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Related Concept Videos

Cardiac Catheterization II: Right Heart Catheterization01:21

Cardiac Catheterization II: Right Heart Catheterization

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Related Experiment Video

Updated: Jul 18, 2026

Patient Directed Recording of a Bipolar Three-Lead Electrocardiogram using a Smartwatch with ECG Function
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Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data.

Steven Mullane1, Jacob B Hicks2, Kazi Sharmin1

  • 1BIOTRONIK Inc., Lake Oswego, OR, 97035, USA.

Pragmatic and Observational Research
|December 25, 2024
PubMed
Summary

This study successfully transitioned a cardiac lead post-approval study to real-world data, demonstrating high agreement in identifying lead complications and enabling long-term safety monitoring.

Keywords:
cardiac leadpacemakerreal-world datareal-world evidence

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Area of Science:

  • Cardiovascular Medicine
  • Medical Device Technology
  • Health Informatics

Background:

  • The Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION) initiative aimed to improve post-market surveillance of cardiovascular implantable electronic devices.
  • A 5-year bradycardia lead study evolved from a traditional post-approval study (PAS) to a real-world data (RWD) approach for evaluating chronic lead complications.

Purpose of the Study:

  • To develop and validate a novel RWD methodology for assessing long-term safety of cardiac leads.
  • To compare the efficacy of RWD in identifying lead complications versus traditional PAS methods.
  • To obtain FDA approval for using RWD in ongoing safety surveillance of cardiac leads.

Main Methods:

  • Utilized diagnosis and procedure codes from Medicare claims data (2013-2020) and BIOTRONIK device data.
  • Performed a proof-of-concept analysis using McNemar's test to compare complication identification between PAS and RWD.
  • Evaluated lead safety using Kaplan-Meier survival and incidence rates for long-term outcomes.

Main Results:

  • Proof-of-concept analysis showed 99.7% agreement in identifying lead complications between PAS and RWD (p=0.0833).
  • Analysis of 1841 leads in 1015 patients identified 33 lead complications (0.005 per lead-year).
  • Achieved a 5-year complication-free rate of 97.2% (95% CI: 96.07%, 98.06%).

Conclusions:

  • This study represents the first FDA approval for transitioning a cardiac lead PAS to RWD-based safety reporting.
  • The validated RWD approach offers a robust and efficient method for long-term surveillance of cardiac leads and devices.
  • This paves the way for broader adoption of RWD in post-market device evaluation and regulatory submissions.