Heart Rhythm Society (HRS) Indications for Lead Removal1

 

Infection

HRS Class I Indications for Extraction of Cardiac Leads:

  1. Complete device and lead removal is recommended in all patients with definite CIED system infection, as evidenced by valvular endocarditis, lead endocarditis or sepsis.
  2. 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.
  3. Complete device and lead removal is recommended in all patients with valvular endocarditis without definite involvement of the lead(s) and/or device.
  4. Complete device and lead removal is recommended in patients with occult gram-positive bacteremia (not containment).

HRS Class IIa Indications for Extraction of Cardiac Leads

  1. Complete device and lead removal is reasonable in patients with persistent occult gram-negative bacteria.

HRS Class III Indications for Extraction of Cardiac Leads

  1. CIED removal is not indicated for a superficial or incisional infection without involvement of the device and/or leads.
  2. CIED removal is not indicated to treat chronic bacteremia due to a source other than the CIED, when long-term suppressive antibiotics are required.

HRS Class I Indications for Extraction of Cardiac Leads

1.Complete device and lead removal is recommended in all patients with definite CIED system infection, as evidenced by valvular endocarditis, lead endocarditis or sepsis.

2.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.

3.Complete device and lead removal is recommended in all patients with valvular endocarditis without definite involvement of the lead(s) and/or device.

4.Complete device and lead removal is recommended in patients with occult gram-positive bacteremia (not containment).

HRS Class IIa Indications for Extraction of Cardiac Leads

1.Complete device and lead removal is reasonable in patients with persistent occult gram-negative bactermia.

HRS Class III Indications for Extraction of Cardiac Leads

1.CIED removal is not indicated for a superficial or incisional infection without involvement of the device and/or leads.

2.CIED removal is not indicated to treat chronic bacteremia due to a source other than the CIED, when long-term suppressive antibiotics are required.

Chronic Pain

HRS Class IIa Indications for Extraction of Cardiac Leads

  1. 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.

HRS Class IIa Indications for Extraction of Cardiac Leads

1.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.

Thrombosis or Venous Stenosis
HRS Class I Indications for Extraction of Cardiac Leads

  1. Lead removal is recommended in patients with clinically significant thromboembolic events associated with thrombosis on a lead or a lead fragment.
  2. Lead removal is recommended in patients with bilateral subclavian vein or SVC occlusion precluding implantation of a needed transvenous lead.
  3. Lead removal is recommended in patients with planned stent deployment in a vein already containing a transvenous lead, to avoid entrapment of the lead.
  4. Lead removal is recommended in patients with superior vena cava stenosis or occlusion with limiting symptoms.
  5. 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).

HRS Class IIa Indications for Extraction of Cardiac Leads

  1. 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.

HRS Class I Indications for Extraction of Cardiac Leads

1.Lead removal is recommended in patients with clinically significant thromboembolic events associated with thrombosis on a lead or a lead fragment.

2.Lead removal is recommended in patients with bilateral subclavian vein or SVC occlusion precluding implantation of a needed transvenous lead.

3.Lead removal is recommended in patients with planned stent deployment in a vein already containing a transvenous lead, to avoid entrapment of the lead.

4.Lead removal is recommended in patients with superior vena cava stenosis or occlusion with limiting symptoms.

5.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).

HRS Class IIa Indications for Extraction of Cardiac Leads

1.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.

Functional Leads

HRS Class I Indications for Extraction of Cardiac Leads

  1. Lead removal is recommended in patients with life-threatening arrhythmias secondary to retained leads.
  2. 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).
  3. Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices.
  4. Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery).

HRS Class IIb Indications for Extraction of Cardiac Leads

  1. 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.
  2. 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).
  3. 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).
  4. 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.
  5. Lead removal may be considered in patients in order to permit the implantation of an MRI conditional CIED system.

HRS Class III Indications for Extraction of Cardiac Leads

  1. Lead removal is not indicated in patients with functional but redundant leads if patients have a life expectancy of less than one year.
  2. 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.

HRS Class I Indications for Extraction of Cardiac Leads

1.Lead removal is recommended in patients with life-threatening arrhythmias secondary to retained leads.

2.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).

3.Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices.

4.Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery).

HRS Class IIb Indications for Extraction of Cardiac Leads

1.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.

2.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).

3.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).

4.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.

5.Lead removal may be considered in patients in order to permit the implantation of an MRI conditional CIED system.

HRS Class III Indications for Extraction of Cardiac Leads

1.Lead removal is not indicated in patients with functional but redundant leads if patients have a life expectancy of less than one year.

2.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.

Non-Functional Leads

HRS Class I Indications for Extraction of Cardiac Leads

  1. Lead removal is recommended in patients with life-threatening arrhythmias secondary to retained leads or lead fragments.
  2. 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).
  3. Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices.
  4. Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery).

HRS Class IIa Indications for Extraction of Cardiac Leads

  1. 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).
  2. 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.
  3. 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.

HRS Class IIb Indications for Extraction of Cardiac Leads

  1. Lead removal may be considered at the time of an indicated CIED procedure, in patients with non-functional leads, if contraindications are absent.
  2. Lead removal may be considered in order to permit the implantation of an MRI conditional CIED system.

HRS Class III Indications for Extraction of Cardiac Leads

  1. Lead removal is not indicated in patients with non-functional but redundant leads if patients have a life expectancy of less than one year.
  2. 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 Definitions

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.

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AHA Recommendations for Management of CIED Infections2

AHA Recommendations for Management of CIED Infections

Recommendations for removal of infected devices [HK3] 

  1. Complete device and lead removal is recommended for all patients with:
  • Definite device infection as evidenced by valvular and/or lead endocarditis or sepsis.
  • Pocket infection as evidenced by abscess formation, device erosion, skin adherence, or chronic draining sinus without clinically evident involvement of the transvenous portion of the lead system.
  • Valvular endocarditis without definite involvement of the lead(s) and/or device.
  • Occult staphycoccal bacteremia.
  • Persistent occult Gram-negative bacteremia despite appropriate antibiotic therapy.
  1. Device removal is not indicated for a superficial or incisional infection without involvement of the device or leads.

1.Complete device and lead removal is recommended for all patients with:

  • Definite device infection as evidenced by valvular and/or lead endocarditis or sepsis.
  • Pocket infection as evidenced by abscess formation, device erosion, skin adherence, or chronic draining sinus without clinically evident involvement of the transvenous portion of the lead system.
  • Valvular endocarditis without definite involvement of the lead(s) and/or device.
  • Occult staphycoccal bacteremia.
  • Persistent occult Gram-negative bacteremia despite appropriate antibiotic therapy.

Device removal is not indicated for a superficial or incisional infection without involvement of the device or leads.

Recommendations for antibiotic prophylaxis at the time of device implantation

  1. Prophylaxis with an antibiotic that has in vitro activity against staphylococci should be administered. If cefazolin is selected for use, then it should be administered intravenously within 1 hour before incision; if vancomycin is given, then it should be administered intravenously within 2 hours before incision.
  2. Prophylaxis with an antibiotic that has in vitro activity against staphylococci should be administered. If cefazolin is selected for use, then it should be administered intravenously within 1 hour before incision; if vancomycin is given, then it should be administered intravenously within 2 hours before incision.

Recommendations for diagnosis of device infection and associated complications

  1. When a device infection is suspected, two sets of blood cultures should be drawn before starting antibiotics.
  2. Gram stain and cultures should be obtained from the hardware when a device is explanted.
  3. Patients with suspected CIED infection who either have positive blood cultures or have negative blood cultures but have had recent anti-microbial therapy before blood cultures were obtained should undergo transesophogeal echocardiogram (TEE) for CIED infection or valvular endocarditis.
  4. Adult patients with suspected device infection should undergo a TEE. In young adults with good views, a surface echocardiogram may be sufficient.
  5. Patients should seek evaluation for device infection by cardiologists or infectious disease specialists if they develop fever or bloodstream infection for which there is not initial explanation.
  6. Percutaneous aspiration of the generator pocket should not be performed as part of the diagnostic evaluation of device infection.

 

1.When a device infection is suspected, two sets of blood cultures should be drawn before starting antibiotics.

2.Gram stain and cultures should be obtained from the hardware when a device is explanted.

3.Patients with suspected CIED infection who either have positive blood cultures or have negative blood cultures but have had recent anti-microbial therapy before blood cultures were obtained should undergo transesophogeal echocardiogram (TEE) for CIED infection or valvular endocarditis.

4.Adult patients with suspected device infection should undergo a TEE. In young adults with good views, a surface echocardiogram may be sufficient.

5.Patients should seek evaluation for device infection by cardiologists or infectious disease specialists if they develop fever or bloodstream infection for which there is not initial explanation.

6.Percutaneous aspiration of the generator pocket should not be performed as part of the diagnostic evaluation of device infection.

Recommendations for antibiotics for device infections

  1. Choice of antibiotics should be based on the results of culture and sensitivities.
  2. Duration of antibiotics after device removal should be:
  • 10 to 14 days for a pocket-site infection.
  • ≥ 14 days for a bloodstream infection.
  • ≥ 4 to 6 weeks for a complicated infection such as endocarditis.

1.Choice of antibiotics should be based on the results of culture and sensitivities.

2.Duration of antibiotics after device removal should be:

  • 10 to 14 days for a pocket-site infection.
  • ≥ 14 days for a bloodstream infection.
  • ≥ 4 to 6 weeks for a complicated infection such as endocarditis.

Recommendations for re-implantation after infection

  1. Each patient should be evaluated carefully to determine whether there is a continued need for a new device.
  2. Re-implantation should not be on the same side as the extraction site if possible.
  3. Blood cultures should be negative for at least 72 hours before re-implantation.
  4. New transvenous lead placement should be delayed for at least 14 days after device system removal when there is evidence of valvular infection.

 

1.Each patient should be evaluated carefully to determine whether there is a continued need for a new device.

2.Re-implantation should not be on the same side as the extraction site if possible.

3.Blood cultures should be negative for at least 72 hours before re-implantation.

4.New transvenous lead placement should be delayed for at least 14 days after device system removal when there is evidence of valvular infection.

Click for more information about AHA recommendations for management of CIED infections.

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References

  1. 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.
  2. Baddour, L.M., Epstein, A.E., Erickson, C.C., Knight, B.P., Levison, M.E., Lockhart, P.B., et al. (2010). Update on cardiovascular implantable electronic device infections and their management: A scientific statement from the American Heart Association. Circulation, 121, 458-477. http://circ.ahajournals.org/content/121/3/458.full