New Balloon-Assisted Technique Enhances Safety and Efficacy in Mitral Valve Replacement

Recent findings from a comprehensive international registry indicate that a novel balloon-assisted technique, known as Balloon-Assisted Anterior Mitral Leaflet Modification (BATMAN), demonstrates both safety and effectiveness in patients undergoing transcatheter mitral valve replacement (TMVR). The results were unveiled during the Society for Cardiovascular Angiography & Interventions (SCAI) 2025 Scientific Sessions.

Mitral valve regurgitation, a prevalent form of heart valve disease, affects approximately four million individuals in the United States. TMVR serves as a minimal invasive alternative to traditional open-heart surgery for replacing malfunctioning mitral valves. However, a significant complication associated with TMVR is left ventricular outflow tract (LVOT) obstruction, which restricts blood flow from the left ventricle and can precipitate heart failure, notably increasing mortality risks.

The BATMAN technique aims to mitigate the risk of LVOT obstruction during TMVR, yet its safety and efficacy had not been thoroughly evaluated prior to this study. The research involved a cohort of 41 patients deemed high-risk for LVOT obstruction, all of whom underwent transseptal TMVR with balloon-assisted modification of the anterior mitral leaflet at 12 structural heart centers located in the United States, Canada, and Europe.

The primary efficacy endpoint evaluated the success rate of TMVR while ensuring freedom from LVOT obstruction (defined as a mean gradient >50 mmHg) and the absence of procedural deaths. Conversely, the primary safety endpoint monitored in-hospital occurrences of death, stroke, or major cardiac structural complications as outlined by the Mitral Valvular Academic Consortium (MVARC) criteria.

Remarkably, the study revealed that 92.7% of participants met the primary efficacy endpoint, with successful leaflet traversal and balloon laceration achieved across all cases. No residual LVOT obstruction was noted, and the median time from leaflet traversal to valve implantation was a mere 28 minutes.

In terms of safety, the primary safety endpoint was recorded in 9.8% of the patients, attributed to two fatalities in the Valve in Mitral annular calcification (ViM) cohort and one in the Valve in Valve (ViV) group. Notably, the Valve in Ring (ViR) group reported no primary safety events, and no cardiac structural complications were directly linked to the BATMAN technique, nor were there any instances of stroke.

Traditionally, the LAMPOON technique, along with its various adaptations, has been employed to facilitate TMVR in patients at elevated risk of LVOT obstruction. However, this method poses a steep learning curve and is often more technically demanding and time-consuming. The findings of this study propose that BATMAN might serve as a viable alternative to LAMPOON, showcasing excellent efficacy and safety profiles, particularly for ViR and ViV procedures, thus providing additional options for healthcare practitioners.

Future research is warranted to further refine the BATMAN technique and to compare its effectiveness against the LAMPOON method for patients requiring anterior mitral leaflet modification during TMVR to prevent LVOT obstruction.