Download Lead Extraction - Department of Mechanical Engineering

Lead Extraction
Medical Device Innovation Workshop
1
Table of Contents
Problem Statement .....................................................3
Challenges .....................................................................5
Current Solutions ........................................................6
Related Patents...........................................................14
Heart Rhythm Society Expert Consensus on Lead
Extraction
2
Problem Statement
Sometimes pacemaker and ICD leads need to be
removed from the body due to






Infection
Related chronic pain
Thrombosis
Vein stenosis
Lead malfunctions
Problem Statement: To safely remove pacing and ICD
leads without harm to the patient

3
Challenges: Free leads encapsulated in
fibrosis
Leads encapsulated by Fibrosis
Pictures from Mayo Clinic, Rodchester,
Minnesota
4
Challenges: Leads fibrosed into the
triscupid valve
Pictures from Mayo Clinic, Rodchester,
Minnesota
5
Challenges: Tearing the walls of the heart
and veins due extraction
Thin structures of the
heart and veins are easily
torn



Right atrial appendage (12mm thick)
Free wall of the cardiac
veins
Pictured above is the right atrial appendage
Picture from Mayo Clinic, Rodchester, MN
6
Current Solutions: Approaches
Lead extractions typically
are approached through
superior vena cava
When complications occur
access to the heart can
also be obtained through
the femoral vein


7
Current Solution: Traction Alone
Pulling on the lead itself or
on a locking stylet is
typically attempted first
A locking stylet is a wire
that is inserted into the
lead lumen and locked in
place


8
As seen above leads have a coil lumen
in which the locking stylet below is inserted
into and can lock in place. Pictures are from
The Lead Extraction Symposium at the St. Paul
Heart Clinic
Current Solution: Laser Sheath
The spectranetics laser
power sheath is applied
over the lead and
burns through tissue
binding sites
Disadvantage: it cannot
burn through
calcification


9
Current Solution: Non-powered Mechanical
Sheaths




Cook telescoping sheaths
Apply counter-traction to
break through lead binding
sites
Inexpensive
Disadvantage: not effective
on calcification
Picture from St. Paul Heart Clinic
10
Current Solution: Powered Mechanical
Sheaths


Cuts through calcified
tissue with drilling-like
mechanism
Disadvantages


11
Can damage adjacent leads
Difficult to align with the
lead due to stiffness
Current Solution: RF Sheaths


Uses RF to burn through
binding sites
Cannot perform for long
procedures due to its lack
of power
Picture from St. Paul Heart Clinic
12
Current Solutions: Femoral Access

The cook snare
ensnares the lead
and extracts it
out through the
femoral vein
13
Lead Management
GLIDELIGHT™
Laser SHEATH
Versatility. Efficiency. Control.
Always Reaching Farther
UNPRECEDENTED ADVANCES IN
LASER LEAD REMOVAL TECHNOLOGY
VERSATILITY
Safely and efficiently removing leads depends on tools that
No two lead removal procedures are the same. Each
give you versatility and control. GlideLight™ Laser Sheath
binding site is unique, lead designs vary, and every
offers the unprecedented ability to customize the laser’s
patient’s anatomy is different.
repetition rate throughout a procedure. When GlideLight
Laser Sheath is set at 80Hz, you can use up to 55% less
advancement force1, and you can smoothly advance up to
Flexible Pulse Repetition Rate8
62% more efficiently through tough binding sites2.
80 Hz
25 Hz
0 second
1/5 second
GlideLight Laser Sheath allows you to customize
the repetition rate.
GlideLight Laser Sheath allows you
to adjust from 25Hz to 80Hz based
on anatomical and
procedural considerations.
EFFICIENCY
CONTROL
Stalled progression during lead removal procedures can
Using a high degree of mechanical force when removing
lengthen the time they take to complete. GlideLight
leads can compromise lead integrity3-6. GlideLight Laser
Laser Sheath may enable smoother and more consistent
Sheath provides critical control when progressing through
progression.
binding sites7.
Advancement Rate (mm/sec)
Advancement Rate at Constant Force8
Less Unintended Forward Motion
1.0
0.8
0.6
0.4
0.2
0
40Hz
80Hz
Rate of progression through binding sites at
40Hz and 80Hz.
GlideLight Laser Sheath provides a high degree of
control when progressing through binding sites7.
GlideLight Laser Sheath enables you
to advance up to 62% more efficiently
through tough binding sites 2.
GlideLight Laser Sheath allows
physicians to use up to 55% less
advancement force1.
GlideLight Laser Sheath
Model Number
500-301
500-302
500-303
12F
14F
16F
Maximum target lead diameter (F/inches/mm)
7.5/0.098/2.50
9.5/0.124/3.17
11.5/0.150/3.83
Minimum tip inner diameter (F/inches/mm)
8.3/0.109/2.77
10.2/0.134/3.40
12.5/0.164/4.17
Maximum tip outer diameter (F/inches/mm)
12.5/0.164/4.17
14.7/0.192/4.88
17.2/0.225/5.72
Working length (cm)
50
50
50
Repetition rate (Hz)
25-80
25-80
25-80
Clinical energy setting (mJ/mm)
30-60
30-60
30-60
Sheath size
GlideLight™ Laser Sheath Important Safety Information
GlideLight Laser Sheath is intended for use with other lead extraction tools in patients who are suitable candidates for removal of
implanted pacemaker and defibrillator leads. The use of GlideLight Laser Sheath may be unsafe in some patients, or with certain leads,
or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a
patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo
lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Leads not intended for
extraction may be damaged during the procedure and may require replacement. Ask your doctor if you are a candidate for lead
extraction with GlideLight Laser Sheath.
Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment
include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung.
Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood
vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments.
Other serious complications may include: irregular heartbeat, weakened heart muscle, infection, respiratory failure or complications
associated with anesthesia, stroke or death.
This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure
to you.
Citations
1. Comparison of average peak push forces required to advance Laser Sheath at 40Hz vs. 80Hz Pulse Repetition Rate through
simulated fibrosis material at an advancement rate of 1.0 mm/second. D015722, Data on file at Spectranetics.
2. Comparison of ablation force vs. advancement rate of Laser sheath 40Hz vs. 80Hz by use of the data collected in D015786, Data on
file at Spectranetics.
3. Maytin M, Epstein, L (2011). The challenges of transvenous lead extraction. Heart, 97(5): 425-34.
4. Henrikson, C.A., et al. (2008). How to prevent, recognize, and manage complications of lead extraction. Part III: Procedural factors
Heart Rhythm. Jul;5(7):1083-7. Epub 2007 Oct 9.
5. Smith MC, Love CJ. Extraction of transvenous pacing and ICD leads. Pacing Clin Electrophysiol 2008:31:736-52.
6. 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), 1671-1676.
7. Reduced advancement force lowers the forces applied to leads during extraction, D015861-01, Data on file at Spectranetics.
8. Design Verification Report for Ablation Force Testing. D015722, Data on file at Spectranetics.
The Spectranetics Corporation
9965 Federal Dr., Colorado Springs, CO 80921
Tel: 719-447-2000 • Fax: 719-447-2022 • Customer Service: 800-231-0978
©2013 Spectranetics All rights reserved. Approved for external distribution. D017256-02 012013
Always Reaching Farther
Pacemaker and Defibrillator Lead Extraction
Eric Buch, Noel G. Boyle and Peter H. Belott
Circulation. 2011;123:e378-e380
doi: 10.1161/CIRCULATIONAHA.110.987354
Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231
Copyright © 2011 American Heart Association, Inc. All rights reserved.
Print ISSN: 0009-7322. Online ISSN: 1524-4539
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CARDIOLOGY PATIENT PAGE
Pacemaker and Defibrillator Lead Extraction
Eric Buch, MD; Noel G. Boyle, MD; Peter H. Belott, MD
S
urgically implanted cardiac devices play an important role in the
treatment of heart disease. In the 50
years since the first pacemaker was
implanted, technology has improved
dramatically, and these devices have
saved or improved the quality of
countless lives. Pacemakers treat slow
heart rhythms by increasing the heart
rate or by coordinating the heart’s
contraction for some heart failure patients.1 Implantable cardioverter defibrillators stop dangerous rapid heart
rhythms by delivering an electric
shock.2 As the range of applications
widens, the number of patients with
cardiac devices continues to increase.
Approximately 400 000 devices are
implanted each year in the United
States, and there ⬎3 million patients
with implanted cardiac devices
currently.
Occasionally, pacemaker and implantable cardioverter defibrillator systems must be removed. The removal of
such systems is potentially a high-risk
procedure. With the increasing number
of implanted devices, removal is required more frequently. To ensure patient safety, the Heart Rhythm Society
has published guidelines for safe lead
removal or extraction. These guidelines outline the indications for lead
extraction, physician qualifications
and training, and the tools and techniques used in the procedure.3
One part of the system is the pulse
generator, a metal can that contains
electric circuits and a battery, usually
placed under the skin on the chest wall
beneath the collarbone. To replace the
battery, the pulse generator must be
changed by a simple surgical procedure every 5 to 10 years. The other
parts are the wires, or leads, which run
between the pulse generator and the
heart. In a pacemaker, these leads allow the device to increase the heart
rate by delivering small bursts of electric energy to make it beat faster. In a
defibrillator, the lead has special coils
to allow the device to deliver a highenergy shock and convert dangerous
rapid rhythms (ventricular tachycardia
or fibrillation) back to a normal
rhythm. For both of these functions,
leads must be in contact with heart
tissue. Most leads pass through a vein
under the collarbone that connects to
the right side of the heart (right atrium
and right ventricle). To remain attached to the heart muscle, most leads
have either a small screw or hooks at
the end. Within a few months, the
body’s natural healing process forms
scar tissue along the lead and at its tip,
which fastens it even more securely in
the patient’s body. Leads usually last
longer than device batteries, so leads
are simply reconnected to each new
pulse generator (battery) at the time of
replacement.
When Is Lead
Extraction Recommended?
Although they are designed to be implanted permanently in the body, occasionally these leads must be removed, or extracted. The most
common reason for lead extraction is
device infection. If any part of the
system becomes infected, it is usually
impossible to cure the infection without completely removing all hardware
from the body. This requires removal
of the pulse generator from the chest
wall, as well as removal of all leads
from the veins and heart. Another reason for lead extraction is when a lead
fails to work properly (for example,
due to a break in the metal wire or
surrounding insulation). Sometimes,
the broken lead can be abandoned in
The information contained in this Circulation Cardiology Patient Page is not a substitute for medical advice, and the American Heart Association
recommends consultation with your doctor or healthcare professional.
From the University of California, Los Angeles Cardiac Arrhythmia Center (E.B., N.G.B.), Ronald Reagan University of California, Los Angeles
Medical Center, David Geffen School of Medicine at University of California, Los Angeles; and Sharp Grossmont Hospital, La Mesa, CA (P.H.B.).
Correspondence to Eric Buch, MD, UCLA Cardiac Arrhythmia Center, David Geffen School of Medicine at UCLA, A2-237 CHS, 10833 Le Conte
Ave, Los Angeles, CA 90095. E-mail [email protected]
(Circulation. 2011;123:e378-e380.)
© 2011 American Heart Association, Inc.
Circulation is available at http://circ.ahajournals.org
DOI: 10.1161/CIRCULATIONAHA.110.987354
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by guest on November 23, 2013
e378
Buch et al
Pacemaker and Defibrillator Lead Extraction
Figure 1. Pacemaker and implantable cardioverter defibrillator leads are removed from
the inside of the heart by use of specialized tools, such as the laser sheath shown
above. The most common approach follows the course of the lead through the subclavian vein under the patient’s shoulder. Arrows show areas where scar tissue is most
likely to form.
the heart, with a new lead placed
alongside. However, veins can only
accommodate a limited number of
leads due to space constraints, and
sometimes, nonfunctioning leads must
be extracted to make space for a new
lead. Occasionally, younger patients
opt for removal of broken leads even if
there are no space limitations because
they will probably need more leads in
the future, and leads are more difficult
to extract after more time in the body.
An uncommon reason for lead extraction is a mechanical lead failure that
could be dangerous to the patient, such
as a protruding wire.
How Is Lead Extraction
Performed, and What Should
I Expect From
the Procedure?
The pulse generator can be removed
relatively easily because it is contained
in the chest wall pocket and can be
reached through a surgical incision.
The leads, however, run a long course
through the veins into the heart (Figure
1). The body’s natural healing process
forms scar tissue at multiple sites
along the lead that can create strong
attachments to the wall of a blood
vessel or a heart chamber. Freeing a
lead from these attachments requires
considerable skill and experience and
is more difficult and risky than implanting the leads in the first place.
Leads can be extracted from the shoulder area or the leg and shoulder area.
Historically, doctors did not have
specialized tools for lead extraction.
They used pulling force, or traction, to
slowly break the lead free of its attachments. Sometimes they applied force
gradually with weights and a pulley
system. However, these techniques
often failed, which resulted in broken
e379
leads with fragments left behind or
damage to vital body structures and
serious complications. A variety of
tools have been developed to make
lead extraction safer and more successful. One of these is a wire that
passes down the length of the lead,
locking into place and allowing force
to be applied to the tip of the lead.
Another tool is a flexible tube called
a sheath that passes over the lead,
surrounding it and freeing it from the
body by disrupting scar tissue as it is
advanced toward the heart (Figure
1). Sheaths can be made of stainless
steel or plastic. Some work mechanically, relying on force to free the
lead. These are much more effective
than simple traction.
The latest technologies for lead extraction deliver various forms of energy to the tip of the sheath. These are
called power sheaths. As the sheath is
pushed over the lead and comes to an
area of attachment, the operator can
turn on the sheath’s energy source to
heat or vaporize scar tissue. This has
the effect of cutting the lead from its
attachments, allowing the lead to be
removed with much less force. Once
the entire lead is freed from scar tissue,
it can be pulled out of the body safely.
One of these specialized sheaths uses
electrocautery, similar to what is used
to cut through tissue in surgery. Another commonly used sheath has a ring
of tiny lasers at its tip. When activated,
the lasers vaporize water molecules in
scar tissue within 1 mm, which allows
the sheath to be passed slowly over the
entire lead until it can be removed
(Figure 2). Occasionally, leads cannot
be extracted from the chest and are
instead removed through the femoral
vein in the groin by use of specialized
tools. There is also a mechanical cutting tool for breaking through dense or
calcified scar.
Usually, the lead-extraction procedure is performed with patients under
general anesthesia, but sometimes,
sedating medications may be used
instead. A team of medical professionals, including a cardiologist or
cardiac surgeon, anesthesiologist,
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e380
Circulation
March 22, 2011
to save the patient’s life. Other major
complications of lead extraction include a blood clot lodging in the lung,
stroke, or various problems related to
anesthesia. Less severe problems that
have been reported include fluid accumulation around the heart or lung (not
requiring drainage), bleeding under the
skin, swelling of the arm, and a small
amount of air entry into the vein. In the
large published studies on lead extraction, the rate of major complications
was 1.6% to 2.0%, or approximately 1
in 50 patients.
Summary and Conclusions
Figure 2. These 3 leads were removed from a single patient. Scar tissue is seen
attached to each lead. Specialized sheaths can separate the lead from the blood vessel
and heart wall to allow safe extraction.
nurses, and technicians, is required
to perform the operation safely. Facility and equipment requirements
include a wide array of leadextraction tools, high-quality x-ray
and ultrasound, and a well-equipped
operating room. Because of these
complex technical requirements, lead
extraction is usually performed in
specialized centers. Studies have
shown that the procedure is more
likely to be successful when performed by operators and medical
centers with more experience. The
overall success rate in a large series
of procedures at 89 hospitals in the
United States was ⬎90%, but this
depends on many factors, such as the
specifications of the leads and the
amount of time the leads have been
implanted. Lead extractions usually
take between 2 and 6 hours, and
patients are usually admitted to the
hospital for a minimum of 1 night.
Certain medications, such as blood
thinners, might be stopped before the
procedure. If the patient needs a new
cardiac device and leads, these may
be implanted at the same time as the
lead extraction or on a different day.
What Are the Risks and
Complications of
Lead Extraction?
Lead extraction is a complex surgical
procedure with some unavoidable
risks. Each time the lead is separated
from scar tissue, there is a small
chance of tearing the surrounding
blood vessel or perforating the heart,
which can result in major bleeding in
the chest or around the heart. In some
cases, this requires blood transfusion
or even immediate open heart surgery
When an implanted cardiac device
must be removed, experts can use specialized tools and techniques according to the Heart Rhythm Society
guidelines to extract the device and
leads safely and effectively. Patients
should discuss the risks and benefits
with their physicians before the procedure. As lead extraction becomes more
common and more research in the area
is performed, this procedure will continue to evolve and improve.
Disclosures
Dr Belott has served as a consultant to
Spectranetics Inc. The remaining authors
report no conflicts.
References
1. Wood MA, Ellenbogen KA. Cardiology
patient pages: cardiac pacemakers from the
patient’s perspective. Circulation. 2002;105:
2136 –2138.
2. Reiffel JA, Dizon J. Cardiology patient page:
the implantable cardioverter-defibrillator:
patient perspective. Circulation. 2002;105:
1022–1024.
3. Wilkoff BL, Love CJ, Byrd CL, Bongiorni
MG, Carrillo RG, Crossley GH III, Epstein
LM, Friedman RA, Kennergren CE, Mitkowski P, Schaerf RH, Wazni OM. Transvenous lead extraction: Heart Rhythm
Society expert consensus on facilities,
training, indications, and patient management: this document was endorsed by the
American Heart Association (AHA). Heart
Rhythm. 2009;6:1085–1104.
Downloaded from http://circ.ahajournals.org/ by guest on November 23, 2013
Journal of the American College of Cardiology
© 2010 by the American College of Cardiology Foundation
Published by Elsevier Inc.
Vol. 55, No. 6, 2010
ISSN 0735-1097/10/$36.00
doi:10.1016/j.jacc.2009.08.070
Heart Rhythm Disorders
Lead Extraction in the
Contemporary Setting: The LExICon Study
An Observational Retrospective Study
of Consecutive Laser Lead Extractions
Oussama Wazni, MD,* Laurence M. Epstein, MD,‡ Roger G. Carrillo, MD,§ Charles Love, MD,†
Stuart W. Adler, MD,储 David W. Riggio, MD,¶ Shahzad S. Karim, MD,# Jamil Bashir, MD,#
Arnold J. Greenspon, MD,** John P. DiMarco, MD, PHD,§§ Joshua M. Cooper, MD,††
John R. Onufer, MD,储储 Kenneth A. Ellenbogen, MD,¶¶ Stephen P. Kutalek, MD,‡‡
Sherri Dentry-Mabry, MSN,## Carolyn M. Ervin, PHD,## Bruce L. Wilkoff, MD*
Cleveland and Columbus, Ohio; Boston, Massachusetts; New York, New York; St. Paul, Minnesota;
Phoenix, Arizona; Vancouver, British Columbia, Canada; Philadelphia, Pennsylvania;
Charlottesville, Norfolk, and Richmond, Virginia; and Colorado Springs, Colorado
Objectives
This study sought to examine the safety and efficacy of laser-assisted lead extraction and the indications, outcomes, and risk factors in a large series of consecutive patients.
Background
The need for lead extraction has been increasing in direct relationship to the increased numbers of cardiovascular implantable electronic devices.
Methods
Consecutive patients undergoing transvenous laser-assisted lead extraction at 13 centers were included.
Results
Between January 2004 and December 2007, 1,449 consecutive patients underwent laser-assisted lead extraction of
2,405 leads (20 to 270 procedures/site). Median implantation duration was 82.1 months (0.4 to 356.8 months).
Leads were completely removed 96.5% of the time, with a 97.7% clinical success rate whereby clinical goals associated with the indication for lead removal were achieved. Failure to achieve clinical success was associated with body
mass index ⬍25 kg/m2 and low extraction volume centers. Procedural failure was higher in leads implanted for ⬎10 years
and when performed in low volume centers. Major adverse events in 20 patients were directly related to the procedure (1.4%) including 4 deaths (0.28%). Major adverse effects were associated with patients with a body mass index
⬍25 kg/m2. Overall all-cause in-hospital mortality was 1.86%; 4.3% when associated with endocarditis, 7.9% when associated with endocarditis and diabetes, and 12.4% when associated with endocarditis and creatinine ⱖ2.0. Indicators of allcause in-hospital mortality were pocket infections, device-related endocarditis, diabetes, and creatinine ⱖ2.0.
Conclusions
Lead extraction employing laser sheaths is highly successful with a low procedural complication rate. Total mortality
is substantially increased with pocket infections or device-related endocarditis, particularly in the setting of diabetes,
renal insufficiency, or body mass index ⬍25 kg/m2. Centers with smaller case volumes tended to have a lower rate of
successful extraction. (J Am Coll Cardiol 2010;55:579–86) © 2010 by the American College of Cardiology Foundation
From the Department of Cardiovascular Disease, *Cleveland Clinic, Cleveland, Ohio;
†Ohio State University, Columbus, Ohio; ‡Brigham and Women’s Hospital, Harvard
Medical School, Boston, Massachusetts; §Mt. Sinai Medical Center, New York, New
York; 储St. Paul Heart Clinic, St. Paul, Minnesota; ¶Arizona Heart Hospital, Phoenix,
Arizona; #University of British Columbia, Vancouver, British Columbia, Canada;
**Thomas Jefferson University, ††University of Pennsylvania, and ‡‡Drexel College of
Medicine, Philadelphia, Pennsylvania; §§University of Virginia, Charlottesville,
Virginia; 储 储Sentara Cardiovascular Research, Norfolk, Virginia; ¶¶Virginia Commonwealth University, Richmond, Virginia; and the ##Spectranetics Corporation,
Colorado Springs, Colorado. This study was sponsored by Spectranetics Inc. Dr.
Epstein has received honorarium for speaking, research, and consulting from Spectranetics, St. Jude, Medtronic, and Boston Scientific. Dr. Carrillo is a consultant for
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Spectranetics and Medtronic. Dr. Love is an advisor for Spectranetics. Dr. Adler is a
consultant for Medtronic Inc., and has industry-sponsored research from Medtronic Inc.
and Boston Scientific. Dr. Riggio is a physician-trainer for Spectranetics. Dr. Karim is a
consultant and proctor for Spectranetics. Dr. DiMarco has received research support from
and is a consultant for Medtronic, St. Jude Medical, and Boston Scientific. Dr. Onufer is
a consultant for St. Jude. Dr. Ellenbogen is a consultant for and has received honoraria and
research support from Medtronic, Boston Science, and St. Jude Medical, and has received
honoraria from Biotronik. Dr. Kutalek is a consultant for Spectranetics. Ms. DentryMabry is an employee of Spectranetics. Dr. Ervin is the senior biostatistician with
Spectranetics. Dr. Wilkoff is on the advisory board of Spectranetics.
Manuscript received April 10, 2009; revised manuscript received July 13, 2009,
accepted August 3, 2009.
580
Wazni et al.
Laser Lead Extraction
The need for percutaneous transvenous lead extraction has been
increasingly required in direct reBMI ⴝ body mass index
lationship to the increased numCIED ⴝ cardiovascular
bers of cardiovascular implantimplantable electronic
able electronic devices (CIEDs)
device
and is expected to continue to
DRE ⴝ device-related
grow.
endocarditis
Unfortunately, the compoLALE ⴝ laser-assisted
lead extraction
nents of the CIED, the leads and
pulse generators, do not function
MAE ⴝ major adverse
event
perpetually. As the population
and the CIED ages, components
NASPE ⴝ North American
Society of Pacing and
of the system need to be exElectrophysiology
tracted for a variety of reasons
including infection, lead malfunction, venous stenosis, and occlusion, as well as safety
alerts. Perceptions of lead extraction safety and effectiveness
and the outcomes of patients undergoing transvenous lead
extraction have been based on early, relatively small trials,
and a voluntary reporting of outcomes in a multicenter
extraction registry (1–3). Historically, the perceived risk of
extraction has limited the referral and performance of this
procedure to patients with life-threatening situations (Class
1 indications). Growing physician experience and the development of newer tools have influenced the outcomes of
transvenous lead extraction and thereby indications.
The goal of this study was to determine the contemporary
safety and efficacy of excimer laser-assisted lead extraction,
in a large series of consecutive patients who presented to 13
centers. In addition, the indications for extraction, outcomes, and risk factors for complications and mortality were
determined.
Abbreviations
and Acronyms
Methods
Consecutive patients who underwent laser-assisted lead
extraction (LALE) using the CVX-300 (Spectranetics,
Colorado Springs, Colorado) laser system and the SLS II
(Spectranetics) laser sheath between January 1, 2004, and
December 31, 2007, were included. Patients were excluded
if another nonlaser, nontraction device was used in the same
procedure.
Data was collected at 13 sites in the U.S. and Canada. A
pre-study, self-reported questionnaire to determine lead
extraction caseloads over the previous 4-year period and
practice type (academic vs. private practice) was used to
ensure a wide range of settings and experience. Centers were
divided into 3 groups (small ⱕ60 cases, mid ⬎60 and ⱕ130
cases, and large ⬎130 cases). The protocol was reviewed and
approved by the institutional review board of each center.
Definitions published in 2000 in the North American
Society of Pacing and Electrophysiology (NASPE) (now
the Heart Rhythm Society) guidance document on transvenous lead extraction were used to calculate the safety and
effectiveness of the extraction procedure and the rates of
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JACC Vol. 55, No. 6, 2010
February 9, 2010:579–86
procedural (radiographic) and clinical success and complications (4).
Indications for lead extraction were classified as: 1) pocket
infection; 2) device-related endocarditis (DRE); 3) pain;
4) venous stenosis or occlusion; 5) functional but abandoned; or 6) nonfunctional leads.
Pocket infection was defined as erythema with or without
purulent discharge, device erosion, fat necrosis, and/or
adherence of device to the skin, which may be accompanied
by pain. All other infections in the presence of a CIED were
considered device-related endocarditis. This included all
persistent bacteremia or sepsis in the absence of another
identifiable source or vegetations on the leads or valves in
the presence of a device. Pain was defined as a lead
extraction done to relieve pain associated with the device
and leads without suspected infection. Extraction for nonfunctional lead status was defined as being related to a
mechanical lead failure established on the basis of clinically
significant alterations in pacing, sensing, lead impedance, or
inappropriate tachycardia therapies.
Leads may be extracted when upgrading 1 system to
another such as pacemaker to an implantable cardioverterdefibrillator or a pacemaker/implantable cardioverterdefibrillator to a cardiac resynchronization device when
ipsilateral venous occlusion or stenosis is encountered. In
addition, concern regarding possible interference with another device, treatment of malignancy, or causing another
medical condition were indications for extraction. Potential
future venous occlusion and infection due to superfluous
abandoned leads were also reasons for extraction of the
functional lead. If venous stenosis or occlusion was present,
then the extraction indication was so designated, but if the
concern was for abandoning leads, then the indication was
designated a “functional abandoned lead.”
Laser extraction. Laser sheaths were employed in all cases
when the leads could not be explanted by simple traction.
The extraction procedure has been described in detail
previously (3). In brief, the lead was prepared by inserting a
locking stylet into the inner coil lumen when possible. A
suture is then tied onto the insulation and the locking stylet.
The laser sheath was then advanced over the lead. Laser
application was performed at binding sites and advanced
gradually from 1 binding site to another until the tip of the
lead was reached. Once abutting the myocardium, a combination of traction and countertraction was performed and
the lead was freed.
The procedural and clinical success definitions employed
in this study were as defined in the NASPE 2000 Policy
Statement (4). Procedural success was defined as complete
or partial and is identified for each lead extracted. Complete
success was defined as the ability to remove “all lead material
from the vascular space.” Partial success was defined as
“removal of all but a small portion of the lead; this may be
the electrode, 4 cm or less of conductor coil, and/or
insulation, or the latter two combined.” Procedural failure is
defined as “abandoning a significant length of lead (more
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February 9, 2010:579–86
than 4 cm) after attempted removal.” Clinical success,
defined as achievement of “all clinical goals associated with
the indication for lead removal,” was identified only once for
each procedure. At a minimum, the clinical goals included:
“resolution of the clinical indication for lead removal” and
“absence of major complications and control of pacing
status.” Clinical failure was defined as the “inability to
achieve all of the clinical goals” outlined herein (4).
Data collection procedures. In each institution, a patient
identification log was generated that included all lead
extractions. Each patient was given a unique identifier. Each
medical record was reviewed from admission to discharge
and an initial data collection form was completed by a
trained data collector. To reduce potential bias, a blinded
trained second data collector then independently reviewed
the medical record and completed a second data collection
form on a random selection of ⱖ10% of the medical records
and 100% of the medical records of patients who had
sustained an adverse event during hospitalization.
Definitions for major and minor complications (adverse
events) are described in the NASPE 2000 Policy Statement
(4). A major adverse event (MAE) was defined as “any
complication related to the procedure that required procedural intervention or transfusion to prevent death, threat to
life, or any complication related to the procedure that
resulted in death or serious harm to bodily function or
structure.” A minor adverse event was “any complication
related to the procedure that required medical or minor
procedural intervention to remedy or prolonged hospital
stay or limited the patient’s function but did not threaten
life, cause death or cause serious harm to bodily function or
structure.”
The clinical events committee reviewed all adverse events.
The clinical events committee members were blinded to all
patient and site identifiers. The events were reviewed and
adjudicated as major or minor and categorical relationships
were defined in relation to: 1) LALE procedure; 2) another
procedure; or 3) pre-existing conditions. Within the preexisting conditions category, specific medical conditions or
treatments were further evaluated for relationship to the
event, including: sepsis, use of anticoagulants, renal insufficiency, and loss of biventricular pacing.
Data analysis. Data analyses were conducted using the
SAS system, version 9.1 (SAS Institute Inc., Cary, North
Carolina). Descriptive statistics for continuous variables
were expressed as mean, median, standard deviation, and
ranges. Discrete variables were expressed as frequencies and
percentages. Proportions, such as implant duration category
versus procedural/clinical success and procedural MAE
versus center size, were compared using the chi-square test.
Fisher exact test was used for small cell sizes (⬍5 cases).
Median implant duration of lead time for MAE versus
those leads without MAE was assessed using the Wilcoxon
rank sum test, due to lack of normality. All tests of
significance were 2-sided, with statistical significance set at
p ⬍ 0.05. In addition, surrogate modeling was performed
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for the duration of lead implant in patients who had more
than 1 lead extracted. The longest duration of any lead with
LALE was then used to represent the individual patient.
Multivariate logistic regression analysis was performed to
determine predictors within 6 categories: 1) clinical failure;
2) procedural failure; 3) procedural MAE; 4) all-cause
in-hospital mortality; 5) all-cause in-hospital mortality in
the infected population (DRE ⫹ pocket infection); and
6) all-cause in-hospital mortality in the DRE population.
Predictors were selected from the previously conducted
univariate analyses where the coefficients were significant.
Additional covariate relationships were analyzed, interaction/confounding testing was also performed to produce a
predictive model at p ⬍ 0.05. Model-building strategy and
goodness of fit test was derived from Hosmer and Lemeshow test (5). The candidate variables used in the models
included: 1) type of lead (pacer or implantable cardioverterdefibrillator); 2) duration of the lead implantation;
3) volume of procedures at the center; 4) body mass index
size ⬍25 (underweight and normal weight); 5) renal insufficiency defined as a pre-procedure serum creatinine ⱖ2.0
mg/dl; 6) diabetes; 7) endocarditis; 8) pocket infection;
9) age ⬎65 years; and 10) sex.
Results
During the period of January 1, 2004, to December 31,
2007, a total of 1,449 patients underwent LALE in the 13
centers (see the Online Appendix for centers and cases per
center). Physicians had a mean of 11.4 ⫾ 6.32 years (range
2.0 to 19.0 years, median 13.0 years) of experience with lead
extraction and a mean of 7.87 ⫾ 3.56 years (range 2.0 to
13.0 years, median 8.0 years) of experience with LALE at
the study completion. In these patients, extraction was
attempted on 2,405 leads including 1,684 pacemaker (70%),
703 defibrillator (29.2%), and 18 (0.7%) unknown leads.
Most leads were active fixation leads (1,226 active, 832
passive, 347 unknown). Patient characteristics can be seen
in Table 1. The mean age of patients was 63.4 ⫾ 17.1 years;
71.8% of the patients were male, and the mean left ventricular ejection fraction was 37.7 ⫾ 16.6%. Diabetes mellitus
was present in 403 (27.8%) patients, and 728 (50.2%)
Demographics
and Risk Factors
Table 1
Demographics
and Risk Factors
Age, yrs
Sex, % male (n ⫽ 1,041)
63.4 ⫾ 17.06
71.8
Ejection fraction, %
37.7 ⫾ 16.57
Diabetes mellitus*
403 (28.1%)
CAD†
728 (50.1%)
ICD
703 (29.2%)
NYHA functional class III‡
145 (41.6%)
Values are mean ⫾ SD, %, or n (%). There were a total of 1,449 patients and 2,405 leads. *A total
of 1,433 patients had data regarding history of diabetes mellitus available. †A total of 1,435
patients had data regarding history of CAD available. ‡A total of 349 patients had data regarding
NYHA functional class available.
CAD ⫽ coronary artery disease; ICD ⫽ implantable cardioverter-defibrillator; NYHA ⫽ New York
Heart Association.
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February 9, 2010:579–86
Indications
Lead Extraction
ⴝ 1,449) (n ⴝ 1,449)
Table 2 for
Indications
for Lead(nExtraction
Infection
825 (56.9%)
DRE: sepsis/endocarditis/bacteremia
423 (29.2%)
Pocket infection/erosion—no bacteremia
402 (27.7%)
Functional, abandoned leads
386 (26.6%)
Nonfunctional leads
161 (11.1%)
Venous stenosis/occlusion
65 (4.5%)
Chronic pain at device or insertion site
12 (0.8%)
DRE ⫽ device-related endocarditis.
patients had coronary artery disease. Among the 349 patients with a reported New York Heart Association functional class, 41.6% had class III heart failure symptoms at
the time of the extraction. Most leads were extracted from
the right ventricle (63.5%, n ⫽ 1,528) and right atrium
(32%, n ⫽ 769); 11 (0.5%) were located in the superior vena
cava, 70 (2.9%) were coronary sinus leads, and 27 (1.1%)
were unknown. The median implant duration was 82.1
months (range 0.4 to 356.8). The number of patients at each
site ranged from 20 to 270 patients.
The indications for lead extraction in the study are
presented in Table 2. The most common indication for
extraction was infection (56.9%, n ⫽ 825) with 29.2% (n ⫽
423) related to DRE and 27.7% (n ⫽ 402) due to pocket
infections. Venous stenosis or occlusion was noted in 4.5%
(n ⫽ 65), and pain at the device implant or lead insertion
site accounted for 0.8% (n ⫽ 12). Nonfunctional leads
represented 26.6% (n ⫽ 386) and functional but abandoned
leads represented 11.1% (n ⫽ 161). Of the functional and
nonfunctional leads extracted, the Medtronic Sprint Fidelis
lead, with or without documented failure, contributed 2.5%
(n ⫽ 61) of the patients with 100% clinical and procedural
success.
Overall, 2,322 leads (96.5%) were completely and 56
leads (2.3%) were partially removed with a combined success
rate of 98.8%. Clinical success was achieved in 1,416
patients (97.7%) (Table 3).
The multivariate model indicated that failure to achieve
clinical success was associated (model likelihood ratio of p ⫽
0.0128) with patient body mass index (BMI) ⬍25 kg/m2
and when the extraction center volume was ⱖ60 cases over
a period of 4 years. In contrast, the multivariate model
indicated that failure to achieve procedural success was
associated (model likelihood ratio of p ⫽ 0.0005) with lead
implantation durations of ⱕ10 years and when the extraction center volume of extraction was ⱖ60 cases over a period
of 4 years.
Procedural adverse events. All-cause adverse events collected during the hospitalization included 63 MAEs in 58
patients (4.0%), and 27 minor adverse events in 26 patients
(1.8%). Of these, 24 major events in 20 patients (1.4%) and
8 minor events in 8 patients (0.6%) were directly related to
the lead extraction portion of the procedure. In addition, a
total of 27 patients (1.86%) died during the index hospitalization of which 4 (0.28%) were deemed to be directly
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related to the extraction procedure. Table 4 lists all major
and minor adverse events noted in the study. The multivariate model indicated that only patients with a BMI ⬍25
kg/m2 (p ⫽ 0.0132) were more likely to experience a
procedural MAE related to the lead extraction procedure.
Procedural MAE were not significantly associated with any
other parameter as listed in Table 5.
In-hospital mortality and comorbidities. Patients requiring transvenous lead extraction have overlapping comorbidities that increase the risk for death during their hospitalization. The multivariate model indicates that patients with
creatinine ⱖ2.0 mg/dl, diabetes mellitus, BMI ⬍25 kg/m2,
and infection (pocket infection or DRE) were all at increased risk of death (model likelihood ratio of p ⬍ 0.0001).
Although mortality was higher in patients with DRE
compared with patients with pocket infection, this difference was not statistically significant 4.35% versus 1.7% (p ⫽
0.06). The overall demographic comparisons of patients
with infection versus those without infection are listed in
Table 6.
There were 825 (56.9%) patients with device-related
infections, 423 with DRE and 402 with pocket infections.
The infected patients were more likely to be older men, who
had slightly better ejection fractions. In addition, they were
more likely to be diabetic (35.0% vs. 18.3%, p ⬍ 0.0001)
and have renal insufficiency with a creatinine ⱖ2.0 mg/dl
(16.0% vs. 6.4%, p ⬍ 0.0001). The all-cause in-hospital
mortality in infected patients was also increased (3% vs.
0.3%, p ⬍ 0.0001, odds ratio [OR]: 9.7), but there was no
association with clinical success rate or procedure-related
MAE rates (Table 6). Separately, the DRE patient cohort
in-hospital mortality was much higher (4.3%, 18 of 423)
compared with the pocket infection patient cohort (1.7%, 7
of 402). When diabetes or renal insufficiency was additionally present, the DRE patients fared more poorly. Among
those DRE patients with concomitant diabetes, 7.9% (13 of
164) died versus 2% (5 of 253) without a history of diabetes
(p ⫽ 0.0075, OR: 4.3). The odds of an in-hospital mortality
were 7.0 times higher in DRE patients with renal insufficiency (creatinine ⱕ2.0 mg/dl) than among those with
DRE and creatinine ⬍2.0 mg/dl (12.4% vs. 2.0%, p ⬍
0.0001).
Procedural
Clinical and
Success
Table 3 and
Procedural
Clinical Success
Complete (Per Lead)
Partial
Combined complete and partial
Failure
Total
2,322 (96.5%)
56 (2.3%)
2,378 (98.8%)
27 (1.1%)
2,405
Clinical success (per patient)
Success
Failure
Total
1,416 (97.7%)
33 (2.3%)
1,449
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583
Adverse
Table 4Events
Adverse Events
All-cause adverse events
Death
27 (1.86%)
Bleeding requiring transfusion
17 (1.17%)
Hematoma requiring drainage
13 (0.90%)
Cardiac avulsion or tear requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair
9 (0.62%)
Vascular tear requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair axillary artery tear
requiring surgical repair
6 (0.41%)
Thrombosis of implant vein resulting in medical intervention
4 (0.28%)
Arrhythmia requiring cardioversion
3 (0.21%)
Hemothorax from any source requiring transfusion
2 (0.14%)
Pulmonary embolism not requiring surgical intervention
2 (0.14%)
Respiratory failure without arrest
2 (0.14%)
Pulmonary embolism requiring surgical intervention
1 (0.07%)
Stroke
1 (0.07%)
Vascular repair near the implant site or venous entry site
1 (0.07%)
Pericardial effusion not requiring pericardiocentesis or surgical intervention
1 (0.07%)
DVT lower extremity, post-operative
1 (0.07%)
Total events
90
Minor adverse events directly related to lead extraction
Thrombosis of implant vein resulting in medical intervention
3 (0.21%)
Arrhythmia requiring cardioversion
2 (0.14%)
Pulmonary embolism not requiring surgical intervention
1 (0.07%)
Respiratory failure without arrest
1 (0.07%)
Vascular repair near the implant site or venous entry site
1 (0.07%)
Total events (among 8 patients)
8
Major adverse events directly related to lead extraction
Cardiac avulsion or tear requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair
9 (0.62%)
Vascular tear (including axillary artery tear) requiring thoracotomy, pericardiocentesis, chest tube, or
surgical repair
6 (0.41%)
Bleeding requiring transfusion
4 (0.28%)
Death secondary to another major complication (3 vascular tears [2 SVC, 1 SVC/RA], 1 cardiac tear [RV])
4 (0.28%)
Hemothorax from any source requiring transfusion
1 (0.07%)
Total events (among 20 patients)
24
Values are n (%).
DVT ⫽ deep vein thrombosis; RA ⫽ right atrium; RV ⫽ right ventricle; SVC ⫽ superior vena cava.
Discussion
We evaluated the safety and efficacy of laser-assisted lead
extractions using current indications based on the NASPE
2000 Policy Statement. Since the initially reported experiences, which employed earlier editions of the extraction
tools and largely represented the learning curve with laser
extraction techniques, this consecutive patient experience
represents the mature contemporary practice in multiple
centers with varying degrees of experience. Each of the
earlier studies addressed the efficacy and safety of the initial
models of laser sheath. In this study, the modified SLS II
sheath was employed, which has improved mechanical
properties enhancing advancement over the lead. Compared
with previous studies, LALE was associated with higher
procedural and clinical success and a similar proceduralrelated major complication rate, but a lower procedural
mortality rate. When BMI was ⬍25 kg/m2, it predicted
procedural MAE and clinical failure, whereas renal insufficiency, diabetes, BMI ⬍25 kg/m2, and presence of pocket
infection or DRE were all independent predictors of all
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cause in-hospital mortality. The somewhat higher all-cause
in-hospital mortality of 1.86% reflects the complex comorbid conditions of this patient population, especially DRE.
The original PLEXES (Pacing Lead Extraction With the
Excimer Sheath) trial (3), a randomized prospective clinical
trial, compared the first iteration of the 12-F SLS laser
sheath to a nonlaser cohort in 301 subjects with 465 chronic
pacemaker leads. The procedural success in the laser group
was 94% with an associated major complication rate of
1.96% compared with 64% success rate with the use of only
locking stylets and nonpowered telescoping sheaths. The
use of laser tools resulted in quicker lead extraction; 10.1 ⫾
11.5 min with versus 12.9 ⫾ 19.2 min without laser (p ⬍
0.04) (3). Subsequently, when the total initial experience of
laser lead extraction in the U.S. was reported by Byrd et al.
(5) on 2,561 pacing and defibrillator leads from 1,684
patients at 89 sites, the procedural success rate was 90% with
a major complication rate of 1.9% with an in-hospital death
rate of 0.8%. Only implant duration independently predicted procedure failure and female sex was the only
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Demographic
Characteristics:
Procedural MAE
Table 5
Demographic
Characteristics:
Procedural MAE
MAE (n ⴝ 20)
p Value
Center size (LALE experience over 4-yr study period),
cases
ⱕ60
6 (2.88%)
⬎60–ⱕ130
8 (1.70%)
⬎130
6 (0.78%)
0.0532
Location
EP laboratory
Operating room
12 (1.43%)
1.00
8 (1.36%)
Anesthesia
General
9 (1.16%)
IV sedation
9 (1.58%)
Unknown
2 (1.89%)
0.68
Pre-operative arterial line
Present
17 (1.48%)
Absent
0 (0%)
Unknown
3 (1.07%)
—
Sex
Men
Women
13 (1.25%)
0.66
7 (1.72%)
BMI, kg/m2
⬍25
11 (2.6%)
ⱖ25
5 (0.7%)
0.0164
Diabetes
Yes
4 (1.00%)
No
16 (1.55%)
0.62
Renal insufficiency, mg/dl
Cr ⱖ2.0
5 (3.11%)
Cr ⬍2.0
13 (1.10%)
0.05
Duration of lead (surrogate: longest lead represents
each patient), yrs
0–5
4 (0.80%)
⬎5–ⱕ10
7 (1.67%)
⬎10
6 (1.8%)
Age, yrs
64.5 ⫾ 21.4
0.34
0.78
Values are n (%).
BMI ⫽ body mass index; Cr ⫽ creatinine; EP ⫽ electrophysiology; IV ⫽ intravenous; LALE ⫽
laser-assisted lead extraction; MAE ⫽ major adverse event.
multivariate predictor of complications (5). In agreement
with the study by Byrd et al. (5), we found that longer
implantation duration was associated with procedural failure. In contrast with Byrd et al. (5), we found no association
between gender and adverse events directly related to lead
extraction; instead BMI ⬍25 kg/m2 (underweight and
normal weight) also predicted procedure related MAE.
Additionally, in our study, clinical or procedural failure was
associated with low procedure volumes.
Device-related infections continue to be the most common indication for extraction (2,3,6,7). Local infection at
the pocket site has a variety of presentations including
erosion, erythema, frank purulent discharge, or wound
dehiscence, which may be accompanied by pain. It is
important to recognize and treat these local manifestations
of infection promptly and effectively so as to prevent
festering indolent infections that may lead to bacteremia
and possible resultant endocarditis as these latter more
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serious sequelae are associated with a higher mortality rate
(6). In our study, although the in-hospital mortality consequence of DRE was numerically larger, the less impressive
manifestations of pocket infection were statistically not
distinguishable from the DRE patients. Although there is
clear indication that the entire device system should be
removed in the presence of systemic infection, there has
continued to be some controversy regarding localized pocket
infection. The NASPE 2000 guidelines stated that it was
acceptable to remove the device and cut the exposed parts of
the leads. Such a strategy is proving to be unsuccessful and
puts the patient at risk of smoldering infection that could
spread and increase the patient’s risk of death (8).
In this study, nonpocket infections, which presented as
bacteremia, lead, or valvular vegetations, and/or sepsis were
defined as device-related endocarditis. We elected to classify
this group of patients as having DRE because when there is
persistent bacteremia, it is assumed that any intravascular
device is seeded and therefore infected. About half of all
infections were classified as DRE, and these patients were
older and had a higher rate of diabetes and renal insufficiency (defined as a creatinine ⱖ2.0 mg/dl). Despite the fact
that the clinical success and MAE rates were similar to
patients with no DRE, the risk ratio for all-cause inhospital mortality in this group of patients was 4.8 times
higher (4.3%). Patients with DRE and concomitant diabetes had a 4 times higher mortality risk (7.9%) and DRE plus
renal insufficiency yielded a 6.3 times higher mortality risk
(12.4%). This is all compared to the mortality rate in
patients without DRE (patients with either pocket infections or not infected) of 0.9%.
The literature reports DRE represents 10% to 23% of all
device infections (8 –10). In this analysis, DRE represented
51% of device infections and is likely due to the broader
definition employed in our study and the referral patterns of
some study centers. This broader definition was chosen as
the clinical implications of endocarditis, bacteremia, and
sepsis in the setting of a CIED are the same: each requires
complete extraction of the CIED and prolonged antibiotic
therapy.
Mortality rates of DRE treated medically with antibiotics
alone are very high, as much as 66% in some series; this is
compared with a strategy that employs device extraction
where mortality in the literature is reported to be 13% to
21% (11–14). In our study, the all-cause in-hospital mortality rate for the DRE population was 4.3%, 1.7% for
pocket infection and 0.3% for all noninfected patients. This
emphasizes the seriousness of bacteremia and/or vegetations
in patients with a CIED system, but also the seriousness of
pocket infections. In such patients, it is imperative to extract
and remove the pulse generator, the active and abandoned
leads, and debridement of the infected pocket tissue.
In agreement with previous studies, the presence of
nonfunctional and abandoned leads was the second most
common indication for extraction (2,3,15). Extraction of
leads in noninfected patients is considered controversial by
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585
Device-Related
Endocarditis Endocarditis
and Pocket Infection
Table 6
Device-Related
and Pocket Infection
DRE ⴙ Pocket Infection
Others
n
825 (56.9%)
624 (43.1%)
p Value
⬍0.0001
Men (n ⫽ 1,449)
618 (74.9%)
423 (67.8%)
0.003
Age, yrs (n ⫽ 1,449)
67.8 ⫾ 14.6
57.6 ⫾ 18.3
⬍0.0001
Ejection fraction ⬎30% (n ⫽ 1,449)
449 (54.4%)
397 (63.6%)
0.0005
History of diabetes (n ⫽ 1,449)
289 (35.0%)
114 (18.3%)
⬍0.0001
Cr ⱖ2.0 mg/dl
125 (16.0%)
36 (6.4%)
⬍0.0001
Cr ⱖ2.5 mg/dl
93 (11.9%)
19 (3.4%)
⬍0.0001
810 (98.2%)
606 (97.1%)
0.24
Procedure-related MAE (n ⫽ 1,449)
12 (1.5%)
8 (1.3%)
All-cause mortality (n ⫽ 1,449)
25 (3.0%)
2 (0.3%)
History of renal failure (n ⫽ 1,347)
Clinical success (n ⫽ 1,449)
0.96
⬍0.0001*
Values are n (%) or mean ⫾ SD. *Odds ratio: 9.7.
Abbreviations as in Tables 2 and 5.
some physicians, because there are alternative approaches.
Nonfunctional leads may be abandoned rather than extracted. As the duration of implant for devices and leads
increases along with an aging population, a large number of
leads become nonfunctional. These can either be extracted
at the time of another planned procedure such as an
upgrade, or be left to be extracted when there is no other
choice, such as in the presence of infection. This may result
in a large number of leads in any 1 patient that over time
may pose an increased risk of complications. Abandoned
leads may also serve as a nidus for lead-related endocarditis.
In patients with device implants of more than 6 months,
endocarditis usually resulted from bacteremia from a remote
source (16). Suga et al. (17) reported that up to half of all
abandoned pacemaker leads (611 of 1,207) in their cohort
became nonfunctional. They found that more abandoned
leads were associated with a greater number of complications (17). Silvetti and Drago (18) reported on abandoned
leads in young patients. Five and 10 years after lead
abandonment, 2 patients developed lead endocarditis of a
total of 18 patients with abandoned leads. The investigators
concluded that abandonment just postpones inevitable lead
extraction (18). In this study, we found that the success rate
was high and the complication rate exceedingly low for the
removal of nonfunctioning leads. Extraction after some
years of abandonment may be more difficult and be associated with increased risk. In this study, there was a progressive increase in procedural failure with prolonged implantation duration. The cumulative rate was 0.75% at 5 years,
0.93% at 10 years, 1.2% at 15 years, 2.4% at 20 years, and
10.9% at 25 years. Procedural failure was statistically increased when leads were implanted for ⬎10 years. Extraction of leads may also be needed to establish and retain
venous access if the target vein is occluded in a situation
when there is a need for upgrade from a pacemaker (19). In
this study, extraction for this indication was also associated
with a high success rate and low complication rate. When
considering extraction for a noninfection-related indication
it is very important to weigh the risks for a particular
patient, including operator experience, against the risk of
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abandoning these leads. The decision to extract should be
individualized and discussed in detail with the patient and
family.
It is at this point where the consideration of center laser
lead extraction experience is most important. Operator
experience with laser lead extraction is important in determining clinical outcome. In this study, the small centers had
a higher cumulative procedural MAE. A less experienced
center (ⱕ60 cases) was also associated with procedural and
clinical failure. These findings are in agreement with previous studies demonstrating a significant learning curve for
this procedure (20). Therefore, centers should consider their
extraction volume when deciding to perform this procedure
and whether extractions should be referred to higher volume
centers.
Study limitations. The major limitation of this study is
its retrospective nature. Although this study is a consecutive series, patients who did not undergo laser-assisted
extraction were not included. Therefore, there could have
been selection bias, but the bias was most likely to the
most challenging clinical scenarios as laser-assisted extraction is reserved for leads with ingrown tissue and
inability to be removed with traction only. It is possible
that the high success rate and low complication rates in
this study are due to the very experienced centers and
operators in this study. However, in the community,
these more challenging cases are usually referred to
centers experienced in LALE.
Despite this limitation, the study is still valuable because
it represents the current real-world experience with LALE.
Follow-up was limited in this study to hospital discharge or
death. The study found a significant mortality in patients
with DRE. A longer follow-up period would have been
valuable in determining the ultimate outcomes in this
patient population.
We only studied patients undergoing laser lead extraction. Other techniques are currently used. When compared
to only countertraction sheaths, powered tools are much
more effective as the results of the PLEXES trial revealed
when this was compared with laser-powered sheaths (3).
586
Wazni et al.
Laser Lead Extraction
Electrosurgical dissection sheaths that use radiofrequency
are also currently in use and achieve a much higher complete
extraction rate than nonpowered countertraction sheaths,
93% versus 73%. The electrosurgical-powered sheaths also
resulted in less time needed for complete extraction 9.6 ⫾
6.2 min versus 21 ⫾ 9 min (20).
A new Evolution Mechanical Dilator Sheath (Cook
Medical, Bloomington, Indiana) with a stainless steel
bladed rotating tip has been recently introduced and described (21). However, the efficacy and safety has not been
studied in a large patient population and has not been
compared with standard tools. There have been no studies
comparing the different powered tools to each other.
Conclusions
Transvenous laser-assisted lead extraction is highly successful with a low procedural complication rate for a wide range
of indications. Device-related infection was the most common indication for lead extraction and both DRE and
pocket infections carry a substantial in-hospital mortality
risk despite successful removal of the infected device and
leads. Therefore an increased emphasis must be placed on
techniques that reduce the potential for DRE. Indicators of
a decreased clinical and procedural success include average
to small BMI, lead implantation duration of over 10 years,
and extraction centers with small extraction volumes. The
single indicator of lead extraction associated complications
is an average or small BMI, whereas in-hospital mortality is
increased by a clinical history of pocket infection or DRE as
well as diabetes and renal insufficiency.
Reprint requests and correspondence: Dr. Oussama M. Wazni,
Cleveland Clinic, Department of Cardiovascular Medicine/J2-2,
9500 Euclid Avenue, Cleveland, Ohio 44195. E-mail:
[email protected].
REFERENCES
1. Byrd CL, Wilkoff BL, Love CJ, et al. Intravascular extraction of
problematic or infected permanent pacemaker leads: 1994 –1996. U.S.
Extraction Database, MED Institute. Pacing Clin Electrophysiol
1999;22:1348 –57.
2. Epstein LM, Byrd CL, Wilkoff BL, et al. Initial experience with larger
laser sheaths for the removal of transvenous pacemaker and implantable defibrillator leads. Circulation 1999;100:516 –25.
3. Wilkoff BL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with
the laser sheath: results of the Pacing Lead Extraction with the
Excimer Sheath (PLEXES) trial. J Am Coll Cardiol 1999;33:1671– 6.
Downloaded From: http://content.onlinejacc.org/ on 11/23/2013
JACC Vol. 55, No. 6, 2010
February 9, 2010:579–86
4. Love CJ, Wilkoff BL, Byrd CL, et al. Recommendations for extraction
of chronically implanted transvenous pacing and defibrillator leads:
indications, facilities, training. North American Society of Pacing and
Electrophysiology Lead Extraction Conference Faculty. Pacing Clin
Electrophysiol 2000;23:544 –51.
5. Byrd CL, Wilkoff BL, Love CJ, Sellers TD, Reiser C. Clinical study
of the laser sheath for lead extraction: the total experience in the
United States. Pacing Clin Electrophysiol 2002;25:804 – 8.
6. Sohail MR, Uslan DZ, Khan AH, et al. Infective endocarditis
complicating permanent pacemaker and implantable cardioverterdefibrillator infection. Mayo Clin Proc 2008;83:46 –53.
7. Sohail MR, Uslan DZ, Khan AH, et al. Management and outcome of
permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol 2007;49:1851–9.
8. Chua JD, Wilkoff BL, Lee I, Juratli N, Longworth DL, Gordon SM.
Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Ann Intern Med 2000;133:604 – 8.
9. Arber N, Pras E, Copperman Y, et al. Pacemaker endocarditis. Report
of 44 cases and review of the literature. Medicine (Baltimore) 1994;
73:299 –305.
10. Baddour LM, Bettmann MA, Bolger AF, et al. Nonvalvular cardiovascular device-related infections. Clin Infect Dis 2004;38:1128 –30.
11. Cacoub P, Leprince P, Nataf P, et al. Pacemaker infective endocarditis. Am J Cardiol 1998;82:480 – 4.
12. Klug D, Balde M, Pavin D, et al. Risk factors related to infections of
implanted pacemakers and cardioverter-defibrillators: results of a large
prospective study. Circulation 2007;116:1349 –55.
13. Klug D, Lacroix D, Savoye C, et al. Systemic infection related to
endocarditis on pacemaker leads: clinical presentation and management. Circulation 1997;95:2098 –107.
14. Massoure PL, Reuter S, Lafitte S, et al. Pacemaker endocarditis:
clinical features and management of 60 consecutive cases. Pacing Clin
Electrophysiol 2007;30:12–9.
15. Verma A, Wilkoff BL. Intravascular pacemaker and defibrillator lead
extraction: a state-of-the-art review. Heart Rhythm 2004;1:739 – 45.
16. Greenspon AJ, Rhim ES, Mark G, Desimone J, Ho RT. Leadassociated endocarditis: the important role of methicillin-resistant
Staphylococcus aureus. Pacing Clin Electrophysiol 2008;31:548 –53.
17. Suga C, Hayes DL, Hyberger LK, Lloyd MA. Is there an adverse
outcome from abandoned pacing leads? J Interv Card Electrophysiol
2000;4:493–9.
18. Silvetti MS, Drago F. Outcome of young patients with abandoned,
nonfunctional endocardial leads. Pacing Clin Electrophysiol 2008;31:
473–9.
19. Gula LJ, Ames A, Woodburn A, et al. Central venous occlusion is not
an obstacle to device upgrade with the assistance of laser extraction.
Pacing Clin Electrophysiol 2005;28:661– 6.
20. Neuzil P, Taborsky M, Rezek Z, et al. Pacemaker and ICD lead
extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial. Europace
2007;9:98 –104.
21. Dello Russo A, Biddau R, Pelargonio G, et al. Lead extraction: a new
effective tool to overcome fibrous binding sites. J Interv Card Electrophysiol 2009;24:147–50.
Key Words: leads y cardiac implantable electronic devices y extraction
y laser.
APPENDIX
For a list of the centers and cases per center,
please see the online version of this article.
Transvenous Lead Extraction: Heart Rhythm Society
Expert Consensus on Facilities, Training, Indications, and
Patient Management
This document was endorsed by the American Heart Association (AHA).
Bruce L. Wilkoff, MD, FHRS,* Charles J. Love, MD, FHRS,† Charles L. Byrd, MD,‡
Maria Grazia Bongiorni, MD,§ Roger G. Carrillo, MD, FHRS,储 George H. Crossley, III, MD, FHRS,¶
Laurence M. Epstein, MD,# Richard A. Friedman, MD, MBA, FHRS,**"
Charles E. H. Kennergren, MD, PhD, FHRS,†† Przemyslaw Mitkowski, MD,‡‡
Raymond H. M. Schaerf, MD, FHRS,§§ Oussama M. Wazni, MD*
*Cleveland Clinic, Department of Cardiovascular Medicine, Cleveland, OH, †Ohio State University, Division of
Cardiovascular Medicine, Columbus, OH, ‡Broward General Medical Center, Fort Lauderdale, FL, §University Hospital,
Division of Cardiovascular Medicine, Pisa, Italy, 储University of Miami, Cardiothoracic Surgery, Miami, FL, ¶St. Thomas
Research Institute, University of Tennessee College of Medicine, Nashville, TN, #Brigham and Women’s Hospital, Boston,
MA, **Baylor College of Medicine, Pediatrics and Texas Children’s Hospital, Houston, TX, ††Sahlgrenska University
Hospital, Gothenburg, Sweden, ‡‡University of Medical Sciences, Poznan, Poland, §§Providence St. Joseph Medical
Center, Burbank, CA, "American Heart Association Representative.
Preamble
On May 15, 2008, the lead extraction community convened to
critically review the prior April 2000 NASPE policy statement
on Recommendations for Extraction of Chronically Implanted
Transvenous Pacing and Defibrillator Leads: Indications, Facilities, Training.1 This gathering was held as a co-sponsored
satellite symposium* during the Heart Rhythm Society’s 29th
Annual Scientific Sessions to examine ways to revise and
implement effective lead management standards.2
This writing committee, appointed by the Heart Rhythm
Society, is a representative group of international experts in
device and lead management from North America and Europe. Each of these physicians is an expert concerning the
management of leads used with cardiovascular implantable
electronic devices (CIEDs) including transvenous lead extraction. We were charged with the development of a consensus document for the lead extraction community regarding standards for safe and effective lead management.
Central to this effort was a focus on transvenous lead extraction, including standards for training, and standards for
the evaluation of new tools and techniques. Although the
This document was approved by the Board of Trustees of the Heart
Rhythm Society on May 6, 2009. It can be found on the Heart Rhythm
Society website at www.HRSonline.org/Policy/ClinicalGuidelines. Address reprint requests and correspondence: Donna Goldberg, MPH,
Heart Rhythm Society, 1400K Street, NW, Suite 500, Washington DC
200005. E-mail address: [email protected].
*Co-sponsored by Cleveland Clinic Center for Continuing Education
and the Heart Rhythm Society, supported by unrestricted educational
grants from Spectranetics, Cook Vascular Inc, Medtronic, Boston Scientific, St. Jude Medical, Biotronik and ELA Medical Inc.
major intervention discussed in this document is transvenous lead extraction, it was strongly recommended that
this document should focus on the management of the
patient, and in particular the management of the leads.2
The writing group consisted of nine cardiac electrophysiologists and three cardiothoracic surgeons, who specialize
in CIED implantation and extraction. This statement represents expert consensus of the writing committee based on a
review of the literature, their own experience in treating
patients and input from the extraction community gathered
at the symposium. It is directed to all health care professionals and health care institutions that are involved in the
care of patients with CIEDs.
The document represents the strong consensus of the writing committee, which was developed as a result of comments
collected at the 2008 satellite symposium; as well as during a
separate face-to-face all day writing group meeting, multiple
international conference calls, and three web based questionnaires. In writing a “consensus” document, it is recognized that
consensus does not mean that there was complete agreement
among all writing group members. We identified those aspects
of transvenous lead extraction for which a true “consensus”
could be identified. Surveys of the entire writing group were
used to identify these areas of consensus. For the purposes of
this Consensus Document we defined a consensus as 83% or
greater agreement by the authors of this document.
When using or considering the guidance given in this
document, it is important to remember that there are no
absolutes with regard to many clinical situations. The ultimate judgment regarding care of a particular patient must be
made by the health care provider and patient in light of all
1547-5271/$ -see front matter © 2009 Heart Rhythm Society. All rights reserved.
doi:10.1016/j.hrthm.2009.05.020
1086
the circumstances presented by that patient, the management options available as well as the relative risks and
benefits. Indicated procedures are appropriate reasons for
considering an intervention. This document focuses on patient and lead management, and not just lead extraction in
order to place the indications for intervention in the context
of the contraindications, timing, training, facilities and personnel.
TABLE OF CONTENTS
Introduction....................................................................1086
Definitions......................................................................1086
Extraction Tools ............................................................1087
Outcomes: Defining Technical and Clinical Success...1087
TABLE 1: Classification of Complications..................1088
Personnel, Roles and Responsibilities ..........................1089
TABLE 2: Required Personnel .....................................1089
Physician Qualifications and Training ..........................1090
Indications for Lead Removal.......................................1094
TABLE 3: Indications for Transvenous Lead
Extraction.................................................................1096
TABLE 4: Principles for CIED Replacement
following Infected Removal....................................1097
Registry and Data Management....................................1099
New Devices and Techniques.......................................1099
Recommendation for Clinical Evaluation of Lead
Extraction Devices...................................................1099
Conclusion .....................................................................1099
Appendix........................................................................1100
References......................................................................1101
Introduction
Perceptions of lead reliability, performance, complications
and approaches to management have evolved dramatically
since the inception of pacemaker and implantable defibrillator therapy. At various points since the first implantable
pacemaker was placed in 1958, conductors, insulation materials, lead construction, implantation techniques, infection
and venous occlusion have been the source of significant
clinical problems.3,4,5,6,7,8,9,10,11,12 However, not until the
late 1980s was a serious attempt made to develop tools and
techniques to safely remove problematic leads. Inspection
of these leads after extraction contributed substantially to an
understanding of clinical and mechanical failure modes. It
thus resulted in iterative improvements in the design of
leads and implantation techniques in the pursuit of improved patient management. The techniques of transvenous
lead extraction have been detailed elsewhere.13,14,15,16,17,18
The penetration of transvenous lead extraction techniques
into general use was slow due to the potential for fatal complications and the limited training in the tools and techniques.
The North American Society of Pacing and Electrophysiology
[NASPE, which is now the Heart Rhythm Society (HRS)]
convened a policy conference on May 11, 1997, during the
18th Annual Scientific Sessions to formalize standards: for
Heart Rhythm, Vol 6, No 7, July 2009
training of physicians in extraction techniques; for equipment
and emergently needed support staff at each institution; and for
indications and contra-indications for lead extraction. These
standards were published as a guidance document in April
2000.1
Since the publication of this document, the community of
physician experts in the management of lead problems and
transvenous lead extraction has grown substantially. However, the safety and effectiveness of transvenous lead extraction as well as the application of indications vary
widely. The training of physicians and the extraction team
still lags behind demand. It has become the consensus of the
physician community that transvenous lead extraction is a
central treatment in patients with pathologic lead conditions. It is also recognized that lead extraction is only one of
the tools available to physicians in what is more properly
identified as lead management. Lead management requires a
broad understanding of the pathophysiology of the mechanical and clinical issues associated with lead dysfunction, and
a primary commitment to measuring outcomes and quality.
Definitions
Within the general category of “lead removal,” distinctions
must be made between simple procedures that can be performed via the implant vein without specialized tools (“lead
explant”), and removal of leads involving more complex
procedures (“lead extraction”). This is necessary when designing training programs, for classification of procedures
in registries and databases, for assuring a uniform definition
in the literature, for determining the personnel and facilities
for the procedure, as well as for the goal of appropriate
reimbursement levels for the different procedures. Although
leads with less than one year of implantation can sometimes
be challenging to remove, it is the exception. The standards
for lead extraction, including surgical backup, personnel,
facilities, training and outcomes, pertain to leads implanted
for at least one year or requiring the assistance of specialized equipment that is not included as part of the typical
implant tool set. Even so, extreme caution should be used
when removing any lead.
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 one year, 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. Implantable cardioverter defibrillator
(ICD) leads may require specialized extraction equipment
even when implantation duration is less than one year.
Lead Extraction Approach: Leads are usually removed
via the same transvenous access by which they were inserted, termed the implant vein. However, sometimes alternative venous access is required from a non-implant vein.
Wilkoff et al
Transvenous Lead Extraction: HRS Expert Consensus
Examples of alternative lead extraction approaches include
from the femoral, jugular or subclavian veins.19,20,21,22,23
On occasion, the leads need to be removed via a trans-atrial
or via a ventriculotomy approach.24,25,26
Extraction tools
Simple Traction: Manipulation of the lead so that the lead
exits the vasculature via the implant vein using tools typically supplied for lead implant, with the addition of traction.
These tools include such items as standard stylets (nonlocking), and fixation screw retraction clips.13,16,27
Traction Devices: Specialized locking stylets, snares,
sutures, grasping or other devices used to engage or entrap
and remove the lead or lead fragments. Locking stylets are
a special type of a traction device designed to hold onto the
inside of the conductor coil along its length or near the distal
stimulating electrode, improve tensile properties and prevent elongation of the lead body during traction.13,16,27
Mechanical Sheaths: Sheaths composed of metal, TeflonTM, polypropylene or other materials that require manual
advancement over the lead and rely on the mechanical properties of the sheath to disrupt fibrotic attachments.3,16,27,28,45
Laser Sheaths: Sheaths that employ fiberoptics to transmit
laser light to disrupt the fibrotic attachments.3,16,27,29,30,31
Electrosurgical Sheaths: Sheaths that use radiofrequency energy (such as found in an electrosurgical unit)
emitted between two electrodes at the sheath tip to disrupt
the fibrotic attachments.3,16,27,32,33
Rotating Threaded Tip Sheath: Sheaths that are
equipped with a rotationally powered mechanism that bore
through and disrupt fibrotic attachments with a threaded
screw mechanism at the sheath tip.27,34
Telescoping Sheaths: Any extraction sheath that can be
used as a single sheath or may be paired with a second
sheath. The use of two sheaths takes advantage of the
flexibility of the inner sheath and the stiffness of the outer
sheath to prevent kinking and to improve the effectiveness
of advancement over the lead without overstressing the lead.
The outer sheath is usually mechanical, even when the inner
sheath uses some other technology such as laser, electrosurgical or rotating threaded tip.13,16,27
Outcomes: Defining technical and clinical
success
Transvenous lead extraction has been effectively accomplished in many centers, many operators and with various
techniques. Despite the provision of standard definitions in
the NASPE policy statement in 2000, the results have been
variously reported.23,26,27,28,29,30,31,32,35,36,37,38,39,40,41,42,43
Problems with the interpretation of these results are related
to how the cases were selected for inclusion as well as the
definition of success and failure. Extraction centers from the
continental United States, Hawaii and Europe voluntarily
submitted data for a national registry between December
1988 and December 1999.44,45 The most recently published
data from 1996 included data from 226 centers, 2,338 patients and 3,540 leads; these data demonstrated major com-
1087
plications in 1.4%, ⬍1% for centers with ⬎300 extraction
procedures.46 Although these data are not retrievable, the
final public report of this registry, which was presented at
the XIth World Symposium on Cardiac Pacing and Electrophysiology in Berlin and at Cardiostim, Nice, France in
June of 2000, included 7,823 extraction procedures with
12,833 leads. Multivariate analysis of the data from 1994 –
1999 demonstrated four predictors of major complications
using the definitions described in the NASPE recommendations document.1 The major complication rate was 1.6%.
The four predictors of major complications were: 1) implant
duration of oldest lead, 2) female gender, 3) ICD lead
removal and, 4) use of laser extraction technique.47 Most of
these data represented non-laser assisted extraction but also
represented an earlier version of the laser hardware and the
physician learning curve for laser use.
The prospectively collected PLEXES and early laser
reported results can be used to reasonably estimate the
currently reported overall safety and effectiveness of lead
extraction. The PLEXES trial was a randomized prospective
clinical trial comparing the first iteration of the 12-French
laser sheath to a non-laser cohort in 301 subjects with 465
chronic pacemaker leads. The procedural success in the
laser group was 94% with an associated major complication
rate of 1.96%.29 Subsequently, when the total initial experience in the United States was reported, Byrd et al.43
reported on the laser lead extraction of 2,561 pacing and
defibrillator leads 1,684 patients at 89 sites. The procedural
success rate was 90% with a major complication rate of
1.9% with an in-hospital death rate of 0.8%.
Though most leads are removed safely and completely,
some portion of the lead may be left in situ. In many
instances the retained fragment still allows for the desired
clinical outcome, which may include multiple clinical goals.
The success of lead extraction is based on the achievement
of the desired clinical outcome. Procedural success rate ⫽
(equals) number of clinically successful procedures/(divided by) number of procedures performed. This is calculated as complete procedural success rate and clinical procedural success rate calculated using the complete removal
of all targeted leads or the achievement of all targeted
clinical goals for the procedure. Failure to remove all components of intravascular leads in a patient with systemic
infection is a failure to achieve complete or clinical procedural success, while the same result in a noninfected patient
achieves clinical but not complete procedural success.
Leaving a tip in a case of local infection is not a failure but
hopefully a clinical success.
Lead clinical success rate ⫽ (equals) number of leads
removed with clinical success/(divided by) total number of
leads attempted.
These targeted clinical outcomes may include one or
more of the following:
●
●
Elimination of infection (pocket infection, device related
endocarditis)
Creation of venous access in an occluded vessel
1088
●
●
●
●
Heart Rhythm, Vol 6, No 7, July 2009
Elimination of an identified risk (perforation, arrhythmia)
produced by a lead or portion of a lead
Preservation of desired pacing mode
Removal of all non-functional leads
Resolution of all pocket related symptoms (i.e. pain)
Complete Procedural Success: Removal of all targeted
leads and all lead material from the vascular space, with the
absence of any permanently disabling complication or procedure related death.
Clinical Success: Removal of all targeted leads and lead
material from the vascular space, or retention of a small
portion of the lead that does not negatively impact the
outcome goals of the procedure. This may be the tip of the
lead or a small part of the lead (conductor coil, insulation, or
the latter two combined) when the residual part does not
increase the risk of perforation, embolic events, perpetuation of infection or cause any undesired outcome.
Failure: Inability to achieve either complete procedural
or clinical success, or the development of any permanently
disabling complication or procedure related death.
Defining complications
Recording all complications is crucial for quality assessment and quality improvement. The assessment of complications requires both a time frame and a level of severity.
This is complicated by the fact that several procedures may
be performed on the patient in succession during the same
or closely spaced hospitalizations. For example, one will
typically remove a system from an infected site on one day,
and implant a replacement system a few days later. Because
the cause of the complication cannot always be attributed to
a specific procedure, reporting consistency is needed. The
standard methodology used to classify surgical complications is by the time of occurrence. The definitions for time
frames are:
TABLE 1
Intra-procedural complication: Any event related to
the performance of a procedure that occurs or becomes
evident from the time the patient enters the operating room
until the time the patient leaves the operating room. This
includes complications related to the preparation of the
patient, the delivery of anesthesia, and opening and closing
the incision.
Post-procedural complication: Any event related to the
procedure that occurs or becomes evident within 30 days
following the intra-procedural period. Extraction events are
classified as major complications, minor complications, or
observations, according to their severity, as described below. Examples of classifications using these definitions are
shown in Table 1.
Major complication: Any of the outcomes related to the
procedure which is life threatening or results in death. In
addition, any unexpected event that causes persistent or significant disability, or any event that requires significant surgical
intervention to prevent any of outcomes listed above.
Minor complication: Any undesired event related to the
procedure that requires medical intervention or minor procedural intervention to remedy, and does not limit persistently or significantly the patient’s function, nor does it
threaten life or cause death.
Lead management environment
The number of lead extractions that need to be performed
annually continues to increase. Given the technical challenges and risk of life threatening complications, physicians
should only seek training, and hospitals should only provide
this service, when there is an ongoing commitment to a
procedural volume adequate to maintain the skills of the
physician and team. In addition to volume, it is essential that
there be an upfront sustained commitment by the physician
and the hospital to maintain the proficiency of the entire
Classification of complications
Classification
Examples
Major Complication
1.
2.
3.
4.
5.
6.
7.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Minor Complication
Death
Cardiac avulsion or tear requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair
Vascular avulsion or tear (requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair)
Pulmonary embolism requiring surgical intervention
Respiratory arrest or anesthesia related complication leading to prolongation of hospitalization
Stroke
Pacing system related infection of a previously non-infected site
Pericardial effusion not requiring pericardiocentesis or surgical intervention
Hemothorax not requiring a chest tube
Hematoma at the surgical site requiring reoperation for drainage
Arm swelling or thrombosis of implant veins resulting in medical intervention
Vascular repair near the implant site or venous entry site
Hemodynamically significant air embolism
Migrated lead fragment without sequelae
Blood transfusion related to blood loss during surgery
Pneumothorax requiring a chest tube
Pulmonary embolism not requiring surgical intervention
Wilkoff et al
Transvenous Lead Extraction: HRS Expert Consensus
extraction team, and to track outcomes of both device implantation and lead extraction.
Transvenous lead extraction is a grouping of techniques
primarily designed to solve cardiac pacemaker and ICD lead
management problems. A commitment to lead extraction procedures requires a commitment to quality and continuous quality improvement. This commitment to clinical outcome measurement is fundamental to the performance of transvenous
lead extraction, in part because it is essential to an accurate
informed consent process. Only when the risks of both doing
and not doing the procedure are accurately understood by both
the physician and the patient can an appropriate informed
decision be made. In addition, it is not enough to estimate the
hypothetical risk of a procedure done by a hypothetical physician and hospital, but it is important to estimate what the risk
is for this patient under the proposed conditions.
There are additional principles that are also fundamental to
quality outcomes, and these principles provide the context for
the remainder of this document. Examples in subsequent sections of this document include adequate initial and continuing
training in both the physical and cognitive aspects of lead
management, maintaining an adequate volume of device implantation and extraction activities, ongoing assessments of the
adequacy of the facilities, techniques and personnel required to
safely perform the procedure, as well as the systematic measurement of the outcomes with internal and sometimes external
review of outcomes. The outcomes measures should include
both implantation and extraction outcomes. It is essential that
the reported outcomes employ standardized definitions, and
should be focused in the best tradition of a local morbidity and
mortality review which looks for root causes and opportunities
for improvement.
Hospitals offering lead extraction and personnel participating in these programs must have a protocol for emergency
response when the need arises. There should be a mechanism
in place to activate a rapid operating room response team that
is capable of performing emergency surgery. This “disaster
plan” should be regularly tested on a scheduled basis so that
each member of the team knows exactly what to do and how
to accomplish their role. This plan must be recorded as part of
the written standard operating procedure of every extraction
laboratory or operating room.
Finally, the lead extraction team must be committed to open
review of complications and continuous improvement process.
If physician and institutional expertise is not available locally,
it is in the best interest of an individual patient to be referred to
a center with the appropriate training and expertise.
Personnel, roles and responsibilities
The development of a successful lead extraction program
requires a team approach. Each member of the team is
crucial to successful outcomes, a low complication rate and
the rescue of a patient should a complication occur. A
successful lead extraction program requires a wide range of
tools and techniques. The staff involved in these procedures
must be familiar with the equipment required and its location and use. In addition, the clinical situation during an
1089
extraction procedure can change rapidly and the team must
be prepared to deal with any eventuality. This can only
come with proper planning and training.
Centers planning to develop a lead extraction program
should identify a team of providers, procedures, equipment
and plans for emergent response. In addition to becoming
familiar with the indications for and complications of lead
extraction, the team must understand the operation and use
of all equipment potentially required. It is essential that the
team observe procedures at an experienced center prior to
launching an extraction program. Industry representatives
are not a substitute for appropriately trained staff and must
always function under the direction and responsibility of the
attending physician. A list of required personnel can be
found in Table 2.
Primary Operator: The physician performing lead extraction should meet the qualifications and training described below. In some centers a single physician trained in
CIED therapy (most often an electrophysiologist or cardiac
surgeon) performs the extraction. However, in some centers
a team approach is taken with physicians all trained in CIED
therapy (again most often an electrophysiologist and a cardiac surgeon) working together, each with their individual
expertise. Given that this procedure is part of the bigger
picture of “lead management”, the physician should be well
versed in cardiac device implantation and management.
Cardiothoracic Surgeon: In some centers the primary
operator is a CIED trained cardiothoracic surgeon, while in
others a CIED trained cardiologist and surgeon will operate
together. In centers where the primary operator is a CIED
trained cardiologist, a cardiothoracic surgeon must be immediately available to manage any of the life threatening
complications that may require surgical intervention. In the
event of a significant complication, time is of the essence.
We therefore strongly recommend that the surgeon is aware
of the procedure, especially in smaller hospitals that may
not have operating rooms and support staff available at all
times. The surgeon must be well versed in all the potential
TABLE 2
Required personnel*
Primary Operator: A physician performing the lead extraction
who is properly trained and experienced in device
implantation, lead extraction and the management of
complications.
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 (eg. the extractor could be the
cardiothoracic surgeon), but at least 5 people (1 – airway and sedation
management 2 - scrubbed and 2 - non scrubbed) need to be in the room
at all times with the immediate availability of additional personnel as
needed.
1090
complications of lead extraction and re-implantation, and
understand the required surgical approach to each anatomic
injury that is likely to occur. For example, the surgical
approaches to a superior vena cava tear, right ventricular
tear or coronary sinus tear are each very different.
Anesthesia Support: Some centers perform lead extractions in an operating room under general anesthesia. Other
centers perform lead extractions in catheterization laboratories under intravenous sedation. In the event of a complication requiring further surgical intervention, immediate
anesthesia support must be available. This includes the
ability to manage a patient undergoing open-heart surgery.
Fluoroscopic Support: Given that lead extraction requires the use of fluoroscopy to guide the procedure, personnel must be present who can operate and troubleshoot
the fluoroscopic equipment.
Scrub Personnel: Lead extraction procedures often require a variety of equipment and technologies. In order to
safely perform the procedure, a minimum of two “scrubbed”
personnel must be available - the primary operator and an
assistant. In centers where the cardiologist and surgeon
perform the procedure together, an additional scrub nurse/
tech may or may not be desired. In other centers, an additional “scrubbed” person is required to assist during the
procedure. This could be an additional physician, physician
assistant, nurse or technician. These team members should
be trained so that they are familiar with the procedure,
equipment and potential complications and emergency response protocols.
Non-Scrub Personnel: Depending on the center and
location of the procedure, two or more “non-scrubbed”
personnel must be available during the procedure. If one of
these is responsible for monitoring sedation (e.g. a nurse) a
third non-scrubbed person must be available to provide
equipment and assist in an emergency. These personnel
must be trained so that they are familiar with the procedure,
equipment and potential complications. Most importantly
for these staff members, they must know how to activate the
emergency protocols and whom to call.
Echocardiography: Emergent echocardiography (transthoracic and/or transesophageal) may be required to rapidly
diagnose a complication. A physician capable of performing
and interpreting these studies must be immediately available. This may be the physician performing the procedure or
the anesthetist involved in the case. In centers where there
is not a physician skilled in echocardiography in attendance
during the procedure, an additional physician must be available to perform and interpret these studies.
It is also recommended that a designated “extraction
coordinator” be identified to coordinate the procurement,
storage, maintenance and reordering of the extraction equipment. There should also be a person (possibly the same
person) responsible for maintaining protocols in concert
with the hospital’s requirements that ensure patient safety
throughout the procedure.
Heart Rhythm, Vol 6, No 7, July 2009
Physician qualifications and training
Lead extraction is an invasive procedure that requires training and experience to consistently deliver safe and effective
care. Physicians wishing to perform this procedure should
be properly trained in extraction techniques and management of complications.
The simple combined acts of watching an instructional
video demonstration and observing an operator perform the
procedure are not adequate. Other procedures with similar
operator skill requirements and patient risk (e.g., percutaneous angioplasty of coronary or peripheral vessels) require
at least an additional year of training. Unfortunately there
are limited data available for procedural volumes required
for training and ongoing competency for transvenous lead
extractions. Therefore, recommendations are based on these
limited data as well as data available for other intravascular
procedures.
Analysis of lead extraction outcomes suggests that the
frequency of complete procedural success improves dramatically after the first 10 –20 procedures have been performed.48,49,50 Even physicians with many years of experience have a reduced frequency of complete procedural
success when 60 or fewer laser assisted lead extraction
procedures were accomplished over the prior 4 years.80
Lower complication rates are associated with a prior experience of 30 procedures.47,51 These studies demonstrated
the steepest decline in complications over the first 30
cases. It is also important to note that the complication
rate continued to decline throughout the study (up to
400 cases). These findings are consistent with guidance
documents that delineate the training requirements for the
implantation of pacemakers, ICDs and cardiac resynchronization devices, which require 25 procedures of each device
type.52 A review of the Medicare database revealed that for
ICD implantation, mechanical complications decreased after a minimum volume of 10 implantations per year, and
infections were reduced for implanters performing at least
30 implants per year.53 Given the relationship demonstrated
between lead extraction experience and safety and efficacy,
and since these techniques are much more technically demanding and are associated with a much larger opportunity
for failure and complications, it was the consensus of the
writing group that a volume of extraction procedures, similar to those required for device implantation, should be
required.
Simulator program
Procedures that require technical expertise can only be learned
through careful training, repetition and practice. However, the
ability to provide adequate “hands-on” training, especially outside of formal fellowship programs, is limited. Even within
formal fellowship programs, the number of “high volume”
centers where fellows or practitioners could gain adequate
clinical experience is inadequate. Simulators of surgical and
catheter procedures are now a part of medical training in a
variety of areas. Simulation allows practitioners to make mistakes in a “risk free” environment and gain experience not
Wilkoff et al
Transvenous Lead Extraction: HRS Expert Consensus
possible in actual practice. Studies have demonstrated an accelerated learning curve and a reduction in complications with
simulator training.54,55,56,57,58,59,60 In addition, simulation of a
wide range of clinical scenarios allows for team building and
enhanced response to emergent situations.
The success of a lead extraction program, as the mainstay
of a lead management strategy, requires experience. These
skills, for both the operator and the other members of the
lead extraction team, must be obtained and maintained
through repetition. Preliminary tests (n ⫽ 36) of a simulator
in 6 previously inexperienced trainees, which incorporated real time feedback of extraction forces along with
the use of locking stylets, extraction sheaths and fluoroscopy, produced measureable improvement in technique.
Although the current experience is preliminary, it was the
consensus of the writing committee that continued development and testing of lead extraction simulators with
realistic scenarios is likely to become an important future
component of the initial training and maintenance of
extraction skills.
Recommendations on minimum training and volume
●
●
●
●
Physicians being trained in this technique should extract
a minimum of 40 leads as the primary operator under the
direct supervision of a qualified training physician. Exposure to various venous entry sites as well as femoral
retrieval techniques should be included. In addition the
trainee should be exposed to the wide variety of extraction tools and techniques. These are minimum requirements, recognizing that volume alone does not guarantee
competency.
A minimal number of procedures should be performed on
an annual basis to maintain skills. This is crucial to
maintain one’s acquired skills and team preparedness. In
addition, expertise in lead extraction is clearly developed
with each and every procedure performed. We therefore
recommend the extraction of a minimum of 20 leads
annually per operator.
Physicians who have already extracted over 40 leads as a
primary operator and maintain the minimum volume of
20 leads extracted annually are considered as meeting the
training and volume requirements.
Training should be obtained at centers with adequate
volume, experience, and expertise. The supervisor should
have extracted 75 leads, performed with an efficacy and
safety record that is consistent with published data.
We realize that outside of a formal fellowship training
program at a high volume center, even this minimal requirement will be very difficult to achieve. However, the difficulty of receiving adequate training should not be viewed as
a reason to reduce the minimum requirements. This issue
highlights the need for the development of an adequate
simulator that would allow for a supplemental pathway to
achieve and maintain competency.
1091
It is recognized that in the pediatric population, a very
limited number of lead extractions are performed. It is
therefore suggested that extractions for this population be
referred to centers that have the personnel and expertise to
safely and effectively manage this specialized group. It
would also be beneficial to develop a partnership between a
pediatric center and a higher volume adult center. This will
allow a team approach to manage the issues unique to
younger patients (often with complex congenital abnormalities), and at the same time provide input and assistance
from a physician with more extraction experience. These
patients may require the expertise of physicians with experience in congenital heart disease device management specific skills. Although the pediatric specialists may not have
the opportunity to extract at least 20 leads per year on an
ongoing basis due to the reduced volume of CIED implantation in this population, the experience gained as a primary
operator in the extraction of 40 leads is still an appropriate
expectation. In circumstances like this, extra precautions
including the consistent use of a simulator to practice the
actual extraction scenario might be used to augment the
exposure to volume in lieu of 20 annual lead extractions.
Using general anesthesia and having the surgical team in the
room and scrubbed are additional advanced precautions.
●
●
Performing a specific number of procedures does not
guarantee proficiency, competency, or safety; outcomes
data are necessary to assess performance. A quality-oriented database should be maintained at each institution to
document procedure activities and outcomes.
Given the acknowledged learning curve for this procedure, even through hundreds of cases, it is recommended
that a staged approach be used when starting an extraction
program. While one can never predict the ease of extraction in any given individual, strong consideration should
be given to starting with less challenging or risky cases.
Examples would include patients with prior cardiac surgery, which reduces the risk of serious bleeding but increases the difficulty of surgical rescue. Additional examples are patients with a single lead of relatively short
implantation duration or patients with relatively “young”
non-ICD leads. More complex cases, with multiple leads
and long implant duration, should be avoided initially and
referred to experienced centers. As a physician’s and a
center’s experience grows, so can the degree of difficulty
of the cases increase.
New extractors must realize that there is a community of
lead extractors who are available for ongoing mentoring.
Discussions around difficult clinical situations can be very
valuable and allow clinicians to arrive at the most appropriate treatment approach. When beginning a new program,
a mentor or mentors should be identified.
Facility and equipment
As discussed in the above section, a successful lead extraction program requires a coordinated, team approach. In
addition to appropriate and adequately prepared personnel,
1092
a center must have the required facilities and equipment to
perform lead extractions safely and effectively. There must
be a commitment to ensuring the availability and functionality of all facilities and equipment on an ongoing basis.
This is especially true for equipment used only rarely, but
required without delay in life threatening situations.
Facility
Lead extraction procedures must only be performed at centers with accredited cardiac surgery and cardiac catheterization programs. As stated previously, a cardiothoracic surgeon must be physically on site and capable of initiating an
emergent procedure promptly. In addition, the cardiac surgery team, equipment and facilities must be readily available. Through the external review of fatal cases around the
world, it was the strong consensus that when the superior
vena cava was torn or perforated, delays from the injury to
having open access to the heart of more than 5-10 minutes
were often associated with a fatal outcome. Rescue efforts initiated within this time period have been usually successful.
Procedures can be performed in either operating rooms, or
procedural laboratories specifically designed for device implantation procedures. The room must be of adequate size to
allow for emergent interventions such as thoracotomy and
sternotomy. The room must be equipped with a ventilation
system designed to prevent surgical infections and to handle
anesthetic gases.
Equipment
Below is a review of the minimal equipment and supply
requirements and is by no means inclusive. With experience, active extraction centers continually add equipment
they find useful in performing these procedures.
High-quality fluoroscopy: The value of a high-quality
fluoroscopy system cannot be overstressed. Visualization of
small lead components (such as fixation screws on leads
with retractable screws, migrated lead fragments and pieces
of elongated conductor coil) is necessary for the safe performance of lead extraction techniques. This may be a fixed
fluoroscopic system or a “high-quality” mobile C-arm.
Surgical instruments: These include instruments appropriate for transvenous lead extraction and device implantation. In addition, surgical instruments to perform vascular
repairs, thoracotomy, sternotomy and cardio-pulmonary bypass must be immediately available and in good functional
order.
Extraction tools: There is a wide variety of lead extraction tools. While we do not promote one over the other, it is
widely accepted that having a broad variety of extraction
tools increases the chance of success and limits complications. Essential tools include locking stylets, mechanical
“telescoping” sheaths, and “powered” sheaths.13,27,61
Extraction snares: In cases with “free floating” leads,
an approach from other than the implant vein is required.
This is also true when lead disruption occurs during the
procedures. Tools for retrieval from the non-implant vein
must be available. These include large sheaths (worksta-
Heart Rhythm, Vol 6, No 7, July 2009
tions) with a hemostatic valve, and a variety of grasping and
snaring devices. Venous access for these snares can be from
the femoral, internal jugular, subclavian or trans-atrial sites.
CIED implantation tools: Stylets, wrenches, fixation
tools, repair kits, adapters, sterile sleeves for the programmer, pin plugs, lead anchoring sleeves, and lead end caps
should be available. Also required are the standard implantation equipment including, but not limited to, a variety of
introducer sheaths, guide wires, and venous entry needles.
Transthoracic and transesophageal echocardiography: The ability to perform both transthoracic echocardiography and transesophageal echocardiography must be immediately available. In some centers intracardiac echocardiography
is employed.62
Additionally required supplies and equipment include an
anesthesia cart for general anesthesia, invasive and noninvasive arterial pressure monitoring, oxygen saturation and
CO2 monitoring, pericardiocentesis tray, water seal/vacuum
containers for chest tube drainage (2 recommended), temporary transvenous pacemaker and connectors, transcutaneous temporary pacing and defibrillation equipment, intravenous contrast agents, fluids, pressors, and other emergency
medications in the procedure room and equipment for cardio-pulmonary bypass must be readily available.
Patient preparation
Since this procedure may result in life threatening complications, it is imperative that the patient be properly and
thoroughly prepared so that if emergent intervention is required there is no delay.
History and physical examination
A complete patient history and physical exam must be
obtained. Understanding the indications for the initial device implantation, and co-morbidities that may affect the
pre-, intra- and post-procedure care are critical. For example, the need for anticoagulation and “bridging” around the
procedure must be determined for all patients. All medications must be reviewed. All allergies must be identified,
especially contrast allergies since use of the latter may be
required during the procedure and premedication can be
administered if the allergy is identified. A comprehensive
physical examination with specific attention to anatomic
details that may influence the procedure is required. The
operator should look for findings that may affect the
planned procedure. For example, the presence of extensive
venous collaterals of the chest wall suggests central venous
occlusion. This is especially important in patients scheduled
for a device “upgrade’ with the planned addition of ipsilateral leads. A pre-procedure venogram may be indicated to
determine the patency of the implant vein and the potential
need for venoplasty or lead extraction.
Informed consent
Written informed consent, including pertinent elements of
the planned procedure, should be discussed with patient,
preferably in the presence of a family member. The patient
and family must understand that lead extraction is a poten-
Wilkoff et al
Transvenous Lead Extraction: HRS Expert Consensus
tially life threatening procedure and this must be placed into
local context by informing the patient about the hospital’s
extraction volume and outcomes, and the operator’s personal level of experience and outcomes. As extraction is
often one option in a complex device procedure; all reasonable alternatives must be discussed. This is particularly
important when considering extraction versus abandonment
during an upgrade procedure.
Planned procedure and treatment
Prior to undertaking an extraction procedure, a clear plan for
management of co-morbidities, the need for ongoing CIED
therapy, and how that therapy will be provided must be
formulated.
Patients with CIED related infection
A plan for pre-, intra-, and post-operative antibiotics must
be formulated, including the type, route and duration of
antibiotics. The need for additional testing, such as transesophageal echocardiography to evaluate for the presence
and/or size of vegetations, must be determined as this will
help determine the most appropriate approach (transvenous
or open surgical) for the extraction.63,64 An active fixation
temporary pacing lead should be considered in patients
requiring pacing support during the interval before the replacement permanent CIED is implanted.65 In addition, the
timing and need for device re-implantation must be determined prior to the procedure (see discussion and Table 4 in
the indications section).97
Device and lead location
The vast majority of explanted leads were originally introduced transvenously and advanced to a typical pacing/sensing position in the right atrium, right ventricle, coronary
sinus or cardiac veins. However, in some cases leads may
have been advanced into one or both left heart chambers via
a patent foramen ovale, atrial septal defect, ventricular septal defect, or arterial access.66 This is most often done
unintentionally; however there are some leads that are
placed into the left heart chambers for the purpose of pressure monitoring or cardiac resynchronization.67,68,69 Leads
may also perforate the myocardium and penetrate into pericardium or be entrapped in the tricuspid valvular apparatus.70,71,72 The pre-procedure chest X-ray must be examined. If there is any question about device or lead location
or anatomy, additional imaging such as transesophageal
echocardiography (TEE) and/or computed tomography
(CT) scanning may be required for confirmation.73
Device, lead and adapter information (Connected and
Abandoned)
Prior to performing the procedure, the operator must be
aware of all device and lead hardware present, including
those in use and previously abandoned. Simply asking the
patient is not adequate because he/she is often unaware of
prior abandoned leads and current device configurations.
Every attempt should be made to review prior operative
reports and to obtain device registration information from
1093
device manufacturers. The pre-procedure chest X-ray may
be the only way to determine the number and location of
leads. The operator should determine the models and implantation dates for all leads and the pulse generator. The
operator must also be familiar with the physical and structural characteristics of each lead. For example, it is not
adequate to only determine that the lead’s fixation mechanism is active or passive. Some active fixation leads require
special “fixation stylets” to retract the fixation mechanism
[e.g., Telectronics ACCUFIX, some Guidant (Boston Scientific) ICD leads]. Knowing that a patient has one of these
leads and having the appropriate tools are important to
success and safety. The operator must also be familiar with
the physical characteristics of each lead including insulation
material and lead design (coaxial, co-radial, cable, etc.).
Need for pacing support during the procedure
It is crucial to determine if the patient is pacemaker dependant and will require temporary pacing support during the
procedure. Pacemaker dependent patients should have a
temporary pacing wire placed prior to extraction. The temporary wire must be readily accessible during the procedure
because it may be dislodged and require rapid repositioning.
Patients who are not pacemaker dependent prior to the
procedure may become so during the procedure. This is
especially true in patients with sinus node dysfunction after
the initiation of general anesthesia. It is therefore recommended, in non-pacemaker dependent patients, that the device be reprogrammed to a pacing rate below the patient’s
rate (i.e. VVI 40). By doing so, when the device is disconnected from the leads the operator is not surprised to find the
patient has become pacemaker dependent. A venous sheath,
placed in one of the femoral veins, allows for the rapid
deployment of a temporary pacing wire should it be required.
Device interrogation and reprogramming
All devices should be interrogated prior to the procedure.
The settings and lead parameters should be documented.
This will allow for reprogramming of the current device (or
programming of a new device) to the appropriate settings
after re-implantation. In addition, the functioning of preserved leads can be compared to the pre-procedure values to
ensure that no damage to any reused (“bystander”) lead
occurred. It is also recommended that rate responsiveness
should be turned off to prevent rapid pacing with manipulation of the device. Tachycardia devices must have detections turned off to prevent inappropriate therapies.
Need for ongoing device therapy
The original indication for system implantation must be
reviewed as should changes in the patient’s condition since
that procedure. A decision needs to be made and reviewed
prior to the extraction as to the need for re-implantation and
the timing, route and technique for both temporary and
permanent placement.
1094
Procedure preparation
Direct preparation of the patient in the extraction laboratory
includes the availability of baseline blood tests (metabolic
profile, CBC and coagulation profile) and blood that has
been typed and cross-matched. For most procedures, at least
4 units should be available, while for some “high risk”
procedures some blood should be in the procedure room.
Obtaining large bore (18 gauge or larger) venous access is
required, and femoral venous access is strongly encouraged
since it provides venous access, facilitates temporary pacing, and provides a femoral access route for extraction and
delivery of fluids, blood and drugs in the advent of a vascular emergency. The patient will require continuous electrocardiographic and blood pressure monitoring. Though
the blood pressure may be monitored using noninvasive
methods, invasive monitoring provides faster recognition of
changes and is preferred by most experts. The patient’s skin
should be prepared with antiseptic solution in such a manner
as to allow for an emergent pericardiocentesis, thoracotomy,
sternotomy and cardio-pulmonary bypass. The ability to
perform transcutaneous pacing and defibrillation using preapplied adhesive pads is essential.
Indications for lead removal
Indications for transvenous lead removal have previously
been described by the clinically framed “Byrd Classification”74 (Mandatory, Necessary and Discretionary). In 2000,
these were refined and published in the format established
for the American College of Cardiology/American Heart
Association’s methodology for practice guidelines (Class I,
Class II and Class III).1,137 Since the original policy conference in 1997 and its publication in 2000 there has been a
substantial increase in the number of CIED implants, their
leads and the inevitable CIED complications.75,76,77,78,79
Equally important to note is the maturation of the techniques, technologies, and experience with transvenous lead
extraction and with the long-term management of these
leads. This has led to an expanded understanding of lead
management issues, risks, benefits, indications and contraindications, permitting a clarification and update of these
indications. Unless otherwise noted, the references to lead
removal in Table 3 relate to transvenous lead removal and
not to surgical techniques.24,25,26
When considering the indication for any procedure or
therapy, it is important to relate the strength of the clinical
indication for transvenous lead extraction to the early and
the long-term value of the outcome and the risk of the
intervention evaluated on an individualized patient basis.
The risk of transvenous lead extraction is highly dependent
on the training and experience of the practitioner and the
extraction team. Even the strongest indication should be
considered contraindicated when the extraction team has
little experience or inadequate tools.1,46,47,80 The indications listed in Table 3 assume that the extraction environment conforms to the standards set forth in this
document. Alternative lead extraction environments such
as surgical extraction by thoracotomy or median sternot-
Heart Rhythm, Vol 6, No 7, July 2009
omy, despite the obvious clear morbidity associated with
these techniques, may be more appropriate approaches to
lead removal in hospitals without an extraction program
adhering to the guidelines in this document.
Alternative lead placements are also without sufficient
data to make firm recommendations. There is a growing
literature that supports that many cardiac venous leads implanted for cardiac resynchronization therapy can be safely
removed.81,82 However, caution should be applied to lead
removal and extraction of leads that promote tissue ingrowth that are placed into the cardiac veins.83,84 There are
no data to address the removal of leads from the azygous
vein and this and other creative approaches to lead placement need to be approached with extreme caution.85
Certain clinical situations such as patients who require cardiac surgery for another unrelated indication or those with
large infected vegetations may be better served using nontransvenous techniques. Every patient’s situation should be evaluated for life-long consequences, considering the implications
of current decisions on the ultimate outcomes and future management of the patient. There are no specific rules for the size
of a vegetation before a decision is made to remove the leads
and vegetation with open surgical techniques. Vegetation size,
shape, friability, presence or absence of a patent foramen
ovale, ASD or VSD, other surgical indications and goals,
health or hemodynamic instability of the patient, pacemaker
dependency, need for ICD or LV leads and plans for reimplantation all need to be considered when making this decision.64,86,87 Sometimes, a patient with a modest sized vegetation (⬍2 cm) still should be taken to the operating room for
open removal and debridement, especially if the patient is
pacemaker dependent or requires early transvenous re-implantation. Alternatively, re-implantation can be done with an epicardial pacing lead after transvenous extraction. Patients with
larger vegetations (⬎3 cm) will more commonly require open
debridement. These decisions impact the duration and type of
antibiotic therapy and the time of device re-implantation. Temporary pacing and wearable defibrillators are often considerations for these patients.65,88,89
CIED associated infections are the strongest indication
for complete CIED system removal; however, these
patients can present with a broad range of clinical
scenarios. 90,91,92,93,94,95,96 Infection can present with
nothing more than pain in the CIED pocket. However,
when an infection is identified, this produces a strong
indication for removal of all components of the CIED
system including the device, lead, adapters, caps, sutures
and as much of the infected tissue as possible in order to
consistently resolve the infection.97,98 Occasionally a patient’s overall prognosis will be so poor as to favor
chronic suppression instead of extraction, but this is an
exception.99 Documentation of device related infections,
although sometimes obvious with fever, bacteremia, vegetations and sepsis, is also often difficult to diagnose or to
associate with the implantable device. Even in patients
with documented device related infection, cultures can be
Wilkoff et al
TABLE 3
Transvenous Lead Extraction: HRS Expert Consensus
1095
Indications for transvenous lead extraction*
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.
Infection
Class I
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. (Level of evidence: 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. (Level of evidence: 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. (Level of evidence: B)
4. Complete device and lead removal is recommended in patients with occult gram-positive bacteremia (not contaminant). (Level
of evidence: B)
Class IIa
1. Complete device and lead removal is reasonable in patients with persistent occult gram-negative bacteremia. (Level of evidence: B)
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. (Level of evidence: C)
Chronic Pain
Class IIa
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)
Thrombosis or 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. (Level of evidence: C)
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)
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)
4. Lead removal is recommended in patients with superior vena cava stenosis or occlusion with limiting symptoms. (Level of
evidence: 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). (Level of evidence: C)
Class IIa
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)
Functional Leads
Class I
1. Lead removal is recommended in patients with life threatening arrhythmias secondary to retained leads. (Level of evidence: 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. (e.g. Telectronics ACCUFIX J wire fracture with protrusion). (Level of evidence: B)
3. Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices. (Level of
evidence: B)
4. Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy
(radiation/reconstructive surgery). (Level of evidence: C)
Class IIb
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)
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) (Level of evidence: 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) (Level of evidence: 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. (Level of evidence: C)
5. Lead removal may be considered in patients in order to permit the implantation of an MRI conditional CIED system. (Level of
evidence: C)
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TABLE 3
Heart Rhythm, Vol 6, No 7, July 2009
Indications for transvenous lead extraction* - continued
Class III
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)
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 Leads
Class I
1. Lead removal is recommended in patients with life threatening arrhythmias secondary to retained leads or lead fragments.
(Level of evidence: 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. (e.g. Telectronics ACCUFIX J wire fracture with protrusion) (Level of evidence: B)
3. Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices. (Level of
evidence: B)
4. Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy
(radiation/reconstructive surgery). (Level of evidence: C)
Class IIa
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)
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)
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)
Class IIb
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)
2. Lead removal may be considered in order to permit the implantation of an MRI conditional CIED system. (Level of evidence: C)
Class III
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)
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)
CIED(s): cardiovascular implantable electronic device(s)
*Legend for Table 3 can be found underneath Table 4.
Note: Assigning a level of Evidence B or C should not be construed as implying that the recommendation is weak. Many important clinical questions
addressed in this document either do not lend themselves to experimentation or have not yet been addressed by high quality investigations; the authors
of this document felt it was important to include all recommendations.
negative. This may occur in the setting of preoperative
antibiotic therapy, but may occur even in the absence of
antibiotic therapy. Delaying the definitive operation with
removal of all of the components of the CIED system can
be a fatal choice for the patient.100 Dy Chua and colleagues101 documented that the best yield for documenting the pathologic bacteria required culture of the tissue
debrided from the pulse generator pocket fibrosis. However, even this yielded positive results in only 69% of the
clinically infected patients. In addition, patients who
present with signs and symptoms of pocket infection
usually have involvement of the intravascular components of the system. Klug et al.102 demonstrated that there
was evidence of intravascular lead involvement in 88.4%
of patients presenting with clinical pocket infections by
examining the intravascular segments of the lead. The
Cleveland Clinic series noted that only in the 4 patients
with incomplete extraction, out of a total of 123 patients,
did recurrent infection develop.97,103 This is consistent
with the pathophysiology of staphylococcal bacteria, the
predominant pathogen in device infections, in that they
form a protective biofilm.104 This biofilm, which adheres
to the plastic and metal of the devices and leads, makes
these infections resistant to antibiotics and the body’s
immune defense system. Consequently, when pocket pain
is severe enough to require intervention yet there is no
overt evidence of infection, it was the consensus of the
writing committee that strong consideration should be
made to treat the patient as if the cause is infectious. This
should also include the use of antibiotics and delaying
re-implantation to another day and at a different anatomic
location.105
A single positive blood culture without other clinical
evidence of infection should not result in removal of the
CIED system. However, when there are positive cultures
obtained on different days (persistent bacteremia), even
Wilkoff et al
TABLE 4
Transvenous Lead Extraction: HRS Expert Consensus
1097
Principles for CIED replacement following infected removal*
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.
Class I
1. Each patient should be carefully evaluated to determine if there is a continued need for a new CIED. (Level of evidence: C)
2. The replacement device implantation should not be ipsilateral to the extraction site. Preferred alternative locations include the
contralateral side, iliac vein, trans-atrial and epicardial implantation. (Level of evidence: C)
Class IIa
1. A new CIED system can be implanted into patients who have no valvular or lead associated vegetations but preoperative positive
blood cultures, when there is no further clinical evidence of systemic infection and the blood cultures drawn within 24 hours of
CIED system removal remain negative for at least 72 hours (Level of evidence: C)
2. A new CIED system can be implanted into patients who have no valvular or lead associated vegetations but positive lead tip
cultures, when there is no further clinical evidence of systemic infection and the blood cultures drawn within 24 hours of CIED
system removal remain negative for at least 72 hours (Level of evidence: C)
3. A new CIED system can be implanted into patients who have no valvular or lead associated vegetations but preoperative sepsis
and positive blood cultures, when there is no further clinical evidence of systemic infection and the blood cultures drawn within
24 hours of CIED system removal remain negative for at least 72 hours (Level of evidence: C)
4. It is reasonable to delay transvenous re-implantation of a new CIED system into patients with valvular or lead associated
vegetations for at least 14 days after CIED system removal. However there are options to reduce this delay including debridement
of the vegetations and epicardial lead implantation. (Level of Evidence: C)
CIED(s): cardiovascular implantable electronic device(s)
*Legend for Table 3 and Table 4: Classification of Recommendations and Level of Evidence are expressed in the American College of Cardiology/American
Heart Association format:137
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.
Level of Evidence
Level of Evidence A: Data derived from multiple randomized clinical trials or meta-analyses
Level of Evidence B: Data derived from a single randomized trial, or non-randomized studies
Level of Evidence C: Consensus opinion of experts, case studies, or standard of care
Note: Assigning a Level of Evidence B or C should not be construed as implying that the recommendation is weak. Many important clinical questions
addressed in this document either do not lend themselves to experimentation or have not yet been addressed by high quality investigations; the
authors of this document felt it was important to include all recommendations.
when there is no clear source of the positive culture in the
heart, on the leads or from another part of the body despite
a complete evaluation (occult infection), transvenous lead
extraction should be strongly considered.100 Superficial or
incisional erythema or infection is not clear evidence of
CIED system infection, but the patient should be closely
followed for progression to a deeper infection, which would
require extraction.106 Gram-negative bacteremia is less
commonly a pathogen in CIED related infections and persistence of the bacteremia should be documented past the
treatment of other sources of the bacteria before extraction
is contemplated.97,98,107
CIED re-implantation after removal for an infection provides little tolerance for strategic error. The implantation
approaches are limited (only 2 pectoral sites) and re-implantation at the site of CIED and lead removal, when done
before the infection has been eradicated, can be associated
with an early or late recurrence of the infection. Table 4
provides recommendations or principles to be followed for
timing device re-implantation, but there are little published
data and no firm consensus about the best approach to
patient management. When there is concern for ongoing
infection, alternatives to early re-implantation (after 2–3
days) include wearable defibrillators, epicardial lead implantation and surgical debridement of vegetations.88,89
However, it is clear that in the absence of intracardiac
vegetations, when there is no further evidence of systemic
infection, that relatively early (3 days) transvenous implantation can usually be done without concern for infection
recurrence.97 Although there are no clinical trials that have
tested the minimal duration of antibiotic therapy or when it
is appropriate to switch from IV to PO antibiotics, there is
over 20 years of experience using guidelines similar to that
used for non CIED related endocarditis.14,97 It is generally
agreed that 2-6 weeks of IV or sometimes oral antibiotics
may still required depending on the microbiologic isolate,
antibiotic sensitivities and clinical scenario.
Transvenous lead extraction for patients without infection is
a more controversial topic. It is often possible to abandon a
failed or no longer required lead and/or implant the needed
leads through the same or alternative implantation route. Since
it is less common for a patient to exhibit symptoms or be at risk
of death from the abandonment of non infected leads, it is more
difficult to calculate the risk to benefit ratio of lead extraction
1098
in these patients. Therefore when these indications are considered, it is crucial to balance the risk of the intervention, including the experience of the lead extraction operator, with the
patient’s situation.108,109,110,111
There are several other important observations that favor
earlier lead extraction instead of abandonment. Leads, when
left behind, are more difficult to remove and when removed
are associated with an increased risk of major complications, which progresses as the implantation duration prolongs.14,46,80 Therefore it is difficult to anticipate how taking risk now versus later is to be best assessed. These
extraction risks increase as the inter-lead fibrosis thickens
and covers more of the surface of the lead, especially when
there are multiple leads.3,6 Also proportional to implant
duration is lead fragility, which increases with the body’s
chemical and mechanical stresses and reduces the likelihood
of complete lead removal.11,14,46,80 The risks are further
increased with even modest calcification of the fibrosis.6
Therefore, in a 20 year old patient with complete heart block
and two failed leads, implanting new leads without extracting the old ones, although feasible, is usually inadvisable.
Alternatively, in a 90 year old patient with one failed lead or
an occluded vessel precluding the reuse of the ipsilateral
subclavian vein, it may be more reasonable to consider that
failure to remove the lead would never become a clinical
issue for the patient. It is also important to consider how
long the lead had been implanted, the fragility or tensile
robustness of each particular lead, and the ease or difficulty
of extraction of the particular lead model. The indications in
Table 3 were developed on the basis of the complete consensus of the document writing committee, and take into
account the relative safety and effectiveness of transvenous
lead extraction when done in conformance with the standards in this document.
For each of the indications listed for noninfected lead
extraction, there must be a clinical goal that balances the
risk of removal and reasonable alternatives should be
considered. Although there are no clinical trials proving
the relative advantage of lead extraction, there is a literature that supports the rationale for extraction. Severe
chronic pain for which there is not alternative therapy is
sometimes infection related but is most commonly responsive to generator and lead removal in the experience
of the authors.
Venous thrombosis alone is not an indication for lead
extraction, but when there are symptoms or when the occlusion prevents the application of pacemaker, ICD or other
therapies it is often appropriate to extract the leads to
achieve the clinical goal.112 For example, it is inappropriate to stent open a vein, trapping the pacing leads against
the vein wall and preventing future safe lead extraction.110,113,114,115 Other approaches such as allowing collaterals to develop over time, use of limb elevation, anticoagulation or venoplasty are effective in alleviating symptoms
and should be considered prior to lead extraction. Removal
of the leads can also be associated with thrombosis and
Heart Rhythm, Vol 6, No 7, July 2009
occlusion, but acute occlusions with thrombus usually responds to anticoagulation, while chronic occlusion that develops into a fibrosis does not.
Leads can sometimes induce life threatening arrhythmias, pose physical risk to a patient such as the Telectronics
ACCUFIX lead with a fracture, interfere with the normal detection of arrhythmias by an ICD or get in the way of radiation
therapy or required surgery.108,109,116,117,118,119,120,121,122,123 Alternatives to lead extraction are sometimes available and
should be considered, such as moving a newly implanted lead
further from the chronically implanted lead that had caused
interference with arrhythmia detection.
Magnetic Resonance Imaging (MRI) scanning is formally contraindicated in patients with pacemakers and
ICDs; however not all patients with indications for MRI
scanning have reasonable alternatives.124,125,126 The American Society for Testing and Materials (ASTM) and the U.S.
Food and Drug Administration (FDA) have classified pacemaker systems as either MRI safe, MRI condition⫹al or
MRI unsafe.127,128 Even with new pacemaker or ICD systems that are considered MRI safe or MRI conditional, there
will continue to be some situations where it will be appropriate to extract leads from patients to permit appropriate
scanning of patients. However, all other alternatives should
be explored before choosing to extract the leads.
The removal of functional and nonfunctional leads that
are not being employed for the CIED depends on the patient’s clinical situation. As discussed above, there is some
risk to leaving leads in, although when the risk will come
into play is uncertain.129,130,131,132,133 A long-term perspective is required to allow the appropriate decision to be made,
since over the first few years it would be rare for the risk of
leaving the lead implanted would outweigh the potential
risks of lead extraction.134,135 Not all abandoned leads
should be removed and there must be another clinical indication for the CIED procedure to overcome the risks associated with opening the device pocket such as infection.136
There should be an additional clinical indication for opening
the pocket when there is a safety alert for the lead while the
lead is still functional and as such does not pose a manifest
risk to the patient. This is supported by the experience with
the Telectronics ACCUFIX extractions.108
Finally, removal of leads when there are multiple (4 or
more) leads implanted through a single vein or 5 or more
through the superior vena cava is not only more difficult but
also more dangerous. This appears to be most important in
medium to small sized patients (body mass index ⬍ 25)
who had a 3.7 times higher major adverse event rate (2.6%
absolute rate) than larger patients in the Lexicon study.80
This is also consistent with the 7% major complication rate
in women with 3 or more leads extracted, which was also
3.7 times higher than women with one lead and 7 times
higher than men with one lead extracted as reported from
the multivariate analysis of the Cook voluntary national
extraction registry.46,47
Wilkoff et al
Transvenous Lead Extraction: HRS Expert Consensus
Registry and data management
The lead management environment, as discussed earlier in
this document, requires a commitment to quality through
the collection and review of personal and institutional outcomes for device implantation and transvenous lead extraction. In addition to the local collection and review of outcomes, a mechanism needs to be developed to benchmark
local outcomes to national and international outcomes. This
will require a pragmatic registry with low barriers for collecting, reporting, analyzing and benchmarking the outcomes. This tool needs to be accessible to all committed
lead management centers, and requires clear definitions,
simplified data collection tools and transparent administration. Although the data are not primarily to be a source of
research, the publication of these data is fundamental to the
goal of quality. The support for this registry should include
physicians, hospitals, manufacturers of implantable devices,
manufacturers of extraction and lead management devices
and national regulatory bodies.
It is the consensus of the writing committee that there
should be a coordinated effort to make this lead management registry a reality. The effort should be supported by
CIED and extraction equipment manufacturers, but should
be administered by a third party such as the Heart Rhythm
Society. Data collection would be done by each medical
center. Use of a web based data collection tool would meet
the criteria for accessibility. Each center would be able to
access only their own data and benchmarked summary data
from the entire dataset. These un-audited data should be
supplemented with additional benchmark summary data
from a set of core centers that would submit to periodic data
audits. These data would then be published and serve to
provide for core data elements for the evaluation of new
technologies, and would advance the standards for quality
measures.
could be used or that the new tool had to be compared to a
single existing tool. The interpretation of results from such
trials is further complicated by difficulties in the definitions
of success and complications, by the lack of adequate data,
by sources of bias (such as unbalanced crossover), and by
patient selection criteria. Therefore, it is essential that systematic principles are applied to the technical and clinical
evaluation of both new techniques and new tools.
Recommendation for clinical evaluation of lead
extraction devices
New devices typically follow a path from a proof of concept
stage (phase 1) to preclinical studies (phase 2) and only then
to clinical studies (phase 3). We provide the following
recommendations for these trials:
●
●
●
●
New devices and techniques
The introduction of new devices and their use is regulated in
the United States by the Food and Drug Administration. The
purpose of this regulation is to assure that newly released
devices are safe and effective when used according to the
device labeling. The successful extraction of leads associated with a CIED often requires the use of multiple tools
and techniques. Therefore, it must be understood that a
single device or technique is unlikely to be proven safe and
effective in all situations. Rather, as with many surgical
techniques, the instruments used are chosen in a given
situation due to the specific needs as they present during the
procedure. Further, devices are often used in combination,
such as locking stylets and telescoping sheaths, or in tandem, such as laser sheaths followed by polymer sheaths or
rotating cutting sheaths. This makes the design of a clinical
trial to test a new device or technique very difficult because
the effects of the new device or technique alone may be
impossible to separate from the effects of all the devices and
techniques used as a group. It would be most unwise to
devise a clinical trial that mandated that only the new tool
1099
●
The clinical trial (phase 3) to examine safety and effectiveness should not be initiated until a stable technique or tool
has been established with phase 1 and phase 2 evaluations.
The initial evaluation (phase 1) should involve bench and
animal testing and the proof of concept clinical testing. The
phase 2 evaluation should be done in 3 to 5 centers having
prolonged and documented experience with lead extraction.
The goal is to document the utility of the tool, provide for
minor modifications in the design and technique, and to
confirm the lack of predictable harm.
The phase 3 clinical trial design should be appropriate to
assess the marginal effects of a new device on safety and
effectiveness, given the combined use with existing devices.
Given that lead extraction is now a relatively mature
science with standard tools available, it is appropriate that
new tools for lead extraction be submitted to randomization in prospective controlled trials.
The phase 3 clinical trial design should have a statistical
plan addressing adequate sample size, stratification (e.g.,
ICD vs pacing lead), crossover bias if applicable, assessment of covariates, and appropriate methods for hypothesis testing.
All of these studies should use the definitions of indications, successes, and complications that have been delineated in this document.
Conclusion
The procedure of lead extraction has now become part of
the larger concept of lead management. While extraction
has matured into a definable, teachable art with its own
specific tools and techniques, there remain challenges in
our ability to impart these skills to physicians so that safe
and effective transvenous lead extraction is available to
patients around the world While the authors strongly
endorse the indications as described, we also recognize
the unique circumstances surrounding each patient and
clinical situation. What cannot be accepted is the application of these techniques by those not adequately
trained, or by those practicing at institutions that do not
provide the level of support required to assure the safety
of the patient during an extraction procedure. This up-
1100
Heart Rhythm, Vol 6, No 7, July 2009
dated document is intended to serve as a resource and set
of guidelines to define and support the development of
this safe medical environment.
It is also no longer acceptable to treat most CIED infections in a “conservative” manner. Curative therapy nearly
always requires removal of the foreign bodies from the
infected site, with re-implantation of a new system at an
alternate site. The use of suppressive antibiotics should be
reserved for special cases as noted in the text of this document, and there is rarely (if ever) a place for pocket revision
by reimplanting an eroded or infected device in the same
pocket that has been debrided.
Complications will periodically occur, even in the most
experienced hands and centers, during transvenous lead
extraction and the survival of the patient requires that the
operator and extraction support team be prepared. It is the
rapid response of the physician, extraction team, and the surgical backup that will give the patient the greatest chance of
surviving.
The fundamental precept in the provision of quality is
measurement. We have precisely provided definitions for
indications, clinical and procedural success and complications. It is just as clear what personnel and the facility
requirements that are required to assemble, train and maintain the extraction team. However, implementation of these
recommendations will require significant effort and cooperation from practicing physicians, medical societies, hospital administrations, and industry. The final, missing and
required element in order for each extraction program and
operator to measure quality is to have a tool for each center
to collect, review and compare its individual outcomes to
national benchmark data.
Appendix
The writing group would like to thank the Heart Rhythm Society members, and the representatives of the American College
of Cardiology and the American Heart Association, for their thoughtful reviews of this document.
Author Disclosures
Authors
Consultant Fees/
Honoraria
Maria Grazia Bongiorni, MD Boston Scientific
Medtronic
St. Jude Medical*
Sorin Group
Charles L. Byrd, MD
Cook Medical,
Inc.
Medtronic
Roger G. Carrillo, MD
Spectranetics*
Tycos
George H. Crossley, III, MD Boston Scientific
Medtronic*
St. Jude Medical
Laurence M. Epstein, MD
Boston Scientific*
GE Medical
Hansen Medical
Medtronic*
St. Jude Medical*
Spectranetics*
Richard A. Friedman, MD
None
Charles E. H. Kennergren, Boston Scientific
MD, PhD
Medtronic
Mentice
St. Jude Medical
Spectranetics*
Charles J. Love, MD
Biotronik
Boston Scientific
Cook Vascular
Medtronic*
St. Jude Medical
Sorin/ELA
Spectranetics
TyRx
Speaker’s
bureau
Research grant
Fellowship
support
Board mbr/Stock
options/Partner Other
None
None
None
None
None
None
None
None
Cook Medical,
Inc.
None
None
None
None
None
None
None
Medtronic*
St. Jude Medical
None
None
None
None
Boston Scientific* Biosense Webster Carrot Medical
Medtronic*
Boston Scientific*
St. Jude Medical* Medtronic*
St. Jude Medical*
None
None
None
None
Biotronik
Boston Scientific
ELA Medical
Medtronic
St. Jude Medical
Spectranetics
Biotronik
Boston Scientific
Medtronic*
St. Jude Medical
None
Medtronic*
None
None
None
None
None
None
None
None
Wilkoff et al
Transvenous Lead Extraction: HRS Expert Consensus
Authors
Przemyslaw Mitkowski, MD
Raymond H. M. Schaerf,
MD
Oussama M. Wazni, MD
Bruce L. Wilkoff, MD
1101
Consultant Fees/
Honoraria
Speaker’s
bureau
Research grant
Fellowship
support
Board mbr/Stock
options/Partner Other
Biotronik
Boston Scientific
HammerMed
Medtronic*
None
None
Medtronic
Spectranetics
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
Biotronik*
Boston Scientific*
Medtronic*
St. Jude Medical*
Spectranetics*
None
Medtronic*– Patent
Royalty
Boston Scientific
Medtronic
St. Jude Medical
Boston Scientific
Inner Pulse
LifeWatch*
Medtronic
St. Jude Medical
Sorin
Spectranetics
*Significant
A relationship is considered to be “significant” if (1) the person receives $10,000 or more during any 12-month period or 5% or more of the person’s
gross income; or (2) the person owns 5% or more of the voting stock or share of the entity or owns $10,000 or more of the fair market value of the entity.
A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.
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