The research team, led by Dr. William Abraham Medical Center at Ohio State University Wexner, publish their findings in the Journal of the American College of Cardiology(JACC) Heart Failure . Heart failure occurs when the heart is unable to pump enough blood and oxygen throughout the body to support other organs. Around 5.1 million people in the United States have the condition.
There is no cure for heart failure, but there are medications to help manage the symptoms. But Dr. Abraham notes these treatments are not always effective. “The best therapies we have today are often not enough to manage this disease for some patients,” he said,“if we are always looking for new types of therapies.” To their study, Dr. Abraham and his team implanted the C-Pulse device in 20 patients either functional class III or ambulatory functional class IV heart failure as defined by New York Heart Association.
According to the website of Sunshine Heart, the device is designed to get more oxygen to the heart muscle, reduce the workload of the left ventricle of the heart and increase blood flow to the heart. One wire connects the device through the abdomen to an external power supply called a “pilot”, which the patient wears. Drivers can be battery powered or plugged in, and so can be removed temporarily to allow the patient to take a shower, for example, or perform other tasks where the short packet can be annoying.
The C-Pulse may be implanted in 1 hour using a mini-thoracotomy(a small incision through the rib) and a mini-sternotomy (a small incision through the sternum) or by via a full sternotomy. Patients in the study were assessed 6 months and 1 year after implantation of the device. The team says that 16 of the 20 patients showed significant improvements in symptoms at two points in time. The researchers also found that patients were able to walk an average of 100 feet away, and the average quality of life score in patients an improvement of nearly 30 points. “The medical devices and therapies that are currently available to improve heart failure the same score for quality of life by only five or 10 points,” says Dr. Abraham. “So it really is a significant improvement.”
The most common adverse event in the trial was the exit site infections, experienced by participants 8 out of 20 The researchers noted that the strict management of site guidelines exit wound care and antibiotic therapy may reduce this risk in future studies. There were no hospitalizations among participants of stroke, thrombosis, sepsis or bleeding, which often occurs in patients using left ventricular assist devices(LVADs). Researchers said that this is due to staying out of circulation device. Another important difference is the device C Pulse may be temporarily out of service and disconnected, allowing patients to facilities that LVAD does not allow. Researchers are currently conducting a randomized controlled trial of this device at Ohio State Ross Heart Hospital of and 18 other academic medical centers across the country candidates who want to break into medical sales.
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