New Procedure Found Safe and Effective for Patients Undergoing Transcatheter Mitral Valve Replacement

In the United States, approximately four million people suffer from mitral valve regurgitation, the most common type of heart valve disease. As an alternative to open-heart surgery, transcatheter mitral valve replacement (TMVR) provides a minimally invasive option to replace a malfunctioning mitral valve. However, a significant complication of TMVR is left ventricular outflow tract (LVOT) obstruction, which restricts blood flow from the left ventricle and can lead to heart failure. This condition is associated with a high mortality rate. Balloon-assisted anterior mitral leaflet modification (BATMAN) is a new technique designed to prevent LVOT obstruction during TMVR, but its safety and effectiveness have not been fully established. Now, new findings from a large, international registry, presented as late-breaking clinical research at the SCAI 2025 Scientific Sessions, demonstrated that BATMAN is a safe and effective method that reduces procedure times for patients undergoing TMVR.

The study, led by Atlantic Health System (Morristown, NJ, USA), involved 41 high-risk patients undergoing transseptal TMVR with balloon-assisted anterior mitral leaflet (AML) modification across 12 structural heart centers in the United States, Canada, and Europe. The primary efficacy endpoint was defined as the successful completion of TMVR with no LVOT obstruction (mean gradient >50 mmHg) and no procedural deaths. The primary safety endpoint was the in-hospital composite of death, stroke, or major cardiac structural complications, as assessed by the mitral valvular academic consortium (MVARC) criteria. The primary efficacy endpoint was achieved in 92.7% of the patients. Leaflet traversal and balloon laceration were successful in all cases, with no instances of residual LVOT obstruction.

The median time between leaflet traversal and valve implantation was just 28 minutes. The primary safety endpoint occurred in 9.8% of patients, which was attributed to two deaths in the Valve in Mitral annular calcification (ViM) group and one death in the Valve in Valve (ViV) group. The Valve in Ring (ViR) group experienced no primary safety events. Additionally, there were no cardiac structural complications related to the BATMAN technique, and no cases of stroke were reported. Further studies are necessary to refine the BATMAN technique and compare its effectiveness to the LAMPOON method in patients undergoing TMVR with AML modification to prevent LVOT obstruction.

“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."

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