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Partitioning device linked to positive long-term HF outcomes
MUNICH — A novel, minimally invasive device designed to separate healthy and damaged heart muscle and restore ventricular function was associated with improved outcomes at 3 years in patients with ischemic HF.
Researchers used multi-slice CT to evaluate structural and functional changes of the left ventricle and determined long-term outcomes of percutaneous ventricular restoration therapy (PVRT) utilizing the Parachute Ventricular Partitioning Device (CardioKinetix). The device is implanted in the left ventricle via a small catheter inserted in the femoral artery in the cath lab under conscious sedation, according to a press release.
“The device creates a barrier between the nonfunctioning, damaged segment of the heart muscle and the healthy, functional segment of heart muscle. This decreases the overall volume of the left ventricle chamber and restores its optimal geometry and function,” presenter Marco Costa, MD, PhD, of University Hospitals Case Medical Center, Cleveland, stated in the release.
Marco Costa
Earlier this year at EuroPCR 2012, researchers presented 2-year data demonstrating improved overall cardiac function and quality of life for patients treated with this device.
Here, the researchers presented 3-year data from the first-in-man pilot study, which included 31 successfully implanted patients in the United States and Europe who were treated with the Parachute device. NYHA Class was used to define HF severity at 1, 2 and 3 years after treatment.
Mean NYHA Class was 2.6 at baseline. After device implantation, NYHA Class improved to 1.6 at 1 year (P<.001), 1.9 at 2 years (P<.01) and 1.8 at 3 years (P<.0001).
The proportion of patients hospitalized due to worsening HF increased from 29.7% at 2 years to 33.2% at 3 years. According to Costa, “this small increase could be because the Parachute [device] is specifically targeting the structural heart problem by excluding the scar caused from a heart attack which initiated the negative ventricular remodeling.”
The low cardiac mortality rate of 6.5% at 2 years remained unchanged at 3 years.
The researchers noted an approximate 30% to 50% reduction in the combined endpoint of HF hospitalization or all-cause mortality with the Parachute device over 3 years, as compared with historical controls, William T. Abraham, MD, director of the division of cardiovascular medicine at The Ohio State University, said at a press conference.
According to Abraham, the longevity of the Parachute device has been “good.” Only two patients required device removal due to difficulties with positioning, he noted.
“These data are highly suggestive that this approach … may improve outcomes and serve as the basis for a randomized, controlled, pivotal trial that will begin late this year or early in 2013,” Abraham said during the press conference.
The Parachute Ventricular Positioning Device received CE Mark in 2011. It is currently an investigational device in the United States. – by Katie Kalvaitis
For more information:
Bezerra H. Abstract #3147. Presented at: the European Society for Cardiology Congress; Aug. 25-29, 2012; Munich.
Disclosure: Dr. Abraham reports receiving consulting fees from CardioKinetix.