New combo implant helps heart failure symptoms

More than 6.5 million Americans are living with heart failure, and that number is expected to grow significantly over the next five years.

A leading cause of death in people, current therapies do little to relieve symptoms, but there may be new hope thanks to an implantable device.

“I’ve been riding motorcycles since I was seven,” said Jim Balala.

He was riding his Harley when the trip took an unexpected turn. His wife, Kathy, said they instead rushed to the hospital.

“They told me at that time that he probably was having a heart attack for about 13 hours,” Kathy Balala said.

Jim was taken into surgery, after which he was kept in a medically induced coma for 12 days. Medications and a defibrillator kept his heart beating but left Jim with debilitating fatigue.

“They don’t treat heart failure. Patients are still left with their symptoms. And the debilitation,” said his doctor, Niraj Varma, a cardiac electrophysiologist with Cleveland Clinic.

Varma is leading a national study for a device called Integra-D. Jim was the first person in the world to have this implant, which combines two proven cardiac therapies into a single implantable device. “It delivers cardiac contractility modulation as well as defibrillator therapy.”

Based upon cardiac contractility modulation, the device works to improve contraction of the heart. Making it stronger and relieving symptoms.

A defibrillator treats life-threatening arrhythmias that can cause sudden death but needs to be replaced every ten years.

The Integra-D will last 20 years.

“This is a game-changer in the world of implantable device therapies because it is rechargeable,” said Dr. Varma.

Within two weeks of getting the implant, Jim had twice as much energy is was looking forward to spending a summer on his motorcycle.

The Integra-D clinical study is still evaluating the safety and effectiveness of the device.

Plans are to enroll 300 patients from 75 centers across the U.S. and follow them for two years.