Author + information
- Received January 12, 2019
- Revision received February 22, 2019
- Accepted February 25, 2019
- Published online May 20, 2019.
- Jaffar M. Khan, BM, BCha,∗,
- Vasilis C. Babaliaros, MDb,∗,
- Adam B. Greenbaum, MDb,c,
- Jason R. Foerst, MDd,
- Shahram Yazdani, MDe,
- James M. McCabe, MDf,
- Gaetano Paone, MDc,
- Marvin H. Eng, MDc,
- Bradley G. Leshnower, MDb,
- Patrick T. Gleason, MDb,
- Marcus Y. Chen, MDa,
- Dee Dee Wang, MDc,
- Xin Tian, PhDg,
- Annette M. Stine, RNa,
- Toby Rogers, BM, BCh, PhDa,h and
- Robert J. Lederman, MDa,∗ (, )@nih_nhlbi
- aCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- bStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia
- cCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan
- dCarilion Roanoke Memorial Hospital, Roanoke, Virginia
- eInova Fairfax Hospital, Fairfax, Virginia
- fUniversity of Washington, Seattle, Washington
- gOffice of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- hMedstar Washington Hospital Center, Washington, DC
- ↵∗Address for correspondence:
Dr. Robert J. Lederman, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 2c713, MSC 1538, Bethesda, Maryland 20892-1538.
Background Left ventricular outflow tract (LVOT) obstruction is a leading cause of mortality and exclusion from transcatheter mitral valve replacement (TMVR). Intentional laceration of the anterior mitral valve leaflet to prevent LVOT obstruction (LAMPOON) is a transcatheter mimic of surgical chord-sparing leaflet resection.
Objectives The purpose of this prospective multicenter trial was to study LAMPOON with transseptal (Edwards Lifesciences, Irvine, California) TMVR in annuloplasty rings or native mitral annular calcification (MAC).
Methods Subjects at high or extreme surgical risk and prohibitive risk of LVOT obstruction from TMVR were included. Eligibility was modified midtrial to exclude subjects with threatened LVOT obstruction from a Sapien 3 valve fabric skirt. The primary endpoint was procedure survival with successful LAMPOON, with successful TMVR, without reintervention, and with LVOT gradient <30 mm Hg (“optimal”) or <50 mm Hg (“acceptable”). Secondary endpoints included 30-day mortality and major adverse cardiovascular events. There was universal source-data verification and independent monitoring. All endpoints were independently adjudicated. Central laboratories analyzed echocardiogram and CT images.
Results 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.
Conclusions 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)
- mitral annular calcification
- structural heart disease
- transcatheter electrosurgery
- transcatheter mitral valve replacement
- transseptal interventions
↵∗ Drs. Khan and Babaliaros contributed equally to this work.
This work was supported by the Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health (Z01-HL006040-7), and by the intramural programs of the participating centers. The National Heart, Lung, and Blood Institute and Edwards Lifesciences have a collaborative research and development agreement on transcatheter modification of mitral valve leaflets, including joint financial support of this study. Drs. Khan, Rogers, and Lederman are coinventors on patents, assigned to the National Institutes of Health, on catheter devices to lacerate valve leaflets. Dr. Babaliaros has served as a consultant for Edwards Lifesciences and Abbott Vascular; and his employer has research contracts for clinical investigation of transcatheter aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific. Dr. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and has served as a consultant and a scientific advisor for and is an equity holder in Transmural Systems. Drs. Foerst and Rogers have served as consultants/proctors for Edwards Lifesciences and Medtronic. Dr. Yazdani, Paone, and Eng have served as proctors for Edwards Lifesciences. Dr. Leshnower has served on the Speakers Bureau for Medtronic. Dr. Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, and Materialise. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received January 12, 2019.
- Revision received February 22, 2019.
- Accepted February 25, 2019.
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