lead extraction: when and why? · lead extraction: when and why? ... * includes cases with a...

Lead Extraction: When and Why?

Angel R. León MDEmory University School of Medicine

2009 Heart Rhythm SocietyTransvenous Lead Extraction: Expert

Consensus on Facilities, Training, Indications, and Patient Management

No Disclosures

©2009 Spectranetics All Rights Reserved. Approved for External Distribution D008109-00 6/20/2009 3

Overview• Indications• Personnel, Facility, and Equipment

Requirements • Patient and Procedure Requirements

All Rights Reserved. Approved for External Distribution. D012173-00 122010 4

Device infections increasing faster than implants

* Includes cases with a primary discharge diagnosis of CIED infection (ICD-9-CM code 996.61). In addition, patients with device explantation (ICD-9-CM codes 37.77, 37.79, 37.89, or 37.99) and a primary discharge diagnosis of sepsis (ICD-9-CM code 038 or 785.59), bacteremia (ICD-9-CM code 790.7), endocarditis (ICD-9-CM codes 421.0, 421.9, or 424.90), cellulitis (ICD-9-CM code 682.9), or fever (ICD-9-CM code 780.6) were defined as having CIED infection.

1 Cabell, C.H., et al. (2004). Increasing rates of cardiac device infections among Medicare beneficiaries: 1990-1999. Am Heart J, 147(4), 582-586.2 Voight, A., et al. (2006). Rising rates of cardiac rhythm management device infections in the United States: 1996 through 2003. JACC, 48(3), 590-

591.3 Voight, A., et al. (2010). Continued rise in rates of cardiovascular implantable electronic device infections in the United States: Temporal trends and

causative insights. PACE, 33(4), 414-419.

42% 40%

380%

124%

0%

100%

200%

300%

400%

500%Increase in CIEDImplants

Increase in CIEDInfections

Medicare Data(1990-1999)1

National Hospital Discharge Survey

(1996-2006)2,3

12,979 CIED infections*222,940 CIED implants

5.8% infection rate in 20063


0.50

1.00

1.50

2.00

2.50

3.00

3.50

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Implanted CIEDs

Infected CIEDs*

Trends in CIED Implantation and Infection in the U.S.

National Hospital Discharge Survey

CIED Implants and

Hospitalizations for Infected

CIEDs(Indexed to

1996)

Proportional increase in the number of cardiac rhythm management devices (CRMD) implanted and those infected by the year of hospitalization, normalized to the number of devices implanted and infected in the year 1996, respectively.

12,979CIED infections

222,940CIED implants

5.8% infection rate

* Includes cases with a primary discharge diagnosis of CIED infection (ICD-9-CM code 996.61). In addition, patients with device explantation (ICD-9-CM codes 37.77, 37.79, 37.89, or 37.99) and a primary discharge diagnosis of sepsis (ICD-9-CM code 038 or 785.59), bacteremia (ICD-9-CM code 790.7), endocarditis (ICD-9-CM codes 421.0, 421.9, or 424.90), cellulitis (ICD-9-CM code 682.9), or fever (ICD-9-CM code 780.6) were defined as having CIED infection.

1 Cabell, C.H., et al. (2004). Increasing rates of cardiac device infections among Medicare beneficiaries: 1990-1999. Am Heart J, 147(4), 582-586.2 Voight, A., et al. (2006). Rising rates of cardiac rhythm management device infections in the United States: 1996 through 2003. JACC, 48(3), 590-

591.3 Voight, A., et al. (2010). Continued rise in rates of cardiovascular implantable electronic device infections in the United States: Temporal trends and

causative insights. PACE, 33(4), 414-419.


Biofilm on leads supports bacteria growth

• Cobblestone-like surface of

pacing leads creates a protected

environment for bacteria growth

Marrie, T.J. & Costerton, J.W. (1984). Morphology of bacterial attachment to cardiac pacemaker leads and power packs. Journal of Clinical Microbiology, 19(6), 911-914.


• TTE (Transthoracic echocardiography)1

– Non-invasive and low cost

• TEE (Transesophageal echocardiography)1

– More invasive– Higher sensitivity

diagnosing endocarditis

AHA guidelines recommend TEE in cases of positive blood cultures or

prior antibiotic treatment

1 Gandelman, G., et al. (2007). Intravascular device infections epidemiology, diagnosis, and management. Cardiology in Review, 15(1), 13-23.

2 Baddour, L.M., et. al. (2003). Nonvalvular Cardiovascular Device-Related Infections. Circulation, 108(16), 2015-2031.

0%

25%

50%

75%

100%

TTE TEE

Diagnostic Sensitivity:Lead Related Endocarditis2

<30%

>95%


Dialysis patients are more likely to get infections from resistant bacteria

Centers for Disease Control and Prevention. (2005). Invasive methicillin-resistant Staphylococcus aureus infections among dialysis patients–United States. Morbidity and Mortality Weekly Report, 56(9),197-199.

45.2

0.30

10

20

30

40

50

Hemodialysis Patients

General Population

Risk of MRSA infection per 1000 patients

85% of dialysis patients had an invasive device or catheter in place at

time of infection


Leads in a CIED system act as apathogenic conduit

Pocket infections can spread to the bloodstream

Image downloaded on April 26, 2010 from http://www.bostonscientific.com/templatedata/imports/HTML/lifebeatonline/spring2005/living.shtml

CIED systems can be infected by bloodborne pathogens

Location of Potential Complications

Subclavian vein tear / AV fistula

Innominate tear / perforation

High SVC tear / perforation

SVC tear / perforation

SVC / RA junction tear / perforation

Atrial wall perforation

Inferior Vena Cava

Valvular damage

Ventricular wall perforation


Indications

• 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.1

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. Retrieved May 13, 2009, from www.hrsonline.org/Policy/ClinicalGuidelines/leadextract_cieds.cfm

Incidence of Procedural MAEs and Mortality is Low

– The overall rate of procedural major adverse events during a lead extraction is low and decreasing

– Survival from procedural MAEs can be high if proper procedural protocols are instituted and followed

Year 1999 2002 2009

Procedural MAEs 2.0% 1.9% 1.4%

Procedural Mortality 0.65% 0.6% 0.28%

% MAE Patients Surviving(Data extracted from references)

67% 69% 80%

1. Wilkoff, B., L., et al. (1999). Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) trial. JACC, 33(6).

2. Byrd, C., et al. (2002). Clinical study of the laser sheath for lead extraction: The total experience in the United States. Journal of Pacing and Electrophysiology, 125(5).

3. Wazni, O et. al. (2010). Lead extraction in the contemporary setting: The LExICon study: A multicenter observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol, 55, 579-586.


0%

1%

2%

3%

4%

5%

6%

A-Fib Ablation DFT

5.9%1

0.08-0.23%2

PCIs

4-5%3

1-2%3

0.4%6

* See References on Page 42 (3rd to last slide)^ The LExICon study reports a procedural MAE rate of 1.4%, as defined by the 2000 NASPE Policy Statement. However, 0.3% (n=4) of the MAEs

were bleeding requiring transfusion, which is no longer defined as an MAE by the 2009 HRS Expert Consensus Document

Procedural MAEsProcedural Mortality

Safety of other common EP procedures*

0.07%6

Lead Removal(LExICon)

1.4%5

0.28%5

2.2%4

Lead Addition/Revision

1.1%^


Indications Overview1

Class I Class IIa Class IIb Class III

Infection X X X

Chronic Pain X

Thrombosis or Venous Stenosis

X X

Functional Leads X X X

Non Functional Leads

X X X X



InfectionClass III Indications1 Comments

1. CIED removal is not indicated for a superficial or incisional infection without involvement of the device and/or leads (Level of evidence: C)

-

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. (Level of evidence: C)

-



Chronic PainClass IIa Indications1 Comments

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. (Level of evidence: C)

Previously Class II


Note: Red text denotes new, important, or interesting indication additions or changes compared to Love, Charles J. et al, NASPE Policy Statement – Recommendations for Extraction of Chronically Implanted Transvenous Pacing and Defibrillator Leads: Indications, Facilities, Training. PACE, Vol 23, April 2000.


Thrombosis or Venous StenosisClass I Indications1 Comments

1. Lead removal is recommended in patients with clinically significant thromboembolic events associated with thrombus on a lead or a lead fragment. (Level of evidence: C)

Same as NASPE 2000

2. Lead removal is recommended in patients with bilateral subclavian vein or SVC occlusion precluding implantation of a needed transvenous lead. (Level of evidence: C)

Same as NASPE 2000

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. (Level of evidence: C)

New

4. Lead removal is recommended in patients with superior vena cava stenosis or occlusion with limiting symptoms. (Level of evidence: C)

New

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). (Level of evidence: C)

New




Thrombosis or Venous StenosisClass IIa Indications1 Comments

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. (Level of evidence C)

Previously Class II




Functional LeadsClass I Indications1 Comments

1. Lead removal is recommended in patients with life-threatening arrhythmias secondary to retained leads. (Level of evidence: B)

Similar to NASPE 2000

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). (Level of evidence: B)

Similar to NASPE 2000

3. Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices. (Level of evidence: B)

Same as NASPE 2000

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

Previously Class II




Functional LeadsClass IIb Indications1 Comments

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. (Level of evidence: C)

New

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. Telectronics ACCUFIX withoutprotrusion) (Level of evidence: C)

New

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) (Level of evidence: C)

New

4. Lead removal may be considered in patients who require specific imaging techniques (e.g. MRI) that can not be imaged due to the presence of the CIED system for which there is no other available imaging alternative for the diagnosis. (Level of evidence: C)

New

5. Lead removal may be considered in patients in order to permit the implantation of an MRI conditional CIED system. (Level of evidence: C)

New




Functional LeadsClass III Indications1 Comments

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

1-year life expectancy

criterion

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. (Level of evidence: C)

-




Non Functional LeadsClass I Indications1 Comments

1. Lead removal is recommended in patients with life-threatening arrhythmias secondary to retained leads or lead fragments. (Level of evidence: B)

Same as NASPE 2000

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) (Level of evidence: B)

Same as NASPE 2000

3. Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices. (Level of evidence: B)

Same as NASPE 2000

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

Previously Class II




Non Functional LeadsClass IIa Indications1 Comments

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) (Level of evidence C)

Previously Class II

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. (Level of evidence C)

New

3. Lead removal is reasonable in patients that require specific imaging techniques (e.g. MRI) and can not be imaged due to the presence of the CIED system for which there is no other available imaging alternative for the diagnosis. (Level of evidence: C)

New




Non Functional LeadsClass IIb Indications1 Comments

1. Lead removal may be considered at the time of an indicated CIED procedure, in patients with non-functional leads, if contraindications are absent. (Level of evidence C)

New

2. Lead removal may be considered in order to permit the implantation of an MRI conditional CIED system. (Level of evidence: C)

New




Non Functional LeadsClass III Indications1 Comments

1. Lead removal is not indicated in patients with non-functional leads if patients have a life expectancy of less than one year. (Level of evidence C)

1-year life expectancy

criterion

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. (Level of evidence: C)

-




Indications Summary• HRS Indications for Transvenous Lead

Extraction have expanded and become more detailed with 30 total indications (vs. 14 in 2000 NASPE recommendations)

Category # IndicationsInfection & Chronic Pain 6Thrombosis or Venous Stenosis 6Functional Leads 9Non Functional Leads 9


Personnel, Facility, and Equipment Requirements


Required Personnel*• Primary Operator• Cardiothoracic surgeon well versed in the potential

complications of lead extraction and techniques for their treatment, on site and immediately available

• Anesthesia support• Personnel capable of operating fluoroscopic

equipment• “Scrubbed” assistant (nurse/technician/physician)• Non “scrubbed” assistant• Echocardiographer

*Depending on the environment, one person can hold expertise in several areas and satisfy the requirements (e.g. the extractor could be the cardiothoracic surgeon), but at least 5 people (1-airway and sedation management, 2-scrubbed, 2-non scrubbed) need to be in the room at all times with the immediate availability of additional personnel as needed.

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. Retrieved May 13, 2009, from www.hrsonline.org/Policy/ClinicalGuidelines/leadextract_cieds.cfm


Facility Requirements• Center must have accredited cardiac surgery and

cardiac catheterization programs• Cardiothoracic surgeon and cardiac surgery team,

equipment, and facilities must be physically on site and readily available– When SVC was torn or perforated, delayed access to the

heart of more than 5-10 minutes was often associated with a fatal outcome

• Procedures can be performed in either operating rooms; or procedural laboratories specifically designed for device implantation procedures– Room must be of adequate size to allow for emergent

interventions (i.e. thoracotomy and sternotomy)– Must be equipped with a ventilation system designed to

prevent surgical infections and to handle anesthetic gasWilkoff, 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. Retrieved May 13, 2009, from www.hrsonline.org/Policy/ClinicalGuidelines/leadextract_cieds.cfm


Equipment Requirements• High-quality fluoroscopy

– Fixed fluoroscopic or “high-quality” mobile C-arm

• Surgical instruments– For transvenous lead extraction and device

implantation– To perform vascular repairs, thoracotomy,

sternotomy, and cardio-pulmonary bypass must be immediately available and in good functional order

• Lead Extraction tools



Equipment Requirements (cont’d)

• CIED implantation tools e.g. stylets, wrenches, fixation tools, etc.

• Transthoracic and transesophageal echocardiography–Some centers employ intracardiac

echocardiography



Need for Pacing Support• Pacemaker dependent patients should

have temporary pacing wires placed prior to the procedure

• Non pacemaker dependent patients should have device reprogrammed below patients intrinsic rate

• Venous sheaths should be placed in femoral veins for rapid deployment of temporary pacing wires if needed.


SummaryLead extraction requires a thorough risk

to benefit analysisMany leads can be left in place without a

significant risk to the patientInfection, venous obstruction/embolism,

or electrical interference associated with implanted leads justify extraction

The procedure is very operator and center dependent

lead extraction: when and why? · lead extraction: when and why? ... * includes cases with a...

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