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Novel annuloplasty device feasible for treatment of functional mitral regurgitation
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In early use, a novel adjustable mitral annuloplasty device was a feasible treatment for patients with functional mitral regurgitation at high risk for reoperation due to recurrent mitral regurgitation, according to new findings.
Researchers evaluated the safety and feasibility of the device (enCorSQ, MiCardia) in 94 patients (median age, 71 years; 66% men; EuroSCORE II, 6.7; 48% with ischemic mitral regurgitation; 37% with dilated cardiomyopathy; 15% with degenerative disease) from five centers in Europe participating in an observational registry. The device received a CE mark in September 2011 but has not yet been approved by the FDA for use in the United States.
According to the study background, the D-shaped mitral ring is implanted similarly to a conventional mitral annuloplasty procedure, and if necessary, an operator is able to downsize the anterior-posterior diameter after initial surgery.
The primary endpoints were survival, valve-related adverse events and adjustment procedures.
Martin Andreas, MD, MBA, PhD, from the department of surgery, division of cardiac surgery, Medical University of Vienna, and colleagues reported that operative mortality was 1% and 1-year survival was 93%.
They wrote that they attempted a ring adjustment in 12 patients an average of 9 months after initial surgery.
Of those patients, three experienced a technical failure during their adjustment, one had mitral regurgitation reduced two grades, two had mitral regurgitation reduced one grade and six had no significant change in mitral regurgitation. Mean grade of mitral regurgitation changed from 2.9 to 2.1 (P = .02).
After 11 months, five patients required reoperation, Andreas and colleagues wrote. Two had ring dehiscence and three had failed adjustment.
They wrote that 9.5% of patients required an early revision for bleeding, but no cases of bleeding were related to the lead of the device.
Two patients had strokes after the procedure, they wrote.
At 6 months, mean NYHA status improved from 3 to 1.5 (P < .001), according to the researchers.
“This device may provide an additional treatment option in patients with functional mitral regurgitation, who are at risk for reoperation due to recurrent mitral regurgitation,” Andreas and colleagues wrote. “Clinical results in this complex disease were ambiguous and patient selection seems to be a crucial step for this device. Further trials are required to estimate the clinical value of this therapeutic concept.” – by Erik Swain
Disclosure: The study was funded in part by MiCardia. The researchers report no relevant financial disclosures.
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