REALISM: MitraClip improved functional status, QOL in prohibitive surgical risk patients

Transcatheter mitral valve repair with the MitraClip device was associated with improved functional status and quality of life at 1 year in elderly patients with degenerative mitral regurgitation at prohibitive surgical risk, according to new data from the REALISM study.

D. Scott Lim, MD, with the University of Virginia, Charlottesville, Va., and fellow researchers studied treatment of mitral regurgitation in a prohibitive risk cohort of patients with severe degenerative mitral regurgitation identified by a heart team that performed a retrospective evaluation of high-risk patients with degenerative mitral regurgitation in the EVEREST II trials. In total, 127 patients were consecutively enrolled and had at least 1 year of follow-up, according to the study. The mean age of the cohort was 82.4 years and 87% had NYHA class III or IV HF.

All patients met the definition of prohibitive surgical risk, which was defined as the presence of at least one of the following factors: ≥8% predicted mortality risk for mitral valve replacement at 30 days; porcelain or extensively calcified ascending aorta; frailty; hostile chest; severe liver disease or pulmonary hypertension; or other extenuating circumstances. The mean Society of Thoracic Surgeons score was 13.2.

D. Scott Lim

According to the findings, transcatheter mitral valve repair with the MitraClip (Abbott Vascular) was successful in 95.3% of cases. The patients’ mean hospital stay was 2.9 days.

Major adverse events at 30 days included death (6.3%), stroke (2.4%) and MI (0.8%). At 1 year, 23.6% of patients had died. Survival did not differ significantly according to the grade of mitral regurgitation. The researchers reported no difference in survival between patients discharged with mitral regurgitation ≤1+ or 2+.

Among surviving patients, 82.9% maintained a regurgitation grade of ≤2+ at 1 year, and 86.9% had NYHA class I or II HF. The researchers also reported a significant decrease in left ventricular end-diastolic volume, from 125.1 ± 40.1 mL to 108.5 ± 37.9 mL, among 69 patients with paired data available (P<.0001).

Among patients with a baseline mitral regurgitation grade of ≥3+, 86.1% improved to a grade of ≥2+ after transcatheter mitral valve repair, while 68.4% of patients with a baseline grade of ≥4+ improved to a grade of ≥2+. Improvement to ≥1+ was observed in 58.3% of patients with a grade of ≥3+ at baseline and in 36.8% of those with a grade of ≥4+ at baseline.

In other results, HF-related hospitalizations and Short Form 36 quality of life scores were reduced in patients whose mitral regurgitation was reduced following transcatheter mitral valve repair.

“This is the first report on the use of the [transcatheter mitral valve repair] device specifically in patients with [degenerative mitral regurgitation] considered at prohibitive risk for [mitral valve] surgery,” Lim and colleagues wrote.

In a related editorial, Blase A. Carabello, MD, from the Icahn School of Medicine, Mt. Sinai Beth Israel department of cardiology, wrote that the improvement to quality of life in this elderly cohort was the most impressive finding and, this trial, along with the results from EVEREST II, indicate efficacy of the MitraClip device in this patient population. However, he also noted the stark difference between degenerative and functional mitral regurgitation, and called for separate analysis of the two disease types.

“For secondary [mitral regurgitation], where there is no proof that surgery prolongs life, this less-invasive therapy would appear ideal,” Carabello wrote. “… In the future, to fully understand the role of percutaneous [mitral regurgitation] repair, we must study it separately in the two very different diseases for which it is being applied, so we can define its role in primary vs. secondary [mitral regurgitation].”

For more information:

Carabello BA. J Am Coll Cardiol. 2014;193-195.

Lim DS. J Am Coll Cardiol. 2014;182-192.

Disclosure: See the full study for a list of relevant financial disclosures. Carabello reports no relevant financial disclosures.