Aspirex for Upper and Lower Extremity DVT
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1 Aspirex for Upper and Lower Extremity DVT Steven Kum MD Vascular & Endovascular Surgeon Director of Vascular Service Changi General Hospital Singapore
2 Disclosure Speaker name:... 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
3 What is the utility of Mechanical Thrombectomy Relieve obstructed arterial or venous flow eg acute limb ischemia, phlegmasia Unmask underlying offending lesion, reduce stent lengths Debulking Improve absorption of Drug eg DCBs
4 Common Scenarios Acute Arterial Occlusions Lower Limb (Native artery and Bypass Grafts) Upper Limb Visceral organs EVAR Limbs Chronic Arterial Occlusions CTOs ISRs/occlusions Acute Venous Occlusions Upper and lower limb DVTs AVF Occlusions
5 Why not slow Thrombolysis? Bleeding Risk Rochester trial 11% (urokinase) STILLE trial 5.6% (urokinase and r-tpa) TOPAS trial 12.5% (urokinase) Time to relieve obstruction Costs Logistics
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7 PTS after DVT Frequent, but underestimated chronic complication after DVT > 25% at risk for developing PTS following an acute DVT 5-10% severe PTS Courtesy Lichtenberg
8 The open vein hypothesis Early thrombus removal and restoration of flow is critical for the prevention of postthrombotic syndrome
9 ATTRACT TRIAL
10 Performance of PCDT INITIAL PCDT METHOD Trellis (Technique A) 50 Patients (15%) Angiojet (Technique B) 75 Patients (23%) Infuse-First (Technique C) 194 Patients (59%) ADJUNCTIVE PROCEDURE Balloon maceration (56%) Balloon angioplasty (56%) Angiojet (55%) Aspiration (19%) Trellis (14%) Stent placement (30%) IVUS: NO!!! No definitions when to stent and where to stent in the protocol
11 The ATTRACT failures Inclusion of femoropopliteal DVT (43%) No definition of criteria for stenting No IVUS No dedicated venous stents (59%) Outcome 24 months PCDT (n=336) No-PCDT (n=355) P Value Recurrent DVT 12.5% 8.5% Placebo around 10% recurrent DVT ASA 6% recurrent DVT NOACS 1% recurrent DVT
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13 Rotational thrombectomy (Aspirex ) Archimedisches Wirkprinzip Förderantrieb U/min Magnetkopplung 1,5 ml/s mit 8 F System 0,66 ml/s mit 6 F System 6 10 French 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
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15 Patient Demographics Retro-ASPIREX Total N (%) 56 (100 %) Age Mean (Median [Range]) in years 52 (51 [17-89]) Female N (%) 37 (66 %) Male N (%) 19 (34 %) General Medical History N (%) Smoking status (valid observations) 55 (100 %) Current 9 (16 %) Former 4 (7 %) Hypertension 56 (100%) Yes 28 (50 %) Immobilisation (valid observations) 55 (100 %) Yes 4 (7 %) Malignancy 56 (100 %) Current active 4 (7 %) Condition post 5 (5 %) Oral contraceptive 56 (100 %) Yes 21 (38 %) No 35 (62%) Study is sponsored by Klinikum Arnsberg
16 Diagnostic details (contd.) N (%) Type of occlusion 56 (100 %) Acute 40 (71 %) Subacute 13 (23 %) Chronic 2 (4 %) Acute / Chronic 1 (2 %) D-Dimer test positive 56 (100 %) Not done 37 (66 %) Yes 17 (30 %) No 2 (4 %) Underlying lesion 56 (100 %) May Thurner 25 (45 %) Not determined 14 (25 %) Cancer 5 (9 %) Post-thrombotic alterations 5 (9 %) Benign prostate hypertrophy 1 (2%) Factor V 1 (2 %) May Thurner / Condition after surgical 1 (2 %) intervention May Thurner / Protein C deficiency 1 (2 %) Mechanical (e.g. V. cava clip) 1 (2 %) Peripartal 1 (2 %) Thoracic outlet syndrome 1 (2 %) Study is sponsored by Klinikum Arnsberg
17 Diagnostic details (contd.) N (%) Location of occlusion (vessel) 56 (100 %) Left complete pelvic veins including com. femoral vein, left sup. femoral vein (may also include profunda femoral vein and 42 (75 %) distal part of IVC) Left common iliac vein only 7 (13 %) Left common iliac vein / Left external iliac vein without com. femoral vein 3 (5 %) Right complete pelvic veins 4 (7 %) Length of occlusion [mm] N=56 (100 %) Statistics Mean (SD) (72.0) Median (Range) (60 410) Study is sponsored by Klinikum Arnsberg
18 Aspirex treatment (contd.) N (%) Heparin [IU] 56 (100) 5, (89 %) 10,000 3 (5 %) 7,000 OR 7,500 OR 9,000 (1 patient each) 3 (5 %) Thrombolysis 56 (100 %) No 52 (93 %) Yes 4 (7%) Technical success Yes 56 (100 %) Number of implanted stents 56 (100 %) Mean (SD) 1.9 (1.2) Median (Range) 2 (0 6) Treatment duration [min] N=34 Mean (SD) 94.2 (44.8) Median (Range) 81.5 ( ) Study is sponsored by Klinikum Arnsberg
19 Safety Patients (N=56) by number of adverse events (non device related but procedure related) N (%) no 45 (80 %) yes (hematoma, puncture site infection, bleeding 11 (20 %) complication) Patients (N=56) by number of serious adverse events (non device related but procedure related) no 48 (86 %) yes (rehospitalization, re-occlusion of target vein, prolonged hospitalization because AV-Fistula operation or operation of access site complication) 8 (14 %) Device malfunction reported Aspirex None 56 (100 %) Complaints reported on Aspirex None 56 (100 %) Study is sponsored by Klinikum Arnsberg
20 Patency analysis: DUS with restenosis < 50% N (%) Patency on FU month 1 (valid observations) 47 (100 %) Yes 44 (94 %) Patency on FU month 6 (valid observations) 37 (100 %) Yes 35 (95 %) Patency on FU month 12 (valid observations) 26 (100 %) Yes 24 (92 %) Patency rate including scondary patency rate after 12 months 92 % Study is sponsored by Klinikum Arnsberg
21 Outcome: Post thrombotic syndrome N (%) Post-thrombotic syndrome 53 (100 %) low PTS (CEAP Score < 3, rvcss Score < 3) 34 (64 %) moderate/severe PTS (CEAP Score > 3, rvcss Score > 3) 19 (36 %) Prevention of moderate and severe PTS in 64 % of patients Study is sponsored by Klinikum Arnsberg
22 CASE EXAMPLES
23 LOWER LIMB THROMBOSIS
24 Courtesy Lichtenberg
25 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
26 UPPER ARM THROMBOSIS
27 Acute Upper Arm DVT x 10 days Paget Schroetter Syndrome Groin Approach Basilic Vein 8F Puncture
28 Groin Approach
29 Supplement with 120,000 units of Urokinase to soften up clot
30 8F Aspirex
31 Webs in 1 st part of left SCV Protégé 14mm stent
32 1 st Rib Resection Post op doppler Immediate resolution of swelling
33 Conclusion We have excellent VTE guidelines for anticoagulation therapy We have no! consensus guidelines for endovascular treatment of DVT Individual/subjective society interpretation of data ATTRACT: only iliac vein thrombosis should be treated There is a must for more prospective well controlled trials with mechanical or pharmacomechanical therapy
34 Aspirex for Upper and Lower Extremity DVT Steven Kum MD Vascular & Endovascular Surgeon Director of Vascular Service Changi General Hospital Singapore
- Our patients with iliofemoral DVT - Effective thrombus removal with purely mechanical thrombectomy can lead to better outcomes
- Our patients with iliofemoral DVT - Effective thrombus removal with purely mechanical thrombectomy can lead to better outcomes Michael K. W. Lichtenberg, FESC Conflict of Interest - Disclosure Within
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