Focus of the Report: The focus of this Health Technology Assessment is the use of phrenic nerve stimulation (PNS) with the remedē System for the treatment of central sleep apnea (CSA).

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 remedē 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 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?

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