AbstractBackgroundCardiac implantable electronic device (CIED) infection is a serious adverse event, but there are limited contemporary real‐world data on treatment pathways and associated costs in the Medicare population following diagnosis of CIED infection. Hence, this study evaluates postinfection treatment pathways and associated healthcare expenditures and mortality among Medicare fee‐for‐service beneficiaries with CIED infection.MethodsRetrospective cohort analysis of 5,401 beneficiaries who developed a device‐related infection in the year following implantation/upgraded CIED (1/1/2010–12/31/2012). Patients were followed‐up to 12 months/death following diagnosis of infection and were divided into mutually exclusive groups based on whether they underwent CIED system removal (Group I), or no CIED system intervention (Group II; IIA with or IIB without infection hospitalization). All‐cause healthcare resource utilization/expenditures were also measured.ResultsIn the year following infection, 64.1% of patients underwent device extraction, of who 2,109 (39.0%) had their device replaced (Group IA) and 1,355 (25.1%) had their device extracted without replacement (Group IB); 62.2% of patients were hospitalized and 25.3% of patients died. Mean Medicare payments‐per‐patient for facility‐based services by group were: IA = $62,638 (standard deviation [SD]: $46,830), IB = $50,079 (SD: $45,006), IIA = $77,397 (SD: $79,130), and IIB = $22,856 (SD: $31,167).ConclusionsHospitalizations were the largest cost driver; infection‐related costs, including cost of extraction/replacement, accounted for >50% of expenditures for patients with surgical/hospital intervention. Management of CIED infection in Medicare beneficiaries is associated with high healthcare expenditures in the year following infection. Additional measures to prevent device infection are needed to improve the outcomes and reduce costs in these patients.
Cost-effectiveness of TYRX absorbable antibacterial envelope for prevention of cardiovascular implantable electronic device infection
Background— Because of the increasing use of cardiac implantable electronic devices (CIEDs), it is important to estimate the incidence and annual healthcare expenditures associated with CIED infections. Methods and Results— Patients with a record of an initial or replacement (full implant or generator only) CIED implant during the calendar years 2009 to 2012 in MarketScan Commercial Claims and Medicare Supplemental database were identified. CIED infections were classified into 4 categories: (1) infection not managed by inpatient admission nor implant removal, (2) infection managed by inpatient admission but no implant removal, (3) infection managed by an implant removal either in an inpatient or in an outpatient setting, and (4) infection with severe sepsis and managed in an inpatient setting with implant removal. Using separate models for initial and replacement cohorts, annualized incidence of infection and incremental annual expenditures by treatment intensity were estimated. Cumulative incidence of infection at 1 year post implant was 1.18% for initial CIED implants and 2.37% for replacement. Median time to infection was 35 days for initial and 23 days for replacement. Incremental healthcare expenditures by treatment intensity categories for initial implant patients at 1 year were $16 651, $104 077, $45 291, and $279 744. For replacement patients, incremental expenditures at 1 year by treatment intensity categories were $26 857, $43 541, $48 759, and $362 606. Conclusions— The management of CIED infections results in a substantial healthcare burden with a significant increase in annual expenditures the year after implant when device infection occurs.