Parachute device improves outcomes for patients with HF

SAN DIEGO — A meta-analysis of three clinical trials demonstrates 1-year safety and efficacy of a minimally invasive, catheter-based partitioning device in patients with HF due to ischemic heart disease, researchers reported at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.

Left ventricle remodeling after anterior wall MI can lead to increased LV volume, myocardial stress and HF; however, treatment options for patients with high-risk HF are limited, according to Peter S. Fail, MD, FSCAI, from the Cardiovascular Institute of the South in Houma, La., and colleagues.

Peter S. Fail

“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,” Fail said in a press release.

Researchers performed a meta-analysis of the PARACHUTE Cohort A, PARACHUTE US Feasibility and PARACHUTE III studies to assess the 1-year safety and efficacy of the Parachute Implant System (CardioKinetix) in the partitioning of the LV in patients with HF due to ischemic heart disease. The Parachute Implant System is a catheter-based partitioning device that is deployed within the LV after the development of ischemic HF following MI.

In total, 134 patients in Europe and the United States were enrolled in the three trials. All patients had NYHA class II to IV HF secondary to anterior wall MI with akinetic or dyskinetic wall motion abnormality and LV ejection fraction < 40%.

Ninety-six percent of the patients were successfully treated with the Parachute Implant System.

The rate of stroke was 2.4%, all-cause mortality occurred in 8.8% and the rate of all-cause mortality/repeat hospitalization for worsening HF was 23.6%.

Mean NYHA HF class improved from 2.5 at baseline to 1.9 at 1 year (P < .0001). Performance on a 6-minute walk test increased from 369 m at baseline to 391 m at 1 year (P < .01).

The researchers also reported improvements to systolic cardiac function as indicated by LV volume indices, LVEF, stroke work, contractility index and left atrial volume. The data also indicated a trend toward fractional shortening at 1 year, according to the abstract.

The PARACHUTE IV randomized clinical trial is currently underway to evaluate the implant in 560 patients with ischemic HF at 80 U.S. centers. Key endpoints include all-cause mortality, hospitalization for worsening HF, hemodynamic measures as indicated by echocardiography and imaging measures by CT, according to the CardioKinetix website.

The Parachute Implant System has CE mark for commercial use in Europe but is currently approved only for investigational use in the United States. – by Katie Kalvaitis

Reference:

Fail PS, et al. Best of the Best Abstracts. Presented at: Society for Cardiovascular Angiography and Interventions; May 6-9, 2015; San Diego.

Disclosure: Fail reports financial ties with CardioKinetix.