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Author Notes:

Correspondence: Dr. Vasilis C. Babaliaros, Emory Structural Heart and Valve Center, 550 Peachtree Street NE, 4th Floor, Davis-Fischer Building, Atlanta, Georgia 30308., vbabali@emory.edu

Acknowledgements: The authors thank Lauren Wheeler-Roberts, Kristy Pitts, Elizabeth Charles, Emily Jones, Alex Hall, and Patricia Keegan at Emory for their work in coordinating the compassionate-use protocol; Keshav Kohli at the Georgia Institute of Technology for his assistance with image analysis;

And Sam Brenny, Neal Moat, MD, Tom Vilkama, Ihsen Merioua, and Adam Hoyhtya at Abbott for their thoughtful commentary on the manuscript and allowing compassionate use of the Tendyne TMVI system in these patients.

Disclosures: Dr. Greenbaum is a proctor for Edwards Lifesciences and Medtronic; and has an equity interest in Transmural Systems. Dr. Greenbaum’s employer has research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific.

Dr. Khan is a proctor for Edwards Lifesciences and Medtronic. Dr. Paone is a consultant and proctor for Edwards Lifesciences. Dr. Grubb is a speaker, proctor, and principal investigator for Edwards Lifesciences; is a speaker, a proctor, and an advisory board member for Boston Scientific; and is a speaker, a proctor, a principal investigator, an advisory board member, and a national principal investigator for Medtronic.

Dr. Rogers is a proctor for Edwards Lifesciences and Medtronic. Drs. Khan, Lederman, and Rogers are coinventors on patents, assigned to the National Institutes of Health, on devices for electrosurgical leaflet laceration.

Dr. Lederman’s employer has received research support from Edwards Lifesciences for transcatheter modification of the mitral valve. Dr. Babaliaros is a consultant for Edwards Lifesciences and Abbott Vascular; and has an equity interest in Transmural Systems.

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Research Funding:

This study was supported by Emory Structural Heart and Valve program intramural funds and by grant Z01-HL006040 from the National Institutes of Health.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • MitraClip
  • mitral regurgitation
  • transcatheter electrosurgery
  • transcatheter mitral valve implantation
  • Outflow tract obstruction
  • Regurgitation
  • Replacement
  • Laceration
  • Definitions
  • Repair
  • Impact

Electrosurgical Detachment of MitraClips From the Anterior Mitral Leaflet Prior to Transcatheter Mitral Valve Implantation

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Journal Title:

JACC: Cardiovascular Interventions

Volume:

Volume 13, Number 20

Publisher:

, Pages 2361-2370

Type of Work:

Article | Post-print: After Peer Review

Abstract:

OBJECTIVES The aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis. BACKGROUND Patients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI. METHODS This was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days. RESULTS MitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet. CONCLUSIONS Transcatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak.

Copyright information:

© 2020 Published by Elsevier on behalf of the American College of Cardiology Foundation.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/rdf).
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