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Lead Extraction (Final)

The use of cardiovascular implantable electronic devices (CIEDs) is done for various purposes. CIEDs use leads that
connect a generator to cardiac tissue to treat patients with many conditions including symptomatic bradycardia,
morbid tachycardia and advanced heart failure.

Once implanted, leads are held in place by scar tissue in the major veins and surrounding cardiac structures, making
their withdrawal challenging.

The degree of endothelial fibrosis is proportional to the length of time the lead has been implanted and the patient’s
vascular inflammatory reactivity.

Over time, fibrosis develops leading to adherence of the lead at several points within the venous system. Common
sites for adherence include the subclavian vein as it passes under the clavicle, the junction between the innominate
vein and superior vena cava (SVC), and within the cardiac chambers (at the point right ventricular leads pass through
the tricuspid valve and at the electrode tips).

Many patients also develop calcification at these fibrotic points. Fibrosis and calcification result in tethering of CIED
leads within the venous system and act as obstacles to their removal.

While open heart surgery was initially used to remove leads in the 1980s, transvenous lead extraction has evolved as
the premier method over the past three decades. Compared with median sternotomy, transvenous lead extraction is
an endovascular intervention more amenable for patients with several comorbidities necessitating lead removal.

Indications for lead extraction –

 Infectious (valvular endocarditis, lead endocarditis, sepsis, device erosion,

Pocket infection with or Localised signs of inflammation such as erythema, swelling, pain, tenderness, warmth
without bacteraemia or drainage with positive or negative blood cultures
Left-sided endocarditis in a Left heart vegetations with or without tricuspid valve or CIED involvement, and positive
CIED carrier blood cultures
CIED-related endocarditis Positive blood cultures and lead or valvular vegetation(s), without local signs of pocket
infection
Occult bacteraemia with Bacteraemia without an alternative source, resolves after CIED extraction
probable CIED infection

Infections

 Infections make up 52.8 % (19.3 % systemic and 33.1 % local) of the indications for lead extractions
 Infection requires aggressive treatment. This aggressive treatment includes the complete removal of all
hardware and antimicrobial therapy.
 Symptoms of lead-associated endocarditis (LAE):  
o Early LAE (defined as signs and symptoms occurring within 6 months of the most recent CIED
procedure) presented more frequently with signs of local pocket infection, which included erythema,
pain, swelling, warmth and pus or drainage from the pocket.
o Late LAE (defined as signs and symptoms occurring after 6 months of the most recent CIED
procedure) typically presented with signs of systemic infection, such as fever, chills, sweats and signs
of sepsis.
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 Non-infectious

Thrombosis /  Clinically significant thromboembolic events attributable to thrombus on a lead or a lead

vascular Issues fragment that cannot be treated by other means (class I)
 Superior vena cava (SVC) stenosis or occlusion that prevents implantation of a necessary
lead (class I)
 Planned stent deployment in a vein already containing a transvenous lead to avoid
entrapment of the lead (class I)
 Maintaining patency of SVC stenosis or occlusion with limiting symptoms (class I)
 Ipsilateral venous occlusion preventing access to the venous circulation for required
placement of an additional lead (class IIa)
Chronic pain  Severe chronic pain at the device or lead insertion site or believed to be secondary to the
device, which causes significant patient discomfort, is not manageable by medical or
surgical techniques, and for which there is no acceptable alternative (Class IIa)
Other  Life-threatening arrhythmias secondary to retained leads (class I)
 Lead removal can be useful for patients with a CIED location that interferes with the
treatment of a malignancy (class IIa) (in the path of radiation beam therapy)
 CIED implantation requires more than four leads on one side or more than five leads
through the SVC (class IIa)
 Abandoned lead(s) that interfere with the operation of a CIED system (class IIa)
 Leads that pose a potential future threat to the patient if left in place, because of their
design or failure (class IIb)
 Lead removal may be considered to facilitate access to MRI (class IIb)
 The setting of normally functioning, non-recalled pacing or defibrillation leads for selected
patients after a shared decision-making process (class IIb)

Facilities, Equipment and Personnel

Lead extractions are performed in operating theatres, catheterisation/electrophysiology (EP) labs and hybrid labs. A
hybrid lab is a surgical suite with a movable, high-quality fluoroscopy system. The ability to provide immediate
surgical intervention in cases of major complications make the operating theatre and the hybrid labs the best
options to perform lead extractions. Major vascular injuries or cardiac perforations requiring surgical or
endovascular intervention are rare, and these procedures may carry a higher mortality in EP laboratories than in
operating theatres.

This should be in the room at the start of every procedure and includes equipment for transoesophageal
echocardiography (TEE), fluoroscopy and arterial blood pressure monitoring, as well as a crash cart,
pericardiocentesis kit, sternal saw, cardiopulmonary bypass machine, cell-saver and matched blood on standby.

The surgeon must be immediately available and be able perform an emergent thoracotomy within 5–10 minutes.
Although data from a National Cardiovascular Data Registry of 11,304 ICD extractions revealed that only 0.36 %
patients required urgent cardiac surgery, these emergent procedures had a 34 % mortality rate.

Definitions

Lead extraction is a procedure where the removal of the lead requires equipment not typically employed during lead
implantation or where at least one lead has been implanted for longer than 1 year.

Lead explantation is as a procedure in which a lead is removed without specialised tools and all leads have been
implanted for less than 1 year.

In addition, clinical success for a lead extraction is defined by the removal of all targeted leads and lead material
from the vascular space or retention of a small portion (< 4 cm) that does not negatively affect the outcome goals of
the procedure.
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Failure refers to inability to achieve complete or clinical success, or when the procedure is complicated by death or a
permanent life-altering complication.

Pre-procedure Phase

A thorough patient history should be documented including age, height, weight, current medications, New York
Heart Association class and previous surgeries. There should be an evaluation of cardiac and non-cardiac conditions
that could affect the procedure outcome such as diabetes, reduced left ventricular ejection fraction and out atrial
fibrillation.

Implanted devices and information about their leads (including number, location, construction, fixation type and
implantation dates) should be documented.

The patient’s intrinsic rhythm and dependency should be checked by CIED interrogation.

Intraoperative Preparation

In case of a revision of an ICD system, tachytherapies need to be turned off prior to the beginning of the surgery,
after external defibrillation pads have been placed. Furthermore, the patient should once more be checked for
pacemaker dependency prior to procedure initiation. In case of a pacing system explantation due to infection in a
pacemaker-dependent patient, there are different options to establish temporary pacing until definite
reimplantation after cure of the infection: (i) percutaneous implantation of an active fixation right ventricular
pacemaker lead via the internal jugular vein with proximal fixation to the skin and connection to an external
pacemaker and (ii) implantation of an epicardial single-chamber pacemaker system via a subxiphoidal approach.

Imaging

First, a chest X-ray should be performed for lead localisation, lead analysis and to determine the existence of
calcifications. It should be noted whether the implanted leads are passively or actively fixated, given that passive
fixation and dual-coil lead design may correlate with fibrous adhesions. The type of fixation is easily determined on
chest X-ray as passively fixated leads use tines, fins or conical structures at the tip of the lead, while actively fixated
leads use a corkscrew helix to screw into the myocardium. The X-ray is also useful to determine the presence of
undocumented leads or devices that may pose issues during the extraction.

Second, a TEE is recommended for patients with suspected systemic CIED infection to determine any cardiac
abnormalities including reduced ejection fraction, vegetations, tricuspid regurgitation, intracardiac shunts and pre-
existing pericardial effusions. If large vegetations (> 2.5 cm) are present, the procedure may require an alternative
approach such as an open extraction. Because of thromboembolic risk, the presence of vegetations and their relative
size should be accounted in management of antithrombotic therapy.

Third, a gated cardiac CT scan is taken in some centres to check for venous stenosis or the presence of extravascular
lead segments.

Last, fluorine–18–fluorodeoxyglucose (18F–FDG) PET and CT can be used to identify infections in patients where this
is suspected but not clearly evident using other imaging modalities.

Extraction Approach

The extraction is conducted through the subclavian vein, the femoral vein or the internal jugular or using a
combination of methods.

The subclavian approach allows the complete procedure to be performed through a single incision and permits
ipsilateral access to the implanting vein; it is therefore the most popular approach.
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Open surgical approaches are rare and usually reserved for complex and high-risk cases that preclude percutaneous
methods. Such cases usually necessitate a hybrid approach that combines open heart surgery and transvenous lead
extraction to remove the intracardiac and intravascular portions of the leads respectively.

Procedure Phase

First, the patient is prepped and draped in the same manner as for an open-heart procedure (from chin to knees).

Then, general anesthesia is administered, and a TEE is carried out.

Next, an incision is made through the original CIED implantation site to gain access to the device pocket.

If there is a localised pocket infection, the pocket is debrided and microbial cultures of the pocket tissue obtained.

If no infection is present, minimal debridement should be performed while freeing the lead from the fibrotic
constraints in the pocket. The leads are then removed from the header and are dissected away from the fibrous
tissue.

To prevent the lead from unraveling and to apply traction across the whole length of it, the components are often
secured to a lead-locking device using suture ties or a compression coil.

If the lead locking device cannot be inserted, a lead extender can be used.

The next step usually involves concentrating force at the resistive hinge points by inserting a locking stylet through
the lumen of a lead, advancing it to the tip and fixing the proximal end to the body of the lead with either a silk
suture or compression coil (One-Tie®, Cook Medical LLC, Bloomington, IN, USA) (figures 1 and 2). Traction is thus
transmitted more effectively to the distal end (Liberator, Cook Medical LLC, Bloomington, IN, USA) and Extor Set
(VascoMed, Binzen, Germany) or along the entire length (Lead Locking Device EZ, The Spectranetics Corporation,
Colorado Springs, CO, USA).

The next step depends on the degree of fibrosis, which is proportional to the age of the lead. If the lead was
implanted recently, simple traction (or mild pulling with no specialised extraction tools besides a standard stylet)
was found to be effective in removal of 27 % of the leads in the ELECTRa registry.

On the other hand, if simple traction alone is unsuccessful, a specialised sheath can be used on the intravascular
adhesions around the lead. The choice of sheath depends on the nature of the lesions as well as the experience,
training and preference of the operator. Because of this, different sheaths may be used throughout the course of a
single lead extraction depending on the circumstances (Table 2).

Table 2: Specialised Sheaths: Types and Uses –

Type of Specialised Sheath Useful For Less Useful For

Non-powered telescoping sheaths Fibrous adhesions Dense fibrotic or heavily calcified
lesions
Laser sheaths Fibrous lesions and scar tissue Heavily calcified lesions
Rotational mechanical cutters Dense calcified fibrotic lesions Scar tissue

The sheath is advanced coaxially to reach the distal end of the lead (at the myocardial interface). Once the sheath is
close to the myocardial interface, the lead is gently pulled in a traction-countertraction motion to release and
remove the lead tip from the myocardium (Figure 2).

If a new lead implant is required, a guide wire is threaded through the retained sheath to maintain venous access.

In special circumstances such as venous occlusion and leads with minimal adhesions, femoral snaring can aid in
maintaining traction while the sheath breaks through the occluded veins.
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In addition, a femoral approach is also useful for removing lead fragments that may break off during the extraction
procedure.

Furthermore, if the subclavian approach fails due to an intravascular lead break, extraction can be performed via the
femoral or the internal jugular approach.

Using sheath 85% success rate

Powered traction

If blunt dissection with mechanical dilator sheaths fails to free the lead from its fibrous attachments, then powered
tools are required. They have tips that burn or cut through fibrous tissue reducing the reliance on traction. These
sheaths include electrical devices using either laser (Excimer, The Spectranetics Corporation, Colorado Springs, CO,
USA) or radiofrequency energy (Perfecta Electrosurgical Dissection Sheath, Cook Vascular Incorporated, Vandergrift,
PA, USA) and mechanical with a rotating threaded tip (Evolution®, Cook Medical LLC, Bloomington, IN, USA;
TightRail™ Spectranetics Corporation, Colorado Springs, Colorado, USA).

If traction alone is not sufficient to extract a targeted lead, non-powered and/or powered extraction sheaths are
applied to dissect the leads free of fibrotic adhesions. This is termed counter-pressure along the course of the lead
and requires a forward movement of the sheath. The applied traction must be sufficient to allow the extraction
sheath to follow the course of the lead, especially at the curves of the vascular system. This rail effect prevents
vascular or myocardial injury due to the extraction sheath. At the lead tip close to the myocardial interface, further
advancement of the sheath could potentially lead to myocardial perforation; therefore, the sheath is fixed in this
position with constant, controlled traction applied to the lead until it is freed. This action is called counter-traction
(Table 1) 

Laser sheaths

The Excimer laser sheath passes over the lead and at points of resistance, a circumferential laser beam with a
penetration depth to 100 µm is delivered to vaporise adhesions. The laser is unlikely to be effective on calcified
fibrous tissue.

Greater complete success rate 94% (vs. 64%) with a mean reduction in extraction time of three minutes. However,
there were three life-threatening complications (including death, injury to the SVC)

Electrosurgical dissection sheath (EDS)

EDS uses radiofrequency energy to diathermy through fibrous tissue using bipolar current from two electrodes. It
allows the localised application of energy instead of circumferential dissection as in laser sheath. There remains a
paucity of data on the clinical effectiveness and complications of EDS with only three large single-centre studies
performed, with similar success rates as laser sheath reported. In a randomised-controlled study of 120 patients,
there was a 93% complete success rate with EDS compared with 73% with standard non-powered mechanical
sheaths, with no deaths in either group. The EDS is less effective on calcified areas, sutures or insulation materials.
Advances in mechanical methods have effectively eliminated the EDS from the market.

Rotational mechanical sheaths

These sheaths are the most recent major addition to the lead extractors’ armamentarium. Both currently available
products have a handle trigger driven rotational tip at the end of a flexible sheath, which helps bore through the
adhesions. The Evolution® system came to market first and, hence, has more published data than the TightRail™
system. The cutting action of these devices makes them ideal for cases where there is a large burden of calcification,
successful in 96% of cases with no major complications. 

Femoral snare
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The success of extraction techniques using a superior approach has led to a reduction in the number of femoral
extraction procedures performed. At the current time, it is usually a rescue procedure when extraction via the vein
of implant is not possible, e.g. for free-floating lead ends or when leads remain adherent to the endocardium.
Procedure and fluoroscopy duration are usually higher. comes with a 16-Fr femoral sheath that acts as a work
station and a 12-Fr inner sheath, pre-loaded with tip-deflecting wire and Dotter retriever snare. The procedure has a
high success rate of more than 90%.

Postprocedure Phase

After the procedure, the patient should be checked for any complications – early and late – using a chest X-ray,
transthoracic echocardiogram (TTE) and physical examination.

First, it is useful to take a chest X-ray within 24 hours of the procedure to rule out an occult hemothorax or
pneumothorax.

Second, a TTE after the procedure is used to assess for tricuspid valve injury, pericardial effusion and intracardial
masses such as retained fragments.

Third, physical examinations should include checking for the presence of arteriovenous fistulas from the upper arm
to the subclavian area. Moreover, in patients with infections, additional post-procedure considerations include
antibiotic selection and wound care management.

Complications

Mortality rates from 0.2–1.2 %.

Serious complications that require emergent intervention may still arise in 0.2–1.8 % of cases

Notable risk factors identified include:

 longer lead implant duration (> 6 years);

 female sex;
 low BMI or body surface area;
 number of implanted leads (three or more);
 infectious indication for extraction;
 presence of dual-coil ICD lead;
 aggressive calcified adhesions;
 extravascular leads;
 venous occlusions;
 femoral extraction approach;
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 use of powered sheaths

 renal disease (end-stage renal failure and dialysis);
 type 2 diabetes mellitus;
 congestive heart failure;
 cerebrovascular disease;
 anticoagulation or antiplatelet use;
 chronic pulmonary disease;
 corticosteroid use;
 non-target lead dislodgement;
 non-electively scheduled extraction;
 low volume extraction centres; and
 lack of operator experience (carrying out fewer than 30 cases per year).

Complications Incidence (%)

Major 0.19–1.80
 Death 0.19–1.20
 Cardiac avulsion 0.19–0.96
 Vascular laceration 0.19–0.96
 Respiratory arrest 0.20
 Pericardial effusion requiring intervention 0.23–0.59
 Hemothorax requiring intervention 0.07–0.20
 Massive pulmonary embolism 0.08
Minor 0.60–6.20
 Hematoma requiring evacuation 0.90-1.60
 Pneumothorax requiring chest tube 1.10
 Bleeding requiring blood transfusion 0.08-1.00
 Worsening tricuspid valve function 0.32-0.59
 Pulmonary embolism 0.24-0.59
 Venous thrombosis requiring medical intervention 0.10-0.21
 Migrated lead fragment without sequelae 0.20
 Pericardial effusion without intervention 0.07-0.16

Minor complications include bleeding, pocket hematoma, pneumothorax necessitating chest tube placement,
venous thrombosis and migrated lead fragment. Although these events are significant and require rapid
intervention, they are usually not life threatening.

When a sudden drop in blood pressure occurs, the team should immediately use fluoroscopy or TEE to identify the
cause. A growing pericardial effusion, identified by the cessation of movement at the left heart border, suggests
either a myocardial perforation or an SVC tear below the pericardial reflection. An empty ventricle on TEE and
hemothorax on fluoroscopy suggests massive blood loss from a vascular tear above the pericardium.

Rescue devices such as the occlusion balloon (Bridge™; Spectranetics Corporation) (Figure 3) can be rapidly deployed
to help stem the loss of blood in the event of an SVC tear. The device is a compliant, endovascular balloon that
occludes the SVC from the innominate veins to the right atrium and can be deployed in less than two minutes.
Inflation times can be reduced to less than 15 seconds by prophylactically placing the device in the inferior vena cava
of high-risk patients before extraction. In the event of a suspected tear, the occlusion balloon can be threaded up a
prepositioned wire and inflated to provide temporary hemostasis and hemodynamic stability, thereby facilitating a
more controlled surgical repair.

Prevention of Infection
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Given that a substantial portion of lead extractions are indicated because of infection, methods to reduce rates of
infection are being explored. A promising technique under study is the use of an antibiotic-eluting mesh (TYRX™
Anti-bacterial Envelope; Medtronic plc) to reduce CIED infections in high-risk patients. This bio-absorbable mesh is
placed in the CIED pocket at the time of implantation and releases minocycline and rifampicin for a 7-day period.

Another important area of investigation is the use of perioperative antibiotics after CIED implantation. Currently, no
guideline recommendations support the use of post-procedural antibiotic prophylaxis. A 2017 HRS survey suggested
that real-world prescribing patterns vary considerably, and that post-procedural antibiotics are administered after
22–50 % of CIED surgeries. Moreover, the recent Prevention of Arrhythmia Device Infection Trial (PADIT), involving
19,603 patients in Canada, found that increased postoperative antibiotics after CIED implantation had no substantial
effect on infections. Future analyses may help identify effective post-procedure prophylactic antibiotics strategies.

Leadless Alternatives

Limited to a few clinical indications; ICD no available.

Advances in Imaging

Novel imaging modalities have the potential to make lead extraction even safer through better preprocedural
planning and intraoperative navigation. The use of three-dimensional (3D) reconstruction of gated cardiac CT
provides an unparalleled ability to visualize the CIED system in relation to intravascular and intracardiac structures.

Colour 3D Doppler echocardiography of the SVC was used by a team at Drexel University to predict lead fibrosis. This
demonstrated the feasibility of a low-cost, noninvasive screening method to predict whether complex procedures
would be needed.

Additionally, recent advancements in 3D imaging technology (CartoSound™, Biosense Webster Inc) have allowed for
real-time assessment of binding sites during transvenous lead extraction.

Prospective Innovation

 Expanding balloon or mechanical vibratory sheaths that break adhesions with ease.
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