by Esha Sharma, MBBS
When patients suffer from heart failure, the heart does not pump properly, causing the blood to back up in the heart, resulting in shortness of breath and fatigue, “congestive heart failure”. Now a new parachute ventricular partitioning device is changing that. The device is a first-of-its-kind for patients with this condition.
How it Works
The parachute ventricular partitioning device uses a procedure that involves placing a catheter (a tube), which is placed in the large artery of the leg to deliver the parachute device into the left ventricle. It is minimally invasive (similar to “stent procedure”), and requires only a one overnight stay in the hospital. The parachute is placed in the apex or the bottom of the left ventricle to partition or wall-off muscle that has been damaged due to a heart attack. It closes off the non-functional segment of the heart from the healthy segment. This reduces the heart wall stress and restores the geometrical shape of the heart. The device improves cardiac performance and quality of life in patients who have received this remarkable device.
Currently Approved in Europe
The parachute device is currently approved in Europe, but is being evaluated in clinical trials in the United States. Buffalo Heart Group is one of 80 participating sites and is actively recruiting patients with heart failure who qualify. Tom Desmond was the first patient to be enrolled in the Parachute trial in Buffalo over one year ago. Following implantation he experienced a drastic improvement in his quality of life. When asked about his limitations prior to the procedure he said, “I was out of breath most of the time.” He said that now he has “more energy.” In fact, he was recently able to undertake remodeling of his house.
Clinical Trials at Buffalo Heart Group
Several clinical trials involving the parachute device have been conducted, and 133 patients who were treated are now in the follow-up phase. Currently the Parachute IV trial is enrolling patients designed to evaluate the parachute implant. Plans are to enroll approximately 500 patients with ischemic heart failure in up to 65 centers in the United States. Patients who suffer from low pumping action of the heart, heart wall motion abnormality are given priority, along with those classified as New York Heart Association (NYHA) Class III-IV patients. The NYHA places patients in one of four categories based on the degree to which they have limited physical activity. CT imaging and ultrasound are performed to confirm the eligibility of these patients.
Statistics Demonstrate Success
About half of people who develop heart failure die within five years of diagnosis. Data collected from parachute trials showed that 89% of patients improve or maintain their quality of life at one year. Two out of three patients avoid being re-hospitalized for heart failure at three years and 94% of patients avert cardiac death three years following the procedure. Buffalo Heart Group physicians are pleased that patients receiving the device experienced significant improvement of heart failure and a significant reduction in the hospitalizations. They are also encouraged because the heart pumping action improved providing patients with significant quality of life improvements.
To learn more about this clinical trial and your possible eligibility to participate, please call (716) 835-2966.
About the Author
Esha Sharma, M.D. is a cardiology clinical research intern who is preparing for her residency at Buffalo Heart Group. Dr. Sharma graduated from medical school in 2012 in Mumbai, India.
Watch a video about the procedure and Mr. Desmond at http://wivb.com/2015/01/03/new-medical-device-helps-local-man-survive/.
