Evidence map›Paper›PMID 19929037›Full record

Trial reportAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2009

Examination of the effect of implantable cardioverter-defibrillators on health-related quality of life: based on results from the Multicenter Automatic Defibrillator Trial-II.

Katia Noyes, Ethan Corona, Peter Veazie, Andrew W Dick, Hongwei Zhao, Arthur J Moss

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

NCT01576042 naterminatednot on this mapstarted 2012, after this paper: background citation

Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (CALYPSO) PILOT TRIAL

TypeinterventionalSponsorDuke UniversityRan2012 to 2014Enrolled27ConditionsVentricular TachycardiaArmsamiodarone, sotalol, Biosense Webster's NAVI-STAR Thermo-Cool
NCT06543173 narecruitingnot on this mapstarted 2026, after this paper: background citation

Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator (PRIMARY PREVENT-VT TRIAL)

TypeinterventionalSponsorUniversity of RochesterRan2026 to 2030Enrolled62ConditionsHeart FailureArmsProphylactic Catheter-based VT Ablation
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Trial
  2. Psychological trauma and health-related quality of life following ventricular tachycardia ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Inappropriate ICD Shocks in Pediatric and Congenital Heart Disease Patients.The Journal of innovations in cardiac rhythm management · 2017
    Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. 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

6 authors.

Katia NoyesDepartments of Community and Preventive Medicine, University of Rochester Medical Center, Rochester, New York, USA. katia_noyes@urmc.rochester.edu
Ethan Corona
Peter Veazie
Andrew W Dick
Hongwei Zhao
Arthur J Moss

Funding

UNIVERSITY OF ROCHESTER'S RESEARCH ASSOCIATE ORGANIZATIONUL1RR024160 · NCRR · UNIVERSITY OF ROCHESTER · PI PEARSON, THOMAS ARTHUR · 2006 to 2011
$38.7M
Economic and Policy Analyses in Geriatric DiseaseK01AG020980 · NIA · UNIVERSITY OF ROCHESTER · PI NOYES, EKATERINA I · 2002 to 2006
$543k
NCRR NIH HHS 1UL1 RR024160-01NCRR NIH HHS UL1 RR024160NIA NIH HHS K01 AG020980
6 · The paper itself

Abstract

While implantable cardioverter-defibrillators (ICDs) improve survival, their benefit in terms of health-related quality of life (HRQOL) is negligible. To examine how shocks and congestive heart failure (CHF) mediate the effect of ICDs on HRQOL. The US patients from the MADIT-II (Multicenter Automatic Defibrillator Trial-II) trial (n = 983) were randomized to receive an ICD or medical treatment only. HRQOL was assessed using the Health Utility Index 3 at baseline and 3, 12, 24, and 36 months following randomization. Logistic regressions were used to test for the effect of ICDs on the CHF indicator, and linear regressions were used to examine the effect of ICD shocks and CHF on HRQOL in living patients. We used a Monte Carlo simulation and a parametric Weibull distribution survival model to test for the effect of selective attrition. Observations were clustered by patients and robust standard errors (RSEs) were used to control for the non-independence of multiple observations provided by the same patient. Patients in the ICD arm had 41% higher odds of experiencing CHF since their last assessment compared with those in the control arm (RSE = 0.19, p = 0.01). Developing CHF reduced HRQOL at the subsequent visit by 0.07 (p < 0.01). Having ICD shocks reduced overall HRQOL by 0.04 (p = 0.04) at the subsequent assessment. The negative effect of ICD firing on HRQOL was an order of magnitude greater than the effect of CHF. A higher prevalence of CHF and shocks among patients with ICDs and their negative effect on HRQOL may partially explain the lack of HRQOL benefit of ICD therapy.

Indexed as

Health Status IndicatorsAge FactorsDefibrillators, ImplantableFemaleHeart FailureHumansMaleMiddle AgedQuality of LifeRisk FactorsSex FactorsTime FactorsTreatment Outcome

Identifiers

PMID19929037
PMCPMC4743243

What OpenQuestion holds

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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.