What is New in Acute Pulmonary Embolism? Interventional Treatment. Prof. Nils Kucher University Hospital Bern Switzerland

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1 What is New in Acute Pulmonary Embolism? Interventional Treatment Prof. Nils Kucher University Hospital Bern Switzerland

2 Disclosure of Interest Dr. Kucher received research grants from Sanofi-Aventis, GSK, BMS, Pfizer and Bayer Dr. Kucher is consultant to EKOS Corporation and Bayer Dr. Kucher received speaker honoraria from Sanofi-Aventis, Bayer, GSK, BMS, Boehringer Ingelheim, and Pfizer

3 - PE 2011 Guidelines -

4 Confirmed or intermediate/high clinical probability of acute PE Initial treatment Unfractionated heparin, low molecular weight heparin, or fondaparinux for at least 5 days (Grade I A; for intermediate/high clinical probability of acute PE Grade I C) No routine IVC filter placement (Grade III C) except contraindication to anticoagulation (Grade I C) or recurrent PE with therapeutic anticoagulation (Grade IIa C) Risk stratification Low-risk PE (BP > 90 mm Hg, biomarkers, ECHO ) Intermediate-risk or submassive PE (BP > 90 mm Hg, biomarker +, ECHO +) High-risk or massive PE (BP < 90 mm Hg, shock, CPR) No thrombolysis, catheter intervention, or surgical embolectomy (Grade III B) Long-term treatment Systemic thrombolysis if bleeding risk is low (Grade IIb C) Catheter intervention or surgical embolectomy (Grade IIb C) Systemic thrombolysis (Grade IIa B) Catheter intervention or surgical embolectomy, if fibrinolysis contraindicated or if remains unstable after fibrinolysis (Grade IIb C) Vitamin K antagonist for 3 months (Grade I A) Engelberger R, Kucher N. Circulation 2011; 124:

5 The problems with Systemic PE Thrombolysis There is a 13% risk of major bleeding and a 1.8% risk of intracranial hemorrhage in randomized trials 1 There is a 20% risk of major bleeding and a 3% risk of intracranial hemorrhage in clinical practice 2 The rates of clinically relevant non-major bleeding have not been studied for patients undergoing systemic PE thrombolysis In clinical practice, systemic thrombolysis is withheld in up to two thirds of patients with high-risk (massive) PE 3. 1 ESC Guidelines. Eur Heart J 2008: 29: Am J Cardiol. 2006;97: ICOPER. Circulation 2006;113:577-82

6 Goals of Catheter Embolectomy for Massive Pulmonary Embolism Decrease in pulmonary vascular resistance and pulmonary artery pressure Recovery of right ventricular dysfunction Increase in systemic arterial pressure Improvement of symptoms and survival Kucher N, Goldhaber SZ. Circulation 2006;112:e28-32

7 Old & New Interventional Devices for Acute Pulmonary Embolism Greenfield Pigtail Clot buster AngioJet Aspirex

8 The Greenfield Suction Embolectomy Device Courtesy of Lazar Greenfield, MD

9 Courtesy of Lazar Greenfield, MD

10 Combined Mechanical Techniques: Fragmentation and Thrombectomy Eidt-Lid et al. Chest 2008; 134:54

11 Combined Mechanical Techniques: Fragmentation and Thrombectomy Patients without additional thrombolysis (N=16) Hemodynamics Before Procedure After Procedure p Value ssbp, mm Hg 94.8 ± ± msbp, mm Hg 74.0 ± ± spap, mm Hg 64.1 ± ± mpap, mm Hg 37.1 ± ± Miller index 20.8 ± ± Shock index 1.2 ± ± Eidt-Lid et al. Chest 2008; 134:54

12 Pharmacomechanical Interventions AngioJet Power Pulse thombolysis + thrombectomy (Venturi effect) EKOS Ultrasound-assisted thrombolysis

13 Clinical Outcome after PE Catheter Intervention Catheter technique Aspiration technique No lytics (81) 6 (17) 22 (25) Systemic lytics (100) 0 (0) 1 (10) Local lytics (100) 0 (0) 0 (0) Systemic + local (100) 0 (0) 0 (0) Fragmentation technique n Mean BP, mmhg Before After Mean PAP, mmhg Before After Clinical Success Major Bleeding No lytics (67) 0 (0) 0 (0) Systemic lytics (71) 0 (0) 1 (5) Local lytics (95) 2 (2) 5 (4) Systemic + local (80) 3 (10) 6 (20) Amplatz catheter No lytics (88) 1 (13) 1 (12) Local lytics (100) 0 (0) 0 (0) AngioJet No lytics (75) 0 (0) 0 (0) Local lytics (87) 0 (0) 3 (13) Hydrolyzer Local lytics (92) 0 (0) 1 (8) Systemic + local (100) 0 (0) 1 (12) Mortality Skaf E et al. Am J Cardiol 2007;99:

14 Meta-analysis (35 studies) PE catheter interventions Clinical success* Clinical success in studies with >80% patients receiving thrombolysis Clinical success in studies with <80% patients receiving thrombolysis Major complications Minor complications N = % 91% 83% 2% 8% *defined as stabilization of hemodynamic parameters, resolution of hypoxia, and survival of massive PE Kuo WT, et al. J Vasc Interv Radiol. 2009;20:

15 Complications of Catheter Embolectomy Pulmonary hemorrhage/ hemoptysis Right ventricular failure from distal embolization or contrast injections Bleeding from anticoagulation or thrombolysis Hemolysis, hemoglobinuria Arrhythmia Contrast-induced anaphylaxis and contrast-induced nephropathy Vascular access complications Kucher N, Goldhaber SZ. Circulation 2006;112:e28-32

16 Ultrasound-Assisted Thrombolysis Effect of Ultrasound Without Ultrasound Fibrin strands prevent drug from penetrating thrombus and binding to plasminogen receptor sites With Ultrasound Destabilization of fibrin strands, enabling penetration of drug into thrombus Ultrasound + Thrombolysis Ultrasound pressure waves force drug into thrombus, resulting in rapid removal of thrombus even at low drug dose

17 The Ekosonic Endovascular System Ekosonic Control Unit Ekosonic Mach4 Endovascular Device 5 fr Intelligent side-hole drug delivery catheter Ultrasound MicroSonic Core

18 Ultrasound-Assisted Thrombolysis Improvement in Right Ventricular Enlargement RV/LV ratio Normal : <0.7 Prognosis : > Pre to Post RV/LV Ratio N= 24 mean rt-pa dose 33 ± 15 mg over 20 hours P < RV/LV Ratio ± ± 0.13 Pre RV/LV Baseline CT Engelhardt TC, et al. Thromb Res 2011;128: Post RV/LV Follow-up CT at 38 ± 14 hours

19 Main pulmonary artery Upper pulmonary artery Embolus Pulmonary artery trunk EKOS catheter devices Proximal lower lobe pulmonary artery Distal lower lobe pulmonary artery Lower lobe segmental branches

20 The Bern PE Experience with EKOS EKOS for acute PE: r-tpa 10 mg per device over 15 hours Improvement of symptoms after procedure Improvement of right heart dysfunction after procedure (hemodynamic parameters or echocardiography) Submassive PE: Systolic arterial pressure 90 mmhg and RV dysfunction or troponin test positive Massive PE: Systolic arterial pressure < 90 mmhg, cardiogenic shock, or CPR N=14 N=11 12 (86%) 10 (91%) 11 (79%) 10 (91%) Death during hospitalization - 1 (9%) Death from worsening RV failure Major bleeding 30 days 1 (7%) Intrapulmonal bleeding requiring lobectomy 1 (9%) Drop of hemoglobin without overt bleeding requiring transfusion Minor bleeding 30 days 1 (7%) Access site bleeding Recurrent VTE or death at 3 mts (18%) Access site bleeding

21 50 of 62 patients randomized as of August 2012

22

23 Take Home Points Systemic thrombolysis is recommended treatment for massive PE patients, however it is withheld in up to two thirds of patients Catheter interventions are promising minimal-invasive alternatives for massive PE patients who are not ideal candidates for systemic thrombolysis There is little evidence for mechanical catheter interventions without adjunctive thrombolytics There is a need for clinical trials to establish the role for pharmacomechanical interventions in submassive PE patients

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