Novel, balloon-assisted anterior mitral leaflet modification shown to be safe and effective for patients undergoing transcatheter mitral valve replacement
Patients undergoing TMVR experience reduced risk of obstruction and shorter procedure times
2025-05-02
(Press-News.org) Washington, D.C. – MAY 2, 2025 – 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.
Session Details:
“Balloon-Assisted Modification of the Anterior Mitral Leaflet to Prevent Outflow Track Obstruction During Transeptal Transcatheter Mitral Valve Replacement”
Friday, May 2, 2025; 11:03-11:11 AM ET
Walter E. Washington Convention Center, Hall D, Theater 4
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About Society for Cardiovascular Angiography & Interventions (SCAI)
The Society for Cardiovascular Angiography & Interventions, established in 1978, stands as the primary nonprofit medical society dedicated to representing invasive and interventional cardiology. SCAI's mission is to guide the global interventional cardiovascular community by fostering education, advocacy, research, and upholding standards for quality patient care. For more than 40 years, SCAI has exemplified professional excellence and innovation worldwide, cultivating a reputable community of over 5,000 members committed to advancing medical science and providing life-saving care for individuals, both adults and children, affected by cardiovascular disease. For more information, visit https://scai.org/.
For more information about the SCAI 2025 Scientific Sessions, visit https://scai.org/scai-2025-scientific-sessions. Follow @SCAI on X for the latest heart health news and use #SCAI2025 to follow the latest discussions.
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[Press-News.org] Novel, balloon-assisted anterior mitral leaflet modification shown to be safe and effective for patients undergoing transcatheter mitral valve replacement
Patients undergoing TMVR experience reduced risk of obstruction and shorter procedure times
