REKANALISATION CHRONISCH VENÖSER VERSCHLÜSSE. Michael K. W. Lichtenberg, FESC
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1 REKANALISATION CHRONISCH VENÖSER VERSCHLÜSSE Michael K. W. Lichtenberg, FESC
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
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4 C6, 58 year female, postthrombotic syndrome
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6 Sinus XL Stent (22 x 80 mm) 4 x Veniti Stent (16 x 120 mm + 14 x 60 mm)
7 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.)
8 Autor Jahr Stent N = Patienten Lichtenberg (1) 2016 Zilver Vena % 12 Monate Ye (2) 2012 Wallstent % 48 Monate Hartung (3) 2009 Wallstent % 120 Monate Neglen (4) 2008 Wallstent % 72 Monate Knipp (5) 2007 Wallstent % 60 Monate Nazarin (6) 1996 Wallstent, Palmaz Primäre Patency Sekundäre Patency % 48 Monate 100 % 48 Monate 93 % 120 Monate 93 % 72 Monate 73 % 60 Monate 75 % 48 Monate Ye K et al. J Vasc Interv Radiol 2012;23: Hartung O et al. J Vasc Endovasc Surg 2009;38: Nazarin et al. Cardiovasc Intervent Radiol 1996 Jul-Aug;19(4): Neglen et al. Journal of Vascular Surgery, Volume 48, Pages , 2008 Knipp et al. Journal of Vascular Surgey, Volume 46, Issue 4, Pages e1, October 2007 Lichtenberg et al. Oral presentation during DGA annual congress 2016
9 Why not arterial stents? Venous obstruction Very different than arterial obstruction, and venous stents need to do a different job Involves high compressive forces from external pressure and/or fibrosis
10 Desired 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 Goal Ideal BALANCE strength, flexibility, and lumen quality.
11 Performance Characteristics Closed Cell Open Cell Design Attributes All struts interconnected Not all struts interconnected Performance Crush Resistance ++ + Flexibility + ++ Coverage ++ +
12 Radial Resistive Force at 1mm oversize (N/mm) Local Compression Force (N) Radial Force and Crush Resistance Radial Resistive Force Crush Resistance 0,146 2,65 1,94 0,049 1,18 0,030 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
13 3 Point Bending Stiffness (N) Stent Flexibility 1,29 0,62 0,43 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
14 Stent options! Boston Wallstent Optimed Cook Zilver Vena VIVO (EU) Trial Veniti Vici VIRTUS Trial Optimed Sinus obliquus Sinus Obliquus-01-NIS Bard Venovo VERNACULARTrial Upcoming: Medtronic, Gore, ab Medica, INTACT, Abbott Vascular
15 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. Michael Lichtenberg, M.D. Marta Ramirez Ortega, M.D. 15
16 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) 16
17 Baseline Lesion Data Side treated Lesion Location Vessel location(s) 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. 17
18 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. 18
19 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. 19
20 VICI 14 x 120 mm
21 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
22 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%
23 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
24 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
25 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
26 Safety Endpoint Results Primary Safety Endpoint through 30 Days (n=30) n % Composite Major Adverse Events (MAE) 0 0 Device or procedure-related death 0 0 Device or procedure-related bleeding 0 0 Device or procedure-related vessel injury 0 0 Device or procedure-related DVT (non-target vessel segment)* 0 0 Clinically significant PE 0 0 Embolization of stent 0 0 No 30 days
27 VCSS Pain Scale 45% had substantial symptomatic improvement (VCSS 2
28 CIVIQ-20
29 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
30 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)
31 Lesion analysis N=90 Sides treated Both Left Right Lesion location(s) Left: Right: 64 / 90 (71%) patients: Postthrombotic 26 / 90 (29%) patients: NIVL 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 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 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) Both: vein 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) 1.1% (N=1) 2.2% (N=2) 2.2% (N=2) 1.1% (N=1) 1.1% (N=1)
32 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
33 Mean VCSS score (±SD) Claudication, Pain, Swelling, Ulceration improvemnt , ,4 4,9 4,2 2 N=90 N=82 N=50 N=21 0 Baseline FU1 FU2 FU3
34 5 4,5 4 3,5 3.6 Mean CEAP score (±SD) ,5 2 1,5 1 0,5 N=90 N=82 N=50 N=21 0 Baseline FU1 FU2 FU3
35 Conclusions Initial 6 and 12-Month efficacy data in the VIRTUS Trial and Arnsberg Registry are better than reported data: NIVL PTS Primary patency: 100% 87% Secondary Patency: 100% 97% Safety data is positive Patients feel substantially better 85% of population showed symptomatic improvement after venous stenting (VCSS 2) at 12-Months 45% had substantial symptomatic improvement (VCSS 2 ) at 12-M Venous anatomy and disease require dedicated venous stents 35
36 Take home message Use dedicated venous stent! Choose wisely - based on lesion morphology Choose wisely based on stent technology More prospective data is needed
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