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Related Experiment Videos

Cardiac pacemakers. When clinical evaluation lags behind technological progress.

B Cuzin1, G Kirkorian, H Maisonneuve

  • 1Hôpital Cardiovasculaire et Pneumologique Louis Pradel.

International Journal of Technology Assessment in Health Care
|October 12, 2000
PubMed
Summary

Clinical efficacy of cardiac pacemakers is not well-proven by evidence-based medicine. Available data do not justify price differences for pacemakers, highlighting a gap in clinical evaluation.

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Area of Science:

  • Cardiology
  • Medical Device Evaluation
  • Health Technology Assessment

Background:

  • Increasing cardiac pacemaker implantations raise concerns for health decision-makers.
  • The clinical efficacy of pacemakers requires thorough assessment to justify market prices.

Purpose of the Study:

  • To assess the intrinsic and relative clinical efficacy of cardiac pacemakers.
  • To determine if scientific evidence supports current market price variations.

Main Methods:

  • Systematic review of cardiac pacing literature (1993-1998) from five databases.
  • Selection of studies based on evidence-based medicine (EBM) criteria, including randomized controlled trials.
  • Classification of studies by clinical indication and type of efficacy evaluation.

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Main Results:

  • Less than 10% of retrieved references met EBM criteria.
  • Clinical efficacy, even for common indications like sick sinus syndrome, was not robustly proven.
  • Comparative studies of different pacing modes lacked randomization and consistent evidence of superiority.

Conclusions:

  • Limited data exist on the natural history of diseases treated with pacemakers.
  • A significant gap exists between technological advancement and clinical evaluation of pacemakers.
  • Current pacemaker efficacy data do not justify market price disparities.