patency rates and clinical results of a dedicated … › media › 1140_michael...patency rates and...
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Patency rates and clinical results of a dedicated closed-cell design stent for thetreatment of iliac vein lesion
Michael K. W. Lichtenberg MD, FESCVascular Centre Arnsberg / German Venous Centre Arnsberg
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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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C6, 58 year female with chronic outflow obstruction
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2 Sinus XL Stent (22 x 80 mm)4 x Veniti Vici Stent (16 x 120 mm + 14 x 60 mm)
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Cell Architecture
• All Internal inflection points are connected by bridging elements.
• Regular peak-to-peak connections.
• Uniform surface, regardless of the degree of bending.
• Generally less flexible than a open-cell design.
Closed-cell stents have an intrinsically greater potential to scaffold
and support thrombogenic material away from the blood flow.
Open-cellClosed-cellBasic design concept.
Cell shape and
bridging element
designs varies among
stent manufacturers.
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VICI VENOUS STENT® DESIGN
Self-expanding nitinol- 12, 14, and 16mm diameter
- 60, 90, and 120mm length.
Closed-cell Geometry
Designed for
Strength High crush resistance
Flexibility Multi-directional
Uniform shape (end-to-end)
Lumen quality
Coverage No gaps, closed-cell
Deployment Predictable placement Closed-Cell
Alternating Curved Bridges
Flexibility
Sinusoidal rings
24 Struts per ring
Strength
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Closed Cell Open Cell
Design Attributes • All struts interconnected • Not all struts interconnected
Performance
Crush Resistance ++ +Flexibility + ++Coverage ++ +
Performance Characteristics
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VICI Lumen QualityUniform Strength and Coverage
Gap
Gap No Gap
24 Struts12 Struts8 Struts4 Struts
Closed-cellOpen-cellOpen-cell
Str
en
gth
Co
ve
rag
e
VICI STENT
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VIRTUS Feasibility Trial 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 Dr. Mahmood Razavi
Study DesignProspective, multicenter, single arm non-randomized, up to 45 sites worldwide
PatientPopulation
200 subjects with clinically significant chronic non-malignant obstruction of the iliofemoral venous segment – first 30 were feasibility.
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 Mr. Mahmood Razavi
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Demographics & Medical HistoryFemale 24 (80%) Male 6 (20%)
Age 44.4 ±14.1 years
CEAP* 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%
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Target Lesion Location
Lesion1 Location
Patients N = 30
Left N = 25 (83%)
Right N = 5(17%)
CIV lesions 26/30 (87%)
EIV lesions 18/30 (60%)
CIV & EIV lesions 15/30 (50%)
Lesions that extended into CFV2 9/30 (30%)
Average Target Lesion Length
11.9 ±6.7 cm
1. Some patients have more than 1 lesion or lesion extends in multiple vein segments2. No lesions were isolated to the CFV alone
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Improvement in % Lesion Stenosis
% Lesion StenosisPre Procedure by Venogram (Site
Reported)
% Lesion StenosisPost Procedure by
Venogram (Site Reported)
Full Cohort N=30 85.2±17.2 1.8±3.8
Gender
Female 80% 88.4±15 1.5±3.6
Male 20% 73.2±19.4 2.8±4.5
Etiology
PTS 63% 89.3±16.3 2.1±4.2
NIVL 37% 77.5±16.1 1.4±3.1
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Patency by Duplex Ultrasound(Corelab Analysis)
Courtesy of Dr. Ediberto Soto-Cora
Patency Results of Feasibility Cohort (N=30)
Primary Patency1 Secondary Patency
1- M 93% 100%
6 – M 90% 100%
12 – M 93% 97%
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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 MAEs @ 30 days
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Patient Outcomes in the VIRTUS Trial
Using QOL and Patient Outcome Data to Evaluate How Patients Feel
Three different scales were used in VIRTUS to evaluate QOL VCSS
VAS
CIVIQ-20
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VCSS Pain Scale
45% had “substantial symptomatic improvement” (VCSS ≥2 ) @12-M
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VAS Scale
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CIVIQ-20
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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
Principle Investigators Dr. Michael Lichtenberg Dr. Rick de Graaf
Study DesignOngoing 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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Demographics N=90
Age in years(mean ± SD [range]) 57.4 ± 16.4 [19-84]
GenderMaleFemale
47.8% (N=43)52.2% (N=47)
EthnicityCaucasian 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)
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Lesion analysis N=90
Sides treatedBothLeftRight
7.8% (N=7)74.4% (N=67)17.8% (N=16)
Lesion location(s)
Left:Common iliac veinExternal iliac veinCommon femoral veinCommon iliac vein, external iliac veinCommon iliac vein, external iliac vein, common femoral veinExternal iliac vein, common femoral vein
Right:Common femoral veinCommon iliac veinExternal iliac veinCommon iliac vein, external iliac veinCommon iliac vein, external iliac vein, common femoral veinExternal iliac vein, common femoral vein
Both:External iliac (R), common iliac (L) veinExternal iliac (R), common iliac (L), external iliac (L) veinCommon iliac (R+L), external iliac (L) veinCommon iliac (R+L), external iliac (R+L), common femoral (L) veinCommon iliac (R+L), external iliac (R+L), common femoral (R+L) vein
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)
64 / 90 (71%) patients: Postthrombotic
26 / 90 (29%) patients: NIVL
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Effectiveness analysis
0
10
20
30
40
50
60
70
80
90
100
FU 4 w FU 6 mo FU 12 mo
% Patentcy analysis
NIVL PTS
N=50N=82 N=21
100 % 100 % 100 %
97% 90 %87 %
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0
2
4
6
8
10
12
14
Baseline FU1 FU2 FU3
Mean VCSS score (±SD)
N=90 N=82 N=50 N=21
9.2
5.34.9
4.3
Claudication, Pain, Swelling,
Ulceration improvement
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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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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
27
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Patency rates and clinical results of a dedicated closed-cell design stent for thetreatment of iliac vein lesion
Michael K. W. Lichtenberg MD, FESCVascular Centre Arnsberg / German Venous Centre Arnsberg