Transcatheter annuloplasty system shows promising outcomes in mitral regurgitation

In patients with functional mitral regurgitation, use of a transcatheter annuloplasty system was effective and associated with a safety profile similar to that of equivalent procedures, according to interim results of a feasibility study presented at EuroPCR.

For the single-arm, prospective trial, researchers evaluated use of the Cardioband Annuloplasty System (Valtech Cardio) in 40 adults (mean age, 72 years) with moderate-to-severe functional mitral regurgitation at high risk for mitral valve surgery. Three-quarters of patients also had atrial fibrillation, 68% had moderate-to-severe renal failure, 33% had previous CABG, 20% had chronic obstructive pulmonary disease and 20% had severe pulmonary hypertension.

The Cardioband device combines an annuloplasty implant with a transfemoral venous delivery system and connects the implant to the mitral annulus using anchors instead of sutures. Reshaping of the mitral annulus to eliminate mitral regurgitation is performed under physiological conditions and echocardiographic guidance, according to a press release.

The primary safety endpoints included major serious adverse events and serious adverse device effects until hospital discharge and at 30 days. The primary performance endpoints included technical success, feasibility and ability to reduce mitral regurgitation during the procedure at hospital discharge and at 30 days.

The system was successfully deployed in all cases. The average reduction of septo lateral diameter was 20% (29 ± 5 mm vs. 37 ± 5 mm at baseline; P < .01), Georg Nickenig, MD, PhD, chairman of the department of cardiology at University Hospital Bonn, Germany, said during a presentation.

At hospital discharge, 90% of 38 evaluable patients had mitral regurgitation 2+ or less, and 27 patients had mild or no mitral regurgitation.

At 6 months, 80% of 21 evaluable patients had NYHA class I/II HF (P < .05). The patients also experienced significant improvements in quality of life as indicated by the Minnesota Living with Heart Failure Questionnaire score (18 vs. 38 at baseline; P < . 05) and 6-minute walk test results (322 m vs. 248 m at baseline; P < .01). At 12 months, 93% of 14 evaluable patients had mitral regurgitation 2+ or less.

No patients died during the procedure. Two deaths occurred within 30 days. Two patients experienced renal failure and one had bleeding complications. The researchers reported no cases of MI, respiratory failure or cardiac tamponade at 30 days.

The researchers concluded that transcatheter surgical annuloplasty using the Cardioband Annuloplasty System is a feasible treatment option.

“[Mitral regurgitation] repair with Cardioband can be the first-line therapy for severe [mitral regurgitation] patients,” Francesco Maisano, MD, chairman and professor of cardiovascular surgery at the University Hospital Zurich, Switzerland, said in a press release. “Additionally, early-stage repair can support ventricular reverse remodeling while keeping the options open for the patient, supporting the technology’s use at earlier stages.” – by Adam Taliercio

Reference:

Nickenig G, et al. Emerging interventions for mitral and tricuspid valve regurgitation. Presented at: EuroPCR; May 19-22, 2015; Paris.

Disclosure: Nickenig reports no relevant financial disclosures. Maisano reports consulting for Abbott, Edwards Lifesciences, Medtronic, St. Jude Medical and Valtech Cardio; receiving royalties from Edwards Lifesciences; and founding 4Tech.