Arrhythmias & electrophysiology
Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry
Authors' conclusion
In the LAAO Registry, International Classification of Diseases-Tenth Revision codes have moderate agreement with stroke, GIB, and intracranial hemorrhage, and overestimate most event rates compared to adjudicated registry-reported events. Nonclaims-based methods are needed to ensure accurate assessment of clinical events in postmarketing surveillance.
Study context
- Population
- Patients aged ≥65 years in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry
- Participants
- 71,043 LAAO Registry patients
- Exposure
- Primary diagnosis International Classification of Diseases-Tenth Revision codes from inpatient hospitalizations were compared to adjudicated registry-reported stroke and major bleeding events after discharge
- Outcome
- Ischemic stroke: claims vs registry-reported events
Methodological detailsadjudicated registry-reported events, 2016 to 2021 Medicare claims
- Adjudicated registry-reported events
- 2016 to 2021 Medicare claims
Main finding
As reported in the abstract
| Group | Sensitivity | Positive predictive value | Kappa |
|---|---|---|---|
| Claims | 60.8% | 50.5% | 0.55 |
Claims
Sensitivity60.8%
Positive predictive value50.5%
Kappa0.55
Observational data: associations, not effects.
Further findings
| Outcome | Claims | RegistryIncidence rate |
|---|---|---|
| Hemorrhagic stroke: claims vs registry-reported events | ||
| Sensitivity | 42.7% | — not stated in the abstract |
| Positive predictive value | 50.5% | — not stated in the abstract |
| Kappa | 0.46 | — not stated in the abstract |
| Gastrointestinal bleeding (GIB): claims vs registry-reported events | ||
| Sensitivity | 55.9% | — not stated in the abstract |
| Positive predictive value | 40.3% | — not stated in the abstract |
| Kappa | 0.43 | — not stated in the abstract |
| Intracranial hemorrhage: claims vs registry-reported events | ||
| Sensitivity | 62.2% | — not stated in the abstract |
| Positive predictive value | 38.0% | — not stated in the abstract |
| Kappa | 0.47 | — not stated in the abstract |
| Other major bleeding: claims vs registry-reported events | ||
| Sensitivity | 20.4% | — not stated in the abstract |
| Positive predictive value | 10.0% | — not stated in the abstract |
| Kappa | 0.12 | — not stated in the abstract |
| Ischemic stroke incidence · Two-yearHigher in claims | incidence rate 2.5% | 2.2% |
| GIB incidence · Two-yearHigher in claims | incidence rate 6.8% | 5.2% |
| Intracranial hemorrhage incidence · Two-yearHigher in claims | incidence rate 1.6% | 1.1% |
| Other bleeding incidence · Two-yearHigher in claims | incidence rate 3.1% | 1.5% |
| Hemorrhagic stroke incidence · Two-yearLower in claims | incidence rate 0.4% | 0.5% |
— not stated in the abstract
- Ischemic stroke incidence: P < 0.01 for all events
- Gastrointestinal bleeding (GIB) incidence: P < 0.01 for all events
- Intracranial hemorrhage incidence: P < 0.01 for all events
- Other bleeding incidence: P < 0.01 for all events
- Hemorrhagic stroke incidence: P = 0.03
Sensitivity and negative predictive values, all events
- Sensitivity and negative predictive values for all events
- >92%
Original publication
Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry. JACC Adv. Published 24 July 2025. doi:10.
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