Health Technology Brief

supporting sound, evidence-based decision making

Phrenic Nerve Stimulation (remed? System) for Central Sleep Apnea

June 12, 2018

Health Problem: Central sleep apnea (CSA) is a group of syndromes that are characterized by sleep-disordered breathing associated with diminished or absent respiratory effort. Conditions associated with CSA include: problems that affect the brainstem, including brain infection, stroke, or conditions of the cervical spine; severe obesity; certain medicines, such as narcotic painkillers; and heart failure. Symptoms associated with CSA may include chronic fatigue, excessive daytime sleepiness, frequent nocturnal awakenings, morning headaches, and restless sleep.

Technology Description: Phrenic nerve stimulation (PNS), also known as diaphragm pacing, is the electrical stimulation of the phrenic nerve using a surgically implanted device. This device contracts the diaphragm rhythmically, improving breathing function in patients with respiratory insufficiency. The remed? System (Respicardia Inc.) is a fully implanted neurostimulator intended for treatment of moderate-to-severe CSA in adults.

Controversy: Positive airway pressure (PAP) therapies for CSA have raised concern in light of recent findings of large randomized controlled trials that suggest suboptimal adherence and increased risk of cardiovascular death among patients with CSA and heart failure. However, some investigators have raised concerns that PNS may have similar negative effects on patients with underlying heart conditions as PAP therapies.

Key Questions:

  • Is PNS effective in treating adults with CSA?
  • How does PNS compare with other treatments for CSA?
  • Is PNS safe in patients with CSA?
  • Have definitive patient selection criteria been identified for PNS in patients with CSA?