San Diego, California — Patients who develop a specific form of heart failure characterized by severe enlargement of the heart muscle can be safely and effectively treated with a new device that is implanted during a minimally invasive procedure, according to a meta-analysis of three trials to be presented at the SCAI 2015 Scientific Sessions.

Patients who suffer a heart attack due to a blocked artery supplying the anterior (front) wall of the heart muscle tend to fare worse than patients who have heart attacks from blockages in other locations. The scarring associated with anterior heart attacks causes the heart to pump less effectively, which can lead to severe congestive heart failure.

"Surgical treatment options, such as removing the scar tissue and patching the area, are designed to separate the dead territory from healthy tissue to promote healthier blood flow. These procedures have had varied results, so the treatment options we can offer patients are limited to ACE inhibitors, beta blockers, left ventricular heart devices or heart transplant," said Peter Fail, MD, FSCAI, of the Cardiovascular Institute of the South in Houma, La.

The Parachute Implant System (CardioKinetix), which has CE mark for commercial use in Europe and is currently approved only for investigational use in the United States, may provide a less invasive treatment option for these patients, said Dr. Fail.

"The goal of treatment with the Parachute device is to separate the muscle segment that isn’t functioning from the healthy part of the heart to help the heart function better," explained Dr. Fail.

An interventional cardiologist delivers the device to the heart through a catheter inserted in an artery in the leg. The device is then implanted in the heart, where it expands to block off the non-functioning portion of the heart. Separating the non-functional muscle segment from the functional segment can decrease the overall volume and restore geometry and function of the ventricle.

Dr. Fail and colleagues undertook a meta-analysis of the three completed trials of the device: PARACHUTE Cohort A, PARACHUTE US Feasibility and PARACHUTE III. The primary objective was to assess one-year safety and efficacy of the device in patients with heart failure.

A total of 134 subjects with New York Heart Association (NYHA) class II-IV heart failure secondary to anterior wall myocardial infarction with akinetic or dyskinetic wall motion abnormality were enrolled in the trials. Ninety-six percent of the patients were successfully treated. Rates of stroke, all-cause death and the combination of all-cause death and repeat hospitalization for worsening heart failure were 2.4 percent, 8.8 percent and 23.6 percent, respectively.

The baseline mean NYHA class was 2.5 +/- 0.5 and improved to 1.9 +/-0.7 at one year, showing functional improvement.

"That clinical number means a lot. It shows that patients are feeling better," said Dr. Fail.

Performance on a 6-minute walk test, a more objective assessment than NYHA Class, rose from 369 meters at baseline to 391 meters at one year, a significant result.

"We are still trying to define the appropriate patient population for the device. This may provide patients who aren’t transplant candidates an option. We hope that PARACHUTE IV, which is a randomized clinical trial, will provide the answers," said Dr. Fail.

Dr. Fail will be available at the SCAI 2015 ePosters Bar to discuss the study "Percutaneous Ventricular Restoration (PVR) Therapy Using the Parachute® Device in Subjects with Ischemic Dilated Heart Failure: One-Year Meta-Analysis" on Friday, May 8, at 1:00 p.m. (Pacific Time).