Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry
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 Registr...
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Elsevier
2025-08-01
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772963X25004430 |
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| author | Kamil F. Faridi, MD, MSc James V. Freeman, MD, MPH, MS Yongfei Wang, MS Lucy Pereira, BA Sarah Zimmerman, MS Daniel J. Friedman, MD Richa Sharma, MD, MPH Angela Y. Higgins, MD Bobak J. Mortazavi, PhD Joseph S. Ross, MD, MHS Harlan M. Krumholz, MD, SM Robert W. Yeh, MD, MSc, MD, MPH Jeptha P. Curtis, MD |
| author_facet | Kamil F. Faridi, MD, MSc James V. Freeman, MD, MPH, MS Yongfei Wang, MS Lucy Pereira, BA Sarah Zimmerman, MS Daniel J. Friedman, MD Richa Sharma, MD, MPH Angela Y. Higgins, MD Bobak J. Mortazavi, PhD Joseph S. Ross, MD, MHS Harlan M. Krumholz, MD, SM Robert W. Yeh, MD, MSc, MD, MPH Jeptha P. Curtis, MD |
| author_sort | Kamil F. Faridi, MD, MSc |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-bacb1060c41a49ada92bc664a2b552d6 |
| institution | Kabale University |
| issn | 2772-963X |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
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| series | JACC: Advances |
| spelling | doaj-art-bacb1060c41a49ada92bc664a2b552d62025-08-20T03:32:40ZengElsevierJACC: Advances2772-963X2025-08-014810201910.1016/j.jacadv.2025.102019Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion RegistryKamil F. Faridi, MD, MSc0James V. Freeman, MD, MPH, MS1Yongfei Wang, MS2Lucy Pereira, BA3Sarah Zimmerman, MS4Daniel J. Friedman, MD5Richa Sharma, MD, MPH6Angela Y. Higgins, MD7Bobak J. Mortazavi, PhD8Joseph S. Ross, MD, MHS9Harlan M. Krumholz, MD, SM10Robert W. Yeh, MD, MSc, MD, MPH11Jeptha P. Curtis, MD12Section 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; Address for correspondence: Dr Kamil F. Faridi, Section of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, 300 George Street, Suite 759, New Haven, Connecticut 06511, USA.Section 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, USACenter for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut, USACenter for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut, USACenter for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut, USADivision of Cardiology, Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USADepartment of Neurology, Center for Brain and Mind Health, Yale University School of Medicine, New Haven, Connecticut, USADivision of Cardiology, Maine Health, Scarborough, Maine, USADepartment of Computer Science and Engineering, Texas A&M University, College Station, Texas, USACenter for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut, USA; Section of General Internal Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USASection 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, USARichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USASection 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, USABackground: 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.http://www.sciencedirect.com/science/article/pii/S2772963X25004430administrative claimsbleedingleft atrial appendage occlusionoutcomesstroke |
| spellingShingle | Kamil F. Faridi, MD, MSc James V. Freeman, MD, MPH, MS Yongfei Wang, MS Lucy Pereira, BA Sarah Zimmerman, MS Daniel J. Friedman, MD Richa Sharma, MD, MPH Angela Y. Higgins, MD Bobak J. Mortazavi, PhD Joseph S. Ross, MD, MHS Harlan M. Krumholz, MD, SM Robert W. Yeh, MD, MSc, MD, MPH Jeptha P. Curtis, MD Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry JACC: Advances administrative claims bleeding left atrial appendage occlusion outcomes stroke |
| title | Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry |
| title_full | Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry |
| title_fullStr | Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry |
| title_full_unstemmed | Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry |
| title_short | Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry |
| title_sort | comparing claims data to stroke and bleeding in the ncdr left atrial appendage occlusion registry |
| topic | administrative claims bleeding left atrial appendage occlusion outcomes stroke |
| url | http://www.sciencedirect.com/science/article/pii/S2772963X25004430 |
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