ABSTRACT

RESULTS OF MITRACLIP® USE IN FMR Early Experience: Roll-in EVEREST I and II Patients The initial data suggesting that the MitraClip® effectively treats functional MR was derived from roll-in patients from the EVEREST I and II studies (19). There were 23 patients with functional MR who underwent percutaneous mitral repair with the MitraClip® device. Median age was 75 years (74% were older than 65 years), 87% had a history of congestive heart failure, and 83% were New York Heart Association (NYHA) functional class III or IV. Ten patients (43%) had one or more prior median sternotomies. In this very early

FMR Patients: EVEREST I, II, and High-Risk Registry: 2-Year Follow-Up A subsequent analysis examined 122 patients with FMR consecutively treated within the EVEREST I and II studies, including the high registry, who underwent percutaneous mitral repair with the MitraClip® device and who had the two-year follow-up (Table 9.2) (20) outlines the enrollment details in these patients. The median age of this group was 71.1 years, 55% were male, 57% had a prior myocardial infarction, 55% had prior sternotomy, 50% had a history of atrial fi brillation, 14% had severe renal dysfunction, and 31% had signifi cant COPD. Nearly 80% had NYHA functional class III or IV symptoms. Moderately severe (3+) or severe (4+) MR was present in 95% and the overall mean EF was 48.2% + 10%.