Richard Sheu

BACKGROUND: Mitral annular calcification with valve dysfunction remains a challenging syndrome. Operative risk is high, and available transcatheter therapies are limited. METHODS: This study describes our initial experience with a novel procedure to address large mitral annuli when no surgical or trial-based transcatheter mitral valve replacement device is available. The rationale was to shorten the intercommissural distance using commissural mitral transcatheter edge-to-edge repair (TEER) followed by valve-in-mitral annular calcification transcatheter mitral valve replacement with a balloon-expandable aortic valve platform. Patients with long intercommissural distances and large mitral annulus areas were selected based on a high perceived risk of transcatheter valve embolization. Patients underwent mitral TEER with MitraClip in a commissural position, followed immediately by transseptal transcatheter mitral valve replacement with a 29 mm SAPIEN 3 valve. RESULTS: Thirteen patients were included. Median intercommissural distance and annular area were 39.1 mm and 930 mm ² , respectively. Commissural mitral TEER was successful in all patients with no instances of single leaflet detachment. In 10 of 13 instances, an NTW device size was used. In 12 of 13 patients, valve implantation was successful, including 1 case that required a second valve for atrial positioning of the first valve. In 1 case, frank valve embolization into the left atrium occurred. Among the 12 successful cases, paravalvular leak was 1+ or less, and there were no instances of paravalvular leak adjacent to the TEER device. CONCLUSIONS: In patients with large annuli and sufficient annular calcium, a hybrid mitral TEER and valve replacement with the SAPIEN platform can be successfully used to facilitate transcatheter mitral valve replacement.

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.