Patency rates and clinical results of the Veniti VICI Stent for treatment of iliac vein lesion Data from the Arnsberg Venous Registry
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1 Patency rates and clinical results of the Veniti VICI Stent for treatment of iliac vein lesion Data from the Arnsberg Venous Registry Michael K. W. Lichtenberg MD, 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
3 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.
4 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 // Clincal 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
5 Clinical assessment
6 Demographic / Clinical data 90 patients Demographic/comorbidity No. (%) Age 57.4±16.4 Male 43 (48%) Female 47 (52%) Post-thrombotic Syndrome 49 (54%) Non-thrombotic 41 (46%) History of venous 81 (90%) thromboembolic disease Pulmonary embolism 22 (24%) Deep vein thrombosis 43 (48%) Coronary Artery Disease 6 (7%) Myocardial Infarction 1 (1%) Congestive Heart Failure 7 (8%) High Blood Pressure 48 (55%) Renal Disease 6 (7%) Stroke 3 (3%) Cancer 13 (14%) Diabetes 13 (14%) Smoker (current or previous) a 15 (17%) CEAP score, prior to stenting 1 0 (0%) 2 1 (1%) 3 56 (62%) 4 20 (22%) 5 8 (9%) 6 4 (4%) Signs and symptoms, prior to stenting b Pain (inc. venous claudication) 89 (99%) Varicose veins 83 (92%) Edema 89 (99%) Pigment Changes 41 (46%) Ulcers 10 (11%) Use of compression stockings 88 (98%)
7 Lesion location All Patients Left Right No. (%) No. (%) No. (%) Unilateral 83 (92%) 67 (74%) 16 (18%) Bilateral 7 (8%) CIV 40 (44%) 35 (39%) 5 (6%) EIV 13 (14%) 4 (4%) 9 (10%) CFV 4 (4%) 2 (2%) 2 (2%) CIV + EIV 22 (24%) 20 (22%) 2 (2%) EIV + CFV 6 (7%) 3 (3%) 3 (3%) CIV + EIV + CFV 12 (13%) 10 (11%) 2 (2%)
8 Primary 12 months 12 months
9 Patency rates non-thrombotic vs. post-thrombotic 12 months 12 months
10 Clinical efficacy: rvcss analysis Baseline 1 month P value 6 months P value 12 months P value N=90 N=56 N=29 N=13 All Patients 8 (4, 27) 4 (1, 15) < (0, 12) < (0, 15).008 PTS [N=49 a ] 8 (5, 20) 4 (1, 15) < (0, 9) < (2, 15).19 NIVL [N=41 b ] 8 (4, 27) 5 (2, 15) < (2, 12) < (0, 7).007
11 5 4, Mean CEAP score (±SD) , ,5 2 1,5 1 0,5 0 N=90 N=82 N=50 N=21 Baseline FU1 FU2 FU3
12 Adverse events Adverse Event No. (%) Access-site complications 1 (1%) Hematoma 1 (1%) Stent reocclusion 5 (6%) Stent migration 0 (0%) Pulmonary embolism 0 (0%) Venous rupture 0 (0%) Infection 0 (0%) Blood transfusion 0 (0%)
13 VIRTUS Study 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, UNC Chapel Hill Dr. Mahmood Razavi, St. Joseph s Orange Prospective, multicenter, single arm nonrandomized, conducted at 22 sites worldwide 200 subjects with clinically significant chronic nonmalignant obstruction of the iliofemoral venous segment Feasibility Cohort 1 st 30 patients 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 Dr. Mahmood Razavi
14 Target Lesion Location Lesion 1 Location Patients N = 30 Left N = 25 (83%) CIV lesions 11/30 (37%) EIV lesions 4/30 (13%) CIV & EIV lesions 6/30 (20%) Lesions that extended into CFV 2 9/30 (30%) Right N = 5 (17%) Average Target Lesion Length 12.8 (3-24.7) 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 Razavi M, et al. J Vasc Surg Venous Lymphat Disord Dec 28. pii: S X(17)
15 12-month Patency Data Secondary 100% Assisted-primary 96% Primary 93% Razavi M, et al. J Vasc Surg Venous Lymphat Disord Dec 28. pii: S X(17)
16 Patient Outcome Measures 63% of patients had 50% VCSS score reduction 81% of patients with pain reduction at 12 months 78% of patients considered QOL improved Baseline N=30 6 months N=26* P value 12 months N=27 P value VCSS 1 10 (2-25) 5 (0-30) < (0-23) <.001 VAS 2 60 (6-98) 23 (0-84) (0-94).001 CIVIQ (24-97) 28 (20-91) (20-89) <.001 * At 6 months, 27 patients had VCSS scores. The 1 patient with 6-month VCSS data (and no VAS or CIVIQ- 20 data) at 6 months only had completed form responses for 3 of 10 VCSS domains (all 0 s). 1. VCSS venous clinical severity score 2. VAS visual analogue scale 3. CIVIQ-20 chronic venous insufficiency quality of life questionnaire Razavi M, et al. J Vasc Surg Venous Lymphat Disord Dec 28. pii: S X(17)
17 Conclusions Use dedicated venous stents! Choose wisely - based on lesion morphology Choose wisely based on stent technology Initial 6 and 12-Month efficacy data in the VIRTUS Trial and Arnsberg Venous Registry are promising Patients feel substantially better 85% of population showed symptomatic improvement after venous stenting (VCSS 2) at 12-Months Safety data raise no concerns 17
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