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Published on: February 26, 2013
Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry
Kamil F Faridi1, James V Freeman1, Yongfei Wang2
1Section of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USA; Center for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut, USA.
Insights
Claims data for transcatheter left atrial appendage occlusion (LAAO) show moderate agreement for stroke and bleeding events but overestimate rates. Non-claims-based methods are crucial for accurate postmarketing surveillance of LAAO therapies.
Area of Science:
- Cardiovascular Medicine
- Health Informatics
- Medical Device Surveillance
Background:
- Claims data are increasingly utilized for postmarketing surveillance of medical therapies.
- Accuracy of claims data for monitoring transcatheter left atrial appendage occlusion (LAAO) outcomes remains uncertain.
Purpose of the Study:
- To compare stroke and bleeding event reporting between the National Cardiovascular Data Registry (NCDR) LAAO Registry and Medicare claims data.
- To assess the accuracy of International Classification of Diseases-Tenth Revision (ICD-10) codes in claims data for identifying adjudicated events.
Main Methods:
- Linked NCDR LAAO Registry data (patients ≥65 years) with Medicare claims (2016-2021).
- Compared primary diagnosis ICD-10 codes from inpatient hospitalizations with adjudicated registry-reported stroke and major bleeding events.
- Calculated sensitivity, positive predictive value (PPV), and kappa statistics for claims data accuracy.
Main Results:
- Claims data demonstrated moderate agreement (kappa 0.12-0.55) for ischemic stroke, hemorrhagic stroke, gastrointestinal bleeding (GIB), and intracranial hemorrhage (ICH).
- Sensitivity and PPV varied by event type, with lower values for GIB (55.9%, 40.3%) and other major bleeding (20.4%, 10.0%).
- Claims data generally overestimated event rates compared to registry data, except for hemorrhagic stroke.
Conclusions:
- ICD-10 codes in claims data exhibit moderate agreement with adjudicated stroke, GIB, and ICH events from the LAAO Registry.
- Claims data tend to overestimate the incidence of most major clinical events following LAAO.
- Non-claims-based methodologies are essential for precise clinical event assessment in postmarketing surveillance.
Background:
Claims data are increasingly used for postmarketing surveillance of therapies such as transcatheter left atrial appendage occlusion (LAAO), but their accuracy remains uncertain.
Objectives:
This study aimed to compare stroke and bleeding events in the National Cardiovascular Data Registry LAAO Registry with claims data.
Methods:
LAAO Registry data for patients aged ≥65 years were linked to 2016 to 2021 Medicare claims. 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, including estimation of sensitivity and positive predictive value of claims for identifying registry-reported events. Kappa statistics and incidence rates were also assessed.
Results:
Among 71,043 LAAO Registry patients, sensitivity and positive predictive value of claims were 60.8% and 50.5% for ischemic stroke (kappa 0.55), 42.7% and 50.5% for hemorrhagic stroke (kappa 0.46), 55.9% and 40.3% for gastrointestinal bleeding (GIB) (kappa 0.43), 62.2% and 38.0% for intracranial hemorrhage (kappa 0.47), and 20.4% and 10.0% for other major bleeding (kappa 0.12). Sensitivity and negative predictive values were >92% for all events. Two-year incidence rates were higher in claims vs registry data for ischemic stroke (2.5% vs 2.2%), GIB (6.8% vs 5.2%), intracranial hemorrhage (1.6% vs 1.1%), and other bleeding (3.1% vs 1.5%; P < 0.01 for all events), and lower for hemorrhagic stroke (0.4% vs 0.5%; P = 0.03).
Conclusions:
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.
