Good Outlook for Heart Failure Patients Given Ventricular Restoration Device

MUNICH, Germany—In patients with ischemic heart failure, percutaneously implanted device that separates healthy and damaged heart muscle and restores ventricle function improves 3-year outcomes in patients with ischemic heart failure. The results were presented on August 27, 2012, at the European Society of Cardiology Congress.

Two-year data released earlier this year at EuroPCR 2012 in Paris, France, showed the device improved overall cardiac function and quality of life.

Promising Results

For the study, Marco A. Costa, MD, PhD, of Case Western Reserve University (Cleveland, OH), and colleagues analyzed 31 patients treated in the United States and Europe with the Parachute ventricular positioning device (CardioKinetix, Menlo Park, CA). At baseline, all patients were designated as New York Heart Association (NYHA) Class II-IV, had LVEF between 15% and 40%, and had previously experienced LAD MI.

At 3 years, NYHA class improved from 2.6 at baseline to 1.8 at 3 years (P < 0.0001). The cardiovascular mortality rate of 6.5% at 2 years remained unchanged at 3 years; no deaths were device related. There were no major complications and 14.7% of patients experience minor complications. However, rehospitalization due to worsening heart failure increased from 29.7% at 2 years to 33.2% at 3 years.

In a substudy of 14 patients using multi-slice CT, anterior wall segmental EF remained unchanged from baseline to 6 months (22.8% to 22.6%). On the other hand, non-anterior wall segment EF increased from 25.6% to 28.6%, although this was not statistically significant.

All Signals Go for Randomized Trial

“The device creates a barrier between the non-functioning, damaged segment of heart muscle and the healthy, functional segment of heart muscle,” Dr. Costa said in a press release. “This decreases the overall volume of the left ventricle chamber and restores its optimal geometry and function.”

Dr. Costa said his team plans to begin a large, randomized trial with the device later this year. “We have shown that the Parachute device is safe and leads to sustained improvements in symptoms, heart function, and clinical outcomes over 3 years,” he concluded. “This points to a potentially historical turning point in the treatment of heart failure caused by heart attack.”

 

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Source:
Costa MA. First-in-human experience with percutaneous ventricular restoration therapy in patients with ischemic heart failure and dilated left ventricle: Multi-slice computer tomography and 3-year outcome. Presented at: European Society of Cardiology Congress; August 27, 2012; Munich, Germany.

 

 

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