Initial experience with the fourth generation MitraClipâ„¢: Outcomes, procedural aspects, and considerations for device selection.

Garcia-Sayan, Enrique; Raghunathan, Deepa; Li, Flora M; Dhoble, Abhijeet; Sheu, Richard D; Jelacic, Srdjan; Reisman, Mark; Smalling, Richard W; Mackensen, G Burkhard

OBJECTIVES We present our initial experience with the fourth-generation MitraClipâ„¢ (G4) system and propose preliminary criteria for device selection. BACKGROUND The MitraClipâ„¢ 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 MitraClipâ„¢, 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 MitraClipâ„¢ 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.