"Power Pulse Spray" Technique in DVT: Part 2

Angiojet in the “PP-Spray” mode

Tight Proximal Iliac Lesion

Kissing BES’s From the left brachial And right femoral approach

Aortic PTA/BES

Aorto-Bi-Iliac PTA/Stenting

Massive IVC thrombus post IVC filter • 63 year old male presents with SOB and chest pain (from Texas!) • History of PE, 2 DVT’s, and IVC filter placement (1999) • V/Q scan “high probability” for Pulmonary Embolus

Greenfield IVC Filter in Place

Large IVC Thrombus Above Filter Greenfield Filter

Optease IVC Filter Placed Above Thrombus Via Jugular Approach Greenfield Filter

Angiojet “P-PS” Technique

Angiojet P-PS (UK)

IVC Filter Post “P-PS” (30 min) No residual thrombus

Gooseneck Snare Removal of IVC Filter

Removal of IVC Filter

After Before 30 Min P-PS

AngioJet AngioJet

Acute Iliofemoral DVT • A 56 y/o male presented with a 3-day hx of acute onset of right leg swelling and pain following a 8-hour transatlantic flight • PMHx – HTN, hyperlipidemia, carpal tunnel syndrome • Med: aspirin, simvastatin • CT abdomen – right ileofemoral DVT

OPTEASE™ Filter – One kit – 6F – Self Centering – Dual basket filtration – Placement from IJ, femoral, brachial approach – retrieval from femoral vein

Placed patient in prone position and examination of right popliteal vein

Introducer sheath placement in popliteal vein under ultrasound guidance

Initial Venogram

First Venogram post – PPS (30 minutes)

Left Iliac Vein Stenosis Wallstent placement and post-stenting balloon angioplasty

Completion venogram

Pre - thrombectomy

Post – thrombectomy 4 days later • Procedural time – 2 hours • No ICU stay

Angiojet Chronic clot, underlying venous stenosis

Lytic + AngioJet, followed by balloon angioplasty venous stenosis.

Before – left arm After – left arm

Before After

NOVEMBER 1-4, 2006 Micheal Debakey, MD

2 nd November 1-4, 2006

ALI Will!!

The “Power-Pulse Spray” Technique Conclusion: • Amputations are not benign!! • The “P-PS” works for DVT too! • “P-PS” allows rapid revascularization Total procedure time: Overall mean=74 min! “Treat the ischemic limb like the ischemic LAD” Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

The “Power-Pulse Spray” Technique Conclusion: ALI is just that! ACUTE!! therefore we…. “Must take the bull by the horns” or Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

The “Power-Pulse Spray” Technique Conclusion: • ALI is not benign! Death! True Limb Salvage! • The “P-PS” works for DVT too! • “P-PS” allows rapid revascularization… Total procedure time: Overall mean = 74 min! “Treat the ischemic limb like the ischemic LAD” Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

Post Plaque Excision

Pre Post

H-4 • I.D.- 72-year-old male with severe right leg limb threatening ischemia. • PMHX- s/p CABG and failed femoral to popliteal bypass grafts, 2 yrs. s/p right SFA PTA/stent and 1 yr. s/p reintervention of the same SFA. • P/E- diminished bilateral femoral pulses with ischemic changes to the right foot • Labs- creatinine 1.8 mg/dL with hyperglycemia

H-6 • I.D.- 64-year-old male with severe limb threatening ischemia of the left leg. • PMHX- CABG, bilateral femoral to popliteal bypass grafts, CEA, CVA, HBP and no GSV • P/E- bilateral 2+ femoral pulses with absent distal pulses, left foot ischemic changes • Misc- Bilateral ABI = 0.40 with DU bilateral mild iliac with disease and bilateral 100% SFA occlusions with diminished IPA flow.

After Before

Before After

Proximal Infusion Port

Distal Infusion Port

After 12-Hr Lytic Infusion

After 18 hrs. lysis

100% SFA Occlusion Post PTA/Stent x2

Silverhawk Atherectomy Device

Silverhawk Atherectomy Device Open “Cutter”

Post 4 Quadrant Atherectomy

International Rinspiration in AMI Registry Marco De Carlo, MD, PhD on behalf of the registry investigators

Rinspiration (Rinsing while aspirating) Impact of Rinspiration Motivates thrombus Aspirates from a distance Assists in lysis FDA cleared for coronary and peripheral vessels

Investigators,Institutions Investigators Monitors and Labs Marco De Carlo MD, PhD University of Pisa, Pisa, Italy Eberhard Grube MD Heart Center Siegburg, Siegburg, Germany John G. Webb MD St. Paul’s, Vancouver, BC Anna S. Petronio MD, PhD University of Pisa, Pisa, Italy Jaap N. Hamburger MD, PhD University of British Columbia, Vancouver, BC Luc Bilodeau, MD, PhD Montreal Heart, Montreal, QC Vlad Dzavik, MD Toronto General, Toronto, ON ST Resolution Core Lab Mitchell W. Krucoff, MD, PhD Duke Clinical Research Institute - Durham, NC Angiographic Core Lab John Mancini, MD CardiABC - Vancouver, BC Data Monitors Canada Valerie Willetts & Associates. Inc Vancouver, BC Germany MPS GmbH – Braunfels, Germany Italy MPS GmbH – Braunfels, Germany

Rinspiration Registry Design One protocol – 3 Countries, 6 Centers and 17 physicians International Rinspiration Registry in AMI n=111 pts to date Roll-ins n= 9 Canada Germany Italy n=38 n=22 n=51 Montreal Heart Siegburg University of St. Paul’s Heart Center Pisa Toronto General Enrollees Vancouver General n = 102 Inclusion Criteria Primary Endpoint ↑ ST 2mm, 2 cont. leads or LBBB Pain < 12 hours ST Resolution @ 60 min. n = 93

Rinspiration Registry Overview Baseline Characteristics Intra Procedural # of Patients 102 Device Delivery (%) 97% Age 61 ± 11 yrs Device Success (%) 97% LAD (%) 47% Procedure Success (%) 98% Peak ST 4.3 ± 2.6 mm Rinspiration Alone ↑ Flow Onset to Cath Lab 4.8 ± 3.5 hr (%) 70% Init. TIMI 0/I Flow Procedure Time 51 min (%) 60% Filter wire (%) 39% Diabetes (%) 13% Stenting (%) 98% Prior MI (%) 6% Other DP/Thrombectomy 0%

Validity of Surrogate Marker Complete Resolution (>70% STR) CADILLAC All <=70% >70% (n=700) p-value Patients STR STR Death and Re-MI 30-Days 3.6% 6.2% 2.0% 0.001 1-Year 6.5% 9.4% 4.8% 0.02 EMERALD <30% 30%-70% >70% p-value Death (%) STR STR STR 7 Months 8.7% 7.0% 0.0% 0.0001

Primary Endpoint: 24-Hour Holter Monitor Rinspiration Registry in AMI Rates of Complete (>70%) ST Resolution 100% Prim ary End Point % Pts. with Complete STR 90% 81% 83% 80% 78% 79% 80% 73% 70% 60% 50% 40% 30 60 90 120 180 240 (n=94) (n=93) (n=94) (n=94) (n=92) (n=92) Time After Last Contrast (min)

Primary Endpoint: % STR at 60 minutes Rinspiration Registry in AMI 100% Rates of Complete (>70%) STR @ 60 min. % Pts. with Complete STR 90% 94% 80% 83% 80% 70% 67% 60% 64% 50% 40% All LAD Non-LAD < 6 Hours >= 6 Hours (n=93) (n=45) (n=48) (n=71) (n=21) Time from Sym. Onset By Vessel

Primary Endpoint: % STR at 60 minutes Rinspiration Registry in AMI 100% Rates of Complete (>70%) STR @ 60 min. % Pts. with Complete STR 90% 94% 80% 80% 82% 70% 77% 60% 64% 50% 40% All LAD Non-LAD Rinsp. Rinsp. + (n=93) (n=45) (n=48) Alone FW (n=39) (n=54) By Vessel FilterWire

Death and Reinfarction at 30- Days 10% Rinspiration Registry in AMI 30–Day Death and Reinfarction % Patients [No device related events] 5% 3% 2% 1% 0% Death Reinfarction Composite

Unmatched ST Segment Resolution % Patients with ST Resolution 90%- Rinspiration 80.9 80%- Rinspiration Rinspiration EMERALD 73.4 79.6 69.7 70%- AngioJet- Diver CE- EMERALD EMERALD AiMI REMEDIA 62.6 66.8 60.0 60%- 58.0 50%- 30 60 90 TIME (minutes after PCI) Citations REMEDIA: JACC 2005;46:371-376 EMERALD: JAMA. 2005;293:1063-1072 Rinspiration Registry (n=88) AngioJet-AiMI: TCT 2004

PROCEDURAL TIME min 80 AMI Trial Procedural Time (minutes) 70 76 60 Rinspiration is Fast 60 50 54 53 51 49 40 45 39 30 20 Angiojet (n=240) X-Sizer (n=100) Export (n=252) All Controls Rinspiration Control (n=240) Control (n=101) Control (n=249) (n=590) (n=102)

Historical Comparison Rinspiration and Composite EMERALD (Tx + Control) 100% Rates of Complete (>70%) ST Resolution % Pts. with Complete STR Prim ary End Point 90% 81% 83% 80% 78% 79% 80% 73% 70% 74.1% 73.2% 72.3% 69.7% 60% 66.8% 62.6% 50% 40% 30 60 90 120 180 240 (p=.015) Time After Last Contrast (min)

Historical Comparison - Kerberos and Combined EMERALD (Tx + Control) EMERAL Population Rinspiration Odds Ratio p-value D 0.61 All pts. 62.6% 73% 0.046 [0.37-0.99] 0.34 LAD 34.1% 60% 0.0013 [0.18-0.67] 0.59 Non-LAD 80.5% 86% 0.25 [0.24-1.46] 0.45 < 6 Hours 62.6% 79% 0.008 [0.25-0.82]

The “Power-Pulse Spray” Technique Conclusion: ALI is just that! ACUTE!! therefore we…. “Must take the bull by the horns” or Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

ALI Will!!

Subacute Limb Ischemia • Needs revascularization within 2-3 weeks • Usually occurs in the iliofemeral vessels • Usually have a history of PVD---- with previous procedures!!

Total Occlusion of the Abdominal Aorta

Brachial Artery Access

Balloon Inflation in Abdominal Aorta

Kissing Balloon Inflations

Post PTA Result

Bilateral Balloon Expandable Stents (Iliac Artery)

Balloon Expandable Stent (Distal Aorta)

2 Year Follow-up Angiogram

PTA/Stent of the Abdominal Aorta

Bilateral External Iliac Occlusion

Long Sheath Via Lt Brachial Artery

Guidewire Across Total Occlusion

Balloon Inflation

Post PTA/Self Expanding Stent

Limb Salvage Via Brachial Approach Before After

TASC D

2.5 Laser Probe

After laser-stent

Occluded SFA

4F Glidecath

2.3 mm Laser .018 V-18 Wire

Following Laser & PTA

Before After Laser & PTA

Anterior Peroneal Tibial 80-90% >90% Stenosis Stenosis

0.9 mm Laser .014 Coronary Wire

2.5 Coronary 3.0 Coronary Balloon Balloon

Following Laser & PTA

Before After Laser Laser PTA PTA

Subacute Occlusion Of the distal anastamosis

Post Laser

Polar cath PTA “cryotherapy”

Polar cath inflation

BEFORE Post Laser-Polar Cath PTA

Open Cutter Fox Hollow Silverhawk Atherectomy Device Nosecone

Plaque excision CFA-Proximal Anastamois

Total Tissue Collected: 252 mg

PTA only of The distal anastamosis

6 Fr. Sheath is totally occlusive

2.3 mm Eximer Laser thromboablation

Post Laser- PTA-stent

Subacute Limb Ischemia • Needs revascularization within days-weeks (1-2) • High AMPUTATION rate otherwise!! • Excellent Variety Endovascular “tools”! • Excellent Limb Salvage rates!!

Miam 2 0 i, 0 5

Miami Intercontinental Hotel

Critical Limb Ischemia (CLI): • Rutherford Classification 4, 5, 6 • ~ 100% require amputation in 12 months “without revascularization” • ~ 220-240,000 amputations/yr USA/Europe • ~ 4-30% 30-day perioperative mortality! • ~ 8-37% 30-day perioperative morbidity! “>8,000 amputations/month!”

Critical Limb Ischemia (CLI): • < 50% of all amputees achieve mobility • < 50% of amputees are alive at 3-4 years • 1/4 all diabetics will face CLI • ~ $10-20 billion yearly costs (USA only) • “Shockingly” primary amputations (PA) are “still the most common CLI treatment”

Critical Limb Ischemia (CLI): • In 2000-2001, 67% of USA CLI pts had primary amputation as initial treatment ** • “More shockingly” 50% PA are performed without angiography or a simple ABI!! • Despite > 85-90% 12-mo limb salvage rates reported with revascularization ** Strategic Health Resources

Glidewire Across Total

Proximal Infusion Port

Distal Infusion Port

After Lytic Infusion

After Stent Placement

The Possis® GuardDOG® Occlusion System is the industry’s first 0.035” guidewire with a CO2 filled occlusion balloon for peripheral interventions

Critical Limb Ischemia (CLI): Presentation Goals: Awareness of CLI !! Referral … (Podiatry-WC-FP-IM-Endo-Renal-etc) Diagnosis - CTA … Revascularization Tools … Multidiciplinary Treatments – Cases … “MULTIDISCIPLINARY CLI TOOL-BOX”

Critical Limb Ischemia (CLI): Allie DE, Walker CM, et al Critical Limb Ischemia: A Global Epidemic Eur Interv 2005 (1):75-84 US 2.5 million N = 417 Diagnosis CLI Treatment Pathway - Initial Treatment & and Consultants Spectranetics Grant

Diagnostic Evaluation Prior to First Key Procedure # Patients Percent of Patients Receiving with Lesion Total # Patients in Lesion Assessment Before First Key Procedure Assessment Pathway Group First Key Procedure Amputation 138 281 49% Bypass 67 96 70% PTA 33 40 83% Total 238 417 57% Less than 1/2 (49%) of the patients that eventually received a primary amputation had any diagnostic evaluation prior to their amputation! “Not even a simple ABI!”

Diagnostic Evaluation Detail % of # # Patients Assessed Pathway Assessment Patients with Lesion with Type of Total # % of Group Type [1] Assessment Assessment Patients Total Amputation First Amputation First Amputation First ABI Angiography 98 45 138 138 71% 33% 281 281 35% 16% Amputation First Pathway MRA 3 138 2% 281 1% ABI = 35% Amputation First Other 74 138 54% 281 26% Bypass First ABI 48 67 72% 96 50% Angiography = 16% !! Bypass First Bypass First Angiography MRA 42 1 67 67 63% 1% 96 96 44% 1% Bypass First Other 44 67 66% 96 46% PTA First ABI 25 33 76% 40 63% PTA First Angiography 16 33 48% 40 40% PTA First MRA 1 33 3% 40 3% PTA First Other 19 33 58% 40 48%

Healthcare Consultants % Patients Having a Visit Average # Provider Category # Patients [1] Visits Home Health Care 162 53% 20 Internal Medicine 120 39% 9 Radiology 118 39% 6 DME/Prosthetics/Supplies 100 33% 4 Independent Lab 96 31% 5 Other Nephrology Cardiology = 26% 95 87 31% 29% 3 21 CV Surgery = 21% Cardiology and Cardiovascular Disease 78 26% 7 General Surgery 72 24% 5 Laboratory 70 23% 5 Family/General Practice 65 21% 5 Emergency Medicine 64 21% 2 Cardiovascular/Thoracic/Vascular Surgery 63 21% 3 Ambulance/Transportation 63 21% 5 Pathology 58 19% 5 Podiatry 58 19% 4 Anesthesiology 54 18% 3 ER 49 16% 2 Surgery 43 14% 2 Orthopedics/Orthopedic Surgery 33 11% 4 Infectious Diseases 33 11% 8 [1] Percentages are based on the 305 patients (of 417 in study population) who had provider visit after the first episode of care for a PTA, Bypass Graft, or Amputation. Inpatient and Outpatient hospital visits are not included in this analysis.

Critical Limb Ischemia (CLI): • Within 1 year of diagnosis of CLI … 50 - 60 % - major amputation! 25 - 30% - dead! • Amputation rate per 100,000 persons years has increased from 19 to 30 since 1985 …. • 140 per 100,000 persons years in > 85 years “> 4-5 fold increase in the elderly”

Critical Limb Ischemia (CLI): • Within 18-mo of successful limb salvage … 1/3 require “re-salvage” reintervention 1/3 require contralateral CLI intervention “Bilateral Disease” • Within 18-mo of unilateral limb loss … 1/3 will lose the contralateral limb !!

Critical Limb Ischemia (CLI): • < 50% of all amputees achieve mobility • < 50% of amputees are alive at 3-4 years • ~ $10-20 billion yearly costs (USA only) • Multiple reports of > 85-90% 12-24 mo. LS rates – Surgical &Endovascular Therapy.

Critical Limb Ischemia (CLI): Diabetes (DM): • 5 - 6% worldwide population (200 million) • Increase worldwide is an Amputation Worldwide there to 330 million by 2020 • 21 million US diabetics 30 Seconds !! In a Diabetic every !! • DM in the US increase by 60% by 2020 • In 2002 82,000 US DM underwent Amput.

Critical Limb Ischemia (CLI): Diabetic Foot Ulcers (DFU): • 15 – 25% of all DM - - DFU !! • ¼ DM (21 million US) DFUAmputation Worldwide there is an in their lifetime • #1 cause of hospitalization Seconds !! In a Diabetic every 30 in DM • 70% all US amputations – DM patient • 85% all DM amputations – preceded - DFU

FIVE P’s of ALI Pain Pallor Pulseless Parasthetics Paralytic

Combination Therapy (Chemical Thrombolysis & Mechanical Thrombectomy) • Concept : “Power-Pulse Spray Tech.” To maximize and combine the advantages and minimize the risks and disadvantages of both Chemical Thrombolysis and Mechanical Thrombectomy. “Novel Device and Pharmaceutical Combination”

Combination Therapy (Chemical Thrombolysis & Mechanical Thrombectomy) • Goals: A. Rapid revascularization (minutes) B. Minimize exposure to systemic lysis (Decrease bleeding complications) C. Decrease embolic risk D. Improve clinical outcomes

Subacute RT Iliac Artery Occlusion

Post P-PS 20-30 min (UK)

Post PTA/Stent 30 min

30 Day Result

Pre Post

Subacute Lt Iliac Occlusion

Angiojet Glidewire Across Occlusion

Angiojet

Following P-PS/UK (20-30 min)

Post Bilateral Iliac PTA/Stent (40 minutes)

Post Before “P-PS” PTA, & Stent

4 Month Follow-up Post P-PS & PTA

Graft Marker

Graft Profunda SFA

P-PS/UK Proximal Graft

P-PS/UK Distal Graft Graft Marker

P-PS/UK Popliteal

Post P-PS (45 min)

Post P-PS (45 min) Note Residual “Flap”

Self Expanding Stent Across Distal Anastamosis

“Flap” Successfully “Tacked-up”

CIS “Power-Pulse Spray” Protocol (Angiojet-UK/TNK/TPA) 1. Cross occlusion-thrombus with .035 glidewire 2. Set-up 6 Fr. Possis Xpeedior Device (normal) 3. Pump out 12 ml of NS prime 4. Exchange NS bag for UK 1,000,000 units, TNK 10-20 mg or TPA 10 mg in 50cc NS 5. Lytic prime catheter (12 ml activated) 6. Reset Infused Volume meter to Zero 7. Add stopcock to “outflow port” of Angiojet 8. Close The Stopcock

CIS “Power-Pulse Spray”Protocol (Angiojet-UK/TNK/TPA) 9. 1 pedal tap = 1 pump stroke = 0.6ml lytic solution 10. Advance Angiojet catheter slowly at 1.0 mm - 2.0 mm increments 11. 1 pedal pump/pulse per advanced increment 12. Advance antegrade until occlusion - thrombus crossed 13. Repeat “P-PS” retrograde and remove catheter 14. The Infused Volume meter will calculate total solution. (Convertible to total lytic dose) 15. Lytic to “Lyse” for 20-30 min in PAD and 30-40 min in DVT 16. OPEN STOPCOCK

CIS “Power-Pulse Spray” Protocol (Angiojet-UK/TNK/TPA) 17. Exchange lytic bag with saline bag 18. Evacuate 12 ml lytic residual (OUTSIDE the patient) 19. Reintroduce Angiojet catheter in “Thrombectomy Mode” 20. Make a single antegrade and retrograde pass with Angiojet 21. Obtain post Thrombectomy Angiogram 22. Further treatment at discretion of clinician “Treat the Lesion” (PTA/Stent)

Angiojet in the Non “PP-S” mode

Before After

The “Power-Pulse Spray” Technique Conclusion: • Amputations are not benign!! • The “P-PS” works for DVT too! • CIS “P-PS” allows rapid revascularization Total procedure time: Overall mean=74 min! “Treat the ischemic limb like the ischemic LAD” Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

"Power Pulse Spray" Technique in DVT: Part 2

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