Scientists have developed a new catheter-based treatment for patients with ischemic heart failure.
University Hospitals (UH) Case Medical Center and CardioKinetix have recently reported positive results from the first-of-its-kind catheter-based Parachute Ventricular Partitioning Device, which is a Percutaneous Ventricular Restoration Therapy (PVRT) technology for patients with ischemic heart failure.
After two years of clinical trials, the researchers have now published their first results from two human studies, which show meaningful and sustained low clinical events two years following treatment with the device.
UH Case Medical Center's Marco Costa said: "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. This novel technology could revolutionise care for our patients because the procedure is relatively simple and the outcomes are surprisingly remarkable for such a high-risk population."
The human trials showed several positive results. Patients demonstrated a near-full New York Heart Association (NYHA) class improvement at two years. There was a reduction in left ventricular volume which was maintained out to two years. Additionally, researchers found that the procedure stabilised the remodelling process as demonstrated by no statistical change in post-procedure functional volume.
Dr Costa said that the clinical results were very successful, and that they have enough evidence to conduct a randomised pivotal trial in order to anticipate potential reduction of death and hospitalisation.
Many patients suffer from an enlargement of the left ventricle after a heart attack, which can cause a decrease in cardiac output. To compensate for this loss, the healthy portion of the heart works doubly hard, and therefore becomes overloaded.
To fix this, a small catheter inserted in the femoral artery, and the Parachute implant is deployed in the left ventricle to partition the damaged muscle, which excludes 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.
Dr Costa explained: "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."