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June 2010
An Interview with J. A. Mustapha, MD
A discussion on lesion access techniques, lowering amputation rates, and device development for below-the-knee interventions.
What are some unique lesion access techniques that
you have employed that may be useful to our readers?
In advanced limb salvage procedures, the common
femoral artery antegrade stick is the preferred primary
access site for the delivery of our peripheral interventional
equipment and devices. For tibial lesions that do not have
visualized takeoff from the parent vessel,
we have adopted the technique of antegrade/
retrograde approach via the pedal
arch and/or the anterior communicating
artery. We are also accessing tibial lesions
via direct tibial stick using a 5-F micropuncture
kit dilator for initial diagnostic
angiography and lesion crossing.
Is a drug-eluting stent–first approach
to below-the-knee (BTK) intervention
becoming a reality for treating critical
limb ischemia? How do you determine
your initial approach?
In the majority of limb salvage procedures, drug-eluting
stent placement in BTK interventions should not be the first
attempted method of treatment in critical limb ischemia.
Initially, it is best to avoid stenting of proximal tibials to prevent
jailing of other hibernating vessels. Also, there is an
unpredictable flow velocity after intervention in the tibial
vessels. When there is decreased flow velocity secondary to
outflow obstruction, there is a significant increased risk for
in-stent thrombosis. On the other hand, once all tibial vessels
are defined and stenting of a tibial artery is required to
maintain patency, drug-eluting stents are a viable option.
I have developed scoring classification and mapping systems to determine the initial method of treatment for BTK/below-the-ankle lesions. My mapping system is very precise and specific to which tibial vessel is treated first. With the mapping system, I can pinpoint exactly which one of the major tibial vessels is the culprit vessel and/or which branch of the tibial vessel is contributing to the tissue loss or nonhealing ulcer. I have seen cases with two-vessel runoff to the foot where the patient still has a painful nonhealing ulcer. I believe that it is not the number of tibial vessels open to the foot that is the answer for amputation prevention or wound healing. The answer is simply to provide tibial vessel runoff with direct flow to the ischemic BTK or below-theankle nonhealing ulcer site.
Tell us about the new standard for amputation at your
institution.
We have implemented an amputation prevention program
at Metro Health Hospital (Wyoming, MI). All referred
patients who are scheduled for amputation are seen within
24 hours of referral. If there is no contraindication, patients
will then undergo peripheral angiography
with planned intervention within 48 hours.
We have found that early revascularization
has led to limb preservation in more than
95% of our patients who were previously
scheduled for amputation.
Referring physicians are just becoming aware of the new technology and interventional techniques that are available to help this population. Over the past year, we started to receive more and more patients that were already scheduled for amputation or patients that were told that they did not have any other option. I strongly believe that many patients scheduled for amputations can still have their limbs preserved.
What are the key aspects of building and maintaining a
successful multidisciplinary peripheral vascular disease
(PVD) program?
An important key to building a successful PVD program
is partnering with and educating our referring physicians,
which include primary care providers and podiatrists. We
have implemented a program in which peripheral interventionists
travel to physicians' offices, educate them on PVD
screening, and share with them the latest available treatment
options. After our initial visit, we maintain communication
with referring physicians and provide them with
patient outcomes after the procedure. Furthermore, to educate
the public on PVD, we have also scheduled outreach
community screening programs.
Our PVD program includes collaboration among interventional radiology, cardiology, vascular surgery, and our wound healing center to evaluate the best available treatment for each patient. To ensure the success of our PVD program at Metro Health Hospital, we are continuously collecting data and monitoring our outcomes. We are currently performing multiple internal retrospective PVD studies. Most recently, we participated in the CALCIUM 360º trial, and we are also currently involved in additional ongoing trials.
Newer devices are allowing for higher rates of limb salvage,
but what is still needed to continue to improve
patient outcomes?
Limb salvage outcomes can be improved by following
these steps. First, we need to educate and train physicians
on the use of new interventional devices in conjunction
with education on the pathophysiology of tibial pedal disease.
Second, we need to continue providing patient education
on risk factor modification including smoking cessation,
diet, and exercise. As care providers, we must be
involved directly with our patients to help them understand
their disease, its urgency, and the need for change of risk factors.
Finally, we need more randomized, prospective, comparative
research trials to evaluate and determine the best
therapeutic options.
What percentage of your patients return for secondary
BTK interventions? Are you able to revascularize the
reoccluded vessels, or does the likelihood of amputation
increase with each intervention?
We are in the process of analyzing these data.
Anecdotally, we are not seeing an increased risk for amputation
with secondary BTK interventions. In fact, we are seeing
a decrease in the number of amputations in this population,
as well. The decrease in the amputation rate is due to our
ability to provide two-vessel runoff in the primary intervention.
What devices are you currently developing that you are
most excited about?
I am cofounder of TDJAM Medical Technologies, LLC
with Dr. Tony Das. One of the most exciting devices that we
are currently developing is a chronic total occlusion device.
This device has the ability to be used anywhere in the
peripheral vascular tree. It is unique in that it can center
itself and precisely enter a chronic total occlusion cap. This is
a device that can be used after failure of other crossing
devices including failed wire catheter technique, which is the
most commonly used technique when operators advance a
wire to the chronic total occlusion. A second device currently
under development is a peripheral vascular interventional
sheath that allows perfusion of the distal vessels while
treating the target vessel. The sheath can also easily traverse
vessels with severe tortuosity and deliver devices to the target
lesions.
We are working on many other new devices at TDJAM LLC. All of our innovative devices are developed to address an unmet need. Our hope is that future innovations will continue to lead us to eliminating amputations due to peripheral vascular disease.
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