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

Abstract

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.

Transcatheter mitral valve repair for primary mitral regurgitation

“…High safety and efficacy of the G4 system, with 96.5% of patients having reduction in MR grade to 2+ at 30 days were reported. Garcia-Sayan et al [38] also reported similar outcomes in their cohort of 61 patients. They reported procedural success rate of 96.7% and technical failure rate of 1.6%.…”

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

“…Similar with other TEER devices, the ValveClasp systems also need to be tested before they were introduced in vascular approach, but the process has been simplified (only six steps) 1 : Testing the bending properties of the outer deflectable guiding sheath (from 0° to 90°); 2 Testing the bending properties of the inner deflectable guiding sheath (from 0° to 135°); 3 Pushing forward, pulling back, and rotating the clip control system to test the smoothness between the clip control system and the inner sheath when the control system passes through the inner sheath; 4 Opening the clip arms (from 0° to 270°) by twisting the control system knob, then closing the clip arms by rotating the knob in the opposite direction. Next, lock the clip and rotate the knob to see if the clip arms are open 5 .…”

“…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. As a result, between 30% and 50% of patients still require more than one clip to be deployed during an operation, which adds to the complexity of the process, lengthens its duration, and increases the risk of complications 3,4 . Wider clips are expected according to the MitraClip G4 procedure outcomes; however, the G4 clamp arm is rigid and challenging to expand further.…”

“…Transcatheter edge‐to‐edge repair (TEER) is the only guideline‐indicated transcatheter therapy for mitral regurgitation 1,2 . However, due to width constraints with current TEER device clip arms, up to half of the patients require more than one clip to obtain the desired outcome and prevent mitral regurgitation (MR) recurrence 3–7 …”

“…1,2 However, due to width constraints with current TEER device clip arms, up to half of the patients require more than one clip to obtain the desired outcome and prevent mitral regurgitation (MR) recurrence. [3][4][5][6][7] Multiple clip implantations increase the number of procedural steps, which will make the procedure more complex, increase the risk of complications, and lengthen the operation time. Therefore, allowing patients to be treated with one clip more often has always been the main goal of current mainstream TEER device advancements.…”