Customer Communications
Performance Note: General Follow-Up and Replacement of ICD Leads

Performance Note: General Follow-Up and Replacement of ICD Leads

ICD Leads
Original Date of Communication: January 1997

View specific models that this applies to

Revised 2007

Implanted leads operate in the challenging biochemical environment of the human body and the body’s response to foreign objects. Implanted leads are also subject to mechanical stresses associated with heart motion, body motion, and patient anatomy.

In this environment, pacemaker and defibrillation leads cannot be expected to last forever. Unlike implantable cardioverter defibrillators (ICDs), a lead’s longevity cannot be predicted nor are there simple indicators that a lead is approaching the end of its service life. The determination that a lead may be approaching end of service life requires follow-up of the chronically implanted lead and thorough evaluation of lead integrity at ICD replacement.

Follow-Up of Chronically Implanted Leads

The frequency of follow-up for ICD patients will depend on a number of factors including the patient’s medical condition, ICD system implant time, hospital/clinic follow-up practice, and Medicare guidelines. In all cases, it is important to assess the functionality of the ICD system and the integrity. For newly implanted leads, it is beneficial to establish a baseline of chronic performance parameters once the lead has stabilized, generally within 6 to 12 months after implant. These performance parameters should include pacing and sensing thresholds and impedance. During routine patient follow-up, these procedures can be used to evaluate lead integrity.

  • Measure pacing and sensing threshold and compare to the chronic baseline. Significant increases or decreases may be indicative of lead failure, dislodgement, perforation, exit block, etc.
  • Measure pacing impedance where possible and compare to the chronic baseline. Decreases of 30% or more or pacing impedances below 200-250 ohms may be indicative of insulation failure. Sudden and significant increases in pacing impedance may be indicative of conductor fracture.
  • High voltage lead circuit impedance should be between 10-75 ohms at system implant. Chronic measurements below 10 and above 200 ohms may be indicative of high voltage lead circuit failure.
  • Carefully review ECGs or the nonsustained detection log on Medtronic ICDs for indications of pacing and/or sensing abnormalities such as oversensing, undersensing, and loss of capture.
  • Elicit and investigate any patient complaints/symptoms that may be suggestive of potential lead failure.

Where routine follow-up indicates, additional tools should be used to further evaluate performance. Tools include radiographic data, ICD electrograms, ICD Patient Alert and performance information from the System Longevity Study (SLS).

The final decision on the functional integrity and continued use of an implanted lead must be a matter of medical judgment based on these factors as well as specific patient conditions.

General Criteria for Lead Replacement

The evaluation of a chronically implanted lead is an important part of the decision to continue to use the lead with a new ICD. However, these results alone do not necessarily predict the future integrity of that lead. With the expected longevity of today’s ICDs varying between approximately 5 and 10 years, a physician replacing a device should consider a number of factors, including those listed below.

Factors that should be considered in a decision to replace or continue to use include:

  • Pacing and sensing thresholds should be evaluated for the potential to maintain acceptable levels
  • Pacing impedance should be measured. Bear in mind that pacing impedance below 250 ohms results in excessive battery current drain, which may seriously compromise ICD longevity, regardless of lead integrity.
  • The physical appearance of the lead should be examined for insulation cracks, breaches, or other indications of lead wear or degradation
  • Medtronic System Longevity Study data should be referenced. Actuarial survival of the lead and the observed lead failure mechanisms are specific factors to consider. Use of a new lead should be considered if failure mechanisms suggest an increased time dependency as suggested in the shape of performance curve for the specific lead model.
  • Current publications may provide additional information on the clinical management of leads.1-3 Ultimately, the decision to replace an implanted lead involves medical judgment.

1 Hauser RG, Cannom D, Hayes DL, et al. Long-term structural failure of coaxial polyurethane implantable cardioverter defibrillator leads. PACE. June 2002;25(6):879-882.

2 Ellenbogen KA, Wood MA, Shepard RK, et al. Detection and management of an implantable cardioverter defibrillator lead failure: incidence and clinical implications. J Am Coll Cardiol. January 1, 2003;41(1):73-80.

3 Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm. July 2007;4(7):892-896.

Specific Models This Applies To 726050