MitraClip failure secondary to loss of leaflet insertion (LLI) or single leaflet detachment (SLD) is not a rare phenomenon and may occur during and beyond hospitalization, according to a new analysis of registry data. The study, published online Monday and in the Feb. 28 issue of JACC: Cardiovascular Interventions, reports that cumulatively, SLD, LLI and clip embolization are relatively uncommon in experienced centers, but are associated with recurrent significant mitral regurgitation (MR) and increased death at follow-up. Led by Antonio Mangieri, MD, from Humanitas University, Pieve Emanuele-Milan, and IRCCS Humanitas Research Hospital, Rozzano-Milan, and Francesco Melillo, MD, from IRCCS, San Raffaele Scientific Institute, Milan, the authors noted that while MitraClip is an established treatment for MR, data on the prognosis of patients with MitraClip failure are “scarce” and the modes of failure are “poorly descripted.” “Nowadays, the MitraClip system is considered a key tool to treat MR,” they said, noting that the technology replicates the surgical edge-to-edge technique that has demonstrated effectiveness even in high-risk patients. “Even through MitraClip has proven safety and efficacy, a relapse of significant MR can be observed after the index procedure as result of multiple causes,” they said, adding that while it is clear that LLI and SLD are complications that can be responsible for MR relapse –acutely or at follow-up – no data are available regarding the prevalence and the outcome of patients with LLI or SLD after MitraClip procedures. Study details Mangieri, Melillo and colleagues evaluated the incidence, management and outcome of patients who experienced MitraClip failure secondary to LLI, SLD or embolization. The team retrospectively screened 4,294 procedures of MitraClip performed in 19 centers between January 2009 and December 2020. In the study, LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. They reported a total of 147 cases of MitraClip failure in the registry (overall incidence = 3.5%). Device failure was secondary to LLI in 47 (31.9%) cases or SLD in 99 (67.3%) cases, whereas in one (0.8%) case, clip embolization was observed, the analysis showed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR and in 16 (10.8%) with mixed etiology. Mangieri and colleagues noted that although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%), including four cases of surgical conversion of the index procedure and seven cases of bailout surgery after unsuccessful redo MitraClip. Furthermore, after an average follow-up of 163 days (interquartile range [IQR]: 22-720 days), 50 (43.9%) subjects presented with moderate to severe MR and 43 (29.3%) patients died, the analysis showed. “Up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death,” the authors added. The team concluded that while cumulatively, SLD, LLI and clip embolization are relatively uncommon in experienced centers, they are associated with recurrent significant MR and increased death at follow-up. “In such cases, a repeat MitraClip seems to be associated with improved survival vs other approaches,” they said, adding that the findings of the analysis highlight the importance of a prompt diagnosis – even beyond hospital discharge – and of appropriate treatment by a multidisciplinary expert team. A significant challenge Writing in an accompanying editorial, Amar Krishnaswamy, MD, and Samir R. Kapadia, MD, from the Heart and Vascular Institute at the Cleveland Clinic, noted that edge-to-edge repair is an important therapy for patients with severe MR at high risk for complications with traditional cardiac surgery – adding that more than 100,000 patients have been treated with the MitraClip. “Most importantly, single-leaflet detachment (SLD) or loss-of-leaflet insertion (LLI) present a significant challenge to operators and patients and carries substantial morbidity and mortality risk,” they noted. The editorialists noted that while the biases inherent to a self-reported registry make drawing definitive conclusions about patient management recommendations difficult, the analysis demonstrates the poor outcome that patients with a failed MitraClip procedure face. “Despite the inherent limitations of this multi-center registry study, there is a suggestion that early treatment may be associated with better outcomes,” they said. “Clearly, there are important clinical and anatomic features that may render some patients infeasible for a subsequent procedure. However, using contemporary imaging and innovative techniques, operators and imaging specialists can collaborate to provide some patients a solution.” Sources: Mangieri A, Melillo F, Montalto C, et al. Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty. Insight From an International Registry. JACC Cardiovasc Interv 2022;15:411-422. Krishnaswamy A, Kapadia SR. Contemporary 3D TEE Imaging Can Provide Guidance in Treating Patients With MitraClip Failure. JACC Cardiovasc Interv 2022;15:423-426. Image Credit: iushakovsky – stock.adobe.com