Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients,JACC: Cardiovascular Imaging

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Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients
JACC: Cardiovascular Imaging ( IF 14.0 ) Pub Date : 2023-12-13 , DOI: 10.1016/j.jcmg.2023.09.015
Leo Marcoff , Konstantinos Koulogiannis , Lilian Aldaia , Anuj Mediratta , Scott M. Chadderdon , Moody M. Makar , Tobias Friedrich Ruf , Theresa Gößler , Jonathan G. Zaroff , Gordon K. Leung , Ivy A. Ku , Michael Nabauer , Paul A. Grayburn , Zuyue Wang , Katie M. Hawthorne , Dale E. Fowler , Jacob P. Dal-Bianco , Mani A. Vannan , Carmine Bevilacqua , Massimiliano Meineri , Joerg Ender , Anna Flo Forner , Jyothy J. Puthumana , Atizazul Hassan Mansoor , Dustin J. Lloyd , Steven J. Voskanian , Andrew Ghobrial , Rebecca T. Hahn , Feroze Mahmood , Christiane Haeffele , Geraldine Ong , Leonhard Moritz Schneider , Dee Dee Wang , Nishant K. Sekaran , Elana Koss , Priti Mehla , Serge Harb , Rhonda Miyasaka , Maria Ivannikova , Terri Stewart-Dehner , Lucas Mitchel , Sasan R. Raissi , Daniel Kalbacher , Santanu Biswas , Edwin C. Ho , Ythan Goldberg , Robert L. Smith , Jörg Hausleiter , D. Scott Lim , Linda D. Gillam

The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; )

中文翻译：

经导管边对边修复退行性二尖瓣反流手术风险禁止患者的超声心动图结果

背景

CLASP IID 随机试验（Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial；NCT03706833）证明了 PASCAL 系统对于具有显着症状的手术风险较高的患者进行二尖瓣经导管边对边修复 (M-TEER) 的安全性和有效性退行性二尖瓣反流（DMR）。

目标

本研究描述了 CLASP IID 试验的超声心动图方法和结果，并分析了与残余二尖瓣反流 (MR) ≤1+ 相关的基线变量。

方法

独立的超声心动图核心实验室根据美国超声心动图协会指南评估超声心动图参数，重点关注 MR 机制、严重性和 M-TEER 的可行性。使用逻辑回归确定与残余 MR ≤1+ 相关的因素。

结果

在 180 名随机患者中，PASCAL (n = 117) 组和 MitraClip (n = 63) 组之间的基线超声心动图参数匹配良好，79.2% 的患者存在连枷传叶。 76.4% 的患者基线 MR 为 4+，23.6% 的患者基线 MR 为 3+。所有患者出院时均达到 MR ≤ 2+。两组出院时 MR ≤ 1+ 的患者比例相似，但在 6 个月时出现差异，有利于 PASCAL（83.7% vs 71.2%）。总体而言，连枷间隙较小的患者出院时达到 MR ≤ 1+ 的可能性明显更高（调整后 OR：0.70；95% CI：0.50-0.99）。使用 PASCAL 治疗的患者和连枷间隙较小的患者更有可能将 MR ≤1+ 维持至 6 个月（调整后 OR：2.72 和 0.76；95% CI：分别为 1.08-6.89 和 0.60-0.98）。

结论

该研究使用 DMR 特异性超声心动图方法进行 M-TEER，反映了 3 维超声心动图的当前指南和进展。 PASCAL 治疗和较小的连枷间隙是将 MR ≤1+ 维持至 6 个月的重要因素。结果表明，MR ≤1+ 是成功 M-TEER 的可实现基准。（Edwards PASCAL TrAnScatheter 瓣膜修复系统关键临床试验 [CLASP IID]；NCT03706833）

更新日期：2023-12-13

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