Gloria Keyes is a walking, talking advertisement for the Impulse Dynamics, Inc., Optimizer® Smart System.
“I think the Optimizer is an awesome tool for people with a weak heart muscle, people with congestive heart failure,” said the 64-year-old Milwaukee native. “I’ve had friends with the same condition who are already gone, because all they had was a defibrillator, not the Optimizer.”
She’ll tell anyone with congestive heart failure (CHF) who is willing to listen that they should get the device.
And now they can. Thanks in part to her participation in the initial Optimizer clinical trial at Aurora St. Luke’s Medical Center in Milwaukee, the U.S. Food and Drug Administration in March 2019 approved the device for the treatment of heart failure.
Advocate Aurora Research Institute enrolled 18 participants in the Optimizer study under site principal investigator and electrophysiologist Imran Niazi, MD. And, in December 2020, Dr. Niazi implanted the health system’s first commercial Optimizer device.
An eager participant
Congestive heart failure is an incurable disease in which the heart does not pump blood throughout the body as well as it should, causing shortness of breath, dizziness, fainting and even death. More than 450,000 new cases are diagnosed in the U.S. each year, adding to the more than 2.8 million people already living with the condition.
Keyes had suffered from CHF since 2000. After eventually winding up in the hospital following a stroke in 2006, she was referred to Dr. Niazi.
“He told me I needed some help, that I was really sick,” Keyes said.
When initial treatment didn’t resolve the issue and her symptoms returned, Dr. Niazi and Rebecca Stebnitz, RN, research nurse coordinator, approached Keyes about participating in a clinical trial for an investigational treatment for CHF. It was Keyes’s first time learning about clinical research, but she didn’t hesitate.
“I was ready to sign up,” she said. “I just wanted to feel better. I was still young.”
Strengthening the heart muscle
The clinical trial was designed to evaluate whether the Optimizer system was safe and effective in treating the symptoms of CHF.
“Not all congestive heart failure is a result of an arrythmia, for which cardiac resynchronization therapy using a pacemaker or defibrillator would be appropriate,” Dr. Niazi said. “For these patients, medications can sometimes lessen symptoms by making it easier for the heart to pump or supplying more oxygen to the heart. But there remained an unmet need for patients who remained symptomatic despite therapy with medication.”
Optimizer was developed to improve heart strength by stimulating the heart muscle with an electrical signal, called cardiac contractility modulation (CCM) treatment.
“Whereas a pacemaker or defibrillator modulates the rhythm of the heart, CCM works by modulating the strength of the heart,” said senior clinical trial coordinator Phyllis Runningen, BSN, who worked with Keyes during part of her study follow-up.
The device is about the size of a deck of playing cards and is surgically implanted through a small incision in the upper chest. Insulated wires, or leads, connect the device to the patient’s heart, recording electrical signals generated by the heart and delivering the CCM treatment.
“The way I explain it is my heart beats first on its own,” Keyes said. “Then the Optimizer sends an electrical shock, and this time my heart pumps harder.”
After receiving the device as part of the clinical trial in 2006, Keyes began to immediately feel better, her life going “back to normal.” Her last study followup was in 2019 when Runningen told her that the device had been approved for use outside of clinical trials.
“I thought that was fantastic,” said Keyes, who, with her husband, Billy, has six kids and 12 grandkids. “So many people need to enjoy life like I have. It was a good feeling knowing I was one of the people who helped get it approved. “I thank God I’m here to see my youngest granddaughter. My son didn’t have any children yet at the time I began the clinical trial. I thank God for getting me here. And I thank the Optimizer for helping.”
To learn more about Advocate Aurora’s research, visit aah.org/research.