Korean Circ J.  2019 Aug;49(8):742-752. 10.4070/kcj.2018.0361.

The Burden and Risk Factors for Infection of Transvenous Cardiovascular Implantable Electronic Device: a Nationwide Cohort Study

Affiliations
  • 1Department of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
  • 2Medtronic Korea, Ltd., Seoul, Korea. hyung.deuk.park@medtronic.com
  • 3Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea. cby6908@yuhs.ac
  • 4Graduate School for Medical Device Management and Research, Samsung Advanced Institute for Health Science & Technology (SAIHST), Sungkyunkwan University, Seoul, Korea.

Abstract

BACKGROUND AND OBJECTIVES
There are limited published data on the incidence and cost associated with cardiac implantable electrical device (CIED) infection for Asian patients. We analyzed the infection burden associated with the implantation of CIEDs in Korea.
METHODS
In the Health Insurance Review & Assessment Service (HIRA) database during the period from January 1, 2014 to December 31, 2016, we identified 16,908 patients with CIED implantation. CIED infection was defined as either: 1) Infection-related diagnosis code by the Korean Standard Classification of Diseases after any CIED procedure; or 2) CIED removal along with systemic infection.
RESULTS
The proportions of first implantation and replacement were 77.6% and 22.4%, respectively. During the follow-up period of 17.1±10.6 months, a total of 462 patients had CIED infection with incidence of 1.95 per 100 person-years with higher infection rate in replacement than first implantation (3.97 vs. 1.4 per 100 person-years, p<0.001). The average cost per person was US$ 16,584 (pacemaker, $13,736; implantable cardioverter defibrillator, $28,402; cardiac resynchronization therapy, $29,674). The risk factors of CIED infection were generator replacement (adjusted hazard ratio [aHR], 3.14; 95% confidence interval [CI], 2.60-3.78), diabetes mellitus (aHR, 1.94; 95% CI, 1.58-2.38), and congestive heart failure (aHR, 1.86; 95% CI, 1.51-2.28).
CONCLUSIONS
The rate of CIED infection in Korea was 1.95 per 100 person-years with average cost of US$ 16,584. The most important risk factor was generator replacement. This result suggests that generator replacement should be performed cautiously to avoid CIED infection.

Keyword

Pacemaker; Implantable cardioverter-defibrillator; Infection; Cost; Risk factors

MeSH Terms

Asian Continental Ancestry Group
Cardiac Resynchronization Therapy
Classification
Cohort Studies*
Defibrillators
Defibrillators, Implantable
Diabetes Mellitus
Diagnosis
Follow-Up Studies
Heart Failure
Humans
Incidence
Insurance, Health
Korea
Risk Factors*

Figure

  • Figure 1 Study population. CIED = cardiac implantable electrical device; HIRA = Health Insurance Review & Assessment Service; NHI = National Health Insurance.

  • Figure 2 Kaplan-Meier curve for CIED infection in patients with first implantation and generator change of CIED. CIED = cardiac implantable electrical device.


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