Evidence map›Paper›PMID 31855160›Full record

ArticleJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2019

Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea: A Pooled Cohort Analysis.

Marat Fudim, Andrew R Spector, Maria-Rosa Costanzo, Sean D Pokorney, Robert J Mentz, Dariusz Jagielski, Ralph Augostini, William T Abraham, Piotr P Ponikowski, Scott W McKane and 1 more

Abstract read
In one paragraph

Article in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Article
  2. Review
  3. Insights, recommendations, and research priorities for central sleep apnea: report from an expert panel.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Sleep Apnea and Heart.Sleep medicine research · 2019
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Marat FudimDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Andrew R SpectorDepartment of Neurology, Duke University Medical Center, Durham, North Carolina.
Maria-Rosa CostanzoDivision of Cardiology, Advocate Heart Institute, Naperville, Illinois.
Sean D PokorneyDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Robert J MentzDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Dariusz JagielskiDepartment of Cardiology, Centre for Heart Disease, 4th Military Hospital, Wroclaw, Poland.
Ralph AugostiniDivision of Cardiology, Department of Medicine, The Ohio State University, Columbus, Ohio.
William T AbrahamDivision of Cardiology, Department of Medicine, The Ohio State University, Columbus, Ohio.
Piotr P PonikowskiDepartment of Cardiology, Centre for Heart Disease, 4th Military Hospital, Wroclaw, Poland.
Scott W McKaneRespicardia, Inc., Minnetonka, Minnesota.
Jonathan P PicciniDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesEarly evidence with transvenous phrenic nerve stimulation (PNS) demonstrates improved disease severity and quality of life (QOL) in patients with central sleep apnea (CSA). The goal of this analysis is to evaluate the complete prospective experience with PNS in order to better characterize its efficacy and safety, including in patients with concomitant heart failure (HF).

methodsUsing pooled individual data from the pilot (n = 57) and pivotal (n = 151) studies of the remedē System in patients with predominant moderate to severe CSA, we evaluated 12-month safety and 6- and 12-month effectiveness based on polysomnography data, QOL, and cardiac function.

resultsAmong 208 combined patients (June 2010 to May 2015), a remedē device implant was successful in 197 patients (95%), 50/57 pilot study patients (88%) and 147/151 pivotal trial patients (97%). The pooled cohort included patients with CSA of various etiologies, and 141 (68%) had concomitant HF. PNS reduced apnea-hypopnea index (AHI) at 6 months by a median of -22.6 episodes/h (25th and 75th percentile; -38.6 and -8.4, respectively) (median 58% reduction from baseline, P < .001). Improvement in sleep variables was maintained through 12 months of follow-up. In patients with HF and ejection fraction ≤ 45%, PNS was associated with improvement in systolic function from 27.0% (23.3, 36.0) to 31.1% (24.0, 41.5) at 12 months (P = .003). In the entire cohort, improvement in QOL was concordant with amelioration of sleep measures.

conclusionsTransvenous PNS significantly improves CSA severity, sleep quality, ventricular function, and QOL regardless of HF status. Improvements, which are independent of patient compliance, are sustained at 1 year and are associated with acceptable safety.

Indexed as

AgedCohort StudiesElectric Stimulation TherapyFemaleFollow-Up StudiesHumansMalePhrenic NervePilot ProjectsPolysomnographyProspective StudiesSleep Apnea, CentralTreatment Outcomecentral sleep apneaclinical outcomesheart failurephrenic nerve stimulation

Identifiers

PMID31855160
PMCPMC7099184

What OpenQuestion holds

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Registered trials

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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.