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Improved clinical outcomes – Evidence on venous mechanical thrombectomy followed by stenting
Michael K. W. Lichtenberg, MD, FESC Vascular Centre Arnsberg, Germany
German Venous Centre Arnsberg, Germany
Disclosure
Speaker name:
Michael Lichtenberg
I have the following potential conflicts of interest to report:
Consulting (CR Bard, Veniti, Volcano, Biotronik, Terumo, Boston, Straub
Medical,Veryan, TVA medical, Spectranetics, Cook, Optimed)
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
X
Venous disease Western Europe
1. Wikipedia, 2016: Western Europe [https://en.wikipedia.org/wiki/Western_Europe] 2. Coon WW, Willis III PW, Keller JB. Venous thromboembolism and other venous disease in the Tecumseh Community Health. Circulation. 1973;48:839-846. 3. Oguzkurt L, Ozkan U, Ulusan S, Koc Z, Tercan F. Compression of the left common iliac vein in asymptomatic subjects and patients with left iliofemoral deep vein thrombosis. J Vasc Interv Radiol. 2008;19:366-371. 4. Maurins U, Hoffmann BH, Lösch C, Jöckel K-H, Rabe E, Pannier F. Distribution and prevalence of reflux in the superficial and deep venous system in the general population - results from the Bonn Vein Study, Germany. J Vasc Surg. 2008;48:680-87. 5. Ananikian PP, Nanian AM, Galstian SM, Pogoisan BS. Clinical aspects, diagnosis and treatment of varicose veins of the lower limbs associated with extravasal compression of the external iliac vein. Kardiologiia. 1984 Feb;24(2):97-100. 6. Raju S, Neglén P. High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: A permissive role in pathogenicity. J Vasc Surg. 2006;44:136-44. 7. Marston W, Fish D, Unger J, Keagy B. Incidence of and risk factors for iliocaval venous obstruction in patients with active or healed venous leg ulcers. J Vasc Surg. 2011;53:1303-1308.
*UK, DE, IT, ES, FR, NL
Country: Western Europe Population ≥ 18 Years Age 1 2016 Projection
Incidence 2 Annual Patients Annual Treatable Patients
DVT 0,25% 833.237 61% 3 508.274
CEAP Classification Prevalence 4 Affected Population Treatable Patients
C0 No Disease 9,7% 32.396.246 N/A 0
C1 Reticular Veins 59,0% 196.643.879 N/A 0
C2 Varicose Veins 14,3% 47.627.814 22,00% 5 10.478.119
C3 Edema 13,4% 44.694.821 21,80% 6 9.743.471
C4 Skin Pigmentation 2,9% 9.532.229 21,80% 6 2.078.026
C5 Healed Ulcers 0,6% 2.066.427 21,80% 6 450.481
C6 Active Ulcers 0,1% 333.295 60,00% 7 199.977
CVD (C2-C6): 104.254.585 23.458.348
% Obstuctive Component
Venous Outflow Obstruction
333.294.710
Acute
% Obstuctive Component
Chronic
Venous outflow obstruction
webs, spurs, chords
Konservative Therapie
KAHN et al. Determinants of health-related quality of life during the 2 years following deep vein thrombosis. Journal of Thrombosis and Haemostasis 2009, 6: 1105–1112
Catheter-directed thrombolysis plus anticoagulation versus anticoagulation alone in the treatment of proximal deep vein thrombosis - a meta-analysis
Vasa 2015 May;44(3):195-202
Iliofemorale
Offenheitsrate nach
6 Monaten
Persistierende
venöse Obstruktion
Im FU
Vasa 2015 May;44(3):195-202
Young and active patient
Descending ileofemoral
thrombosis
May-Thurner Syndrome
Phlegmasia, descending IVC
thrombosis
Bowel cancer
Stenosis of right iliac vein
With thrombus
Lymphocele compression
23 y female
patient
65 y male
patient 80 y female
patient
Indication for proximal venous thrombectomy
CDT with
high risk
CDT with
high risk
AngioJet® EKOS® Peripheral
Infusion System Trellis™ System
M. Lichtenberg (Hrsg.), C. Tiefenbacher, M. Katoh, P. Minko, E. Minar, C. Wissgott, A. Storck, B. Hailer: Thrombektomie: medikamentös, mechnisch, operativ. Uni-med Verlag,
2013
Early Clot Removal Many Choices
6 – 10
French
Aspirex® (Rotational thrombectomy) Indigo System ® (Penumbra)
21 y, female, descending DVT in May – Thurner syndrome. Transpopliteal access, 10 F Aspirex®
8 F: blood volume aspiration up to 75 ml/min
10 F: blood volume aspiration up to 130 ml/min
6 – 10
French Veniti Vici
Standard Treatment vs. CDT
Enden T, et al: CaVenT Study
– Follow-Up 24 months:
– Number needed to treat: 7
Lancet. 2012 Jan 7;379(9810):31-8.
Long-Term Results using Catheter-directed Thrombolysis in 103 Lower Limbs
with Acute Iliofemoral Venous Thrombosis
N. Bækgaard, R. Broholm, S. Just, M. Jørgensen, L.P. Jensen
European Journal of Vascular and Endovascular Surgery , Volume 39, Issue 1, Pages 112-117 (January 2010)
All patients with patent veins and normal valve
function
showed no sign of dermal pigmentation,
ulceration or venous
claudication at follow-up
1 major
bleeding
complication
PEARL Comparison Treatment of Lower Extremity DVT
PEARL* Venous Registry†
CaVenT‡
CDT Standard
# of Patients 329 287 90 99
# of Sites 32 63 20
Prior DVT 40% 31% 10% 9%
Primary Treatment AngioJet Thrombectomy
With or Without PMT CDT CDT LMWH
Stent Placement 35% 33% 17% NA
Primary access Popliteal Popliteal Popliteal NA
Male 57% 48% 64% 62%
Age (mean) 52.2 yrs 47.5 yrs 53.3 yrs 50.0 yrs
Treatment Location Iliofemoral – femoral pop Iliofemoral – femoral pop CFV or iliofemoral
Limbs Involved Left=62%; Right=38%
Left=61%; Right=39%
Left=60%; Right=40%
Left=62%; Right=38%
CDT, catheter-directed thrombolysis; CFV, common femoral vein;
LMWH, low molecular weight heparin; PMT, pharmacomechanical thrombolysis *Garcia,MJ, et al. J Vasc Interv Radiol 2015; 26:777-785 †Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 ‡Enden , Haig Y. Lancet 2012:379:31-38
PEARL* Venous Registry†
CaVenT‡
CDT Standard Overall % Thrombus
Removal 96% 83% 89% NA
By Lytic Groups: % thrombus removal
CDT (N=28)
93% NA NA
CDT+PPS/RL (N=167)
97% NA NA
PPS/RL (N=113)
95% NA NA
Acute: % Thrombus Removal
97% 86% 89%
Chronic: % Thrombus Removal
95% 68% NA
Primary Patency NA 6 Mon=65%; 12 Mon=60%
6 Mon = 65.9% 6 Mon = 47.4%
Freedom from Rethrombosis
6 Mon= 87%; 12 Mon=83%
NA NA NA
*Garcia,MJ, et al. J Vasc Interv Radiol 2015; 26:777-785 †Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 ‡Enden , Haig Y. Lancet 2012:379:31-38
PEARL Comparison Treatment of Lower Extremity DVT
• 2. Indications for early thrombus removal
• 2.1. We suggest a strategy of early thrombus removal in selected patients meeting the following criteria:
• (a) a first episode of acute iliofemoral deep venous thrombosis
• (b) symptoms <14 days in duration
• (c) a low risk of bleeding
• (d) ambulatory with good functional capacity and an acceptable life expectancy (Grade 2C)
Two center retrospective data analysis for DVT thrombectomy with the Aspirex® catheter
43 Aspirex thrombectomy procedures for
iliofemoral DVT
Technical success analysis
Safety analysis
Dr. Thomas Heller Dr. Michael Lichtenberg
Ileofemoral DVT therapy with Aspirex catheter
• May-Thurner syndrom: 43.1 years, 66 % female • Cancer patients with more phlegmasia symptoms • Duration of symptoms: 1 day – 3 months • Hemodynamic technical success in cath lab with Aspirex
and stent implantation: 97 % (42/43 patients) • No prolonged lytic therapy • Stent rate 100 % in Arnsberg patients / 95 % Rostock • IVUS 100 % • Stent rate 1,25 / patient • Complications: No bleeding, PE
Overall, the 2-year data supported the use of standard therapy/anticoagulation
alone in most DVT patients
PCDT was not shown to prevent postthrombotic syndrome (PTS) and was
associated with increased bleeding.
However, PCDT was shown to reduce early DVT symptoms as well as PTS
severity
The PCDT arm saw a statistically significant higher rate of major bleeding
within 10 days (1.7% vs 0.3%; P = .049),
Leg pain and leg swelling were significantly improved in patients who received
PCDT vs no-PCDT: (leg pain, 10 days: -1.62 vs -1.29; P = .019; 30 days: -2.17
vs -1.83; P = .026) (leg swelling, 10 days: -0.26 vs +0.27; P = .024; 30 days: -
0.74 vs -0.28; P = .051).
The difference in PTS severity was almost entirely seen in the
iliofemoral DVT patients with moderate/severe PTS seen in
18.4% of PCDT patients versus 28.2% in the no-PCDT group
Conclusion DVT thrombectomy
• Is effective in venous thrombus removal
• Even in more organized thrombus
• Restores vein patency in upper and lower limb
• Has low risk and less side effects with PMT
• No ICU stay
• „End it in the Angiolab“
• PMT will be the standard treatment
Treat the underlying reason with a
dedicated iliac vein stent
THANK YOU FOR YOUR ATTENTION
Improved clinical outcomes – Evidence on venous mechanical thrombectomy followed by stenting
Michael K. W. Lichtenberg, MD, FESC Vascular Centre Arnsberg, Germany
German Venous Centre Arnsberg, Germany
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