Arrhythmias & electrophysiology
Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study
Authors' conclusion
These results show a close agreement between RWD-detected and PAS-reported lead complication rates, which highlights the potential benefits of RWD-based methods to enhance the generation of clinical evidence for lead safety.
Study context
- Population
- Patients implanted with Abbott Optisure lead, August 27, 2014 to June 14, 2016444 post-approval study (PAS) participants in Medicare Fee-For-Service (FFS) for 1:1 comparison
- Participants
- 5,804 vs 1,171
- Exposure
- Real-world data (RWD) method vs PAS method for detecting lead complications
- RWDn = 5,804
- PASn = 1,171reference
- Outcome
- Agreement in detecting mechanical lead-related complications; survival free from complications
- Follow-up
- 3 years
Methodological detailsMedicare FFS claims linked to Abbott device databases, 1:1 method comparison, equivalence acceptance criterion ±2.5%, Patients observed through December 31, 2018
- Medicare FFS claims linked to Abbott device databases
- 1:1 method comparison
- Equivalence acceptance criterion ±2.5%
- Patients observed through December 31, 2018
Main finding
As reported in the abstract
- Complete agreement between PAS-reported and claims-detected complications (McNemar P value)
- 1
- Cohen κ
- 1
Observational data: associations, not effects.
Original publication
Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study. Heart Rhythm. Published 25 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →