SilverHawk

SilverHawk™
Peripheral Catheters
Case studies
114357-001 A 01/08
PLAQUE EXCISION FROM A SUPERFICIAL FEMORAL ARTERY
USING THE SILVERHAWK DEVICE
45-DAY ANGIOGRAPHIC FOLLOW-UP
OPERATOR:
Alberto Foschi, MD, FACC, Shahriar Dadkhah, MD, FACC
AFFILIATION & FACILITY:
Saint Francis Hospital, Evanston, IL
CLINICAL HISTORY:
This is a 70-year-old female, a smoker of 40+ years, with a history of coronary
artery disease, diabetes mellitus type 2, hypertension, and hyperthyroidism.
She presented in the doctor’s office complaining of intermittent claudication in
both legs. On examination, resting ABI was 0.68 on the right and 0.74 on the
left.
ANGIOGRAPHY:
Diagnostic angiography revealed a totally occluded right superficial femoral
artery, 80% stenosis in the left external iliac artery, and 95% stenosis in the
left superficial femoral artery.
PROCEDURE:
Right femoral artery access was obtained and a contralateral sheath was
placed to treat the left external iliac and left superficial femoral arteries. The
tip of the sheath was advanced into the left common iliac artery. To cross the
superficial femoral artery lesion, a Mallinckrodt Wholey Hi-Torque 0.035” extra
support wire was used. The Fox Hollow SilverHawk™ LS catheter was passed
along the lesion 7-8 times, cutting and removing plaque with each pass.
Immediately post-procedure, there was an approximate 10% residual stenosis
at the left superficial femoral artery site. A self-expandable S.M.A.R.T®
stent (9x40 mm) was inserted into the external iliac artery.
CONCLUSIONS/RESULTS:
Six weeks later, angiography of the left leg demonstrated no residual stenosis
of the left superficial femoral and left external iliac arteries, and good distal
flow was observed.
Acute and two-month results have been excellent – this patient is without
claudication two months following the procedure.
LESSONS LEARNED:
The SilverHawk™ Plaque Excision system allows for efficacious treatment of
infra-inguinal disease, without the need for adjunctive stenting or PTA. As seen
in this case, the device is an ideal treatment for disease of the superficial
femoral artery.
PLAQUE EXCISION FROM A SUPERFICIAL FEMORAL ARTERY IN
A BILATERAL CLAUDICANT USING THE SILVERHAWK DEVICE
60-DAY ANGIOGRAPHIC FOLLOW-UP
OPERATOR:
Barry Weinstock, MD, FACC
AFFILIATION & FACILITY:
Mid-Florida Cardiology Specialists, Florida Hospital, Orlando, FL
CLINICAL HISTORY:
The patient is a 69-year-old white male with bilateral claudication, with a
history of type II diabetes, dyslipidemia with elevated triglycerides and low
HDL, moderate to severe bilateral carotid artery disease, hypertension, and
extensive known coronary disease with prior stenting of the RCA,
circumflex artery, and circumflex marginal branch. Noninvasive studies
showed markedly reduced ankle-brachial index bilaterally. Duplex arterial
examination was consistent with superficial femoral artery disease, and the
patient was referred for angiography and revascularization.
ANGIOGRAPHY:
Left Lower Extremity: Diagnostic angiography revealed 60-70% stenosis
in the proximal left common iliac artery. A 30-35 mmHg pressure gradient
was recorded across the stenosis when measured by pullback of the
contralateral sheath. In the left internal iliac artery, a focal stenosis of 80%
was observed proximally. The left superficial femoral artery showed a focal
75-80% stenosis proximally. More distally, above the level of the adductor
canal, a longer 70-75% stenosis was observed. The popliteal artery was
normal, and the patient had single-vessel runoff via the anterior tibial
artery.
Right Lower Extremity: Diagnostic angiography revealed a focal 95%
stenosis in the proximal superficial femoral artery in the same location as in
the left leg. However, in the distal right superficial femoral artery, only a
40-45% stenosis was observed. The right popliteal artery was normal, with
two-vessel runoff distally via the posterior tibial and peroneal arteries. The
right anterior tibial artery appeared occluded.
PROCEDURE:
The patient underwent a left superficial femoral artery intervention. A
0.035” guide wire and 7Fr Pinnacle® Destination™ contralateral sheath
were exchanged for the 5Fr sheath and flush catheter used previously for
diagnostic angiography. The patient was anticoagulated with Angiomax®.
A 0.014” Cougar™ guide wire was advanced to the left peroneal artery
without difficulty, and was used to advance a SilverHawk LX catheter over
the bifurcation to the left superficial femoral artery. The more proximal
stenosis was treated with multiple passes of the SilverHawk catheter, with
an excellent angiographic result.
Plaque was then removed from the catheter, followed by several passes of
the SilverHawk LX catheter along the more distal stenosis. Extensive
plaque was removed. The angiographic result was highly satisfactory and
the interventional system was removed.
CONCLUSIONS/RESULTS:
Plaque excision was performed using the SilverHawk LX catheter in both
the proximal and distal segments of the left superficial femoral artery. The
proximal 75-80% stenosis was reduced to 0%. The distal 75% stenosis
was reduced to approximately 15-20%.
There was no dissection or thrombus at either interventional location.
There was brisk, normal flow through treated areas at the conclusion of
the procedure. Sixty days following the left leg intervention, the patient
returned for plaque excision in the right superficial femoral artery with the
SilverHawk LS catheter. The 95% stenosis in the right proximal superficial
femoral artery was reduced to 10%. Left leg angiography
showed a patent left superficial femoral artery with only 30% stenosis in
the midsegment of the vessel, an area not treated previously. Symptoms of
claudication resolved post-intervention, and the patient remains
asymptomatic five months later.
COMMENTS/LESSONS LEARNED:
The SilverHawk Plaque Excision system is an excellent therapy for lifestylelimiting claudication. Both the left and right superficial femoral artery
stenoses were well treated with the SilverHawk device. Optimal results
were achieved without additional angioplasty or stenting following plaque
excision with the SilverHawk catheter.
PLAQUE EXCISION FROM AN OCCLUDED POPLITEAL ARTERY USING
THE SILVERHAWK DEVICE
OPERATOR:
Naveen Sachdev, MD, FACC
AFFILIATION & FACILITY:
Providence St. Vincent Medical Center; Portland, Oregon
CLINICAL HISTORY:
This is an 80-year-old male, former smoker, who was unable to
walk and was suffering from rest pain. The patient presented
with a non-healing wound on his left foot, left ABI measured
0.66, and he was classified as Rutherford Becker Class V. He
was scheduled for a below knee amputation.
PROCEDURE:
Angiography revealed an occlusion of the left popliteal artery,
with singlevessel runoff below the knee. Plaque excision with the
SilverHawk device was planned for the popliteal artery.
Contralateral access was obtained, and a sheath was advanced
to the left common femoral artery. A Frontrunner CTO catheter
and angled Glidewire® were used to cross the occlusion.
Subsequently, a ChoICE® PT guide wire was advanced to the
lesion, followed by multiple passes with SilverHawk ES and SS
catheters.
CONCLUSIONS/RESULTS:
Immediately post-procedure, improved flow was visible to the
foot. Thirty days following the procedure, healing of the foot
wound was observed.
Ninety days post-procedure, the patient is walking and has no
rest pain.
Amputation was avoided due to a successful SilverHawk
procedure.
PLAQUE EXCISION FROM AN OCCLUDED SUPERFICIAL FEMORAL
ARTERY USING THE SILVERHAWK DEVICE
OPERATOR:
Roger Gammon, MD, FACC
AFFILIATION & FACILITY:
Austin Heart Hospital, Austin, TX
CLINICAL HISTORY:
This is a 64-year-old male, with multi-level, bilateral peripheral
vascular disease and right critical limb ischemia. He had a history of
coronary artery disease and hypercholesterolemia. He presented with
a right ankle brachial index (ABI) of 0.71, and a left ABI of 0.42.
PROCEDURE:
Right leg: Angiography revealed mild disease in the common iliac,
occlusions throughout the external iliac and CFA, and diffuse disease
in the SFA. A total occlusion with heavy calcification was observed in
the distal SFA. Below the knee, three-vessel runoff was observed, with
all three vessels diseased. Plaque excision with the SilverHawk device
was planned in the SFA.
A 7Fr Pinnacle® Destination sheath was placed into the right common
iliac artery using a contralateral approach. Occlusions in the external
iliac, CFA, and SFA were crossed using various CTO devices. Stents
were placed in the external iliac and CFA. After balloon dilation,
plaque was excised in the SFA with the SilverHawk SS catheter, using
a Miraclebros3 guide wire. Plaque was then excised from proximal
segments in the SFA with a SilverHawk LS catheter.
CONCLUSIONS/RESULTS:
Post-procedure, brisk flow was observed throughout the right SFA and
into the tibial vessels. This created much more filling into the tibial
vessels than before the intervention, and a large, widely patent
anterior tibial artery was observed.
The right leg was successfully treated with angioplasty and stenting of
the external iliac and common femoral artery, and stand-alone
SilverHawk plaque excision in the SFA. Six weeks post-procedure,
visible healing of foot ulcers was observed.
PLAQUE EXCISION FROM AN OCCLUDED POPLITEAL ARTERY LESION
USING THE SILVERHAWK DEVICE 30-DAY ANGIOGRAPHIC FOLLOW-UP
OPERATOR:
Mehrdad Rezaee, MD, PhD
AFFILIATION & FACILITY:
Stanford University Medical Center, Stanford, CA
CLINICAL HISTORY:
This is a 50-year-old gentleman with a history of insulin-dependent diabetes and a 4year history of intermittent claudication in both legs. A lesion in the right iliac artery was
stented in August 2003. The patient returned again in October with severe claudication
on the left side. On examination, resting ABI was 0.67 on the left and 0.80 on the right.
ANGIOGRAPHY:
Diagnostic angiography showed a focal and occlusive lesion in the left popliteal artery
about one centimeter above the popliteal fossa and extending through the popliteal
area, but not into the trifurcation vessels. The stent in the right artery was patent and
there was minimal diffuse disease seen in the left iliac, common and superficial femoral
arteries.
PROCEDURE:
Ultrasound examination was done on the left popliteal lesions to rule out popliteal artery
thrombosis or aneurysm.
Using a contralateral approach, the LuMend Frontrunner™ CTO Catheter was used to
cross the totally occluded left popliteal, which was subsequently wired with a Terumo
Glidewire®. In a stand-alone procedure, the FoxHollow SilverHawk™ Plaque Excision
Catheter was passed along the lesion 8 times, cutting and removing plaque with each
pass.
CONCLUSIONS/RESULTS:
Immediately post-procedure, there was about a 10% residual stenosis in the popliteal,
good distal flow, no sign of dissection or clot, and excellent reconstitution of the vessels
at the foot. One month later, the patient returned to the clinic complaining of increasing
claudication on the right side. Repeat angiography showed minimal neointimal
hyperplasia in the right iliac stented segment. The discomfort was attributed to small
vessel disease on the right side and the patient was started on cilostazol (in addition to
his daily aspirin and clopidogrel). At this time, angiography of the left side showed no
residual stenosis in the popliteal artery, complete healing of the vessel wall, and great
distal flow. On later telephone follow-up, the patient reports he has no claudication on
the left side and no difficulty with walking.
COMMENTS/LESSONS LEARNED:
Because of the occlusion within the popliteal fossa, stenting was an undesirable option.
The SilverHawk device was easy to use and allowed me to avoid stenting in difficult
anatomy. Acute and one-month results were excellent. What was initially called residual
stenosis on the post-procedure angiogram probably wasn’t so much stenosis as minor
plaque and vessel wall disruption that looked like intraluminal irregularities. A perfect
acute result, however, doesn’t seem necessary. With vascular healing, the vessel
remained patent and appeared on angiography to be healthy and smooth.
POPLITEAL ARTERY CLAUDICATION INTERVENTION WITH
THE SILVERHAWKTM
OPERATOR:
Gregory A. Barber, MD
AFFILIATION & FACILITY:
Vascular and Transplant Specialists
Norfolk, VA
CLINICAL HISTORY:
This 63-year-old diabetic African-American woman presented with complaints of bilateral lower extremity
claudication after walking for about 10 minutes. She is a former smoker.
She has already tried exercise and noninvasive interventions and requested an arteriogram and possible
intervention.
On examination, she had 2+ radial and brachial pulses, 1+ carotid pulses, and 2+ femoral pulses. Her left
popliteal and dorsalis pedis pulses were 1- and no pulse was felt in the posterior tibial area. Her right
popliteal, dorsalis pedis and posterior tibial pulses were 1+.
Noninvasive testing showed an ankle brachial index of 1.03 on the right and 0.65 on the left.
The waveforms were suggestive of superficial femoral disease. An exercise study showed a significant
drop in her left lower extremity ABI of 46%,
correlating with aortoiliac disease.
PROCEDURE:
An aortagram with bilateral run-off was
performed.
Angiography revealed popliteal disease with a
90% stenosis in the distal superficial femoral
artery.
The FoxHollow MS SilverHawk™ Peripheral
Catheter was passed through a 7 French Cook
Flexor® Check-Flo® Introducer-Raabe sheath
over an ASAHI Grand Slam™ 0.014” wire and
used to excise plaque from the diseased
segment of the popliteal. A 2 cm long highgrade stenosis was significantly improved upon first insertion with four SilverHawk™ passes made in 90°
quadrants. A second insertion was performed to remove plaque from a proximal 4 cm, 50% stenosis with
excellent results. Less than 10% residual remained upon completion.
CONCLUSIONS/RESULTS:
Post-procedurally, the left SFA was widely patent with strong flow and no significant residual stenoses or
flow-limiting dissections. The patient is noted to have nice two vessel run off.
The patient tolerated the procedure well and was discharged on clopidogrel 75 mg daily.
PLAQUE EXCISION FROM DORSALIS PEDIS USING
THE SILVERHAWK® DS DEVICE
PODIATRIST
Jeffrey Glaser, DPM
Ryan Foot and Ankle Clinic, Charlotte, NC
OPERATOR:
Adeyemi S. Johnson, MD
Mid Carolina Cardiology, Charlotte, NC
CLINICAL HISTORY:
The patient is a 59-year-old white male with a 90-year pack tobacco history, hypertension, and diabetes. He presented
to his podiatrist in June 2006 with a non-healing, painful ulcer on his left foot. This ulcer had been present for 3-4
months, progressively increasing in size and discomfort. The patient thought he might have caused the ulcer by
overcompensating for left knee pain and therefore walking on the outside of his foot. In addition to the pain in his
knee, he was experiencing a cramping pain in his calf muscles when ambulating certain distances.
PHYSICAL EXAMINATION:
Inspection of the left foot revealed a full thickness, non-infected ulcer along the plantar aspect of the foot underneath
the 5th metatarsal head. The ulcer measured 0.5 cm x 0.5 cm in diameter with necrotic tissue at the base without
drainage. The pain due to the ulcer was out of proportion to palpation. Vascular examination revealed that his pulses
were 1/4 dorsalis pedis and posterior tibialis bilateral, CFT was approximately 7 seconds x 10, skin temperature cool-tocool tibia to toes with +1 pitting edema along the dorsal left foot and pre-tibial area. Neurological examination revealed
that the protective sensation was absent in >5 areas to indicate diabetic neuropathy. Orthopedic examination was
positive for a supinated forefoot, consequently placing abnormal pressure underneath the left 5th metatarsal head.
Radiographic examination was insignificant for osseous pathology.
At this time, his diagnosis was a neuropathic ulcer with a vascular component indicated by his poor vascular perfusion
and the fact that the ulcer was painful in a patient with dense sensorimoto neuropathy. The patient was referred for
non-invasive vascular examinations. Wound care was instituted, which consisted of light surgical and chemical
debridements.
His non-invasive vascular examinations revealed that his vessels were
noncompressible at rest with an ABI of 1.38 on the left and 1.50 on the right. Duplex
Doppler surprisingly demonstrated normal flow throughout the iliac arteries and lef
without significant stenosis. The distal dibial arteries were patent on the left. The
right Duplex Doppler demonstrated normal flow through the iliacs, common femoral,
superficial femoral and popliteal arteries without significant stenoses. However, there
was mild stenosis of both the tibioperoneal and dorsalis pedis artery.
Due to the initial thought that his vascular perfusion was adequate to heal the ulcer,
the wound was treated for approximately three months with serial debridements,
wound gels, and offloading. However, the ulcer subsequently increased in size to
approximately 1.0 cm x 1.0 cm in diameter and became infected. This required
several courses of PO antibiotics and subsequently the patient had to postpone his
scheduled total knee arthroplasty;
DIAGNOSTIC ANGIOGRAPHY AND TREATMENT:
The patient was subsequently referred to an interventional cardiologists. A diagnostic
angiogram was performed, which revealed a subtotally occluded anterior tibialis
artery on the left side, with moderate stenosis in the mid segment and a long area of
subtotal occlusion distal into the dorsalis pedis. The left posterior tibialis was occluded proximally and did not
reconstitute. The peroneal artery was patent to the ankle, supplying collaterals to the dorsalis pedis, but was also
critically stenosed in its mid segment. The significant infrapopliteal disease (Figure 1) was felt to be amenable to
percutaneous intervention with the SilverHawk DS Plaque Excision Catheter.
PLAQUE EXCISION FROM DORSALIS PEDIS USING
THE SILVERHAWK® DS DEVICE
DIAGNOSTIC ANGIOGRAPHY AND TREATMENT: continued…
One week later, plaque excision of the left infrapopliteal region was
done using an antegrade approach. A three-way wire was used to
cross the dorsalis pedis in the foot and the SilverHawk DS catheter
was used to remove plaque from the dorsalis pedis artery (Figure
2). A SilverHawk SS catheter was then used to remove multiple
levels of plaque from the proximal anterior tibialis and the peroneal
arteries.
Post-procedure angiography revealed complete opening of the
dorsalis pedis artery, allowing swift blood flow to the foot and ankle
(Figure 3).
Subsequently, the ulcer healed and the patient’s intermittent
claudication symptoms resolved.
DISCUSSION:
The above case illustrates a classic example of a diabetic patient
with infrapopliteal disease amenable to percutaneous
intervention with the SilverHawk DS Plaque Excision Catheter. This
technique can greatly expand the armamentarium available to
health care professionals who often deal with difficult-to-heal
diabetic wounds secondary to peripheral arterial disease. With
thorough knowledge of the various techniques available to wound
care specialists, a referral to an interventional specialist can be
made to expedite the recovery of these patients.
PLAQUE EXCISION FROM OCCLUDED POPLITEAL AND SUPERFICIAL
FEMORAL ARTERIES USING THE SILVERHAWK DEVICE
OPERATOR:
Lakshmikumar Pillai, MD, FACS
AFFILIATION & FACILITY:
West Virginia University Medical Center, Ruby Memorial
Hospital Morgantown, WV
CLINICAL HISTORY:
This is a 90-year-old female with a history of coronary artery
disease. She presented with claudication and rest pain in the
left leg and a non-healing ulcer on her left great toe. Her left
ankle brachial index (ABI) was measured at 0.34.
PROCEDURE:
Left leg: Diagnostic angiography revealed diffuse SFA
occlusive vascular disease. The popliteal artery was occluded
above the knee, with reconstitution below the knee. Onevessel runoff to the ankle was observed. Plaque excision
with the SilverHawk device was planned in the popliteal
artery and SFA.
Contralateral access was obtained with a 7Fr Pinnacle®
Destination sheath. The popliteal occlusion was crossed with
a Bernstein catheter over a Roadrunner wire, followed by a
MICROGLIDE® catheter. Then, a Mailman 0.014” guide wire
was passed down to the popliteal artery, and plaque was
excised with the SilverHawk SS catheter from just above the
knee to the level of the knee. The SilverHawk LS catheter
was then passed to the SFA, and plaque was excised from
the groin to the knee area.
CONCLUSIONS/RESULTS:
Immediately post-procedure, angiography revealed a widely
patent left superficial femoral, popliteal, and peroneal
arterial system all the way to the ankle level, with
collateralization into the foot via the posterior tibial artery.
Thirty days following the procedure, visible healing of the
patient’s great toe ulcer was observed. The patient reports
that her left great toe pain has resolved completely, and that
she is very satisfied with the results of the intervention. Her
post-procedure arterial duplex examination revealed a
widely patent reconstruction with an ABI of 0.94.
PLAQUE EXCISION FROM SUPERFICIAL FEMORAL AND TIBIALPERONEAL TRUNK ARTERIES USING THE SILVERHAWK DEVICE
OPERATOR:
John Paul Runyon, MD, FACC
AFFILIATION & FACILITY:
Christ Hospital, Cincinnati, Ohio
CLINICAL HISTORY:
This is an 80-year-old-male, ex-smoker, with a history of
CAD, hypercholesterolemia, prior CABG procedure, and a
prior aortic valve replacement. He presented with a nonhealing wound and tissue loss on his left great toenail.
His left ankle-brachial index (ABI) was measured as 0.61,
and he was classified as Rutherford Becker V.
PROCEDURE:
Angiography in the left lower extremity revealed long diffuse disease and a 90% stenosis in the distal
SFA, an occluded left anterior tibial artery just distal to the takeoff, and a sub-total occlusion of the left
tibial-peroneal trunk artery. Plaque excision with the SilverHawk device was planned for the SFA and
TPT.
Contralateral access was obtained with a 7 Fr Pinnacle® Destination sheath. A Mailman guide was
passed to lesion areas in the SFA, and a SilverHawk LS catheter was used to excise plaque.
Subsequently, plaque was excised from the left tibial-peroneal trunk artery with several passes of the
SilverHawk SS catheter.
CONCLUSION/RESULTS:
Immediately following the SilverHawk procedure, brisk flow was observed through the left superficial
femoral and tibial-peroneal trunk arteries. Sixty days following the procedure, the patient’s left foot was
warm, and regrowth of the great toenail was observed. The patient is walking daily without leg pain.
PLAQUE EXCISION FROM A TIBIAL-PERONEAL TRUNK ARTERY
USING THE SILVERHAWK DEVICE
ONE YEAR ANGIOGRAPHIC FOLLOW-UP
OPERATOR:
Mark W. Mewissen, MD
AFFILIATION & FACILITY:
Vascular Center at St Luke’s Medical Center, Milwaukee, WI
CLINICAL HISTORY:
The patient is a 75-year-old mildly obese, Caucasian woman with
insuling dependent diabetes who presented to the Vascular Center at
St-Luke’s Medical Center in June 2004 with a recurrent, non-healing
right toe ulcer.
Her medical history is significant for coronary artery disease, post
bypass grafting (5/1/2003), hypertension and peripheral vascular
disease. In September 2003, she underwent a right femoro-popliteal
vein bypass graft, with subsequent healing of a right third toe ulcer.
She is also status post left second toe amputation, possibly secondary
to osteomyelitis.
On examination, an ABI revealed non-compressible vessels and a
transmural pressure (TP) of less than 20 mm Hg. A duplex scan
identified a patent graft and a proximal tibial-peroneal occlusion.
ANGIOGRAPHY:
Diagnostic angiography was performed on June 13, 2004 using an
antegrade access into the right common femoral artery. The
femoropopliteal vein graft was patent, with a 50% stenosis in its midcourse that was not felt to be significant. Below the anastomosis, there
was a distal popliteal occlusion with peroneal reconstitution. The
peroneal artery was the only available outflow vessel.
PROCEDURE:
After advancing a 5 French catheter to the level of the distal popliteal
artery, a GlideWire was used to gently probe the occlusion. A 0.014” PT
Graphix Wire was used to traverse the 4 cm long lesion and gain access
to the peroneal artery. The tibioperoneal trunk was successfully
recanalized using an ES SilverHawk plaque excision catheter. Multiple
passes were performed.
FOLLOW-UP:
Final angiogram showed complete patency of the treated site with brisk
flow to the foot and reconstitution of the plantar arch. At 2 months, the
toe ulcer was healed and the TP was 65 mm Hg. The patient reported
feeling good.
On May 26, 2005, routine vein graft surveillance Duplex scan identified
a high-grade graft stenosis. Her foot was warm without ulceration. At
angiography, the graft stenosis was confirmed. The tibio-peroneal trunk
treated one year prior with SilverHawk plaque excision, however, was
noted to be patent. The graft stenosis was successfully treated with the
MS SilverHawk plaque excision catheter.
CONCLUSION:
This patient’s plaque excision procedure was done in June 2004 and,
although her disease has progressed elsewhere, her SilverHawk-treated
right tibio-peroneal trunk remains patent. This is an excellent example
of the stable long-term results that can be expected with the
SilverHawk device in patients with critical limb ischemia.
PLAQUE EXCISION FROM A TIBIAL PERONEAL TRUNK, PERONEAL,
AND ANTERIOR TIBIAL ARTERIES USING THE SILVERHAWK DEVICE
OPERATOR:
Gary Murray, MD, FACC, FACA, FASCI, FASA
AFFILIATION & FACILITY:
Memphis Cardiology/Baptist Hospital; Memphis,
Tennessee
CLINICAL HISTORY:
This is an 81-year-old female with a history of
hypertension, type 2 non-insulin dependent diabetes, and
coronary artery disease. She presented with rest pain and
gangrenous toes on the left foot. The foot was cold and
painful to touch. The patient previously underwent an
excimer laser procedure of the arteries below the knee.
Lower limb amputation was recommended by a vascular
surgeon.
PROCEDURE:
Doppler study showed monophasic wave forms in the
dorsalis pedis artery. Angiography revealed an occluded
tibial peroneal trunk artery, and the anterior tibial artery
had severe focal stenoses in the proximal section and
diffuse disease in the distal portion of the vessel. Plaque
excision was performed with the SilverHawk SS device in
the tibial peroneal trunk and peroneal arteries, followed
by the ES device in the anterior tibial artery. Postprocedure angiography showed strong flow to the foot.
CONCLUSION/RESULTS:
Subsequent to plaque excision, the patient underwent
amputation of the great toe and fourth toe of the left
foot. Lower limb amputation was avoided.
Twenty days following the procedure, healing of the foot
and remaining toes was observed, the patient had a warm
foot, and a pulse was felt in the dorsalis pedis artery.
The SilverHawk device was used to successfully avoid
lower limb amputation and limit amputation to the toes,
after a failed prior excimer laser procedure.
PLAQUE EXCISION FROM A TOTALLY OCCLUDED SUPERFICIAL
FEMORAL ARTERY USING THE SILVERHAWK DEVICE
OPERATOR:
Ovid O. Neulander, MD
AFFILIATION & FACILITY:
Surgical Associates of Upstate New York
Community General Hospital,Syracuse, NY
CLINICAL HISTORY:
The patient is a 76-year-old-man with at least a four-year history of left leg pain. He
initially presented with a long segment occlusion of the left superficial femoral artery
(SFA) and reconstitution at the infragenicular popliteal artery with some distal
disease. In October 2001, the patient underwent a left common femoral artery to
posterior tibial bypass graft in-situ which occluded several years later. The patient
repeatedly declined intervention because of minimal symptoms due to collateral
flow. Over the next several years he experienced an increasing level of leg pain and
in 2005 requested intervention. Pre-operative objective workup with color flow
Doppler ultrasound of the arterial system as well a CT angiogram documented the
arterial disease present. At this time, we decided to attempt an endovascular
revascularization procedure using the Silverhawk plaque excision system.
PROCEDURE:
In April 2005, the patient was taken to the operating room. Angiography of the left
lower extremity was accomplished using a contralateral approach via the right
common femoral artery catheter placement and an up-and-over technique.
Arteriogram revealed a totally occluded superficial femoral artery and occluded
femoral-posterior tibial bypass in-situ graft The infragenicular popliteal artey was
visualized as was in-line flow to the ankle via patent anterior and posterior tibial
vessels. The left SFA total occlusion was crossed using a .035” Gliderwire®/4F
Glidecath® approach and the popliteal artery was canalized after exchange with
a.014” Ironman™ guidewire. The .014” Ironman wire was advanced into the distal
infragenicular arterial vessels. At this time, the Silverhawk LX plaque excision
catheter was advanced over the wire and delivered to the target lesion. Multiple
passes were performed using the Silverhawk LX catheter until the entire
lesion/occlusion was debulked.
FOLLOW-UP:
Final angiogram in the opetratinf room showed open and patent in-line flow to th
infragenicular popliteal artery. After discharge, surveillance color flow Doppler
ultrasound demonstrated the arteries to be open and patent. The patient is fully
functional and is on anti-platelet therapy of Plavix 75mg and aspirin 81mg daily.
CONCLUSIONS:
The patient’s left SFA CTO re-vascularization procedure was performed in April 2005
with excellent results using the Silverhawk plaque excision procedure. This is an
excellent example that the Silverhawk plaque excision system can be used to open
up a logstanding CTO and re-establish in-line flow to the lower leg arterial
structures.
PLAQUE EXCISION OF BILATERAL CHRONIC TOTAL OCCLUSIONS
OPERATOR:
AFFILIATION & FACILITY:
Michael D. Fugit, MD, FACC
Sacramento Heart & Vascular Medical Associates
Sacramento, CA
REFERRING PHYSICIAN:
Thomas C. Park, MD, FACS
CLINICAL HISTORY:
This 80 year old diabetic male with a history of prior coronary bypass surgery and aortic valve replacement presented
with severe, left greater than right, lower extremity claudication. Diagnostic angiography revealed bilateral Chronic
Total Occlusions (CTO) of the Tibio-Peroneal Trunk (TPT), with the reconstituted Peroneal Artery providing single
vessel runoff to the foot.
PROCEDURE 1:
LEFT LOWER EXTREMITY
The lesion was crossed with an .014
AsahiTM wire. SilverHawk®
atherectomy was performed with the
FoxHollow SilverHawk ES, SX and MS
devices. At the completion of the
case, there was restored single
vessel runoff and palpable distal
pulses.
PROCEDURE 2:
RIGHT LOWER EXTREMITY
The patient reported being
essentially claudication free in the
left leg following the procedure. Two
weeks later, the right leg was
treated by crossing the CTO utilizing
an Asahi wire, supported with a
Sprinter® 2.0 x 10mm balloon.
Following predialation, SilverHawk
atherectomy utilizing an SS+
device resulted in restored singlevessel runoff and palpable distal
pulses.
DISCUSSION:
This case shows how a high-risk diabetic patient with infrapopliteal disease can benefit from therectomy with the
SilverHawk Plaque Excision System. Claudicants and patients with difficult-to-heal diabetic wounds due to peripheral
arterial disease may greatly benefit from treatment by this technique.
THROMBUS REMOVAL AND PLAQUE EXCISION OF AN SFA CTO
OPERATOR:
David K. Roberts, MD, FACC, FSCAI
Richard E. Ward, MD, FACS
AFFILIATION & FACILITY:
Sacramento Heart & Vascular Medical Associates
Sacramento, CA
CLINICAL HISTORY:
The 55 year old male claudicant presented
with a completely occluded left Superficial
Femoral Artery (SFA) at the origin, leaving
what appeared to be a stump at the proximal
end.
Diagnostic angiography also revealed a
widely patent profunda that collateralized the
distal SFA at the adductor canal.
PROCEDURE:
To cross the total occlusion of the SFA, the
wire was passed via the subintimal space,
and reentered the distal lumen with the aid
of an Outback® catheter.
Thrombus removal with the FoxHollow
Rinspirator® was performed due to the soft
thrombotic plaque from the ostium to the
mid SFA, removing large amounts of red
organized thrombus. All lesion sites were
then atherectomized using multiple passes of
the FoxHollow SilverHawk® LX device.
RESULTS:
The successful removal of significant
amounts of thrombus and plaque is
illustrated and brisk filling was noted, with
approximately 20% residual at the SFA. The
filling continued down into the patent
popliteal artery, with increased flow into the
posterior tibial artery for brisk one-vessel
runoff down into the ankle.
DISCUSSION:
This case illustrates device synergy in a complex case consisting of a totally occluded
Superficial Femoral Artery, the Rinspirator Thrombus Removal System and the
SilverHawk Plaque Excision System. This combination of treatment modalities
illustrates the high yield of thrombus and plaque possible given a highly experienced
physician, the appropriate devices and the early treatment of claudicants.
PLAQUE EXCISION FROM A TOTALLY OCCLUDED SUPERFICIAL
FEMORAL ARTERY USING THE SILVERHAWK DEVICE
OPERATOR:
Enrico Vecchiati, MD
AFFILIATION & FACILITY:
S. Maria Nuova Hospital,
Reggio Emilia - Italy
PROCEDURE:
Angiography of the right lower extremity demonstrated a
total occlusion in the medial portion of the SFA and
popliteal. Plaque excision with the SilverHawk was
planned.
Antegrade access was gained with a 8F sheath. The target
lesion was crossed with an .035”guidewire and pre-dilated
with 2,5 mm balloon. After exchange with .014” guidewire
a SpiderFx distal protection was placed into the distal
peroneal artery. At this time, the SilverHawk LX Plaque
excision catheter was advanced over the filter wire.
Multiple passes were required to remove the entire burden
plaque.
FOLLOW-UP:
Post-procedure and 1 month echo-doppler examination
revealed a widely patent reconstruction with an ABI of 1.
The patent was similar to the post-procedure arterial
duplex.
CONCLUSIONS:
Final angiogram showed an open and patent SFA.
The filter was removed and captured emboli were
observed.
The patient was discharged home on double antiplatelet
antiaggregation for 3 months and low weight heparin.
This is an example of SilverHawk Plaque excision system
can be used to open long occlusion.
PROCEDURE
CLINICAL HISTORY:
The patient is 77 – years-old male, a smoker, with a
history of insulin-dependent diabetes (IDDM) and
hypertension.
He had a severe claudication on his right side.
On examination, resting ABI was 0.45
He was classified as Fontaine class II B
PLAQUE EXCISION FROM AN OCCLUDED POPLITEAL ARTERY
USING THE SILVERHAWK
AFFILIATION & FACILITY:
S. Maria Nuova Hospital,
Reggio Emilia - Italy
CLINICAL HISTORY:
This is a 79 year-old female, ex smoker, with a
history of severe claudication in the left leg.
On examination, resting ABI was 0.5
She was classified as Fontaine IIB
PROCEDURE
OPERATOR:
Enrico Vecchiati, MD
FOLLOW-UP:
3 days post-procedure and 1 month echodoppler examination of the left leg
demonstrated no residual stenosis with good
distal flow.
DISCUSSION:
Acute results have been excellent – this patient
is without claudication.
The SilverHawk™ Plaque Excision system allows
for efficacious treatment of infrainguinal
atherosclerotic arterial occlusive disease
disease.
This device is an ideal treatment for disease of
the popliteal artery where the stent are not
recommended.
DUPLEX IMAGE
PROCEDURE:
Diagnostic angiography revealed a short tight
fibrocalcific stenosis of the left popliteal artery.
Only collaterals to the ankle were observed with
limited revascularization.
Left femoral artery access was obtained and a
sheath Accuflex 7F was placed into the common
femoral artery. To cross the popliteal artery
lesion, antegrade access was gain.
The ev3 SilverHawk™ MS catheter was passed
along the lesion few times, cutting and
removingplaque.
The post-procedure angiography showed a
patent vessel.
PLAQUE EXCISION FROM A SUPERFICIAL FEMORAL ARTERY
USING THE SILVERHAWK DEVICE
AFFILIATION & FACILITY:
S. Maria Nuova Hospital,
Reggio Emilia - Italy
Patient’s foot with non-healing ulcer
CLINICAL HISTORY:
The patient is 79 – years-old male,
smoker, dialyzed with cardiopathy after
myocardial infarction.
He presented a non-healing ulcer on his
left great toe. He was classified as
Fontaine class IV
PROCEDURE:
Angiography revealed diffuse disease and
a 90-95% stenosis in the SFA (or stenotic
and calcified lesion of the SFA, with single
runoff below the knee. Plaque excision
with the SilverHawk was planned.
Antegrade access was gained with a 7F
sheath. The target lesion was crossed
with an 0.35” guidewire and pre-dilated
with 2,5 mm balloon. Then a filter was
deployed in the distal popliteal artery.
The filter wire was used to advance a
SilverHawk MS Catheter.
Large quantities of plaque and small
pieces of calcium were removed after
several passes.
The angiographic result was satisfactory.
The filter was removed and captured
emboli were observed.
DISCUSSION:
Immediately post-procedure, angiography
revealed a patent SFA.
This created more filling into the peroneal
artery with an improved revascularization
of the foot.
PROCEDURE
OPERATOR:
Enrico Vecchiati, MD