First-in-Human Percutaneous Excision ofa Failed MitraClip Followed byTranscatheter Mitral Valve Replacement

David Elison, MD,a Gabriel Aldea, MD,b Srjdan Jelacic, MD,c Christine J. Chung, MD,a G. Burkhard Mackensen, MD,c James M. McCabe, MDa


Acomorbid 76-year-old man was treated locally in August 2021 with transcatheter edge-to-edge repair (TEER) using an XTW MitraClip (Abbott Vascular) to the A2/P2 scallops. He

continued to experience New York Heart Association functional class IIIb symptoms with severe residual regurgitation and mitral stenosis caused by the clip and significant mitral annular calcification (Figure 1). Transesophageal echocardiography demonstrated a 3-dimensional vena contracta area of 0.88 cm2 and a mitral valve area of 1.8 cm2 (Figures 2A and 2B). By cardiac-gated computed tomography angiography, the valve measured 45 mm  39 mm, and his pre- dicted neo–left ventricular outflow tract was >300 mm2. For several reasons, he was deemed inop- erable, and it was determined that the only viable op- tion would be compassionate use of a dedicated transcatheter mitral valve replacement (TMVR) de- vice facilitated by excision of his MitraClip.

Recreating a single mitral orifice in preparation for TMVR by liberating the TEER device from the anterior mitral leaflet has been previously described as elec- trosurgical laceration and stabilization of failed MitraClip (ELASTA-Clip).1 Preserving TEER attach- ment to the posterior leaflet obviates challenges with explantation, although in certain scenarios the re- sidual clip may interfere with the implantation of a dedicated TMVR device, as was anticipated in this case with the use of an M3 valve (Edwards Life- sciences). Thus, explantation was required.

The procedure was performed with general anes- thesia and TEE guidance using a prophylactic 50-mL

From the aUniversity of Washington Medical Center, Department of Medicine, Division of Cardiology, Seattle, Washington, USA; bUniversity of Washington Medical Center, Department of Surgery, Division of Cardiothoracic Surgery, Seattle, Washington, USA; and the cUniversity of Washington Medical Center, Department of Anesthesia and Pain Medicine, Seattle, Washington, USA. The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.

Manuscript received October 29, 2023; revised manuscript received November 8, 2023, accepted November 14, 2023.


intra-aortic balloon pump for hemodynamic support. Two 26-F sheaths were placed in the right femoral vein. The upper sheath was used for the retrieval system—a 14-F Destino Twist [OSCOR Inc] steerable

guide directing a 20-mm snare within a nitinol retrieval basket [O"NO", O"NO"COR Vascular]). The lower sheath was for the lacerating system—2 11-F DiRex (Boston Scientific) steerable guides each with a JR4 guide catheter directed to the medial and lateral ori- fices, respectively, to create the “flying V” as previ- ously described.1


followed by readvancing the “flying V” into the ventricle and torquing it anteriorly while torquing the snared clip posteriorly to repeat the laceration pro- cess on the anterior leaflet (Figure 3).

Once the clip was freed, it was drawn into the O"NO", which was used to orient the snared clip “lengthwise” so it could be successfully drawn back across the interatrial septum and into the sheath (Figures 4 and 5). The incremental increase in mitral regurgitation during TEER removal and implantation of the M3 valve was well tolerated with just the assistance of the prophylactic intra-aortic balloon pump. At the 6- month follow-up, the patient remains well with no residual mitral stenosis or regurgitation.

In conclusion, this case demonstrates a first-in- human procedure to percutaneously remove an imperfect MitraClip via a “double” ELASTA-Clip method in order to accommodate dedicated TMVR implantation.

Before leaflet laceration, the clip was snared and held by the retrieval system. Liberating the TEER device from both the anterior and posterior mitral leaflets was performed sequentially by electrifying the “flying V” and cutting the posterior leaflet first.


REFERENCE

1. Lisko JC, Greenbaum AB, Guyton RA, et al. Electrosurgical detachment of MitraClips from the anterior mitral leaflet prior to transcatheter mitral valve implantation. J Am Coll Cardiol Intv. 2020;13(20):2361–2370.

KEY WORDS edge-to-edge repair, mitral regurgitation/stenosis, percutaneous electrosurgery, transcatheter mitral valve replacement in mitral annular calcium


About ŌNŌCOR 

ŌNŌCOR LLC is a medical technology company dedicated to developing essential safety tools and other facilitating technologies for the modern-day catheterization lab. For more information, please go to www.onocorvascular.com.  

About B. Braun Interventional Systems
B. Braun Interventional Systems offers interventional solutions designed with the patient in mind. Many of the products offered have been developed in response to the needs of physicians, technicians, and nurses. The company is committed to delivering safety, precision and convenience to interventional procedures. B. Braun Interventional Systems Inc. is part of the B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, Pa., and includes B. Braun Medical Inc., Aesculap® and CAPS®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Interventional Systems Inc., visit www.bisusa.com/about-us and connect with B. Braun Interventional Systems on LinkedIn.


For more information, please contact:

Mark Piper, CEO, ŌNŌCOR, 

mpiper@onocorvascular.com, (610) 764-1882   


Judy Marushak, Director, Marketing Communications, B. Braun Medical Inc.

judy.marushak@bbraunusa.com

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