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FORT LAUDERDALE, FLA. — Lower short-term morbidity and more favorable long-term outcomes are among the advantages of a biodegradable ring used for mitral valve repair in children with rheumatic disease, compared with a traditional rigid ring, according to a study.
Rheumatic mitral valve disease in children is progressive and surgery is the treatment of choice, Dr. Afksendiyos Kalangos said at the annual meeting of the Society of Thoracic Surgeons. To gauge the impact of a biodegradable ring on short- and long-term outcomes for these children, Dr. Kalangos and his associates assessed 220 valve repairs at the University Hospital of Geneva.
The single surgical team's experience included 143 girls and 77 boys with a mean age of 12 years (and a range of 2-16 years). The valve repairs were performed from January 1994 to March 2007. The majority of patients—198, or 90%–had predominant mitral valve deficiency.
“Mitral valve repair can be performed in a significant number of young rheumatic patients, depending on surgical expertise,” said Dr. Kalangos, chairman of the division of cardiovascular surgery and the unit of pediatric cardiology, University Hospital of Geneva.
The surgeons also simultaneously addressed aortic valve insufficiency in 57 patients and tricuspid valve insufficiency in 51 patients.
Echocardiography was performed at 1 week, 3 months, and 6 months postoperatively, and then annually. Complete data were available for 213 participants.
A total of 173 participants received a rigid annuoplasty ring (the Carpentier-Edwards ring, manufactured by Edwards Lifesciences LLC), until 2003. Thereafter, another 40 children received a biodegradable annuoplasty ring (manufactured by Bioring SA). The biodegradable ring has an investigational status with the Food and Drug Administration.
One immediate mitral valve repair failure led to a reoperation, Dr. Kalangos said. There was one late death from septicemia at 9 months. There were no hospital deaths or major postoperative morbidities.
There have been five reoperations during a mean follow-up of 76 months. “All reoperations so far were in the Carpentier-Edwards group,” Dr. Kalangos said. Dr. Kalangos and his colleagues are royalty holders and consultants for Bioring SA.
The mean gradient was significantly lower for the biodegradable ring, compared with the rigid ring, at follow-up: 5.2 mm Hg versus 2.8 mm Hg at 7 days, 6.2 mm Hg versus 3.1 mm Hg at 6 months, and 7.0 mm Hg versus 3.3 mm Hg at 1 year after the procedure.
The researchers also found a statistically significant difference in the percentage of patients who had an unchanged gradient during the first year: 26 of 40 (65%) biodegradable ring patients and 35 of 173 (20%) of the rigid ring participants.
