Division of Cardiology, Emory Structural Heart and Valve Center, Emory University Hospital Midtown, Atlanta, Georgia.
Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
JACC Cardiovasc Interv. 2020 Oct 26;13(20):2361-2370. doi: 10.1016/j.jcin.2020.06.047. Epub 2020 Sep 30.
The aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis.
Patients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI.
This was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days.
MitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet.
Transcatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak.
本研究旨在验证以下假设,即经导管电外科手术可能允许从前瓣有意图地分离先前放置的 MitraClip,以重新创建用于经导管二尖瓣置换术(TMVI)的单一二尖瓣口,同时将保留的 MitraClip 牢固地固定在后瓣上,且不干扰二尖瓣生物瓣。
尽管 MitraClip 进行了边缘对边缘二尖瓣修复,但仍存在严重二尖瓣反流或狭窄的患者,其治疗选择通常较少,因为由此产生的双瓣口会妨碍 TMVI。经导管电外科手术可能允许从前瓣分离失败的 MitraClip,以重新创建单一瓣口用于 TMVI。
这是一项单中心、5 例连续回顾性观察队列研究。患者接受经导管电外科切开术和失败的 MitraClip 固定术,以重新创建单一瓣口,同时将 MitraClip 牢固地固定在后瓣上。随后,在同情治疗的基础上,患者接受了经导管电外科切开术和 Tendyne 二尖瓣生物瓣的 TMVI。患者随访至 30 天。
所有患者均成功从前瓣分离 MitraClip,且 Tendyne 植入成功。所有患者均存活至出院。所有患者出院时中心二尖瓣反流均为 0 级。两名患者有中度瓣周二尖瓣反流,无需再次干预。在 30 天的随访期间,无死亡、瓣膜功能障碍或再次干预。无证据表明仍附着在后瓣上的保留 MitraClip 引起侵蚀或生物瓣功能障碍。
经导管电外科从前瓣分离失败的 MitraClip,随后进行 TMVI,在 30 天内是可行和安全的。需要进行更长时间的研究,以确定这种方法的临床益处以及在电外科切开和稳定失败的 MitraClip 后用于 TMVI 尺寸调整的新算法,以避免瓣周漏。