Currently, edge-to-edge therapy with MitraClip has demonstrated efficacy and safety for the treatment of patients with degenerative or functional mitral regurgitation who are at high risk for surgery. However, device-related complications are still present—though their frequency is subsiding due to greater experience, 3D doppler echocardiography development, and technological advancements: loss of leaflet insertion (LLI), single leafleat detachment (SLD), or device embolization (EMB).
The first two complications generate mitral regurgitation, which on numerous occasions is severe and causes symptoms.
The best treatment for them is currently unknown.
In this paper, researchers analyzed 147 patients (83.5%) from the FILM R (Failed MitraClip Long-term follow-up and Management) Registry who experienced LLI, SLD, or EMB between 2009 and 2020.
Forty-seven patients experienced LLI (31.9%), 99 had SLD (67.3%), and 1 suffered from EMB (0.8%).
The mean age was 77 years, 38% of patients were women, 21.8% were diabetic, 27.2% had previous acute myocardial infarction (AMI), 32% had undergone previous main coronary artery angioplasty (MCAG), 12.2% had undergone myocardial revascularization surgery (MRS), and 4.8% had had mitral valve surgery.
The presence of atrial fibrillation (AF) was 52.7%, the eGFR was 50.7 mL/min/m2, and the ejection fraction was 48% (in functional patients, 28%). Leaflet calcification was 6.4% and ring calcification was 12%. The Society of Thoracic Surgeons (STS) score was 3.8%.
The cause of mitral regurgitation was functional in 67 patients, degenerative in 64, and mixed in 16.
Most patients received one or two clips; the most commonly used clip was the NTR.
Cases of MitraClip failure (60%) were diagnosed—mostly—before discharge; the rest, at follow-up (with a mean of 142 days).
There were no differences in mortality regarding the cause of device failure.
The initial strategy was reintervention with MitraClip in 51 patients (34.7%), medical treatment in 71 (48.2%), and surgery in 25 (17%).
Of the 51 patients who underwent MitraClip reintervention, the procedure was successful in 38. The remaining 13 were referred to medical treatment (6) and to surgery (7). On the other hand, of the 71 patients initially assigned to medical treatment, 4 were referred to surgery. Finally, patients who underwent surgery (36 patients in total) were classified as follows: 23 underwent valve replacement, 7 underwent valve repair, and 6 received a ventricular assist device.
Follow-up was 163 days, mortality was 29.3%, moderate to severe mitral regurgitation was 43.9%, and the need for a ventricular assist device was 6.1%. There was a trend towards lower mortality in those who received MitraClip reintervention (35.2% for medical treatment, 21.6% for MitraClip reintervention, and 28% for surgery, p = 0.067).
Predictors of mortality were acute renal failure, age, and moderate to severe tricuspid regurgitation.
MitraClip failure secondary to LLI and SLD is not rare, and could also happen during hospitalization. MitraClip reintervention, when compared with surgery or medical treatment, showed a tendency to reduce mortality.
One third of patients continue to have more than moderate mitral regurgitation with substantial mortality at intermediate-term follow-up.
Dr. Carlos Fava.
Member of SOLACI.org Editorial Board.
Reference: Antonio Mangieri, et al. J AmColl Cardiol. Intv 2022;15:411–422.
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