Cardioband Shows Benefits for Secondary Mitral Regurgitation

A “surgical-like” mitral annuloplasty ring implanted using a transseptal approach is effective in patients with significant secondary mitral regurgitation (MR), with safety similar to that of other transcatheter mitral procedures, researchers are reporting this week at TCT 2015. The device provides consistent reduction in MR up to 12 months after the procedure.

Alec Vahanian, MD, of Bichat Hospital, Paris, France, and colleagues conducted a feasibility study of the Cardioband system (Valtech), which consists of an adjustable annuloplasty ring implanted percutaneously using a transfemoral approach. The researchers enrolled 40 high-risk patients with significant secondary MR between February 2013 and March 2015 at six European sites. At baseline, 93% had NYHA class III-IV symptoms, with a mean LV ejection fraction of 33.3%.

Acute procedural success, defined as successful implantation with acute MR reduction to grade < 2+, was achieved in all but three patients (92%). The average reduction in septolateral diameter was 20% after the device was cinched. At 30 days, the mortality rate was 5.0%. None of the deaths were considered device-related.

Most patients were considered NYHA Class I-II at 6 months (80%) and 12 months (70%) and had MR grade ≤2+ (85% and 94% at 6 and 12 months, respectively). There also were improvements in quality of life as assessed with the Minnesota Living With Heart Failure Questionnaire at both time points and in 6-minute walk test (from 288 to 360 meters; P < .05 for both).

Mean age of patients in the study was 72 years, and three-quarters were men. Mean EuroSCORE II was 9.0%, and the median STS score was 7.2%. All patients were screened for feasibility using echocardiography and cardiac CT angiography.

Vahanian told TCT Daily that the results matched his group’s expectations. “Efficacy is at least equal to the most effective transcatheter devices available now,” he said. “[Cardioband] is durable up to 1 year, and safety is good.”

He noted that the device cannot be used as a stand-alone treatment for primary MR but said it could have a role in that patient population. “One of the advantages of this device is that it can be combined with other transcatheter devices such as MitraClip [Abbott Vascular] or chordal replacement in primary MR,” he said.

Disclosures:

• Vahanian reports serving as a consultant for Valtech.