Newswise — Surgeons at University Hospitals Cleveland Medical Center have improved the prognosis of several cardiac patients after emergency FDA approval of a diaphragm pacing device. An abstract detailing these findings will be presented at the 17th Annual Society of Thoracic Surgeons Annual Perioperative and Critical Care Conference.
In April, Synapse Biomedical, a spin out company from University Hospitals (UH) Cleveland Medical Center and Case Western Reserve University (CWRU), received FDA approval for emergency use of its TransAeris® Diaphragmatic Pacing Stimulator System to help wean patients, including those with COVID-19, off of mechanical ventilation (MV). Diaphragm pacing has the potential to free up ventilators because patients can be moved off of ventilators more quickly and easily with the help of this diaphragm pacing system.
The TransAeris® Diaphragmatic Pacing (DP) functions with temporary small electrodes implanted either at the time of surgery, or by an additional minimally invasive procedure, to stimulate the diaphragm (the breathing muscle). DP was initially developed for patients with spinal cord injuries, but has proven effective in helping patients to be weaned off the ventilator while they are recovering from cardiac surgery in the intensive care unit. UH was the first site in the United States to use this innovative procedure for cardiac surgery patients.
“The ability to decrease the need for mechanical ventilation frees up more ventilator units,” said Raymond Onders, MD, Chief of General and Gastrointestinal Surgery and the Remen Chair in Surgical Innovation at UH and Professor of Surgery at CWRU. “Not only is this technology more efficient in weaning from the ventilator but it also decreases the complications from the ventilator. During the COVID-19 pandemic, we know it is important for all patients to reduce the amount of time they are on ventilators and this technology can potentially help.”
The team identified patients for implantation with DP who had unilateral diaphragm dysfunction and were to be placed on a ventilator. These patients all underwent extensive cardiac surgery, and ranged in age from 24 to 72 years old. The patients were extubated in 6.7 hours on average, which is a short period of time given their operation and other medical conditions. No patients were re-intubated or developed any respiratory complications. All patients were discharged within nine days of surgery.
These findings are critical because prolonged ventilation and intubation after cardiac surgery is a complication which can lead to other problems. In this small series, Diaphragm Pacing positively affected diaphragm function and ventilation. Continued experience with DP can help enhance the recovery and weaning from a ventilator after cardiac surgery.
“Diaphragm pacing has allowed us to get some very sick patients off of the ventilator in surprisingly easy fashion. This has the potential to be tremendously helpful for many patients,” said Marc Pelletier, MD, Chief of Cardiothoracic Surgery at UH Cleveland Medical Center.
These findings are even more important during this pandemic, since the TransAeris® system could reduce ventilator burden in COVID-19 patients by a significant amount. This could lead to more ventilators being available in a time of great demand, creating a better environment for other patients in need.
About University Hospitals
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 50 health centers and outpatient facilities, and 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship academic medical center, University Hospitals Cleveland Medical Center, located in Cleveland’s University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; University Hospitals MacDonald Women's Hospital, Ohio's only hospital for women; University Hospitals Harrington Heart & Vascular Institute, a high-volume national referral center for complex cardiovascular procedures; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals – part of The Harrington Project for Discovery & Development. UH is one of the largest employers in Northeast Ohio with 28,000 physicians and employees.
Advancing the Science of Health and the Art of Compassion is UH’s vision for benefitting its patients into the future, and the organization’s unwavering mission is To Heal. To Teach. To Discover. Follow UH on LinkedIn, Facebook @UniversityHospitals and Twitter @UHhospitals. For more information, visit UHhospitals.org.
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17th Annual Society of Thoracic Surgeons Annual Perioperative and Critical Care Conference