References

Spectranetics
  1. Voigt, Andrew, et al. Rising Rates of Cardiac Rhythm Management Device Infections in the United States: 1996 through 2003. JACC Vol. 48, No. 3, 2006: 590-1.
  2. Voigt, Andrew, et al. Continued Rise in Rates of Cardiovascular Implantable Electronic Device Infections in the United States: Temporal Trends and Causative Insights. PACE Vol. 33, No. 4, 2010: 414-9.
  3. Greenspon AJ, Patel JD, Lau E, et al. 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008. J Am Coll Cardiol. 2011;58(10):1001-1006. doi:10.1016/j.jacc.2011.04.033.
  4. Data on file, see infographic references
  5. de Bie, Mihály K., et al. "Cardiac device infections are associated with a significant mortality risk." Heart Rhythm 9.4 (2012): 494-498.
  6. Chua, J.D., et al. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Annals of Internal Medicine, 133(8): 604-608
  7. Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.
  8. Sohail, MR, et al. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859
  9. Margey, R. et al. Contemporary management of and outcomes from cardiac device related infections Europace (2010) 12 (1): 64-70 first published online November 11, 2009 doi:10.1093/europace/eup362
  10. del Rio, A, Anguera I, Miro JM, et al. Surgical treatment of pacemaker and defibrillator lead endocarditis: the impact of electrode lead extraction on outcome. Chest 2003;124:1451–9.
  11. Wazni, O. et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55:579-586.
  12. Wilkoff, B.L., et al. (2009). Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications and patient management. Heart Rhythm, 6, 1085-1104.
  13. Wilkoff, B.L., et al. (1999). Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. Journal of the American College of Cardiology, 33(6).
  14. Byrd, C., et al. (2002). Clinical study of the laser sheath for lead extraction: The total experience in the United States. Journal of Pacing and Electrophysiology, 25(5)
  15. Le KY, Sohail MR, Friedman PA, et al. Impact of timing of device removal on mortality in patients with cardiovascular implantable electrophysiologic device infections. Heart Rhythm 2011;8:1678 – 85.
  16. Lazãr, Veronica, and C. Chifiriuc. "Medical significance and new therapeutical strategies for biofilm associated infections." Rom Arch Microb & Immunol 69 (2010): 125-138.
  17. Chen L. and Wen, Y. “The role of bacterial biofilm in persistent infections and control strategies.” Int J Oral Sci, 2011, DOI: 10.4248/IJOS11022
  18. Baddour, L.M., et al. (2010). Update on cardiovascular implantable electronic device infections and their management: A scientific statement from the American Heart Association. Circulation, 121, 458-477.
  19. Deharo, J. C., et al. "Pathways for training and accreditation for transvenous lead extraction: a European Heart Rhythm Association position paper."Europace 14.1 (2012): 124-134.
  20. Klug, Didier, et al. "Involvement of adherence and adhesion Staphylococcus epidermidis genes in pacemaker lead-associated infections." Journal of clinical microbiology 41.7 (2003): 3348-3350.
  21. Sohail, MR, Henrickson, CA, Braids-Forbes M, Forbes K, Lerner DJ, Mortality and cost associated with cardiovascular implantable electrophysiologic device infections. Arch Inern Med/Vol 171(No.20). Nov 14, 2011.
  22. Inpatient Prospective Payment System (IPPS) Final Rule FY13
  23. Cappato R, Calkins H, Chen SA, et al. Worldwide Survey on the Methods, Efficacy, and Safety of Catheter Ablation for Human Atrial Fibrillation. Circulation 2005; 111:1100-11105
  24. Cappato R, Calkins H, Chen SA, et al. Prevalence and causes of fatal outcome in catheter ablation of atrial fibrillation. J Am Coll Cardiol 2009; 53:1798-1803.
  25. Kern M. SCAI Interventional Cardiology Board Review Book. Lippincott Williams & Wilkins 2006; p.165.
  26. Poole, J. et. al., Complication Rates Associated with Pacemaker and ICD Generator Replacements when Combined with Planned Lead Addition or Revision, American Heart Association, November 15, 2009.
  27. Brignole, M. et. al., Defibrillation testing at the time of implantation of cardioverter defibrillator in the clinical practice: a nation-wide survey, Europace 2007 Vol. 9 No. 7: 540-543.
  28. Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H.,et al. (2009). Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management. Retrieved May 13, 2009, from http://www.hrsonline.org/Practice-Guidance/Clinical-Guidelines-Documents/2009-Expert-Consensus-Statement-on-Lead-Extraction-in-Patients-w-CIEDs#axzz3hrpADBXP
  29. de Cock, CC, et al. Long-term outcome of patients with multiple (> or = 3) noninfected leads: a clinical and echocardiographic study. PACE, Vol. 23, No. 4, 2000, 423-6.
  30. Larsen, JM, MD, Prospective Nationwide Fluoroscopic and Electrical Longitudinal Follow-up of Recalled Riata Defibrillator Leads in Denmark, Heart Rhythm, http://dx.doi.org/10.1016/j.hrthm.2014.09.003
  31. Inpatient Prospective Payment System (IPPS) Final Rule FY13.
  32. Centers for Medicare & Medicaid Services, US Department of Health and Human Services. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatroy Surgical Centers. Baltimore, MD: Centers for Medicare & Medicaid Services; 2012. CMS publication CMS-1588-P.
  33. Rungpradubvong, V et al. Outcomes of early and delayed removal in patients with cardiac implantable electronic device infection. Poster Presentation. 2014 Heart Rhythm Society Annual Scientific Sessions, San Francisco, CA
  34. 1999 - 2013 AHA Annual Survey, Copyright 2015 by Health Forum, LLC, an affiliate of the American Hospital Association. Special data request, 2015. Available at http://www.ahaonlinestore.com.
  35. Maytin M, Jones SO, Epstein LM. Long-Term Mortality After Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2012;5:252-257.

References for “Infection by the Numbers"

  1. Product Performance Review: St Jude First Edition 2013.
  2. Product Performance Review: Medtronic First Edition 2013
  3. Product Performance Review: Boston Scientific Q1 2013
  4. Product Performance Review: Biotronik July 2013
  5. iData (2012)
  6. Nery, P. et al. (2012). Device-Related Infection Among Patients With Pacemakers and Implantable Defibrillators: Incidence, Risk Factors, and Consequences. Journal of Cardiovascular Electrophysiology, Volume 21, Issue 7. Pages 789-790.
  7. Greenspon AJ, Patel JD, Lau E, et al. 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008. J Am Coll Cardiol. 2011;58(10):1001-1006. doi:10.1016/j.jacc.2011.04.033.
  8. de Bie, Mihály K., Johannes B. van Rees, J. Thijssen, C. Jan Willem Borleffs, Serge A. Trines, Suzanne C. Cannegieter, Martin J. Schalij, Lieselot van Erven, Cardiac device infections are associated with a significant mortality risk, Heart Rhythm, Volume 9, Issue 4, April 2012, Pages 494-498, ISSN 1547-5271
  9. Romeyer-Bouchard, Cécile, Antoine Da Costa, Virginie Dauphinot, Marc Messier, Laurence Bisch, Bernard Samuel, Patrick Lafond, Philippe Ricci, and Karl Isaaz Prevalence and risk factors related to infections of cardiac resynchronization therapy devices Eur Heart J (2010) 31 (2): 203-210 first published online October 28, 2009 doi:10.1093/eurheartj/ehp421
  10. Margey, R. et al. Contemporary management of and outcomes from cardiac device related infections Europace (2010) 12 (1): 64-70 first published online November 11, 2009 doi:10.1093/europace/eup362
  11. Mounsey, J. P., et al. "Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial." British heart journal 72.4 (1994): 339-343.
  12. Voigt, A., et al. (2006). Rising rates of cardiac rhythm management device infections in the United States: 1996 through 2003. JACC, 48(3), 590-591.
  13. Klug, D., et al. "Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators results of a large prospective study." Circulation 116.12 (2007): 1349-1355
  14. Tarakji, Khaldoun G., et al. "Cardiac implantable electronic device infections: presentation, management, and patient outcomes." Heart Rhythm 7.8 (2010): 1043-1047
  15. Leclercq C, Cazeau S, Lellouche D, Fossati F, Anselme F, Davy JM, Sadoul N, Klug D, Mollo L, Daubert JC. Upgrading from single chamber right ventricular to biventricular pacing in permanently paced patients with worsening
  16. Number of extractions for infections based on: Internal sales data, Centers for Medicare & Medicaid Services (CMS), Lead Management survey conducted by in2ition for Spectranetics (n=100), September 2010, Lead Management survey conducted by in2ition for Spectranetics (n=125), September 2011, Lead Management survey conducted by Optimal Strategix Group for Spectranetics (n=95), May 2013.
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THIS EDUCATIONAL CONTENT IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY. CARDIAC DEVICE REMOVAL MAY NOT BE APPROPRIATE FOR SOME PATIENTS DEPENDING ON INDIVIDUAL HEALTH FACTORS. TREATMENT DECISIONS SHOULD ALWAYS BE BASED ON THE JUDGMENT AND EXPERTISE OF A HEALTHCARE PROFESSIONAL. IF YOU ARE A PATIENT WITH QUESTIONS OR CONCERNS ABOUT AN IMPLATED CARDIAC DEVICE, PLEASE CONSULT WITH YOUR PHYSICIAN.

 
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