Key result
Medicare claims show ~95% agreement with adjudicated registries for 30-day Micra leadless pacemaker complications.
Why the study?
Assessing the validity and reliability of real-world data event measurement is critical, but Medicare claims have not been validated against physician-adjudicated clinical study data in pacemaker patients.
Does Medicare claims data accurately identify acute clinical events compared to physician-adjudicated registry data in patients implanted with leadless pacemakers?
Observational (n=230)
Yes
Does Medicare claims data accurately identify acute clinical events compared to physician-adjudicated registry data in patients implanted with leadless pacemakers?
Medicare claims data demonstrates high agreement with physician-adjudicated clinical registries for identifying acute complications following leadless pacemaker implantation, supporting the validity of real-world data for event measurement.
Answers are grounded in this paper and cite their sources.
Supports claims-based tracking of leadless pacemaker complications; leaves open broader validation across populations.
BACKGROUND: There is heightened interest in how real-world data (RWD) can be used to supplement or replace traditional mechanisms for collecting clinical information. A critical component in evaluating utility of RWD is assessing the validity and reliability of event measurement. Only two studies have validated Medicare claims with physician-adjudicated data collected in a clinical study and none in the pacemaker patient population. This study compares events identified in physician-adjudicated clinical registry data collected in the Micra Post-Approval Registry (PAR) with events identified via Medicare administrative claims in the Micra Coverage with Evidence (CED) Study. METHODS: Patients who were dually enrolled in the Micra CED and the Micra PAR between March 9, 2017 and December 1, 2017 were included in the validation analysis. All patients intended to be implanted with a Micra device were eligible for participation in the Micra PAR. All Medicare fee-for-service beneficiaries implanted with a Micra device who met the 12-month continuous enrollment criteria were included in the Micra CED. We compared the count of acute (30-day) complications identified in the Medicare claims and the physician-adjudicated PAR data to assess agreement between data sources. RESULTS: There were 230 patients dually enrolled in the Micra CED and Micra PAR studies during the study period. Overall, there were 17 acute events reported in either the Micra CED or the Micra PAR, with 95% agreement in the identification of events and absence of events between studies. Study disagreement between events reported in either study varied: arteriovenous fistula (50%), pulmonary embolism (67%), hemorrhage/hematoma (75%), and deep vein thrombosis (100%). Among physician-adjudicated events, there was no disagreement between the Micra CED and Micra PAR studies in any event type. CONCLUSION: Findings from this study demonstrate high agreement in event identification between Medicare claims data and registries for patients implanted with Micra leadless pacemakers.
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Wherry et al. (2020) conducted an observational in Patients implanted with Micra leadless pacemakers (n=230). Medicare administrative claims data vs. Physician-adjudicated clinical registry data (Micra PAR) was evaluated on Agreement in the identification of acute (30-day) complications between Medicare claims and physician-adjudicated registry data. Medicare claims data demonstrated 95% overall agreement with physician-adjudicated clinical registry data in identifying the presence or absence of 30-day acute complications following Micra leadless pacemaker implantation.
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