Percutaneous Mitral Annuloplasty for Functional Mitral Regurgitation

Abstract

Background-Functional mitral regurgitation (FMR), a well-recognized component of left ventricular remodeling, is associated with increased morbidity and mortality in heart failure patients. Percutaneous mitral annuloplasty has the potential to serve as a therapeutic adjunct to standard medical care. Methods and Results-Patients with dilated cardiomyopathy, moderate to severe FMR, an ejection fraction Ͻ40%, and a 6-minute walk distance between 150 and 450 m were enrolled in the CARILLON Mitral Annuloplasty Device European Union Study (AMADEUS). Percutaneous mitral annuloplasty was achieved through the coronary sinus with the CARILLON Mitral Contour System. Echocardiographic FMR grade, exercise tolerance, New York Heart Association class, and quality of life were assessed at baseline and 1 and 6 months. Of the 48 patients enrolled in the trial, 30 received the CARILLON device. Eighteen patients did not receive a device because of access issues, insufficient acute FMR reduction, or coronary artery compromise. The major adverse event rate was 13% at 30 days. At 6 months, the degree of FMR reduction among 5 different quantitative echocardiographic measures ranged from 22% to 32%. Six-minute walk distance improved from 307Ϯ87 m at baseline to 403Ϯ137 m at 6 months (PϽ0.001). Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved from 47Ϯ16 points at baseline to 69Ϯ15 points at 6 months (PϽ0.001). Conclusions-Percutaneous reduction in FMR with a novel coronary sinus-based mitral annuloplasty device is feasible in patients with heart failure, is associated with a low rate of major adverse events, and is associated with improvement in quality of life and exercise tolerance. (Circulation. 2009;120:326-333.)

Percutaneous mitral valve repair using the edge-to-edge technique in a high-risk population

“…17,18 Therefore, different percutaneous techniques were developed, offering an alternative treatment for MR in patients who are poor candidates for surgery. 7,19,20 One of the recent developments is the edge-toedge technique using a clip. Goar and colleagues demonstrated for the first time that this technique can be performed successfully on the beating heart in a porcine model.…”

Therapeutic decision-making for patients with fluctuating mitral regurgitation

“…45,46,60,[64][65][66][67][68] Percutaneous devices used to reshape the mitral annulus can be separated into indirect and direct types; the former are positioned in the coronary sinus, whereas the latter addresses the mitral annulus. Indirect annulopasty involves the placement of a device into the coronary sinus to promote favourable annulus remodelling, thereby optimizing leaflet coapta tion.…”

Emerging Trends in Heart Valve Engineering: Part III. Novel Technologies for Mitral Valve Repair and Replacement

“…First and second generations of the Carillon device were studied in the Amadeus and Titan clinical trials respectively. 56,58 Patients who received the device had significant benefits with reductions in quantitative measures of functional MR severity, sustained LV remodeling and improved quality of life. However, this technology does have several important limitations including: (1) Concern for the anatomic distance between the coronary sinus and the mitral annulus in some patients with dilated hearts.…”