Wang Kai, Xu Dongyang, Xiao Bowen, He Zhaoming, Tan Jianfong, Kar Saibal
Advance Technology Department, Peijia Medical Limited, Suzhou, China.
Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester, MA, United States.
Front Cardiovasc Med. 2025 Jun 25;12:1558454. doi: 10.3389/fcvm.2025.1558454. eCollection 2025.
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.
This study compares the acute MR reduction and leaflet anchoring stability of a novel TEER device, GeminiOne (GEM), and MitraClip (MC).
In this study, 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, in the leaflet stability study which compared the various TEER devices under full grasp and partial grasp conditions, 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 ± 2.42 vs. 6.36 ± 0.96 N, = 0.1214; partial grasp detachment force: 6.03 ± 2.05 vs. 2.97 ± 0.76 N, = 0.0021).
In the pulsatile experiments, both GEM0626 and XTW are effective in terms of acute reduction of MR caused by DMR and FMR. However, in an anchored leaflet stability study, under partial grasp conditions, GEM0626 demonstrated a significantly higher leaflet detachment force. The better anchored stability of GeminiOne TEER may have long-term clinical benefits for MR treatment.
经导管缘对缘修复术（TEER）常用于治疗二尖瓣反流（MR）患者。尽管其疗效已被广泛报道，但诸如单叶瓣装置附着（SLDA）和瓣叶插入丧失（LLI）等并发症可导致MR复发，从而影响临床结局。
本研究比较了新型TEER装置GeminiOne（GEM）和MitraClip（MC）在急性减少MR及瓣叶锚定稳定性方面的效果。
在本研究中，使用台式退行性二尖瓣反流（DMR）和功能性二尖瓣反流（FMR）模型，在BDC脉动流复制器中评估MitraClip XTW和GeminiOne 0626减少MR的急性有效性。此外，进行了一项台式研究，比较XTW和GEM0626之间的瓣叶锚定稳定性，以探讨术后瓣叶脱离的可能性。
DMR和FMR模型的脉动流评估结果表明，两种TEER装置均能有效降低反流分数（DMR：GEM0626 vs. XTW，59.21±10.29% vs. 35.73±6.62% vs. 43.50±8.89%；FMR：GEM0626 vs. XTW，56.99±8.74% vs. 27.99±11.30% vs. 28.13±10.64%）。然而，在比较各种TEER装置在完全夹持和部分夹持条件下的瓣叶稳定性研究中，GeminiOne锚定瓣叶的脱离力显著高于MitraClip，尤其是在部分夹持时（完全夹持脱离力：7.89±2.42 vs. 6.36±0.96 N，P = 0.1214；部分夹持脱离力：6.03±2.05 vs. 2.97±0.76 N，P = 0.0021）。
在脉动实验中，GEM0626和XTW在急性减少DMR和FMR引起的MR方面均有效。然而，在锚定瓣叶稳定性研究中，在部分夹持条件下，GEM0626显示出显著更高的瓣叶脱离力。GeminiOne TEER更好的锚定稳定性可能对MR治疗具有长期临床益处。
