Department of Surgery, Vascular and Endovascular Surgery Unit San Giovanni di Dio Hospital, Florence, Tuscany, Italy
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1 IL TRATTAMENTO ENDOVASCOLARE CON PALLONI MEDICATI RIDUCE IL RISCHIO DI NUOVA RESTENOSI IN PAZIENTI DIALIZZATI CON STENOSI RECIDIVE DELL ACCESSO VASCOLARE Pierfrancesco Frosini Direttore Chirurgia Vascolare Ospedale San Jacopo, Pistoia Dip. Chirurgico USL Centro Toscana Chir. Vasc. Firenze Prato Pistoia Empoli
2 BACKGROUND
3 BACKGROUND
4 BACKGROUND
5 BACKGROUND
6 BACKGROUND
7 BACKGROUND
8 BACKGROUND
9 BACKGROUND
10 BACKGROUND April 2016
11 DECISIONAL ALGORITHM April 2016
12 AIM OF THE 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
13 METHODS Between July 2013 and June 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
14 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
15 RESULTS - AVF Most of patients were males (22, 57.9%) with a mean age of 70.8 years (range 13-91) Arteriovenous fistula was distal in 13 cases (34.2%), mid-arm in 3 cases (7.9%), and proximal in 22 cases (57.9%) In 6 cases (15.8%) a prosthetic graft was present
16 RESULTS - Intraoperative DCB used was Freeway in 22 cases (57.9%), IN.PACT Pacific in 14 cases (36.8%), and Ranger in 2 cases (5.3%) Intraprocedural technical success was obtained in 97.4% of the cases In one patient the procedure was interrupted due to acute recoil and massive bleeding at the access site
17 FOLLOW-UP ABSENCE OF TLR During the follow-up (mean duration 14.3 months, range 2-33) 19 patients (50%) developed a new restenotic lesion with an estimated 2-year absence of TLR of 32.8%
18 FOLLOW-UP RESTENOSIS Mean time BA-DCB was 6.4 months, and the mean time DCB-restenosis was 7.9 months with a statistically significant difference at T-test (P<0.001)
19 OUTCOMES 40,8%
20 2-YEAR OUTCOMES 73.1%
21 2-YEAR OUTCOMES 82.5%
22 CONCLUSIONS In our experience DCBs were safe and effective in the treatment of recurrent stenosis in hemodialysis patients with failing arteriovenous fistula Half of patients had no new restenotic lesion during the follow-up In patients with a new restenosis the time to new restenotic lesion was longer respect to that necessary to have a new restenosis after BA
23 CONCLUSIONS Finally, the great difference in terms of primary and primary assisted patencies at 2 years demonstrates that a strict collaboration between nephrologists and vascular surgeons/interventional radiologists is mandatory to avoid the failure of the vascular access
24
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