CLINICAL REVIEW
Clinical Overview of the Jetstream
Atherectomy System
Ronald P. Caputo, MD, FACC, FSCAI
From St. Joseph’s Hospital and SUNY Upstate Medical School, Syracuse, New York.
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extensive clinical evaluation culminating in widespread commercial availability. A description of the device and brief
summary of its clinical utility follow.
DEVICE DESCRIPTION
The Jetstream system (Bayer HealthCare) consists of two main components: (1) a nonsterile console which
contains an electric motor and two
peristaltic pumps (for saline infusion
and blood/saline aspiration) which is
mounted on an IV pole and (2) a control “pod” which is used by the operator for device activation (Figure 1).
The console is attached to a standard
electric power source and is reusable.
The control pod is a sterile single-use
component.
The current Jetstream expandable
cutter (XC) catheters achieve graded
atherectomy using two sets of rotating
stainless steel blades. One set of blades
sits within a fenestrated metal housing
at the tip of the catheter. This set will
affect cutting in a diameter of just over
3 mm when rotated clockwise. The
second set of five blades are hinged
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hile bypass surgery may
still be considered the
standard for peripheral
revascularization, the requirement for
anesthesia, the relatively high incidence of morbidity, and the significant
time required for postoperative recovery remain a concern. Consequently,
there has been growing interest in
new technologies for the percutaneous revascularization of peripheral arterial disease (PAD) in patients with
chronic limb ischemia and symptoms
refractory to conservative medical
treatment.
In order to improve on the shortand long-term results of standard balloon angioplasty (PTA), several forms of
atherectomy have been recently applied
to peripheral revascularization. Our
group was privileged to perform a firstin-man feasibility study in 2004 using
a prototype Pathway Medical Technologies aspiration and atherectomy device
for the treatment of femoral-popliteal
and infrapopliteal disease. Since that
time the device has gone through several iterations, dramatic refinement, and
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ABSTRACT: There has been significant interest in percutaneous atherectomy as a technique for treating peripheral
arterial disease (PAD). Relatively recently, the Jetstream Atherectomy System was approved for use in the United
States. This device is unique as it incorporates an aspiration component. This manuscript includes a description of
the device, its method of use, and a summary of the available clinical data regarding its use in the lower extremities.
VASCULAR DISEASE MANAGEMENT 2013:10(10):E212-E215
Key words: atherectomy, peripheral arterial disease, claudication
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October 2013 Vascular Disease Management®
and mounted just proximal to the distal housing. These blades will affect
cutting in a diameter of 3 mm when
rotated counterclockwise (Figure 2).
Both sets are powered by an electric
motor that spins them at 60 krpm to
70 krpm.
The Jetstream single-cutter (SC)
catheters designed for subpopliteal
use.The SC devices are available in 1.6
mm and 1.85 mm sizes for use in vessels with a reference diameter of 2.0
mm to 3.0 mm. The working shaft
is also longer allowing the catheter to
reach infrapopliteal disease. Both the
XC and SC devices use the principal
of differential cutting in which fibrous
and calcified tissue/plaque is preferentially cut in favor of more compliant
normal tissue.
All Jetstream devices must be used
through a 7 Fr diameter sheath and are
designed for use with 0.014” diameter,
300-cm-long guidewires. The Jetwire
is a proprietary wire available through
Bayer HealthCare. It should be noted
that hydrophilic-coated wires are not
recommended. During device activa-
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CLINICAL REVIEW
When advancing the device a “pecking” motion is recommended whereby the tip of the catheter is repeatedly
advanced into the lesion with gentle
pressure and then withdrawn. This allows for the infusate to infiltrate the
lesion area and also prevents excessive
aspiration/suction with tissue collapse
around the catheter. This can result in
intimal dissection and device stalling.
When removing the device a reverse
function is used on the control pod
that causes aspiration alone without
any blade action.
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Figure 1. Jetstream control pod.
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CLINICAL DATA
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Figure 2. Jetstream expandable cutter catheter.
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tion, saline is infused through the distal tip of the catheter and aspirated at
a similar rate in order to help prevent
dissection and potentially retrieve
small embolic material into a collection bag. Saline infusion and aspiration rates depend on both the catheter size and the blades down or up
condition. Variables that increase these
rates are catheter size and the blade
down condition. The large catheter has
a maximum infusion rate of 43 mm/
min and aspiration rate of 51 mm/min
with the blades down. Although there
is no formal data, many operators add
vasodilators and heparin to the in-
fusate. In our lab we add 2,000 units
of heparin, 5 mg of verapamil, and 1
mg of nitroglycerin to each liter of
normal saline infusate.
Instructions for use state that the
Jetstream G3 or Navitus device is intended for use in atherectomy of the
peripheral vasculature and to break
apart and remove thrombus from upper and lower extremity peripheral
arteries ≥3 mm in diameter. It is not
intended for coronary, carotid, iliac, or
renal vasculature. Use of this device in
the subintimal (or potentially subintimal) space should be avoided in order
to reduce the chance of perforation.
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In a seminal study designed to support regulatory approval, Zeller et al
reported on a series of 210 lesions
treated in 172 patients between 2006
and 2007 with the earlier pre-G2 iteration of the device. The patients were
relatively complex with a high prevalence of diabetes (47%), hypertension (93.6%), renal disease (15.75%),
prior lower extremity revascularization (51.2%) and documented coronary disease (16.9%). Maximum lesion
lengths were ≤10 cm and ≤3 cm for
femoral/popliteal and infrapopliteal
lesions respectively. Fifty-one percent
of lesions were moderately to heavily calcified and 31% of lesions were
total occlusions. While thrombotic lesions were included, in-stent restenosis lesions were excluded. The lesion
crossing and debulking success rate
was 99% with a mean device activation time of 3.5 minutes. Only 7% of
lesions were stented. Minor embolic
events were noted in 10% of cases
and 4 perforations (2%) occurred. At
6 months major adverse events had
occurred in 19% of patients. Most of
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and chronic total occlusions compared to de-novo lesions and (3.2%
vs 2.4% vs 0.9%; P=.01) but also with
device type. The incidence of angiographically apparent emboli was 22%
for Jetstream and 22% for Diamondback (Cardiovascular Systems, Inc.)
compared to 1.9% for Silverhawk
(Covidien) and 3.6% for laser (Spectranetics). It must be noted however
that far fewer cases were performed
with the former two devices compared to the latter (n=36 vs n=791),
possibly indicating an operator effect.
Importantly, these embolic events are,
in general, successfully managed using
endovascular techniques, as has been
described.7
Further information regarding the
clinical safety and efficacy of this device will be available following completion of the industry-sponsored
JET registry (n=500) whose primary
endpoint is 12-month binary restenosis determined by duplex ultrasound.
Smaller studies investigating its utility
in specific lesion subsets such as instent restenosis and calcified are also
ongoing.
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concluded that calcium modification
contributed to the increase in lumen
size. Importantly, there were no major
adverse events reported at 30 days.3
Although a potential concern, clinically apparent hemolysis does not appear to be a frequent occurrence with
Jetstream atherectomy.There is a single
clinical report describing hemoglobinuria, elevated lactate dehydrogenase, low haptoglobin, and a decrease
in serum hemoglobin (12.1 to 10.8 g/
dL) occurring after a cumulative 11.7
minutes of device activation. The patient was observed overnight without
any clinical deterioration. The urine
cleared and there was no further drop
in hemoglobin.4
A more relevant concern is the incidence and clinical importance of embolization related to device use. Boiangui et al examined particulate debris
retrieved with an embolic protection
device (Emboshield, Abbott Vascular)
following Jetstream atherectomy in
22 patients with SFA disease (>70%
stenosis, mean lesion length 120 mm).
Macroscopic debris was retrieved in
95.4 % (n=21) patients with clinically
significant emboli, defined as ≥2 mm
in its longest axis, was recovered in
72.4% (n=16) of patients.5 Shrikande
et al used prospective registry data to
examine the incidence of embolization occurring in the treatment of
2,137 lesions (1,029 patients) undergoing atherectomy with four different
atherectomy devices.6 Angiographic
review of pre and post device runoff angiograms was performed. The
overall rate of embolization was 1.6%.
Higher rates of embolization were associated not only with more complex
lesions such as in-stent stenotic lesions
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these events were target lesion revascularizations (TLR), which occurred
in 15% and 26% of patients at 6 and
12 months respectively.1
The results for diabetic (n=80) and
nondiabetic patients (n=92) in this
study were compared. Other than
higher weight in the diabetic cohort
there were no significant differences in
baseline clinical parameters between
groups. Lesion-specific variables were
also similar. Other than a higher incidence of embolic events noted in
the diabetic group (13.8% vs 6.5%;
P<.001), acute procedural outcomes
were similar. At 12 months major adverse event rate (death, myocardial
infarction, amputation, TLR, target
vessel revascularization) was 25% for
diabetics and 31.5% for nondiabetics (P=NS). Most events were related
to TLR, which occurred in 20% and
28% of the diabetic and non-diabetic
groups (P =NS).2
Use of this device in moderate and
severely femoral/popliteal calcified
lesions was examined by intravascular
ultrasound (IVUS) in a small (n=26)
single-center study. Baseline mean
lesion length was 55 mm and diameter stenosis 82% with a calcium arc
of ≥90°. The primary endpoint of the
study was calcium removal and lumen gain as measured by IVUS. Lumen area significantly increased from
6.6 mm2 to 9.8 mm2 (P<.0001). Although there was not a significant
decrease in the calcium arc following atherectomy, the maximum arc of
calcium reverberations increased significantly (21° to 69°; P=.0006) and
the convexity of the surface shape of
the calcium decreased significantly
(67% to 26%; P=.0004). The authors
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CONCLUSION
Although published data are limited, the Jetstream atherectomy device
appears to be safe and has a high rate
of acute success providing acceptable
mid- and long-term arterial patency
rates. The use of embolization protection may be beneficial when using this
device.
Editor’s Note: Disclosure: The author has completed and returned the ICMJE Form for Disclosure of Potential
Conflicts of Interest. The author reports
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1.Zeller T, Krankenberg H, Steinkamp H,
et al. One-year outcome of percutaneous
rotational atherectomy with aspiration in
infrainguinal peripheral arterial occlusive
Analysis of retrieved particulate debris after
superficial femoral artery (SFA) atherectomy using the Pathway Jetstream G3 device.
Paper presented at: SCAI 2011 Scientific
Sessions; Baltimore, Maryland.
6.Shrikhande GV, Khan SZ, Hussain HG,
Dayal R, McKinsey JF, Morrissey N. Lesion
types and device characteristics that predict
distal embolization during percutaneous
lower extremity interventions. J Vasc Surg.
2011;53(2):347-352.
7.Reeves R, Imsais JK, Prasad A. Successful management of lower extremity distal
embolization following percutaneous
atherectomy with the JetStream G3 device.
J Invasive Cardiol. 2012;24(6):E124-E128.
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2.Sixt S, Scheinert D, Rastan A, et al.
Rotational and aspiration atherectomy in
infrainguinal arteries in patient with and
without type 2 diabetes mellitus. Ann Vasc
Surg. 2011;25(4):520-529.
3.Maehara A, Mintz GS, Shimshak T, et al.
Jetstream atherectomy can remove superficial calcium in severely calcified peripheral
arteries. Poster presented at: ISET 2013;
Miami, FL. http://www.eventscribe.
com/2013/posters/isetcio/SplitViewer.
asp?PID=MTEwNTg2MjU2#
4.Korabathina R, Staniloae CS. Intravascular
hemolysis following peripheral atherectomy
with the pathway Jetstream catheter. Vasc
Dis Manag. 2010;7(4):110-111.
5.Boiangiu C, Fissha M, Kaid K, et al.
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honoraria from Medtronic and AstraZeneca.
Manuscript received August 26, 2013;
provisional acceptance given September 9,
2013; final version accepted September 11,
2013.
Address for correspondence: Ronald P.
Caputo, MD, SJH Cardiology Associates,
4820 W Taft Rd, Liverpool NY, 13088,
United States. Email: caputo331@msn.
com n
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