AHN Physicians Become First in Western Pennsylvania to Implant Central Sleep Apnea Device

AHN Sleep Medicine Division Partners with Network’s Cardiovascular Institute to Introduce Groundbreaking Technology for Heart Failure Patients Diagnosed with CSA

Key Takeaways:

• Allegheny Health Network is the first health system in western Pennsylvania to offer remedē® — a pacemaker-like device that treats central sleep apnea (CSA).
• Remedē is implanted under the skin in the upper chest and stimulates the phrenic nerve to regulate breathing, improving sleep quality and reducing daytime sleepiness.
• CSA is most often seen in patients diagnosed with progressive heart failure.
• Clinical studies have shown that remedē is effective in reducing sleep apnea events and improving quality of life in patients with moderate to severe CSA.
• Remedē can also reduce the need for external CPAP devices and masks during sleep.

PITTSBURGH — Allegheny Health Network (AHN) announced today it is the first health system in western Pennsylvania to implant remedē, a pacemaker-like device that works to restore restful sleep for adult patients living with central sleep apnea (CSA).

This groundbreaking therapy was made possible through a collaborative effort between the AHN Sleep Medicine Center and the AHN Cardiovascular Institute. The remedē device, which stimulates normal breathing rhythms with small electrical currents to the diaphragm, can also 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.

“Unlike obstructive sleep apnea (OSA), 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.”

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 is often 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.

The remedē device is implanted by a cardiac electrophysiologist 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 airward 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.

In a study published by cardiologists and clinical researchers in the Journal of Cardiology (doi: 10.1016/j.amjcard.2018.02.022), phrenic nerve stimulation was shown to be beneficial for 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 co-existing 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.

Patients with CSA are often prescribed a CPAP device which includes an external mask that’s often uncomfortable and not well tolerated by patients. As a result, it’s not worn consistently over time. 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. The device is covered by most major insurance carriers.

To make an appointment or learn more about AHN, visit ahn.org. To learn more about the CSA device and/or to see if you may qualify, please call 412-442-2522.

Link to download animation: https://remede.zoll.com/wp-content/uploads/Remede-PatientAnimation.mp4

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