The Rate of CIED Infection By Severity: Evidence from a Large US Payer Database

Background: The objective of this analysis was to analyze, by severity, cardiac implantable electronic device (CIED) infection rate within one year following device implant.

Methods: Data from MarketScanâ Commercial Claims and Medicare Supplemental database (Truven Health Analytics, New York, NY) were used for this analysis. Patients with a record of a complete CIED implant (initial or replacement) or generator replacement only (replacement) determined by ICD-9 and CPT codes during the calendar years 2009 – 2012 with 6 months continuous medical and prescription enrollment prior to their first record of an implant were identified. Patients were excluded if there was a record of a major cardiac surgery during their initial implant or if implant type was unknown. CIED infections were classified into four mutually-exclusive categories: [1] infection not managed in an inpatient setting or implant removal; [2] infection managed in an inpatient setting but no implant removal; [3] infection managed by an implant removal either in an inpatient or outpatient setting; or, [4] infection managed in an inpatient setting with implant removal and severe sepsis. Infection rates by severity were estimated separately for both the initial and replacement cohort. Survival analysis was performed to estimate annualized infection risk.   

Results: Of the total 93,031 (N=62,414 initial and N=30,617 replacement) implanted patients, 1,306 (n=654 initial and n=652 replacement) had a record of infection within the year following their implant with an estimated overall annualized infection risk of 1.18% for initially implanted patients and 2.37% for patients having replacements at index. Table 1 displays the percentage of patients in each infection category. Infections of Severity 1 made up 38.4% of the initial and 47.2% of the replacement infected patients, with an estimated incremental annual healthcare burden of $16,651 and $26,857 respectively. 

Conclusion: A large portion of CEID infections are not managed by hospitalization or device removal. However, these infections do present a substantial healthcare burden for payers.

Infection Category	Initial Implant (N=654)		Replacement Implant (N=652)
Severity 1	251	38.4%	308	47.2%
Severity 2	127	19.4%	103	15.8%
Severity 3	254	38.8%	220	33.7%
Severity 4	22	3.4%	21	3.2%