Jimmy Wei Hwa Tan, Surg, MD - lincapac2018.cncptdlx.com · Jimmy Wei Hwa Tan, Surg, MD Director,...

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%.

陳偉華neugine@gmail.com

Jimmy Wei Hwa Tan, Surg, MDDirector, Department of Surgery

Chief , Department of Cardiovascular Surgery

Tainan An-Nan Municipal Hospital , China Medical University, Taiwan