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Jet Stream Pathway Device in Peripheral Arterial Disease.
1. 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
4030-014 01/13 Slide # 0
2. Bayer HealthCare is sponsoring this
presentation. Dr. Ramaiah is presenting
on behalf of and is a paid consultant of Bayer.
4030-014 01/13 Slide # 1
24. JETSTREAM Atherectomy Above the Knee
• Expandable blades: provide
treatment from CFA-Popliteal
• OTW front cutting
• 135cm
• 0.014"GW / 7F sheath
compatible
Blades down
4030-014 01/13 Slide # 24
Blades up
2.1 mm / 3.0mm
25. Jetstream Atherectomy Below the knee
1.6mm
• 1.6 and 1.85mm
cutting tips
• OTW front cutting
• 135cm working length
• .014GW / 7F sheath
compatible
4030-014 01/13 Slide # 25
1.85mm
26. 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
4030-014 01/13 Slide # 26
27. 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
4030-014 01/13 Slide # 27
28. 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
4030-014 01/13 Slide # 28
30. Classification of Lesions on Basis
of TASC II Guidelines
30
25
24
23
18
20
13
15
8
10
27.9%
26.7%
TASC A
5
TASC B
20.9%
15.1%
9.4%
TASC C
TASC D
Undefined
0
Presented at iCON 2009
4030-014 01/13 Slide # 30
31. Operative Findings
Type of Pathology:
Occlusion: 47 (54.7%)
Stenosis: 27 (31.4%)
Both:
12 (13.9%)
Distal Run Off:
Single Vessel:
Double Vessel:
Triple Vessel:
Collaterals:
Presented at iCON 2009
4030-014 01/13 Slide # 31
43 (50%)
31 (36%)
3 (3.5%)
9 (10.5%)
32. JETSTREAM Atherectomy of Severe
Calcific Popliteal Stenosis
Severe calcific 90%
stenosis of the popliteal
artery across the knee joint
Presented at iCON 2009
4030-014 01/13 Slide # 32
Excellent post JETSTREAM atherectomy results,
without dissection, PTA or embolization
33. 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
4030-014 01/13 Slide # 33
35. Conclusion
• The JETSTREAM device with thrombectomy and
aspiration capabilities has added advantages to femoropopliteal 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
4030-014 01/13 Slide # 35
36. 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
38. Pathway PVD Study
Patient Characteristics (n=172)
Mean age (years)
Male
Diabetes mellitus
Smoking within last 90 days
Hypercholesterolemia
Family Hx Coronary artery disease
Hypertension
Prior lower limb revascularization
Rutherford Classification:
1
2
3
4
5
J ENDOVASC THER 2009;16:653–662
4030-014 01/13 Slide # 38
71.9
49%
47%
31%
69%
23%
94%
51%
5%
17%
64%
5%
10%
39. Pathway PVD Study
Lesion Characteristics (n=210)
Average reference vessel
Average lesion length
Moderate to high calcium
Total occlusion
Target Lesion Location:
SFA
64%
Popliteal
28%
Tibial/Peroneal 9%
J ENDOVASC THER 2009;16:653–662
4030-014 01/13 Slide # 39
3.7mm (2.1mm-6.1mm)
3.5cm (0.7cm-14.7cm)
51%
31%
40. Pathway PVD Study
Procedural Outcomes (n=210)
Device success rate^
Mean PVS activation time
99%
3.5 min (range 0.5-12.9)
Average diameter stenosis*
Pre-treatment
Post Pathway
Post adjunctive
79%
35%
21%
Adjunctive treatment
None
Balloon angioplasty
Stent
34%
59%
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
4030-014 01/13 Slide # 40
41. Outcomes
Pathway PVD Study ABI improvement
N
Mean
Baseline
159
0.59
Discharge
150
0.88
30 Day
149
Pathway PVD Study - Rutherford Classification
0.90
6 Month
138
0.77
12 Month
109
0.82
J ENDOVASC THER 2009;16:653–662
4030-014 01/13 Slide # 41
N
Mean
Baseline
169
3.0
30 days
142
1.2
6 months
135
1.5
12 months
110
1.5
42. 6 and 12 Month Freedom From TLR
100%
6 months
12 months
90%
80%
85%
70%
74%
60%
50%
40%
30%
20%
10%
0%
Mean time follow-up (months)10.5
J ENDOVASC THER 2009;16:653–662
4030-014 01/13 Slide # 42
43. Diabetic vs. Non Diabetic Results
12 Month
30%
25%
20%
15%
10%
5%
0%
Death
MI
TLR
TVR
Amputation
Diabetics
1.30%
1.30%
20.00%
3.80%
2.50%
Non- Diabetics
1.10%
1.10%
28.30%
5.40%
0.00%
Ann Vasc Surg 2011; 25: 520-529
4030-014 01/13 Slide # 43
45. 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
4030-014 01/13 Slide # 45
46. 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
4030-014 01/13 Slide # 46
47. 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
4030-014 01/13 Slide # 47
48. 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
53. 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
Popliteal
Occlusion
Post
Jetstream
Post 5x40mm
POBA
Post 5x20mm POBA
4030-014 01/13 Slide # 53
54. 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
