DCB in the treatment of av-accessa single center prospective study

Transcription

1 DCB in the treatment of av-accessa single center prospective study Dr. med. Tobias Steinke Schön Klinik Fachzentrum Gefäßchirurgie, Düsseldorf

2 Disclosure Speaker name: Dr. med. Tobias Steinke I have the following potential conflicts of interest to report: X 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

3 Hospitalization in Haemodialysis Patients

4 ESRD Patients New creation AV-A Revision AV-A CVC PDC Total

5 Stenotic lesions cephalic arch central ven. stenosis ven. anastomosis AVG native vein juxtaanastomotic

6 POBA plain old ballon angioplasty ven. anastomosis AVG

7 protheto-venous anastomotic stenosis Implant. Graft

8 Stentgraft Implant. Stent-Graft

9 Prevention-Strategy of (Re)Stenosis Endovascular POBA Cutting / Scoring Balloon Stent Stentgraft DCB Cryotherapie Extern/topic Paclitaxel Polymer-Gel Antiproliferative Polymer wraps allogene endothelial cells Fat-cells/Glitazone Recombinante Elastase Infrared radiation Brachytherapie Endovascular Genetherapy Microinfusion

10 DCB drug coated balloon breakthrough...?

11 DCB AV-A Katsanos, Kitrou Author n= Type RCT single Teo RCT single Patane Cohort Lai Cohort prosp. Swinnen Cohort retro. Massmann Cohort prosp. Steinke Cohort prosp.

12 Demographics Patient Characteristics Düsseldorf # of cases to date 76 Dialysis patients 74/76 (97%) Age (median, min.-max.) 60 (19-84) Gender: male 47/76(63%) BMI (median, min.-max.) 28,8 (21,6-37,0) Diabetes 48/76 (63%) Hypertension 67/76 (88%) Hyperuricemia 47/76 (63%)

13 Localisation of stenosis n= % prothetovenous 28 37,8 nativ vein 16 21,1 juxtaanastomotic 18 23,7 central 14 18,4

14 prothetovenous 37,8% Localisation native vein upper extrem. 21,1% juxtaanastomotic 23,7% Upper arm/central n=58 / 76% Lower arm n=18 / 24% Graphik aus Shenoy, S. J Vasc Access Oct-Dec;10(4):

15 Technical procedure If necessary: thrombektomie, angiographie Terumo wire 0,035, predilatation 1mm smaller than the final diameter (standard balloon or high pressure (Conquest)) postdilatation DCB 120 sec. Final-angio

16 Technical success n= % prothetovenous 27/28 96,5 nativ vein 16/ juxtaanastomotic 17/18 94,5 central venous 14/14 100

17 TL PP 6 month n=74/30 40,5% Access survival 6m 74/71 95%

18 TL primary Patency after DCB in AV access

19 TL PP 6 month n=74/30 40,5% prothetovenous 27/2 7% nativ vein 16/12 75% juxtaanastomotic 17/9 53% central venous 14/7 50%

20 Patency depending on localisation of reconstruction arterial anastomosis venous anastomosis of graft stenosis distal to anastomosis in combination with aneurysma N=415 Brittinger WD, Anschl. Verfahren an die künstliche Niere, 2005;6 Surgical results after patch-reconstruction of AV-Access-stenosis

21 Patency depending on localisation of intervention Graph shows the Kaplan-Meier survival analysis for assisted primary patency rates in patients with venous stenosis in the cutting and conventional percutaneous transluminal angioplasty(pta) groups. No significant differences in assisted primary patency rates were identified between groups (P ¼.360). The number of patients at risk in each time period is listed arterial anastomosis venous anastomosis of graft stenosis distal to anastomosis in combination with aneurysma J Vasc Surg.2014 Sep;60(3): Prospective, randomized study of cutting balloon angioplasty versus conventional balloon angioplasty for the treatment of hemodialysis access stenoses. Saleh HM 1, Gabr AK 2, Tawfik MM 2, Abouellail H 3, Ain Shams University, Cairo

22 Patency depending on localisation of intervention Fig 4. Graph shows the Kaplan-Meier survival analysis for assisted primary patency rates in patients with arterial anastomotic stenosis in the cutting and conventional percutaneous transluminal angioplasty (PTA) groups. No significant differences in assisted primary patency rates were identified between groups (P ¼.921). Note that the line is interrupted beyond the point at which standard error exceeds 10%. The number of patients at risk in each time period is listed Arterial anastomosis venous anastomosis of graft stenosis distal to anastomosis in combination with aneurysma J Vasc Surg.2014 Sep;60(3): Prospective, randomized study of cutting balloon angioplasty versus conventional balloon angioplasty for the treatment of hemodialysis access stenoses. Saleh HM 1, Gabr AK 2, Tawfik MM 2, Abouellail H 3, Ain Shams University, Cairo

23 Cohort studies

24 12 Month

25 Conclusion DCB in AV-Access: DCB promising in terms of: restenosis-rate (most beneficial in which location.?) extending the intervention-free interval High primary technical success (cave!! vessel preparation ) Inhomogeneous local findings throughout the studies (Still) expensive More RCT needed We are not there..!!

26 THANK YOU

27 Randomized Controlled Trial

28 Prospective Randomized, Katsanos et al.

29 Prospektiv randomisiert Teo et al. Anatomic success 92.9% (13/14) in the DEB arm and 81.3% (13/16) in the PTA arm At 6 months, the circuit primary patency 43% in the DEB arm 63% in the PTA arm Restenosis rates were 33.3% (3/9) in the DEB arm 75.0% (9/12) in the PTA arm Conclusion Restenosis rate and late luminal loss in the DEB arm are superior to PTA alone at 6 months (not statistical significant) The use of DEB did not prolong 6-month circuit or targeted lesion primary patency rates compared to PTA alone, despite improved restenosis rate and less late luminal loss.

30 Cutting balloon n=340 3Monate 6 Monate PCB 65,8% 47,9% PTA 63,4% 40,5% J Vasc Interv Radiol Dec;16(12): Use of the peripheral cutting balloon to treat hemodialysisrelated stenoses. Vesely TM, Siegel JB. CONCLUSION: This prospective, randomized trial comparing use of the PCB versus standard PTA for treatment of hemodialysis-related venous stenoses demonstrated that the PCB provides equivalent 6-month patency to PTA for stenotic and thrombosed grafts. n=22 3Monate 6 Monate PCB Nur flow Nur flow PTA Nur flow Nur flow n=623 6Monate 12 Monate PCB 86% 63% PTA 37% 37% J Vasc Access Oct-Dec;11(4): Ultrahigh-pressure angioplasty versus the Peripheral Cutting Balloon for treatment of stenoses in autogenous fistulas: comparison of immediate results. Kundu S, Clemens R, Aziza J, Tam P, Nagai G, You J, Au V. CONCLUSIONS: In this small group of HD patients with autogenous fistulas our comparison of UHP to the PCB demonstrated that the immediate results, as determined by measurement of intra-access blood flow, were equivalent. Further long-term follow-up will be required to determine the longevity of these results. J Vasc Surg.2014 Sep;60(3): Prospective, randomized study of cutting balloon angioplasty versus conventional balloon angioplasty for the treatment of hemodialysis access stenoses. Saleh HM 1, Gabr AK 2, Tawfik MM 2, Abouellail H 3, Ain Shams University, Cairo CONCLUSIONS: Cutting balloon angioplasty proved to be a safe and effective treatment of graft-to-vein anastomotic stenosis, with significantly higher patency than that of conventional balloon angioplasty.

31 DCB in the treatment of av-accessa single center prospective study Dr. med. Tobias Steinke Schön Klinik Fachzentrum Gefäßchirurgie, Düsseldorf