Study Offers Hope For Heart Failure Patients With Minimally Invasive Parachute™ Ventricular Partitioning Device

“The sustained and concordant improvements in symptoms, heart function and clinical outcomes are compelling, with a very acceptable safety profile”

In short

According to a press release issued on Friday by University Hospitals (UH) Case Medical Center, Californian Cardiac specialist CardioKinetix Inc., has seen trial data from its innovative Parachute™ Ventricular Partitioning Device presented at the 2012 EuroPCR Conference in Paris.

Background

After a heart attack, many patients experience enlargement of the left ventricle of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose heart has enlarged are limited.

The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterisation laboratory under conscious sedation.

Study results

Two-year results from two first-in-human studies of the Parachute system were presented during a Trials, Registries and Late Breaking Science Hot Line session by Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University in Cleveland, Ohio.

The session, titled “Percutaneous ventricular restoration therapy in patients with ischemic dilated heart failure: 2-year clinical and echocardiographic outcomes of the first-in-human study of the parachute left ventricle partitioning device” suggested that use of the device resulted in “meaningful and sustained low clinical events two years following treatment”.

Results from 31 treated U.S and European patients demonstrate:

  • a near-full NYHA class improvement at two years compared to baseline (2.6 vs. 1.9, p-value<0.01).
  • a reduction in left ventricular volume, maintained out to two years (p-value<0.001).
  • a stabilised remodelling process as demonstrated by no statistical change in post-procedure functional volume over a two-year period (p-value=0.74).

The combined rate of all-cause death and hospitalisation due to worsening heart failure was 16.1 percent at one year and 32.3 percent at two years. The rate of cardiac death was 6.5 percent at two years. These outcomes compare favourably with current medical therapy in a similar high-risk patient population.

The next phase of the trial will be to enroll close to 500 patients in both the United States and Europe. UH Case Medical Center and The Ohio State University Medical Center will serve as the focal points for the efforts conducted in USA.

Clinician comments

“We are extremely pleased with the two-year clinical results from the Parachute implant. This data supports the design of our randomized pivotal trial, in which we anticipate a potential reduction of death and hospitalization due to worsening heart failure on the order of 30 to 50 percent for patients treated with the Parachute system compared to optimal medical therapy,” said William T. Abraham, MD, director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center who was also part of the first U.S. trial. “This innovative device has the potential to bring together two cardiology disciplines – heart failure and interventional cardiology – to address a significant unmet need in heart failure.”

Regulatory status

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

Source: UH Case Medical Center, CardioKinetix Inc.