LUTONIX DCB in AV Access: A Single Center Experience
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1 LUTONIX DCB in AV Access: A Single Center Experience Dr Kate Steiner Consultant Interventional Radiologist East and North Hertfordshire NHS Trust
2 Disclosure Speaker name:... I have the following potential conflicts of interest to report: Consulting Bard and Boston Scientific Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Disclaimer The opinions and clinical experiences resented herein are for informational purposes only and may not be predictive for all cases. Individual results may vary depending on a variety of patient specific attributes. The results and data presented herein reflect Dr. Steiner s clinical experience in a single-center, investigator-initiated and funded study. These results have not been published or peer-reviewed. Bard /Lutonix has not sponsored or funded these studies, nor has Bard/Lutonix validated underlying test methods or data presented herein. These results are presented for general education purposes only and may not be predictive for all patients or of Lutonix DCB usage.
4 Disclaimer, continued The physician has been compensated by Lutonix for the time and effort to present this information. Any discussion regarding Bard products during the presentation today is limited to information that is consistent with the CE Marking and clearances for those products. Please consult Bard/Lutonix product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.
5 Introduction Use of DCB in femoropopliteal arterial lesions well established Use in AV fistulas not well studied Restenosis Repeat interventions Loss of fistula Failure to mature Dialysis per fistula/line dialysis
6 Physiology AV fistulas High pressure Low Pressure Vessel wall stress Endothelial NO High Shear stress gradient Endothelial cell damage Intimal hyperplasia Compliance mismatch Pulsatile wall stress Intimal hyperplasia Traumatic Balloon dilation Neointimal proliferation
7 Histology of AV stenoses Venous intimal hyperplasia Chang et al (2004) Increase in proliferation index, intima and media in aggressive restenotic lesions vs primary stenotic lesions Chang CJ, Ko PJ, Hsu LA, Ko YS, Ko YL, Chen CF, Huang CC, Hsu TS, Lee YS, Pang JH: Highly increased cell proliferation activity in the restenotic hemodialysis vascular access after percutaneous transluminal angioplasty: Implication in prevention of restenosis. Am J Kidney Dis 43: 74 84, 2004
8 Venous Intimal Hyperplasia Duplex native AV fistulas Intimal hyperplasia Fibrotic stenosis
9 Fistuloplasty of Juxta-anastomotic stenoses :Plain balloon fistuloplasty vs DCB Walton H, Errete L, Ramskold L, Cloran J, Guest M, Selvakumar S, Metcalfe M, Steiner K Native AV fistulas Juxta-anastomotic stenosis 93 Consecutive Patients 75 PBA (81%) 18 DEB (Lutonix Bard)(19%) 20 month period Technical success rate 100% No complications
10 Results Primary Patency PBA DCB P-Value 3 Months 96% 100% Months 68% 92% Months 33% (n=30) 80% (n=5) Primary Assisted Patency PBA DCB P-Value 3 Months 100% 100% N/A 6 Months 98% 100% Months 87% 100% 0.19
11 Results PBA DCB Increase in Volume Flow (Mls/min)
12 Further Follow up 20 consecutive patients DCB 1 died 12 months 12 patients - 3 transplanted - 1 died DCB 3 Months 6 Months 12 Months Primary Patency 100% 94% 64% Primary Assisted Patency 100% 100% 100%
13 Juxta-anastomotic fistuloplasty DCB Patane et al consecutive patients mature RCF Juxta-anastomotic stenoses DCB Technical and clinical success 100% No complications PP 6 months 96% 12 months 82% SP 24 months 95% Only one fistula lost Mortamais et al 2013 PBA Juxta-anastomotic lesions SP 12 months 76.1%
14 Conclusions Balloon angioplasty of juxta-anastomotic stenoses using DCB is safe and effective DCB group Primary patency rates higher (p<0.05 at 6 months) Less repeat interventions Greater increase in Volume Flow Larger numbers, prospective randomised control trials are needed. Cost analysis
15 Venous intimal hyperplasia; A target for drug elution?
16 Thank You
17 LUTONIX DCB in AV Access: A Single Center Experience Dr Kate Steiner Consultant Interventional Radiologist East and North Hertfordshire NHS Trust
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