Marco Costa, Cleveland, USA, presented two-year clinical results for the first-of-its-kind catheter-based Parachute Ventricular Partitioning device (CardioKinetix), a percutaneous ventricular restoration (PVR) therapy for patients with ischaemic heart failure. Data were presented on 18 May during a Trials, Registries and Late Breaking Science Hot Line session at EuroPCR.
Results from 31 treated US and European patients demonstrate a near-full New York Heart Association (NYHA) class improvement at two years compared to baseline (2.6 vs. 1.9, p<0.01). In addition, reduction in left ventricular volume was maintained out to two years (p<0.001). Furthermore, the procedure stabilised the remodeling process as demonstrated by no statistical change in post-procedure functional volume over a two-year period (p=0.74). The combined rate of all-cause death and hospitalisation due to worsening heart failure was 16.1% at one year and 32.3% at two years. The rate of cardiac death was 6.5% at two years. These outcomes compare favorably with current medical therapy in a similar high-risk patient population.
“Heart failure is such a morbid condition and, in spite of our best efforts, we have so little to offer to our patients. Today we shared unprecedented news for cardiologists and heart failure patients. It is difficult to contain our enthusiasm because the procedure is relatively simple and the outcomes are surprisingly remarkable for such a high-risk population,” said Costa, 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, Cleveland, USA. “The sustained and concordant improvements in symptoms, heart function, and clinical outcomes are compelling, with a very acceptable safety profile. If these results are confirmed in the upcoming large randomised trial, the Parachute implant will revolutionise the treatment of patients with ischaemic dilated cardiomyopathy, reducing debilitating symptoms and allowing patients with heart failure to live with dignity again.”
“We are extremely pleased with the two-year clinical results from the Parachute implant. These data supports the design of our randomised pivotal trial, in which we anticipate a potential reduction of death and hospitalisation due to worsening heart failure on the order of 30 to 50% for patients treated with the Parachute system compared to optimal medical therapy,” said William T Abraham, director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center. “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.”
About the Parachute Ventricular Partitioning device
The Parachute Ventricular Partitioning device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
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.
The Parachute Ventricular Partitioning device received CE mark in 2011. In the USA, the device is limited by federal law to investigational use only and is not available for sale.