The role of Drug-Coated Balloon (DCB) in arteriovenous fistulas and the clinical experience in Taiwan

Taiwan

Vascular Surgeon

Po-Jen Ko

Disclosure

Speaker name:

Po-Jen Ko.……………………………………………………

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Access stenosis neointimal hyperplasia

@Aruny JE. Quality improvement for percutaneous management of the thrombosed or dysfunctional dialysis

access. J Vasc Interv Radiol. 2003;14:S247-S253.

#Haskal ZJ. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med.

2010;262:494-503.

Balloon angioplasty in HAM

6-month restenosis rate : 62% to 77% after angioplasty@

cutting-balloon angioplasty, cryoplasty, stent or stent graft# implantation, and local irradiation after PTA

Coronary arteries & peripheral circulations

Hemodialysis access stenosis?

Lanka V. Outcomes with first- versus second-generation drug-eluting stents in coronary chronic total

occlusions (CTOs): a systematic review and meta-analysis. J Invasive Cardiol 2014 26 304 310

Kang S-H. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting

stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J 2014 35 1147 1158

Fröhlich GM. Drug eluting balloons for de novo coronary lesions - a systematic review and meta-analysis.

BMC Med 2013 11 123

Indermuehle A. Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-

analysis of randomised controlled trials. Heart 2013 99 327 333

DEB/DES

Antineoplastic agent

Inhibit smooth muscle cell proliferation & migration

Paclitaxol

Patanè D. Drug-eluting balloon for the treatment of failing hemodialytic radiocephalic arteriovenous

fistulas: our experience in the treatment of juxta-anastomotic stenoses. J Vasc Access 2014 15 338 343

DCB on Juxta anastomosis stenosis

DCB in HAM (MetaAnalysis)

Six studies/ 254 interventions/162 participants (mean 27 ± 10 SD). follow-

up:12 months (range 6-24 months).

2 (RCTs)

Target lesions (TLs) ranged from under 2 mm to 5.9 mm/51 de novo stenosis.

Device failure reported in two studies (55% and 92.8%).

At 6 months TL PP was reported between 70% to 97% for DeBs in the RCTs

and cohort studies, and 0% to 26% for non-DeBs.

Aurang Z. Khawaja. Systematic review of drug eluting balloon angioplasty for arteriovenous haemodialysis

access stenosis

J Vasc Access 2016; 17(2): 103 - 110

Kitrou PM Katsanos K Spiliopoulos S Karnabatidis D Siablis D Drug-eluting

versus plain balloon angioplasty for the treatment of failing dialysis access: Final

results and cost-effectiveness analysis from a prospective randomized controlled

trial (NCT01174472). Eur J Radiol 2015 84 418 423

Katsanos K, Karnabatidis D, Kitrou P, et al. Paclitaxel-coated balloon angioplasty

vs. plain balloon dilation for the treatment of failing dialysis access: 6-months

interim results from a prospective randomized controlled trial. J Endovasc Ther.

2012;19:263-272.

6-month primary patency rates of 70% versus 25%

RCT

Teo T. Prospec ve randomized trial com- paring drug-elu ng balloon versus

conven onal percutaneous transluminal angioplasty (DEBAPTA) for the treatment

of hemodialysis arteriovenous fistula or arteriovenous graft stenoses - interim

report of first 30 patients. J Vasc Interv Radiol. 2013;24:S40-S41.

6 mo, circuit primary potency 43% vs 63%

targeted lesion primary patency 50% vs 68%

restenosis rates were 33.3% vs 75.0%

mean late luminal loss 29% vs 44%

RCT

Courtesy of KH Tay DEBAPTA

Lai CC, Fang HC, Tseng CJ, et al. Percutaneous angioplasty using a paclitaxel-

coated balloon improves target lesion restenosis on inflow lesions of autogenous

radiocephalic fistulas: a pilot study. J Vasc Interv Radiol. 2014;25:535-541.

TLR-free duration (251.2 d vs 103.2 d; P < .01).

TL patency @ 6 months(70% vs 0%; P < .01)

but not at 12 months (20% vs 0%; P > .05).

20 lesions in 10 patients

randomized to DCB vs PB

RCT

Retrospective study

using Lutonix

KPaclitaxel-Coated Balloons for the Treatment of Dysfunctional Dialysis Access.

Results from a Single-Center, Retrospective Analysis. Cardiovascular and

Interventional Radiology, 2017 40(1), 50–54. http://doi.org/10.1007/s00270-016-1479-y

72.2%

@ 6 m

Lutonix (Bard Peripheral Vascular, Inc.) AV trial

PAVE trial, a randomized trial in the United

Kingdom

APERTO randomized trial being undertaken in the

Netherlands

FISBAL randomized trial recruiting participants in

Spain

more coming…

Treatment with Drug balloon in`CGMH

Pre OP Finding:

-Increase VP during HD, favor outlet stenosis.

Arm access stenosis

• Pre treatment: 55% stenosis

• Boston Mustang 6mm*4cm

-Pressure: 24 atm

• Residual stenosis after treatment: 0%

Lesion preparation

OPEN

• Medtronic DCB 7mm*6cm

• Pressure: 8 atm

• 3 minutes.

Use DCB

DCB

• ECHO 23% stenosis

• Venography 17% stenosis

3 month follow up

• ECHO 23%

stenosis

• 3 months

• Venography

17% stenosis

• 3 months

Some are not that lucky

1 week later

1 months later

3 months later

4 months later

Drug balloon may the solution

for some of the access problem

cephalic arch

swing segments

puncture site stenosis

V-junction stenosis

immature fistula

The role of Drug-Coated Balloon (DCB) in arteriovenous fistulas and the clinical experience in Taiwan

Taiwan

Vascular Surgeon

Po-Jen Ko