Catheter Interventions for pulmonary embolism:

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1 Catheter Interventions for pulmonary embolism: From Directed tpa Drips to Suction Thrombectomy Efthymios Avgerinos, MD Associate Professor of Surgery Division of Vascular Surgery University of Pittsburgh Medical Center

2 PE - Increasing Incidence Huang et al - Am J Med 2014 Most common preventable cause of in-hospital death 50% have exercise limitation at 1 year 4% will develop Pulmonary Hypertension at 2-3 years

3 PE Clinical Presentation & Risk of Death Non Massive Low Risk No RVD - Biomarkers Submassive Intermediate Risk +/- ECHO RVD +/- Biomarkers Massive High Risk Hypotension Int. Low 3-15% Int. High 15-30% Arrest 1% PEITHO Study: 6% will decompensate or die >60%

4 PE Clinical Presentation & Risk of Death Non Massive Low Risk No RVD No + Biomarkers Submassive Intermediate Risk +/- ECHO RVD +/- Biomarkers Massive High Risk Hypotension Escalation of Treatment Anticoagulation Systemic Thrombolysis

5 Catheter Interventions Systemic vs Catheter Thrombolysis Systemic thrombolysis vs. AC is associated with a 47% mortality risk reduction but also high major bleeding rates (9.2% - 1.5% Stroke) Chatterjee et al JAMA 2014 In intermediate risk PE us-assisted catheter directed thrombolysis is superior to heparin alone in reversing RV dilatation at 24 hours, without an increase in bleeding events Kucher et al Circulation Pubmed Search Citations "Pulmonary Embolism AND Catheter" US National Inpatient Sample

6 Catheter Interventions for PE It is more than a catheter

7 Catheter Interventions for PE Standard Catheter Thrombolysis Ultrasound Assisted Thrombolysis Percutaneous clot extraction

8 Catheter Interventions for PE

9 Interventions for PE Thrombolysis Standard Catheter Thrombolysis Multisidehole catheter introduced within the clot hour tpa infusion 0.5-2mg/hour tpa penetrates & softens clot particles

10 Interventions for PE Thrombolysis Ultrasound Assisted Thrombolysis (EKOS) Technically similar to catheter directed dripping Fibrin Separation Active Drug Delivery Fibrin without Ultrasound Fibrin With Ultrasound Acoustic streaming drives lytic into clot Acoustic Pulse Lysis can in-vitro increase thrombus clearance by 50%

11 Interventions for PE Thrombolysis Ultrasound Assisted Thrombolysis (EKOS) Technically similar to standard catheter dripping Ultrasound may reduce dripping time & tpa dose (?) Most literature supporting it FDA approved ULTIMA RCT SEATTLE II Registry Multiple small series OPTALYSE PE No evidence of superiority over standard catheters

12 Interventions for PE Thrombolysis Ultrasound Assisted Thrombolysis (EKOS) Technically similar to standard catheter dripping Ultrasound may reduce dripping time & tpa dose (?) Most literature supporting it FDA approved ULTIMA RCT SEATTLE II Registry Multiple small series OPTALYSE PE No evidence of superiority over standard catheters

13 Interventions for PE Thrombolysis Ultrasound Assisted Thrombolysis (EKOS) Recommended Treatment Time: 2, 4, 6, 12 Hours

14 Interventions for PE - Clot Extraction Thrombectomy Devices (no need for lytics) Small bore Aspiration Catheters/Systems Large bore Aspiration Catheters/Systems

15 Interventions for PE - Clot Extraction Thrombectomy Devices Small bore Aspiration Catheters/Systems Any catheter Pronto Catheter (Vascular Solutions) Aspire (Control Medical Technology)

16 Pronto Catheter Manual Fragmentation and Aspiration Courtesy: E. Avgerinos Univ. of Pittsburgh

17 Interventions for PE Suction Thrombectomy Thrombectomy Devices Large bore Aspiration Catheters (Rapid debulking of proximal thrombus) Trerotola (Teleflex) Angiojet (Boston Scientific) Angiovac (Angiodynamics) Indigo (Penumbra Inc) Flowtriever (Inari medical)

18 Interventions for PE Suction Thrombectomy Thrombectomy Devices Angiovac

19 Interventions for PE Suction Thrombectomy Courtesy: R. Chaer Univ. of Pittsburgh

20 Interventions for PE Suction Thrombectomy Thrombectomy Devices Indigo Penumbra

21 Interventions Click to play for PE Suction Thrombectomy Thrombectomy Devices Indigo Penumbra PA Pressure 80 Click to play

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23 Before After PA Pressure 49 Courtesy: E. Avgerinos Univ. of Pittsburgh

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25 Interventions for PE Suction Thrombectomy Thrombectomy Devices Flowtriever Inari

26 Courtesy: C. Toma Univ. of Pittsburgh

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28 Safety of Catheter Interventions RCT Trial Kuo et. al 2009 Type of Intervention Pts Major Bleed ICH Various 594 ~3.2% 0.1% ULTIMA-2014 EKOS (Lysis) 30 0% 0% PERFECT 2015 SEATTLE II 2015 NIS Data 2015 scdt EKOS (Lysis) 101 0% 0% EKOS (Lysis) % 0% Various 352 ~3.7% 0.3%

29 Major Complications EXIST Coronary Sinus Perforation Tricuspid Rupture

30 Study Major Bleeding (by PE Severity) ES (95% CI) % Weight Avgerinos et al, J Vasc Surg 2018 in press Metaanalysis of 20 Studies of Catheter Thrombolysis ( ) 1,168 patients Massive PE 8% Mortality 6.7% Major Bleeding Submassive PE <1% Mortality 1.4% Major Bleeding High risk PE Lin 2009 Engelberger 2013 Kennedy 2013 Dumantepe 2014 Quintana 2014 Kuo 2015 Nykamp 2015 Piazza 2015 Yoo 2016 Avgerinos 2017 Subtotal (I^2 = %, p = 0.038) Intermediate risk PE Engelberger 2013 Kennedy 2013 Dumantepe 2014 Gaba 2014 Kucher 2014 Quintana 2014 Bagla 2015 Kuo 2015 Mccabe 2015 Nykamp 2015 Piazza 2015 Ozmen 2016 Yoo 2016 Avgerinos 2017 Fuller 2017 Ozcinar 2017 Subtotal (I^2 = %, p = 0.328) Heterogeneity between groups: p = Overall (I^2 = %, p = 0.004); (0.042, 0.300) (0.013, 0.315) (0.015, 0.354) (0.000, 0.434) (0.000, 0.658) (0.000, 0.121) (0.000, 0.228) (0.114, 0.398) (0.015, 0.354) (0.142, 0.556) (0.010, 0.153) (0.005, 0.135) (0.000, 0.074) (0.000, 0.215) (0.009, 0.246) (0.000, 0.114) (0.000, 0.324) (0.012, 0.148) (0.000, 0.051) (0.010, 0.128) (0.000, 0.107) (0.034, 0.127) (0.000, 0.278) (0.000, 0.194) (0.026, 0.089) (0.000, 0.125) (0.000, 0.278) (0.003, 0.028) (0.003, 0.040) Proportion with outcome

31 UPMC Algorithm High Risk Intermediate - High Intermediate - Low Low Risk Assess Bleed Risk

32 UPMC Algorithm Intermediate - Low Low Risk Assess Bleed Risk AC vs IVC Filter Low or Intermediate High AC IVC filter

33 UPMC Algorithm Intermediate - High Assess Bleed Risk Low Intermediate High Catheter Lysis Catheter Lysis or Suction Thr. or AC IVC filter

34 UPMC Algorithm High Risk Assess Bleed Risk Low High Systemic Lysis +/- ECMO Suction Thrombectomy or Surg. Thrombectomy or ECMO

35 Take Home Messages Catheter Interventions for PE are here to stay Catheter Lysis vs Catheter Thrombectomy are complimentary Faster Clot removal & RV function recovery Prevention of RV failure / decompensation Prevention of Pulmonary Hypertension (?) They are not complication-free procedures but complications are less than those of systemic lysis Careful patient selection in high-volume centers with appropriate expertise is essential till larger studies are available.