Jet Stream Pathway Device in Peripheral Arterial Disease.

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Jet Stream Pathway Device in Peripheral Arterial Disease.

  1. 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. 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
  3. 3. Extension / Contraction Flexion Torsion Compression PAD The Unmet Challenge 4030-014 01/13 Slide # 2
  4. 4. Balloon it Subintimally dissect it Stent it Cover it PAD Spin it Excise it Freeze it 4030-014 01/13 Slide # 3 JET it Lase it
  5. 5. Terrain Challenges in the Lower Extremities • Long, diffuse lesions • Often calcified • Concomitant disease • Occlusions common 4030-014 01/13 Slide # 4
  6. 6. Stenting of the FemoroPopliteal Segment: “The Dark Side and Implications” 4030-014 01/13 Slide # 6
  7. 7. In the ABSOLUTE trial, stents superior to PTA at 12 months NEJM 2006;354:1879-88 4030-014 01/13 Slide # 7
  8. 8. Long Term PAD Treatment Results J Endovas Ther 2004;11(suppl II):II-107-II-127 Lower Extremity Endovascular Interventions Bates and AbuRahma 4030-014 01/13 Slide # 8
  9. 9. 4030-014 01/13 Slide # 9
  10. 10. Type I Stent Fracture • Single fracture of stent strut 4030-014 01/13 Slide # 10
  11. 11. Type II Stent Fracture • Multiple fracture of stent struts 4030-014 01/13 Slide # 11
  12. 12. Type III Stent Fracture • Complete linear stent fracture without displacement 4030-014 01/13 Slide # 12
  13. 13. Type IV Stent Fracture • Class III with displacement of stent 4030-014 01/13 Slide # 13
  14. 14. The challenges of physical force 4030-014 01/13 Slide # 14
  15. 15. 4030-014 01/13 Slide # 15
  16. 16. SFA STENTING IS A BAILOUT 4030-014 01/13 Slide # 16
  17. 17. Preserve Your Options “LEAVE NOTHING BEHIND” 4030-014 01/13 Slide # 17
  18. 18. 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 4030-014 01/13 Slide # 18
  19. 19. PAD will Progress Decreasing options/irreversible Healthy Leg PAD screening / Rx management Angioplasty/ Atherectomy Stenting Bypass Amputation Preserve options/less invasive Decisions today have implications tomorrow 4030-014 01/13 Slide # 19 Death
  20. 20. There is Great Debate About Optimal Interventional Therapy Stenters vs. Debulkers Stenting Atherectomy (Both evolving) 4030-014 01/13 Slide # 20
  21. 21. 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 4030-014 01/13 Slide # 21
  22. 22. JETSTREAM Atherectomy System 2.1/3.0mm 1.85mm 1.6mm Disposable Catheter 4030-014 01/13 Slide # 22 Console
  23. 23. JETSTREAM Blades up and Down 4030-014 01/13 Slide # 23
  24. 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. 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. 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. 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. 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
  29. 29. Clinical Findings • 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%) Presented at iCON 2009 4030-014 01/13 Slide # 29
  30. 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. 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. 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. 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
  34. 34. 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 4030-014 01/13 Slide # 34
  35. 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. 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
  37. 37. 4030-014 01/13 Slide # 37
  38. 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. 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. 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. 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. 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. 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
  44. 44. 12 Month Freedom from TLRDiabetic vs Non-Diabetic 82% 80% 78% 80.00% 76% 74% 72% 71.70% 70% 68% 66% 12 month Non-DM Ann Vasc Surg 2011; 25: 520-529 4030-014 01/13 Slide # 44 DM
  45. 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. 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. 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. 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
  49. 49. SFA CTO 4030-014 01/13 Slide # 49
  50. 50. No-Stent Zone 4030-014 01/13 Slide # 50
  51. 51. Another No-Stent Zone 4030-014 01/13 Slide # 51
  52. 52. Recorded Live Case 4030-014 01/13 Slide # 52
  53. 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. 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
  55. 55. Questions? 4030-014 01/13 Slide # 55

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