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. 2021 May;44(5):708-714.
doi: 10.1002/clc.23599. Epub 2021 Mar 24.

Percutaneous edge-to-edge repair of severe mitral regurgitation using the MitraClip XTR versus NTR system

Philipp M Doldi  1   2 , Isabel Brinkmann  1 , Mathias Orban  1 , Lukas Stolz  1 , Martin Orban  1 , Thomas Stocker  1 , Kornelia Loew  1 , Joscha Buech  3 , Michael Nabauer  1 , Ben Illigens  2 , Tiago Lemos Cerqueira  2 , Timo Siepmann  4   5 , Steffen Massberg  1 , Joerg Hausleiter  1 , Daniel Braun  1
Affiliations

Percutaneous edge-to-edge repair of severe mitral regurgitation using the MitraClip XTR versus NTR system

Philipp M Doldi et al. Clin Cardiol. 2021 May.

Abstract

Background: Transcatheter mitral valve repair (TMVR) has shown to improve symptoms and functional capacity in patients with severe mitral valve regurgitation (MR). Novel device developments provide the technology to treat patients with complex anatomies and large coaptation gaps. Nevertheless, the question of superiority of one device remains unanswered. We aimed to compare the MitraClip XTR and MitraClip NTR system in a real world setting.

Hypothesis: TMVR with the MitraClip XTR system is equally effective, but associated with a higher risk of leaflet injury.

Methods: We retrospectively analyzed peri-procedural and mid-term clinical and echocardiographic outcomes of 113 patients treated for severe MR between March 2018 and August 2019 at the University Hospital of Munich.

Results: Postprocedural MR reduction to ≤2+ was comparable in both groups (XTR: 96.1% vs. NTR: 97.6%, p = .38). There was a significant difference in a composite safety endpoint of periprocedural Major adverse cardiac and cerebrovascular events (MACCE) including leaflet injury between groups (XTR 14.6% vs. NTR 1.7%, 95% CI [2.7, 24.6], p = .012). After a median follow-up of 8.5 (4.4, 14.0) months, durable reduction of MR was confirmed (XTR: in 91.9% vs. NTR: 96.8%, p = .31) and clinical and symptomatic improvement was comparable in both groups accordingly.

Conclusion: While efficacy was comparable in both treatment groups, patients treated with the MitraClip XTR systems showed more events of acute leaflet tear and single leaflet device attachment (SLDA). A detailed echocardiographic assessment should be done to identify risk candidates for acute leaflet injury.

Keywords: leaflet injury; mitral valve regurgitation; single leaflet device attachment; transcatheter mitral valve repair.

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Conflict of interest statement

Daniel Braun, Mathias Orban and Michael Nabauer received speaker honoraria from the Abbott Vascular. Joerg Hausleiter received speaker honoraria from and serves as consultant for Abbott Vascular and Edwards Lifesciences.

Figures

FIGURE 1
FIGURE 1
Acute leaflet injury. (A,B) show transesophageal echocardiographic images in one case of acute leaflet tear after implantation of the MitraClip XTR device. The MitraClip XTR device is tilted towards the anterior mitral leaflet (AML) due to tear (B, red arrow) of the posterior mitral leaflet (PML) causing eccentric MR. Left ventricle (LV), left atrium (LA), AML, and PML are labeled accordingly
FIGURE 2
FIGURE 2
Single leaflet device attachment (SLDA). (A) Shows transesophageal echocardiographic imaging of a patient with SLDA. The MitraClip XTR device (red arrow) is exclusively attached to the posterior mitral leaflet (PML) causing severe MR. (B) Demonstrates an intraoperative image taken during surgery in the same patient. From an atrial perspective one can identify the mitral valve and the MitraClip XTR device held by the surgeon
FIGURE 3
FIGURE 3
Mitral valve regurgitation grade. Shows the distribution of mitral valve regurgitation grades between baseline and last FU in both groups
See this image and copyright information in PMC

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