jet stream pathway device in peripheral arterial disease
TRANSCRIPT
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JETSTREAMTM
Atherectomy/Thrombectomy in
Infrainguinal Arterial Disease:
What Makes it Different From Other Devices?
Venkatesh G. Ramaiah, MD, FACS
Medical Director Arizona Heart Hospital
Director Peripheral Vascular & Endovascular Research
Arizona Heart Institute
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Bayer HealthCare is sponsoring this
presentation. Dr. Ramaiah is presenting
on behalf of and is a paid consultant of Bayer.
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PAD The Unmet Challenge
Extension / Contraction
Torsion
Compression
Flexion
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Freeze it
Subintimally dissect it
Stent it
Balloon it
Excise it Lase it
PAD
Spin it
Cover it
JET it
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Terrain Challenges in the Lower Extremities
• Long, diffuse lesions
• Often calcified
• Concomitant disease
• Occlusions common
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Stenting of the Femoro-
Popliteal Segment:
“The Dark Side and Implications”
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In the
ABSOLUTE trial,
stents superior
to PTA at 12
months
NEJM 2006;354:1879-88
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J Endovas Ther 2004;11(suppl II):II-107-II-127
Lower Extremity Endovascular Interventions Bates and AbuRahma
Long Term PAD Treatment Results
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Type I Stent Fracture
• Single fracture of
stent strut
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Type II Stent Fracture
• Multiple fracture
of stent struts
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Type III Stent Fracture
• Complete linear stent fracture without displacement
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Type IV Stent Fracture
• Class III with
displacement of
stent
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The challenges of physical force
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SFA STENTING IS A BAILOUT
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Preserve Your Options
“LEAVE NOTHING BEHIND”
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Atherectomy –
A front line therapy
• Preserves future options
• Leaves nothing behind
• Facilitates low pressure angioplasty
• Minimize barotrauma to arterial wall
• Does not prevent surgical bypass or
change surgical distal target
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PAD will Progress
Preserve options/less invasive
Decreasing options/irreversible
Healthy
Leg
PAD screening /
Rx management Death Angioplasty/
Atherectomy Stenting Bypass Amputation
Decisions today have implications tomorrow
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There is Great Debate About Optimal Interventional Therapy
Stenters vs. Debulkers
Atherectomy
Stenting
(Both evolving)
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Why JETSTREAM Atherectomy?
• Facilitates both atherectomy and
thrombectomy-- mixed morphology lesions
• Front Cutting--CTOs
• Expandable blade technology--single device
solution
• Circumferential cutting--concentric lumens
• Reduce risk of embolization--active aspiration
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JETSTREAM Atherectomy System
Console
1.6mm
1.85mm
2.1/3.0mm
Disposable
Catheter
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JETSTREAM Blades up and Down
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• Expandable blades: provide
treatment from CFA-Popliteal
• OTW front cutting
• 135cm
• 0.014"GW / 7F sheath
compatible
JETSTREAM Atherectomy Above the Knee
Blades down Blades up
2.1 mm / 3.0mm
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• 1.6 and 1.85mm
cutting tips
• OTW front cutting
• 135cm working length
• .014GW / 7F sheath
compatible
Jetstream Atherectomy Below the knee
1.85mm
1.6mm
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Initial Experience with The
JETSTREAM Atherectomy
Device for Femoropopliteal
Disease
Imran Javed, MBBS, FCPS; Venkatesh Ramaiah, MD, FACS; David Terry, MD;
Julio Rodriguez, MD, FACS; Matt Nammany, MD
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Patients & Methods
• Duration: Mar 2008 to Nov 2009 (21M).
• Total patients: 86 patients/113 lesions
• Sex: Males 55(64%) Females 31(36%).
• Age range: 36 to 87 Yrs.
• Inclusion Criterion: – All patients underwent JETSTREAM Atherectomy during this
time period regardless of their previous status.
• End point of study: – TLR, ABI’s, Duplex Patency and Safety were monitored
Presented at iCON 2009
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Clinical Findings
• Total No of Lesions: 113
• Site of Lesion:
– SFA: 74 (65.5%)
– Popliteal: 30 (26.6%)
– Other Vessels: 4 (3.5%)
– Instent Restenosis: 4 (3.5%)
– Femropopliteal Bypass: 1 (0.9%)
Presented at iCON 2009
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• Presentation: Claudication: 58 (67.4%)
Rest Pain: 13 (15.1%)
Tissue Loss: 15 (17.5%)
Diabetic patients: 42 (50%)
• Limb Involved: • Right: 32 (37%)
• Left:54 (63%)
Clinical Findings
Presented at iCON 2009
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Classification of Lesions on Basis
of TASC II Guidelines
24 23
18
13
8
0
5
10
15
20
25
30
TASC A TASC B TASC C TASC D Undefined
27.9% 26.7% 20.9% 15.1% 9.4%
Presented at iCON 2009
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Operative Findings
Type of Pathology:
Occlusion: 47 (54.7%)
Stenosis: 27 (31.4%)
Both: 12 (13.9%)
Distal Run Off:
Single Vessel: 43 (50%)
Double Vessel: 31 (36%)
Triple Vessel: 3 (3.5%)
Collaterals: 9 (10.5%)
Presented at iCON 2009
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JETSTREAM Atherectomy of Severe Calcific Popliteal Stenosis
Severe calcific 90%
stenosis of the popliteal
artery across the knee joint
Excellent post JETSTREAM atherectomy results,
without dissection, PTA or embolization
Presented at iCON 2009
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Results
• Freedom from TLR was 78% at one year
• Reintervention was more common in first 3
months after first intervention (learning curve)
• Thrombectomy capabilities were essential in 16%
of cases
• Adjunctive balloon angioplasty was 68% and
stents were used in 7%
• Primary patency was 72% (Duplex) in one year
Presented at iCON 2009
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Types of Re-interventions
Balloon Angioplasty ± Stent: 7 (6.1%)
Remote Endarterectomy/Fem-pop Bypass: 4 (3.5%)
Repeat Atherectomy +Angioplasty: 13(11.5%)
Below Knee Amputation: 1 (0.8%)
Presented at iCON 2009
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Conclusion
• The JETSTREAM device with thrombectomy and
aspiration capabilities has added advantages to femoro-
popliteal atherectomy.
• Low embolization (1.7%) and dissection (0.88) rates
• Adjunctive stenting remains very low in this difficult
segment
• Long term follow up will definitely be needed for
durability and patency
Presented at iCON 2009
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The Credo in SFA Total Occlusions
Debulk rather than displace obstructive
material creating an increase in luminal gain.
Leaving options open for future treatment
4030-014 01/13 Slide # 36
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Pathway PVD Study
Patient Characteristics (n=172)
Mean age (years) 71.9
Male 49%
Diabetes mellitus 47%
Smoking within last 90 days 31%
Hypercholesterolemia 69%
Family Hx Coronary artery disease 23%
Hypertension 94%
Prior lower limb revascularization 51%
Rutherford Classification:
1 5%
2 17%
3 64%
4 5%
5 10%
J ENDOVASC THER 2009;16:653–662
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Pathway PVD Study
Lesion Characteristics (n=210)
Average reference vessel 3.7mm (2.1mm-6.1mm)
Average lesion length 3.5cm (0.7cm-14.7cm)
Moderate to high calcium 51%
Total occlusion 31%
Target Lesion Location:
SFA 64%
Popliteal 28%
Tibial/Peroneal 9%
J ENDOVASC THER 2009;16:653–662
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Pathway PVD Study
Procedural Outcomes (n=210)
Device success rate^ 99%
Mean PVS activation time 3.5 min (range 0.5-12.9)
Average diameter stenosis*
Pre-treatment 79%
Post Pathway 35%
Post adjunctive 21%
Adjunctive treatment
None 34%
Balloon angioplasty 59%
Stent 7% ^ Defined as crossing and debulking lesion (208/210 lesions) * Per lesion based on angiographic results measured by core lab
J ENDOVASC THER 2009;16:653–662
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Outcomes
Pathway PVD Study ABI improvement
N Mean
Baseline 159 0.59
Discharge 150 0.88
30 Day 149 0.90
6 Month 138 0.77
12 Month 109 0.82
N Mean
Baseline 169 3.0
30 days 142 1.2
6 months 135 1.5
12 months 110 1.5
Pathway PVD Study - Rutherford Classification
4030-014 01/13 Slide # 41
J ENDOVASC THER 2009;16:653–662
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6 and 12 Month Freedom From TLR
85%
74%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
6 months
12 months
Mean time follow-up (months)10.5
J ENDOVASC THER 2009;16:653–662
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Diabetic vs. Non Diabetic Results
12 Month
0%
5%
10%
15%
20%
25%
30%
Diabetics 1.30% 1.30% 20.00% 3.80% 2.50%
Non- Diabetics 1.10% 1.10% 28.30% 5.40% 0.00%
Death MI TLR TVR Amputation
Ann Vasc Surg 2011; 25: 520-529
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12 Month Freedom from TLR-
Diabetic vs Non-Diabetic
80.00%
71.70%
66%
68%
70%
72%
74%
76%
78%
80%
82%
12 month
Non-DM DM
4030-014 01/13 Slide # 44
Ann Vasc Surg 2011; 25: 520-529
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PVD Study Conclusion
• The device appeared to be safe based on a low incidence
of MAE.
• 99% device success rate
• High procedural success and significant improvement in
Rutherford and ABI at 30 days, 6 months and 1 year.
• 93% of cases performed as a stand-alone or adjunctive
balloon-angioplasty procedure.
• The device was effective with an 85 and 74 percent
freedom from TLR at 6 and 12 months respectively.
• Results similar for diabetic and non-diabetics
J ENDOVASC THER 2009;16:653–662
Ann Vasc Surg 2011; 25: 520-529
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Atherectomy – When to use
Conclusions
• Different for all lesion morphologies – preserving
future options
• Debulking reduces the need of stents
• Initial diabetics data shows benefit from debulking
• Debulking prior to local drug delivery might become
the future of endovascular treatment
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JETSTREAM Atherectomy – Where to use
• Calcified lesions
• Total occlusions with mixed composition
of occlusive material (e.g. thrombus)
• Diabetic patients
• Preparation of the artery for definitive
therapy
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SO !!! WHY JETSTREAM??
• One device to treat different plaque morphologies (calcium/plaque/thrombus)
• Treat multivessel disease with single catheter (aspiration and cutting)
• Quickly restoring flow
• Debulking – preserve future options
4030-014 01/13 Slide # 48
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SFA CTO
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No-Stent Zone
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Another No-Stent Zone
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Recorded Live Case
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JETSTREAM Case of the Day Dr. Venkatesh Ramaiah, Arizona Heart Institute 11/18/2008
• 5mm Occluded Popliteal.
• 3 Passes Blades-up, 2 Passes Blades-down.
• 5x40 mm POBA Post-Dilation.
• JETSTREAM Runtime 5:41
Post 5x20mm POBA
Post 5x20mm POBA
Popliteal
Occlusion
Post
Jetstream
Post 5x40mm
POBA
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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 country-specific Information for Use for your
country
Bayer, the Bayer Cross, JETSTREAM, Navitus and JETSTREAM G3 are
trademarks of the Bayer group of companies.
4030-014 01/13 Slide # 54
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4030-014 01/13 Slide # 55
Questions?
4030-014 01/13 Slide # 55