Christopher Reeve Receives New Implantable Breathing Device: Cleveland Researchers Develop Device to Replace Ventilator

3/13/2003

From: Eileen Korey of the University Hospitals of Cleveland, 216-844-3825 George Stamatis of the Case Western Reserve University, 216-368-3635

CLEVELAND, March 13 -- Nearly eight years after the accident that left Christopher Reeve paralyzed and dependent on a ventilator, the 50-year old actor and activist has hopes of breathing more normally, with the aid of a surgically implanted investigational device. On Friday, February 28, 2003, Reeve underwent minimally invasive surgery at University Hospitals of Cleveland, where a team led by surgeon Raymond Onders, MD, and program director Anthony DiMarco, MD, implanted the device, developed in partnership with biomedical engineers at Case Western Reserve University.

Working through a small laparoscope in what is essentially an outpatient procedure, surgeons placed electrodes in Reeve's diaphragm muscle. The electrodes are attached through wires under the skin to a small external battery pack that electrically stimulates the muscle and the phrenic nerves, causing the muscle to contract and air to enter the lungs. Diaphragm contraction accounts for most of the ventilation required for normal breathing.

Because the surgical placement of the device is performed in an outpatient setting through minimally invasive techniques, risks and costs of this diaphragm pacing system are significantly less than standard procedures to electrically activate the diaphragm. The standard technique requires surgeons to make large incisions in the chest (thoracotomy) to place electrodes in direct contact with the phrenic nerves. That procedure carries substantially more risk and requires a prolonged hospital stay. The standard procedure typically costs more than $100,000 (device plus surgery, hospitalization and follow-up), whereas the laparoscopic surgery and implantation of the new device could cost less than half that amount.

The development of the investigative diaphragm pacing system is currently being supported by a Food and Drug Administration Orphan Products Development grant to Dr. DiMarco as principal investigator, and a U.S. Surgical Corporation grant to Dr. Onders as principal investigator.

Dr. Onders, a surgeon at University Hospitals of Cleveland specializing in minimally invasive techniques and assistant professor of surgery at CWRU, implanted the first such device in a patient nearly three years ago. The patient, a 36-year-old quadriplegic from Ohio, had a similar injury to Reeve, having damaged the upper part of his spinal cord (C2 level) in a swimming accident. The patient has been successfully breathing without the need for mechanical ventilation for more than two years.

"This device allows patients to breathe and speak more normally, and it increases mobility," explains Dr. DiMarco, professor of medicine and physiology at CWRU. "Patients realize an improved sense of smell." Moreover, in social situations, diaphragm pacing gives the appearance of normal breathing whereas mechanical ventilation has ventilator tubing and constant ventilator noise.

Since the implantation of the first device by Dr. Onders three years ago, biomedical engineers J. Thomas Mortimer, PhD, professor emeritus of biomedical engineering at CWRU, and Anthony R. Ignagni, project director and chief biomedical engineer, have improved the operation of the pacing device. Reeve has continued to keep updated on this research, and expressed interest as a study participant about a year ago.

Reeve became a candidate after a thorough evaluation and determination that his phrenic nerve function is normal, as demonstrated in nerve conduction studies and fluoroscopic examination of diaphragm movement. On February 28, 2003, he underwent a 4 1/2 hour outpatient surgical procedure at University Hospitals of Cleveland to implant the electrodes and lead-wires. "Our initial test in the operating room to activate Reeve's diaphragm yielded impressive results," says Dr. Onders. "As the diaphragm contracted, his lungs filled with air and the volume of air that was exhaled and measured was certainly adequate for us to believe that this device would provide successful breathing support." Reeve returned home the following day.

Reeve returned to Cleveland on March 9 to begin the reconditioning process of strengthening the diaphragm through a series of intermittent stimulations at the National Institutes of Health-funded CWRU General Clinical Research Center at MetroHealth Medical Center. "Each electrode is individually evaluated to determine the degree of diaphragm contraction and resulting inspired volume of air," explains Dr. DiMarco. Since the diaphragm is atrophied from disuse, a period of gradually increasing stimulation is necessary to regain normal strength and endurance. Reeve will continue the conditioning process at home, with the ultimate goal of eliminating the need for the mechanical ventilator.

Of the 10,000 new cases of spinal cord injury each year in the United States, approximately 1,000 patients require mechanical ventilation for some period after injury. Researchers believe that implanting this device shortly after the spinal cord is damaged may enable some to maintain diaphragm muscle strength and prevent atrophy, which develops on mechanical ventilation. Many of these individuals eventually are able to breathe on their own, as the nerves that control breathing recover from the initial injury. Others, like Reeve (perhaps 300 cases each year), would benefit from life-long breathing support as the implanted device itself activates the nerves that inspire breathing.

Said Christopher Reeve, "The constant and high cost of care for ventilator dependent patients not only exhausts most insurance policies but contributes to strain on families and caregivers. Once this procedure receives FDA approval, these patients and their caregivers should be able to achieve significant improvements in their quality of life. Diaphragm pacing unlocks a door to greater independence, one of the most important goals for all people living with disabilities."

The development of the investigational diaphragm pacing system has been a collaborative effort involving numerous physicians and engineers at several institutions in Cleveland, including University Hospitals of Cleveland, Case Western Reserve University, the VA Medical Center, and MetroHealth Medical Center. Drs. Onders and DiMarco currently work closely with Mr. Ignagni and with Dr. Mortimer, who devoted more than 20 years of research to electrically activating the nervous system at the Applied Neural Control Laboratory in the biomedical engineering department at CWRU.

The investigational diaphragm pacing system, portions of which were patented by CWRU, is now being developed by Synapse Biomedical, Ltd, of Cleveland. Funding assistance was provided by the Food and Drug Administration, U.S Surgical Corporation, University Hospitals of Cleveland, the VA, and the National Center for Research Resources of the National Institutes of Health.

More information about this clinical investigation can be found at University Hospitals of Cleveland's website at http://www.uhhs.com. Patients who are interested in becoming candidates for the investigational diaphragm pacing system can also call 216-844-UHHS (8447).