Elsevier

Heart Rhythm

Volume 9, Issue 4, April 2012, Pages 494-498
Heart Rhythm

Clinical
Devices
Cardiac device infections are associated with a significant mortality risk

https://doi.org/10.1016/j.hrthm.2011.10.034Get rights and content

Background

Cardiac device infections (CDIs) are a serious complication associated with the implantation of cardiac rhythm devices. However, the effect of CDI on the subsequent risk of mortality is unknown.

Objective

To assess the prognostic importance of CDI in recipients of implantable cardioverter-defibrillator and cardiac resynchronization therapy – defibrillator.

Methods

All patients who received their initial implantable cardioverter-defibrillator/cardiac resynchronization therapy – defibrillator between January 2000 and September 2009 were included. During follow-up, the occurrence of CDI and all-cause mortality were noted. The prognostic importance of the first CDI on mortality was assessed by modeling CDI as a time-dependent covariate in the Cox proportional hazards model.

Results

A total of 2476 patients (79% men; mean age 62 ± 13 years) were included in this analysis. During follow-up, CDI occurred in 64 (2.6%) patients. The 1-year mortality following first CDI was 16.9% (95% confidence interval 6.7%–27.1%). Experiencing the first CDI was associated with a 1.9-fold (hazard ratio 1.87; 95% confidence interval 1.07–3.26) increased risk of mortality compared to patients who did not experience CDI. After controlling for possible confounders, this increased to a 2.4-fold (hazard ratio 2.40; 95% confidence interval 1.35–4.28) increased risk of mortality.

Conclusions

In a large cohort of patients who receive implantable cardioverter-defibrillator/cardiac resynchronization therapy – defibrillator after their initial implant, the 3-year incidence of CDI was 2.6%. The occurrence of CDI was associated with substantial 1-year mortality, and patients experiencing CDI had a more than 2-fold increased risk of mortality compared with patients who remained free from CDI.

Introduction

In the past decades, evidence-based indications for the implantation of cardiac rhythm devices expanded rapidly, resulting in a large increase in the number of device implantations.1, 2, 3, 4, 5, 6 The incidence of complications, of which cardiac device infections (CDIs) are among the most important, also increased subsequently, and it has been reported that the increase in the incidence of CDI has outpaced the increase in implantation rates.7, 8, 9

Current annual CDI rates vary from ∼1% after the first device implant up to 7% after device replacements and/or upgrades.10, 11, 12

CDIs present with a broad range of symptoms, varying from local complaints at the generator pocket site to severe systemic manifestations, and are associated with substantial morbidity and mortality.13 In addition to this high morbidity and mortality, CDI is associated with significant costs, which have been estimated at $50,000 per patient.14

Despite several studies reporting on considerable mortality rates following CDI, no risk assessments were conducted. The extent to which patients with CDI are at increased risk of death as compared with those who remain free from this condition is therefore yet unknown. The objective of this study was to assess the incidence, pathogens, and prognostic importance of CDI in recipients of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy – defibrillator (CRT-D).

Section snippets

Patient selection

At our tertiary care facility (Leiden University Medical Center, Leiden, The Netherlands), data of all patients who receive an ICD or CRT-D are recorded in the departmental cardiology information system (EPD-Vision, Leiden University Medical Center, Leiden, The Netherlands). At baseline, information of the implant procedure and clinical characteristics is collected and all ICD/CRT-Ds are interrogated during regular follow-up. For the current study, all patients who received their initial ICD or

Patient population

Between January 2000 and September 2009, 2574 patients received their initial ICD or CRT-D. Of these, 98 (3.8%) patients were considered lost to follow-up. The remaining 2476 patients (79% men; mean age 62 ± 13 years) were included in this analysis. The majority of these patients received an ICD (59%) and had ischemic heart disease (64%). Table 1 summarizes their baseline characteristics.

CDI

During a median follow-up of 30 [14, 55] months, 64 of the 2476 patients (2.6%) underwent device and lead

Discussion

In our study, the cumulative incidence of CDI in a large cohort of recipients of ICD and CRT-D was 1.1% at 1 year and 2.6% at 3 years after the initial device implantation. Ninety-two percent of late-occurring CDIs (>4.5 years after the initial device implantation) were observed following generator replacement. Importantly, those with CDI had 1-year and 3-year cumulative mortality rates of 16.9% and 27.5%, respectively, following device explantation, reflecting a 2-fold increased risk of death

Conclusions

CDI is a condition that might have serious implications. The incidence of CDI is 2.6% 3 years after the initial device implantation. Furthermore, the annual incidence appears to increase from 4.5 years after the initial device implantation. CDI is associated with a 2.4-fold increased risk of mortality compared to patients in whom CDI does not occur, necessitating the development of effective preventive strategies.

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    Professor Schalij received research grants from Medtronic, Biotronik, and Boston Scientific.

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