TAVR Operators Urged to Tread Carefully on BASILICA

Don't move too fast toward the BASILICA technique in practice, one TVT Registry leader argued, although his group will start tracking real-world use of this leaflet laceration method in transcatheter aortic valve replacement (TAVR).

Yet, the "line between impulsive madness and creative ethical scientific investigation must be drawn," urged John Carroll, MD, of University of Colorado Hospital, Aurora. He is vice chair of the Society of Thoracic Surgeons/American College of Cardiology TVT Registry Steering Committee.

"On the one hand, the frontiers of medicine are advanced with new and creative ideas versus, on the other hand, the back-alleys of tinkering-dabbling may lead to a serious compromise of a patient's well-being when the physician attempts something novel with little to no planning," Carroll wrote in an editorial published online in JACC: Cardiovascular Interventions.

BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction) employs catheters and guidewires to direct focused radiofrequency energy that splits valve leaflets prior to TAVR.

The 30-person feasibility study reported in March at the Cardiovascular Research Technologies (CRT) meeting showed 93% primary success with BASILICA by operators at five institutions. There were no cases of coronary obstruction or reintervention at 30 days among high-risk people with severe native or bioprosthetic aortic valve disease who were at elevated risk of experiencing coronary artery obstruction.

Outcomes at 30 days included one death, one disabling stroke, and two non-disabling strokes.

"The encouraging preliminary efforts presented by the authors could suffer irreparable damage if BASILICA related deaths or major strokes emerge by premature dispersion of the technique and hasty reclassification that it is no longer an investigative technique," Carroll warned.

To that end, BASILICA is being added to a drop-down list of adjunctive procedures in the data collection form of the TVT Registry to capture the real-world experience with this technique, he said.

Crucial questions include whether stroke risk increases with BASILICA and how many operators should be performing the technique in the first place. Carroll cited estimates of a one in 500 frequency of coronary obstruction in native-valve TAVR and a median U.S. hospital TAVR volume of 54 per year and operator TAVR volume of 27.

"Is it worth our effort to learn BASILICA to perform it once every 5 years? After spending time to learn the technique, would our threshold to perform it be inappropriately lowered?" he asked. "A system of valve care that triages complex patients to high-volume and more comprehensive valve centers is proposed, but for BASILICA do we need more than a handful of centers in the U.S.?"

"Other issues that must be clarified include the regulatory pathway, the evidence needed for CMS [Centers for Medicare & Medicaid Services] coverage, the role of the TAVR companies in supporting cases involving BASILICA, and the interest and liability of companies supplying the equipment," Carroll added.

On the bright side, the early data are "encouraging enough" for now, he wrote.

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