Rethink Atherectomy

, LLC
September 2013
Volume 25/ Supplement B
™
an HMP Communications Holdings Company
www.invasivecardiology.com
The Official Journal of the International Andreas Gruentzig Society
Rethink Atherectomy:
Expert Insights Into Clinical
Application and Use of the
JETSTREAM System
Copyright© 2013 HMP Communications, LLC. All rights reserved. Opinions expressed by authors are their own and not necessarily those of HMP Communications, the editorial staff, or any member of the editorial advisory board. This material was submitted as
a supplement and was not reviewed by the journal editor or the editorial advisory board. Reprints of articles are available. Contact
HMP Communications for information (www.invasivecardiology.com)
Print ISSN 1042-3931 / Electronic ISSN 1557-2501
Cover_BayerSupplement_0913.indd 1
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Optimizing Strategy in Peripheral Vascular Interventions:
The Role of JETSTREAM® Atherectomy
Nicolas W. Shammas, MD, EJD, MS, FACC, FSCAI, FICA
O
ver the past several years, major advancements have
been made in the treatment of infrainguinal disease.
The “tool box” has expanded with several manufacturers bringing to the market multiple balloons, wires,
stents, atherectomy devices, CTO catheters, and so forth.
Endovascular specialists are left to choose the right device for
the right lesion based on their experience and understanding of how these devices operate and where they are most
effective. In general, high-level evidence comparing effectiveness and safety of these devices is generally lacking with
available data mostly derived from small, randomized trials
or observational registries. Given the lack of clear recommendations about when certain devices are best applied for
the most effective and safe results, a general guiding strategy to approach infrainguinal disease may be necessary. The
“leave nothing strategy” appears to have gained momentum
and reflects on our desire to keep the vessel free of stents.
Despite randomized data indicating stenting can improve
patency over balloon angioplasty, stents continue to have
several problems in infrainguinal interventions with reduced
patency on long-term follow-up, fractures, re-occlusion by
a restenotic-thrombotic process, and possible interference
with surgical options and emerging anti-restenotic technologies such as drug-coated balloons or drug-coated stents.
Changing vessel compliance to reduce dissections, bail
out stenting and vessel barotrauma, protecting the outflow
vessels, and reducing smooth muscle cell proliferation have
been the main anchors of a guiding strategy in our laboratory when approaching infrainguinal disease. Recently
published or presented randomized trials have shown that
atherectomy can accomplish the task of reducing dissections
and bail out stenting. Embolic filter protection and embolic capture balloon technology have added a level of protection to the outflow vessels, and now with drug-coated
balloons, restenosis, and target lesion revascularization can
be improved upon.
In this supplement to the Journal of Invasive Cardiology,
I discuss the multiple challenges operators encounter when
treating infrainguinal disease with a focus on the importance
of atherectomy in addressing the issue of changing vessel
compliance, reducing dissection, and stenting. The importance of protecting the outflow vessels during atherectomy
is also presented. Dr. Ramaiah presents the JETSTREAM
device and its distinguishing features from existing atherectomy devices on the market including active aspiration, front
cutting rotational design, and expandable blade technology.
Dr. Davis explores key tips and tricks with the use of the
JETSTREAM device including introducers and wire selection, the importance of audible and tactile feel during the
operation of the device, the technique of catheter advancement and pullback, the use of the blades-up and bladesdown feature, and how to avoid distal embolization. Finally,
Dr. Shimshak presents 2 case reports with the JETSTREAM
system illustrating its strengths in treating severe calcified
lesions. Intravascular ultrasound assessment of the lesion
before and after treatment is also presented and shows the
ability of the device to effectively remove calcium.
Nicolas W. Shammas, MD, MS, FACC, FSCAI
President and Research Director,
Midwest Cardiovascular Research Foundation
Davenport, IA
From the Midwest Cardiovascular Research Foundation, Davenport, IA.
Disclosure: The author has no commercial, proprietary, or financial interest in any products described in this article. Dr Shammas received related research and educational
grants to the Midwest Cardiovascular Research Foundation from Covidien, Spectranetics, Bayer HealthCare, Medtronic, Boston Scientific, Abbott, and CSI. Supported in part
by the Nicolas and Gail Shammas Research Fund at MCRF. Full disclosure at www.mcrfmd.com.
Address for correspondence: Nicolas W. Shammas, MD, MS, FACC, FSCAI, FICA, President and Research Director, Midwest Cardiovascular Research Foundation, 1622 E
Lombard Street, Davenport, IA 52803. Email: [email protected]
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Editorial-Shammas_0913.indd 2
The Journal of Invasive Cardiology®
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Addressing Challenges in the Treatment of Infrainguinal Arterial
Disease: an Endovascular Specialist’s Perspective
Nicolas W. Shammas, MD, EJD, MS, FACC, FSCAI, FICA
ABSTRACT: Infrainguinal interventions remain challenging to
endovascular specialists. Treatment of the femoropopliteal (FP) artery represents approximately 40% of all infrainguinal interventions.
The FP artery is subject to multiple external forces. The use of selfexpanding nitinol stents in this vessel modestly improves patency but
is associated with several potential problems including stent fracture,
in-stent restenotic-thrombotic re-occlusions and continued low patency rate on long-term follow-up. Also, infrapopliteal (IP) vessels
are generally small in diameter and tend to be calcified with long
segments of disease and occlusions. IP vessels are therefore likely to
have a high rate of dissection with balloon angioplasty as a primary
treatment. Stenting the IP vessels with current stent technology is
a suboptimal strategy that should generally be avoided. Literature
review supports a strategy based on a triad of improving vessel compliance and reducing barotrauma and dissection, minimizing distal
embolization and applying anti-restenotic measures to improve patency and reduce target lesion revascularization. We review current
literature and tools available to the endovascular specialist to achieve
these goals.
Key words: femoropopliteal artery, restenosis, atherectomy, drug
coated balloon, in-stent restenosis, distal embolization, tibial runoff,
stent fracture, patency, target lesion revascularization, tibial artery,
peroneal artery
Peripheral artery disease (PAD) is an endemic problem,
predominantly apparent in elderly, diabetics, and smokers.
Currently 12%-14% of people in the United States have PAD.
The severity of PAD is a strong predictor of cardiovascular
mortality. Therefore, treatment needs to focus on aggressive
risk factor modification in addition to revascularization strategies to improve symptoms of claudication, reduce amputation, and improve survival.1
Endovascular treatment of infrainguinal disease (FP and IP)
has remained a challenge particularly in advanced type C and D
lesions as defined by The Trans-Atlantic Inter-Society Consensus Document on the Management of Peripheral Arterial Disease (TASC II).2 With the advent of multiple tools to treat these
complex lesions, endovascular specialists are now approaching
these lesions non-surgically. Despite a relatively high initial
procedural success with catheter-based therapies, the long-term
outcomes have been less than encouraging with an overall lower
patency and high repeat target lesion revascularization (TLR).
From the Midwest Cardiovascular Research Foundation, Davenport, IA.
Disclosure: The author has no commercial, proprietary, or financial interest in any
products described in this article. Dr Shammas received related research and educational grants to the Midwest Cardiovascular Research Foundation from Covidien,
Spectranetics, Bayer HealthCare, Medtronic, Boston Scientific, Abbott, and CSI.
Supported in part by the Nicolas and Gail Shammas Research Fund at MCRF. Full
disclosure at www.mcrfmd.com
Address for correspondence: Nicolas W. Shammas, MD, MS, FACC, FSCAI,
FICA, President and Research Director, Midwest Cardiovascular Research Foundation, 1622 E Lombard Street, Davenport, IA 52803. Email: [email protected]
Vol. 25, Supplement B, 2013
Shammas_0913.indd 3
We describe our approach in treating infrainguinal disease
with a focus on improving compliance and minimizing dissection and bailout stenting, preserving distal runoff and applying
anti-restenotic therapies for more durable long-term results.
Treatment of the Femoropopliteal Artery
De novo lesions
There is little debate that TASC II A and B lesions are
best suited for endovascular therapies. Although the TASC II
committee recommends surgical therapy for TASC C and D
lesions, these are now increasingly being handled using an endovascular approach. There is no consensus to the best endovascular approach in treating de novo lesions in the FP artery.
Both primary and provisional stenting of the FP segment are
strategies practiced widely. Balloon angioplasty (PTA) alone
leads to a higher rate of dissection and need for bailout stenting.13 In one study, predictors of bailout stenting included
TASC D lesions, moderate (versus mild or none) calcification
and primary use of PTA (versus initial debulking prior to adjunctive PTA).4
We have previously proposed a strategy based on the triad
of improving vessel compliance and reducing bailout stenting
(mechanical), preserving the outflow vessels (procedural), and
reducing restenosis (biological) in approaching the treatment
of FP segments.5
Several trials have evaluated the value of stenting in FP
disease. Data suggest that stenting of the superficial femoral
artery (SFA) reduces the rate of restenosis when compared to
PTA. In 104 patients randomized to primary stenting versus
PTA of the SFA (mean lesion length in the stent group 11.2
cm), Schillinger et al6 noted that the 6-month rate of restenosis on angiography was 24% in the stent group and 43% in
the PTA group (P=0.05). At 2-year follow-up, restenosis rates
were 45.7% vs 69.2%, respectively, by an intention-to-treat
analysis (P=0.031) and 49.2% vs 74.3% (P=0.028), respectively, by actual treatment received.7 In a recent randomized
trial, Laird et al8 reported freedom from TLR at 12 months
to be 87.3% for the Lifestent (Bard Peripheral Vascular) compared with 45.1% for PTA as a primary therapy in treating
short FP lesions (mean lesion length 7.1 cm in the stented
group) (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% vs
36.7%; P<0.0001). At 3-year follow-up freedom from TLR
was significantly better in the stent group (75.5% vs 41.8%,
P<0.0001).9 In contrast, Krankenberg et al10 randomized 244
patients with SFA disease (mean lesion length 4.5 cm) to the
Bard Luminexx 3 stent vs PTA. There was no difference in
restenosis rates between the stent (31.7 %) and the PTA
(38.6%) arms at 1 year. TLR rates at 1 year were 18.3% and
14.9% (non-significant), respectively. Differences in stent
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SHAMMAS
design may have been one factor that accounted for the lack
of improvement in patency and TLR in this study.
Irrespective of the stent used, there were continued significant high TLR rates at one and 2 years in patients who received stenting of the FP artery.6-11 Stenting reduces restenosis
by preventing negative remodeling and recoil rather than reducing neointimal proliferation.12 Cryoplasty has been used to
improve on stent results. Cryoplasty does reduce neointimal
proliferation using cell apoptosis.13 Adjunctive cryoplasty after
stenting of the FP segment did show a reduction in restenosis
in diabetics. In the COBRA (cryoplasty therapy or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments) randomized trial, FP
binary restenosis after adjunctive cryoplasty was significantly
reduced compared to PTA (29.3% vs 55.8%, p=0.01).14 Recently the Zilver PTX,15 a paclitaxel-coated self-expanding
stent, was approved in the US. In the Zilver PTX randomized trial, the ZilverPTX stent (Cook Medical) had a superior
12-month event-free survival (90.4% vs 82.6%; P=0.004) and
primary patency (83.1% vs 32.8%; P<0.001) when compared
with PTA.
Stents in the FP segment can fracture over time because
they are subject to repetitive external forces, including flexion, torsion, and compression. Low grade stent fracture is less
likely to cause restenosis but high grade fractures were associated with higher rate of restenosis.16,17 Furthermore, stent total
re-occlusion is a restenotic-thrombotic process generally more
difficult to treat and carries a higher rate of procedural complications, recurrent restenosis, and re-stenting.18,19 In addition, it is unclear how a stented FP segment interferes with the
effectiveness of emerging anti-restenotic technologies such as
drug-coated balloons or drug-coated stents. Finally, stents involving the popliteal or common femoral arteries may reduce
future surgical options and are best avoided in these locations
except in bailout situation.
Atherectomy has emerged as an alternative option to primary stenting of the FP artery. Using directional cutting of FP
de novo lesions, SilverHawk atherectomy (Covidien) improved
vessel compliance and reduced dissection and bailout stenting
compared to PTA alone.3 In the COMPLIANCE 360 trial,20
differential sanding using the Diamondback 360° of calcified
FP lesions improved lesion compliance and resulted in reduction in bailout stenting. In addition to debulking with differential cutting or sanding, plaque modification with cutting
balloon may improve compliance and reduce dissection. In
short, in de novo SFA lesions (<5 cm), CB had less restenosis
than PTA (13% vs 36%; P=0.049) at 12-month follow-up.21
However, this was not consistent across studies.
Amighi et al22 showed no reduction in restenosis post-CB
treatment of short de novo FP lesions compared to PTA (32%
PTA vs 62% CB at 6 months, respectively; P=0.048). The
impact of ablative treatment using excimer laser (Spectranetics) or cutting with rotational atherectomy and aspiration
with the JETSTREAM device (Bayer HealthCare) on vessel
compliance and bailout stenting is unknown. In the CELLO
trial (Clirpath Excimer Laser System to Enlarge Lumen Openings) patency of FP de novo lesions were 59% and 54% at 6
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and 12 months, respectively.23 Furthermore, in observational
studies, bailout stenting of the FP segment after excimer laser was variable, ranging from 23% to 50% but these studies did not assess vessel compliance and had no comparative
PTA arm.19,24 Zeller et al25 reported a 99% device success rate
in the multicenter Pathway Peripheral Vascular disease trial
(using the JETSTREAM Atherectomy System, Bayer HealthCare) in infrainguinal disease (including non-stent restenotic
lesions). In this study, clinically driven TLR rates at 6 and 12
months were 15% and 26%, respectively and the 1-year restenosis rate was 38.2% based on duplex imaging. Currently the
ongoing JET multicenter prospective registry is evaluating the
JETSTREAM rotational and aspiration catheter on TLR at 1
year, acute procedural results, distal embolization and bailout
stenting in claudicants with de novo or non-stent restenotic FP
lesions.26 At present, there are no randomized data comparing
atherectomy with adjunctive drug-coated balloon (DCB) vs
atherectomy alone or stenting alone or stenting with adjunctive DCB. A small non-randomized study from Italy suggested that atherectomy with DCB yielded better patency rates
and improved TLR compared to atherectomy alone.27
Paclitaxel-coated angioplasty balloons have reduced restenosis in the FP arteries. In the multicenter Thunder (local
Taxan with short time exposure for reduction of restenosis in
distal arteries) trial,28 TLR was 37% at 6 months and 52%
at 24 months in the control group and 4% and 15% in the
paclitaxel-coated balloon group (P<0.001), respectively. In addition, Werk et al29 reported a TLR rate of 33% in control and
6.7% in the paclitaxel-coated balloon (P<0.002) at 6 months.
DCB are likely to be a game changing technology in the treatment of FP disease.
We have adopted the strategy of atherectomy with low
pressure adjunctive PTA as the initial preferred therapy in our
laboratory with a significant reduction in dissection rates and
need for bailout stenting. The ongoing XL-PAD, a multicenter
prospective registry, is currently collecting data on FP treatment to evaluate 6-month and 1-year outcomes using various
treatment modalities and comparing them to stenting.30
In-stent restenotic lesions
Treatment of in-stent restenosis (ISR) is challenging, particularly when re-occlusion has occurred. These re-occlusions
are typically thrombotic-restenotic lesions with high distal
embolic potential and may require additional stenting over
existing stents.18,19 In patients with a previously placed stent,
smooth muscle cell proliferation accounts for restenosis as
recoil and negative remodeling are not likely. Re-stenting of
the FP artery is generally not recommended. The short- and
long-term outcomes of more than one layer of stent in the FP
segment are unknown.
PTA has very high rate of restenosis and debulking has
been attempted as a way to reduce or delay TLR. Zeller et al31
reported on 43 patients with FP ISR (mean lesion length of
131 mm) treated with SilverHawk atherectomy. Patency rate
was 54% at 1-year. Using excimer laser and the Viabahn (WL
Gore and Associates) stent, Laird et al32 reported a primary
patency at 12 months of 48% in the SALVAGE trial. In the
The Journal of Invasive Cardiology®
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Addressing Challenges in the Treatment of Infrainguinal Arterial Disease
PATENT (Photo-Ablation Using the Turbo-Booster and Excimer Laser for In-Stent Restenosis Treatment) study,33 a prospective registry evaluating laser atherectomy for treating FP
ISR, Zeller et al reported 82% and 52% freedom from TLR
at 6 and 12 months, respectively. Similarly, Shammas et al34
reported a TLR of 48.7% at 1 year in 40 patients treated with
the excimer laser for FP ISR with mean lesion length of 201.4
mm. Finally, Beschorner et al35 reported their data on 40 infrainguinal ISR lesions treated with the Pathway PV atherectomy system. Primary patency was 33% after 12 months
and 25% after 24 months. The ongoing JETSTREAM ISR
registry36 is currently evaluating rotational atherectomy with
aspiration in treating FP ISR lesions. In addition to its ability
to remove de novo and restenotic tissue, the JETSTREAM is
also a thrombectomy device, an added advantage in treating
totally occluded FP ISR lesions. The ongoing EXCITE-ISR
(Randomized Study of Laser and Balloon Angioplasty Versus
Balloon Angioplasty to Treat Peripheral In-stent Restenosis)
trial is a superiority study evaluating debulking with the excimer laser on ISR compared to PTA.37
Debulking is emerging as an important tool in treating FP
ISR. The value of debulking is mostly delaying TLR in the
intermediate follow-up phase, which may reduce the need for
early reintervention compared to PTA alone. Almost half the
patients will return for reintervention at 1 year. Therefore debulking may need to be coupled with anti-restenotic measures
to have a significant clinical impact on altering the course of
FP ISR. Also it is unclear whether debulking in FP ISR would
add a significant improvement in patency to DCB alone. Excimer laser followed by a paclitaxel-coated angioplasty balloon
(PTX PTA) is currently being compared in Europe to PTX
PTA alone in the treatment of FP ISR lesions.
Treatment of Infrapopliteal Artery
The treatment of IP lesions is mostly reserved for critical
limb ischemia patients with the goal of limb salvage or in severe claudicants with only severe outflow obstructive disease.
Stenting of IP vessels is currently not recommended except as
a bailout strategy when other non-stent modalities have failed.
Although some operators have used drug-eluting stents to
treat tibial vessels, use for IP vessels is off-label in the United
States. Improving vessel compliance, avoiding flow limiting
dissection, and minimizing distal embolization are primary
intraprocedural goals when treating the IP vessels.
A clear dichotomy exists between patency, need for TLR,
and limb salvage in the treatment of IP lesions.38 Restenosis is
typically high in treating IP vessels but limb salvage rates are
in the upper 80% to low 90% at 1 year irrespective of what
modality has been used to treat these vessels. TLR is also less
likely to be needed after the wound has healed and despite loss
of patency. This is likely attributable to the fact that a limb
with an active wound requires significantly more blood flow
for healing than a limb with no ulceration.38
A large percentage of IP vessels have moderate to severe
calcification. PTA is likely to result in significant dissection
in IP vessels. Debulking prior to adjunctive low pressure PTA
may improve compliance and reduce dissection rates. This
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Shammas_0913.indd 5
hypothesis was validated in the Calcium 360 trial.39 In this
multicenter randomized study of adjunctive balloon angioplasty following orbital atherectomy (CSI) of moderate to
severely calcified IP vessels in patients with predominantly
critical limb ischemia, debulking yielded an improvement in
vessel compliance, less flow limiting dissection, and less bailout stenting when compared to PTA alone. Of interest in the
Calcium 360 trial, the presence of a high residual narrowing
post-PTA correlated with increased major adverse events on
follow up, a finding that needs to be reproduced in larger clinical trials. Furthermore, Zeller et al40 reported their experience
with directional atherectomy using the SilverHawk catheter
(Covidien) in the treatment of IP disease. Only 4% of lesions
required bailout stenting. In 98% of lesions treated, residual
narrowing was <30%. Primary and secondary patency rates
were 67% and 91% after 1 year and 60% and 80% after 24
months, respectively.
The main advantage of atherectomy over PTA in treatment
of IP vessels is the reduction of dissection and bailout stenting.
Although cryoplasty had favorable results in treating critical
limb ischemia,41 two small, randomized trials suggested that
cryoplasty using the PolarCath (Boston Scientific) does not
significantly reduce dissection rate and need for stenting in the
FP artery but randomized data in the IP vessels is lacking.42,43
Atherectomy with or without adjunctive balloon angioplasty
will likely remain an important first line therapy of IP vessels.
Distal embolization
The treatment of FP or IP lesions carries the risk of distal
embolization (DE),44-47 which requires treatment in 2%-3%
of unselected infrainguinal interventions.44 Predictors of DE
include thrombotic occlusion, long lesions, TASC D lesions,
heavy calcification, mechanical thrombectomy, and atherectomy.3,46-48 DE is associated with limb loss,48 longer procedure
times, higher contrast use, and increased radiation exposure.49
Also, compromised distal runoff post-procedure may be a predictor for early restenosis/re-occlusion after FP PTA.50
Embolic protection devices in treating the lower extremity vessels have recently been approved by the FDA: Spider
Filter (Covidien) and Proteus balloon (Angioslide).51-53 Embolic protection adds significant cost to the procedure and is
currently not reimbursed. The JETSTREAM System (Bayer
HealthCare) is a rotational atherectomy device with simultaneous aspiration, a unique feature among all existing atherectomy devices and with a theoretical advantage of minimizing
DE and possibly the need for routine embolic filter use. Both
the JET and JETSTREAM ISR registries are evaluating occurrence of DE with the use of the JETSTREAM catheter in
treating FP lesions.
Conclusion
A strategy of improving vessel compliance with debulking, minimizing flow limiting dissection, and bailout stenting
coupled with adjunctive low pressure balloon inflation using
a paclitaxel-coated balloon is likely to emerge as an effective
strategy in treating infrainguinal PAD. The use of embolic protection devices to protect the outflow vessels will be important
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SHAMMAS
particularly with excimer or SilverHawk atherectomy. Rotational atherectomy with simultaneous aspiration (JETSTREAM) or
orbital atherectomy may reduce clinically significant DE and the
need for routine embolic protection devices.
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http://clinicaltrials.gov/ct2/show/NCT01436435
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30. Banerjee S, et al. Multi-Center Registry For Peripheral Arterial Disease Interventions and
Outcomes. http://xlpad.org/study.html
31. Zeller T, Rastan A, Sixt S, et al. Long-term results after directional atherectomy of femoropopliteal lesions. J Am Coll Cardiol. 2006;48:1573-1578.
32. Laird JR Jr, Yeo KK, Rocha-Singh K, et al. Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal
artery in-stent restenosis: twelve-month results from the SALVAGE study. Catheter Cardiovasc Interv. 2012;80(5):852-859.
33. PATENT trial. Photo-Ablation Using the Turbo-Booster and Excimer Laser for In-Stent
Restenosis Treatment study. Presented at LINC 2012 at the Leipzig Interventional Course,
in Leipzig, Germany. Article online in Endovascular Today. http://www.bmctoday.net/evtoday/2012/01/article.asp?f=interim-results-presented-for-spectranetics-patent-study
34. Shammas NW, Shammas GA, Hafez A, et al. Safety and One-Year revascularization
outcome of excimer laser ablation therapy in treating in-stent restenosis of femoropopliteal arteries: A retrospective review from a single center. Cardiovasc Revasc Med.
2012;13:341-344.
35. Beschorner U, Krankenberg H, Scheinert D, et al. Rotational and aspiration atherectomy
for infrainguinal in-stent restenosis. Vasa. 2013;42:127-133.
36. Shammas NW. Safety and Effectiveness of JETSTREAM (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions: A Prospective Registry. http://clinicaltrials.gov/ct2/
show/NCT01722877
37. Dippel EJ. Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis (EXCITE ISR). http://www.clinicaltrials.gov/
ct2/show/NCT01330628
38. Jaffery Z, Grant AG, White CJ. Critical limb ischemia: does long-term patency matter?
Vasc Med. 2010;15:439-441.
39. Shammas NW, Lam R, Mustapha J, et al. Comparison of orbital atherectomy plus balloon
angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of
the CALCIUM 360 randomized pilot trial. J Endovasc Ther. 2012;19:480-488.
40. Zeller T, Sixt S, Schwarzwälder U, et al. Two-year results after directional atherectomy of
infrapopliteal arteries with the SilverHawk device. J Endovasc Ther. 2007;14:232-240.
41. Das TS, McNamara T, Gray B, et al. Primary cryoplasty therapy provides durable support
for limb salvage in critical limb ischemia patients with infrapopliteal lesions: 12-month
follow-up results from the BTK Chill Trial. J Endovasc Ther. 2009;16(2 Suppl 2):II19-30.
42. Spiliopoulos S, Katsanos K, Karnabatidis D, et al. Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results
from a prospective randomized single-center controlled trial. Cardiovasc Intervent Radiol.
2010;33:929-938.
43. Shammas NW, Coiner D, Shammas G et al. Percutaneous lower extremity arterial interventions using primary balloon angioplasty versus cryoplasty: a randomized pilot trial.
Cardiovasc Revasc Med. 2012;13:172-176.
44. Shammas NW, Shammas GA, Dippel EJ, et al. Predictors of distal embolization in peripheral percutaneous interventions: a report from a large peripheral vascular registry. J Invasive
Cardiol. 2009;21(12):628-631.
45. Siablis D, Karnabatidis D, Katsanos K, et al. Outflow protection filters during percutaneous recanalization of lower extremities’ arterial occlusions: a pilot study. Eur J Radiol.
2005;55:243-249.
46. Suri R, Wholey MH, Postoak D, et al. Distal embolic protection during femoropopliteal
atherectomy. Catheter Cardiovasc Interv. 2006;67:417-422.
47. Shammas NW, Dippel EJ, Coiner D, et al. Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry. J Endovasc Ther.
2008;15:270-276.
48. Lam RC, Shah S, Faries PL, et al. Incidence and clinical significance of distal embolization during percutaneous interventions involving the superficial femoral artery. J Vasc Surg.
2007;46:1155-1159.
49. Shammas NW, Shammas GA, Dippel EJ, Jerin M. Intraprocedural outcomes following
distal lower extremity embolization in patients undergoing peripheral percutaneous interventions. Vasc Dis Manage. 2009;6:58-61.
50. Salapura V, Blinc A, Kozak M, et al. Infrapopliteal run-off and the outcome of femoropopliteal percutaneous transluminal angioplasty. Vasa. 2010;39:159-168.
51. Covidien’s SpiderFX Embolic Protection Device Approved for Use in Lower Extremities.
Endovascular Today. http://bmctoday.net/evtoday/2011/11/article.asp?f=covidiens-spiderfx-embolic-protection-device-approved-for-use-in-lower-extremities.
52. Zankar A, Brilakis ES, Banerjee S. Embolic capture angioplasty of lower extremity lesion
following distal embolization. Cardiovasc Revasc Med. 2011;12:337-340.
53. Shammas NW. Commentary: balloon angioplasty with built-in embolic protection mechanism: the dual role of the proteus balloon. J Endovasc Ther. 2012;19:617-619.
The Journal of Invasive Cardiology®
8/20/13 8:26 AM
The JETSTREAM Atherectomy System:
Addressing The Clinical Challenges
Venkatesh G. Ramaiah, MD, FACS
Peripheral arterial disease (PAD) is a major cause of morbidity in the United States, currently affecting 8 to 12 million Americans.1 During the last 10 years, there has been a
paradigm shift away from open surgery toward endovascular
therapy. In the United States, the rate of endovascular lower
extremity interventions has quadrupled for critical limb ischemia and doubled for claudicants. This has been accompanied
by a reduction in the rate of major amputations and length
of hospital stay, despite an increase in the burden of patient
comorbidities.2
Endovascular therapy continues to have significant limitations. Balloon angioplasty of complex lesions and chronic
total occlusions (CTOs) is associated with dissection, perforation, and distal embolization. Stents must be able to withstand significant biomechanical forces including compression,
flexion, and stretching, which may lead to stent fractures, instent stenosis, and stent occlusion.3 Atherectomy may provide
a viable alternative to the more established treatment strategies as we strive to employ a “leave nothing behind strategy.”
Atherectomy offers the ability to debulk atherosclerotic plaque
with minimal change in vessel diameter4 and reduce the need
for subsequent stent placement.5
JETSTREAM Technology
The JETSTREAM Atherectomy System (Bayer HealthCare) is a novel technology indicated for both atherectomy
and thrombectomy. The JETSTREAM System’s unique rotational design allows it to debulk and evacuate the liberated
debris through continuous aspiration. The JETSTREAM
System consists of 2 primary components: the console that
mounts to a standard IV pole and a sterile, single-use catheter
and control pod unit.
Console
The electrically driven console consists of two peristaltic
pumps for aspiration of debris and infusion of saline (Figure
1). The console also serves as a power source for the drive
motors located in the catheter pod. The drive motor rotates
the cutting tips to a maximum of 70,000-73,000 RPMs during system operation. The disposable catheters are easily attached to the console power source and pumps prior to a
procedure. The console is maintained on an IV pole that
From the Arizona Heart Hospital and Arizona Heart Institute, Phoenix, AZ.
Disclosure: Dr. Ramaiah reports that he is a consultant for Bayer HealthCare.
Address for correspondence: Venkatesh G. Ramaiah, MD, FACS, Medical Director, Arizona Heart Hospital, Director, Vascular and Endovascular Research, Arizona
Heart Institute, 2632 North 20th Street, Phoenix, AZ 85006. Email: vramaiahmd@
gmail.com.
Vol. 25, Supplement B, 2013
Ramaiah_0913.indd 7
holds a bag of normal saline for
infusion and the collection bag
for aspirated debris.
Catheters
The disposable sterile, single-use JETSTREAM atherectomy catheter set is available
in 4 different sizes, providing
a treatment solution for both
above and below the knee disease. Each catheter set includes
a control pod, cutting catheter,
infusion and evacuation line,
and collection bag. The system is 7 Fr compatible and is
operated over a 300 cm 0.014"
guidewire.
The recently released JETSTREAM SC/XC family of
catheters demonstrates further
innovation, providing a new
user interface, improved er- Figure 1. JETSTREAM console.
gonomics, and wire management. A new lighter and more
ergonomically designed pod makes the device easier to use by
single operators (Figure 2). Redundant control buttons have
been removed and integrated into the removable “mouse” to
facilitate dual or single operator technique. All JETSTREAM
atherectomy catheters have a front cutting rotational tip. The
front cutting five-fluted design has been optimized to deliver
performance across a diverse mix of thrombus, plaque, and
even complex calcium. The rotational design of this front cutting system makes it a good choice for treating diffuse disease
and total occlusions.
The JETSTREAM XC catheters, intended to treat above
and to the knee peripheral artery disease (PAD), offer two
stage cutting with expandable blade technology. This allows
physicians to treat both common femoral artery (CFA) and
superficial femoral artery (SFA) disease with a single catheter.
The XC devices come in 2 sizes: 2.1/3.0 mm and 2.4/3.4
mm and are indicated for minimal reference vessels of 3.1 mm
and 3.4 mm, respectively (Figure 2). As the device is operated
in the blades down configuration, the distal cutter spins clockwise. This is typically used during the initial pass or passes of
the catheter to create a channel roughly equivalent to the small
tip size. If a larger flow channel is required, the tip direction
is reversed via a button on the control pod at which time the
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RAMAIAH
1.6 SC
1.85 SC
2.1/3.0 XC
2.4/3.4 XC
B.
A.
Figure 3. JETSTREAM atherectomy catheters. Current JETSTREAM catheters include the non-expandable, SC single cutter devices (1.6 mm and 1.85 mm tips) and the XC devices with expandable
cutters (2.1 mm blades down, 3.0 mm blades up and 2.4 mm blades
down, 3.4 mm blades up).
Figure 2. JETSTREAM XC 2.1/3.0 mm device POD. All device
controls integrated into removable mouse (A). Wire GARD: wire exits
proximal pod and is positioned tightly in GARD (B).
blades spin counterclockwise allowing the tip to expand to the
maximum cutter size. Maximum luminal gain is achieved in
the blades up position with the XC catheters.
The JETSTREAM SC catheters are primarily intended for
below the knee application and are available in 1.6 mm and
1.85 mm cutter sizes (Figure 3). The 145 cm long SC devices
have a single rotational cutting tip and are designed for vessels with a minimal diameter of 2.5 mm. With the exception
of expandable blade technology, the SC catheters contain all
features found in the XC line of catheters.
The versatility of this atherectomy system makes it a truly
unique treatment option. JETSTREAM is the only FDA
cleared atherectomy system with active aspiration. Continuous aspiration of ablated atheroma and thrombus is a feature
offered across the device platform. Proximal to the cutting
tip is an internal rotating cutter that breaks up particles entering the aspiration port (Figure 4). Liberated material and
thrombus are continually aspirated from the treatment site
to a collection bag, which is hung on the IV pole. Active
aspiration is a safety feature that acts to minimize distal embolization and effectiveness in thrombus.
The true front cutting rotational design of the system provides options for treating multiple lesion morphologies, including calcium and thrombus. The front cutting feature of
this device allows engagement of total occlusions when the
lesion can be crossed with a wire. Additionally, the front cutting rotational design shortens procedural time when treating
long segments of diffuse disease. Debulking is accomplished
by blades specifically designed to cut less resilient and less elastic plaque and thrombus while reducing the risk of affecting
the more resilient healthy tissue.
Results from the early multicenter PVD trial are promising.6 There were 210 lesions treated with a 99% success
rate. The average lesion length was 2.7 cm. Thirty-one
percent were total occlusions; 51% had moderate to high
calcium scores; and 15% had post-angioplasty restenosis.
8B
Ramaiah_0913.indd 8
Figure 4. JETSTREAM cutter and XC catheter. Five flute design
on the distal end of the cutter of all currently available JETSTREAM
devices is shown (A). The XC cutter demonstrates the aspiration port
on the shaft of the catheter and the expandable blades. The blades are
either up or down depending on the direction of torque of the drive shaft
within the shaft of the catheter (B).
The clinically driven target vessel revascularization rates were
15% at 6 months and 26% at 1 year. The restenosis rate was
38.2% at 1 year based on duplex ultrasound, as per core lab
analysis. A post hoc analysis of this study showed that there
were comparable results using the JETSTREAM atherectomy
catheter in both diabetic and non-diabetic patients with similar major adverse event rates and clinically driven target lesion
revascularization.7 The JETSTREAM System Endovascular
Therapy post-market registry (JET) is currently enrolling patients globally. It will evaluate 6-month and 1-year patency
with the JETSTREAM catheters in long, occluded, diffuse,
thrombotic, or calcified lesions in PAD of the common femoral, superficial femoral, or popliteal arteries.
Conclusion
Recent technological advances have made it possible to
increase the spectrum of treatable peripheral arterial lesions
with high acute procedure success rates. However, the choice
of the best endovascular strategy for the treatment of PAD
still remains challenging because of the specific features of
this vascular bed and the diffuse nature of the atherosclerotic
process. Durability and long-term patency remain the major challenges to therapy in endovascular treatment of PAD.
Despite significant advances and availability of new devices,
The Journal of Invasive Cardiology®
8/20/13 9:20 AM
The JETSTREAM Atherectomy System: Addressing The Clinical Challenges
the principal failure continues to be recurrent restenosis. The
role of atherectomy may be to overcome the limitation of balloon angioplasty and stent placement. A number of debulking
modalities and devices are now available with good procedural
results. Long-term outcomes need to be addressed by large,
randomized trials.
The JETSTREAM System is an innovative peripheral
revascularization platform designed to restore flow through
many types of plaque morphologies encountered in PAD. Offering a range of sizes to treat vessels above and below the knee,
this unique technology offers features that provide effective
atherectomy in difficult arterial obstructions while preserving
options for further treatment. The JETSTREAM System gives
physicians a powerful tool to help fight PAD.
Vol. 25, Supplement B, 2013
Ramaiah_0913.indd 9
References
1. Fowkes FG, Murray GD, Butcher I, et al. Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. JAMA.
2008;300(2):197-208.
2. Egorova NN, Guillerme S, Gelijns A, et al. An analysis of the outcomes of a decade of
experience with lower extremity revascularization including limb salvage, lengths of stay,
and safety. J Vasc Surg. 2010;51(4):878-885.
3. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after
femoropopliteal stenting. J Am Coll Cardiol. 2005;45(2):312-315.
4. Hassan AH, Ako J, Waseda K, et al. Mechanism of lumen gain with a novel rotational
aspiration atherectomy system for peripheral arterial disease: examination by intravascular
ultrasound. Cardiovasc Revasc Med. 2010;11(3):155-158.
5. Shammas NW, Coiner D, Shammas GA, Dippel EJ, Christensen L, Jerin M. Percutaneous
lower-extremity arterial interventions with primary balloon angioplasty versus SilverHawk
atherectomy and adjunctive balloon angioplasty: randomized trial. J Vasc Interv Radiol.
2011;22(9):1223-1228.
6. Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the
multicenter pathway PVD trial. J Endovasc Ther. 2009;16(6):653-662.
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Tips for Success with JETSTREAM Atherectomy System
Thomas Davis, MD
PAD is a complex and challenging disease state. As tools
continue to improve, we are able to treat increasingly complex
disease. As interventionalists, our objectives are to restore flow,
improve symptoms, and ultimately save limbs. My objective
is to accomplish all of the above with hopes to preserve my
future treatment options with my PAD patients. Therefore,
we reserve stent use as a bailout strategy to keep all future
treatment options open at my institution. We employ debulking PAD with atherectomy as a front line treatment strategy to
accomplish this endpoint.
The JETSTREAM Atherectomy System (Bayer HealthCare) has rapidly evolved into a versatile tool in our treatment armamentarium for PAD. In 2008, the FDA cleared
the first generation JETSTREAM device for atherectomy of
peripheral vasculature and in 2009, an indication for thrombectomy of upper and lower extremity peripheral arteries
was added. Since the initial product clearance, rapid evolution of the technology has resulted in seven new product
introductions, the most recent being the JETSTREAM SC/
XC family. The new catheters have a lighter control POD,
simplified user interface, and a removable control mouse,
which potentially reduces radiation exposure. Additionally,
the new wire management GARD simplifies wire management during the case.
Clinical Sweet Spots
In our laboratory we use all commercially available atherectomy devices as we believe each have their own unique
strengths and no single device is right for every case. The
strengths of JETSTREAM technology are in its ability to
manage mixed morphology lesions. The JETSTREAM System is our product of choice for total occlusions and diffuse disease from the common femoral artery through the
popliteal because it allows front cutting and active aspiration. Total occlusions are typically composed of mixed morphology of disease (thrombus, calcium, and plaque) and the
ability to both debulk and remove the liberated material is
very important. Particulate matter (mobile plaque elements)
within the target vessel have significant thromboembolic
risk. Aspiration of these mobile elements has implicit value,
and technique management should help mitigate the risks
associated with JETSTREAM usage. The only prerequisite
From the division of Cardiovascular Disease, Department of Internal Medicine, St.
John Hospital and Medical Center, Detroit, MI.
Disclosure: Dr. Davis reports that he owns stock in Avinger. He is also on the
advisory board for Bayer HealthCare and Bard.
Address for correspondence: Thomas Davis, MD, Director of the Cardiac Catheterization Lab and Director of Peripheral Interventions and Disease, St. John Hospital and Medical Center, 22101 Moross Road, Detroit, MI 48236. Email: tpdavis60@
aol.com.
10B
Davis_0913.indd 10
Figure 1. Wire in GARD with tight loop.
to using this device is being able to cross the lesion with a
0.014" wire. Typically I will cross with a crossing assist device to avoid sub-adventitial areas, which allows the device
to make direct contact with the plaque rather than through
a sub-adventitial space.
We also typically use JETSTREAM Atherectomy in long
segments of diffuse disease. The rotational front cutting
technology effectively prepares lesions for definitive therapy
and minimizes fluoroscopy and procedural times. As demonstrated in the Calcium Study, JETSTREAM atherectomy
remodels luminal irregularities and delivers a statistically significant improvement in luminal symmetry.1 The improved
luminal symmetry better facilitates balloon angioplasty as
balloon-to-vessel wall apposition is markedly improved
when the luminal space is symmetric.
Wires
JETSTREAM is an over-the-wire system and requires a
300 cm 0.014" guidewire for delivery. Because the mechanism of action is high speed rotation (70,000-73,000 RPM),
this device should only be used over approved wires. The
JETSTREAM JETWIRE (Bayer HealthCare) was specifically
manufactured for use with the JETSTREAM Atherectomy
System and performs quite well. In addition to the JETWIRE,
a list of compatible wires is included in the device instructions
for use. A supportive wire is needed to allow lesion engagement with the front cutting technology. Never attempt to insert or operate the device over a bent or kinked wire because it
causes poor tracking over the wire and can lead to loss of distal
The Journal of Invasive Cardiology®
8/20/13 9:24 AM
Tips for Success with JETSTREAM Atherectomy System
Figure 2. Pre-JETSTREAM imaging of a tandem subtotal lesion in
the popliteal artery with longitudinal IVUS pullback and VH volumetric analysis, which shows a bulky, concentric mixed morphology plaque
and evidence of IEM calcification.
wire placement when taking the device out after use. It is better to replace a compromised wire at the beginning of the procedure rather than struggling to re-cross after the initial passes.
Wire Management
Wire management during the case is an important and often overlooked operator responsibility. The device has a wire
GARD that prevents the wire from rotating during operation.
Once the lesion has been wired, the device is front loaded onto
the wire. The wire exits the POD on the back end and should
be inserted into the wire GARD forming a tight loop (Figure
1). As the device operates over the wire, the wire loop should
grow if the guidewire is effectively anchored distally. If the
loop fails to grow you can assume the wire is moving distally
with the device. Distal wire movement is the result of inadequate wire parking. You should always strive to position your
wire in the deepest possible distal position.
JETSTREAM Procedure
Procedural technique is the most important driver of success with the JETSTREAM atherectomy catheters. Maintaining discipline in the catheter advancement speed is imperative. The recommendation is 1 mm/second. Initially you
may want to use radiopaque tape to help gauge your speed.
We found that slow forward advancement followed by subtle
pullback improves both the cutting and aspiration efficiency.
Not to be confused with a pecking motion, the desired technique is analogous with one step forward—two steps back.
Adhering to this technique allows the device to aspirate the
liberated debris. This technique is equally important despite
the lesion morphology (ie, thrombus, soft plaque, fibrous tissue, or calcium). It is common to advance the catheter too
fast, but doing so may overwhelm the aspiration capability
or stall the catheter.
In addition to the high-level guidance of 1 mm/second,
the most important information you should use to guide catheter advancement is the auditory and tactile feedback from the
Vol. 25, Supplement B, 2013
Davis_0913.indd 11
Figure 3. Post-JETSTREAM imaging of treatment site shows significant volume plaque reduction (17%) and lumen enlargement (26%),
but an unchanged vessel volume (2%) signifying minimal “dottering”
effect from the device. The lumen is smooth and concentric without
evidence of dissection.
Table 1. Catheter Advancement Technique
1.
Engage lesion and advance catheter 1 mm/second.
2.
Advance catheter (1 mm) and pullback (2 mm) during
treatment to maximize aspiration.
3.
Listen to the device. The motor sounds will provide
feedback to guide advancement.
4.
Process the tactile feedback—slow down with resistance,
never exceeding 1 mm/second.
5.
Resist the temptation to go fast through soft plaque and
thrombus.
device. The auditory feedback comes from the device motor
and the objective is to maintain constant or near constant motor sounds. As the device engages lesion composed of calcium
and hard plaque, you will typically hear the motor slow as it
manages through the disease. This is less true with soft plaque
and thrombus so in these morphology types the 1 mm/second
advancement speed is imperative. Tactile feedback is transmitted through the catheter as it is advanced across the lesion.
In more stubborn disease (hard plaque/calcium), the disease
typically will not allow you to go too quickly. Table 1 provides
a list of catheter advancement tips.
Blades up or Blades down
The JETSTREAM XC catheters have expandable blades allowing treatment of multilevel disease with one device. The initial passes across a lesion should be down in the “blades-down”
or minimum tip configuration. Two blades down passes are
recommended. Verbal and auditory feedback from the system
will indicate when the lesion is prepped for blades up configuration. “Blades-up” should be performed from proximal to
distal across the lesion. Generally, two passes will adequately
debulk the lesion. Similar to the blades down configuration,
the auditory and tactile feedback will indicate when debulking
is complete.
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DAVIS
Aspiration
Embolization
The unique active aspiration feature on the JETSTREAM
family of products makes this product a great choice in total
occlusions and mixed morphology lesions. On rare occasion the
device may lose aspiration, which is most typically the result of
overwhelming the aspiration and quick advancement during active treatment. It is also important to note that aspiration works,
albeit not at as high a flow, during REX mode too.
The following tips will optimize aspiration performance:
Long segments of diffuse disease, total occlusions, and heavy
thrombotic lesions may pose a challenge to the aspiration capability of the device, which may be mitigated by operator
technique. Catheter advance technique is again paramount
to the discussion. To allow the aspiration to remove the infused saline and debris, the operator must use 1 mm/second
of forward movement with slight pullback following each step
forward. Remember the auditory feedback will be limited in
this setting as soft plaque and thrombus will have minimal
impact on the device’s motor speed. In this setting you must
be disciplined and allow the device time to work.
Embolization is a potential risk in all interventional procedures. The published literature and our personal experience
do not suggest the risk is any higher with this device than
other competitive technologies. As discussed in this manuscript optimal performance of this device is contingent upon
proper user technique. Though not guaranteed, risk of distal
embolization with this atherectomy device can be comparable
to other interventional procedures if you are disciplined with
regard to technique.
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Davis_0913.indd 12
Summary
Atherectomy is evolving as an acceptable treatment option
for peripheral arterial disease. While the newest entrant to
the field, the JETSTREAM System has quickly evolved into
a useful tool in the battle against this debilitating disease. The
set of features on this product uniquely differentiates it from
competitive devices and fills a clinical void. Though the device
necessitates a specific technique, it is well worth developing.
As technology and techniques continue to evolve so will the
results we are able to deliver.
The Journal of Invasive Cardiology®
8/20/13 9:24 AM
JETSTREAM® Rotational Atherectomy with Dynamic Aspiration
for Common Femoral Arterial Occlusive Disease
Thomas M. Shimshak, MD, FACC, FSCAI
Peripheral arterial disease (PAD) is a major cause of morbidity and mortality in the United States, affecting 8 to 12
million people. The incidence of PAD is generally higher in
older age groups and affects approximately 1 out of 5 people
aged 55 and older. In addition to adversely impacting an individual’s quality of life and survival, PAD is associated with
significant social and economic costs.1
Over the past decade, advances in percutaneous catheterbased therapies have resulted in improved early and late clinical results for symptomatic patients.2 Successful percutaneous
revascularization leads to improved quality of life measures,
functional capacity, avoidance of amputation, and improved
survival in patients with intermittent claudication and critical
limb ischemia. As a result of therapeutic advances, the number
of percutaneous interventional procedures has increased fourfold for patients with critical limb ischemia and doubled for
patients with intermittent claudication.2
Recently, several new atherectomy devices have been approved for use in the United States for the treatment of arterial occlusive disease, including the JETSTREAM rotational
atherectomy system with dynamic aspiration (Bayer HealthCare). The introduction of the JETSTREAM device has expanded the endovascular treatment options for patients with
symptomatic PAD. In addition, patients with complex disease
who were not ideal candidates for percutaneous revascularization can now be treated. Two cases using this new and unique
technology for the treatment of significant obstructive disease
of the common femoral artery are presented.
Case Reports
Case Report 1. A 61-year-old man with known history
of diffuse PAD and prior percutaneous revascularization was
re-evaluated in April 2011 for progressive and lifestyle-limiting intermittent claudication affecting both legs, though
his symptoms were worse in the right leg. He complained
of exertional bilateral calf pain after walking <2 blocks with
improvement of his symptoms within a few minutes of rest.
He had a history of hypertension and cigarette smoking. His
physical exam demonstrated a diminished right femoral pulse
From the Cardiovascular Institute of Wheaton Franciscan Healthcare – All Saints,
Racine, WI.
Disclosures: Dr. Shimshak has participated as a speaker, consultant, clinical investigator, and teacher for preceptorship programs sponsored by Bayer HealthCare and is
a member of their medical advisory board. He has no personal financial relationship
with Bayer HealthCare.
Address for correspondence: Thomas Shimshak, MD, Cardiovascular Institute of
Wheaton Franciscan Healthcare – All Saints, 3801 Spring Street, Racine, WI. Email:
[email protected]
Vol. 25, Supplement B, 2013
Shimshak_0913.indd 13
Figure 1. Right common femoral artery angiogram and JETSTREAM
atherectomy device. Right common femoral artery is demonstrating diffuse calcific disease (A). JETSTREAM device is shown with blades down
(2.1 mm cutter) advancing over a .014" JETSTREAM JETWIRE to
debulk the right common femoral artery (B).
Figure 2. Balloon angioplasty and final angiogram. 5.0 mm balloon
inflated in right common femoral artery post-atherectomy (A). Final selective angiogram of right common femoral artery post-atherectomy and
adjunctive balloon angioplasty (B).
compared to the left side. Pedal pulses were diminished bilaterally. Resting ankle-brachial indices (ABI) performed 6
months earlier demonstrated an ABI of the right and left leg
of 0.60 and 0.81, respectively. He underwent selective right
iliac and femoral arteriography using contralateral access in
April 2011. Arteriography demonstrated diffuse calcific disease of the right common femoral artery and mid superficial
femoral artery with a 70%-75% stenoses (Figure 1). Intravascular ultrasound using the Volcano Eagle Eye® with Chromoflo (Volcano) was also performed, demonstrating similar disease severity with eccentric fibro-calcific disease. A 7
Fr Pinnacle Destination contralateral sheath (TERUMO
Medical Corp) was introduced and advanced to the right
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SHIMSHAK
of the procedure, the right femoral and pedal pulses were significantly improved. He was dismissed later that day on daily
aspirin (81 mg) and clopidogrel (75 mg). He had significant
improvement in his symptoms. Follow-up ABI 2 weeks later
was 0.94. He has remained asymptomatic nearly 2 years after
his procedure.
Figure 3. Left common femoral artery angiogram and IVUS. Selective angiogram of left common femoral artery using digital subtraction
angiography demonstrates a focal eccentric high-grade stenosis (A). Intravascular ultrasound image with Volcano Eagle eye using ChromoFlo
of the left common femoral artery stenosis. Lumen cross-sectional area
= 3.5 mm2 (B).
Figure 4. Left femoral artery angiogram and IVUS post-atherectomy.
Left femoral angiogram post-JETSTREAM atherectomy and angioplasty (A). Intravascular image with Volcano Eagle Eye with ChromoFlo of
left common femoral artery post-atherectomy and angioplasty. Lumen
cross-sectional area = 12.5 mm2 (B).
external iliac artery over a .035" Hi-Torque Supra Core guide
wire (Abbott Vascular). A 5,000 unit bolus of intravenous
heparin was administered and activated clotting time (ACT)
remained >250 seconds throughout the procedure. A .014"
JETSTREAM JETWIRE was advanced to the popliteal artery
with fluoroscopic guidance. We then selected and prepared a
JETSTREAM atherectomy device (Bayer HealthCare), which
was subsequently used to treat both the common femoral
artery and mid superficial femoral artery. Multiple passes at
each site were performed, initially with the blades of the cutter
down (2.1 mm profile), followed by blades up (3.0 mm profile) (Figure 1). The atherectomy device maintained roughly
70,000 RPMs during activation and continuous aspirate of
blood and generated particulate material was obtained. Following atherectomy, adjunctive balloon angioplasty with a 5.0
and 6.0 mm balloon catheter was performed, at 4-6 atm for
2-3 minutes at each site (Figure 2). Final angiography demonstrated wide patency of the common femoral artery without
significant residual disease and/or intimal dissection. The left
femoral arterial sheath was removed when the ACT was <170
seconds, followed by manual compression. At the conclusion
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Case Report 2. A 74-year-old man with hypertension and
coronary disease presented in June 2011 with progressive and
limiting intermittent claudication of his left leg characterized
by exertional calf pain after walking <100 feet. His physical
examination revealed a very weak left femoral pulse. Resting ABIs were performed demonstrating an ABI of 0.69. He
underwent left selective iliofemoral arteriography and IVUS
with the Eagle Eye catheter with ChromoFlo over a .014"
guide wire. Angiography demonstrated an eccentric 75%80% focal stenosis of the left common femoral artery. IVUS
showed an eccentric dense fibrocalcific lesion with both superficial and deep calcium and a cross-sectional area (CSA) of
3.5 mm2 (Figure 3). A 7 Fr contralateral sheath was tracked
across the aortoiliac bifurcation over a .035" guide wire with
fluoroscopic guidance and advanced to the left external iliac
artery. A 5,000 unit bolus of intravenous heparin was given
and the ACT was maintained >250 seconds during the procedure. The lesion was crossed with a .014" JETSTREAM
JETWIRE and advanced into the superficial femoral artery.
We then performed rotational atherectomy with dynamic aspiration using the JETSTREAM device. Several slow passes
were made with the cutter blades down (2.1 mm) and up (3.0
mm). The device was slowly advanced with each pass in a back
and forth motion, maintaining roughly 70,000 RPMs. Atherectomy was followed by dilatation with a 5.0 mm balloon for
3 minutes at 6 atm. Repeat angiography demonstrated a mild
(<30%) eccentric residual stenosis. Post-atherectomy and angioplasty IVUS demonstrated significant improvement in the
lesion with a CSA of 12.5 mm2 and significant reduction in
the extent of calcium (Figure 4). He was dismissed on aspirin
(325 mg) and clopidogrel (75 mg). The patient’s post-procedure left leg ABI was .98 and he has remained asymptomatic
at late follow-up.
Discussion
These two cases demonstrate the effectiveness of the JETSTREAM atherectomy device for the treatment of complex
disease, including calcified common femoral arteries. Approved for clinical use in the United States in 2008, the JETSTREAM system has undergone multiple design iterations to
improve its safety and performance. It is currently approved as
both an atherectomy and thrombectomy device for the treatment of PAD. The JETSTREAM system consists of a sterile,
single-use catheter and control pod, and a reusable power console. The catheter is a .014" over-the-wire (non-hydrophilic)
system with a rotating 5-flute, front-end cutting tip. The
cutter on all catheters rotates at 70,000-73,000 RPMs. Currently, catheters are available with 1.6 or 1.85 mm single cutters (SC), and 2.1/3.0 mm or 2.4/3.4 mm expandable cutters
The Journal of Invasive Cardiology®
8/20/13 8:30 AM
Rotational Atherectomy for CFA Occlusive Disease
Figure 5. JETSTREAM cutter and XC catheter. Five-flute design on
the distal end of the cutter of all currently available JETSTREAM devices is shown (A). The XC cutter demonstrates the aspiration port on
the shaft of the catheter and the expandable blades. The blades are either
up or down depending on the direction of torque of the drive shaft within
the shaft of the catheter (B).
Figure 6. JETSTREAM atherectomy catheters. Current JETSTREAM catheters include the fixed, single cutter, small vessel devices
(1.6 mm and 1.85 mm cutter), and the expandable XC devices (2.1
mm blades down; 3.0 mm blades up or 2.4 mm blades down;3.4 mm
blades up).
(XC). All catheters are compatible with a 7 Fr sheath (Figures
5 and 6). The shaft length is either 120 cm or 135 cm for the
XC catheters or 145 cm for the SC small vessel catheters. The
device is effective in treating a variety of lesion morphologies
including soft, fibrotic, calcified, and/or thrombus. By virtue
of its property of differential cutting, the JETSTREAM device
preferentially cuts atheromatous disease, while sparing normal
tissue. It also incorporates dynamic and continuous aspiration
of particulate debris and thrombus, a feature that reduces distal emboli and improves device and procedural safety.
The two case presentations highlight the performance attributes of this unique atherectomy device in complex calcified common femoral artery disease. Historically, endovascular therapy for common femoral artery disease has been
controversial and technically challenging due to its location
and potentially excessive, rigid associated calcium. The introduction of this device and other atherectomy devices have
enhanced endovascular procedural safety and efficacy for
complex lesion and vessel subset.3,4,5 In the two cases presented, the JETSTREAM device combined with IVUS and
adjunctive balloon angioplasty allowed us to effectively treat
two heavily calcified common femoral arteries. In the second
case, IVUS demonstrated an increase in CSA from 3.5 mm2
Vol. 25, Supplement B, 2013
Shimshak_0913.indd 15
pre-intervention to 12.5 mm2 post-intervention. This final
CSA is much larger than the predicted result from the cutter
alone (7.07 mm2) and represents the combined effect of the
rotational cutter and plaque atherectomy, dynamic aspiration,
and final balloon dilatation. IVUS demonstrated significant
removal of calcium as well.
Similar results have recently been reported from the JETSTREAM Calcium Removal Study.6 In this prospective,
single-arm, multicenter study, the JETSTREAM device was
evaluated for its effectiveness in removing moderate and severe calcium in the peripheral arteries based on IVUS criteria.
Lesion location was either the common or superficial femoral
arteries in 81% of cases, of which 33% had moderate calcification and 67% had severe calcification by angiography. Based
on IVUS evaluation, total lesion length was 44±35 mm; maximum arc of calcium was 149±82°. Area stenosis decreased
from 61.8±19.7% to 38.5±19.6% (p<0.0002), minimum
lumen area increased from 6.6±3.7 mm2 to 10.0±3.6 mm2
(p=0.0001). Calcium reduction resulted in a 78±27% increase
in lumen area. Although the arc of superficial calcium did not
change significantly in this small series, the arc of reverberation did increase significantly (21±20° to 69±71°, p=0.0006),
indicating favorable device-related alteration in lesion calcium. These changes in lesion characteristics using the JETSTREAM device occurred without any adverse clinical events.
Although the JETSTREAM System has proven efficacy as
an atherectomy and thrombectomy device in infra-inguinal
PAD, its role as either stand alone or in combination with
other therapies (including angioplasty, stenting, and/or drugeluting balloons) remains to be determined. Future clinical
trials in this country and outside of the US will help clarify
how this technology will be integrated into the endovascular
therapeutic armamentarium.
References
1. Fowkes FG, Murray GD, Butcher I, et al. Ankle brachial index combined with
Framingham Risk Score to predict cardiovascular events and mortality: a metaanalysis. JAMA. 2008;300:197-208.
2. Egorova NN, Guillerme S, Gelijns A, et al. An analysis of the outcomes of a decade
of experience with lower extremity revascularization including limb salvage, lengths
of stay, and safety. J Vasc Surg. 2010;51:878-885.
3. Hassan AH, Ako J, Waseda K, et al. Mechanism of lumen gain with a novel atherectomy system for peripheral arterial disease: examination by intravascular ultrasound.
Cardiovasc Revasc Med. 2010;11:155-158.
4. Garcia L, Zeller T, McKinsey J, et al. Determination of Effectiveness of SilverHawk™/TurboHawk™ Peripheral Plaque Excision System for the Treatment of
Infrainguinal Vessels/Lower Extremities Study. Presented at 10th Annual Vascular
Interventional Advances (VIVA), October 9-12, 2012.
5. Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous
rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive
disease: the multicenter Pathway PVD Trial. J Endovasc Ther. 2009;16:653-662.
6. JETSTREAM Atherectomy System Can Remove Superficial Calcium in Severely
Calcified Peripheral Arteries. Maehara A, Mintz G, Shimshak T, et al. Presented as
abstract at 25th ISET. Miami Beach, FL. January 18-23, 2013.
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JETSTREAM® Atherectomy Systems
The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus
from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature. See product Information for Use for specific and complete prescribing information.
Indications, operating specifications and availability may vary by country. Check with local product representation and countryspecific Information For Use for your country.
Bayer, JETSTREAM, and JETWIRE are trademarks of the Bayer group of companies. Bayer © 2013
All other trademarks are property of their respective companies.
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Copyright © 2013
All Rights Reserved.
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