"Power Pulse Spray" Technique in DVT: Part 1

New Cardiovascular Horizons 2009 Venous Disease 2009 The Power- Pulse Spray Technique David E. Allie MD “ P-PS “ David E. Allie M.D. Director of Cardiothoracic and Endovascular Surgery Louisiana Cardiovascular & Limb Salvage Center Lafayette, Louisiana

Conflict of Interest Statement Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician Name Company/Relationship ALLIE DE Wound Care Tech MAB/Cons. ALLIE DE Toshiba Consultant ALLIE DE Oculus MAB/Cons. ALLIE DE Spectranetics MAB/Cons. ALLIE DE Flowmedica Consultant ALLIE DE CSI Consultant ALLIE DE Flowcardia MAB/Cons. ALLIE DE AngioScore MAB/Cons. ALLIE DE Angiodynamics MAB/Cons. ALLIE DE IDEV MAB/Cons.

Acute Limb Ischemia (ALI) • Death!… Limb salvage… Amputation… Death! • Major surgical thrombectomy - revascularization • Endovascular thrombectomy - revascularization • Continuous lytics • Mechanical thrombectomy “Combination therapy!”

GRAFT MARKER

Endovascular Today March 2003

March 2003

Vascular Disease Management December 2004

“…First Peer Reviewed Article Describing the P-PS Technique In 49 Acute CLI Patients…

Graft Marker

Graft Profunda SFA

P-PS/UK Proximal Graft

P-PS/UK Distal Graft

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”

P-PS Technique in DVT…

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

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® Ultra Thrombectomy System The new AngioJet Ultra console (U.S. Approval pending) features automated set- up and supports a wide range of catheters with all disposable elements integrated into single-package thrombectomy sets.

AngioJet® Spiroflex®VG Thrombectomy Catheter AngioJet® Spiroflex® Thrombectomy Catheter 4 french spiral cut shaft with rapid exchange 5 french spiral cut shaft -- rapid exchange with twice the removal power of 4 french catheters

Saline jets inside the AngioJet® catheter travel backwards at high speed to create a negative pressure zone. The Cross-steam ® windows optimize fluid flow, drawing thrombus into the catheter where it is fragmented and removed from the body. AngioJet® Family of Thrombectomy Catheters 4 french to 6 french with indications for coronary and peripheral arterial thrombectomy and AV declot

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

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

US Guided Popliteal Vein “Stick” Placed patient in prone position and examination of right popliteal vein

US Guided Popliteal Vein “Stick” Introducer sheath placement in popliteal vein under ultrasound guidance

Femor-Popliteal DVT Initial Venogram

Femor-Popliteal DVT Wire Crossing… Initial Venogram

Good Debulking Results after P-PS … First Venogram post – P-PS (30 minutes)

Left Iliac Vein Stenosis PTA/Stenting of Left Iliac Vein Stenosis…

Completion venogram Final Results after P-PS & PTA/Stenting…

Pre – P-PS…

Post – P-PS… 36 Hours… • Procedural time – 2 hours • No ICU stay…

Acute & Chronic DVT

Angiojet Chronic clot, underlying venous stenosis

Results after P-PS Technique…

Before – left arm After – left arm P-PS PTA/Stent (36 Hours)…

After – left arm P-PS PTA/Stent Before – left arm Before After (36 Hours)…

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

P-PS Technique In DVT Conclusion: “Take Away Messages” • Venous Diseases (Acute & Chronic) are Underdiagnosedbe considered “and should & Undertreated… a First-Line Therapy in the The P-PS Technique is Safe & Treatment of Acute/Chronic DVT” Feasible (Effective)…DVT… The Contemporary P-PS Technique has Been Streamlined & Simplified…

Phlegmasia Cerolia Dolens

IVC Filter Patent Iliac Vein Stent

Thrombosed IVC Filter Small Distal IVC Patent Right Iliac Vein

Multiple P-308 Stents Across the IVC Filter

Venous-IVC Flow Through the P-308 Stents

Excellent Suprarenal IVC Venous Flow Suprarenal Temporary IVC Filter

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

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

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

Mechanical Thrombectomy AngioJet Possis Medical

Power Pulse Spray Thrombolytic Therapy A Single Center Experience

The Power-Pulse Spray Technique for Deep Venous Thrombosis (DVT) Objective: A retrospective study performed to evaluate the clinical outcomes of percutaneous rheolytic thrombectomy using the Angiojet (Possis Medical, Minneapolis, MN), with added lytic agent, known as the “power pulse spray” technique, in selected patients with acute and/or chronic DVT.

The Power-Pulse Spray Technique for Deep Venous Thrombosis (DVT) Methods: Patient cohort (January 2003–July 2006) 24 patients (28 DVT events) Therapy- PPS (Possis Medical, Minneapolis, MN) with urokinase or tissue plasminogen activator (tPA)

The Power-Pulse Spray Technique for Deep Venous Thrombosis (DVT) Methods (continued):  Review of medical records and venograms  Demographics  Thrombus location  Lytic agent used  Adjunctive procedures  Degree of clot removal on imaging  Follow-up symptoms

The Power-Pulse Spray Technique for Deep Venous Thrombosis (DVT) Results:  21 of 24 patients: PTA for venous lesions  5 of 21: venous stents  5 of 24 patients with PPS had A B recurrent DVT  3 treated with repeat PPS  5 adjunctive PTA  2 stenting  Overnight lytic infusions: D E  1 acute DVT C showing left femoral vein thrombosis. (A) Venogram  1 acute/chronic DVT (B) Post-interventional venogram demonstrating  3 chronic DVT thrombus removal and markedly improved flow after power pulse spray.

The Power-Pulse Spray Technique for Deep Venous Thrombosis (DVT) Conclusions:  PPS:  Safe  Effective  Advantages:  Disadvantages  Special equipment needed  Rapid recannalization  Chronic DVT may require  Minimal bleeding risk overnight lytic therapy  Reduced systemic thrombolytic effect  Shorter hospital stay  Single session in the majority of patients  No need to monitor laboratory data

Take Home Points

Venous Thromboembolic Disease Catheter – directed thrombolytic therapy Maintains valve function Unmasks underlying pathology Stenosis Occlusion May set the stage for further interventions

Venous Thromboembolic Disease Thrombolytic Therapy – A minimally invasive endovascular treatment Urgent referral is key to reduce morbidity and mortality

Acute Limb Ischemia (ALI) Rapid Revascularization in ALI: Treating “ALI” Like “ACS” David E. Allie, M.D. Director of Cardiothoracic and Endovascular Surgery Cardiovascular Institute of the South Lafayette, Louisiana

Conflict of Interest Statement Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician Name Company/Relationship ALLIE DE Possis Consultant ALLIE DE Toshiba Consultant ALLIE DE Boston Scientific Consultant ALLIE DE Spectranecitics MAB/Cons. ALLIE DE Foxhollow Consultant ALLIE DE Organogenesis Consultant ALLIE DE Oculus MAB/Cons. ALLIE DE Pam Labs MAB/Cons.

FIVE P’s of ALI Pain Pallor Pulseless Parasthetics Paralytic

Critical Limb Ischemia (CLI): • Rutherford Classification 4, 5, 6 • ~ 100% require amputation in 12 months “without revascularization” Wolfe, et al… • ~ 220-240,000 amputations/yr USA/Europe • ~ 4-30% 30-day perioperative mortality! • ~ 8-37% 30-day perioperative morbidity! “>15,000 amputations/month!”

Amputation (Impact!!) • Survivors – 50% Full mobility post BKA – 25% Full mobility post AKA – 40-50% will die within 2 years of amputation!! – Aggressive Limb Salvage! – Rapid (<1-2 hr) Revascularization in Acute CLI! Treat ALI like ASC !!

Acute Limb Ischemia (ALI) • Death!… Limb salvage… Amputation… Death! • Major surgical revascularization • Endovascular revascularization • Continuous lytics • Mechanical thrombectomy “Combination therapy!”

GRAFT MARKER

Combination Therapy (Chemical Thrombolysis & Mechanical Thrombectomy) • Concept : 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 and Mechanical Thrombectomy) • Disadvantages: (Mechanical “ectomy”) 1. Removes only “Fresh?” clot 2. Clot needs to be rather soluble 3. Incomplete thrombectomy 4. May require multiple “Passes” ( intimal injury, emboli, etc.) 5. Limited use in “Small Vessels” 6. Distal emboli 7. Hemolysis and fluid overload

Combination Therapy (Chemical Thrombolysis & Mechanical Thrombectomy) • Disadvantages: (Chemical Lysis) 1. Long infusion times 2. Increased bleeding risks 3. Long ICU - hospital stays with increased resource utilization and costs 4. Incomplete thrombolysis 5. Distal emboli 6. 15-20% contraindication rate

Subacute RT Iliac Artery Occlusion

Post P-PS 20-30 min (UK)

Post PTA/Stent 30 min

30 Day Result

Pre Post

Subacute 100% Lt Iliac Occlusion

Post P-PS 20 min

Post Bil Iliac Artery PTA/Stent 40 min

After Before

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

Limb Salvage Post “P-PS” and PTA/Stent Pre “P-PS” 1 Mo Post “P-PS”

Subacute Thrombosed Bypass Graft NO GRAFT MARKER

Thrombus Ladened Graft Before P-PS

Distal Runoff

P-PS/TNK Proximal Graft

P-PS/TNK Mid-Graft

P-PS/TNK Distal Graft

PTA Proximal Anastamosis

PTA Distal Anastamosis

Post P-PS/PTA (45 min)

Post P-PS/PTA/TNK (45 min)

RT SFA Occlusion 2 yr old stents

Occluded SFA Stent

Glidewire Across Occlusion

Post P-PS 40 min

Post PTA/Stent

After Before 90 min-case “P-PS” & PTA

The “Power-Pulse Spray” Technique Methods: • 49 patients ALI (symptoms < 14 days) – 15 iliac artery – 22 SFA – 12 femoral bypass grafts Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

The “Power-Pulse Spray” Technique Methods: • Group I (pts 1-25) TNK 10-20mg/50cc NS • Group II (pts 26-49) UK 1,000,000 u/50cc NS • Variables: – Clinical procedural success – Total procedural time (TPT-minutes) – 25% fibrinogen drop – Limb salvage (LS) (30 day and 6 month) Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

The “Power-Pulse Spray” Technique Complications: • No major or surgical complications • Minor complications (<5cm hematoma) – Group I - 8% (2/25) – Group II - 8.3% (2/24) No clinical embolic events in either group! Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

The “Power-Pulse Spray” Technique Results: • 6 month LS rate TNK 84% • 6 month LS rate UK 83% • Total procedure time: Overall mean=74 min! – TNK 40-110 minutes – UK 40-115 minutes Cardiovascular Institute of the South - Allie, Hebert, Walker, et. Al.

Left Iliac Artery Thrombosis Tight Right Iliac ISR

"Power Pulse Spray" Technique in DVT: Part 1

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