Dialysis Fistula Malfunction cutting and high-pressure balloon angioplasty, which conflicted with a study by Aftab et al that did show significantly improved patency using cutting balloons compared to high-pressure balloons [47,48]. Drug-eluting balloons coated with paclitaxel have been shown in multiple prospective randomized trials to have significantly improved patency when compared to conventional balloon angioplasty except for a study by Maleux et al that demonstrated higher patency rates but without significance [49-52]. On January 17, 2019, the FDA issued a warning letter about a possible increase in long-term mortality rates among patients with peripheral artery disease treated with paclitaxel-coated balloons and paclitaxel-eluting stents when compared to patients treated with control devices such as noncoated balloons or bare metal stents. The FDA allowed for the continued use of paclitaxel- coated balloons and paclitaxel-eluting stents per the current standard of care with recommendations for continued surveillance and discussion of the risks and benefits with patients, including a possible increased risk of long-term mortality [53]. Indications for placement of an endoluminal stent (bare metal stent or stent graft) as defined by the SIR and KDOQI guidelines, include technical failure of PTA of a culprit lesion, recurrence of the same stenotic lesion within a 3- month period after a prior successful balloon angioplasty, and in the event of a complication during treatment such as venous rupture [3,7]. When indicated, a stent or stent graft can be placed over the stenotic lesion typically following angioplasty. While early studies, such as Quinn et al, did not show significant improvement in patency rates of stents versus PTA, follow-up prospective randomized studies demonstrated a significant improvement in dialysis access patency after bare stent placement [54-57]. Stent grafts have shown superior patency rates when comparing bare stents and angioplasty alone [58-63].
Dialysis Fistula Malfunction. Dialysis Fistula Malfunction cutting and high-pressure balloon angioplasty, which conflicted with a study by Aftab et al that did show significantly improved patency using cutting balloons compared to high-pressure balloons [47,48]. Drug-eluting balloons coated with paclitaxel have been shown in multiple prospective randomized trials to have significantly improved patency when compared to conventional balloon angioplasty except for a study by Maleux et al that demonstrated higher patency rates but without significance [49-52]. On January 17, 2019, the FDA issued a warning letter about a possible increase in long-term mortality rates among patients with peripheral artery disease treated with paclitaxel-coated balloons and paclitaxel-eluting stents when compared to patients treated with control devices such as noncoated balloons or bare metal stents. The FDA allowed for the continued use of paclitaxel- coated balloons and paclitaxel-eluting stents per the current standard of care with recommendations for continued surveillance and discussion of the risks and benefits with patients, including a possible increased risk of long-term mortality [53]. Indications for placement of an endoluminal stent (bare metal stent or stent graft) as defined by the SIR and KDOQI guidelines, include technical failure of PTA of a culprit lesion, recurrence of the same stenotic lesion within a 3- month period after a prior successful balloon angioplasty, and in the event of a complication during treatment such as venous rupture [3,7]. When indicated, a stent or stent graft can be placed over the stenotic lesion typically following angioplasty. While early studies, such as Quinn et al, did not show significant improvement in patency rates of stents versus PTA, follow-up prospective randomized studies demonstrated a significant improvement in dialysis access patency after bare stent placement [54-57]. Stent grafts have shown superior patency rates when comparing bare stents and angioplasty alone [58-63].