Focus on Transcatheter Aortic Valve Replacement
Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement

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Abstract

Objectives

The aim of this study was to evaluate the performance of administrative claims in ascertaining trial clinical events committee–adjudicated outcomes in the U.S. CoreValve studies.

Background

Real-world data offer tremendous opportunity to improve outcome ascertainment in clinical trials. However, little is known about the validity of outcomes ascertained using real-world data to capture trial endpoints.

Methods

Patients enrolled in 3 pivotal trials and 2 pre-market continued-access studies evaluating transcatheter aortic valve replacement were linked to Medicare fee-for-service inpatient claims. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement statistic of claims to detect clinical endpoints and procedural complications in trial patients were calculated.

Results

Claims accurately identified trial-adjudicated deaths (sensitivity, specificity, PPV, and NPV all >99.6%; kappa 1.00). Claims had good performance in identifying trial-adjudicated permanent pacemaker implantation (sensitivity 92.2%, specificity 99.1%, PPV 96.1%, NPV 98.2%, kappa 0.93) and aortic valve reintervention (sensitivity 84.4%, specificity 99.6%, PPV 69.1%, NPV 99.8%, kappa 0.76). Claims had more modest performance in ascertaining trial-adjudicated myocardial infarction (sensitivity 63.6%, specificity 97.2%, PPV 29.9%, NPV 99.3%, kappa 0.39) and acute kidney injury (sensitivity 70.2%, specificity 85.4%, PPV 38.2%, NPV 95.7%, kappa 0.41) and the poorest performance for identifying trial-adjudicated bleeding events (sensitivity 86.4%, specificity 36.8%, PPV 35.0%, NPV 86.3%, kappa 0.16).

Conclusions

Compared with trial-adjudicated outcomes, claims data performed well in ascertaining death and outcomes with procedural billing codes and more modestly in identifying other outcomes. Claims may be cautiously and selectively used to augment data collection in future cardiovascular device trials.

Key Words

administrative claims
clinical trials
TAVR
validation

Abbreviations and Acronyms

AKI
acute kidney injury
CEC
clinical events committee
ICD
International Classification of Diseases
ICD-9-CM
International Classification of Diseases-9th Revision-Clinical Modification
ICD-10-CM
International Classification of Diseases-10th Revision-Clinical Modification
MedPAR
Medicare Provider Analysis and Review
MI
myocardial infarction
NPV
negative predictive value
PPV
positive predictive value
RCT
randomized controlled trial
TAVR
transcatheter aortic valve replacement

Cited by (0)

This study was funded by grant 1R01HL136708 from the National Heart, Lung, and Blood Institute (Dr. Yeh). Dr. Butala is funded by the John S. LaDue Memorial Fellowship at Harvard Medical School; and has received consulting fees from and has ownership interest in HiLabs, outside the submitted work. Dr. Strom is funded by grant 1K23HL144907 from the National Heart, Lung, and Blood Institute. Dr. Brennan holds an Innovation in Regulatory Science Award from the Burroughs Welcome Fund (1014158); holds grant 1U01FD004591-01 from the U.S. Food and Drug Administration; and is a consultant for Edwards Lifesciences and Atricure. Dr. Popma has received grants from Medtronic, Abbott Vascular, Cook, and Boston Scientific; and has received personal fees from Boston Scientific. Dr. Yeh has received additional grant support from Abiomed, AstraZeneca, and Boston Scientific; and has received consulting fees from Abbott, Boston Scientific, Medtronic, and Teleflex, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.