<p>Using Medicare Claims to Identify Acute Clinical Events Following Implantation of Leadless Pacemakers</p>

Abstract

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 physicianadjudicated 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.

Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker

“…The design of the Micra CED study 4 has been described previously. 5 Briefly, the observational study is a continuously enrolling cohort study designed to evaluate complications, utilization, and outcomes of the leadless pacing syst e m i n t h e Me d i c a r e p o p u l at i o n . T h e s t u d y u s e s administrative claims data to enroll patients, ascertain patient characteristics, identify comorbidities, and measure outcomes.…”

“…The methodology of linking the claims and manufacturer device registration data has been previously described. 5 Patients with transvenous VVI pacemakers were identified with International Classification of Diseases, 10th Revision, Procedure Coding System codes for implants occurring in the inpatient hospital setting and Current Procedural Terminology codes for implants occurring in the outpatient hospital setting, as defined in eTable 1 in the Supplement. Patients with transvenous VVI pacemakers were included if the hospital at which they were treated was implanting leadless VVI pacemakers during the study period.…”

Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up

“…However, our prior analyses suggest that this probability is low. 6 Another limitation of using administrative claims is that we are not able to obtain device interrogation data and thus are unable to assess variables such as programmed lower rates, pacing thresholds, and battery longevity. Third, as with any observational study, the possibility of residual confounding or selection bias cannot be completely eliminated.…”

“…The design of the Micra CED study has been described previously. 5 , 6 The CED study is a continuously enrolling cohort study designed to evaluate complications, utilization, and outcomes of the leadless-VVI pacing system in the US Medicare population. The study uses administrative claims data to enrol patients, ascertain patient characteristics, identify comorbidities, and measure outcomes.…”

“…We used Medicare claims and enrollment data from March 9, 2017, to December 31, 2018, and linked it to manufacturer device registration information to identify Medicare beneficiaries implanted with a Micra leadless pacemaker (Model MC1VR01, Medtronic, Inc), employing a previously described methodology. 6 We identified patients implanted with a transvenous VVI pacemaker using the International Classification of Diseases, 10th Revision, Procedure Coding System for implants occurring in the inpatient hospital setting and Current Procedural Terminology for implants occurring in the outpatient hospital setting, as defined in Supplementary material online , Table S1 . We also limited transvenous VVI patients to hospitals that implanted leadless VVI pacemakers during the study period.…”