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

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

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)

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

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

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

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

systemic thrombolysis

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

f, 40y, acute right heart failure, emergency op

1 2

3

mechanical thrombus fragmentation

Dormia-Basket (Pigtail-rotational catheter)

f, 81 y, stroke, dyspnea, DVT, CI for systemic lysis

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

m, 74y, after road accident

m, 74y, after road accident

m, 74y, after road accident

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))

pharmacomechanical thrombolysis - AngioJet

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

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

68 year old male patient, PE

68 year old male patient, PE

68 year old male patient, PAE

68 year old male patient, PE

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

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

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

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