Evidence map›Paper›PMID 30311437›Full record

Trial reportESC heart failure2019

Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction.

David M Kaye, Mark C Petrie, Scott McKenzie, Gerd Hasenfuβ, Filip Malek, Martijn Post, Robert N Doughty, Jean-Noël Trochu, Finn Gustafsson, Irene Lang and 13 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESC heart failure, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01913613 (REDUCE LAP-HF TRIAL), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
7.1field-weighted citation impact, top 2% 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.

NCT01913613 nacompletednot on this map

REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

TypeinterventionalSponsorCorvia MedicalRan2013 to 2018Enrolled64ConditionsHeart FailureArmsIASD
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Atrial Shunting for Heart Failure.Structural heart : the journal of the Heart Team · 2025
    Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Update on Atrial Shunt Therapy for Treatment of Heart Failure.Structural heart : the journal of the Heart Team · 2022
    Review
  14. Review
  15. Review
  16. Review
  17. Short- and long-term haemodynamic consequences of transcatheter closure of atrial septal defect and patent foramen ovale.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2021
    Article
  18. Review
  19. Review
  20. 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

23 authors at 20 institutions in 15 countries.

David M KayeDepartment of Cardiology, Alfred Hospital, Commercial Rd, Melbourne, Victoria, 3004, Australia.
Mark C PetrieUniversity of Glasgow, Glasgow, UK.
Scott McKenzieDepartment of Cardiology, Prince Charles Hospital, Brisbane, Australia.
Gerd HasenfuβGeorg-August-Universität Göttingen, Göttingen, Germany.
Filip MalekNa Homolce Hospital, Prague, Czech Republic.
Martijn PostSt Antonius Ziekenhuis Nieuwegein, Nieuwegein, The Netherlands.
Robert N DoughtyUniversity of Auckland, Auckland, New Zealand.
Jean-Noël TrochuCHU de Nantes, Nantes, France.
Finn GustafssonDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Irene LangAllgemeines Krankenhaus Universitätskliniken, Vienna, Austria.
Adam KolodziejFourth Military Hospital, Wrocław, Poland.
Ralf WestenfeldUniversitätklinikum Düsseldorf, Düsseldorf, Germany.
Martin PenickaCardiovascular Center Aalst, Aalst, Belgium.
Mark RosenbergUniversity Medical Center Schleswig-Holstein, Kiel, Germany.
Jörg HausleiterKlinikum Großhadern, Munich, Germany.
Philip RaakeDepartment of Internal Medicine, University of Heidelberg, Heidelberg, Germany.
Guillaume JondeauBichat AP-HP Hospital, INSERM, Paris, France.
Martin W BergmannCardiologicum Hamburg, Hamburg, Germany.
Tim SpelmanSynergus AB, Stockholm, Sweden.
Huseyin AytugSynergus AB, Stockholm, Sweden.
Piotr PonikowskiWrocław Medical University, Wrocław, Poland.
Chris HaywardDepartment of Cardiology, St Vincent's Hospital, Sydney, Australia.
REDUCE LAP-HF study investigators
Synergetics (Belgium) · BEAssistance Publique – Hôpitaux de Paris · FRBarmherzige Schwestern Krankenhaus Wien · ATCentre Hospitalier Universitaire de Nantes · FRDüsseldorf University Hospital · DEFlanders Environment Agency · BEHeidelberg University · DEMilitary Hospital · PKMünchen Klinik · DENa Homolce Hospital · CZPrince Charles Hospital · AURigshospitalet · DKSt. Antonius Ziekenhuis · NLSt Vincent’s Private Hospital Sydney · AUThe Alfred Hospital · AUUniversity Hospital Schleswig-Holstein · DEUniversity Medical Center · USUniversity of Auckland · NZUniversity of Glasgow · GBUniversity of Göttingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsImpaired left ventricular diastolic function leading to elevated left atrial pressures, particularly during exertion, is a key driver of symptoms and outcomes in heart failure with preserved ejection fraction (HFpEF). Insertion of an interatrial shunt device (IASD) to reduce left atrial pressure in HFpEF has been shown to be associated with short-term haemodynamic and symptomatic benefit. We aimed to investigate the potential effects of IASD placement on HFpEF survival and heart failure hospitalization (HFH). METHODS AND

resultsHeart failure with preserved ejection fraction patients participating in the Reduce Elevated Left Atrial Pressure in Patients with Heart Failure study (Corvia Medical) of an IASD were followed for a median duration of 739 days. The theoretical impact of IASD implantation on HFpEF mortality was investigated by comparing the observed survival of the study cohort with the survival predicted from baseline data using the Meta-analysis Global Group in Chronic Heart Failure heart failure risk survival score. Baseline and post-IASD implant parameters associated with HFH were also investigated. Based upon the individual baseline demographic and cardiovascular profile of the study cohort, the Meta-analysis Global Group in Chronic Heart Failure score-predicted mortality was 10.2/100 pt years. The observed mortality rate of the IASD-treated cohort was 3.4/100 pt years, representing a 33% lower rate (P = 0.02). By Kaplan-Meier analysis, the observed survival in IASD patients was greater than predicted (P = 0.014). Baseline parameters were not predictive of future HFH events; however, poorer exercise tolerance and a higher workload-corrected exercise pulmonary capillary wedge pressure at the 6 months post-IASD study were associated with HFH.

conclusionsThe current study suggests IASD implantation may be associated with a reduction in mortality in HFpEF. Large-scale ongoing randomized studies are required to confirm the potential benefit of this therapy.

Indexed as

Prostheses and ImplantsAgedAtrial PressureAustraliaCardiac CatheterizationEuropeFemaleFollow-Up StudiesHeart AtriaHeart FailureHospitalizationHumansMaleNew ZealandProspective StudiesStroke VolumeHeart failureHFpEFInteratrial shuntMedical deviceSurvival

Identifiers

PMID30311437
PMCPMC6351895
OpenAlexW2895990520

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.