Outcome and Risk Factors of Restenosis Post Percutaneous Transluminal Angioplasty at Juxta-Anastomotic of Wrist Autogenous Radial-Cephalic Arteriovenous Fistulas: A Retrospective Cohort Study.

BACKGROUND: This retrospective cohort study was to determine the factors related to restenosis post percutaneous transluminal angioplasty (PTA) at juxta-anastomotic of wrist radial-cephalic arteriovenous fistulas (RC-AVFs). METHODS: We conducted a retrospective study of patients who underwent their first PTA for juxta-anastomotic stenosis at RC-AVF from January 1, 2016, to December 31, 2020. Patient and stenotic lesion characteristics and PTA procedure factors were included in the analysis. The primary and assisted primary patency post PTA of RC-AVFs were evaluated using the Kaplan-Meier analysis and log-rank test. A Cox proportional hazard model was used to identify factors associated with restenosis post PTA. The receiver operating characteristic (ROC) curve was employed to evaluate the predictive value of the risk factors for restenosis post PTA. RESULTS: A total of 65 patients with a mean age of 59.09 ± 14.94 years were enrolled in the study. The mean RC-AVF age was 9.2 (4.9, 35.05) months, and the median time of intervention for stenosis was 10.8 (4.05, 41.35) months after AVF creation. The primary patency rates following the first PTA at 3, 6, 12, and 24 months were 93.9, 84.6, 63.1, and 55.4%, respectively. The assisted primary patency rates at 3, 6, 12, and 24 months were 95.4, 90.8, 87.7, and 84.6%, respectively. Cox proportional hazard regression analysis revealed the maximum balloon diameter >5 mm had a lower postoperative restenosis rate compared with the maximum balloon diameter ≤5 mm (hazard ratio = 0.422; 95% confidence interval [CI]: 0.201-0.884; P = 0.022). ROC curve analysis showed that the area under the curve of the maximum balloon diameter during PTA was 0.624 (95% CI, 0.486-0.762). The best critical value for the maximum balloon diameter was 6 mm, the sensitivity was 64.5%, and the specificity was 61.8%. CONCLUSIONS: For the first PTA at juxta-anastomotic of wrist RC-AVFs without thrombosis and complete occlusion, the use of a balloon with a maximum diameter of ≤5 mm is a risk factor to the occurrence of restenosis within 12 months post PTA. The result may help in tailoring surveillance programs in patients with RC-AVF stenosis.

Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.

BACKGROUND: The timing of when to initiate dialysis for progressive chronic kidney disease (CKD) patients has not been well established. There has been a strong trend for early dialysis initiation for these patients over the past decades. However, the perceived survival advantage of early dialysis has been questioned by a series of recent observational studies. The only randomized controlled trial (RCT) research on this issue found the all-cause mortality, comorbidities, and quality of life showed no difference between early and late dialysis starters. To better understand optimal timing for dialysis initiation, our research will evaluate the efficacy and safety of deferred dialysis initiation in a large Chinese population. METHODS: The trial adopts a multicenter, cluster randomized, single-blind (outcomes assessor), and endpoint-driven design. Eligible participants are 18-80 years old, in stable CKD stages 4-5 (eGFR > 7 ml/min /1.73 m2), and with good heart function (NYHA grade I or II). Participants will be randomized into a routine or deferred dialysis group. The reference eGFR at initiating dialysis for asymptomatic patients is 7 ml/min /1.73 m2 (routine dialysis group) and 5 ml/min/1.73 m2 or less (deferred dialysis group) in each group. The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups. The secondary outcomes include hospitalization rate and other safety indices. The primary and secondary outcomes will be analyzed by appropriate statistical methods. DISCUSSION: This study protocol represents a large, cluster randomized study evaluating deferred and routine dialysis intervention for an advanced CKD population. The reference eGFR to initiate dialysis for both treatment groups is targeted at less than 7 ml/min/1.73m2. With this design, we aim to eliminate lead-time and survivor bias and avoid selection bias and confounding factors. We acknowledge that the study has limitations. Even so, given the low-targeted eGFR values of both arms, this study still has potential economic, health, and scientific implications. This research is unique in that such a low targeted eGFR value has never been studied in a clinical trial. TRIAL REGISTRATION: The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02423655). The date of registration was April 22, 2015.

Efficacy and safety of ultrasound-guided radiofrequency ablation of hyperplastic parathyroid gland for secondary hyperparathyroidism associated with chronic kidney disease.

BACKGROUND: The purpose of this study was to determine if ultrasound-guided radiofrequency ablation (RFA) of hyperplastic parathyroid glands could be used to treat secondary hyperparathyroidism (HPT) in patients with chronic kidney disease. METHODS: RFA of the hyperplastic parathyroid glands was performed in 34 patients with secondary HPT. Intact parathyroid hormone (iPTH), calcium, and phosphorus were measured. The outcome was based on the ablation extent (ie, 4, 3, and 1-2 glands). RESULTS: The iPTH, calcium, and phosphorus levels decreased in all groups after RFA. One year after ablation, these parameters remained significantly lower in the 4-gland ablation group compared with the 3-gland and 1 to 2-gland groups. The same tendency was observed for the symptom score. The iPTH levels of <272 pg/mL on the day after ablation was the best predictor for maintaining parathyroid hormone (PTH) levels in a reasonable range 1 year after ablation. CONCLUSIONS: RFA of hyperplastic parathyroid glands for treating secondary HPT is feasible in selected patients. © 2016 Wiley Periodicals, Inc. Head Neck 39: 564-571, 2017.