Guidelines of Leads extraction An update - epsegypt.comepsegypt.com/upload/092014/mag/Guidelines of Leads extraction-By Dr... · • Sepsi (rare) and endocarditis Mechanism of infection

10/27/2013

1

Giuseppe Coppola

U.T.I.C & Laboratorio di Cardiostimolazione ed Elettrofisiologia - A.O.U.P.“Paolo Giaccone” Palermo

Guidelines of Leads extraction An update

Giuseppe Coppola


“The advent of implantable devices has produced the subsequent need for removal of these devices. Malfunction, erosion, pocket infection, endocarditis, and other unique device-related issues are common reasons for removal…..” M. Smith, C.J. Love. Extraction of Transvenous Pacing and ICD Leads. PACE 2008; 31:736–752

Introduction

3.25 mln PM

180.000 ICD

400.000-500.000 nuovi impianti/anno

A. Curnis, L.Bontempi, M. Cerini et al. Complicanze infettive nel paziente portatore di dispositivi: l’estrazione di elettrocateteri. G Ital Cardiol 2010; 11 (10 Suppl 1): 42S-47S

200

420

600

300

Today:

(nu

ovi

im

pia

nti

/m

ilio

ne d

i ab

itan

ti) Complication

In contrast to the relative frequency of lead

failure, either as a result of implantation

error or deterioration of the lead materials,

primary malfunction of the pulse generator

is rare. Infection is another complication of

implanted devices; it is reported to occur from 0.13 up to 19% of the PM patients and from 2 to 7% of the ICD patients. M.G. Bongiorni, G. Giannola, G. Arena et al. Pacing and implantable cardioverter defibrillator transvenous lead extraction. Ital Heart J 2005; 6 (3): 261-266

10/27/2013

2

Giuseppe Coppola


CARDIAC DEVICE INFECTION

However, recent data point to a

disturbing trend: infection rates are rising faster than implantation rates. Besides causing morbidity and even

death, infection is also associated

with significant financial cost for

patients and third-party payers.

The estimated average cost of

combined medical and surgical

treatment of CIED-related infection

ranges from $25,000 for permanent

PM to $50,000 for ICD.

Dababneh A., Sohail M. Cardiovascular implantable electronic device infection: a stepwise approach to diagnosis and management. Cleveland clinic journal of medicine: vol.78 (8); August 2011

Giuseppe Coppola


• Comorbilities (DM, IRC,

terapia steroidea e/o

immunosoppressiva, neoplasie)

• Need of OAC

• Post operative ematoma

• Acute Lead repositioning

• Presence of abandoned leads

• Subclavian Venous thrombosis

• Operator skill

• Duration of implant

Why infections?

• Local contamination (pocket

infection)

• Erosion after traumatism

• Sepsi (rare) and endocarditis

Mechanism of infection

Presence of CRM device induce a reduction of local

infection defens

10/27/2013

3

Giuseppe Coppola


MICROBIOLOGY OF DEVICE INFECTION

Site of infection Microorganismo isolato

Device or leads Stafilococco Epidermidis *

(senza coinvolgimento IV) Stafilococco Aureus *

Corinebatteri

Escherichia coli

Proteus

Enterobatteri

Batteriemia o endocardite Stafilococco Aureus *

Stafilococco Epidermidis *

Pseudomonas Aeruginosa

Klebsiella

Proteus

Serratia Marcescens

* = Batteri più comunemente involti (72-95%)

Giuseppe Coppola


Indications for lead Extraction are evolving!

The need for lead extraction is rapidly increasing

due to:

New indication for device treatment

Higher lead prevalence due to increased life expectancy

CIED modes requiring more lead for patient

Upgrading from device systems becoming more frequent

Lead Recalls

Lead Infections

Maytin M and Epstein LM. Cardiology, 2009;6(2):51-3

10/27/2013

4

Giuseppe Coppola


Laser sheath for tunnelled

dialysis catheters

extraction: a case report. Curnis A., Bontempi L., Coppola G. et al.

Giuseppe Coppola


The Byrd Classification (1990) Systemic Infection Mandatory

Local Infection Necessary

Malfunction Discretionary

Indications for lead Extraction are evolving!

PACE 2000

HRS 2009

10/27/2013

5

Giuseppe Coppola


DEFINITION (procedura)

Lead Removal: Removal of a pacing or defibrillator lead using any

technique.

Lead Explant: A lead removal using simple traction techniques (no locking

stylet, telescoping sheaths or femoral extraction tools).

Lead Extraction: Removal of a lead that has been implanted for more than

1 year (less for ICD), or a lead regardless of duration of implant requiring the

assistance of specialized equipment that is not included as part of the typical

implant package, and/or removal of a lead from a route other than via the

implant vein.

Heart Rhythm, Vol 6, No 7, July 2009

Giuseppe Coppola


HRS 2009 Indications

INFECTION

CHRONIC PAIN

THROMBOSIS OR VENOUS STENOSIS

FUNCTIONAL LEADS

NON-FUNCTIONAL LEADS

10/27/2013

6

Giuseppe Coppola


INFECTIONS – Class I

1) Complete device and lead removal is recommended in all patients with

definite CIED systemic infection, as evidenced by valvular endocarditis lead

endocarditis or sepsis. (LOE: B)

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. (LOE: B)

3) Complete device and lead removal is recommended in all patients with

valvular endocarditis without definite involvement of the lead(s) and/or

device. (LOE: B) 4) Complete device and lead removal is recommended in patients with occult

gram+ bacteremia (not contaminant). (LOE: B)

Giuseppe Coppola


INFECTIONS – Class II a

Complete device and lead removal is reasonable in patients with persistent

occult gram-negative bacteremia. (LOE: B)

INFECTIONS – Class III 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.

(LOE: C)

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. (LOE: C)

CHRONIC PAIN – Class II a

10/27/2013

7

Giuseppe Coppola


THROMBOSIS/VENOUS STENOSIS – Class I

1) Lead removal is recommended in patients with clinically significant

thromboembolic events associated with thrombus on a lead or a lead

fragment. (LOE: C)

2) Lead removal is recommended in patients with bilateral subclavian V or SVC

occlusion precluding implantation of a needed transvenous lead. (LOE: C)

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.

(LOE: C)

4) Lead removal is recommended in patients with SVC stenosis or occlusion

with limiting symptoms. (LOE: C)

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).

(LOE: C)

Giuseppe Coppola


THROMBOSIS/VENOUS STENOSIS – Class I

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.

(LOE: C)

OCCLUSION of the vein

with the need to add 1 or

more leads

10/27/2013

8

Giuseppe Coppola


FUNCTIONAL and NON FUNCTIONAL LEADS: Class I

1) Lead removal is recommended in

patients with life threatening arrhythmias

secondary to retained leads. (LOE: B)

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 (Telectronics

ACCUFIX J wire fracture with protrusion).

(LOE: B)

Giuseppe Coppola


FUNCTIONAL and NON FUNCTIONAL LEADS: Class I

3) Lead removal is

recommended in patients

with leads that interfere with

the operation of implanted

cardiac devices. (LOE: B)

4) Lead removal is

recommended in patients

with leads that interfere with

the treatment of a

malignancy (radiation or

reconstructive surgery).

(LOE: C) Inappropriate shocks

10/27/2013

9

Giuseppe Coppola


FUNCTIONAL and NON FUNCTIONAL LEADS: Class II a

1) Lead removal is reasonable in patients

with functioning 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). (LOE: C)

2) Lead removal is reasonable in patients if

a CIED implantation would require 4 or

more leads on one side or 5 or more leads

through the SVC. (LOE: C)

3) Lead removal is reasonable for patients that require specific imaging

techniques (e.g. MRI) and can not be imaged due to the presence of the CIED

system for whom there is no other available imaging alternative for the

diagnosis. (LOE: C)

Giuseppe Coppola


FUNCTIONAL LEADS: Class II b

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. (LOE: C)

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 without protrusion). (LOE: C)

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) (LOE: C)

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. (LOE: C)

5) Lead removal may be considered in patients in order to permit the

implantation of an MRI conditional CIED system. (LOE: C)

10/27/2013

10

Giuseppe Coppola


NON FUNCTIONAL LEADS: Class II b

1) Lead removal may be considered at the time of an indicated CIED procedure,

in patients with non-functional leads, if contraindications are absent. (LOE C)

2) Lead removal may be considered in order to permit the implantation of an

MRI conditional CIED system. (LOE: C)

FUNCTIONAL and NON FUNCTIONAL LEADS: Class III

1) Lead removal is not indicated in patients with redundant leads if patients

have a life expectancy of less than one year. (LOE: C) 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)

Giuseppe Coppola


Undesired LV pacing!! A. Curnis, L. Bontempi1, G. Coppola et al. G Ital Cardiol 2011;12(11):724-725

PFO

10/27/2013

11

Giuseppe Coppola


BE CAREFUL!!!

“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.”

Giuseppe Coppola


…NON FA SCIENZA, SENZA LO RITENERE,

AVERE INTESO….

10/27/2013

12

Giuseppe Coppola


Documents

Guidelines of Leads extraction An update - epsegypt.comepsegypt.com/upload/092014/mag/Guidelines of Leads extraction-By Dr... · • Sepsi (rare) and endocarditis Mechanism of infection