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Transcatheter Mitral Valve Repair for MR Using Cardioband
Study Questions:
What are the 1-year outcomes of consecutive patients who underwent the Cardioband procedure for mitral regurgitation (MR)?
Methods:
The investigators analyzed 60 patients with moderate or severe secondary MR (72 ± 7 years, 60% ischemic origin) on guideline-recommended medical therapy who were treated at 11 European institutions. Safety, performance, and efficacy of the device were assessed. Technical success, device success, and procedural success were defined according to Mitral Valve Academic Research Consortium (MVARC). Overall survival and event-free survival were assessed using the Kaplan–Meier analysis.
Results:
There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification halfway through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on MVARC criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1 year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less in 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1 year (but worsened by at least one grade in 11 patients [22%]). Functional status (79% vs. 14% in New York Heart Association class I/II), quality of life (−19 points on the Minnesota Living With Heart Failure Questionnaire score), and exercise capacity (+58 m by 6-minute walk test) improved significantly (all p < 0.01).
Conclusions:
The authors concluded that the Cardioband mitral system demonstrated reasonable performance and safety at 1 year.
Perspective:
This study reports that the Cardioband system showed a satisfactory safety profile, provided significant MR reduction in most of the patients, and was associated with significant functional improvements. However, one-fifth of the patients experienced MR worsening by at least one grade. In addition, the Cardioband procedure did not preclude a secondary transcatheter mitral procedure. Given the small sample size and single-arm nature of the study, additional prospective studies are indicated, and the randomized controlled ACTIVE trial (NCT03016975), evaluating the Cardioband system in conjunction with guideline-directed medical therapy compared to guideline-directed medical therapy alone, will provide more definitive evidence of efficacy and safety of this device.
Keywords: Cardiac Surgical Procedures, Cardiac Tamponade, Coronary Vessels, Disease-Free Survival, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Hospital Mortality, Mitral Valve Annuloplasty, Mitral Valve Insufficiency, Quality of Life, Stroke
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