Retrospective analysis of the efficacy and safety of ... · safety of interventional techniques in...
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Retrospective analysis of the efficacy and safety of interventional techniques in the
treatment of severe, acute pulmonary embolism
Thomas Heller, MD
University Medicine of Rostock Dept. of diagnostic and interventional Radiology
LINC, 27.01.2016, Leipzig
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Disclosure
Speaker name: Thomas Heller
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
X
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Epidemiology of PE
US: 600.000/y, 150.000 – 300.000 letal
80/100.000 (NCHS 2007)
1/3 postmortem (NEJM 358, 2008, 1037-1052)
Europe: 210/100.00 (Nordstrom M, Lindblad B. Autopsy-verified venous thromboembolism
within a defined urban population—the city of Malmo, Sweden. APMIS 1998;106: 378–384)
60/100.00 (Oger E. Incidence of venous thromboembolism: a community-based study
in Western France. EPI-GETBP Study Group. Groupe d’Etude de la Thrombose de Bretagne
Occidentale. Thromb Haemost 2000;83:657–660)
Course: 10% - 30% letal (wo treatment) (Nowak, Radiologe 2007; 47: 663-672)
complete Recanalisation 65% (Nijkeuter M, Hovens MM, Davidson BL,
Huisman MV. Resolution of thromboemboli in patients with acute pulmonary embolism: a
systematic review. Chest 2006;129:192–197)
CTEPH 0,5 – 5% (Becattini C, Agnelli G, Pesavento R, Silingardi M, Poggio R,
Taliani MR et al. Incidence of chronic thromboembolic pulmonary hypertension after a first
episode of pulmonary embolism. Chest 2006;130:172–175)
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Cohen AT et al. Thromb Haemost. 2007;98:756–764.
Outpatient During hospital stay Total
VTE
Deep vein thrombosis
Pulmonary embolism
200.482
86.511
265.233
209.471
465.715
295.982
VTE associated death
Patient on anticoagulation
Patient not on anticoag.
Sudden death
108.535
8.124
63.541
36.870
261.477
18.349
153.853
89.275
370.012
26.473
217.394
126.145
Chronic complications
Postthrombotic Syndromeb
Pulm. Hypertension
177.236
1.173
218.437
2.961
395.673
4.135
VTE Impact Assessment Group in Europe (VITAE) Estimation in 2004
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Risk stratification of PE
High risk: Hemodynamic instable with shock
(RR syst. <100 mmHg, Puls >100/min)
30% 30d Mortality in case of shock
60 – 90% 30d Mortality ic of resuscitation
Intermediate risk: Hemodynamic stable with
rightventricular dysfunction
1 – 8%
Low risk: Hemodynamic stable without
rightventricular dysfunction
Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Massive pulmonary embolism. Circulation.
2006;113:577–582
Kasper W, Konstantinides S, Geibel A, Olschewski M, Heinrich F, Grosser KD, Rauber K, Iversen S,
Redecker M, Kienast J. Management strategies and determinants of outcome in acute major pulmonary
embolism: results of a multicenter registry. J Am Coll Cardiol. 1997;30: 1165–1171
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Systemic thrombolyis
Local thrombolysis
Endovascular approaches
• Thrombus fragmentation and
removal by Ballon-PTA, Basket,
Aspiration
• Pharmacomechanical thrombolysis
AngioJet (Boston Sc. (Medrad))
EkoSonic (BTG)
• Mechanical thrombectomy devices
Aspirex (Straub)
PE – treatment options
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Antithrombotic Therapy for VTE Disease Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest
Physicians Evidence-Based Clinical Practice Guidelines Clive Kearon , MD , PhD ; Elie A. Akl , MD , MPH , PhD ; Anthony J. Comerota
, MD ; Paolo Prandoni , MD , PhD ; Henri Bounameaux , MD ; Samuel Z. Goldhaber , MD , FCCP ; Michael E. Nelson , MD , FCCP ; Philip
S. Wells , MD ; Michael K. Gould , MD , FCCP ; Francesco Dentali , MD ; Mark Crowther, MD ; and Susan R. Kahn , MD
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systemic thrombolysis
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Placement of the catheter in / on the thrombus, rtpa:
15 mg/pulmonal artery Bolus
1 mg/h, 12 - 24h, control
The more effective, the fresher the fibrin aggregat is
10 x more effective than systemic lysis
AE up to 35% (generally loc. bleeding)
Pieri S, Agresti P; Radiol med (2007) 112; 837-849
Kuo WT et al.; Chest (2008) 134; 250-254
local thrombolysis
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f, 40y, acute right heart failure, emergency op
1 2
3
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mechanical thrombus fragmentation
Dormia-Basket (Pigtail-rotational catheter)
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f, 81 y, stroke, dyspnea, DVT, CI for systemic lysis
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Features 5.4 Fr catheter 106 and 135 cm working length 6, 12, 18, 24, 30, 40 and 50 cm treatment zones
Infusion Catheter
Ultrasonic Core
Ultrasound accelerated thrombolysis -EKOS
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m, 74y, after road accident
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m, 74y, after road accident
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m, 74y, after road accident
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Ultrasound accelerated thrombolysis
Kucher N ea, Randomized, Controlled Trial of Ultrasound-Assisted Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism, Circulation. 2014; 129:479-486
59 patients, mean age was 63±14 years, and 53%
n = 30 USAT regimen of 10 to 20 mg rtpa over 15 hours
n = 29 heparin
Primary outcome was the difference in the RV/LV ratio from
baseline to 24 hours
USAT RV/LV ratio reduced from 1.28±0.19 to 0.99±0.17
heparin group RV/LV ratio 1.20±0.14 to 1.17±0.20
D 90: 1 death (in the heparin group), no major bleeding, 4 minor
bleeding episodes (3 in the USAT group (2 hemoptysis, 1
accesssite groin hematoma and 1 in the heparin group
(muscular hematoma))
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pharmacomechanical thrombolysis - AngioJet
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Size Length cm
GW OD mm
rVD mm
Rotation rpm
MAC ml/min
Head
6 F 110 0,018 2,0 3 – 5 60.000 45 L-shape
135 0,018 2,0
8 F 85 0,018 2,6 5 - 8 40.000 75 L-shape
110 0,018 2,6
10 F 110 0,025 3,3 7 - 12 40.000 130 8-shape
GW-Guidewire, OD-outer diameter, rVD-recommended Vessel Diameter,
MAC-maximum aspiration capacity
mechanical thrombectomy - AspirexS
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Popovic P, Bunc M. Massive pulmonary embolism: percutaneous
emergency treatment using an aspirex thrombectomy catheter.
Cardiovasc Intervent Radiol. 2010 Oct;33(5):1052-5.
Popovič P, Kuhelj D, Bunc M. Superior mesenteric artery embolism
treated with percutaneous mechanical thrombectomy. Cardiovasc
Intervent Radiol. 2011 Feb;34 Suppl 2:S67-9
Horsch AD, van Oostayen J, Zeebregts CJ, Reijnen MM. The Rotarex®
and Aspirex® mechanical thrombectomy devices. Surg Technol Int. 2009
Apr;18:185-92.
Eid-Lidt G, Gaspar J, Sandoval J, de los Santos FD, Pulido T, González
Pacheco H, Martínez-Sánchez C. Combined clot fragmentation and
aspiration in patients with acute pulmonary embolism. Chest. 2008
Jul;134(1):54-60.
Mechanical thrombectomy - Aspirex®S
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68 year old male patient, PE
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68 year old male patient, PE
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68 year old male patient, PAE
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68 year old male patient, PE
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Own Data
1998 - 2015:
96 patients, 15 – 87 y, mean age: 62y, gender: 35 f, 61 m
pre-intervention CT acute PE, Stage I (high risk)
right ventricular dysfunction (clinic, TTE, CT)
local thrombolysis, aspiration-thrombectomy combined with
local lysis, mechanical thrombus fragmentation (Pigtail,
Dormia-Basket) combined with local thrombolysis,
pharmocomechanical thrombolysis, mechanical thrombectomy
control: clinic, heart ultrasound, angiography, CT-scan
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mechanical TE: 20 pat.
local thrombolysis: 37
thrombus fragmentation + loc. lysis: 29
EKOS: 10
36 patients (37%) morphologically incomplete recanalisation (23
loc. lysis, 8 Clotbuster, 4 Aspirex, 1 EKOS) but hemodynamic imp.
2 pat (2%) MAE parenchymal bleeding (2 local lysis)
4 pat (4%) MIE bleeding at the puncture site wo rel. (2 ll, 2 EKOS)
3 pat (3%) died on table due to fulminant right heart failure
2 pat died within 30d (2%) (MOF)
PEITHO-Study: sLyse: 2,6% d, 6,3% b, 2,4% stroke
Hep: 5,6% d, 1,2% b, 0,2% stroke
Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism, Meyer, G. et
al, N Engl J Med 2014; 370:1402-1411
Own Data
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Conclusion
Endovascular approaches can be very effective and
livesaving
Different methods with comparable results
Safe
RCT not available, need more data
Optimal devices does not exist
Operation is on your own responsibility
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Retrospective analysis of the efficacy and safety of interventional techniques in the
treatment of severe, acute pulmonary embolism
Thomas Heller, MD
University Medicine of Rostock Dept. of diagnostic and interventional Radiology
LINC, 27.01.2016, Leipzig