ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Heart Valve Disease
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1558454
GeminiOne Transcatheter Edge-to-Edge Repair: Comparative Hemodynamic and Biomechanical Evaluation
Provisionally accepted
- 1Peijia Medical Limited, Suzhou, China
- 2Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester, Massachusetts, United States
- 3Texas Tech University, Lubbock, Texas, United States
- 4Sierra Valve LLC, Lake Forest, United States
- 5Los Robles Hospital & Medical Center, Thousand Oaks, California, United States
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Background: Transcatheter edge-to-edge repair (TEER) is frequently used to treat mitral regurgitation (MR) patients. Despite its widely reported efficacy, complications such as single leaflet device attachment (SLDA) and loss of leaflet insertion (LLI) can lead to recurrent MR, which compromises the clinical outcomes.Objectives: This study compare the acute MR reduction and leaflet anchoring stability of a novel TEER device, GeminiOne (GEM) and MitraClip (MC).Methods: In this study, ex-vivo benchtop degenerative mitral regurgitation (DMR) and functional mitral regurgitation (FMR) models were used to evaluate the acute effectiveness of MR reduction by MitraClip XTW and GeminiOne 0626 in a BDC pulsatile flow duplicator.Furthermore, a benchtop study was performed to compare leaflet anchoring stability between XTW and GEM0626, in an attempt to investigate the likelihood of post-procedure leaflet detachment.The results of the pulsatile flow evaluation from the DMR and FMR model demonstrate that both TEER devices effectively reduced the regurgitant fraction (DMR vs GEM0626 vs XTW: 59.21±10.29% vs 35.73±6.62% vs 43.50±8.89%; FMR vs GEM0626 vs XTW: 56.99 ± 8.74% vs 27.99 ± 11.30% vs 28.13 ± 10.64%). However, the leaflet stability study which compared the various TEER devices under Full Grasp and Partial Grasp condition, the detachment force of the anchored leaflet for GeminiOne is significantly higher than that of MitraClip especially for the Partial Grasp. Full Grasp detachment force: 7.89±2.42N vs 6.36±0.96N, p=0.1214; Partial Grasp detachment force: 6.03±2.05N vs 2.97±0.76N, p=0.0021.In the ex-vivo pulsatile experiments, both GEM0626 and XTW are effective in term of acute reduction of MR caused by DMR and FMR. However, in anchored leaflet stability study, under Partial Grasp conditions, GEM0626 demonstrated significant higher 2 leaflet detachment force. The better anchored stability of GeminiOne TEER may have long term clinical benefits for MR treatment.
Keywords: Mitral Valve, Teer, mitraclip, geminione, ex-vivo simulator
Received: 10 Jan 2025; Accepted: 05 Jun 2025.
Copyright: © 2025 Wang, Xu, Xiao, He, TAN and Kar. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Jianfong TAN, Sierra Valve LLC, Lake Forest, United States
Saibal Kar, Los Robles Hospital & Medical Center, Thousand Oaks, California, United States
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.