both coronaries through the split Mitroflow leaflets after TAVR with a SAPIEN 3 valve. The RCC is highlighted in green, LCC highlighted in red, noncoronary cusp highlighted in yellow, BASILICA catheters highlighted in blue, coronary arteries outlined by dashed lines, and arrow points indicate traversal target.