Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea.

ABSTRACT:

Study objective

To evaluate long-term efficacy and safety of phrenic nerve stimulation (PNS) in patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy.

Methods

Patients in the remedē System Pivotal Trial were observed every 3 months after implant until US Food and Drug Administration approval. At the time of approval and study closure, all patients completed 24 months of follow-up; 33 patients had not reached the 36-month visit. Sleep metrics (polysomnography) and echocardiographic parameters are reported at baseline, 12, 18, and 24 months, in addition to available 36-month sleep results from polygraphy. Safety was assessed through 36 months; however, analysis focused through 24 months and available 36-month results are provided.

Results

SUBMITTER: Fox H 

PROVIDER: S-EPMC6802564 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature