Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement

Abstract

Background: Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials. Methods: Adult participants in the US CoreValve High Risk and SURTAVI trials (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) were linked to Medicare inpatient claims from January 1, 2006 to December 31, 2016. Claims consistent with CVEs within 14 days of a similar trial-adjudicated CVE were considered a match. The sensitivity, specificity, and positive and negative predictive values of International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification billing codes for cerebrovascular disease were determined against trial-defined CVEs as the criterion standard. Kaplan-Meier estimates of claims-defined versus trial-defined CVEs were compared. Results: Among 4230 linked trial participants (linkage rate 79.8%), 550 (13.0%) sustained 630 adjudicated CVEs over a 5-year follow-up period. Linked and nonlinked individuals were similar. An algorithm using 4 International Classification of Diseases, Ninth Revision, Clinical Modification codes (434.91, 434.11, 433.11, and 997.02) had a sensitivity of 60.9%, specificity of 99.0%, positive predictive value of 86.5%, and negative predictive value of 95.8% for identifying a trial-adjudicated ischemic stroke. An algorithm using 3 International Classification of Diseases, Tenth Revision, Clinical Modification codes (I63.9, I63.40, I63.49) had a sensitivity of 66.7%, specificity of 99.4%, positive predictive value of 88.9%, and negative predictive value of 97.6%. Conclusions: In linked clinical trial and Medicare claims data, 4 International Classification of Diseases, Ninth Revision, Clinical Modification and 3 International Classification of Diseases, Tenth Revision, Clinical Modification billing codes identified half of trial-adjudicated CVEs during follow-up with high specificity and predictive value, but imperfect sensitivity. Although low sensitivity may limit the use of claims to substitute for traditional trial outcomes to identify CVEs, high specificity suggests claims could be used to trigger evaluation of neurological events, potentially improving the efficiency of the evaluation of techniques and devices designed to reduce such events.

Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

“…Despite the rigorous audit by the TVT Registry, there could also be a potential misrepresentation of stroke rates based on the site difference that may have contributed to the different stroke rates. Additionally, the use of administrative claims-based codes for stroke assessment at 1 year appears to have low sensitivity but high specificity, 32 which could potentially misrepresent the stroke rates. Finally, without comparative data on the individual heart team’s nuanced assessment of patient’s surgical risk or the fact that ≈20% of all alternative access patients were not included in the analyses because linkage with CMS was not successful, our findings should be interpreted with caution.…”

“…Despite the rigorous audit by the TVT Registry, there could also be a potential misrepresentation of stroke rates based on the site difference that may have contributed to the different stroke rates. Additionally, the use of administrative claims-based codes for stroke assessment at 1 year appears to have low sensitivity but high specificity, 32 which could potentially misrepresent the stroke rates.…”

Probabilistic Linkage of Randomized Controlled Trial Data to Administrative Claims: A Case Study of Patients from Baricitinib Clinical Trials

“…Hay et al successfully demonstrated the feasibility of linking RCT data to administrative data in Canada with a linkage rate of 90.8% [ 10 ]. Another study by Strom et al achieved a match rate of 79.8% by linking clinical trial data to Medicare inpatient discharge data [ 11 ]. Brennan et al linked Medicare claims data to the clinical data from seven randomized cardiovascular trials and achieved a linkage rate of 55.6% [ 12 ].…”

“…To date, several studies have linked RCT data to administrative claims data with linkage rates ranging from 55.6 to 90.8% [ 10 – 12 ]. Strom et al [ 11 ] assessed the accuracy of identifying cardiovascular events through billing claims in place of clinical event adjudication in structural heart disease trials by linking clinical trial data to inpatient Medicare claims. Their results indicated that claims could be used to trigger evaluation of neurological events, potentially improving the efficiency of the evaluation of techniques and devices designed to reduce such events.…”

Days at Home After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients

“…Patients were linked with indirect identifiers using deterministic matching algorithms based on age, sex, procedure date and type, discharge date, and hospital identifiers as previously described. [9][10][11] We excluded patients who could not be linked to MedPAR files, which included those patients <65 years of age and those who underwent the index procedure at a hospital outside the United States. Medicare advantage beneficiaries, who are included in MedPAR files but have incomplete capture of health care claims, 12 were also excluded from the analysis.…”