Using Real-World Evidence to Quantify Hospital Costs of Subcutaneous Implantable Cardioverter-Defibrillator Infections in the US

OBJECTIVES: There are limited studies showcasing the infection rates of Subcutaneous Implantable Cardioverter-Defibrillators (S-ICD) specifically, and even fewer studies that characterize the cost of S-ICD infections. The goal of this study was to determine the total healthcare utilization hospital costs of S-ICD infections 12 months post implant in the US using top-down cost estimates from Medicare administrative claims and generalized linear models.

METHODS: This study conducts a retrospective analysis using Medicare Fee for service (FFS) claims to determine patients implanted with S-ICDs in 2016-2020. Device infections and hospital costs are identified in a 12-month follow up period after device implant; as infections occur during follow-up, this study uses a crossover research design. Generalized linear regressions estimate adjusted and unadjusted average cost differences between patients with and without device infection; regressions are adjusted using baseline comorbidities from the PADIT score risk factors identifiable in claims. These differences are interpreted as top-down estimates of S-ICD infection costs 12 months after implant. Stratified infection costs by PADIT risk factors are also estimated.

RESULTS: 5,326 Medicare FFS patients had an S-ICD implant in 2016-2020, 311 (5.8%) had a device infection 12 months after implant. The average hospital cost of S-ICD infections is $116,862 unadjusted, and $60,036 adjusting for PADIT risk score factors (unadjusted cost of patients with S-ICD infection $265,992 vs. without S-ICD infection $149,130, 78.4% increase, p-value <0.001; adjusted cost of patients with S-ICD infection $190,749 vs. without S-ICD infection $130,713, 45.9% increase, p-value <0.001). Cost of S-ICD infections by PADIT score risk factors are $197,725 for patients over 65 years old, $85,296 for patients with renal insufficiency, and $45,176 for immunocompromised patients.

CONCLUSIONS: Using real-world evidence in a crossover research design, this study estimates hospital costs of S-ICD infections in the US. S-ICD infections severely impact cost on the US healthcare system especially for older people.