|Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement|
Between June 2017 and June 2018, 30 subjects were enrolled equally between the MAC and ring arms. LAMPOON traversal and midline laceration was successful in 100%. Procedure survival was 100%, and 30-day survival was 93%. Primary success was achieved in 73%, driven by additional procedures for paravalvular leak (10%) and high-skirt neo-LVOT gradients observed before a protocol amendment. There were no strokes.
LAMPOON was feasible in native and annuloplasty ring anatomies in patients who were otherwise ineligible for treatment, with acceptable safety. LAMPOON was effective in preventing LVOT obstruction from TMVR. Despite LAMPOON, TMVR using Sapien 3 in annuloplasty rings and MAC still exhibits important limitations. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194)
|Khan JM et al.||
Journal of the American College of Cardiology, Volume 73, Issue 20, 28 May 2019, Pages 2521-2534
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