Minimally Invasive Thrombectomy Using the AngioVac System. Brian J. deguzman, MD AmSECT Tampa, FL April 14, 2015

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1 Minimally Invasive Thrombectomy Using the AngioVac System Brian J. deguzman, MD AmSECT Tampa, FL April 14, 2015

2 Disclosure Biomet Microfixation Edwards LifeSciences Angiodynamics AtriCure Pavilion Medical Innovations Kaleidoscope Medical Sahpena Medical PAXmed

3 Frontiers in Endovascular Therapy 1990 s 2000 s 2010 s Coronary Peripheral Renal Neuro Aortic DVT PE Right Atrial Arterial Venous

4 VTE Mortality Overall 300,000 VTE Deaths per Year in US - #3 cause Heart Disease 595,000 Cancer 574,000 VTE 296,000 COPD 138,000 Stroke 129,000 Heit JA, et al. Blood. 2005;106:267A. Murphy SL, et al. Deaths: Preliminary Data for National Vital Statistics Reports; 2012.

5 Standard VTE Treatment PHARMACOLOGIC MECHANICAL Anticoagulation Catheter Thrombolytics Surgical

6 Limitations of Thrombolytic Therapy Effectiveness Only works on fresh clot but ALL VTEs have some chronic component Up to 50% of patients have contraindications Residual obstruction increases long term mortality even if symptoms improve Bleeding 10-15% Major 1-3% Intracranial or Fatal Resource Utilization Up to 72 hours in ICU Repeat trips to cath lab

7 Catheter Treatment of PE Modest clinical success Adjuvant thrombolytics in >60% High mortality rates >20% Fundamental obstacles Small catheters don t permit removal of large clot burden Large catheters lead to blood loss

8 Surgical Embolectomy - Operative Surgical Exposure Technique Right Pulm Artery The Day s Catch Pulm Embolus Fresh Clot Left Pulm Artery Chronic Clot

9 Surgical Embolectomy Provides Best Treatment Outcomes Circulation. 2002;105:

10 Surgical Embolectomy

11 Large bore 22F Proprietary Funnel tip Deployed remotely by inflating low pressure balloon Balloon does not occlude vessel Improves flow rates Engages and conforms material larger than Cannula ID AngioVac Cannula

12 AngioVac Circuit Simple veno-veno extracorporeal circuit No reservoir Centrifugal pump Inline filter Transparent provide immediate visual feedback Real-time reinfusion of shed blood Hemodynamic stability Preserves blood volume

13

14 Animal Model - DVT

15 AngioVac Procedure

16 Cannula Insertion Guidewire access to target site Angiogram and/or TEE Insert AngioVac Cannula Percutaneous vs Open IJ/Fem/Axillary/RA/PA Insert Reinfusion Cannula 16-18F Percutaneous Cannula IJ vs Femoral vein Connect Cannulae to Circuit 26F Gore DrySeal Sheath

17 AngioVac First in Man Eisenhauer, et al - Brigham

18 Complete IVC Thrombosis Filter Thrombus

19 AngioVac IVC Thrombectomy Collateral Pre-Angio 100% Occlusion

20 AngioVac IVC Thrombectomy Post-Angio Wide Open IVC

21 6 Saddle PE Rosenfield, et al Mass General

22 7 Saddle PE Rosenfield, et al Mass General

23 Prosthetic Pulmonic Valve Endocarditis Divekar et al U of Iowa

24 Extracardiac Conduit Thrombosis Love/Fischman et al Mount Sinai NYC

25 PE in Transit Ali, et al Fort Worth

26 PE in Transit Ali, et al Fort Worth

27 PE in Transit Ali, et al Fort Worth

28 RA Tumor Eisenhauer, et al - Brigham

29 Tricuspid Vegetation Goldman, et al Lankenau Hosp, PA

30 PICC Line Thrombus Kassas et al - Covenant

31 PICC Line Thrombus Kassas et al - Covenant

32 Proximal Protection for Obstructed IVC Filter Removal Chen/Hirsch et al Phoenix, AZ

33 Proximal Protection for Obstructed IVC Filter Removal Chen/Hirsch et al Phoenix, AZ

34 Proximal Protection Obstructed IVC Filter Removal Chen/Hirsch et al Phoenix, AZ

35 Proximal Protection for Obstructed IVC Filter Removal Goswami et al Springfield IL

36 Intracaval Tumor/Thrombus Rosenfield, Vlahakes Mass General

37 Intrahepatic IVC Thrombus in Liver Transplant Klink, Pagni - Louisville

38 Unilateral DVT/May Thurner Yang/Doemeny Scripps, San Diego

39 FIM Arterial AngioVac Thrombectomy Habib/Siragusa et al - Jacksonville, FL

40 FIM Arterial AngioVac Thrombectomy Habib/Siragusa et al Jacksonville, FL

41 FIM Arterial AngioVac Thrombectomy Habib/Siragusa et al Jacksonville, FL

42 Descending Aortic Thrombectomy Beck et al Univ of FL/Shands. t for IVUS and adjunctive devices. Once ce x 2 and a 26F Medtronic Sentrant 350 seconds. cm markings). The AngioVac was heter was removed and a Medtronic for occlusive distal protection should

43 AngioVac Anatomic Spectrum Right Atrial Mass Vegetations, Thrombus, Tumor Lead/Catheter Associated Tricuspid Valve Endocarditis Inferior Vena Cava IVC Thrombosis IVC Filter Associated Intracaval Tumor Proximal Protection Portal/TIPS/DIPS Arterial Aortic Pulmonary Pulmonary Embolism Pulmonic Valve Endocarditis DVT Iliofemoral

44 AngioVac Clinical Experience A NOVEL ENDOVENOUS APPROACH FOR TREATMENT OF MASSIVE CENTRAL VENOUS OR PULMONARY ARTERIAL THROMBUS, MASS, OR VEGETATION: THE ANGIOVAC SUCTION CANNULA AND CIRCUIT Rahul Sakhuja, Sanjay Gandhi, Robert K. Rogers, Progress Ronan in Cardiovascular JP Margey, Michael Diseases R. 52 (2010) 429 Jaff, and Robert Schainfeld J. Am. Coll. Cardiol. 2011;57;E1535 doi: /s (11) This information is current as of May 5, 2011 Catheter-Based Therapies for Massive Pulmonary Embolism The online version Thomas of this article, M. Todoran, along with updated Piotr Sobieszczyk information and services, is 00 pm - 5:15 Cardiovascular pm Division, located Vascular 7 Medicine on the World Section, Brigham Wide Web and Women's at: Hospital, Boston, MA Initial Use of a Large Bore Suction bstract Massive pulmonary embolism Thrombectomy carries a high mortality Cannula rate as a result offor right the ventricular Treament failure. In addition to anticoagulation, systemic thrombolysis is the standard first line of therapy for of Massive Inferior Vena Cava (IVC) and patients with life-threatening massive pulmonary embolism. Surgical embolectomy is often considered in patients with Iliofemoral contraindications Deep to receiving Venous systemic Thrombosis thrombolysis or when (DVT) thrombolysis has failed. Surgical embolectomy is not without inherent risk and limitations. Although there is a paucity Shirling of large Tsai*, clinical trials, Mark available F. Conrad, data suggests Virendra catheter-based Patel, treatment of massive pulmonary embolism restores hemodynamic stability and thus is an Christopher 1. Kwolek Progress in Cardiovascular Diseases 52 (2010) alternative to surgical therapy. (Prog Cardiovasc Dis 2010;52: ) 2010 Elsevier Inc. All rights reserved. Massachusetts General Hospital, Boston, MA

45 AngioVac Clinical Experience Patients 1559 Mean Age 54 Gender 52% Male 48% Female Primary Location of UIM PA 15% RA 40% Ileofem/IVC 43% Other 2% Material Aspirated 98% Procedural Success 92% Conversion to Open 0.5% Complications 0.57% Procedural Mortality 0.09%

46 Discussion

47 Measured Flow Rate (LPM) Bench Testing AngioVac 22Fr Funnel Designs (25Fr) Input Pump Speed (RPM)

48 Sirius Engineering LLC Bench Testing Trial #5 Distal Valve Partially Open 0.5 of 7 turns. Cannula tip begins 11 cm away from clot. Pump Speed Flow Rate Cannula Vessel Distance to Comments (RPM) (LPM) Pressure (mmhg) Pressure (mmhg) Clot (cm) <11 Moving slowly < <11 Advanced to 5 cm, clot captured Discussion In Trial #1, the cannula tip is 11 cm away from the clot. Since the distal valve is completely closed, then reverse flow is obstructed. The flow through the cannula is not strong enough to engage the clot, even at a pump speed of 3500 RPM and flow rate of 6 liters/min. Vessel pressure remained negligible throughout the trial at this condition.

49 AngioVac Suction AND Kinetic Procedure Flow is your friend

50 Standard Maneuvers Position AngioVac Cannula near UIM Flush Filter Repeat Imaging Deploy Funnel Advance AngioVac Cannula to UIM Initiate and Optimize Flow

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