Lead Management
The Heart Rhythm Society (HRS) recommends removal of pacing and defibrillation leads under class I and II indications. Spectranetics technologies help physicians when removal is necessary in Cardiac Lead Management.
“Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes.”*
SLS® II - The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
LLD®, LLD® E, LLD EZ® - The LLD is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.
HRS Indications for Lead Removal
- Complete device and lead removal is recommended in all patients with definite CIED system infection, as evidenced by valvular endocarditis, lead endocarditis or sepsis.
- Complete device and lead removal is recommended in all patients with CIED pocket infection as evidenced by pocket abscess, device erosion, skin adherence, or chronic draining sinus without clinically evident involvement of the transvenous portion of the lead system.
- Complete device and lead removal is recommended in all patients with valvular endocarditis without definite involvement of the lead(s) and/or device.
- Complete device and lead removal is recommended in patients with occult gram-positive bacteremia (not containment).
- Complete device and lead removal is reasonable in patients with persistent occult gram-negative bactermia.
- CIED removal is not indicated for a superficial or incisional infection without involvement of the device and/or leads.
- CIED removal is not indicated to treat chronic bacteremia due to a source other than the CIED, when long-term suppressive antibiotics are required.
- Device and/or lead removal is reasonable in patients with severe chronic pain, at the device or lead insertion site, that causes significant discomfort for the patient, is not manageable by medical or surgical techniques and for which there is no acceptable alternative.
- Lead removal is recommended in patients with clinically significant thromboembolic events associated with thrombosis on a lead or a lead fragment.
- Lead removal is recommended in patients with bilateral subclavian vein or SVC occlusion precluding implantation of a needed transvenous lead.
- Lead removal is recommended in patients with planned stent deployment in a vein already containing a transvenous lead, to avoid entrapment of the lead.
- Lead removal is recommended in patients with superior vena cava stenosis or occlusion with limiting symptoms.
- Lead removal is recommended in patients with ipsilateral venous occlusion preventing access to the venous circulation for required placement of an additional lead when there is a contraindication for using the contralateral side (e.g., contralateral AV fistula, shunt or vascular access port, mastectomy).
- Lead removal is reasonable in patients with ipsilateral venous occlusion preventing access to the venous circulation for required placement of an additional lead, when there is no contraindication for using the contralateral side.
- Lead removal is recommended in patients with life-threatening arrhythmias secondary to retained leads.
- Lead removal is recommended in patients with leads that, due to their design or their failure, may pose an immediate threat to the patients if left in place (e.g., Telectronics ACCUFIX J wire fracture with protrusion).
- Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices.
- Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery).
- Lead removal may be considered in patients with an abandoned functional lead that poses a risk of interference with the operation of the active CIED system.
- Lead removal may be considered in patients with functioning leads that due to their design or their failure pose a potential future threat to the patient if left in place (e.g., Teletronics ACCUFIX without protrusion).
- Lead removal may be considered in patients with leads that are functional but not being used (i.e., RV pacing lead after upgrade to ICD).
- Lead removal may be considered in patients who require specific imaging techniques (e.g., MRI) that cannot be imaged due to the presence of the CIED system for which there is no other available imaging alternative for the diagnosis.
- Lead removal may be considered in patients in order to permit the implantation of an MRI conditional CIED system.
- Lead removal is not indicated in patients with functional but redundant leads if patients have a life expectancy of less than one year.
- Lead removal is not indicated in patients with known anomalous placement of leads through structures other than normal venous and cardiac structures (e.g., subclavian artery, aorta, pleura, atrial or ventricular wall or mediastinum) or through a systemic venous atrium or systemic ventricle. Additional techniques including surgical backup may be used if the clinical scenario is compelling.
- Lead removal is recommended in patients with life-threatening arrhythmias secondary to retained leads or lead fragments.
- Lead removal is recommended in patients with leads that, due to their design or their failure, may pose an immediate threat to the patients if left in place (e.g., Telectronics ACCUFIX J wire fracture with protrusion).
- Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices.
- Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery).
- Lead removal is reasonable in patients with leads that due to their design or their failure pose a threat to the patient, that is not immediate or imminent if left in place (e.g., Telectronics ACCUFIX without protrusion).
- Lead removal is reasonable in patients if a CIED implantation would require more than 4 leads on one side or more than 5 leads through the SVC.
- Lead removal is reasonable in patients that require specific imaging techniques (e.g., MRI) and cannot be imaged due to the presence of the CIED system for which there is not other available imaging alternative for the diagnosis.
- Lead removal may be considered at the time of an indicated CIED procedure, in patients with non-functional leads, if contraindications are absent.
- Lead removal may be considered in order to permit the implantation of an MRI conditional CIED system.
- Lead removal is not indicated in patients with non-functional but redundant leads if patients have a life expectancy of less than one year.
- Lead removal is not indicated in patients with known anomalous placement of leads through structures other than normal venous and cardiac structures (e.g., subclavian artery, aorta, pleura, atrial or ventricular wall or mediastinum) or through a systemic venous atrium or systemic ventricle. Additional techniques including surgical backup may be used if the clinical scenario is compelling.
Classification of Recommendations
Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective.
Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.
IIa: Weight of evidence/opinion is in favor of usefulness/efficacy.
IIb: Usefulness/efficacy is less well established by evidence/opinion.
Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful or effective, and in some cases may be harmful.
*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. Heart Rhythm, 6, 1085-1104.
D001283-03
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