First‐in‐human report of MitraClip G4 implantation for severe degenerative mitral regurgitation

Raghunathan, Deepa; Garcia‐Sayan, Enrique; Dhoble, Abhijeet; Smalling, Richard W.

doi:10.1002/ccd.28777

Cited by 7 publications

(5 citation statements)

References 3 publications

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“…Multi‐center clinical outcomes, procedural aspects, in‐vivo hemodynamic effects, and criteria for device selection for the G4 system have not yet been described and published. We recently reported our first‐in‐human use of the NTW device for MR, 8 and off‐label use of the XTW device for tricuspid regurgitation, 9 which has been followed by additional successful cases utilizing the G4 system. This retrospective analysis is designed to summarize our initial multi‐center experience and clinical outcomes with the new MitraClip™ G4 system, assess the safety, efficacy, and hemodynamic effects of this new technology, and propose preliminary considerations for guiding device selection.…”

Section: Introductionmentioning

confidence: 99%

Initial experience with the fourth generation MitraClip™ : Outcomes, procedural aspects, and considerations for device selection

Garcia‐Sayan

Raghunathan

et al. 2021

Catheter Cardiovasc Interv

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Objectives We present our initial experience with the fourth‐generation MitraClip™ (G4) system and propose preliminary criteria for device selection. Background The MitraClip™ G4 system recently underwent a “controlled release” for transcatheter edge‐to‐edge mitral valve repair. The four new devices include technical improvements such as controlled gripper actuation (independent leaflet capture) and continuous left atrial pressure monitoring. To date, a patient‐specific device selection algorithm, and the technology's impact on procedural times and success, have not been described. Methods We present an initial multi‐center experience and short‐term outcomes with the new system, suggest procedural and imaging considerations, and propose initial guidance for device selection. Results Sixty‐one procedures performed by three operators at two centers between November 2019 and May 2020 were analyzed. At 30‐day follow‐up, there were three deaths (4.9%), four neurological events (6.6%), and seven re‐hospitalizations (11.5%). Fifty‐nine patients achieved device and procedural success (96.7%), and there was one device‐related technical issue (1.6%). Compared to the same operators utilizing the third generation MitraClip™, the G4 system resulted in a significant reduction in the median number of clips used per patient (1 IQR 1–2 vs. 2 IQR 1–3, p = .023) and a trend toward shorter device times. Conclusion Based on our initial experience, we found that the MitraClip™ G4 system is associated with high procedural success and fewer devices needed per procedure. The expanded device options may allow a more targeted approach to the myriad of pathologic presentations of mitral regurgitation. This early experience should provide a foundational opportunity for further refinement.

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Section: Introductionmentioning

confidence: 99%

Initial experience with the fourth generation MitraClip™ : Outcomes, procedural aspects, and considerations for device selection

Garcia‐Sayan

Raghunathan

et al. 2021

Catheter Cardiovasc Interv

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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 4,10 …”

Section: Disscusionsmentioning

confidence: 99%

“…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. 4,10 Unfortunately, the current improvement appears to be below the anticipated level; the maximum width of The G4 clip device is only 6 mm, which might not be sufficient.…”

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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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“…Finally, the first-in-human report using the newer thirdgeneration MitraClip G4 system (NT, XT, NTW, and XTW) have been published very recently (14). Among other, this new system has iterations regarding the grasping area and mechanism (independent leaflet capture), along with 50% wider clip arms (NTW and XTW devices).…”

Section: Device Design and Procedural Planningmentioning

confidence: 99%

Transcatheter Tricuspid Valve Intervention: Coaptation Devices

Muntané‐Carol

Alperi

Faroux

et al. 2020

Front. Cardiovasc. Med.

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Transcatheter tricuspid valve intervention (TTVI) has recently emerged as an alternative for the treatment of severe tricuspid regurgitation (TR). Multiple percutaneous devices have been developed in the last decade with promising early results. Among them, the coaptation devices are designed to reduce TR severity by valve leaflet plication or occupying the regurgitant orifice with a spacer. To date, the MitraClip/TriClip devices (Abbott, Santa Clara, CA, USA), the PASCAL system (Edwards Lifesciencies, Irvine, CA, USA), and the FORMA device (Edwards Lifesciencies, Irvine, CA, USA) have been used as coaptation devices for treating severe TR. The present document aimed to review the clinical evidence on coaptation devices in the field of TTVI, describing its design characteristics, main procedural steps, and early and mid-term outcomes.

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First‐in‐human report of MitraClip G4 implantation for severe degenerative mitral regurgitation

Cited by 7 publications

References 3 publications

Initial experience with the fourth generation MitraClip™ : Outcomes, procedural aspects, and considerations for device selection

Initial experience with the fourth generation MitraClip™ : Outcomes, procedural aspects, and considerations for device selection

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

Transcatheter Tricuspid Valve Intervention: Coaptation Devices

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