Safety and Effectiveness of BATMAN Technique in TMVR Studied

May 2, 2025—New data from a large, international registry showed that balloon-assisted anterior mitral leaflet modification (BATMAN) was safe, effective, and resulted in shorter procedure times among patients undergoing transcatheter mitral valve replacement (TMVR), according to the Society for Cardiovascular Angiography & Interventions (SCAI).

SCAI noted that BATMAN is a novel technique to prevent left ventricular outflow tract (LVOT) obstruction, which is a significant complication of TMVR associated with high mortality, but the efficacy and safety of the technique are not known.

The late-breaking data were presented at the SCAI 2025 scientific sessions held May 1-3 in Washington, DC. The SCAI study abstract is available online here. The study’s lead author is Gennaro Giustino, MD, a structural interventional cardiologist at Morristown Medical Center, Atlantic Health System in Morristown, New Jersey.

According to SCAI, the study was composed of 41 patients at high risk of LVOT obstruction undergoing transseptal TMVR with balloon-assisted anterior mitral leaflet (AML) modification at 12 structural heart centers in the United States, Canada, and Europe.

As reported in the SCAI press release, the primary efficacy endpoint—the rate of successful TMVR with freedom from LVOT obstruction (LVOT mean gradient > 50 mm Hg) and no procedural death—was met in 92.7% of patients. Leaflet traversal and balloon laceration were successful in all cases, and there were no cases of residual LVOT obstruction. The median time between leaflet traversal and valve implantation was 28 minutes.

The SCAI press release stated that the primary safety endpoint was the in-hospital composite of death, stroke, or major cardiac structural complications according to the Mitral Valvular Academic Consortium criteria. This endpoint occurred in 9.8% of patients with two deaths in the valve-in-mitral annular calcification group and one death in the valve-in-valve (ViV) group. There were no primary safety events in the valve-in-ring (ViR) group. Additionally, there were no cardiac structural complications attributed to the technique and no cases of stroke.

“Traditionally, the LAMPOON [laceration of the anterior mitral leaflet to prevent outflow obstruction] technique and its various iterations has been used to enable TMVR in patients at high risk of LVOT obstruction; however, this technique has a steep learning curve and is technically more challenging and time-consuming,” commented Dr. Giustino in the SCAI press release.

Dr. Giustino continued, “The findings from this study highlight that BATMAN may be considered as an alternative to LAMPOON associated with excellent efficacy and safety, particularly for ViR and ViV procedures, providing another option for physicians.”

More research is needed to refine the BATMAN technique and assess the comparative effectiveness of this technique versus LAMPOON in patients undergoing TMVR and requiring AML modification to prevent LVOT obstruction, noted the SCAI press release.