Lead extraction is a complex issue because the variability of indication, number of leads, and the amount of vascular and myocardial fibrosis require an individual risk assessment
Brigitte Osswald MD
Department of Cardiovascular Surgery,
University of Düsseldorf, Germany
More than 750,000 pacemakers and 250,000 cardioverter defibrillators (ICDs) are implanted worldwide for the first time each year. Therefore, lead extraction strategies play a crucial role for a growing number of patients.(1)
Prophylactic indications for ICDs, and issues such as biventricular pacing being in favour of permanent right ventricular pacing in complete atrioventricular (AV) block, encourage the placement of multiple leads. The number of leads present in the vascular system one of the most important risk factors for difficult lead extraction and venous occlusion.(2) In addition, younger patient age at implantation and higher life expectancy contribute to a growing number of lead- or system-related revisions. The necessity for technical support systems in more recently implanted leads is also unpredictable.(3)
Apart from indication- and patient-related factors, pacemaker implantation is not restricted to specialised institutions in many countries and therefore even surgical technical problems can be a major reason for lead-related (re-)interventions. This is especially true for improper vascular access, placement of multiple leads without knowledge, and the environment for simultaneous lead extraction. Even ‘simple’ procedural steps, such as sleeve fixation or placement of lead remnants, contribute to the performance of pacemaker and ICD leads.
Lead integrity in several mid-term implanted leads requires careful consideration about the benefits and disadvantages of lead extraction. Recently, ICD leads from a number of different manufacturers have been identified as being at a high risk for early lead dysfunction and a statement was made by the German Society for Cardiology.(4) The risk of immediate lead extraction, for example as a simultaneous procedure at the time of a box exchange, was considered to be too high and a simple placement of a further lead was proposed in case of lead dysfunction.
Collaboration between electrophysiologists and cardiac surgeons resulted in the publication of a common statement,(5) calling for differentiated approach, owing to the fact that over time, the advanced vascular ingrowth of disrupted isolation material increases the risk for major complications as future indications for lead removal. Therefore, an attempt for lead extraction is recommended with proper preparation and techniques, especially in patients with >15 years’ life expectancy. Greater consideration is necessary for paediatric patients, because younger patient age and anticipated further lead placements have to been taken into account.
The limited predictability of the simplicity of lead extraction in the individual patient requires a straightforward procedure, according to the current guidelines for lead extraction(6) at ‘centralised centres’ with accredited cardiac surgery and cardiac catheterisation programmes.
One of the main issues during lead extraction is stabilising he total lead body by at least guiding stylets or, preferably, by special locking devices placed up to the very distal end of the lead before the very first pulling attempt. Once the inner lumen is disrupted or stretched, any further transvenous extraction technique becomes much more difficult and sometimes even impossible. From personal experience, the indication for removal always plays a major role if more ‘simple’ actions are insufficient and a more invasive approach becomes necessary.
If a superfluous old lead is to be removed, the aggressiveness of extraction attempts is likely to be less intense than it is in terms of class I indication in cases of pacemaker or ICD system infection. Therefore, a general recommendation for the treatment of remaining non-infected leads might be misleading because factors including the patient’s age, life expectancy and the total patient status have to be considered in all types of lead extraction procedures. In cases of infection, the complete removal of foreign material is mandatory and therefore requires all possible efforts and potentially all kinds of invasive escalation at the same procedure.
Less often mentioned is the fact that unexpected lead revision is sometimes necessary. This is especially true for the so-called ‘simple’ box exchange. Isolation defects and ignorance of the presence of an ‘old’ connector type could immediately increase the complexity of the intervention. Repair kits are still on the market, but extended lead repair is often to be observed at re-revision, even in unipolar leads.
Because of limited venous capacity and considerations about future behaviour of the remaining non-functional lead, many times an attempt is made to remove the lead by (more or less) simple traction, even if no facility for a more complex procedure is available and a straightforward escalation strategy is impossible owing to environmental and educational reasons. In case of non- or ‘partial’ success, lead remnants at different degrees of preserved integrity remain apart from newly inserted functioning leads or the patient is referred to the next centre that has the required equipment for any lead removal and lead placement. Whether or not lead remnants become a crucial factor in terms of necessary lead extraction in the mid- or long-term are dependent on many factors, such as those already mentioned above.
If simple traction is insufficient, sheaths may be used to separate the lead body from the vascular system and/or myocardium.(6)
There are no clear data on superiority or inferiority of mechanical versus electrical or laser energy supplying sheaths because the variability in the amount and distribution pattern of fibrous or calcified tissue around the lead bodies on one hand, and the differences in lead-related issues concerning ease of lead removal on the other hand, are extremely difficult to compare. Results may be best if the technique with the highest personal experience is used and appropriate training is performed. In this context, proctoring may help to establish a programme, but even the most experienced extractors underwent a learning curve and experience is strictly correlated to exposure.
Success rates are likely to be related to personal preference and to the personal experience of the extracting physician.
Although very high overall success rates are published by either method, there are some patients for whom traction fails and neither the mechanical nor the laser sheath strategy is successful. For the majority of these patients, minimal invasive open-heart surgery offers complete lead and lead remnant removal. As seen in many cases, complex removal ending by an open heat approach was justified because of the presence of more extensive fibrotic material and/or vegetations than previously evaluated by transesophageal echocardiography, which is an essential intraoperative diagnostic tool for all kinds of lead removal. In patients with complex cardiac comorbidity, a primary open chest surgery according to the attempted surgical approach is indicated. Although each patient requires an individual weighing of aggressiveness and optimal approach, registries such as ELECTRa can help to identify specified risks for different methodologies.(7)
Despite the growing number of lead-related (re-)interventions, there is no ‘gold standard’ in lead extraction. The variability in general patient status, indication and complexity of implanted systems prohibits a ‘one-for-all’ strategy. The safest treatment option, as carried out in most specialist facilities, is a step-wise increase in the aggressiveness of methods, starting with simple stabilised traction over different kinds of sheath and concluding with a potential open heart procedure. Forced lead traction and all types of sheath manoeuvres carry the risk of life-threatening complications that require immediate surgery potentially combined with circulatory support. In terms of quality assessment, registries on all consecutive patients requiring lead removal are desirable to provide data for a more objective lead extraction strategy.
- Mond HG, Proclemer A. The 11th World Survey of Cardiac Pacing and Implantable Cardioverter-Defibrillators: Calendar Year 2009 – A World Society of Arrhythmias Project. PACE 2011;34:1013–27.
- Mazzone P et al. Predictors of advanced lead extraction based on a systematic stepwise approach: results from a high volume center. Pacing Clin Electrophysiol 2013;36:837–44.
- Maytin M, Epstein LM, John RM. Lead implant duration does not always predict ease of extraction: extraction sheath may be required at < 1 year pacing. Clin Electrophysiol 2011;34:1615–20.
- Israel CW et al. Recommendations of the Working Group of Arrhythmias of the German Society of Cardiology on the approach to patients with Riata® and Riata ST® leads (St. Jude Medical). Nucleus of the Working Group of Arrhythmias of the German Society of Cardiology. Herzschrittmacherther Elektrophysiol 2012;23(2):107–15.
- Osswald B et al. Stellungnahme der Arbeitsgruppe Elektrophysiologische Chirurgie der Deutschen Gesellschaft für Thorax-, Gefäß- und Herzchirurgie zu den Empfehlungen der Deutschen Gesellschaft für Kardiologie (Arbeitsgruppe Rhythmologie) im Umgang von Patienten mit ICD- Elektroden Riata und Riata ST der Firma St. Jude Medical. Herz, Thorax Gefäßchir;2013.
- Wilkoff BL et al. Transvenous lead extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management. Heart Rhythm 2009;6:1085–104.
- Bongiorni MG et al. ELECTRa (European Lead Extraction ConTRolled) Registry: Shedding light on transvenous lead extraction real-world practice in Europe. Herzschrittmacherther Elektrophysiol 2013;24(3):171–5.