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Review

Burden of disease and costs of infections associated with cardiac implantable electronic devices

, ORCID Icon, , & ORCID Icon
Pages 7-16 | Received 18 May 2021, Accepted 10 Sep 2021, Published online: 22 Sep 2021

References

  • Burri H, Starck C, Auricchio A, et al. EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS). (in eng), Europace. 2021 Apr. DOI:https://doi.org/10.1093/europace/euaa367.
  • Balla C, Malagu’ M, Fabbian F, et al. Prognosis after pacemaker implantation in extreme elderly. (in eng), Eur J Intern Med. 2019 Jul;65:37–43.
  • Diemberger I, Mazzotti A, Biffi M, et al. From lead management to implanted patient management: systematic review and meta-analysis of the last 15 years of experience in lead extraction. (in eng), Expert Rev Med Devices. 2013 Jul;10(4):551–573.
  • Blomström-Lundqvist C, Traykov V, Erba PA et al. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). (in eng), Eur Heart J. 2020 Jun;41(21):2012–2032.
  • Diemberger I, Lorenzetti S, Vitolo M, et al. Infective endocarditis in patients with cardiac implantable electronic devices: impact of comorbidities on outcome. (in eng), Eur J Intern Med. 2019 Aug;66:e9–e10.
  • Diemberger I, Bonfiglioli R, Martignani C, et al. Contribution of PET imaging to mortality risk stratification in candidates to lead extraction for pacemaker or defibrillator infection: a prospective single center study. (in eng), Eur J Nucl Med Mol Imaging. 2019 Jan;46(1):194–205.
  • De Maria E, Diemberger I, Vassallo PL, et al. Prevention of infections in cardiovascular implantable electronic devices beyond the antibiotic agent. (in eng), J Cardiovasc Med (Hagerstown). 2014 Jul;15(7):554–564.
  • Balla C, Brieda A, Righetto A, et al. Predictors of infection after “de novo” cardiac electronic device implantation. (in eng), Eur J Intern Med. 2020 Jul;77:73–78.
  • GolzioPG, MagnanoS LioM, Bongiorni MG, et al. Occult bacteraemia in cardiac implantable electronic device patients: a review of diagnostic workflow and mandatory therapy. (in eng), J Cardiovasc Med (Hagerstown). 2019 May;20(5):271–277.
  • Bongiorni MG, Burri H, Deharo JC, et al. 2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS. (in eng), Europace. 2018 Jul;20(7):1217.
  • 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. (in eng), Eur Heart J. 2011 Apr;32(8):991–998.
  • Chauhan A, Grace AA, Newell SA, et al. Early complications after dual chamber versus single chamber pacemaker implantation. (in eng), Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 2):2012–2015.
  • Mounsey JP, Griffith MJ, Tynan M, et al. Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial. (in eng), Br Heart J. 1994 Oct;72(4):339–343.
  • Smith PN, Vidaillet HJ, Hayes JJ, et al. Infections with nonthoracotomy implantable cardioverter defibrillators: can these be prevented? Endotak Lead Clinical Investigators. (in eng), Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 1):42–55.
  • Spinler SA, Nawarskas JJ, Foote EF, et al. Clinical presentation and analysis of risk factors for infectious complications of implantable cardioverter-defibrillator implantations at a university medical center. (in eng), Clin Infect Dis. 1998 May;26(5):1111–1116.
  • Mela T, McGovern BA, Garan H, et al. Long-term infection rates associated with the pectoral versus abdominal approach to cardioverter- defibrillator implants. (in eng), Am J Cardiol. 2001 Oct;88(7):750–753.
  • Bloom H, Heeke B, Leon A, et al. Renal insufficiency and the risk of infection from pacemaker or defibrillator surgery. (in eng), Pacing Clin Electrophysiol. 2006 Feb;29(2):142–145.
  • Sohail MR, Uslan DZ, Khan AH, et al. Risk factor analysis of permanent pacemaker infection. (in eng), Clin Infect Dis. 2007 Jul;45(2):166–173.
  • Klug D, Balde M, Pavin D, et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. (in eng), Circulation. 2007 Sep;116(12):1349–1355.
  • Lekkerkerker JC, van Nieuwkoop C, Trines SA, et al. Risk factors and time delay associated with cardiac device infections: leiden device registry. (in eng), Heart. 2009 May;95(9):715–720.
  • de Oliveira JC, Martinelli M, Nishioka SAD, 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. (in eng), Circ Arrhythm Electrophysiol. 2009 Feb;2(1):29–34.
  • Margey R, McCann H, Blake G, et al. Contemporary management of and outcomes from cardiac device related infections. (in eng), Europace. 2010 Jan;12(1):64–70.
  • Nery PB, Fernandes R, Nair GM, et al. Device-related infection among patients with pacemakers and implantable defibrillators: incidence, risk factors, and consequences. (in eng), J Cardiovasc Electrophysiol. 2010 Jul;21(7):786–790.
  • Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. (in eng), Circulation. 2010 Oct;122(16):1553–1561.
  • Romeyer-Bouchard C, Da Costa A, Dauphinot V, et al. Prevalence and risk factors related to infections of cardiac resynchronization therapy devices. (in eng), Eur Heart J. 2010 Jan;31(2):203–210.
  • Cengiz M, Okutucu S, Ascioglu S, et al. Permanent pacemaker and implantable cardioverter defibrillator infections: seven years of diagnostic and therapeutic experience of a single center. (in eng), Clin Cardiol. 2010 Jul;33(7):406–411.
  • Mittal S, Shaw RE, Michel K, et al. Cardiac implantable electronic device infections: incidence, risk factors, and the effect of the AigisRx antibacterial envelope. (in eng), Heart Rhythm. 2014 Apr;11(4):595–601.
  • Essebag V, Verma A, Healey JS, et al. Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION Study. (in eng), J Am Coll Cardiol. 2016 Mar;67(11):1300–1308.
  • Henrikson CA, Sohail MR, Acosta H, et al. Antibacterial envelope is associated with low infection rates after implantable cardioverter-defibrillator and cardiac resynchronization therapy device replacement: results of the citadel and centurion studies. (in eng), JACC Clin Electrophysiol. 2017 Oct;3(10):1158–1167.
  • Krahn AD, Longtin Y, Philippon F, et al. Prevention of arrhythmia device infection trial: the PADIT trial. (in eng), J Am Coll Cardiol. 2018 Dec;72(24):3098–3109.
  • Olsen T, Jørgensen OD, Nielsen JC, et al. Incidence of device-related infection in 97 750 patients: clinical data from the complete Danish device-cohort (1982–2018). (in eng), Eur Heart J. 2019 Jun;40(23):1862–1869.
  • Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial envelope to prevent cardiac implantable device infection. (in eng), N Engl J Med. 2019 May;380(20):1895–1905.
  • Biffi M, Ammendola E, Menardi E, et al. Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry. (in eng), Europace. 2019 Oct;21(10):1527–1536.
  • El-Chami MF, Jacobsen CM, Griffiths RI, et al. Device-related infection in De Novo transvenous implantable cardioverter-defibrillator medicare patients. (in eng), Heart Rhythm. 2021 Apr;18(8):1301–1309.
  • Ahsan SY, Saberwal B, Lambiase PD, et al. A simple infection-control protocol to reduce serious cardiac device infections. (in eng), Europace. 2014 Oct;16(10):1482–1489.
  • Tarakji KG, Wazni OM, Harb S, et al. Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. (in eng), Europace. 2014 Oct;16(10):1490–1495.
  • Greenspon AJ, Eby EL, Petrilla AA, et al. Treatment patterns, costs, and mortality among Medicare beneficiaries with CIED infection. (in eng), Pacing Clin Electrophysiol. 2018 May;41(5):495–503.
  • Rizwan Sohail M, Henrikson CA, Jo Braid-Forbes M, et al. Increased long-term mortality in patients with cardiovascular implantable electronic device infections. (in eng), Pacing Clin Electrophysiol. 2015 Feb;38(2):231–239.
  • Brough CEP, Rao A, Haycox AR, et al. Real-world costs of transvenous lead extraction: the challenge for reimbursement. (in eng), Europace. 2019 Feb;21(2):290–297.
  • Clémenty N, Carion PL, De Léotoing L, et al. Infections and associated costs following cardiovascular implantable electronic device implantations: a nationwide cohort study. (in eng), Europace. 2018 Dec;20(12):1974–1980.
  • Ludwig S, Theis C, Brown B, et al. Incidence and costs of cardiac device infections: retrospective analysis using German health claims data. (in eng), J Comp Eff Res. 2018 May;7(5):483–492.
  • Ahmed FZ, Fullwood C, Zaman M, et al. Cardiac implantable electronic device (CIED) infections are expensive and associated with prolonged hospitalisation: UK Retrospective Observational Study. (in eng), PLoS One. 2019;14(1):e0206611.
  • Burnhope E, Rodriguez-Guadarrama Y, Waring M, et al. Economic impact of introducing TYRX amongst patients with heart failure and reduced ejection fraction undergoing implanted cardiac device procedures: a retrospective model based cost analysis. (in eng), J Med Econ. 2019 May;22(5):464–470.
  • Boriani G, Maniadakis N, Auricchio A, et al. Health technology assessment in interventional electrophysiology and device therapy: a position paper of the European Heart Rhythm Association. (in eng), Eur Heart J. 2013 Jul;34(25):1869–1874.
  • Da Costa A, Kirkorian G, Cucherat M, et al. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. (in eng), Circulation. 1998 May;97(18):1796–1801.
  • Hussein AA, Baghdy Y, Wazni OM, et al. Microbiology of cardiac implantable electronic device infections. (in eng), JACC Clin Electrophysiol. 2016 Aug;2(4):498–505.
  • Bongiorni MG, Tascini C, Tagliaferri E, et al. Microbiology of cardiac implantable electronic device infections. (in eng), Europace. 2012 Sep;14(9):1334–1339.
  • Wang R, Li X, Wang Q, et al. Microbiological characteristics and clinical features of cardiac implantable electronic device infections at a tertiary hospital in China. (in eng), Front Microbiol. 2017;8:360.
  • Sandoe JA, Barlow G, Chambers JB et al. Guidelines for the diagnosis, prevention and management of implantable cardiac electronic device infection. Report of a joint working party project on behalf of the British Society for Antimicrobial Chemotherapy (BSAC, host organization), British Heart Rhythm Society (BHRS), British Cardiovascular Society (BCS), British Heart Valve Society (BHVS) and British Society for Echocardiography (BSE). (in eng), J Antimicrob Chemother. 2015 Feb;70(2):325–359.
  • Jan E, Camou F, Texier-Maugein J, et al. Microbiologic characteristics and in vitro susceptibility to antimicrobials in a large population of patients with cardiovascular implantable electronic device infection. (in eng), J Cardiovasc Electrophysiol. 2012 Apr;23(4):375–381.
  • Traykov V, Bongiorni MG, Boriani G, et al. Clinical practice and implementation of guidelines for the prevention, diagnosis and management of cardiac implantable electronic device infections: results of a worldwide survey under the auspices of the European Heart Rhythm Association. (in eng), Europace. 2019 Aug;21(8):1270–1279.
  • Asundi A, Stanislawski M, Mehta P, et al. Prolonged antimicrobial prophylaxis following cardiac device procedures increases preventable harm: insights from the VA CART program. (in eng), Infect Control Hosp Epidemiol. 2018 Sep;39(9):1030–1036.
  • Diemberger I, Massaro G, Rossillo A,  et al. Temporary transvenous cardiac pacing: a survey on current practice. (in eng), J Cardiovasc Med (Hagerstown). 2020 Jun;21(6):420–427.
  • Polyzos KA, Konstantelias AA, Falagas ME. Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis. (in eng), Europace. 2015 May;17(5):767–777.
  • Tanner J, Norrie P, Melen K. Preoperative hair removal to reduce surgical site infection. (in eng), Cochrane Database Syst Rev. 2011 Nov;(11):CD004122. DOI:https://doi.org/10.1002/14651858.CD004122.pub4.
  • Franco LM, Cota GF, Pinto TS, et al. Preoperative bathing of the surgical site with chlorhexidine for infection prevention: systematic review with meta-analysis. (in eng), Am J Infect Control. 2017 Apr;45(4):343–349.
  • Darouiche RO, Wall MJ, Itani KM, et al. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. (in eng), N Engl J Med. 2010 Jan;362(1):18–26.
  • Mimoz O, Lucet JC, Kerforne T, et al. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. (in eng), Lancet. 2015 Nov;386(10008):2069–2077.
  • Birnie DH, Healey JS, Wells GA, et al. Continued vs. interrupted direct oral anticoagulants at the time of device surgery, in patients with moderate to high risk of arterial thrombo-embolic events (BRUISE CONTROL-2). (in eng), Eur Heart J. 2018 Nov;39(44):3973–3979.
  • Robinson M, Healey JS, Eikelboom J, et al. Postoperative low-molecular-weight heparin bridging is associated with an increase in wound hematoma following surgery for pacemakers and implantable defibrillators. (in eng), Pacing Clin Electrophysiol. 2009 Mar;32(3):378–382.
  • Du L, Zhang Y, Wang W, et al. Perioperative anticoagulation management in patients on chronic oral anticoagulant therapy undergoing cardiac devices implantation: a meta-analysis. (in eng), Pacing Clin Electrophysiol. 2014 Nov;37(11):1573–1586.
  • Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. (in eng), N Engl J Med. 2013 May;368(22):2084–2093.
  • Kutinsky IB, Jarandilla R, Jewett M, et al. Risk of hematoma complications after device implant in the clopidogrel era. (in eng), Circ Arrhythm Electrophysiol. 2010 Aug;3(4):312–318.
  • Hassoun A, Thottacherry ED, Raja M, et al. Retrospective comparative analysis of cardiovascular implantable electronic device infections with and without the use of antibacterial envelopes. (in eng), J Hosp Infect. 2017 Mar;95(3):286–291.
  • Kolek MJ, Patel NJ, Clair WK, et al. Efficacy of a bio-absorbable antibacterial envelope to prevent cardiac implantable electronic device infections in high-risk subjects. (in eng), J Cardiovasc Electrophysiol. 2015 Oct;26(10):1111–1116.
  • Kolek MJ, Dresen WF, Wells QS, et al. Use of an antibacterial envelope is associated with reduced cardiac implantable electronic device infections in high-risk patients. (in eng), Pacing Clin Electrophysiol. 2013 Mar;36(3):354–361.
  • Shariff N, Patel NJ, Clair WK, et al. Health and economic outcomes associated with use of an antimicrobial envelope as a standard of care for cardiac implantable electronic device implantation. (in eng), J Cardiovasc Electrophysiol. 2015 Jul;26(7):783–789.
  • Bloom HL,  Constantin L, Dan D, et al. Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope. (in eng), Pacing Clin Electrophysiol. 2011 Feb;34(2):133–142.
  • Ullah W, Nadeem N, Haq S, et al. Efficacy of antibacterial envelope in prevention of cardiovascular implantable electronic device infections in high-risk patients: a systematic review and meta-analysis. (in eng), Int J Cardiol. 2020 Sep;315:51–56.
  • Mittal S, Wilkoff BL, Kennergren C, et al. The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: long-term follow-up. (in eng), Heart Rhythm. 2020 Jul;17(7):1115–1122.
  • Birnie DH, Wang J, Alings M, et al. Risk factors for infections involving cardiac implanted electronic devices. (in eng), J Am Coll Cardiol. 2019 Dec;74(23):2845–2854.
  • Ahmed FZ, Blomström-Lundqvist C, Bloom H, et al. Use of healthcare claims to validate the prevention of arrhythmia device infection trial cardiac implantable electronic device infection risk score. (in eng), Europace. 2021 Mar;23(9):1446–1455.
  • Rennert-May E, Raj SR, Leal J, et al. Economic evaluation of an absorbable antibiotic envelope for prevention of cardiac implantable electronic device infection. (in eng), Europace. 2021 May;23(5):767–774.
  • Wilkoff BL, Boriani G, Mittal S,  et al. Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial. (in eng), Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008503.
  • Kay G, Eby EL, Brown B, et al. Cost-effectiveness of TYRX absorbable antibacterial envelope for prevention of cardiovascular implantable electronic device infection. (in eng), J Med Econ. 2018 Mar;21(3):294–300.
  • Boriani G, Kennergren C, Tarakji KG, et al. Cost-Effectiveness analyses of an absorbable antibacterial envelope for use in patients at increased risk of cardiac implantable electronic device infection in Germany, Italy, and England. ed. Value Health. 2021;24(7):930–938.

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