Balloon-Assisted Modification of the Anterior Mitral Leaflet to Prevent Outflow Track Obstruction During Transseptal Transcatheter Mitral Valve Replacement: BATMAN Collaboration
Presenter
Gennaro Giustino, M.D., Gagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, Morristown, NJ
Gennaro Giustino, M.D.1, Ahmad Jabri, M.D., FSCAI2, Santiago Garcia, MD, FSCAI3, Sant Kumar4, Thom Dahle, M.D., FSCAI5, Brian O'Neill, M.D.6, Philippe Genereux MD, M.D.7, Amr E. Abbas, M.D., FSCAI8, Puvi N. Seshiah, M.D., FSCAI3, Hursh Naik, MD9, Brian M. Stegman, M.D.10, Adnan Halboni11, Raviteja Reddy Guddeti, M.D., FSCAI3, Pedro engel-Gonzalez, MD6, Tiberio Frisoli, MD6, Robert Kipperman, M.D.12, William W. O'Neill, MD, MSCAI6 and Pedro A Villablanca, M.D., FSCAI13, (1)Gagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, Morristown, NJ, (2)Beaumont Health, Royal Oak, MI, (3)The Christ Hospital Health Network, Cincinnati, OH, (4)Department of Cardiology, Creighton University School of Medicine, Phoenix, AZ, (5)CentraCare Heart and Vascular Center, Clear Lake, MN, (6)Henry Ford Health System, Detroit, MI, (7)Gagnon Cardiovascular Institute at Morristown Medical Center, Morristown, NJ, (8)Beaumont Hospital - Royal Oak, Birmingham, MI, (9)Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ, (10)CentraCare Heart and Vascular Center, Cleveland, OH, (11)Wayne State University, West Bloomfield, MI, (12)Atlantic Health Morristown Medical Center, Morristown, NJ, (13)Henry Ford Hospital, Detroit, MI
Keywords: TEER/TMVR/Mitral Valve
Background
Left ventricular outflow track (LVOT) obstruction after transcatheter mitral valve replacement (TMVR) is associated with high mortality. Balloon-assisted modification of the anterior mitral leaflet (AML) is a novel technique to prevent LVOT obstruction during TMVR. However, its efficacy and safety are unknown.
Methods
We included all consecutive patients at high risk of LVOT obstruction undergoing transeptal TMVR with balloon-assisted AML modification for valve-in-valve (ViV), valve-in-ring (ViR) and valve-in-MAC (ViM) at 6 structural heart centers. Electrosurgical AML traversal was performed aiming at the leaflet base via an antegrade or retrograde approach. Subsequent AML laceration was performed with non-compliant balloons followed by valve implantation. The primary efficacy endpoint was the rate of successful TMVR with freedom from LVOT obstruction (mean gradient >50 mmHg). The primary safety endpoint was the in-hospital composite of death, stroke, systemic embolism or cardiac structural complications according to the mitral valvular academic consortium.
Results
A total of 21 patients were included. Of these, 7 (33.3%) underwent TMVR for ViV, 7 (33.3%) for ViR and 7 (33.3%) for ViMAC. The median STS score for mortality was 19.4%. The median predicted neo-LVOT was 150 mm
2. Leaflet traversal and balloon laceration was technically successful in all cases. The median time between leaflet traversal and laceration was 16 min and the median time between leaflet laceration and valve implantation was 10 min. The primary efficacy endpoint was met in 90.5% of patients. There were no cases of residual LVOT obstruction. Overall, the primary safety endpoint occurred in 9.5% of patients due to 2 deaths in the ViM group. There were no primary safety events in the ViR and ViV groups. There were no cardiac structural complications attributed to the technique. There were no cases of stroke or systemic embolism. Clinical and imaging follow-up is ongoing and will be presented.
Conclusions
Among patients undergoing TMVR at high-risk of LVOT obstruction, balloon-assisted AML modification was associated with short procedure times, was effective in preventing LVOT obstruction and appeared to be safe, particularly in ViR and ViV.