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cardiovascular implantable electronic device (CIED)

Includes: 1) cardiac pacemaker 2) implantable cardioverter defibrillator (ICD) 3) cardiac resynchronization therapy (CRT) Indications: - see specific device - cardiac pacemakers & implantable cardioverter defibrillators - symptomatic bradycardia - ventricular arrhythmias - ventricular fibrillation - cardiac resynchronization therapy or His bundle pacing [16] - chronic heart failure Complications: - device-related infection carries risk of mortality [1] - obtain blood cultures [5] - documented infection requires antibiotic therapy & removal of device [5] - device pocket infection is a clinical diagnosis [5] - do not aspirate device pocket for diagnostic purposes [5] (see implantable defibrillator) - nonthoracic MRI may be safe with conventional pacemakers or implantable cardioverter-defibrillators (ICDs) [9] - risk for hacking of defibrillators & cardiac pacemakers [10,11] - actual risk is minimal [10] - potential risk for hacking into a hospital network is real & could limit clinicians' abilities to remotely monitor devices - risk for a cybersecurity breach far outweighs the risk for malfunction arising from ICD software fixes [10] - CIEDs are shielded & safe from electric cars [12] - battery malfunction [11] - hospitals have widely varying complication rates [14] - infections with reused devices (explanted at the time of burial or cremation) are uncommon [15] - common electromagnetic devices may interfere with operation of CIEDs - these include Apple iPhone 12, Apple AirPods Pro & their wireless charging case, Microsoft Surface Pen, & Apple Pencil 2nd generation [17] Notes: - implantable cardioverter-defibrillators (ICDs) & cardiac resynchronization therapy (CRT) devices often include a feature that measures intrathoracic impedance, potentially providing an early warning system for decompensation by detecting pulmonary fluid retention - many devices are FDA approved based on weak clinical research ata [4]

Related

cardiac device infection

Specific

Barostim Neo System implant cardiac pacemaker carotid sinus baroreflex activation device implantable cardioverter defibrillator (ICD) left atrial hemodynamic monitor Optimizer Smart System pulmonary artery pressure measurement system pulmonary artery pressure monitor (CardioMEMS HF)

General

implant electronic device

References

  1. Sohail MR et al Mortality and Cost Associated With Cardiovascular Implantable Electronic Device Infections Arch Intern Med. Published online September 12, 2011 PMID: 21911623 http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.441
  2. Journal Watch Massachusetts Medical Society Journal Watch Cardiology November 30, 2011 http://cardiology.jwatch.org
  3. Tracy CM et al 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. A Report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol. September 2012 PMID: 22965336 http://content.onlinejacc.org/article.aspx?articleID=1357576
  4. Chen CE et al. Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval. JAMA 2012 Nov 7; 308:1740. PMID: 23117769
  5. Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 19. American College of Physicians, Philadelphia 2012, 2015, 2022
  6. Lampert R, Hayes DL, Annas GJ et al HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm. 2010 Jul;7(7):1008-26 PMID: 20471915 corresponding NGC guideline withdrawn Jan 2016
  7. Baddour LM, Cha YM, Wilson WR. Clinical practice. Infections of cardiovascular implantable electronic devices. N Engl J Med. 2012 Aug 30;367(9):842-9 PMID: 22931318
  8. Epstein AE, DiMarco JP, Ellenbogen KA et al ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008 May 27;117(21):e350-408 PMID: 18483207
  9. Russo RJ, Costa HS, Silva PD et al Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med 2017; 376:755-764. February 23, 2017 PMID: 28225684 http://www.nejm.org/doi/full/10.1056/NEJMoa1603265
  10. Baranchuk A, Refaat MM, Patton KK et al. Cybersecurity for cardiac implantable electronic devices: What should you know? J Am Coll Cardiol 2018 Feb 20; PMID: 29475627 https://www.sciencedirect.com/science/article/pii/S0735109718302006
  11. FDA Safety Communication. April 17, 2018 Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm604706.htm
  12. Lennerz C, O'Connor M, Horlbeck L et al. Electric cars and electromagnetic interference with cardiac implantable electronic devices: A cross-sectional evaluation. Ann Intern Med 2018 Apr 24 PMID: 29710279 http://annals.org/aim/article-abstract/2679357/electric-cars-electromagnetic-interference-cardiac-implantable-electronic-devices-cross-sectional
  13. Harrison JL, Prendergast BD, Sandoe JA. Guidelines for the diagnosis, management and prevention of implantable cardiac electronic device infection. Heart. 2015 Feb;101(4):250-2. Review. PMID: 25550318 Free Article
  14. Ranasinghe I, Labrosciano C, Horton D et al. Institutional variation in quality of cardiovascular implantable electronic device implantation: A cohort study. Ann Intern Med 2019 Jul 30; PMID: 31357210 - Wong JA, Devereaux PJ. Cardiac device implantation complications: A gap in the quality of care? Ann Intern Med 2019 Jul 30; PMID: 31357214
  15. Khairy TF, Lupien MA, Nava S et al. Infections associated with resterilized pacemakers and defibrillators. N Engl J Med 2020 May 7; 382:1823 PMID: 32374963 https://www.nejm.org/doi/10.1056/NEJMoa1813876
  16. Vinther M et al. A randomized trial of His pacing versus biventricular pacing in symptomatic heart failure patients with left bundle branch block (His-Alternative). JACC Clin Electrophysiol 2021 Apr 25; [e-pub]. PMID: 34167929 https://www.sciencedirect.com/science/article/abs/pii/S2405500X21003285
  17. Fery C et al. Magnetic field measurements of portable electronic devices: The risk inside pockets for patients with cardiovascular implantable devices. Circ Arrhythm Electrophysiol 2022 Mar; 15:e010646 PMID: 35227069 https://www.ahajournals.org/doi/10.1161/CIRCEP.121.010646