Pharmaco-mechanical techniques stand alone procedures? Peter Neglén, MD, PhD SP Vascular Center Limassol Cyprus

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1 Pharmaco-mechanical techniques stand alone procedures? Peter Neglén, MD, PhD SP Vascular Center Limassol Cyprus

2 Faculty Disclosure Peter Neglén, M.D., Ph.D Stockholder/Founder of Veniti, Inc. Member, Medical Advisory Board Veniti, Inc. and Covidien Vascular Therapies Speaker, Cook Medical Wallstents and nitenol stents in these studies are used off-label, e.g., the use for iliac venous stenting is not described on the product s label.

3 General Goals of Therapy Reduce pulmonary embolism Prevent limb loss Prevent extension short term Reduce recurrence long term Restore patency Preserve valve function Prevent the development of PTS by successful early clot removal

4 Percutaneous Pharmaco-mechanical Thrombectomy - Ultimate Objective To achieve rapid clot removal in one sitting Adjuvant use of suction catheters Identify residual thrombus load and underlying compression by using IVUS Perform venoplasty and/or stenting Avoid subsequent CDT

5 Evolution of Thrombolysis Systemic lysis Catheter-directed lysis Mechanical thrombectomy Combined local lysis and mechanical treatment Isolated pharmacomechanical thrombolysis Trellis Power-Pulse Spray Angiojet Ultrasonic accelerated thrombolysis Ekos

6 Strategy Acute Ilio-femoral DVT Anticoagulation Compression stocking Clinical assessment - thrombolysis candidate? No Yes Anticoagulation Compression stocking Early Ambulation CT-scan abdomen/pelvis chest? Remove IVC filter Place temporary filter, if warranted Treat underlying obstruction Venoplasty-stent placement CDT PMTE

7 AngioJet rheolytic thrombectomy catheter The Venturi Effect A low-pressure zone created at the catheter tip using high-pressure pulsatile saline jets Thrombus surrounding the catheter tip is macerated and rapidly evacuated via an effluent lumen into a collection chamber

8 AngioJet rheolytic thrombectomy catheter combined with PowerPulse spray Traverse the clot by the the AngioJet catheter over wire Occlude the catheter outflow lumen Use 10 mg tpa in 50ml NS The tpa is directly infused in a pulse-spray fashion into the clot during withdrawal (PowerPulse Spray) Allowed to work for 15 to 30 min Repeat the thrombectomy with the outflow lumen reopened.

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10 Pre PMT

11 Thrombectomy run 1

12 PowerPulse and thrombectomy run 2

13 PEARL Study an AngioJet registry March lower limb DVT 72% combined with PowerPulse 62% venoplasty/stenting 41% adjuvant CDT 2 complications only bradycardia, creatinine increase 70% complete lysis Gross hemoglobinuria common Bradycardia/hypotension infrequent Nephropathy rare Pancreatitis extremely rare

14 TRELLIS -8 Thrombolysis Device 8Fr Multi-Lumen Catheter Inflation/Infusion Ports Aspiration Port Oscillation Drive Unit Isolated Treatment Zone

15 Trellis-8 system: catheter specifications Proximal Balloon Markers Treatment Zone 15cm or 30cm Distal Balloon Markers Tip Marker 1.88cm Infusion Holes 15cm cm - 7 Integral Aspiration Window

16 Isolated segmental pharmaco-mechanical thombolysis - principle Advance over a guidewire through the thrombus Proximal and distal balloon inflated isolating a segment Guidewire replaced by sinusoidal wire t-pa infused into isolated segment A sinusoidal wire is rotated to disperse the lytic drug in the clot The remaining drug is aspirated The device is removed

17 ASCENDING VENOGRAPHY popliteal vein or femoral vein access FV CFV Iliac vein Left lower limb, prone

18 Technique 1 Place 9-10F sheath Iliac venogram with catheter tip in left EIV: No forward (cephalad) flow Glidewire advanced through clot into IVC 180 Amplatz wire 180 Glidewire Confirmed no clot in IVC Cavogram IVUS Left Lower Limb, Prone

19 Technique 2 Isolating segment with balloons 80cm shaft length 30cm treatment length Left Lower Limb, Prone

20 Post PTA and then Wallstents 16mm#90mm; 14mm#90mm

21 Trellis Clinical Registry Single session 84% Degree of lysis Safety Grade III 38% Grade II 57% (grade III in acute cases 52%) 30-40% reduction in total lytic dose as compared to CDT No major bleeding No symptomatic PE

22 Ultrasonic accelerated thrombolysis - The EkoSonic Endovascular System With Rapid Pulse Modulation Catheter-directed drug delivery system combined with multiple ultrasoundemitting foci along the length of the catheter 5.2 Fr Intelligent side-hole drug delivery catheter MicroSonic Core

23 Ultrasonic accelerated thrombolysis Distort and fragment the fibrin, which increases its surface area and allows greater fibrinbound plasminogen activation. Ultrasound pressure waves drives the lytics into the thrombus all the way to the vessel walls and behind venous valves. Acoustic Streaming Without Ultrasound With Ultrasound

24 Result of ultrasonic accelerated thrombolysis Parikh et al JVIR 2008;19:521-8 Multi-center study of 53 cases Involving the lower limb in 60% Acute 47%; acute on chronic 17% Major bleeding 4% (CDT 11%) Less lytic dose and shorter duration of treatment as compared to CDT (National Registry) Mean infusion time 22h vs 53h Complete lysis in 70% vs 31%

25 Summary Single-session treatment 74% (range: ) Less hospital/icu LOS Decrease of lytic dose by 30-40% Complete lysis 57% (range: 14-84) Adjuvant angioplasty/stenting 79% (63-100) Reduced rate of major bleeding 11% to 0-4% The optimal one-session thrombectomy device still eludes us Assessment of age of thrombus Continuous refining of the techniques Procedure time further shortened Make it an out patient procedure in most cases Arko FR et al. Arch Surg 2007;142: , Rao AS et al. J Vasc Surg 2009;50:1092-8, Comerota AJ. J Vasc Surg 2012;55:607-11