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Improved Functional Status and Quality of Life in Prohibitive Surgical Risk Patients With Degenerative Mitral Regurgitation Following Transcatheter Mitral Valve Repair With the MitraClip® System
Study Questions:
Was there evidence of functional improvement among patients with severe degenerative mitral regurgitation (MR) and prohibitive surgical risks who underwent MitraClip placement?
Methods:
Patients enrolled in the EVEREST II High Risk Study and part of the REALISM trials were retrospectively evaluated; a multidisciplinary team identified “prohibitive-risk” patients with degenerative MR from high-risk patients. Prohibitive risk was defined as any one of Society of Thoracic Surgeons (STS) Predicted Risk of (postoperative) Mortality ≥8%, porcelain aorta; frailty; hostile chest; severe liver disease (MELD score >12); severe pulmonary hypertension; or extenuating circumstances including internal mammary grafts at risk of injury, bleeding diathesis, severe dementia, chemotherapy for malignancy, immobility, or AIDS.
Results:
Patients were elderly (mean age 82 years), severely symptomatic (87% New York Heart Association [NYHA] class III/IV), and at high surgical risk (STS score 13.2 ± 7.3%). MitraClip was successfully implanted in 121 (95.3%); hospital stay was 2.9 ± 3.1 days. Of six patients in whom MitraClip was not implanted, there were procedural complications including cardiac tamponade or hemodynamic instability in two patients. Major adverse events at 30 days included death in eight (6.3%), myocardial infarction in one (0.8%), and stroke in one (2.4%). Through 1 year, there were a total of 30 (23.6%) deaths, with no survival difference between patients discharged with MR ≤1+ or MR = 2+. A majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in NYHA functional class I or II. At 1 year, three patients (2.4%) had mitral stenosis. Left ventricular end-diastolic volume decreased (125.1 ± 40.1 ml to 108.5 ± 37.9 ml, p < 0.0001, n = 69 survivors with paired data). Short Form-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced.
Conclusions:
The authors concluded that transcatheter mitral valve repair using the MitraClip in patients with prohibitive surgical risk is associated with safety and good clinical outcomes, including a decrease in rehospitalization, functional improvements, and favorable ventricular remodeling at 1 year.
Perspective:
Transcatheter therapy for heart valve disease is an exciting area of development. The MitraClip device, designed to approximate the commissural edges of the anterior and posterior mitral leaflets (emulating the ‘Alfieri stitch’), has been studied in several trials with evidence of modest clinical benefit. This retrospective review of patients enrolled in existing trials suggests the possibility of functional improvement when used in prohibitive-risk patients with severe degenerative MR. The absence of a control group makes soft clinical endpoints difficult to interpret.
Keywords: Myocardial Infarction, Mitral Valve Insufficiency, Heart Valve Prosthesis Implantation, Liver Diseases, New York, Heart Diseases, Survivors, Liver Transplantation, Dementia, Ventricular Remodeling, Mitral Valve Stenosis, Hypertension, Pulmonary, Heart Valve Diseases, Cardiac Tamponade, Disease Susceptibility
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