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Jimmy Wei Hwa Tan, Surg, MDDirector, Department of Surgery
Chief , Department of Cardiovascular Surgery
Tainan An-Nan Municipal Hospital , China Medical University, Taiwan
Disclosure
I have the following potential
conflicts of interest to report:
No Conflict of Interest
Life expectancy of AV access
• Low Primary Failure but also low Primary Patency at 1 yr (10-15%)
• Native fistulas survival time : 3 to 7 years
• AV graft survival time :12 to 18 months
Huber TS et al. J Vasc Surg 2003;38:1005–11.
Perera GB et al. Ann Vasc Surg 2004;18:66–73.
Schwartz C et al . Radiology 1995;194:337– 41.
Mechanism of AV Graft Failure
John A. bittl. JACC 2010;3: 1-11
Cummulative Access Survival
Preemptive
Angioplasty
611 AVF
Versus
699 AVG
John A. bittl. JACC 2010;3: 1-11
Number of Interventions required to achieve Secondary Patency
Turmel-Rodrigues et al., Treatment of Stenosis and Thrombosis in Hemodialysis Fistulas and Grafts by
Interventional Radiology, Nephrol Dial Transplant (2000) 15: 2029 - 2036
Forearm Fistula(n=209)
Upper ArmFistula (n=74)
Prosthetic Grafts(n=156)
Balloon Angioplasty 311 136 279
Declot Procedures 60 39 158
Number of Stents used 18 37 80
Total Procedures 389 212 517
Procedures per patientyear 1,8 2,9 3,3
Innovations better than PlainBalloon Angioplasty Alone
• Covered stent
• Bard Flair SG
• Gore Viabahn SG
• Drug-coated
• Bard Lutonix
• Medtronic InPact Admiral
2 yrs Data from RENOVA study
• 28 sites, prospective RCT
• Upper arm AVG
• Flair
• 191 patients
• 97 SG vs 94 PTA
Ziv Haskal et al. JVIR 2016 : 27; 1105-1114
2 yrs Data from RENOVA study
TAPP SG (26.9%) vs PTA (13.5%)
ACPP SG (9.5%) vs PTA (5.5%)
Ziv Haskal et al. JVIR 2016 : 27; 1105-1114
2 yrs Data from RENOVA study
Duration to next intervention(months):
IPF SG (7.1) : PTA (5.3)
Ziv Haskal et al. JVIR 2016 : 27; 1105-1114
Case Demonstration
VGJ stenting with Flair
How to Deploy Accurately
• 1: 1 Predilatationof the lesion site
• Slow Deployment to avoid jumping of SG
• Careful Post-Deployment PTA
Why Flair SG in Upper arm AVG
• To better overcome dynamic compression of adjacent structures
• To overcome size mismatching between artificial graft and venous outflow vein
• Flared end provides laminar flow and decreases turbulent flow compared to straight end
Flair Experience in An-nan Hospital
• First Case 2016/1/29 ( until 2017/8/30)
• 30 Cases reach 6 months follow-up
• 9 cases were Thrombosed AVG at the time of deployment
• At 3M, TLPP 50%
• At 6M , TLPP 39%
• Flair Pivotal Study at 6M
• TLPP 50.6%, ACPP 38.0%
COVERATM Vascular Covered Stent Ongoing Clinical Studies
Prospective, Multi-Center, Randomized, Concurrently-Controlled Clinical Study of
the Bard® Arteriovenous (AV) Stent Graft in the
Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits
Prospective, Multi-Center, Clinical Study of the Bard® COVERA™ Arteriovenous
(AV) Stent Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of
AV Graft Circuits
(AV Fistula) (AV Graft)
Study Device
• COVERATM Vascular CoveredStent
• Dual layer ePTFE covering
• Carbon impregnation on theluminal (blood contacting) surface
• Diameters 6 mm – 10 mm
• Lengths 30 mm – 100 mm
Not Available for Sale in the U.S.
Caution: Investigational Device Exemption, Limited by United States Law to Investigational Use
• Straight and flared implant configuration to accomodatefor diameterdifferences in AV access anatomy
3 mm larger flared outflow end
Not Available for Sale in the U.S.
Caution: Investigational Device Exemption, Limited by United States Law to Investigational Use
Study Device
Study Design Prospective, Multi-Center, Single-Arm
Objective
To assess the safety and effectiveness of the BARD® COVERA™ Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Number of Patients/Sites at 6 months
110 patients enrolled at 14 US sites
Primary Safety Endpoint
Freedom from any protocol defined safety event(s) involving the AV access circuit
through 30 days: Performance Goal = 88%Primary Effectiveness Endpoint
Target Lesion Primary Patency (TLPP) - 6
months: Performance Goal = 40%
Follow UpAt hospital discharge, 30 & 90 days, 6, 12, 18, & 24 months
Status 6 Month Follow Up completed
Key Inclusion Criteria
CLINICAL ANGIOGRAPHIC
• AV access graft in an arm
that has been implanted for
30 days, undergone ≥ 1
dialysis session
• Thrombosed and non
thrombosed AV grafts
• Stenosis ≥ 50% at graft-vein
anastomosis , clinical or
hemodynamic evidence of
AV graft dysfunction
• Target lesion ≤ 9 cm in
length
• Reference vessel diameter
5.0 - 9.0 mm
BPV/SGF3/0118/0005
Key Exclusion Criteria
• Lower extremity access
• Infected AV access graft
• Additional lesions (≥ 50%) in
venous outflow > 3cm from
edge of the target lesion and
are not successfully treated
prior to treating target lesion
• Pseudoaneurysm in target
lesion
• Target lesion within a stent
CLINICAL ANGIOGRAPHIC
BPV/SGF3/0118/0005
Select Patient Demographics
Age Categories
<65 years 47.3%
≥ 65 and < 75 years 28.2%
≥ 75 years 24.5%
Sex
Male 45.5%
Female 54.5%
Race
American Indians/Alaska Native 0.9%
Asian 3.6%
Black or African American 40.0%
White 54.5%
Other 0.9%
BMI Categories
< 30 61.8%
≥ 30 38.2%
Venous Anastomosis
49,1%
40,0%
8,2%
2,7%
Axillary V
Basilic V
Brachial V
Other V
Lesion and Access Circuit Characteristics
Summary of Study Device Details
Stent Graft Configuration
Flared 83.6%
Straight 16.4%
Stent Graft Diameter
7 mm 9.1%
8 mm 56.4%
9 mm 30.0%
10 mm 4.5%
Stent Graft Length
40 mm 49.1%
60 mm 42.7%
80 mm 8.2%
Study Device Characteristics
Flared
device
used in
83.6%
patients
Safety Analysis
Primary Safety Endpoint Proportion
Freedom from any Primary Safety Event through 30 Days
96.4%
•The primary safety endpoint for superiority to the performance goal was met.
•The proportion of subjects free from primary safety events was 96.4%, which was superior to the PG of 88% (p-value = 0.0021).
BPV/SGF3/0118/0005
Effectiveness Analysis
Primary Effectiveness Endpoint Proportion
Target Lesion Primary Patency at 6 Months
70.3 %
•The primary effectiveness endpoint for superiority to the performance goal was met.
•The proportion of subjects with target lesion primary patency was 70.3 % which was superior to the PG of 40% (p-value < 0.0001).
Target Lesion Primary Patency through 6 Months
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Surv
ival Pro
bability
0 30 60 90 120 150 180
Time to Event (Days)
+ Censored
Covera™ Vascular Covered StentTreatment:
C.R.Bard Inc. Page 1 of 1
Protocol: BPV-15-001
Interim 6-Month ReportFigure 14.2-1.1
Kaplan Meier Curve of TLPP During the 6-Month Post Procedure Follow-Up Period
All Treated Population
Data Source: ADSL, ADEF
Program name: ftlpp.sas Cutoff Date: Oct 5, 2017 Date: 11DEC2017 20:20
PG = 40%
71.1%
BPV/SGF3/0118/0005
Summary
• Level 1 evidence showing superior TLPP and ACPP of stent graft in treatingVenous graft anastomosis stenosis fromRENOVA and REVISE Study in upper arm and forearm AVG dysfunction
• Promising 6M TLPP (71.1%) from AVeVAstudy study which was was significantly higher compared to the performance goal of 40%.
Jimmy Wei Hwa Tan, Surg, MDDirector, Department of Surgery
Chief , Department of Cardiovascular Surgery
Tainan An-Nan Municipal Hospital , China Medical University, Taiwan
