Evidence map›Paper›PMID 30303611›Full record

Trial reportEuropean journal of heart failure2018

Phrenic nerve stimulation to treat patients with central sleep apnoea and heart failure.

Maria Rosa Costanzo, Piotr Ponikowski, Andrew Coats, Shahrokh Javaheri, Ralph Augostini, Lee R Goldberg, Richard Holcomb, Andrew Kao, Rami N Khayat, Olaf Oldenburg and 4 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of heart failure, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 3% of its field
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

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Pacing therapies for sleep apnea and cardiovascular outcomes: A systematic review.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Pooled it
  2. Highlights in heart failure.ESC heart failure · 2019
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Review
  9. When LOFTy Ideals Meet Clinical Trial Reality.Annals of the American Thoracic Society · 2025
    Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Treating central sleep apnoea in heart failure: is positive airway pressure and adaptive servo-ventilation in particular the gold standard?European respiratory review : an official journal of the European Respiratory Society · 2024
    Article
  16. Beyond Medical Therapy-An Update on Heart Failure Devices.Journal of cardiovascular development and disease · 2024
    Review
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 6 countries.

Maria Rosa CostanzoAdvocate Heart Institute, Naperville, IL, USA.
Piotr PonikowskiMedical University, Military Hospital, Wroclaw, Poland.
Andrew CoatsUniversity of Warwick, Coventry, UK.
Shahrokh JavaheriBethesda North Hospital, Cincinnati, OH, USA.
Ralph AugostiniThe Ohio State University, Columbus, OH, USA.
Lee R GoldbergUniversity of Pennsylvania, Philadelphia, PA, USA.
Richard HolcombIndependent Biostatistician, Minneapolis, MN, USA.
Andrew KaoMid America Heart Institute, Kansas City, MO, USA.
Rami N KhayatThe Ohio State University, Columbus, OH, USA.
Olaf OldenburgBad Oeynhausen Heart and Diabetes Center, Bad Oeynhausen, Germany.
Christoph StellbrinkBielefeld Medical Center, Bielefeld, Germany.
Scott McKaneRespicardia, Inc., Minnetonka, MN, USA.
William T AbrahamThe Ohio State University, Columbus, OH, USA.
remedē® System Pivotal Trial Study Group
The Ohio State University · USAdvocate Heart Institute · USBethesda North Hospital · USHennepin County Library · USKlinik Bad Oexen · DEKlinikum Bielefeld · DEMidwest Orthopaedic Research Foundation · USMRIGlobal · USUniversity of Pennsylvania · USUniversity of Warwick · GBWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe presence of central sleep apnoea (CSA) is associated with poor prognosis in patients with heart failure (HF). The aim of this analysis was to evaluate if using phrenic nerve stimulation to treat CSA in patients with CSA and HF was associated with changes in HF-specific metrics. METHODS AND

resultsAll patients randomized in the remedē System Pivotal Trial and identified at baseline with HF were included (n = 96). Effectiveness data from treatment and former control groups were pooled based on months since therapy activation. Changes from baseline to 6 and 12 months in sleep metrics, Epworth Sleepiness Scale, patient global assessment health-related quality of life, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and echocardiographic parameters are reported. HF hospitalization, cardiovascular death, and the composite of HF hospitalization or cardiovascular death within 6 months are reported by the original randomized group assignment for safety assessment. Sleep metrics and quality of life improved from baseline to 6 and 12 months. At 12 months, MLHFQ scores changed by -6.8 ± 20.0 (P = 0.005). The 6-month rate of HF hospitalization was 4.7% in treatment patients (standard error = 3.3) and 17.0% in control patients (standard error = 5.5) (P = 0.065). Reported adverse events were as expected for a transvenous implantable system.

conclusionsPhrenic nerve stimulation reduces CSA severity in patients with HF. In parallel, this CSA treatment was associated with benefits on HF quality of life.

Indexed as

Quality of LifeAgedElectric Stimulation TherapyFemaleFollow-Up StudiesHeart FailureHumansMalePhrenic NervePolysomnographyProspective StudiesSleep Apnea, CentralTreatment OutcomeCentral sleep apnoeaHeart failurePhrenic nerve stimulation

Identifiers

PMID30303611
PMCPMC6607512
OpenAlexW2897221947

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.