Management of Cardiac Implantable Electronic Device Infection

Login or register to view PDF.
Abstract

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.

Disclosure
C Podoleanu has nothing to declare; JC Deharo has received honoraria for lectures from Spectranetics
Correspondence
Jean-Claude Deharo, Cardiology Department, CHU La Timone, 264 Rue Saint Pierre, 13385 Marseille Cx 5, France. E: jean-claude.deharo@ap-hm.fr
Received date
11 July 2014
Accepted date
22 September 2014
Citation
Arrhythmia & Electrophysiology Review, 2014;3(3):ePub ahead of print

Pages

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

Epidemiology
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.

Pages

References
  1. Bongiorni MG, Marinskis G, Lip GY, et al. How european centres diagnose, treat, and prevent CIED infections: Results of an European Heart Rhythm Association survey. Europace 2012;14:1666–9.
  2. Voigt A, Shalaby A, Saba S. Continued rise in rates of cardiovascular implantable electronic device infections in the united states: Temporal trends and causative insights. Pacing Clin Electrophysiol 2010;33:414–9.
  3. Baddour LM. Cardiac device infection-or not. Circulation 2010;121:1686–7.
  4. Baddour LM, Epstein AE, Erickson CC, et al. Update on cardiovascular implantable electronic device infections and their management: A scientific statement from the American Heart Association. Circulation 2010;121:458–77.
  5. Baman TS, Gupta SK, Valle JA, Yamada E. Risk factors for mortality in patients with cardiac device-related infection. Circ Arrhythm Electrophysiol 2009;2:129–34.
  6. Greenspon AJ, Patel JD, Lau E, et al. 16-year trends in the infection burden for pacemakers and implantable cardioverterdefibrillators in the United States 1993 to 2008. J Am Coll Cardiol 2011;58:1001–6.
  7. Johansen JB, Jørgensen OD, Møller M, et al. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J 2011;32:991–8.
  8. Uslan DZ, Gleva MJ, Warren DK, et al. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol 2012;35:81–7.
  9. Mittal S, Shaw RE, Michel K, et al. Cardiac implantable electronic device infections: Incidence, risk factors, and the effect of the AigisRx antibacterial envelope. Heart Rhythm 2014;11:595–601.
  10. Gordon RJ, Weinberg AD, Pagani FD, et al. Prospective, multicenter study of ventricular assist device infections. Circulation 2013;127:691–702.
  11. Sohail MR, Uslan DZ, Khan AH, et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol 2007;49:1851–9.
  12. Tarakji KG, Chan EJ, Cantillon DJ, et al. Cardiac implantable electronic device infections: Presentation, management, and patient outcomes. Heart Rhythm 2010;7:1043–7.
  13. Chamis AL, Peterson GE, Cabell CH, et al. Staphylococcus aureus bacteremia in patients with permanent pacemakers or implantable cardioverter-defibrillators. Circulation 2001;104:1029–33.
  14. Klug D, Wallet F, Lacroix D, et al. Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart 2004;90:882–6.
  15. Cassagneau R, Ploux S, Ritter P, et al. Long-term outcomes after pocket or scar revision and reimplantation of pacemakers with preerosion. Pacing Clin Electrophysiol 2011;34:150–4.
  16. Le KY, Sohail MR, Friedman PA, et al. Clinical predictors of cardiovascular implantable electronic device-related infective endocarditis. Pacing Clin Electrophysiol 2011;34:450–9.
  17. Sohail MR, Uslan DZ, Khan AH, et al. Infective endocarditis complicating permanent pacemaker and implantable cardioverter-defibrillator infection. Mayo Clin Proc 2008;83:46–53.
  18. Klug D, Balde M, Pavin D, et al. Risk factors related to infections of implanted pacemakers and cardioverterdefibrillators: results of a large prospective study. Circulation 2007;116:1349–55.
  19. Le Dolley Y, Thuny F, Bastard E, et al. Images in cardiovasclar medicine: pacemaker lead vegetation trapped in patent foramen ovale: a cause of hypoxemia after percutaneous extraction. Circulation 2009;119:e223–4.
  20. Duval X, Selton-Suty C, Alla F, et al. Endocarditis in patients with a permanent pacemaker: a 1-year epidemiological survey on infective endocarditis due to valvular and/or pacemaker infection. Clin Infect Dis 2004;39:68–74.
  21. Nagpal A, Baddour LM, Sohail MR. Microbiology and pathogenesis of cardiovascular implantable electronic device infections. Circ Arrhythm Electrophysiol 2012;5:433–41.
  22. Pichlmaier M, Marwitz V, Kühn C, et al. High prevalence of asymptomatic bacterial colonization of rhythm management devices. Europace 2008;10:1067–72.
  23. Bongiorni MG, Tascini C, Tagliaferri E, et al. Microbiology of cardiac implantable electronic device infections. Europace 2012;14:1334–9.
  24. Le Dolley Y, Thuny F, Mancini J, et al. Diagnosis of cardiac device-related infective endocarditis after device removal. JACC Cardiovasc Imaging 2010;3:673–81.
  25. Narducci ML, Pelargonio G, Russo E, et al. Usefulness of intracardiac echocardiography for the diagnosis of cardiovascular implantable electronic device-related endocarditis. J Am Coll Cardiol 2013;61:1398–405.
  26. Bongiorni MG, Di Cori A, Soldati E, et al. Intracardiac echocardiography in patients with pacing and defibrillating leads: A feasibility study. Echocardiography 2008;25:632–8.
  27. Ploux S, Riviere A, Amraoui S, et al. Positron emission tomography in patients with suspected pacing system infections may play a critical role in difficult cases. Heart Rhythm 2011;8:1478–81.
  28. Cautela J, Alessandrini S, Cammilleri S, et al. Diagnostic yield of FDG positron-emission tomography/computed tomography in patients with CEID infection: a pilot study. Europace 2013;15:252–7.
  29. Sarrazin JF, Philippon F, Tessier M, et al. Usefulness of fluorine-18 positron emission tomography/computed tomography for identification of cardiovascular implantable electronic device infections. J Am Coll Cardiol 2012;59:1616–25.
  30. Baddour LM, Cha YM, Wilson WR. Clinical practice. Infections of cardiovascular implantable electronic devices. N Engl J Med 2012;367:842–9.
  31. Durante-Mangoni E, Casillo R, Bernardo M, et al. High-dose daptomycin for cardiac implantable electronic device-related infective endocarditis. Clin Infect Dis 2012;54:347–54.
  32. Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: This document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009;6:1085–104.
  33. Le KY, Sohail MR, Friedman PA, et al. Impact of timing of device removal on mortality in patients with cardiovascular implantable electronic device infections. Heart Rhythm 2011;8:1678–85.
  34. Athan E, Chu VH, Tattevin P, et al. Clinical characteristics and outcome of infective endocarditis involving implantable cardiac devices. JAMA 2012;307:1727–35.
  35. Lopez JA. Conservative management of infected pacemaker and implantable defibrillator sites with a closed antimicrobial irrigation system. Europace 2013;15:541–5.
  36. Da Costa A, Lelièvre H, Kirkorian G, et al. Role of the preaxillary flora in pacemaker infections: a prospective study. Circulation 1998;97:1791–5.
  37. Bertaglia E, Zerbo F, Zardo S, et al. Antibiotic prophylaxis with a single dose of cefazolin during pacemaker implantation: Incidence of long-term infective complications. Pacing Clin Electrophysiol 2006;29:29–33.
  38. de Oliveira JC, Martinelli M, Nishioka SA, et al. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol 2009;2:29–34.
  39. Hansen LK, Brown M, Johnson D, et al. In vivo model of human pathogen infection and demonstration of efficacy by an antimicrobial pouch for pacing devices. Pacing Clin Electrophysiol 2009;32:898–907.
  40. Bloom HL, Constantin L, Dan D, et al. Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope. Pacing Clin Electrophysiol 2011;34:133–42.
  41. Kolek MJ, Dresen WF, Wells QS, Ellis CR. Use of an antibacterial envelope is associated with reduced cardiac implantable electronic device infections in high-risk patients. Pacing Clin Electrophysiol 2013;36:354–61.
  42. Deharo JC, Bongiorni MG, Rozkovec A, et al. Pathways for training and accreditation for transvenous lead extraction: a European Heart Rhythm Association position paper. Europace 2012;14:124–34.
  43. Marijon E, De Guillebon M, Bordachar P, et al. Safety of deferring the reimplantation of pacing systems after their removal for infectious complications in selected patients: a 1-year follow-up study. J Cardiovasc Electrophysiol 2010;21:540–4.
  44. Rickard J, Tarakji K, Cheng A, et al. Survival of patients with biventricular devices after device infection, extraction, and reimplantation. JACC Heart Fail 2013;1:508–13.
  45. Habib G, Hoen B, Tornos P, et al. Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (new version 2009): the Task Force on the Prevention, Diagnosis, and Treatment of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the International Society of Chemotherapy (ISC) for Infection and Cancer. Eur Heart J 2009;30:2369–413.
  46. Deharo JC, Quatre A, Mancini J, et al. Long-term outcomes following infection of cardiac implantable electronic devices: A prospective matched cohort study. Heart 2012;98:724–31.
  47. Braun MU, Rauwolf T, Bock M, et al. Percutaneous lead implantation connected to an external device in stimulationdependent patients with systemic infection--a prospective and controlled study. Pacing Clin Electrophysiol 2006;29:875–9.
  48. Kawata H, Pretorius V, Phan H, et al. Utility and safety of temporary pacing using active fixation leads and externalized re-usable permanent pacemakers after lead extraction. Europace 2013;15:1287–91.
  49. Uslan DZ, Sohail MR, St Sauver JL, et al. Permanent pacemaker and implantable cardioverter defibrillator infection: a population-based study. Arch Intern Med 2007;167:669–75.
  50. Chua JD, Wilkoff BL, Lee I, et al. Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Ann Intern Med 2000;133:604–8.
  51. Cacoub P, Leprince P, Nataf P, et al. Pacemaker infective endocarditis. Am J Cardiol 1998;82:480–4.
  52. Klug D, Lacroix D, Savoye C, et al. Systemic infection related to endocarditis on pacemaker leads: Clinical presentation and management. Circulation 1997;95:2098–107.
  53. Habib A, Le KY, Baddour LM, et al. Predictors of mortality in patients with cardiovascular implantable electronic device infections. Am J Cardiol 2013;111:874–9.
  54. Brunner M, Olschewski M, Geibel A, et al. Long-term survival after pacemaker implantation. Prognostic importance of gender and baseline patient characteristics. Eur Heart J 2004;25:88–95.
  55. Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005;352:1539–49.
  56. Goldenberg I, Gillespie J, Moss AJ, et al. Long-term benefit of primary prevention with an implantable cardioverterdefibrillator: an extended 8-year follow-up study of the Multicenter Automatic Defibrillator Implantation Trial II. Circulation 2010;122:1265–71.