taiwan vascular surgeon po-jen ko · lai cc, fang hc, tseng cj, et al. percutaneous angioplasty...
TRANSCRIPT
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The role of Drug-Coated Balloon (DCB) in arteriovenous fistulas and the clinical experience in Taiwan
Taiwan
Vascular Surgeon
Po-Jen Ko
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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
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Access stenosis neointimal hyperplasia
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@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
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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
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Antineoplastic agent
Inhibit smooth muscle cell proliferation & migration
Paclitaxol
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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
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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
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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
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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
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Courtesy of KH Tay DEBAPTA
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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
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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
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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…
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Treatment with Drug balloon in`CGMH
Pre OP Finding:
-Increase VP during HD, favor outlet stenosis.
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Arm access stenosis
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• Pre treatment: 55% stenosis
• Boston Mustang 6mm*4cm
-Pressure: 24 atm
• Residual stenosis after treatment: 0%
Lesion preparation
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OPEN
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• Medtronic DCB 7mm*6cm
• Pressure: 8 atm
• 3 minutes.
Use DCB
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DCB
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• ECHO 23% stenosis
• Venography 17% stenosis
3 month follow up
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• ECHO 23%
stenosis
• 3 months
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• Venography
17% stenosis
• 3 months
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Some are not that lucky
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1 week later
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1 months later
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3 months later
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4 months later
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Drug balloon may the solution
for some of the access problem
cephalic arch
swing segments
puncture site stenosis
V-junction stenosis
immature fistula
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The role of Drug-Coated Balloon (DCB) in arteriovenous fistulas and the clinical experience in Taiwan
Taiwan
Vascular Surgeon
Po-Jen Ko