Patients who were treated with percutaneous repair were more likely to require surgery for residual mitral regurgitation (MR) within 1 year of treatment, but were less likely to need to surgery after 5 years with either percutaneous or surgical therapy, according to 5-year results from the EVEREST II (Endovascular Valve Edge-to-Edge Repair) study.
EVEREST II, a multicenter, randomized trial, compared the MitraClip system (Abbott Vascular; Menlo Park, CA) with conventional surgery to treat MR with a 5-year follow-up. Researchers enrolled 279 patients with grades 3+ and 4+ chronic MR from 37 centers in North America between September 2005 and November 2008.
“Our findings suggest that the mechanical reduction of MR with percutaneous repair using this device is durable beyond 6 months,” the authors wrote in the study published in the Journal of the American College of Cardiology. “Additionally, because MR was reduced to a lesser extent following percutaneous repair compared with surgery, it is also an important finding that residual low-grade MR was not associated with either worsening MR or progressive [left ventricular] dilation.”
Researchers randomly assigned 184 patients with grade 3+ or 4+ MR to undergo percutaneous repair with the MitraClip device and 95 patients to have conventional MV surgery. They followed the patients for 5 years to measure freedom from death, additional surgery for MV dysfunction, and 3+ and 4+ MR.
After the 5-year follow-up, 44.2% of patients who underwent percutaneous repair were free from death, surgery, or 3+ or 4+ MR, compared to 64.3% of the patients who had surgical repair (P=.01).
The data revealed that 78% of surgeries in the percutaneous repair group occurred within the first 6 months. The rates of surgery and moderate-to-severe MR were comparable between the percutaneous repair group and the surgical repair group after 6 months. The 5 year mortality rate for the percutaneous repair group was 20.8% vs26.8% in the surgical repair group (P=.4).
The 1-year analysis revealed that percutaneous repair was less effective than surgery, but that the safety was still superior. The authors noted that both procedures improved quality of life.
They concluded that these 5-year results, “support the durability of MR reduction observed after successful device implantation and resultant symptom alleviation and LV reverse remodeling, endorse the long-term safety of this approach, and refute concerns that greater residual MR after percutaneous repair results in reduced-long-term survival.”
Feldman T, Kar S, Elmariah S, et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II. J Am Coll Cardiol. 2015;66(25):2844-54. doi: 10.1016/j.jacc.2015.10.018.