At 2 Years, Surgical Valve Replacement Still Beats Repair in Severe Mitral Regurgitation

Patients with severe mitral regurgitation (MR) who undergo surgical valve replacement have less recurrence, fewer adverse events related to heart failure and fewer rehospitalizations at 2 years than those treated with surgical repair, according to results of a study presented November 9, 2015, at the annual American Heart Association 2015 Scientific Sessions in Orlando, FL, and published simultaneously in the New England Journal of Medicine.

“We believe that replacement provides a more durable correction for severe ischemic mitral regurgitation,” Daniel Goldstein, MD, of Montefiore Medical Center-Albert Einstein College of Medicine (New York, NY), said in a press conference.

Goldstein and colleagues from the Cardiothoracic Surgical Trials Network (CTSN) randomized 251 patients with chronic severe ischemic MR and CAD to surgery for mitral valve repair (n = 126) or replacement (n = 125) at 22 hospitals from 2009-2012. The degree of LV reverse remodeling at 12 months (primary endpoint) was assessed by left ventricular end systolic volume index (LVESVI) using TTE. One year results showed that LV reverse remodeling and survival outcomes were similar between the 2 groups. However, the repair group had higher rates of moderate or severe MR.

Replacement included complete preservation of the subvalvular apparatus. The technique of preservation, type of prosthetic valve, and technique of suture placement were chosen according to the preference of the surgeon, as was the type of annuloplasty ring in the repair group. The repair protocol mandated the use of an approved complete rigid or semirigid annuloplasty ring, which was downsized to correct for annular dilatation.

Replacement Comes Out on Top

Presenting the 2-year data, Goldstein reported that there continued to be no difference between the repair and replacement groups in LV reverse remodeling at two years, nor were there any significant differences in mortality or rates of major adverse cardiac or cerebrovascular events.

However, compared with the replacement arm, the excess hazard of recurrent moderate or severe MR persisted in the repair group at 2 years (58.8% vs 3.8%; P < .001). Patients in the repair group as compared with the replacement group had more serious adverse events related to heart failure and more cardiovascular readmissions, driven largely by rehospitalization for heart failure and need for an ICD or permanent pacemaker. Furthermore, a greater degree of reverse remodeling was seen in patients in the repair group who did not experience recurrent MR compared with those who did (62.6 vs 42.7; P < .001).

Quality of life and functional status as assessed by the Minnesota Living with Heart Failure questionnaire showed a trend toward greater improvement in the replacement group compared with repair (P = .07).

Asked if the 1- and 2-year data are convincing enough that replacement should be considered the first-line treatment for these patients, Goldstein said, “I'm not sure we're exactly quite there yet.” However, he noted that he personally would feel comfortable using a replacement first in most patients.

Commenting on the study, Alain Carpentier, MD, PhD, of Georges Pompidou European Hospital (Paris, France), who has been called the father of modern mitral valve repair, noted that the absence of difference between the 2 techniques still needs to be confirmed over longer follow up.

Goldstein said that while 5 years of follow up would probably be “comfortable” in terms of enough data acquisition to conclude that replacement is the preferred strategy, the study is not currently funded out that far. 

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Sources:
Goldstein D, Moskowitz AJ, Gelijns AC, et al. Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation. N Engl J Med. 2015;Epub ahead of print.

Disclosures:

• The study was funded by the National Institutes of Health (NIH) and the Canadian Institutes of Health Research.
• Goldstein reports grant support from the NIH and serving as a consult or advisory board member for Heartware, Medtronic, SunshineHeart, and Thoratec. 

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• Mitral Regurgitation Surgical Repair Rates, Durability Continue to Improve