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Related Concept Videos

Electrocardiogram Fundamentals01:28

Electrocardiogram Fundamentals

559
Introduction
An electrocardiogram (ECG) is a diagnostic tool for identifying cardiac conditions such as arrhythmias, conduction abnormalities, and myocardial ischemia.
Definition
An electrocardiogram (ECG) visualizes the heart's electrical activity by tracing the electrical movement associated with each heartbeat on a graph or monitor. As the heart beats, an electrical wave passes through it, correlating with the cardiac cycle events.
Parts of an ECG
An ECG utilizes electrodes on the skin...
559
Pulse rhythm01:30

Pulse rhythm

782
Pulse rhythm refers to the pattern of pulsations within specific intervals, offering valuable insights into the regularity or irregularity of the heart's beats as observed through the pattern of pulsation within specific intervals. A regular pulse exhibits a consistent heart rate with uniform waveforms and pulsation force, variations of which can be classified as normal, weak, or bounding.
Conversely, an irregular pulse pattern is termed dysrhythmia, stemming from disruptions in cardiac...
782

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Related Experiment Video

Updated: Jun 22, 2025

Patient Directed Recording of a Bipolar Three-Lead Electrocardiogram using a Smartwatch with ECG Function
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Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study.

Lorenzo Braghieri1, Aamir Ahmed2, Anne B Curtis2

  • 1Department of Internal Medicine, Cleveland Clinic, Cleveland, Ohio.

Heart Rhythm
|June 27, 2024
PubMed
Summary

Real-world data (RWD) closely matched traditional post-approval study (PAS) methods for detecting cardiac lead complications. This proof-of-concept study shows RWD can enhance clinical evidence generation for lead safety.

Keywords:
Cardiovascular implantable electronic devicesClaims dataMedicareOptisurePost-approval study

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Area of Science:

  • Cardiovascular Medicine
  • Medical Device Safety
  • Health Informatics

Background:

  • Traditional post-approval studies (PAS) for cardiac leads have limitations.
  • Regulatory authorities accept PAS designs for postmarketing requirements.

Purpose of the Study:

  • To conduct a proof-of-concept study evaluating alternative methods using real-world data (RWD).
  • To assess RWD's utility in evaluating cardiac lead safety in large patient populations.

Main Methods:

  • Linked Abbott patient device databases with Medicare Fee-For-Service (FFS) claims.
  • Compared RWD method with PAS for detecting mechanical lead-related complications in 444 patients.
  • Evaluated agreement using McNemar test and Cohen κ; compared 3-year survival free from complications.

Main Results:

  • Complete agreement (McNemar P=1; Cohen κ=1) between PAS-reported and claims-detected complications.
  • 3-year survival free from complications was 98.4% for RWD and 98.4% for PAS.
  • RWD results were within the ±2.5% equivalence criterion.

Conclusions:

  • Real-world data (RWD) demonstrated close agreement with traditional post-approval study (PAS) findings for lead complication rates.
  • RWD-based methods show potential to enhance clinical evidence generation for cardiac lead safety.
  • This study supports the use of RWD as a viable alternative or supplement to traditional PAS.