Venous stenting in Marseille

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1 Venous stenting in Marseille Olivier HARTUNG, MD, MSc CHU Nord, Marseille, FRANCE

2 Disclosure Speaker name: Olivier HARTUNG I have the following potential conflicts of interest to report: x Consulting : Boston Scientific

3 IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the on-label use of referenced technologies as well as current standards of care for certain conditions. Of course, patients and their medical circumstances vary, so the clinical considerations and procedural steps described may not be appropriate for every patient or case. As always, decisions surrounding patient care depend on the physician s professional judgment in light of all available information for the case at hand. Boston Scientific Corporation ( BSC ) does not promote or encourage the use of its devices outside their approved labeling. The presenter s experience with BSC products may not be interpreted or relied upon to support clinical claims about BSC devices or product comparison claims regarding BSC and competitive devices. The experiences of other users may vary. Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. PI AA Jan2018

4 Obstructive venous lesions 3 different contexts : Acute DVT Chronic primary (MTS) Chronic postdvt Treatment Medical : mostly insufficient Surgical : invasive and deceiving results ESVS 2015

5 FI +/- IVC stenting Since 1995 : 515 patients stented for femoroiliac and/or IVC lesions 60 Activity in venous stenting Chronic ST + stent 30 ss PCDT

6 Indications Disabling obstructive lesions CFV / iliac veins /IVC Not under the femoral confluence +/- reflux (superficial/deep) Symptomatic CEAP C2-C6, venous claudication, pelvic congestion Acute femoro-iliac DVT Despite best medical treatment

7 Preoperative workup Duplex-scan CFV +++ => percutaneous or hybrid procedure? CTV-MRV Femoro-iliac and IVC DFP for MRV Iliocavography Thrombophilia : acute and post DVT Duration of anticoagulation only

8 Anesthesia Simple lesions (MTS) : local + sedation Complex lesions (postdvt) : L+S or GA PCDT : LA + sedation for stenting Local + sedation Less aggressive Pain in case of perforation

9 Technique Percutaneous echo-guided puncture MTS : CFV Post DVT and acute : PV, FV +/- right IJV Iliocavography +/- IVUS Catheterism +/- recanalization Predilatation, stenting, postdilatation Postoperative course MTS : ES + LMWH 3W+ Plavix 1Y Post or advt : PCD + Plavix + oral anticoagulation 1Y

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14 Why stents? ESVS 2015 Before BA After 16 mm BA

15 Which stents? Self-expanding stents Long stents : at least 60 mm Avoid migration Large diameter : IVC : mm CIV : mm EIV : mm CFV : mm Mullens IJC 2006 Multiple stents : >20 mm overlap

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17 Chronic lesions PI AA Jan2018

18 May-Thurner syndrome Author N Median/mean PP app SP At FU (months) Neglen /NP 79% 100% 100% 6 Y Meng /NP 94% NA NA 5 Y Ye 205 NP/50 99% 100% 100% 4 Y Wittens 87 NP 90% 100% 100% 5 Y Hartung /43 88% 98% 99% 10 Y

19 Recanalizations 22 CEAP class (103 W, age 45 years) complete total occlusion of at least one venous segment on the iliac veins or on the IVC (7 Virtus study patients excluded) 148 venous claudication Median Villalta 9, VCSS 10 and VDS 3 Etiology : 148 postdvt (median delay 72 months (2-624)), 9 RFP, 2 MTS and 3 cancer Thrombophilia : 45 cases C2 C3 C4 C5 C6 Diseased and occluded venous segments 3 (1-8) and 2 (1-7) CFV 119 cases (55 occlusions) and IVC in 44 cases

20 Results 23 failures (TS 85,8%) => no worsening 1 Palma and 1 iliocaval bypass 2 ALV stenting, 1 cavo-azygos stenting 1 IVC recanalization without iliacs, 1 IVC clip stenting 15 endophlebectomies in 14 patients (AVF in 9) 3 stents (1-8)/p, length 230 mm (60-490) 2 IVC clip and 5 IVC filter stenting LOS : 4 days (2 days without endophlebectomy) Left ascending lumbar vein stenting =V LRV

21 Results Median FU : 44 months (mean 51, range 1-209) 6 deaths, all patent (36 months) Clinical outcome of recanalized patients : median Villalta 3 (0-15) and VDS 1 (0-3) C6 : all healed but one (rethrombosis) 12M 60M 90M PP app SP PP app SP PP app SP Recanalized patients 139p 85.3% 89.8% 93.4% 70.3% 85.5% 91.6% 65.7% 82.6% 88.3% Percutaneous 125p 89.3% 93.5% 95.9% 73% 88.8% 93.9% 68.4% 86.3% 90.9%

22 Results of recanalizations Author N % Technical Median PP app SP At postdvt success FU Kolbel 62 71% 92% 25M 67% 75% 79% 60M Rosales % 94% 33M 67% 76% 90% 24M Raju % 83% NP 30% 55% 66% 48M Ye % 95% 25M 70% 90% 94% 36M Ruihua % 95% 19M 81% 91% 93% 24M Hartung % 85.8% 44M 65% 82% 88% 90M percut % 86% 90%

23 Conclusion Sure and efficient treatment Patients selection +++ No worsening in case of technical failure Good long term results (clinical and patency) Anticoagulation +++

24 Recommandations First line treatment for ilio-caval chronic obstructive lesions AHA 2014 : for severely symptomatic patients with postthrombotic occlusion of CFV, IV, and IVC, combined operative and endovenous disobliteration may be considered ESVS 2015

25 Single session PCDT PI AA Jan2018

26 August December 2017 : 31 ss PCDT 21 F, 39 years Median delay : 8 days (1-14) 6 had IVC involvement Procedure : Length : 113 min (45-200) 15 Angiojet Zelante, 13 Trellis, 3 Aspirex 29 stented (2 instent DVT) 6 IVC filters => 2 aspiration No death, no PE, 1 popliteal hematoma No ICU, median LOS 3D (1-8)

27 Results Median FU : 19M (2-51) PP and app 96%, SP 100% at 36M 1 rethrombosis at day 2 => ST Villalta, VCSS and VDS: 1 (0-4), 2 (0-5) and 1 (0-2) No venous claudication Axial deep reflux : 2 (present before that DVT)

28 ST ss PCDT p N Delay since symptoms onset 3 days (1-10) 8 days (1-14) Length of stented vein -without IVC involvement 60 mm (30-120) 60 mm (30-120) 160 mm (60-430) 135 mm (60-220) <0.001 <0.001 Length of stay 8 days (5-22) 3 days (1-8) <0.001 early complications (<30 days) -major bleeding -minor bleeding -rethrombosis 8 (27%) 6 (20%) unknown 3 (10%) 3 (9%) 1 # (3%) 1 (3%) 1 (3%) NA Secondary procedure for AVF closure 26/30* NA NA Patency rates at 24 months -primary 78.9% 96% assisted primary 86.1% 96% secondary 86,1% 100% Villalta 4 (1-11) 2 (0-4) <0.001 VCSS 3 (1-12) 1 (0-5) <0.001

29 Author Tech N Acute results Complications Stenting FU Late results M Bush 12 A 20 Complete removal 65% 2 access site H 61% 10 No data Partial removal 35% 1 HRP Cynamon 13 A 24 Lysis II/III 79% MB 8% 37% 5.3 Recurrence 2 O Sullivan 14 T 19 Lysis II/III 96% 3 rethromboses 100% 1 app 100% No spe/mb Arko T, 12 A 30 6 incomplete thrombus removal => CDT No spe/mb 56% 6 Patency 90% Competence 88% Hilleman 16 T 147 Lysis II/III 93% MB 0% 32% Rao 17 T 12, A 13 T + A 17 43* 37% adjunctive CDT Lysis II/III 95% No spe/mb 35% 5 95% without rethrombosis Gasparis 18 A 14 52% adjunctive CDT Murphy 19 A T Lysis II/III 100% No spe/mb 65% 24 36% reflux 93% VCSS <5 Lysis 88% vs 72% No MB 100% 12 P 94% Residual thrombus 340 vs 788 mm 3 SS Reflux 9% Chaudry 20 T 28 Lysis II/III 100% No spe/mb 78% Patency 80% Gagne 21 T 142 Lysis II/III 87% 29% adjunctive CDT No MB 54% 12 Low severe PTs rate Bozkurt 22 C 16 2 failure (>14 days) No spe/mb 56% 6 12/13 patent at DS Bloom 23 A 11** Lysis >70% 100% 2 rethrombosis => second procedure 20% IVC filter with thrombus 72% % Villalta <5 No reflux Yuksel 24 C 46 Technical success 91% No spe/mb NS 16 Patency 79.5% Villalta <5 67.5% Dopheide 25 A 24 No spe/mb 100% 6 PP 92%, SP 100% 96% Villalta <5 Hartung T 13, A 15 Asp 3 31 Lysis >70% 100% 1 rethrombosis => ST No spe 1 popliteal hematoma 96% 19 PP 96.7%, SP 100% at 24M 100% Villalta <5

30 Comparative studies Author Technique N Acute results Complications Stenting FU Late results M Kim 26 A + CDT CDT /56 hours SS UK 2.9/6/7 M SS Venograms 2.5/3.4 SS Complete lysis 84%/80% MB 5.3% vs 7.7% PE 5.3%vs 3.8% 15%/23% 32 Recurrence 2 vs /10127 $ SS Lin 27 A 52 Lysis III 75%/70% Transfusion 82%/78% 13 PP 68% vs 64% CDT 46 Procedure length 76 need < SS min/18h SS MB 0/1 Improvement 81%/72% Venograms 0.4/2.5 SS ICU LOS 0.6/2.4 days SS LOS 4.6/8.4 days SS / $ SS Huang 28 A 16 Thrombolysis rate 81%/67% SS No spe/mb 83%/42% SS 12 PP 93.8% vs 88.9% CDT 18 Lysis II 100%/88% Villalta 2 vs 5 SS

31 Conclusion Single session PCDT is sure and efficient At least as good as CDT and ST But shorter procedure and LOS, No ICU, less thrombolytics and inferior cost Longer length of stented vein versus ST

32 Conclusion Single session PCDT is sure and efficient At least as good as CDT and ST But shorter procedure and LOS, No ICU, less thrombolytics and inferior cost Longer length of stented vein versus ST

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