Despite improved preventive measures, infection associated with the use of cardiac implantable electronic devices (CIEDs) to treat often life-threatening conditions is rising at an average annual rate of almost 5 %. This rise is being driven by the increasing complexity of CIED technology and by the advancing age and co-morbidities of the patients. Although CIED infection is usually suspected based on local signs at the generator pocket site, diagnosis can be challenging in patients presenting no local manifestations or symptoms. Diagnostic methods include microbiological testing and echocardiography, and may be completed by positron emission tomography (PET)/computed tomography (CT) scan in selected cases. CIED infection requires a multidisciplinary approach in view of hardware extraction, targeted antibiotic therapy and reimplantation on an as-needed basis. Antibiotic prophylaxis targeting staphylococcal flora is recommended but the relation of these infections to medical care exposes patients to multi-resistant bacteria. New preventive measures utilising an antibacterial sleeve look promising. Treatment can be started on an empirical basis using an antistaphylococcal agent but must be continued using targeted antibiotic therapy. Crucial questions remain as to the best prevention strategy, optimal duration and timing of antibiotic therapy, and the most effective reimplantation technique.
The increasing use of cardiac implantable electronic devices (CIEDs) for management of cardiac conditions has over the last few years been associated with higher infection rates.1 Expanded CIED use alone cannot account for this rise,2–4 which involves both patient- and device-related factors. Indeed patients are tending to be older and presenting with co-morbidities, while devices are becoming more sophisticated and requiring more leads and revision.5
Analysis of hospital discharge records including 4.2 million CIED implantations performed over the 16-year period from 1993 to 2008 showed that 69,000 patients required treatment for CIED infection. The average annual increase in CIED implantation was 4.7 %. Implantation of cardiac defibrillators accounted for half of the 96 % overall increase in CIED implantation. The incidence of infection increased by 210 % from 2,660 cases in 1993 to 8,230 cases in 2008. The annual rate of infection rose at a steady pace until 2004 when it jumped from 1.53 % during that year to 2.41 % in 2008 (p<0.001).6 In terms of patient demographics, the occurrence of CIED infection was greatest in white males over 65 years of age, and the most significant associated co-morbidities were renal failure, respiratory failure, heart failure and diabetes. The greatest risk factors for mortality were respiratory failure (odds ratio [OR] 13.58; 95 % confidence interval [CI] 12.88–14.3), renal failure (OR 4.28; 95 % CI 4.04–4.53) and heart failure (OR 2.71; 95 % CI 2.54–2.88).6
These findings are in line with data from a national US survey2 including over 22,000 patients treated between 1996 and 2006. The study showed sharp increases in the proportion of CIED recipients with organ system failure (from 5.0 % to 8.0 % [p<0.001]) and with a diagnosis of diabetes mellitus (from 14.5 % to 16.5 % [p=0.005]). The mean age of patients presenting with CIED infection was 67 ± 16 years with a predominance of white patients (56 %) and males (66 %). The rise in CIED infection-related hospital admissions was not proportional to the increase in number of procedures.
A Danish population-based cohort study including more than 46,000 consecutive patients showed that the incidence rate of surgical site infection after pacemaker (PM) implantation was 4.82 per 1,000 PM-years (192 cases) after initial implantation and 12.12 per 1,000 PM-years (133 cases) after replacement. Independent factors associated with an increased infection risk were: number of operations including replacements, male sex, younger age, implantation during early study period and absence of antibiotics (p<0.001).7
Analysis of the prospective REPLACE Registry (Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures) evaluating complications in patients who underwent CIED replacement at 72 US sites over six months revealed several interesting findings.8 The low infection rate of 1.3 %, was consistent with current practice including widespread use of antibiotic prophylaxis and other preventive measures. Post-operative haematoma was more frequent in patients who developed infection. Sites reporting higher infection rates had sicker patients and lower overall procedure volumes.
Recently a risk evaluation score based on seven factors – early pocket reopening, male sex, diabetes, upgrade procedure, heart failure, hypertension and glomerular filtration rate <60 mL/min – was proposed.9 A retrospective analysis of 1,651 patients showed that scores ranged from 0 to 25 and identified three risk groups:
- Low: score 0–7 with 1.0 % infection,
- Medium: score 8–14 with 3.4 % infection,
- High: score ≥15 with 11.1 % infection.
It has recently been shown that ventricular assist device placement is also frequently complicated by infections.10 However, this specific problem is beyond the scope of this review.
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