Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
What is New in Acute Pulmonary Embolism?
Interventional Treatment
Prof. Nils Kucher
University Hospital Bern
Switzerland
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
- PE 2011 Guidelines -
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)
Low-risk PE (BP > 90 mm Hg, biomarkers – , ECHO – )
High-risk or massive PE (BP < 90 mm Hg, shock, CPR)
Risk stratification
Intermediate-risk or submassive PE (BP > 90 mm Hg, biomarker +, ECHO +)
No thrombolysis, catheter intervention,
or surgical embolectomy (Grade III B)
Systemic thrombolysis (Grade IIa B) Catheter intervention or
surgical embolectomy, if fibrinolysis contraindicated or if remains unstable
after fibrinolysis (Grade IIb C)
Systemic thrombolysis if bleeding risk is low (Grade IIb C)
Catheter intervention or surgical embolectomy (Grade IIb C)
Long-term treatment
Vitamin K antagonist for ≥ 3 months (Grade I A)
Engelberger R, Kucher N. Circulation 2011; 124:2139-44
The problems with Systemic PE Thrombolysis
• There is a 13% risk of major bleeding and a 1.8% risk of intracranial hemorrhage in randomized trials1
• There is a 20% risk of major bleeding and a 3% risk of intracranial hemorrhage in clinical practice2
• 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) PE3.
1ESC Guidelines. Eur Heart J 2008: 29:2276-2315 2Am J Cardiol. 2006;97:127-9
3ICOPER. Circulation 2006;113:577-82
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
Old & New Interventional Devices
for Acute Pulmonary Embolism
Greenfield Pigtail Clot buster AngioJet Aspirex
The Greenfield Suction Embolectomy Device
Courtesy of Lazar Greenfield, MD
Courtesy of Lazar Greenfield, MD
Combined Mechanical Techniques:
Fragmentation and Thrombectomy
Eidt-Lid et al. Chest 2008; 134:54
Hemodynamics Before Procedure After Procedure p Value
sSBP, mm Hg 94.8 ± 11.3 119.6 ± 14.9 0.001
mSBP, mm Hg 74.0 ± 7.9 88.8 ± 11.9 0.001
sPAP, mm Hg 64.1 ± 17.3 48.8 ± 20.1 0.001
mPAP, mm Hg 37.1 ± 8.8 31.1 ± 11.2 0.001
Miller index 20.8 ± 4.6 13.7 ± 6. 1 0.0001
Shock index 1.2 ± 0.2 0.7 ± 0.2 0.001
Eidt-Lid et al. Chest 2008; 134:54
Patients without additional thrombolysis (N=16)
Combined Mechanical Techniques:
Fragmentation and Thrombectomy
Pharmacomechanical Interventions
AngioJet Power Pulse thombolysis + thrombectomy
(Venturi effect)
EKOS Ultrasound-assisted thrombolysis
Aspiration technique
No lytics
89
60
81
33
21
72 (81)
6 (17)
22 (25)
Systemic lytics
9
50
87
31
20
9 (100)
0 (0)
1 (10)
Local lytics
9
-
-
31
24
9 (100)
0 (0)
0 (0)
Systemic + local
1
-
-
20
19
1 (100)
0 (0)
0 (0)
Fragmentation technique
No lytics 3
28
63
38
29
2 (67)
0 (0)
0 (0)
Systemic lytics 21
70
93
25
21
15 (71)
0 (0)
1 (5)
Local lytics 121
67
81
33
22
115 (95)
2 (2)
5 (4)
Systemic + local 30
65
69
32
30
24 (80)
3 (10)
6 (20)
Amplatz catheter
No lytics
8
86
108
49
53
7 (88)
1 (13)
1 (12)
Local lytics
6
85
93
64
60
6 (100)
0 (0)
0 (0)
AngioJet
No lytics 8
-
-
42
30
6 (75)
0 (0)
0 (0)
Local lytics 23
-
-
-
-
20 (87)
0 (0)
3 (13)
Hydrolyzer
Local lytics
12
47
97
46
30
11 (92)
0 (0)
1 (8)
Systemic + local 8
-
-
43
36
8 (100)
0 (0)
1 (12)
Catheter technique n
Mean BP,
mmHg
Before After
Mean PAP,
mmHg
Before After
Clinical
Success
Major
Bleeding Mortality
Clinical Outcome after PE Catheter Intervention
Skaf E et al. Am J Cardiol 2007;99:415-420.
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 = 594
86%
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;20:1431-1440
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
Ultrasound-Assisted Thrombolysis Effect of Ultrasound
Ultrasound +
Thrombolysis
Ultrasound pressure waves force drug
into thrombus, resulting in rapid removal
of thrombus even at low drug dose
Destabilization of fibrin strands,
enabling penetration of drug into thrombus
With Ultrasound
Without Ultrasound
Fibrin strands prevent drug from penetrating
thrombus and binding to plasminogen
receptor sites
The Ekosonic Endovascular System
5 fr Intelligent side-hole drug delivery catheter
Ekosonic Control Unit Ekosonic Mach4
Endovascular Device
Ultrasound MicroSonic™ Core
Pre to Post RV/LV Ratio
RV
/LV
Ratio
Pre RV/LV Post RV/LV0.6
0.8
1.0
1.2
1.4
1.6
1.8
2.0
N= 24
mean rt-PA dose 33 ± 15 mg over 20 hours
1.33 ± 0.24 1.00 ± 0.13
P < 0.001
Ultrasound-Assisted Thrombolysis
Improvement in Right Ventricular Enlargement
Follow-up CT
at 38 ± 14 hours Engelhardt TC, et al. Thromb Res 2011;128:149-54
Baseline CT
RV/LV ratio
Normal : <0.7
Prognosis : >1.0
Main pulmonary artery
Upper pulmonary artery
Pulmonary arterytrunk
EKOS catheterdevices
Lower lobesegmentalbranches
Embolus
Proximal lowerlobe pulmonaryartery
Distal lowerlobe pulmonaryartery
The Bern PE Experience with EKOS
2010-2012 EKOS for acute PE: r-tPA 10 mg per device over 15 hours
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
Improvement of symptoms after procedure
12 (86%) 10 (91%)
Improvement of right heart dysfunction after procedure (hemodynamic parameters or echocardiography)
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
2 (18%) Access site bleeding
Recurrent VTE or death at 3 mts - -
50 of 62 patients
randomized
as of August 2012
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