Clinical trial tests combined defibrillator and heart modulation device
Last March, while on vacation at Disney World, Mike Franczak found himself struggling to keep pace with his children and grandchildren. He decided to stay back at the hotel one day to rest and, while there, felt bad enough that he went to get checked out at the hospital.
Once there, he was shocked to find out that he was suffering from heart failure.
“I’m a pretty physical person — I like to work with my neighbors outside, and I wasn’t keeping up with them,” said Franczak, 62, of Jefferson Hills. “I thought it was just part of getting older. Other than being tired and coughing at night, I didn’t feel any different.”
He stayed in the hospital in Orlando for five days and saw a cardiologist once he got back to Pittsburgh. He was told that his ejection fraction — a measure of how much blood the heart is pumping — was around 20%, far below the standard of 50% or higher.
While his symptoms improved somewhat from medication, he developed an irregular heartbeat just months later. Doctors recommended a cardiac ablation, which would attempt to reroute electricity in the heart to fix the irregularities.
At the time of the ablation procedure, they offered Franczak an additional option: a clinical trial was just starting up for an implantable device that combines a defibrillator and a heart modulation device.
An implantable defibrillator keeps track of the heartbeat and, if needed, delivers an electric shock to restore the heart to its proper rhythm. The heart modulation device, using a therapy called cardiac contractility modulation (CCM), produces electrical impulses to help stimulate the heart.
Bothtreatments have a track record individually but hadn’t previously beencombined into one device.
The first patient received the device, called the OPTIMIZER Integra CCM-D System, at the Cleveland Clinic in May, one of up to 75 sites nationwide expected to participate in the trial that will eventually include 300 patients. In July, Franczak became the 17th patient nationwide when he received his device at Allegheny General Hospital on the North Side.
AGH has now implanted 11 patients with the device, the most of any site participating in the clinical trial.
For Franczak, the results were immediate.
“I felt better as soon as it was
done,” he said. “I wasn’t as tired anymore. The week after I had it, I’m rebuilding this old car. My son bought a house and I’m helping him install a kitchen. I’m doing all sorts of things that I haven’t done in a long, long time.”
While a defibrillator alone won’t make a patient feel better, the CCM therapy “juices the heart” to improve its function, said George Shaw, the cardiac electrophysiologist at AHN who implanted Franczak’s device. “It will oftentimes dramatically and significantly improve their quality of life,” he said. “That’s what’s so exciting about it.”
When Franczak went back for a checkup this fall, his ejection fraction was up to 35%. He hopes that it will continue to improve due to the CCM therapy.
While similar results could likely be achieved by implanting the two devices
separately, Shaw noted benefits to combining them into one device. The battery life on the Integra CCM-D System is supposed to be 20 years, versus 10 years on traditional standalone pacemakers, which have been implanted to help regulate heart function for decades. Over a lifetime, that means fewerbattery changes.
“Every time you touch a device, there’s a meaningful risk of infection,” he said. “Just by doing fewer procedures over a person’s lifetime, there would be lower risk long term.”
AHN is still looking for patients to enroll in the trial, he said.
As for Franczak, Disney World was so accommodating about his vacation ruined by heart failure that it gave the family a gift basket and new park passes.
With his heart function improved, Franczak, his wife, three children and two granddaughtersare about to completethe vacation.
“We’re taking Disney up on it,” he said. “We’re going back for New Year’s.”