AHN implants innovative device to manage central sleep apnea in heart failure patients

George Shaw, MD
Credit: Allegheny Health Network

Teams from the AHN Sleep Medicine Center and the AHN Cardiovascular Institute implanted remedē®, a pacemaker-like device that works to restore restful sleep for adult patients living with CSA. It stimulates normal breathing rhythms with small electrical currents to the diaphragm and can mitigate the need for continuous positive airway pressure (CPAP) systems and the masks that come with them.

George Shaw, MD, cardiac electrophysiologist, and Daniel Shade, MD, pulmonologist, sleep medicine specialist, and director of the AHN Sleep Disorders Center, oversaw the first implant at Pittsburgh’s Allegheny General Hospital (AGH) in December 2023. They were the first in western Pennsylvania to perform the procedure.

“Unlike obstructive sleep apnea, which is caused by airflow blockage in the upper airway, central sleep apnea occurs when the brain fails to send signals to the diaphragm, disrupting regular breathing. This can manifest as deep and rapid breathing, or slow and shallow breathing,” Dr. Shade said. “In severe cases, breathing may stop for up to 90 seconds, triggering the body’s fight-or-flight response, which then affects the cardiovascular system.”

Promising for heart failure patients

CSA disrupts normal breathing resulting in nighttime wakefulness and increased activation of the body’s sympathetic nervous system, which can lead to increased stress on the heart and impaired function of the cardiovascular system. As a result, CSA may contribute to the progression of cardiovascular disorders, and it is frequently seen in patients diagnosed with heart failure.

“The effects of central sleep apnea and heart failure are connected and require a multidisciplinary approach to improve outcomes and the quality of life for these patients,” Dr. Shaw said. “In fact, central sleep apnea occurs in roughly one out of every three patients diagnosed with heart failure and has shown to be an independent predictor of mortality within this patient population.”

For the approximately 75% of patients who have heart failure and/or atrial fibrillation, CSA events significantly worsen their cardiovascular disease and contribute to a downward cycle of heart failure, leading to higher mortality and hospitalization rates.

Small procedure, big results

A cardiac electrophysiologist implants the remedē device during a minimally invasive outpatient procedure. This battery-powered system, positioned under the skin in the upper chest area, employs a thin lead to sense breathing patterns and administer stimulation therapy.

During sleep, the remedē system stimulates a nerve in the chest called the phrenic nerve that in turn sends signals to the diaphragm, the large muscle that controls breathing. Unlike devices used for OSA, which focus on opening obstructed airways, the remedē device targets the regulation of breathing in CSA patients.

Similar pacemaker-like devices on the market instead stimulate a nerve at the base of the tongue to open the upper airway for OSA. In CSA, patient airways are already open, but the diaphragm must be stimulated to regulate breathing.

“This groundbreaking system has been clinically proven to improve a patient's quality of life, reduce daytime sleepiness, and minimize the overall number of disrupted breathing events,” said Dr. Shade.

A study published by cardiologists and clinical researchers in the Journal of Cardiology (doi: 10.1016/j.amjcard.2018.02.022) showed that phrenic nerve stimulation was beneficial to those diagnosed with CSA.

Over 12 months, researchers evaluated 151 patients with moderate to severe CSA as part of a randomized, controlled trial. All participants received a remedē implant, with only half of the devices activated for treatment within the first six months. Within the treatment cohort, 88% of patients had a reduction in the number of sleep apnea events and 78% of patients reported an overall improvement in the quality of life, as well as a significant reduction in daytime sleepiness.

“Diagnosing CSA in heart failure patients is challenging due to subtle symptoms that overlap with coexisting conditions like fatigue. Collaboration with sleep medicine physicians enables efficient identification of potential candidates for sleep studies, helping to determine the primary causes of sleep disturbances and guiding tailored therapeutic approaches,” Dr. Shaw concluded.

Physicians often prescribe a CPAP device to patients. But patients often find the external mask uncomfortable, so they don’t consistently wear it. The remedē system can help to eliminate the need for CPAP therapy.

Remedē, from ZOLL® Respicardia, first received FDA approval in 2017 for adults with moderate to severe CSA. Most major insurance carriers cover the device.

To learn more about the CSA device and see if your patient qualifies, call 412-442-2522.