patency rates and clinical results of the veniti vici ... › media › 1620_michael... · patency...
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Patency rates and clinical resultsof the Veniti VICI Stent for treatment
of iliac vein lesionData from the Arnsberg Venous Registry
Michael K. W. Lichtenberg MD, FESC
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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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• 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
Desired Venous Stent Attributes
Goal… Ideal BALANCE strength, flexibility, and lumen quality.
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Arnsberg Venous RegistryVENITI VICI VENOUS STENT® System
ObjectiveAssess safety & effectiveness in achieving patency of target venous lesion through 36 months post stent placement (VENITI VICI Stent)
Effectiveness Primary Patency @ 12-M // Clincal outcome @ 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 PopulationSubjects with clinically significant chronic non-malignant obstruction of the iliofemoralvenous segment
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Clinical assessment
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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
thromboembolic disease
81 (90%)
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
stentingb
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%)
Demographic / Clinical data 90 patients
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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%)
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Primary patency @ 12 months
92.2% @ 12 months
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Patency ratesnon-thrombotic vs. post-thrombotic
100% @ 12 months
85.7% @ 12 months
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Clinical efficacy: rVCSS analysis
Baseline
N=90
1 month
N=56
P value 6 months
N=29
P value 12 months
N=13
P value
All Patients 8 (4, 27) 4 (1, 15) <.0001 4 (0, 12) <.0001 4 (0, 15) .008
PTS [N=49a] 8 (5, 20) 4 (1, 15) <.0001 3 (0, 9) <.0001 6.5 (2, 15) .19
NIVL [N=41b] 8 (4, 27) 5 (2, 15) <.0001 5 (2, 12) <.001 3 (0, 7) .007
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0
0,5
1
1,5
2
2,5
3
3,5
4
4,5
5
Baseline FU1 FU2 FU3
Mean CEAP score (±SD)
N=90 N=82 N=50 N=21
3.6
2.6 2.7
2.4
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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%)
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VIRTUS Study Design
ObjectiveAssess safety & effectiveness in achieving patency of target venous lesion through 12-M post stent placement
Safety MAEs @ 30 days
Effectiveness Primary Patency @ 12-M
PrincipalInvestigators
Dr. William Marston, UNC Chapel Hill Dr. Mahmood Razavi, St. Joseph’s Orange
Study DesignProspective, multicenter, single arm non-randomized, conducted at 22 sites worldwide
Patient Population200 subjects with clinically significant chronic non-malignant obstruction of the iliofemoral venous segment – Feasibility Cohort 1st 30 patients
Etiologies: Post Thrombotic (75%); Non Thrombotic (25%)
Core Labs
Venography: SyntactxIVUS: St. LukesDUS: VasCore/MGHX-Ray: Syntactx
Non-thrombotic
Post-thrombotic
Image Courtesy of Mr. Stephen Black
Image Courtesy of Dr. Mahmood Razavi
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Target Lesion Location
Lesion1 Location
Patients N = 30
Left N = 25 (83%)
Right N = 5(17%)
CIV lesions 11/30 (37%)
EIV lesions 4/30 (13%)
CIV & EIV lesions 6/30 (20%)
Lesions that extended into CFV2 9/30 (30%)
Average Target Lesion Length
12.8 (3-24.7) cm
1. Some patients have more than 1 lesion or lesion extends in multiple vein segments2. No lesions were isolated to the CFV alone
Razavi M, et al. J Vasc Surg Venous Lymphat Disord. 2017 Dec 28. pii: S2213-333X(17)30509-7.
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12-month Patency Data
Secondary 100%
Assisted-primary 96%
Primary 93%
Razavi M, et al. J Vasc Surg Venous Lymphat Disord. 2017 Dec 28. pii: S2213-333X(17)30509-7.
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Patient Outcome Measures
Baseline N=30
6 months N=26* P value
12 months N=27 P value
VCSS1 10 (2-25) 5 (0-30) <.001 4 (0-23) <.001
VAS2 60 (6-98) 23 (0-84) .002 21 (0-94) .001
CIVIQ-203 48 (24-97) 28 (20-91) .001 33 (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
• 63% of patients had ≥ 50% VCSS score
reduction
• 81% of patients with pain reduction at 12 months
• 78% of patients considered QOL improved
Razavi M, et al. J Vasc Surg Venous Lymphat Disord. 2017 Dec 28. pii: S2213-333X(17)30509-7.
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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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Patency rates and clinical resultsof the Veniti VICI Stent for treatment
of iliac vein lesionData from the Arnsberg Venous Registry
Michael K. W. Lichtenberg MD, FESC