ArticleSleep2019
Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea.
Article in Sleep, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01816776 (A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea), which is not on this map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea
Who cites it
24 citing papers in PubMed, 59 citations in OpenAlex.
- Classifying hypopneas as obstructive or central can enhance transvenous phrenic nerve stimulation therapy patient selection and outcomes.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025Trial
- Nocturnal Oxygen Therapy for Central Sleep Apnea in Patients with Heart Failure: A Multisite, Double-Blind, Sham-controlled Randomized Clinical Trial (LOFT-HF).Annals of the American Thoracic Society · 2025Trial
- Trial
- Improving Nocturnal Hypoxemic Burden with Transvenous Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea.Journal of cardiovascular translational research · 2021Trial
- Reply to "Usage is not efficacy in transvenous phrenic nerve stimulation for central sleep apnea".Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026Article
- Intermittent phrenic afferent activation induces phrenic motor plasticity.Journal of neurophysiology · 2026Article
- Article
- [Central sleep apnea: cessation of central respiration control while we sleep : Suggestions for daily practice in diagnosis and therapy].Innere Medizin (Heidelberg, Germany) · 2025Article
- Improving Obstructive Sleep Apnoea Mitigates Dampened Heart Rate Responses to Respiratory Events in Children With Down Syndrome.Journal of sleep research · 2025Article
- Recent Insights into the Relationship Between Sleep Disordered Breathing and Cardiovascular Disease.Yonago acta medica · 2025Review
- Review
- Revisiting Transvenous Phrenic Nerve Stimulation in Central Sleep Apnoea and Heart Failure: Emerging Innovations in Clinical Trials Analysis.Cardiac failure review · 2025Review
- Research trends and hotspots of central sleep apnea: a bibliometric analysis.Frontiers in neurology · 2025Review
- Phrenic nerve stimulation for treatment of central sleep apnea.Frontiers in sleep · 2023Review
- Impact of Sleep-Disordered Breathing Treatment on Ventricular Tachycardia in Patients with Heart Failure.Journal of clinical medicine · 2022Article
- Effects of Sacubitril-Valsartan on Clinical, Echocardiographic, and Polygraphic Parameters in Patients Affected by Heart Failure With Reduced Ejection Fraction and Sleep Apnea.Frontiers in cardiovascular medicine · 2022Article
- Extra-cardiac targets in the management of cardiometabolic disease: Device-based therapies.ESC heart failure · 2021Review
- Research Priorities for Patients with Heart Failure and Central Sleep Apnea. An Official American Thoracic Society Research Statement.American journal of respiratory and critical care medicine · 2021Article
- Phrenic Nerve Stimulation Improves Physical Performance and Hypoxemia in Heart Failure Patients with Central Sleep Apnea.Journal of clinical medicine · 2021Article
- Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes.Nature and science of sleep · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectiveTo 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.
methodsPatients 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.
resultsPatients were assessed at 24 (n = 109) and 36 (n = 60) months. Baseline characteristics included mean age 64 years, 91% male, and mean apnea-hypopnea index 47 events per hour. Sleep metrics (apnea-hypopnea index (AHI), central apnea index, arousal index, oxygen desaturation index, rapid eye movement sleep) remained improved through 24 and 36 months with continuous use of PNS therapy. At least 60% of patients in the treatment group achieved at least 50% reduction in AHI through 24 months. Serious adverse events (SAEs) related to the remedē System implant procedure, device, or therapy through 24 months were reported by 10% of patients, no unanticipated adverse device effects or deaths, and all events resolved. No additional related SAEs were reported between 24 and 36 months.
conclusionThese data suggest beneficial effects of long-term PNS in patients with CSA appear to sustain through 36 months with no new safety concerns.
trial registrationNCT01816776.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.