Mediastinal radiation therapy accelerates the atherosclerosis process, resulting in early onset coronary artery disease. Valvular disease due to radiation therapy typically affects the left-sided valves, with aortic regurgitation being the most common. Rarely, it may lead to aortic stenosis requiring surgical interventions. Pericardial involvement includes acute and chronic pericardial disease and pericardial effusion. New studies are investigating the prevalence and pathogenesis of autonomic dysfunction in cancer survivors who have undergone mediastinal and neck radiation. Radiation therapy itself causes vascular endothelial dysfunction, resulting in clinical cardiovascular events, manifesting many years after completion of therapy. There remains little guidance regarding screening and therapies to prevent cardiovascular events in this population.
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.
The new MitraClip G4 device (Abbott Vascular) has been recently approved by Food and Drug Administration and is currently in limited release. A patient with a large mitral regurgitation (MR) jet but a relatively small mitral valve area (MVA) was not a surgical repair candidate nor an optimal MitraClip third‐generation device candidate. Therefore, we implanted the new G4 NTW device that resulted in significant MR reduction with a 57% reduction in MVA. To our knowledge, this is the first reported clinical use of the MitraClip G4 NTW device. We find that it may provide better results than a single NTR device and less reduction in MVA than two older generation devices. Further experience is needed to optimize patient selection for the four new G4 devices available.
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