Chronic deep venous occlusions: Case planning, recanalization and stent technique

Transcription

1 Chronic deep venous occlusions: Case planning, recanalization and stent technique Michael K. W. Lichtenberg, FESC German Venous Center Arnsberg, Germany

2 Conflict of Interest - Disclosure Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company 1. Honoraria for lectures: CR Bard, Veniti, AB Medica, Volcano, Optimed GmbH, Straub Medical, Terumo, Biotronik, Veryan 2. Honoraria for advisory board activities: Veniti, Optimed GmbH, Straub Medical, Biotronik, Veryan, Boston Scientific 3. Participation in clinical trials: Biotronik, CR Bard, Veryan, Straub Medical, Veniti, TVA Medical, Boston Scientific, LimFlow 4. Research funding: Biotronik, Boston Scientific, Veryan, Veniti, AB Medica

3 Complexity of Venous Hemodynamics Artery High-pressure High-velocity Small-volume High-resistance diverging pipe system Pulsatile flow Stiffer vessel walls Vein Low-pressure Low-velocity Large-volume Low-resistance converging pipe system Phasic flow High compliance Valves

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5 C6, 58 year female, postthrombotic syndrome

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7 Sinus XL Stent (22 x 80 mm) 4 x Veniti Stents (16 x 120 mm + 14 x 60 mm)

8 What has ilio-caval vein stenting shown us? Venous outflow obstruction plays an important role in clinical expression of CVD, particularly pain 1,3-4 Ulcerated limbs have a high rate of obstruction (37-52%) 5-6 In limbs with obstruction, ulcers occur rarely with isolated obstruction (4%), more often in association with reflux (30%) 1 Treatment results in impressive clinical relief of pain, swelling, VCSS, VDS and QoL, even when associated reflux is left untreated 1-3 Treatment results in healing of ulcers, despite untreated reflux, in 55-58% of the patients 1,3,6 1 Neglén et al, J Vasc Surg 2003;38: Hartung et al, J Vasc Surg 2005;42: Neglén et al, J Vasc Surg 2007;46: Delis KT et al. Ann Surg 2007, 245: Marston et al, J Vasc Surg 2011, 53: Alhalbouni S et al, Ann Vasc Surg. 2012, 26:185-9

9 How do I find patients with ilio-femoral venous obstruction? Awareness Think obstruction! Specific clinical signs and symptoms severe C 3, C 4-6 abdominal collaterals, atypical vv, early vv recurrence typical venous claudication venous visceral type of pain/discomfort postthrombotic disease pain out of proportion to lesion no detectable lesion explaining symptoms

10 Morphological Studies Duplex Doppler scanning (including pelvic outflow) Ascending venogram Transfemoral antegrade venogram CT-V, MR-V or IVUS Morphological diameter/ area stenosis >50% is considered significant.

11 Intravascular Ultrasound Evaluation of lumen diameter and stenosis Evaluation of thrombus, fibrotic tissue and scare tissue Evaluation of compression Intervention without contrast dye Peter Neglen 2002 Journal of Vascular Surgery: In comparison to standard venography IVUS appears to be superior for identify morphologic changes of iliac venous outflow obstruction

12 Visions PV.035 Digital IVUS Catheter Visions PV.035 IVUS Catheter * Product Overview 60 mm field of view, free of wire artifact - 10 MHz 90 cm working length Over-the-wire design guide wire compatible Min. Sheath 8.5 F New radiopaque and inked centimeter markers Radiopaque Markers 12

13 Venous obstruction

14 Can the patient be stented? Assess the Landing Zones Attempt to assess the central and peripheral extent of the disease before the intervention is scheduled using DUS, venogram, CTV, MRV etc. 1. Central landing zone a. Is the IVC patent? b. Does the disease involve the IVC? c. Is the potential outflow of the stent system appropriate? d. Is the contralateral venous outflow compromised? 2. Peripheral landing zone a. Is the CFV involved? b. Is there a potential landing zone in the CFV above the profundafemoral vein confluence? c. Is there a sufficient inflow from the periphery to sustain patency of a stent placed in the pelvic outflow?

15 Tips and trick for access Ipsilateral femoral vein Ultrasound guided access Vein is usually post-thrombotic scarred Orientation can be difficult Stiff hydrophilic guidewire (Terumo) Dilators 6,8,10 F Extra support, long sheaths Different projections

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17 Recanalization Exchange for superstiff guidewire Advance PTA ballons (10,12,14,16,18 mm) Predilatation is eminent Standard inflation pressure is 6 12 atm (PAINFULL!!!!) No rupture risk!

18 Stenting Double barrel Apposition Fenestration Bifurcation

19 Venous Stenting is Not New Significant body of clinical work Existing stents Wallstent Good success treating obstructive component of many venous disorders Current generation of stents being studied VIVO Trial Zilver Vena (Cook Medical) VIRTUS Trial VICI VENOUS STENT (VENITI, Inc.) 19

20 Venous Stent Attributes Self-expandable Crush resistant across length of stent Sufficient chronic outward force Sufficient wall coverage Flexibility sufficient to resist kink at physiological angles Durability allowing repeated shortening, twisting, and bending at the groin Minimal foreshortening on deployment and balloon dilation Predictable, consistent deployment Strength Flexibility Lumen quality

21 Stent options! Boston Wallstent Optimed Cook Zilver Vena VIVO (EU) Trial Veniti Vici VIRTUS Trial Optimed Sinus obliquus Sinus Obliquus-01-NIS Bard Venovo VERNACULAR Trial Upcoming: Medtronic, Gore, ab Medica, INTACT, Abbott Vascular

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24 Venovo Stent 14 x 120 mm and 14 x 80 mm on both CIV and EIV

25 Performance Characteristics Closed Cell Open Cell Design Attributes All struts interconnected Not all struts interconnected Performance Crush Resistance ++ + Flexibility + ++ Coverage ++ +

26 Radial Resistive Force at 1mm oversize (N/mm) Local Compression Force (N) Radial Force and Crush Resistance Radial Resistive Force Crush Resistance BARD VENOVO 14X160 N=20 OPTIMED SINUS VENOUS 14X80 N=3 COOK ZILVER VENA 14X100 N=2 BARD VENOVO 14X160 N=20 OPTIMED SINUS VENOUS 14X80 N=3 COOK ZILVER VENA 14X100 N=3 Bench testing may not be indicative of clinical performance. Different test methods may yield different results. Competitive testing samples represent commercially available venous stents with CE mark as of June This product is not available for sale in the US

27 3 Point Bending Stiffness (N) Stent Flexibility BARD VENOVO 14X160 OPTIMED SINUS VENOUS 14X80 COOK ZILVER VENA 14X100 Bard Bard N=20 Optimed Sinus Venous N=3 Cook Zilver Vena N=3 Bench testing may not be indicative of clinical performance. Different test methods may yield different results. Competitive testing samples represent commercially available venous stents with CE mark as of June Optimed Cook This product is not available for sale in the US

28 Results from VIVO-EU, a Prospective Study of the Zilver Vena TM Venous Stent in the Treatment of Symptomatic Iliofemoral Outflow Obstruction Michael Lichtenberg, M.D. and Jennifer McCann-Brown, Ph.D., RAC 1 Klinikum Arnsberg, Germany; 2 Cook Research Incorporated On behalf of the Investigators: Christoph Binkert, M.D. Narayan Karunanithy, M.D. Gerard O`Sullivan, M.D. Marta Ramirez Ortega, M.D. 28

29 Real World Patient Population Medical History Reported (N=35) Clotting disorder (family history) 14.3% (5) Bleeding diathesis/coagulopathy 14.3% (5) Pulmonary embolism (history or current) 20.0% (7) Deep vein thrombosis (DVT) 62.9% (22) Acute DVT Acute DVT on Chronic DVT Acute DVT Acute DVT Chronic Chronic DVT DVT Chronic DVT 40.9% (9/22) 9.1% (2/22) 50.0% (11/22) 40.9% (9/22) 9.1% (2/22) 50.0% (11/22) DVT (family history) 28.6% (10) History of cancer 8.6% (3) Currently undergoing treatment 33.3% (1/3) 29

30 Side treated Lesion Location Vessel location(s) Baseline Lesion Data Left Right Site Reported (n=35) 94.3% (33) 5.7% (2) Core Lab (n=34) 94.1% (32) 5.9% (2) Common iliac vein 57.1% (20) 55.9% (19) External iliac, common iliac veins 22.9% (8) 14.7% (5) Common femoral, external iliac, common iliac veins 20.0% (7) 20.6% (7) Common femoral vein 0% (0) 5.9% (2) Femoral, common femoral, external iliac, common iliac veins Lesion Characteristics 0% (0) 2.9% (1) Lesion Length (mm; Mean ± SD) 106 ± 69 (n=35) (range: mm) 89.3 ±58.6 mm (n=31) (range: ) Total Occlusion 12.9% (4/31) % (7/31) 1 A determination of total occlusion could not be made in four patients.. Lesion data are consistent with previous reports for this population. 30

31 Major Adverse Events Major Adverse Event Frequency (n=35) Procedural bleeding requiring transfusion 0 Procedure- or device-related death 0 Clinically-driven target lesion reintervention for occlusion 1 1 Stent migration requiring intervention 0 Procedure- or device-related symptomatic pulmonary embolism 2 1 Procedure-related uncorrectable perforation 0 Procedure-related flow-limiting dissection of the target vessel 0 Total 2 1 A clinically-driven reintervention for occlusion at 155 days post-procedure. Edema and a prereintervention INR of 1.1; the occlusion was treated by thrombolysis, balloon angioplasty, and additional stent placement. 2 A symptomatic pulmonary embolism one day post-procedure, categorized as possibly related to the study procedure and managed by a change in medication. No additional clinical sequelae reported. 31

32 Venous Clinical Severity Score Improved Following Treatment Four patients did not complete 12-month follow-up due to unrelated death (n=1), withdrawal (n=1), or lost-tofollow-up (n=2). Patients with any reintervention (n=5) in the stented vessel were excluded from subsequent assessment of venous clinical symptoms. 32

33 Venous Disability Score Improved Following Treatment Four patients did not complete 12-month follow-up due to unrelated death (n=1), withdrawal (n=1), or lost-tofollow-up (n=2). Patients with any reintervention (n=5) in the stented vessel were excluded from subsequent assessment of venous clinical symptoms. 33

34 VICI 14 x 120 mm

35 VIRTUS Feasibility Trial Design Objective Safety Assess safety & effectiveness in achieving patency of target venous lesion through 12-M post stent placement 30 days Post-thrombotic Effectiveness Primary 12-M Principal Investigators Study Design Patient Population Dr. William Marston Dr. Mahmood Razavi Prospective, multicenter, single arm nonrandomized, up to 45 sites worldwide 200 subjects with clinically significant chronic nonmalignant obstruction of the iliofemoral venous segment first 30 were feasibility. Image Courtesy of Mr. Stephen Black Non-thrombotic Etiologies: Post Thrombotic (75%); Non Thrombotic (25%) Core Labs Venography: Syntactx IVUS: St. Lukes DUS: VasCore/MGH X-Ray: Syntactx Image Courtesy of Mr. Mahmood Razavi

36 Demographics & Medical History Female 24 (80%) Male 6 (20%) Age CEAP* 44.4 ±14.1 years Baseline 0 3% (pain by VCSS Score of 2) 1 0% 2 0% 3 47% 4 40% 5 7% 6 3% Etiology PTS 63% NIVL 37%

37 Target Lesion Location Lesion 1 Location Patients N = 30 Left N = 25 (83%) CIV lesions 26/30 (87%) EIV lesions 18/30 (60%) CIV & EIV lesions 15/30 (50%) Right N = 5 (17%) Lesions that extended into CFV 2 Average Target Lesion Length 9/30 (30%) 11.9 ±6.7 cm 1. Some patients have more than 1 lesion or lesion extends in multiple vein segments 2. No lesions were isolated to the CFV alone

38 Patency by Duplex Ultrasound (Corelab Analysis) Patency Results of Feasibility Cohort (N=30) Primary Patency 1 Secondary Patency 1- M 93% 100% 6 M 90% 100% 12 M 93% 97% Courtesy of Dr. Ediberto Soto-Cora

39 Patency by Lesion Etiology (Site Reported) Patency Results at 12-Months (Site Reported) Full Cohort Etiology (N=30) Primary Patency 1 87% (26/30) Secondary Patency 97% (29/30) NIVL 37% 100% (11/11) 100% (11/11) PTS 63% 79% (15/19) 95% (18/19) Courtesy by Dr Michael Sadek All patients enrolled in the study will be followed until study completion

40 VCSS Pain Scale 45% had substantial symptomatic improvement (VCSS 2

41 CIVIQ-20

42 Arnsberg Venous Registry VENITI VICI VENOUS STENT System Objective Assess safety & effectiveness in achieving patency of target venous lesion through 36 months post stent placement (VENITI VICI Stent) Effectiveness Primary 12-M Principle Investigators Dr. Michael Lichtenberg Dr. Rick de Graaf Study Design Ongoing prospective, single arm, single center non-randomized registry FU 1 (4 weeks), FU 2 (6 months), FU 3 (12 months), FU 4 (24 months), FU 5 (36 months) Patient Population Subjects with clinically significant chronic non-malignant obstruction of the iliofemoral venous segment

43 Demographics N=90 Age in years (mean ± SD [range]) 57.4 ± 16.4 [19-84] Gender Male Female 47.8% (N=43) 52.2% (N=47) Ethnicity Caucasian 100% (N=90) Medical history N=90 Coagulation disorder 4.4% (N=4) Pulmonary embolism 24.4% (N=22) Deep vein thrombosis 47.8% (N=43) History of cancer 14.4% (N=13)

44 Lesion analysis N=90 Sides treated Both Left Right Lesion location(s) Left: Common iliac vein External iliac vein Common femoral vein Common iliac vein, external iliac vein Common iliac vein, external iliac vein, common femoral vein External iliac vein, common femoral vein Right: Common femoral vein Common iliac vein External iliac vein Common iliac vein, external iliac vein Common iliac vein, external iliac vein, common femoral vein External iliac vein, common femoral vein Both: 64 / 90 (71%) patients: Postthrombotic 26 / 90 (29%) patients: NIVL External iliac (R), common iliac (L) vein External iliac (R), common iliac (L), external iliac (L) vein Common iliac (R+L), external iliac (L) vein Common iliac (R+L), external iliac (R+L), common femoral (L) vein Common iliac (R+L), external iliac (R+L), common femoral (R+L) vein 7.8% (N=7) 74.4% (N=67) 17.8% (N=16) 37.8% (N=34) 4.4% (N=4) 2.2% (N=2) 17.8% (N=16) 8.9% (N=8) 3.3% (N=3) 2.2% (N=2) 3.3% (N=3) 6.7% (N=6) 1.1% (N=1) 1.1% (N=1) 3.3% (N=3) 1.1% (N=1) 2.2% (N=2) 2.2% (N=2) 1.1% (N=1) 1.1% (N=1)

45 Effectiveness analysis % Patentcy analysis % 100 % 100 % 97% 90 % 87 % 10 0 N=82 N=50 N=21 FU 4 w FU 6 mo FU 12 mo NIVL PTS

46 Mean VCSS score (±SD) Claudication, Pain, Swelling, Ulceration improvemnt N=90 N=82 N=50 N=21 0 Baseline FU1 FU2 FU3

47 Mean CEAP score (±SD) N=90 N=82 N=50 N=21 0 Baseline FU1 FU2 FU3

48 The BARD VENOVO Venous Stent Study A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease an Assessment for Effectiveness and Safety (VERNACULAR)

49 Study Design Type of Study Prospective, multi-center, global, singlearm, non-randomized study Number of Sites Up to 35 Number of Subjects 170 Primary Endpoint Follow Up Follow-Up Intervals 12-Months Post-Procedure 30-Days and 6-, 12-, 24-, & 36-Months Post-Procedure.

50 8 European Sites Dr. Gerard O Sullivan University College Hospital Galway Dr. Rick de Graaf Maastricht Universitair Medisch Centrum+ Maastricht Dr. Stephen Black St. Thomas, London Dr. Houman Jalaie Uniklinik RWTH, Aachen Prof. Salah Dine Qanadli Centre Hospitalier Universitaire Vaudois. Lausanne Dr. Michael Lichtenberg Klinikum Arnsberg Prof. Luis Miguel Izquierdo Lamoca, Hospitales Universitarios Montepríncipe, Madrid Prof. Thomas Zeller Universitäts- Herzzentrum Freiburg Bad Krozingen

51 Efficacy: Primary Endpoint Primary Patency rate at 12 months defined as Freedom from TVR Freedom from thrombus occlusion and stenosis > 50% as measured by DUS.

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54 THANK YOU FOR YOUR ATTENTION

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56 21 y, female, descending DVT in May Thurner syndrome.

57 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:

58 Standard Treatment vs. CDT Enden T, et al: CaVenT Study Follow-Up 24 months: Number needed to treat: 7 Lancet Jan 7;379(9810):31-8.

59 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 (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

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62 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)

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65 Early Clot Removal Many Choices None Perfect! EKOS Peripheral Infusion System Trellis System AngioJet Aspirex (Rotational thrombectomy) Indigo System (Penumbra) 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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68 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 2-Year ATTRACT Data 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. Leg pain and leg swelling were significantly improved in patients who received PCDT vs no-pcdt: (leg pain, 10 days: vs -1.29; P =.019; 30 days: vs -1.83; P =.026) (leg swelling, 10 days: vs +0.27; P =.024; 30 days: vs -0.28; P =.051). 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),

69 THANK YOU FOR YOUR ATTENTION

70 Chronic deep venous occlusions: Case planning, recanalization and stent technique Michael K. W. Lichtenberg, FESC German Venous Center Arnsberg, Germany