Download Removal of superfluous ICD leads

Europace (2002) 4, 25–26
doi:10.1053/eupc.2001.0216, available online at http://www.idealibrary.com on
OPINION
Removal of superfluous ICD leads
C. Byrd
Arrhythmia Center and EP Institute, Broward General Medical Center, Fort Lauderdale, FL; University of Miami
School of Medicine, Miami, FL, U.S.A.
Key Words: Pacemaker lead extraction, defibrillator lead extraction.
The article ‘Malfunction of endocardial defibrillator
leads and lead extraction: Where do they meet?’ is a
comprehensive analysis of the merits of removing ICD
leads. The authors’ detailed discussion is clear and
complete. Arguments are based on their personal
experience and the limited data available in the literature. This article, in essence, concerns the controversial
issue of removing superfluous ICD leads. By definition,
superfluous leads are non-essential abandoned leads.
There is little controversy regarding lead removal
for newly implanted leads, or for most infections.
Controversy does exist for the creation of a conduit in
order to reimplant a new lead, for over sensing of
electrical noise caused by two leads touching one
another (not correctible by relocating the lead), and for
most other indications.
Many believe superfluous leads should not be
removed. One argument for this view is regardless of the
magnitude of any future complication, the patient has the
guaranteed free interval for some indeterminate length of
time. Also, insertion of a new lead is a simple procedure
that seems so benign in comparison to a lead extraction.
The rationale for this approach is the risk of lead
removal, the availability of experienced lead extractors,
and the lack of information regarding the natural history
of these leads. My approach is to remove superfluous
leads unless there are ‘extenuating circumstances’. This is
a change in philosophy from a need to justify removing
superfluous leads to a need to justify not removing these
leads. It is based upon my personal experience. For
example, I have removed one or more ICD leads
from over 230 patients during the last 3 years using the
Spectranetics excimer laser powered extraction sheaths.
The proper course of action is confusing because of
misconceptions regarding the concept of biocompatibility
and the relativity of the success-failure/life-and-death
realities of lead extraction. Biocompatibility means an
implantable device is capable of existing and/or operating
in harmony within the biological environment.
Manuscript submitted 21 November 2001, accepted after revision
5 December 2001.
1099–5129/02/010025+02 $35.00/0
Implanted pacemaker and ICD leads are believed to be
biocompatible and, therefore, can reside indefinitely in
the body without causing a pathological reaction. This is
not true. Industry uses biocompatibility to mean leads do
not cause an autoimmune reaction. This is probably true.
The body reacts to an implanted lead like any other
foreign body; it is excluded from normal tissue by
encapsulating it in fibrous tissue. During lead implantation, tissue disruption and/or the application of physical
stresses (pressure, compression, shearing and traction)
cause an injury to the surrounding tissue. Tissue injury
triggers an inflammatory reaction to clean up microscopic cellular debris; to generate fibrous tissue for
repair of disrupted tissue, and to form a protective
barrier alleviating physical stress. The inflammatory
reaction is an evolving pathological event worsening
with time causing increase in tensile strength of the
fibrous tissue. Over an extended time interval, it mineralizes forming a bone-like substance. Also, injury and
stasis of flow in the intravascular environment causes
clot formation. If clot lysis is incomplete, the clot
matures into fibrous tissue. Exuberant encapsulating
fibrous tissue can cause a recurrent reaction forming
more injury and/or clot formation resulting in vein
thrombosis and/or intracardiac thrombi connecting the
lead and heart wall.
ICD leads are larger and stiffer than current pacemaker leads and cause more injury. The thickness and
tensile strength of the encapsulating fibrous tissue
increases at a faster rate than for pacemaker leads. In
addition, binding fibrous tissue forms in the interstices
of the helical coils on ICD leads. These are the only
differences between pacemaker and ICD leads. With the
more aggressive inflammatory reactions, the leads may
become a part of the vein wall. In implants of long
duration, some leads are actually excluded from the
vascular system e.g. a portion of the lead body lies
totally outside of the vein or heart wall. Removal of
these leads results in loss of wall integrity causing
haemorrhage. If this haemorrhage is into the free pleural
and/or pericardial space it is life threatening and must be
repaired immediately. Another complication found in
2002 The European Society of Cardiology
26
C. Byrd
ICD and pacemaker active fixation leads is penetration
of the electrode through the right ventricular wall, and
the helix screwed into the epicardial fat pad. Upon
removal, these leads leave a hole in the right ventricle
causing haemorrhage. This is more difficult to repair
than defects in the vein or atrial wall.
The decision to extract an ICD lead is ultimately based
upon those success-failure/life-and-death realities associated with the procedure, and not biocompatibility. Separating lead extraction into success-failure and life-death
focuses on the two key components of a lead extraction.
Three true statements regarding success-failure reinforce
the reluctance to remove superfluous ICD leads. First,
ICD leads are technically more difficult to remove than
pacemaker leads because of their size, stiffness, and
defibrillator coils causing more intense tissue reactions.
Therefore, it seems intuitively obvious the failure and
complication rate would be higher. Second, a failed ICD
lead extraction usually leaves a worse situation than
leaving the lead intact. In some cases, a failed lead extraction creates a clinical emergency forcing an emergency
cardiovascular surgical procedure. Third, patients receiving an ICD tend to have less cardiac reserve and more
severe concomitant disease processes. The potential
dangers associated with an organ failure suggest a higher
mortality and/or morbidity.
The first two of the above statements regarding
extracting ICD leads have not influenced the clinical
success rate. In the hands of an experienced extractor
a success rate of 100% is expected using the 16F
Spectranetics excimer laser sheath. This is the only
powered sheath large enough to remove these leads.
Because of the magnitude of the fibrous tissue and the
tissue ingrowths into the interstices of the defibrillator
coils, the laser sheath is essential. Even with the laser
sheath, separation and distortion of the coil causes
mechanical binding of the extraction sheath, further increasing the difficulty of the procedure. In my practice
100% of the ICD leads were removed. Although most of
the leads are removed from the vein entry site, a few were
removed using a transatrial approach. Fear of failure is
not an issue because these leads can be removed.
Negative ‘life-and-death realities’ are the only valid
deterrent to removing ICD leads, especially superfluous
leads. The current risk of removing ICD leads is not
known. The risk associated with ICD lead removal is
not confined to those procedures related to complications causing haemorrhage and the associated surgical
repair. The risk also includes the failure of one or more
essential organ systems such as the lungs and/or kidneys.
In American Society of Anesthesiologists (ASA) physical status class IV patients such failures can occur with
or without a procedure related complication.
Examples of an ASA Class IV physical status would
be a patient with one or more of the following: Class IV
heart disease, advanced chronic renal failure, and/or
advanced chronic pulmonary disease. Even in those
cases where haemorrhage is controlled surgically
and/or an organ failure is successfully treated, the morbidity including time in the hospital can be extensive.
Europace, Vol. 4, January 2002
Having made these damaging statements, why should
superfluous leads be removed?
To justify removal of superfluous leads the safety issue
definitely needs further explanation. Safety is normally
discussed using complicated conditional statements
regarding such issues as ‘extenuating circumstances’, the
extraction approach to use, and those post-procedure
complications such as renal and/or pulmonary failure. It
should be noticed that cardiac failure was not included.
An experienced extractor should be able to support a
non-ischaemic failing heart.
Conditional statements are reflected in the more
intuitively obvious and mostly quantitative clinical
events called ‘pre-existing conditions’. For example, the
patient’s physical status (ASA class I–V) is the dominant
pre-existing condition affecting mortality and morbidity.
Physical status class I through III can successfully tolerate
the procedure, including the management of a procedure
complication. A post-procedural organ complication has
not been a factor in my patient population.
Other pre-existing conditions based upon the inflammatory reactions at the biophysical interface may not be
known prior to the procedure. These include marked
calcification of the encapsulating fibrous tissue, inclusion
into the vein and/or heart wall, and exclusion out of the
vascular system. Complications associated with these preexisting conditions result in loss of integrity of the vein
and heart wall. Control of the resultant haemorrhage is a
recognized part of the lead extraction procedure, and, if
the complication is immediately corrected, it should not
result in loss of life. Extending the magnitude of the
procedure to include an invasive surgical procedure
should not change the outcome. A cardiovascular surgeon is required to repair tears of the veins and heart
wall. If one of these conditions is known or suspected
prior to the procedure, I would approach these patients
using a transatrial procedure. This procedure is safe and
avoids instrumentation of the superior veins.
My personal experience is considered anecdotal and
cannot be extrapolated to other extractors. However,
the types of problems I see are real and will be seen by
other extractors. My ICD experience has confirmed the
statement that these leads are more difficult to remove
than pacemaker leads of comparable implant durations.
The only procedure related complications we have had
using the excimer laser sheaths involves two patients
with penetrating active fixation leads screwed into the
epicardial fat pad surrounding the right ventricle. The
indication for lead removal was not superfluous leads in
these two complications.
Extraction of these leads leaves a hole in the right
ventricle far more difficult to repair than tears in the vein
and/or heart wall. The repair of this complication is at
present a research project. One patient (ASA Class IV
with septicaemia) died post-repair of the ventricular
defect probably of ischaemic disease. Despite these two
complications, I believe that superfluous leads should be
removed from patients ASA class I–III, and early class
IV. Leaving superfluous lead is just creating a problem
to be treated at a later date.