ACS - First in Arizona
Performing Pacemaker Lead Extraction through Excimer Laser Ablation
Results
Of The PLEXES Trial
Advanced Cardiac Specialists’ (ACS) Cardiac Catheterization Laboratory at
Phoenix Memorial Hospital was selected as a primary site to participate in the PLEXES
research trial. The successful outcomes in this trial resulted in the Food and Drug
Administration (FDA) clearing for market the Spectranetics 12 French Laser Sheath
(SLS™), a new device for removing pacemaker and implantable cardioverter
defibrillator (ICD) leads, on December 11, 1997. Data presented to the FDA indicates the
success rate for successful lead removal using the laser sheath was 94%, compared with 65%
in traditional, non-laser procedures.
ACS is the first and only site in Arizona,
and one of a handful of selected sites nationwide, that performs laser extraction of
pacemaker leads using the new laser sheath and catheter. The procedure is performed under
local anesthesia and intravenous sedation at our catheterization laboratory at Phoenix
Memorial Hospital.
The New Laser Technique: Better and Safer
Cardiac pacemakers are used to control arrhythmia, or irregular beating of the heart.
Once a pacemaker is implanted, a number of clinical situations may occur which require its
removal, including infection, product recall or product failure. Traditionally, leads have
been removed using several techniques such as simple traction, counter traction and
snaring. This involved pulling on the wire while pushing against the heart wall with a
surgical brace. This could potentially result in a tear or other trauma to the heart. All
of these methods carry a risk of complication. The Spectranetics Laser Sheath (SLS)
decreases the risk of patient morbidity to practically zero by reducing the physical force
required to tear the lead away from scar tissue that has accumulated over time.
Some
Facts And Figures
Approximately two million people worldwide have pacemakers, and about 500,000
pacemakers and Implantable Cardiac Defibrillators (ICD’s) are implanted annually. As
more people receive pacemakers and implanted cardiac defibrillators, the problem of
implanted leads becoming ineffective and/or beginning to pose serious health hazards, is
expected to grow. Approximately 70,000 people may face lead removal each year.
How Does It
Work?
In the past, old leads have generally been left in place as they are often heavily
embedded in scar tissue, making extraction traumatic and potentially dangerous. Yet,
non-functional leads can cause such medical problems as reduced blood flow or thrombosis
(blood clotting), migration of broken leads in the vascular system, the unavailability of
veins for replacement leads, and possible electrical interactions with new leads. In
addition, they are a potential source of infection.
The SLS uses relatively cool laser energy to
pierce through scar tissue that has grown over the wire. Ultraviolet light cuts through
the tissue, while a sheath slides over the lead to cover it as it becomes freed. When the
wire is cleared, it is pulled out through the protective sheath.
Information
for Referring Physicians
If you are a primary care physician or a
cardiologist and are interested in obtaining additional information on the Laser technique
for pacemaker lead extraction, or if you have a patient who you feel may benefit from this
technique, please contact us at (480) 926-6990 or 1 (800) 73 PULSE, or
e-mail us at bobbie.boyd@acs-im.com.
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