Effect of a novel transcatheter edge‐to‐edge repair device on the three‐dimensional geometry of mitral valve in degenerative mitral regurgitation

Ge, Zhenyi; Pan, Wenzhi; Zhou, Daxin; Li, Wei; Wei, Lai; Liu, Xianbao; Pu, Zhaoxia; Shu, Xianhong; Pan, Cuizhen; Ge, Junbo

doi:10.1002/ccd.29002

Cited by 6 publications

(7 citation statements)

References 19 publications

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“…Device system and procedure: The ValveClamp transapical edge-to-edge mitral valve repair system (Hanyu Medical Technology, Shanghai, China) and its procedure have been described previously. 10,[13][14][15] It comprises of four elements: (1) a clamp device, (2) a valve-crossing device, (3) a delivery system, and (4) a 16 Fr introducer sheath. The clamp device is composed of the front clamp, the rear clamp, and the closed ring.…”

Section: Methodsmentioning

confidence: 99%

Transcatheter Mitral Valve Edge-to-Edge Repair with a Novel System

Long

Pan

et al. 2022

Int. Heart J.

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The ValveClamp system is a novel edge-to-edge mitral valve repair system that is designed for ease of operation. We aimed to report the 1-year outcomes of the early feasibility study of this system.Patients with severe degenerative mitral regurgitation (MR) at higher surgical risk and who received transapical ValveClamp implantation were followed for 1 year for clinical and echocardiographic outcomes.Twelve patients (mean age, 76.5 ± 6.3 years; mean Society of Thoracic Surgery score, 6.9 ± 1.9%) were enrolled at three sites in China. At 1 year, no patient died, received reoperation, or had long-term complications. Of the 12 patients with MR of 3+ or 4+ at baseline, 11 patients (91.67%) remained with MR !2+ at 1 year, and no patient had mitral stenosis. Significant reductions in maximum MR area (from 15.1 ± 6.51 cm 2 to 4.45 ± 1.85 cm 2 , P < 0.001), effective orifice area (from 4.34 ± 0.34 cm 2 to 2.38 ± 0.45 cm 2 , P < 0.001), and vena contracta width (from 8.03 ± 1.11 to 3.38 ± 2.11 mm, P < 0.001) were observed. The left cardiac dimensions were decreased, especially the mitral valve annulus diameter (from 34.79 ± 4.27 mm to 31.42 ± 2.81 mm, P < 0.05). Of the 12 patients with baseline New York Heart Association functional class III/IV, all patients experienced an improvement of at least one class (P < 0.05).Our study provides evidence that transapical ValveClamp implantation in high-risk patients with severe degenerative MR is safe and feasible, with good efficacy in the mid-long term.

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Section: Methodsmentioning

confidence: 99%

Transcatheter Mitral Valve Edge-to-Edge Repair with a Novel System

Long

Pan

et al. 2022

Int. Heart J.

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“…The inclusion criteria for ValveClamp procedures were as follows: (a) age older than 60 years, (b) moderate to severe (3+) or severe (4+) DMR, (c) symptoms [New York Heart Association (NYHA) cardiac function class ≥2] related to MR, (d) primary regurgitant jet originated from malcoaptation of the A2 and P2 scallops, (e) high risk for surgery according the Mitral Valve Academic Research Consortium criteria, and (f) provision of signed informed consent. The exclusion criteria for ValveClamp procedures were as follows: (a) significant regurgitation beyond A2/P2 scallops, (b) rheumatic disease or MV perforation, (c) leaflet calcification of the grasping zone, (d) acute endocarditis, (e) coronary artery disease requiring revascularization, (f) significant concomitant non-MV disease, (g) life expectancy <12 months, and (h) recent cerebral event ( 12 , 13 ).…”

Section: Methodsmentioning

confidence: 99%

“…The configuration of the clamp arms was designed to expand the capture range for grasping leaflets, and it was considerably larger than that of the MitraClip, despite the similar grasping arm dimensions ( Figure 1 ). The implantation procedures were performed as described previously ( 12 , 13 ). Transthoracic echocardiography (TTE) was used to identify the optimal location for an incision to expose the cardiac apex.…”

Section: Methodsmentioning

confidence: 99%

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Impact of Leaflet Tethering on Residual Regurgitation in Patients With Degenerative Mitral Disease After Interventional Edge-to-Edge Repair

Pan

et al. 2021

Front. Cardiovasc. Med.

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Background: Grade 2+ residual mitral regurgitation (MR 2+) is associated with the recurrence of MR and a lower survival rate in interventional mitral valve (MV) edge-to-edge (EE) repair. We sought to determine the MV anatomic factors affecting residual MR 2+ during interventional EE repair with the ValveClamp system in patients with degenerative MR (DMR).Methods: In this multicenter study, 62 patients with significant (grade 3+ to 4+) DMR underwent ValveClamp implantation across eight centers from July 2018 to December 2019. Patient clinical, anatomical, and procedural characteristics were prospectively collected and retrospectively analyzed.Results: A single clamp was implanted in 59 patients, and two clamps were implanted in three patients. Residual MR 2+ was found in 14 patients (22.6%) immediately after the ValveClamp procedure. Patients with residual MR 2+ showed significantly larger preoperative tenting sizes and annular dimensions than the residual MR ≤1+ group. Multivariate analysis identified tenting volume as the major determinant of residual MR 2+ after ValveClamp procedures (odds ratio, 1.410 per 0.1-mL/m2 increase; 95% confidence interval, 1.167–1.705; P < 0.001). Receiver operating characteristic curves identified a tenting volume index ≥0.82 mL/m2 as the optimal cutoff point to predict residual MR 2+ (area under curve, 0.84). Patients with a tenting volume index ≥0.82 mL/m2 were more likely to develop recurrent 3+ MR or undergo MV surgery during short-term follow-up (P < 0.001).Conclusions: Preoperative assessment of the tenting volume index will help to predict intraoperative residual MR 2+ in patients with DMR receiving EE-based interventional repair. Improvements in the interventional strategy are warranted for sustained MR reduction in patients with DMR with unfavorable anatomy.

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“…Since the distance between the mitral anterior leaflet and posterior leaflet was more than 15 mm, capturing the leaflet tissues of the noncentral mitral regurgitation was deemed challenging when using MitraClip NTR/XTR. Thus, he was referred for transcatheter mitral valve repair with the ValveClamp system (Hanyu Medical Technology), a novel edge‐to‐edge mitral regurgitation repair system designed for ease of operation and a wider range of clinical indications requiring mitral regurgitation correction 1,2 …”

Section: Figurementioning

confidence: 99%