Balloon-assisted procedure found safe and effective for patients undergoing transcatheter mitral valve replacement

New data from a large, international registry showed balloon-assisted anterior mitral leaflet modification (BATMAN) was safe, effective, and resulted in shorter procedure times among patients undergoing transcatheter mitral valve replacement (TMVR). The data were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2025 Scientific Sessions.

An estimated four million people in the U.S. have mitral valve regurgitation (the most common form of heart valve disease). As an alternative to open-heart surgery, TMVR is a minimally invasive procedure to replace a mitral valve that is not working properly.

Left ventricular outflow tract (LVOT) obstruction, where blood flow from the left ventricle is limited and can lead to heart failure, is a significant complication of TMVR associated with high mortality. BATMAN is a novel technique to prevent LVOT obstruction during TMVR. However, its efficacy and safety are unknown.

The study included 41 patients at high risk of LVOT obstruction undergoing transseptal TMVR with balloon-assisted anterior mitral leaflet (AML) modification across 12 structural heart centers across the United States, Canada, and Europe. The primary efficacy endpoint was the rate of successful TMVR with freedom from LVOT obstruction (LVOT mean gradient >50 mmHg) and no procedural death. The primary safety endpoint was the in-hospital composite of death, stroke, or major cardiac structural complications according to the mitral valvular academic consortium (MVARC) criteria.

The primary efficacy endpoint 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 only 28 minutes.

The primary safety endpoint occurred in 9.8% of patients due to two deaths in the ViM (Valve in Mitral annular calcification) group and one death in the ViV (Valve in Valve) group. There were no primary safety events in the ViR (Valve in Ring) group. There were no cardiac structural complications attributed to the technique. There were no cases of stroke.

“Traditionally, the LAMPOON 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,” said Gennaro Giustino, MD, Structural Interventional Cardiologist at Morristown Medical Center, Atlantic Health System and lead author of the study.

“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.”

Further 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.