Effect of Far Infrared Radiation on the Proportion of Interventions in Arteriovenous Fistulas in Patients on Hemodialysis: A Randomized Trial.

Kristine Lindhard, Henrik Post Hansen, Kirstine Gliese, Emilie Hansen, Kristine Hommel, Boye Lagerbon Jensen, Ylian Liem, Brian Lindegaard Pedersen, Mahshid Pourarsalan, Marianne Rix, James Heaf, Ditte Hansen
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Abstract

Key points: Far infrared radiation did not improve the proportion of interventions in arteriovenous fistulas in patients on hemodialysis after 12 months of treatment. No difference was seen between treatment groups in time to intervention, number of thrombosed fistulas, and change in access flow. This study does not support the effect of far infrared radiation on fistula survival as proposed in previous vascular access guidelines.

Introduction: In patients on hemodialysis, the risk of arteriovenous fistula (AVF) failure is unacceptably high. Up to 67% of AVFs need an intervention within 1 year after placement. There are no effective treatments to prolong AVF longevity. Far infrared radiation (FIR) treatment has been suggested to enhance AVF survival. The present trial investigated the effect of FIR on the proportion of interventions in the AVF.

Methods: In a multicenter, randomized, controlled trial, patients were allocated to receive FIR treatment or no FIR. Eligible patients were patients on chronic hemodialysis with a well-functioning AVF. The FIR group received FIR above the skin of their AVF for 40 minutes at every hemodialysis session for 1 year. The primary outcome was the difference in the proportion of patients with at least one intervention (thrombectomy or percutaneous transluminal angioplasty) after 12 months. The chi-squared test analyzed the difference. Secondary outcomes included differences in the number of thrombosed AVFs, intervention rate, access flow at various time points, and time to first intervention between groups.

Results: A total of 115 patients were randomized to the FIR group ( n =58) or the control group ( n =57). Baseline characteristics were similar in both groups. There was no significant difference in the proportion of patients with interventions between the FIR and control groups (19% versus 28%, P = 0.25) or in the proportion with thrombosed AVFs (5% versus 3%, P = 0.26). Time to first intervention was 164 (interquartile range, 86-272) days in the FIR group and 127 (interquartile range, 44-164) days in the control group ( P = 0.26). No differences in the change of access flow occurred ( P = 0.86).

Conclusion: During 12 months of treatment, FIR did not affect the overall patency of the AVF. No difference was found in the number of patients with interventions or in any of the secondary endpoints (Clinicaltrials.gov: NCT04011072 ).

Clinical trial registry name and registration number: Clinicaltrials.gov: NCT04011072.

远红外辐射对血液透析患者动静脉瘘干预比例的影响:一项随机试验。
在血液透析患者中,动静脉瘘(AVF)失效的风险高得令人无法接受。高达67%的avf在放置后一年内需要进行干预。目前还没有有效的治疗方法来延长AVF的寿命。远红外辐射(FIR)治疗被认为可以提高AVF的存活率。本试验探讨了FIR对AVF干预比例的影响。方法:在一项多中心、随机、对照试验中,患者被分配接受FIR治疗或不接受FIR治疗。符合条件的患者为慢性血液透析且AVF功能良好的患者。FIR组在一年的时间里,每次血液透析(HD)时,在AVF皮肤上方给予FIR 40分钟。主要结局是12个月后接受至少一种干预(血栓切除术或经皮腔内血管成形术)的患者比例的差异。卡方检验分析差异。次要结局包括组间血栓形成的avf数量、干预率、不同时间点的通道流量和首次干预时间的差异。结果:115例患者随机分为FIR组(n=58)和对照组(n=57)。两组的基线特征相似。在FIR组和对照组之间,接受干预的患者比例(19% vs. 28%, p=0.25)或血栓性avf的比例(5% vs. 3%, p= 0.26)无显著差异。FIR组至首次干预时间为164 (IQR 86;272)天,对照组为127 (IQR 44;164)天(p=0.26)。存取流量的变化无差异(p=0.86)。结论:在12个月的治疗期间,FIR未影响AVF的整体通畅。在接受干预的患者数量或任何次要终点上没有发现差异。(Clinicaltrials.gov: NCT04011072)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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