IMPORTANCEThe safety and efficacy of leadless VVI pacemakers have been demonstrated in multiple clinical trials, but the comparative performance of the device in a large, real-world population has not been examined. OBJECTIVE To compare patient characteristics and complications among patients implanted with leadless VVI and transvenous VVI pacemakers. DESIGN, SETTING, PARTICIPANTS The Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers (Micra CED) is a continuously enrolling observational cohort study evaluating complications, utilization, and outcomes of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted between March 9, 2017, and December 1, 2018, were identified and included. All Medicare patients implanted with leadless VVI and transvenous VVI pacemakers during the study period were enrolled. Patients with less than 12 months of continuous enrollment in Medicare prior to leadless VVI or transvenous VVI implant and with evidence of a prior cardiovascular implantable electronic device were excluded, leaving 5746 patients with leadless VVI pacemakers and 9662 patients with transvenous VVI pacemakers. Data were analyzed from May 2018 to April 2021. EXPOSURES Medicare patients implanted with leadless VVI pacemakers or transvenous VVI pacemakers. MAIN OUTCOMES AND MEASURESThe main outcomes were acute (30-day) complications and 6-month complications. RESULTSOf 15 408 patients, 6701 (43.5%) were female, and the mean (SD) age was 81.0 (8.7) years. Compared with patients with transvenous VVI pacemakers, patients with leadless VVI pacemakers were more likely to have end-stage kidney disease (690 [12.0%] vs 226 [2.3%]; P < .001) and a higher mean (SD) Charlson Comorbidity Index score (5.1 [3.4] vs 4.6 [3.0]; P < .001). The unadjusted acute complication rate was higher in patients with leadless VVI pacemakers relative to transvenous VVI pacemakers (484 of 5746 [8.4%] vs 707 of 9662 [7.3%]; P = .02). However, there was no significant difference in overall acute complication rates following adjustment for patient characteristics (7.7% vs 7.4%; risk difference, 0.3; 95% CI, −0.6 to 1.3; P = .49). Pericardial effusion and/or perforation within 30 days was significantly higher among patients with leadless VVI pacemakers compared with patients with transvenous VVI pacemakers in both unadjusted and adjusted models (unadjusted, 47 of 5746 [0.8%] vs 38 of 9662 [0.4%]; P < .001; adjusted, 0.8% vs 0.4%; risk difference, 0.4; 95% CI, 0.1 to 0.7; P = .004). Patients implanted with leadless VVI pacemakers had a lower rate of 6-month complications compared with patients implanted with transvenous VVI pacemakers (unadjusted hazard ratio, 0.84; 95% CI, 0.68-1.03; P = .10; adjusted hazard ratio, 0.77; 95% CI, 0.62-0.96; P = .02). CONCLUSIONS AND RELEVANCEIn this study, despite significant differences in patient characteristics, patients in whom a leadless pacemaker was implanted were observed to have higher rates of pericardial effusion and/or perforation but lower rates...

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.

Context Health inequity is often associated with race-ethnicity. Objective To determine the prevalence of insulin pump therapy and continuous glucose monitoring (CGM) among Medicare beneficiaries with Type 1 diabetes (T1D) by race-ethnicity, and to compare diabetes-related technology users to non-users. Design The prevalence of technology use (pump, CGM) was determined by race-ethnicity for enrollees in coverage years (CY) 2017-2019 in the Medicare fee-for-service database. Using CY2019 data, technology users were compared to non-users by race-ethnicity, sex, average age, Medicare eligibility criteria, and visit to an endocrinologist. Setting Community Patients or Other Participants Beneficiaries with T1D and at least one inpatient or two outpatient claims in a CY Intervention(s) Pump or CGM therapy, visit to an endocrinologist Main Outcome Measure(s) Diabetes-related technology use by race-ethnicity groups Results Between 2017 and 2019 CGM and insulin pump use increased among all groups. Prevalence of insulin pump use was &lt;5% for Black and Other beneficiaries yet increased from 14% to 18% among White beneficiaries. In CY2019 57% of White patients used a pump compared to 33.1% of Black and 30.3% of Other patients (P&lt;0.001). Black patients were more likely than White patients to be eligible due to disability/end-stage renal disease or to be Medicare/Medicaid eligible (both P&lt;0.001), whether using technology or not. Significant race-ethnicity differences (P&lt;0.001) existed between technology users and non-users for all evaluated factors except visiting an endocrinologist. Conclusions Significant race-ethnicity associated differences existed in T1D management. The gap in diabetic technology adoption between Black and White beneficiaries grew between 2017 and 2019.

Objective Implantable cardiac defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) are well-established but underutilized globally. The Improve SCA study has identified a cohort of patients called 1.5 primary prevention (1.5PP) based on PP patients with the presence of certain risk factors. We evaluated the cost-effectiveness of ICD therapy compared to no ICD among the PP population and the subset of 1.5PP patients in Taiwan. Methods A Markov model was run over a lifetime time horizon from the Taiwan payer perspective. Mortality and utility estimates were obtained from the literature (PP) and the IMPROVE SCA trial (1.5PP). Cost inputs were obtained from the Taiwan National Health Insurance Administration (NHIA), Ministry of Health and Welfare. We used a willingness-to-pay (WTP) threshold of NT$2,100,000, as established through standard WTP research methods and in alignment with World Health Organization recommendations. Results The total discounted costs for ICD therapy and no ICD therapy were NT$1,664,259 and NT$646,396 respectively for PP, while they were NT$2,410,603 and NT$905,881 respectively for 1.5PP. Total discounted QALYs for ICD therapy and no ICD therapy were 6.48 and 4.98 respectively for PP, while they were 10.78 and 7.71 respectively for 1.5PP. The incremental cost effectiveness ratio was NT$708,711 for PP and NT$441,153 for 1.5PP, therefore ICD therapy should be considered cost effective for PP and highly cost effective for 1.5PP. Conclusions ICD therapy compared to no ICD therapy is cost-effective in the whole PP population and highly cost-effective in the subset 1.5PP population in Taiwan.

This study was funded by Medtronic. Declaration of Financial / Other RelationshipsSC, TK, KS, KW and GZ are employees of Medtronic.JME peer reviewers on this manuscript have received an honorarium from JME for their review work, but have no other relevant financial relationships to disclose.The Medtronic Extended-Wear Infusion Set (branded as Medtronic Extended) is a CE marked device in EU, and an investigational device in the US; it is currently not approved for use in the US.

Aims This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients at higher risk of pacemaker complications. Methods and results This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4–5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups [malignancy, HR 0.68 (0.48–0.95); diabetes, HR 0.69 (0.53–0.89); TVD, HR 0.60 (0.44–0.82); COPD, HR 0.73 (0.55–0.98)] had fewer complications, in three subgroups [diabetes, HR 0.58 (0.37–0.89); TVD, HR 0.46 (0.28–0.76); COPD, HR 0.51 (0.29–0.90)) had fewer reinterventions, and in four subgroups (malignancy, HR 0.52 (0.32–0.83); diabetes, HR 0.52 (0.35–0.77); TVD, HR 0.44 (0.28–0.70); COPD, HR 0.55 (0.34–0.89)] had lower rates of the combined outcome. Conclusion In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups. Trial Registration ClinicalTrials.gov ID NCT03039712

Context Racial/ethnic inequities have been observed in diabetes care. Objective To measure changes in prevalence of continuous glucose monitoring (CGM) and insulin pump therapy among Medicare Advantage (MA) beneficiaries with type 1 diabetes (T1D) by race/ethnicity and to determine the impact of socioeconomic factors on racial/ethnic inequities. Design The prevalence of CGM and pump use was assessed by race/ethnicity for MA beneficiaries annually from 2017 - 2020. Models predicting technology use by year, race/ethnicity, age, sex, endocrinology visits, and measures of socioeconomic status (SES) were fit. Setting Community Patients or Other Participants Beneficiaries with T1D and two or more claims with a diabetes diagnosis in the coverage year. Intervention(s) Insulin pump or CGM therapy Main Outcome Measure(s) Use of diabetes technology by racial/ethnic group Results Technology use increased from 2017–2020 in all racial/ethnic groups. The absolute difference in use between White and Black beneficiaries from 2017 to 2020 remained stable for insulin pumps (10.7% to 10.8%) and increased for CGM (2.6% to 11.1%). The differences in pump use from 2017 to 2020 narrowed between White and Hispanic beneficiaries (12.3% to 11.4%) and White and Asian beneficiaries (9.7% to 6.6%), while the opposite occurred for CGM use (3.0% to 15.5% for White vs. Hispanic beneficiaries; 1.5% to 8.0% for White vs. Asian beneficiaries). Racial/ethnic inequities persisted (p &lt; 0.0001) after adjusting for other characteristics. Conclusions Differences in diabetes technology use between racial/ethnic groups often persisted from 2017 through 2020, and could not be explained by demographics, SES, or endocrinology visits.

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