A trial of Valtech Cardio‘s Cardioband transcatheter annuloplasty system showed no device-related mortality, with decreases in mitral regurgitation and septo-lateral dimension.
Results from the 40-patient multicenter observational study, designed to evaluate the safety and performance of the Cardioband, were presented this week at the European Society of Cardiology’s annual meeting in Paris. The study was also published in March in the Journal of the American College of Cardiology.
The study reported a an acute procedural success rate of 89%, as well as a 20% reduction in septo-lateral diameter after adjustment of the device. Mortality after 30 days was 6.8% from 2 deaths, but both were deemed unrelated to the device.
“I think this procedure will be developed rapidly [because] the potential target population is so large. And with the excellent safety data . . . it wasn’t just that the patients tolerated the procedure well, every single surrogate end point went the right way,” Dr Kenneth Dickstein of Norway’s Stavanger University Hospital told heartwire.
One bleeding complication and 2 renal failures were reported at 30 days, the study reported. No incidents of myocardial infarction, respiratory failure, or cardiac tamponade were reported.
“In this high-risk patient population, there’s been no action until now except for medical treatment. So we tried interventionally to mimic what surgeons are doing,” lead author on the study Dr. Karl-Heinz Kuck of Hamburg, Germany’s St. Georg Hospital said in a presentation at the conference. “This really gives hope to patients who otherwise could not be treated.”
Results at 6 months showed an improvement to NYHA class I-II in 90% of patients, with improved scores on the 6-minute-walk test and the Minnesota Living with Heart Failure questionnaire.
“I’m an echocardiographer and the way you evaluate mitral insufficiency is something we could discuss all day. But with this procedure, even moderate mitral insufficiency was almost eliminated – and not just at discharge. It persisted at 12 months, which is equally impressive,” Dickstein said at the conference.
Kuck added that the safety profile was "similar to equivalent transcatheter procedures, particularly to the MitraClip". The MitraClip is produced by Abbott (NYSE:ABT), who presented results from a study of the device last month at the Heart Rhythm Society’s annual meeting in Boston, which touted a 50% overall reduction in ventricular tachyarrhythmias.
European Union approval of the device is hoped for later this year, Kuck said. Once the device has approval a new 250-patient trial is slated, Kuck added.