Ohio State doctors performed the first implant of a device used to combat sleep apnea in the United States on Jan. 21.
The device, known as the RespiCardia System, is used to treat central sleep apnea, a sleep disorder that limits a person’s breathing while he or she is asleep.
Dr. Ralph Augostini, an electrophysiologist, led the procedure at OSU’s Ross Heart Hospital. It was the fourth implant worldwide.
Current treatment of central sleep apnea is limited to a tightly fitting mask that blows air into the lungs to keep the patient breathing. Dr. William Abraham, professor of internal medicine and director of cardiovascular medicine at OSU, said many patients just can’t tolerate the mask.
“The potential (for the RespiCardia System) is that it is implantable, automatic and doesn’t require any work for the patient,” Abraham said. “If proven effective, we want to demonstrate that this device can adequately treat central sleep apnea, and if we can, there will be a lot of appeal for the device.”
Central sleep apnea is a major problem in people with heart disease and people who have suffered a brain injury, Abraham said.
“There are six million Americans with heart failure; about 80 percent of those people have sleep apnea and about 60 percent of those people have central sleep apnea,” Abraham said. “So obviously a lot could benefit from this therapy if it proves to be effective.”
The RespiCardia System is a product of the Minnesota-based company Cardiac Concepts.
“Our goal is primarily to bring a new therapy to meet an unmet clinical need,” said Bonnie Labosky, president and CEO of Cardiac Concepts. “There’s currently no effective or acceptable therapy, so we recognized this need and we’d like to address it.”
Cardiac Concepts was formed about four years ago, Labosky said. The idea for the RespiCardia System was approved for clinical studies and OSU was the first to fulfill all the requirements necessary to begin the studies.
“We’ve had a good working relationship with Ohio State over the past four years that started with Dr. Abraham,” Labosky said.
Abraham said the success of this procedure is a major step for the OSU Medical Center.
“We are attempting, in our heart program, to be national leaders in development of new drugs and procedures to treat heart disease,” Abraham said. “This helps establish the Ohio State Medical Center as an international leader in treating heart disease.”
Labosky said she gives OSU “great kudos” for its work in the medical center and its involvement with Cardiac Concepts.
Abraham has worked with Cardiac Concepts over the last four years, conducting studies on heart disease and its connection with sleep apnea. Dr. Rami Khayat, associate professor of clinical, pulmonary and critical care at OSU, has also been an adviser with Cardiac Concepts and the RespiCardia System.
“We were a part of the technology from the beginning,” Khayat said. “Once it’s shown effective, it’s very promising for eliminating apnea with an implantable device that is very convenient and less cumbersome for the patient.”
The device delivers small electrical pulses to the phrenic nerve, which is connected to the diaphragm, a large breathing muscle, said a press release from Doug Flowers, director of the Medical Center Public Affairs and Media Relations. The diaphragm responds to the pulses resulting in a more natural breathing pattern.
The RespiCardia system earned a CE marking in Europe, allowing the product to be sold, and Labosky said the company would start marketing the system early next year.
The device, however, is still investigational in the U.S.
“It’s a long pathway to get a medical device approved in the United States,” Labosky said. “Here we have to go through the rigors of getting an FDA approval.”
Labosky said the implant’s impact on the future of treating sleep apnea is huge.
“It could have a huge positive effect on patients suffering from the disease,” Labosky said. “Patients will get a great night’s sleep and it can change their whole quality of life because it has the potential to improve their cardiovascular health and can improve heart failure.”