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New information from a big, worldwide registry confirmed balloon-assisted anterior mitral leaflet modification (BATMAN) was protected, efficient, and resulted in shorter process instances amongst sufferers present process transcatheter mitral valve alternative (TMVR). The info had been introduced as we speak as late-breaking scientific analysis on the Society for Cardiovascular Angiography & Interventions (SCAI) 2025 Scientific Classes.
An estimated 4 million folks within the U.S. have mitral valve regurgitation (the most typical type of coronary heart valve illness). As an alternative choice to open-heart surgical procedure, TMVR is a minimally invasive process to exchange a mitral valve that’s not working correctly.
Left ventricular outflow tract (LVOT) obstruction, the place blood circulation from the left ventricle is proscribed and might result in coronary heart failure, is a big complication of TMVR related to excessive mortality. BATMAN is a novel method to forestall LVOT obstruction throughout TMVR. Nevertheless, its efficacy and security are unknown.
The examine included 41 sufferers at excessive threat of LVOT obstruction present process transseptal TMVR with balloon-assisted anterior mitral leaflet (AML) modification throughout 12 structural coronary heart facilities throughout the USA, Canada, and Europe. The first efficacy endpoint was the speed of profitable TMVR with freedom from LVOT obstruction (LVOT imply gradient >50 mmHg) and no procedural loss of life. The first security endpoint was the in-hospital composite of loss of life, stroke, or main cardiac structural problems in response to the mitral valvular tutorial consortium (MVARC) standards.
The first efficacy endpoint was met in 92.7% of sufferers. Leaflet traversal and balloon laceration had been profitable in all instances, and there have been no instances of residual LVOT obstruction. The median time between leaflet traversal and valve implantation was solely 28 minutes.
The first security endpoint occurred in 9.8% of sufferers on account of two deaths within the ViM (Valve in Mitral annular calcification) group and one loss of life within the ViV (Valve in Valve) group. There have been no major security occasions within the ViR (Valve in Ring) group. There have been no cardiac structural problems attributed to the method. There have been no instances 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,” stated Gennaro Giustino, MD, Structural Interventional Heart specialist at Morristown Medical Heart, Atlantic Well being System and lead creator of the examine.
“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.”
Additional analysis is required to refine the BATMAN method and assess the comparative effectiveness of this method versus LAMPOON in sufferers present process TMVR and requiring AML modification to forestall LVOT obstruction.
Extra data:
“Balloon-Assisted Modification of the Anterior Mitral Leaflet to Prevent Outflow Track Obstruction During Transeptal Transcatheter Mitral Valve Replacement”
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Society for Cardiovascular Angiography and Interventions
Quotation:
Balloon-assisted process discovered protected and efficient for sufferers present process transcatheter mitral valve alternative (2025, Might 2)
retrieved 3 Might 2025
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