IN ARTERIOVENOUS FISTULA FAILURE
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1 DRUG ELUTING BALLOON ANGIOPLASTY IN ARTERIOVENOUS FISTULA FAILURE Nicola Troisi, MD
2 GUIDELINES
3 GUIDELINES VAS 2007
4 GUIDELINES VAS 2007
5 GUIDELINES VAS 2007
6 GUIDELINES VAS !!!!!!!!!!
7 GUIDELINES GEMAV 2017
8 GUIDELINES GEMAV 2017
9 GUIDELINES
10 BACKGROUND
11 BACKGROUND
12 BACKGROUND
13 RANDOMIZED TRIAL
14 RANDOMIZED TRIAL
15 COST EFFECTIVENESS
16 IN STENT STENOSIS
17 IN STENT STENOSIS
18 SUMMARY April 2016
19 DECISIONAL ALGORITHM April 2016
20 FREEWAY DCBs 2016
21 MIXED DCBs 2017
22 OUR FREEWAY STUDY Aim of this study was to evaluate the early and mid term outcomes of drug coated balloons (DCBs) in hemodialysis patients with recurrent stenosis of arteriovenous fistula, paying particular attention to their impact to the risk of new restenosis and the time to the new restenotic lesion
23 METHODS Between July 2013 and December hemodialysis patients with recurrent stenosis of arteriovenous fistula underwent endovascular treatment with a DCB at our center All patients were previously treated at the target lesion with a standard balloon angioplasty (BA) All data concerning the procedures were prospectively collected in a dedicated database with about 80 fields
24 STATISTICAL ANALYSIS The intervals in months between the standard BA and the procedure with DCB (time BA DCB) and between the procedure with DCB and the new restenotic lesion (time DCBrestenosis) were evaluated and compared with T test Estimated outcomes at 2 years in terms of survival, primary patency, primary assisted patency, secondary patency, and freedom from target lesion restenosis were assessed with Kaplan Meier curves Statistical significance was defined at the P <.05 level
25 RESULTS AVF Most of patients were males (15, 55.6%) with a mean age of 66.1 years (range 13 90) Arteriovenous fistula was distal in 8 cases (29.6%), mid arm in 3 cases (11.1%), and proximal in 16 cases (59.3%) In 4 cases (14.8%) a prosthetic graft was present
26 RESULTS INTRAOPERATIVE In all patients a predilatation was performed (in 2 cases with cutting balloon) Intraprocedural technical success was obtained in 96.3% of the cases In one patient the procedure was interrupted due to acute recoil and massive bleeding at the access site
27 FOLLOW UP ABSENCE OF TLR During the follow up (mean duration 13.6 months, range 2 33) 13 patients (48.1%) developed a new restenotic lesion with an estimated 2 year absence of TLR of 30.2%
28 FOLLOW UP RESTENOSIS Mean time BA DCB was 4.8 months, and the mean time DCBrestenosis was 7.6 months with a statistically significant difference at T test (P<0.001)
29 FOLLOW UP 2 YEAR OUTCOMES
30 FOLLOW UP 2 YEAR OUTCOMES
31 FOLLOW UP 2 YEAR OUTCOMES
32 CONCLUSIONS In our experience DCBs were effective in the treatment of recurrent stenosis in hemodialysis patients with failing arteriovenous fistula During the follow up about half of patients had no new restenosis at the target lesion Furthermore, the time to a new restenosis was much longer compared to recurrence of stenosis after standard balloon angioplasty
33 PAPER IN PRESS
34 TAKE HOME MESSAGE The great difference in terms of primary, primary assisted and secondary patencies at 2 years demonstrates that a rigorous collaboration between nephrologists and interventional radiologists/vascular surgeons is mandatory to avoid the failure of the vascular access
35 THE FUTURE IS NOW
36 FREEWAY TM 035 AV Shunt: Key Selling Points High pressure DEB for the treatment of shunt stenosis Protects AV fistulas and shunt grafts from early restenosis by opening the artery and delivering paclitaxel, an antiproliferative agent, to the vessel wall Reduces re intervention Feasibility study presented at LINC 2015, showed a low re intervention rate of 11% at follow up Registry presented at LINC 2017 showed significant longer time to re intervention after FREEWAY TM PTA
37 FREEWAY TM 035: Registry AV Fistula Registry 33 lesions DEB dilatation with mandatory predilatation Planned follow up by ultrasound: 3 4 months St. Joseph Hospital Berlin
38 FREEWAY TM 035: Registry AV Fistula Registry BASELINE LESIONS (N=33) ACCESS TYPE AV Fistula (Cimino) 30.3 % AV Fistula Basilic 6.1 % AV Fistula Cephalic 18.2 % AV Graft 45.5 % Target Lesion Location Arterial 6.1 % Venous 90.9 % Anastomosis 3.0 % Lesion Characteristics Reference Vessel Diameter [mm] 5.80 ± 0.76 Lesion Length [mm] ± 11.67
39 FREEWAY TM 035: Registry AV Fistula Registry PROCEDURAL DATA Pre Interention Post Intervention Minimal Lumen 1.97 ± ± 0.62 Diameter [mm] Stenosis Percentage % % FOLLOW UP 120 ± 49 days REVASCULARIZATIONS DURING FOLLOW UP FOLLOW UP (N=18) Re Intervention 11.0% FLOW COMPARISON (DUS) Discharge Follow Up (N=18) Flow [ml/min] 806 ± ± 255
40 Thank you for your attention
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