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No difference between surgical mitral valve repair, replacement in 2-year survival, remodeling
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ORLANDO, Fla. — At 2 years, mortality and left ventricular reverse remodeling were similar in patients who underwent surgical mitral valve repair or replacement, researchers found.
However, those who underwent repair had a much greater rate of recurrent moderate or severe mitral regurgitation.
Researchers investigated whether patients undergoing surgery for severe ischemic mitral regurgitation benefited more from valve repair or replacement.
According to the study background, at 1 year, there was no difference between the groups in mortality, change in LV end-systolic volume index (LVESVI) or adverse events, though the repair group had more moderate or severe mitral regurgitation recurrences. The researchers, from the Cardiothoracic Surgical Trials Network, presented 2-year results at the American Heart Association Scientific Sessions and published them in the New England Journal of Medicine.
Daniel Goldstein, MD, professor of cardiovascular and thoracic surgery at Montefiore Medical Center, Bronx, New York, said during a press conference that mortality and LVESVI change remained similar between the groups at 2 years.
Mortality rates were 19% in the repair group vs. 23.2% in the replacement group (HR = 0.79; 95% CI, 0.46-1.35), Goldstein said. He noted that almost all deaths occurred in the first year, and perioperative mortality was more frequent in the replacement group.
Among those who survived, mean LVESVI was 52.6 ml/m2 of body surface area in the repair group vs. 60.6 ml/m2 in the replacement group, Goldstein said. When the researchers performed a rank-based assessment incorporating deaths, they found that there was no difference in change in LVESVI between the groups (z score = ˗1.32; P = .19).
At 2 years, the rate of mitral regurgitation was higher in the repair group than in the replacement group (58.8% vs. 3.8%; P < .001), Goldstein said.
This, he said, could have contributed to an increased risk for HF-related events. While the overall rates of serious adverse events and readmissions did not differ between the groups, the repair group had a higher rate of HF-related serious adverse events (P = .05) and of CV readmissions (P = .01). Goldstein said that many of the latter appear to be for HF.
The replacement group tended to do better by quality-of-life metrics, as, for example, there was a trend toward better Minnesota Living with Heart Failure questionnaire score (P = .07), Goldstein said.
“We now see a diversion in clinical outcomes that we did not see in the 1-year paper,” Goldstein said. “We believe that replacement provides a more durable correction for severe ischemic mitral regurgitation.” – by Erik Swain
References:
Goldstein D, et al. Late-Breaking Clinical Trials 6. Presented at: American Heart Association Scientific Sessions; Nov. 7-11, 2015; Orlando, Fla.
Goldstein D, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1512913.
Disclosure: The study was funded by the NIH and the Canadian Institutes of Health Research. Goldstein reports receiving grant support from the NIH and personal fees from Medtronic. See the full study for a list of the other researchers’ relevant financial disclosures.
Perspective
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Timothy J. Gardner, MD, FAHA
Although there appeared to be no differences in some of the endpoints, clearly the worsening of the recurrent [mitral regurgitation] over time is a bad signal. This gives further strength to the initial conclusion that replacement is as good as repair for most of these patients, if not better. Although perioperative mortality was higher in the replacement group, as noted in the original report, the difference was not statistically significant. We have to keep this in mind and not assume that replacement has a significantly higher operative mortality risk.
In his discussant comments, Alain Carpentier, MD, PhD, pointed out that repair might be challenging for relatively inexperienced surgeons, and they should take comfort that they can do a straightforward replacement without penalizing the patient. On the other hand, there may be a subgroup of patients with severe ischemic mitral regurgitation for whom repair may still be appropriate.
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