CLINICAL REVIEW
Atherectomy in the Treatment of
Lower-Extremity Peripheral Artery
Disease: A Critical Review
Girish R. Mood, MD, Juyong Lee, MD, PhD, Lawrence A. Garcia, MD
From St. Elizabeth’s Medical Center, Tufts University School of Medicine, Division of Interventional Cardiology and Vascular
Medicine, Boston, Massachusetts.
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ABSTRACT: In the United States, peripheral artery disease (PAD) is on the rise due to an epidemic increase in
metabolic diseases like diabetes, aging population, and tobacco use. Until recently, accepted management strategies for treatment of symptomatic lower extremity PAD were limited to balloon angioplasty and self-expanding nitinol stents (either open design or covered). The goal for endovascular PAD intervention is to maintain and improve
the mobility of the patient. With ambulation there are specific movements to the superficial femoral artery and it
is subjected to various and continuous stresses to include compression, torsion and bending which can ultimately
result in stent fracture or in-stent restenosis for endovascular therapy. Treatment with atherectomy for symptoms
of lower extremity disease has now been shown to be effective in re-establishing blood flow with minimal vessel
trauma and may serve as an alternative to a stent-first approach. Additionally, the presence of plaque with modest
to severe calcification remains common and a debulking approach initially with further adjunctive therapy remains
appealing.
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VASCULAR DISEASE MANAGEMENT 2013:10(10):E192-E197
Key words: atherectomy, peripheral artery disease, peripheral intervention
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its infancy.
Lower-extremity arteries such as the
superficial femoral artery are exposed
to a multitude of chronic conditions
such as torsion, lengthening, and rotation during the activities when the
patient is ambulatory. Along with other metabolic risk factors and physical
strain of the vessel, the lower extremity arteries undergo pathophysiological
stresses that are unique and different
than other vascular beds, resulting in
higher calcified atherosclerotic burden
in the lower extremities.2-4 Most often
PAD is undiagnosed or goes underdiagnosed until the patient presents
with severe lifestyle-limiting claudication, rest pain, critical limb ischemia,
or tissue loss.
In the United States, treatment
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early 8 million Americans
are affected by peripheral
artery disease (PAD) involving the arteries of the lower limb
(Iliac, femoral, popliteal, and tibial).1
This number is expected to increase
in the future as the population ages,
leading to more symptomatic atherosclerotic plaque in various arterial systems including the coronary, carotid,
and lower extremity. Additionally, risk
factors such as diabetes, hypertension,
smoking, morbid obesity, and renal
disease are expected to further contribute to the worsening disease spectrum of PAD in the United States.
Even though there has been an explosion in the treatment options for
coronary artery disease in recent years,
choice of therapy for PAD is still in
October 2013 Vascular Disease Management®
options for the management of PAD
have increased in number but remain
limited in scope. Also we are lacking
substantial scientific data and largescale studies to help define which if
any therapy is best or the “gold standard” for most or all patients. The majority of interventionalists use balloon
expansion as the principal therapy in
treating lower-extremity PAD. This
can be associated with vascular barotrauma leading to an increased incidence of restenosis and the need for
reintervention as lesions become longer (RESILIENT, ABSOLUTE, ZILVER) or more heavily calcified. The
use of stents in the lower extremity
vascular tree has been shown in broad
studies to reduce the restenosis rate
and increase the patency of the vessel
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CLINICAL REVIEW
LASER ATHEROABLATIVE TECHNIQUES
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Laser therapy received FDA approval
with the LACI (Laser Angioplasty for
Critical Limb Ischemia) multicenter
trial, which showed 92% limb salvage
at 6-month follow-up of critical limb
ischemia.19 A total of 145 patients
were included in the study with 155
critical limbs. 71% patients had severity of the disease with Rutherford class
IV or VI. The diseased segments were
equally distributed involving superficial femoral artery and infrapopliteal
segments (41%) and 15% were popliteal lesions. Seventy percent of the
patients had combined occlusion and
stenotic lesions. In this study, a 308nm excimer laser was used to ablate
the plaque and thrombus, restoring
the flow in diseased segments. Laser
was delivered through a flexible fiberoptic catheter using short bursts of
ultraviolet energy, which vaporize the
plaque into small particles with minimal thermal injury in the surrounding
tissues. Hence there is less chance for
distal embolizations. Similarly, Dave et
al showed reduced TLR in 76.9% of
the patients at 1-year follow-up with
laser therapy.20
There are currently three ongoing
studies involving laser atheroablative
strategies: PATENT (Photo-Ablation
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protection devices in the treatment
of PAD to reduce the incidence and
complications associated with embolizations during atherectomy.13-18
Current available atherectomy devices
function on several principles such
as rotational, directional, orbital, or
atheroablative in the management of
PAD for both claudicants and patients
with critical limb ischemia.
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through minimal vessel barotrauma,
the incidence of acute complications
including dissection and acute vessel
occlusion may be reduced.12 It has also
been reported that the final results are
superior to balloon angioplasty alone
in these vessels treated. Current directional atherectomy has been theorized
to provide revascularization without
adjunctive treatment including PTA,
thereby decreasing resultant vessel injury through barotrauma, which may
reduce the rate of restenosis.8 Atherectomy may also provide the ability
to treat longer lesions without the
need for a lengthy endoprosthesis and
further can preserve side branches as
compared to a balloon-stent approach.
By preserving the native vessel anatomy and configuration with regard
to compliance and inherent torsional
forces, future interventions can also
be performed including stenting or
repeated atherectomy. Potential complications associated with atherectomy
devices include hematoma, pseudoaneurysm, distal embolization, or vessel
rupture.
Atherectomy devices were initially
used in the management of coronary
artery disease and were found to be
ineffective compared to contemporary bare metal stents of the day. Ahn
et al reported 82% to 100% success
rate with directional Simpson AtheroCath (Flexi-Cut). However the
intermediate-term patency rates were
35% to 84% with 6-month restenosis
rates ranging from 11% to 55%. Another study reported a large amount
of retained plaque with the Simpson
device,11 which led to reduced use
of atherectomy devices. Many small
studies were performed using distal
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at 1 and 2 years compared with simple
balloon angioplasty.5-7 However, this
therapy has limited applicability in lesions beyond 10 cm or in those with
heavily calcified territories and in lesions of considerable length (usually
approaching 20 cm). From a scientific
perspective, because of ongoing vessel
extrinsic forces from ambulation, the
effective use of stents can be limited
especially near the joint spaces8 or in
highly constrained locations, which
may contribute stent fractures and
contribute ultimately to stent failure.
Changing arterial compliance through
debulking, particularly with calcified
target lesions, has been reported as
beneficial. Recent data has suggested
an increased benefit with atherectomy
with or without adjunctive therapy
with percutaneous transluminal angioplasty (PTA) and/or stenting versus angioplasty alone.9 In this regard,
compared to expanding the vessel by
compressing and dissecting the plaque
by balloon angioplasty, theoretically,
debulking of the atheromatous plaque
will give rise to the larger luminal diameter. In a study reported by Aboufakher et al, total plaque volume was
decreased by 24%, which resulted in a
lumen increase of 66% due to plaque
excision with atherectomy without
any significant increase in the overall
vessel area by intravascular ultrasound
(IVUS).10,11
Principally, atherectomy devices
remove plaque, including calcified
plaque, by physically shaving, drilling, or pulverizing by sanding the
plaque, resulting in modification of
the vessel and its arterial compliance
in the case of those vessels with calcium. Because this can be achieved
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ROTATIONAL DEVICES
The Jetstream Navitus System (Bayer HealthCare) is a rotational atherectomy device that has differential
and circumferential cutting blades to
debulk both hard (calcified, fibrotic)
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in the below-knee segment involving
tibial vessels. This device has a fixed
cutter and is designed to navigate
easily through small-caliber tortuous vessels, debulking heavily calcified segments and chronic total occlusions. The Jetstream G3 Calcium
Study (NCT01273623) is an ongoing nonrandomized trial assessing the
treatment effect of the G3 device on
severely calcified lower-extremity
disease using IVUS.
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ORBITAL ATHERECTOMY
The Diamondback 360 Orbital
Atherectomy System (Cardiovascular
Systems, Inc.) uses a rotational technique causing preferential sanding
of the calcified plaque, resulting in a
fixed luminal gain. The catheter tip
has an eccentrically placed diamondcoated crown (30 micron) which is
driven through a pneumatic powered
console. This device requires a proprietary wire (ViperWire) to advance the
catheter to the desired segment and
lubricant (ViperSlide) to avoid thermal damage to the vessel wall. The
rotational speed can range between
60 krpm and 200 krpm. Sanding the
plaque results in microscopic particulate matter that is flushed by the
bloodstream and hence large-size distal embolizations are minimal.
The OASIS trial was a nonrandomized multicenter registry involving
124 patients with severe infrapopliteal
disease (201 stenoses). Of these, 45%
had critical limb ischemia and 55%
were claudicants. At 30 days, major
adverse events were seen in 3.2% including death, myocardial infarction,
amputation, and repeat revascularization. The procedural success rate was
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and soft (thombus, plaque) tissues
with minimal damage to the vessel
wall. The tissue debris are aspirated
through the side port and disposed
into the bag attached to the pathway
console. The pathway device has the
advantage of being able to adapt to
different sizes with each clockwise
(2.1 mm) and counterclock (3.0 mm)
rotation. This device has two units, the
main console and a single-use catheter electrically driven with a central
pod. The main console is reusable
and includes the main power supply
as well as the infusion and aspiration
chambers. The atherectomy catheter is
advanced over the wire (0.14 in/135
cm) proximal to the diseased segment
and cautiously driven back and forth
maintaining the rotational speed rate
(70 krpm) for better outcome.
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions was a multicenter prospective
efficacy study including 172 patients
with Rutherford class I to V lowerlimb ischemia. All patients had more
than 70% stenotic lesions up to 10 cm
long for the above-knee or 3 cm for
the below-knee segment. The reference vessel diameter was between 3
mm and 5 mm and the mean lesion
length treated was 2.7 cm with 31%
being total occlusions. Major adverse
events at 30 days were 1% with device success rate being 99%. At 1-year
follow-up, Duplex study showed primary patency of 61.8% and the Ankle
Brachial Index (ABI) improved from
0.59 to 0.82.21
In 2011, the Jetstream G3 SF device (Bayer HealthCare) was approved by the FDA for treating vessel
sizes 1.6 mm and smaller, especially
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Using the Turbo-Booster and Excimer Laser for In-Stent Restenosis
Treatment), EXCITE-ISR (EXCImer
Laser Randomized Controlled Study
for Treatment of FemoropopliTEal In-Stent Restenosis) and PHOTOPAC (Photoablation Followed by
a Paclitaxel-Coated Balloon to Inhibit
Restenosis in Instent Femoropopliteal
Obstructions) evaluating the role of
laser therapy in the treatment of peripheral artery in-stent restenosis. Recently the PATENT study reported
6-month interim results showing significant reduction in the percentage
of diameter of the diseased vessel from
87.1% to 7.5% using a combination of
laser atherectomy and balloon angioplasty. Major adverse events were reported to be 2.2% at 1-month followup. The final outcome report will be
presented after 1-year follow-up.
EXCITE-ISR is a phase 3, 2:1 randomized trial, which is currently recruiting patients in the United States.
There will be a total of 318 subjects
enrolled in the study with Rutherford
class I-IV with femoropopliteal artery in-stent restenosis. Similarly, the
PHOTOPAC study is an ongoing pilot study in Europe that is evaluating
the use of laser therapy and Paclitaxel-coated balloon therapy vs balloon
therapy alone in the management of
superficial femoral artery in-stent restenosis. Completion of this study is
expected in 2013.
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mal or no distal embolization.
Zeller et al reported a 2-year follow-up after using a directional atherectomy device in 36 patients (49 lesions) with Rutherford class IV to V
ischemia and infrapopliteal disease. Of
these, 67% of the lesions were treated
with atherectomy. The primary patency was 67% at 12 months and 60%
after 24-month follow-up. The secondary patency rate was 91% and 80%
at 12- and 24-month follow-up respectively.23 McKinsey et al reviewed
275 patients (579 lesions) of whom
174 patients (63.3%) had critical limb
ischemia and 101 patients (36.7%)
were claudicants. Overall limb salvage
was 92.4% with 100% among claudicants. At 18 months, primary patency
was 52.7% and secondary patency was
75%.24 Keeling et al reported 61.7%
primary patency and 76.4% secondary
patency at 12-month follow-up of 60
patients (66 limbs) following directional atherectomy using the SilverHawk device. Restenosis of the vessel
was noted in 16.7% of the patients at
3-month follow-up. Overall limb salvage was 86.2%.25
DEFINITIVE LE (determination
of effectiveness of the SilverHawk peripheral plaque excision system [SIlverHawk Device] for the treatment of
infrainguinal vessels/lower extremities) is the largest prospective nonrandomized PAD atherectomy device
study assessing the effectiveness of directional atherectomy in the management of lower-extremity arterial disease. The final results were presented
at the annual VIVA meeting in 2012.
This study, using sonographic and angiographic independent core lab adjudicated events enrolled 800 subjects
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three registry studies, it was noted
that the complication rates significantly reduced over time, suggesting
the expertise with the use of devices is
associated with improved clinical outcome. Also, during this period it was
also observed that the use of crown
size changed from 2.25 to 1.25 in
CONFIRM-I and CONFIRM-III
respectively.
Similarly, COMPLIANCE 360
study was a prospective multicenter
study involving 50 patients randomized to orbital atherectomy and
low-pressure balloon angioplasty vs
angioplasty alone in the treatment
of above-the-knee disease. After 12
months, the use of the atherectomy
device resulted in lesser mean balloon pressure inflation, 3.97 vs 9.15
atm (P<.0001) as well as significantly
reduced need for bailout stents 5.3%
lesions vs 78.6% (P<.0001) respectively. CALCIUM 360 was also a
similar study except that below-knee
diseased segments were included in
the study. Use of atherectomy devices
resulted in reduced maximum average
balloon inflation (5.9 atm vs 9.4 atm),
dissections (3.3% vs 11.4%), perforation (0% vs 2.8%), embolization (0%
vs 2.8%), and bailout stenting (6.9%
vs 14.3%) compared to balloon angioplasty alone.
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defined as <30% stenosis and was
achieved in 90.1% of the study subjects.22 Recently, the CALCIUM 360
randomized pilot trial showed significant benefit with orbital atherectomy
and balloon angioplasty vs balloon angioplasty alone.This study included 50
patients with 1:1 randomization. Procedural success was noted for 93.1%
of patients in the atherectomy and
angioplasty arm compared to 82.4%
in the angioplasty arm. After 1-year
follow-up there were no amputations
seen in either group. Target vessel revascularization was seen in 6.7% of
the study arm compared to 20% in the
control group. The all-cause mortality
was 31.6% in the control group with
none in the study group.9
Final outcome data from CONFIRM 360 was recently reported at
VIVA 2012, combining results from
three consecutive prospective registries (CONFIRM-I, CONFIRM-II,
and CONFIRM-III) involving 3,135
patients with 4,766 lesions. This is the
largest real-world PAD study including all comers from over 200 hospitals
in the United States between 2009
and 2011. Among these patients, 42%
of the lesions were above the knee and
28% were below the knee and 21% of
the total lesions were multivessel disease. One of the three orbital atherectomy devices (Diamondback 360,
Predator 360, Stealth 360; Cardiovascular Systems, Inc.) were used with
final residual stenosis of 10%±11%.
Overall, the orbital atherectomy devices use resulted in lower incidence
of perforation (0.7%), vessel closure
(1.6%), distal embolization (2.2%),
and use of bailout stents (4.9%). Comparing the final outcomes among the
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CLINICAL REVIEW
DIRECTIONAL ATHERECTOMY
The SilverHawk catheter (Covidien) is a directional cutting device that
contains a rotating blade inside a tubular housing. This catheter is connected
to a battery driven cutter driver and
can be used to treat vessels of 2 mm
to 4 mm in diameter. As the plaque is
shaved using this device, there is mini-
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plaque burdens or heavily calcified
atherosclerotic plaque proves to be
an important step in establishing circulation with minimal trauma to the
vessel and a potential for little to no
plaque left behind following therapy.
Adjunctive therapy with balloon angioplasty and stenting has been shown
to improve vessel patency in selected
patients, however, with the data from
DEFINITIVE LE it seems that directional atherectomy has an equal seat
at the revascularization table with all
other methods of lower-limb revascularization. With the advent of new
technologies and devices, atherectomy
has become a more feasible option in
the management of PAD. An initial
debulking strategy allows for the native vessel and intrinsic vessel characteristics to be maintained such that
if further intervention is required in
the future for restenosis, all interventional options are still available. Ongoing studies are expected to further
strengthen the use of these devices
and potentially allow more robust scientific head-to-head comparisons between devices, which is critically necessary to define any one technology’s
role in the treatment of lower-limb
PAD compared to another. Ultimately, these direct trials will afford us the
critical level of evidence to determine
our “gold standard” for treatment of
our patients with symptomatic lowerlimb PAD.
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Among claudicants, 78% vessel patency
was noted in lesion lengths of less than
4 cm (mean length was 2.3 cm) as compared to 82% in CLI patients. Similarly,
83% patency was seen among claudicants vs 60% in CLI patients with lesion
lengths of 4 cm to 9.9 cm (mean length
was 6.5 cm for claudicants and 6.9 cm
in CLI patients). The SFA lesion length
of more than 10 cm showed 65% vessel patency in claudicants (mean length
14.6 cm) as compared to 63% in CLI
patients (mean length 15.5 cm). Future
trials with DEFINITIVE AR, which is
a prospective, randomized, multicenter
pilot study involving debulking methods with drug-eluting (paclitaxel) balloon vs drug-eluting balloon alone is
currently recruiting patients and the
results are awaited.
The EASE (Endovascular Atherectomy Safety and Effectiveness) study
is an ongoing study to assess for the
safety and effectiveness of the Phoenix
Atherectomy Catheter (AtheroMed,
Inc.) aiming to recruit 90 patients
among 20 centers. This device is proposed to be used in the treatment of
chronic total occluded vessel and projected to have minimal distal embolization-related complication.
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among 47 centers globally. All patients
with ≥50% stenosis and Rutherford
class I to VI were included in the study.
The lesion length included was up to
20 cm with reference vessel diameter
of ≥1.5 mm and ≤7.0 mm.
Among them, 599 patients were claudicants (Rutherford class I to III) and
201 patients with critical limb ischemia (Rutherford class IV to VI). There
were 1,022 total lesions with 27.9% of
them being longer than 10 cm. Primary patency at 6 months was 94.1%
among claudicants and 97.3% in critical limb ischemia patients. Freedom
from amputation was reported to be
95.9%. There was no significant difference noted between diabetics and nondiabetics (94.4% and 93.7%). Periprocedural complications at 6 months were
3.8% for distal embolizations and 3.4%
for perforation.26 The need for intervention regarding all complications occurred in only 1.8% of the patients in
the cohort.
At 12 months, the primary patency
among claudicants continued to be significantly better at 82% and 78% for
peak systolic velocity ratio ≤3.5 and ≤2.4
respectively. There was no major difference noted in the outcomes between
diabetics and nondiabetics. The primary
endpoint among CLI patients was 95%
freedom from major unplanned amputation of the target limb and the primary patency was 71% (peak systolic
velocity ratio ≤2.4). Finally the functional analysis (Rutherford score, ABI,
Walking Impairment Questionnaire,
EQ-5D Questionnaire) at 12 months
was consistently better compared to
baseline. Primary patency of the superficial femoral artery patency varied
according to the length of the lesion.
CONCLUSION
Atherectomy devices have evolved
to become a major therapy in the
management of PAD, specifically in
the lower limbs. Because lower-extremity vessels are exposed to various physical and anatomic stresses,
balloon angioplasty or stenting alone
may not be appropriate for all patients
and all scenarios of plaque burden
or calcification. Appropriate use of
atherectomy devices to debulk large
October 2013 Vascular Disease Management®
Editor’s Note: Disclosure: The authors have completed and returned the
ICMJE Form for Disclosure of Potential
Conflicts of Interest. Dr. Garcia reports
unpaid consultancy to AngioSculpt, Pathway Medical Technologies (Bayer), and
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m
Spectranetics; consultancy to Covidien and
BSC; research for Covidien, iDev (Abbott),
and TriReme; and equity in CV Ingenuity, Tissue Gen, Arsenal, Spirox, and Essential Medical. Drs. Mood and Lee report
no disclosures related to the content of this
manuscript.
Manuscript received December 18,
2012; provisional acceptance given March
11, 2013; final version accepted July 2,
2013.
Address for correspondence: Dr. Lawrence A. Garcia, MD, Tufts University
School of Medicine, St. Elizabeth’s Medical Center, 736 Cambridge Street, Boston, MA 02135, United States. Email:
[email protected] n
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