Edge-to-edge repair: past challenge, current case selection and future advances

Sorajja, Paul; Ukaigwe, Anene

doi:10.21037/acs-2020-mv-17

Cited by 8 publications

(4 citation statements)

References 27 publications

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“… 2 , 3 , 14 , 15 Currently, these diseases are increasingly treated by transcatheter interventions, which all require atrial septal puncture. 4 , 5 , 6 At present, the structures of all conventional ASD occluders with marketing availability are 2 disc and 1 waist self-expanding structures. The framework of occluders is metal meshes weaved by nickel-titanium wire, such as the AMPLATZER Septal Occluder (Abbott-St. Jude Medical).…”

Section: Discussionmentioning

confidence: 99%

“… 2 , 3 These complications are generally treated with transcatheter intervention, such as radiofrequency ablation, left atrial appendage occlusion, and transcatheter edge-to-edge mitral valve repair. 4 , 5 , 6 These techniques of transcatheter intervention all require transfemoral catheterization through the atrial septum to access the left atrium for the treatment procedures. However, in the presence of an ASD occluder, the subsequent puncture of the atrial septum for such patients may be challenging, and this important route for left-sided interventional procedures is correspondingly limited.…”

mentioning

confidence: 99%

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A Novel Puncturable Atrial Septal Defect Occluder

Zhang

Chen²,

Li³

et al. 2022

JACC: Basic to Translational Science

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

A Novel Puncturable Atrial Septal Defect Occluder

Zhang

Chen²,

Li³

et al. 2022

JACC: Basic to Translational Science

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“…5,6 Mitral valve transcatheter edge-to-edge repair (TEER) for treatment of MR has been established as a suitable alternative to mitral valve (MV) surgery for those patients. 7 In this context, the MitraClip device (Abbott Vascular Devices, Santa Clara, CA, USA) is the most frequently applied technique with more than 100 000 patients treated worldwide. 8 Just recently, guideline recommendations for TEER have been upgraded to Class IIa for degenerative as well as functional MR. 9,10 In February 2019, the PASCAL TEER system (Edwards Lifesciences, Irvine, CA, USA) received CE approval for treatment of severe functional and degenerative MR, respectively.…”

Section: Introductionmentioning

confidence: 99%

One‐year results following PASCAL‐based or MitraClip‐based mitral valve transcatheter edge‐to‐edge repair

et al. 2022

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Aims Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a suitable alternative to mitral valve surgery in patients with severe mitral regurgitation (MR) and high surgical risk. The PASCAL system represents a novel device, potentially augmenting the toolkit for TEER. The aim of this study was to assess and compare short and 1 year safety and efficacy of the PASCAL and MitraClip systems for TEER. Methods and results Procedural, short, and 1 year outcomes of a 1:2 propensity-matched cohort including 41 PASCAL and 82 MitraClip cases were investigated. Matching was based on clinical, laboratory, echocardiographic, and functional characteristics. The primary endpoints assessed were procedural success [as defined by the Mitral Valve Academy Research Consortium (MVARC)], residual MR, functional class, and a composite endpoint comprising death, heart failure hospitalization, and mitral valve re-intervention. We found for the PASCAL and the matched MitraClip cohort no significant differences in MVARC defined technical (90.2% vs. 95.1%, P = 0.44), device (90.2% vs. 89.0%, P = 1.0), or procedural (87.8% vs. 80.5%, P = 0.45) success rates. Accordingly, the overall MR reduction and improvement in New York Heart Association (NYHA) class were comparable (1 year follow-up: MR ≤ 2 95% vs. 93.6%, P = 1.0; NYHA ≤ 2 57.1% vs. 66.7%, P = 0.59). The composite outcome revealed no statistically significant difference between both devices (1 year follow-up: 31.7% vs. 37.8%, P = 0.55). Interestingly, we found at both short and 1 year follow-up a significantly higher rate of patients with none or trace MR in the PASCAL-treated cohort (short follow-up: 17.9% vs. 0%, P = 0.0081; 1 year follow-up: 25% vs. 0%, P = 0.0016). Conversely, the rate of aborted device implantations due to an elevated transmitral gradient was higher in PASCAL interventions (9.8% vs. 1.2%, P = 0.04). Conclusions Transcatheter edge-to-edge repair using the PASCAL or MitraClip device results in favourable and comparable outcomes regarding safety, efficacy, and clinical improvement after 1 year.

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“…An arm-width-expandable design for the ValveClasp system was developed because the clamping efficiency of the present TEER devices was insufficient. For instance, MitraClip (Abbott Inc), the most widely used device for the TEER technique 12 , which has extended the width of the clip arm from 4 to 6 mm in its fourth generation, the MitraClip G4 system. 3,13,14 In comparison to earlier products, the MitraClip G4 system lowers the fraction of clip implantation.…”

mentioning

confidence: 99%

Novel arm‐width‐expandable transcatheter edge‐to‐edge repair system: Preclinical experiment and first‐in‐human study

Long

Chen

et al. 2023

Cathet Cardio Intervent

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Background The ValveClasp system is a novel transcatheter edge‐to‐edge repair (TEER) device with an arm‐width‐expandable clip that allows treatment of patients with only one clip more frequently. Objectives This study aimed to evaluate the feasibility and safety of a novel TEER device in porcine models and patients. Methods Fourteen young adult pigs were enrolled. A clip with an expanded arm was implanted under epicardial echocardiography and fluoroscopy guidance. Five patients with at least moderate‐to‐severe mitral regurgitation underwent TEER using the ValveClasp system to test the safety and effectiveness of the device. Results The device success rate was 100% (14/14) in the animal experiments, and all clips were deployed at the A2P2 segments, forming a double‐orifice mitral valve. Gross observations on day 180 showed a wide and continuous tissue bridge between the leaflets. The acute procedural success rate was 100% (5/5). Only one clip was required in all patients, and all achieved effective postoperative endpoints (grade ≤2+). During 30‐day follow‐up, no adverse events occurred. All patients' vena Contracta width (from 8.04 0.71 mm to 3.84 ± 1.18 mm, p = 0.012), mitral regurgitation area (from 12.75 ± 3.13 cm2 to 3.50 ± 1.66 cm2, p = 0.008), and left ventricular end diastolic diameter (from 52.00 ± 2.92 mm to 46.00 ± 3.08 mm, p = 0.040) were considerably decreased, without obvious mitral stenosis. Conclusions The novel arm‐width‐expandable ValveClasp device is safe for TEER for treating severe mitral regurgitation.

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Edge-to-edge repair: past challenge, current case selection and future advances

Cited by 8 publications

References 27 publications

A Novel Puncturable Atrial Septal Defect Occluder

A Novel Puncturable Atrial Septal Defect Occluder

One‐year results following PASCAL‐based or MitraClip‐based mitral valve transcatheter edge‐to‐edge repair

Novel arm‐width‐expandable transcatheter edge‐to‐edge repair system: Preclinical experiment and first‐in‐human study

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