- Over the past 60 years, CIEDs have become established as an important therapeutic modality of cardiovascular care for the treatment of patients with bradycardia, tachycardia, and heart failure.
- Although recent technological advances have eliminated the need for transvenous or epicardial leads for CIEDs used in selected groups of patients, lead management remains critical for a variety of reasons.
- Recent estimates suggest that 1.2–1.4 million CIEDs are implanted annually worldwide.
- Questions on lead management arise in a number of situations, including when changes in a patient’s clinical condition make a different functionality more or less important, if a lead becomes nonfunctional, and if the presence of a lead is thought to interfere with the patients' optimal treatment.
The grading system for indication level of class of evidence was adapted based on that used by the ACC and the AHA (Jacobs, Anderson, Halperin, 2014) (Anderson, 2015).
Colors in tables correspond to the Class of Recommendations and Level of Evidence Table
on pages 18–19.
- The primary focus is on ICD leads due to their higher failure rates compared with pacing leads and the clinical challenges pertaining to lead management in patients with Sprint Fidelis and Riata ICD leads.
- Generally, the same diagnostic principles apply to pacemaker leads, with the exceptions that oversensing in ICD leads results in inappropriate shocks and pacing inhibition and that high-voltage failure modes do not apply to pacing leads.
- In the past, the most common presentation of pace-sense lead fracture was inappropriate shocks.
- In recent years, due to device diagnostics that incorporate the detection of short intervals and changes in impedance and the widespread use of remote monitoring, an increasing number of patients are presenting with lead alerts, enabling early recognition of lead failure before the onset of adverse clinical events.
- Device electrogram (EGM) analysis is important in the diagnostic approach to suspected lead failure, especially pace-sense circuit failures because oversensing (noise) is the most common observation in this failure mode.
Table 1. Definitions
A lead that is not usable due to electrical dysfunction, regardless of whether it is connected to the CIED or not
A functional or nonfunctional lead that is left in place and is not connected to the CIED
Lead removal procedure
A procedure involving the removal of a pacing or defibrillator lead using any technique, regardless of time since implantation
Lead explant procedure
Lead removal procedure where all leads were removed without tools or with implantation stylets and all removed leads were implanted for less than one year
Lead removal procedure where at least one lead removal required the assistance of equipment not typically employed during lead implantation or at least one lead was implanted for greater than one year
Definitions for Extraction Procedures
Complete procedural success
Lead extraction procedure with removal of all targeted leads and all lead material from the vascular space, with the absence of any permanently disabling complication or procedure-related death
Complete procedural success rate
Extraction procedures where there is complete procedural success/total number of extraction procedures
Lead extraction procedures with removal of all targeted leads and lead material from the vascular space or retention of a small portion of the lead (<4 cm) that does not negatively impact the outcome goals of the procedure
Clinical success rate
Extraction procedures where there is clinical success/total number of extraction procedures
Lead extraction procedures in which complete procedural or clinical success cannot be achieved, or the development of any permanently disabling complication or procedure-related death
Failed extraction procedures/total number of extraction procedures
Lead removal with clinical success
Leads with attempted removal where the entire lead is taken out of the body or with retention of a small portion of the lead material (<4 cm) that does not negatively impact the outcome goals of the procedure
Lead removal with clinical success rate
Number of leads removed with clinical success during a lead extraction/total number of leads with attempted removal