Dr. Tapan Padhya (right) Implanting Inspire device
The first use of the implant device reflects the academic health system’s commitment to an integrated, multidisciplinary approach to care that addresses the varied and unique needs of pediatric patients.
December 6, 2023 – Tampa General Hospital (TGH) has achieved a significant milestone for its comprehensive and nationally recognized TGH Ear, Nose & Throat (ENT) Institute, and the successful completion of an Inspire® implant surgery on a pediatric patient diagnosed with Down syndrome and sleep apnea. The groundbreaking procedure is the first of its kind in Florida.
The surgery was performed by University of South Florida (USF) Health otolaryngologist Dr. Abhay Sharma, assistant professor and director of the Division of Interventional Sleep Surgery at the USF Health Morsani College of Medicine. He was assisted by Dr. Tapan Padhya, chief of the TGH ENT Institute; professor, chair, and chief of the Division of Head and Neck Oncology; professor and chair of the Department of Otolaryngology-Head & Neck Surgery, USF Health Morsani College of Medicine; and founder and co-director of the USF Health ENT Sleep and Snoring Center. Both are full-time academic faculty members in the Department of Otolaryngology-Head & Neck Surgery, USF Health Morsani College of Medicine.
TGH ENT Institute will accept referrals from Florida’s East Coast for pediatric patients with Down syndrome between the ages of 12 and 18. TGH recently expanded into Florida’s East Coast to create a framework of state-of-the-art services that connect patients in the Palm Beach County and Treasure Coast areas. Patients who undergo surgery at Tampa General Hospital will receive postoperative care at home with our network of local experts and health care services in Palm Beach and Martin counties.
“More than half of children with the genetic disorder Down syndrome have sleep apnea,” Padhya said. “This implantable device marks a substantial improvement in obstructive sleep apnea care for preteens and teenagers with Down syndrome, and provides greater peace of mind for their parents.”
“The Inspire implant surgery is minimally invasive and the recovery time for the patient is minimal,” Sharma said. “Before this procedure, traditional treatments for Down syndrome patients with obstructive sleep apnea could include major facial surgery to separate and move patients’ upper and lower jaws. The implantable device offers a gentler treatment for these young patients.”
The Inspire device is the only implant that the U.S. Food and Drug Administration (FDA) has approved to treat sleep apnea, and it is one of the few alternatives to using a continuous positive airway pressure (CPAP) machine. The implant is similar to a cardiac pacemaker and is placed under the collarbone during the two- to three-hour surgery. After that, it is operated via a remote control. Electric connectors beneath the skin deliver a small electrical stimulus to the base of the tongue when a patient takes a breath, gently pushing the tongue out to aid airflow. The open airway eliminates the struggle to breathe that characterizes sleep apnea, and patients can experience more restful sleep. To qualify for the pediatric procedure, patients must have Down syndrome. They must be between 12 and 18 years of age, have moderate to severe sleep apnea, and be intolerant of a CPAP device. While trials have suggested that a weight below the 95th percentile is safest for children undergoing this procedure, there is no specific weight criteria for children as there is for adults.
The recovery time for an Inspire implant surgery is typically minimal. Following the pediatric procedure for a 16-year-old patient at the academic health system, the patient stayed one night at the TGH Children’s Hospital.
“We are proud to have been a part of this innovative milestone for the TGH ENT Institute,” said Melissa Golombek, vice president of the TGH Children’s Hospital and Women’s Institute. “This is another example of Tampa General’s leading-edge approach to treating all types of complex pediatric medical conditions, and is an indicator to the families we serve that our academic health system can provide their children with world-class, advanced care.”
Obstructive sleep apnea is a prevalent condition wherein the upper airway becomes blocked repeatedly during sleep, leading to disrupted airflow due to muscle relaxation around the tongue and throat. This condition affects over 18 million individuals, amplifying the likelihood of heart attack, stroke, high blood pressure, and related complications.
According to the National Institutes of Health, 55% to 97% of people with Down syndrome have obstructive sleep apnea. In addition to facial structure differences, excessive weight in patients with Down syndrome often contributes to sleep apnea. It is difficult for young patients with Down syndrome to lose weight. Most typically these patients can’t tolerate CPAP machines due to discomfort and an inability to understand why the machine is necessary, and how it works. The implantable device makes it easier for caregivers of patients with Down syndrome to support their needs and improve their quality of life.
“As the indications continue to evolve, we will likely see even younger kids who are having severe sleep apnea get this therapy,” Sharma said. “We are optimistic that with the right protocols, this could be a game-changer for pediatric sleep apnea.”
Sharma added that this procedure could also have major implications for pediatric patients with autism spectrum disorder (ASD) and other neurodevelopmental conditions. Pending approvals, Inspire implant surgery could potentially be performed on any child with sleep apnea.Florida’s first pediatric sleep apnea implant surgery is the latest leading-edge achievement for the TGH ENT Institute. U.S. News & World Report’s Best Hospitals list for 2023-2024 ranks Tampa General’s ENT program as No. 2 in Florida and No. 39 in the United States. In 2014, the TGH ENT Institute was the first to perform an Inspire implant procedure in Florida. Since then, more than 250 of these surgeries have been completed at Tampa General.
ABOUT TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 1,040-bed, not-for-profit, academic health system, is one of the largest hospitals in America and delivers world-class care as the region’s only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News and World Report’s 2023-24 Best Hospitals, with six specialties ranking among the top 50 best hospital programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic health system’s commitment to growing and developing its team members is recognized by two prestigious Forbes magazine rankings – in the top 100 nationally in the 2023 America’s Best Employers for Women and top 25 in Florida in the 2023 America’s Best Employers by State. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2021, provided a net community benefit worth more than $224.5 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation’s busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With six medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Jennifer Leigh Muma 82-bed neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital’s footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Outpatient Center, TGH Virtual Health, and 21 TGH Imaging outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics. To see a medical care professional live anytime, anywhere on a smartphone, tablet or computer, visit Virtual Health | Tampa General Hospital (tgh.org). As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that provides real-time situational awareness to improve and better coordinate patient care at a lower cost. For more information, go to www.tgh.org.
ABOUT USF HEALTH
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health’s multispecialty physicians’ group. The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News & World Report’s national university rankings than USF. For more information, visit health.usf.edu.
