Can blood flow surveillance and pre-emptive repair of subclinical stenosis prolong the useful life of arteriovenous fistulae? A randomized controlled study (original) (raw)

Should current criteria for detecting and repairing arteriovenous fistula stenosis be reconsidered? Interim analysis of a randomized controlled trial

Nephrology Dialysis Transplantation, 2013

Background. The vascular access guidelines recommend that arteriovenous fistulas (AVFs) with access dysfunction and an access blood flow (Qa) <300-500 mL/min be referred for stenosis imaging and treatment. Significant (>50%) stenosis, however, may be detected in a well-functioning AVF with a Qa > 500 mL/min, too, but whether it is worth correcting or not remains to be seen. Methods. In October 2006, we began an open randomized controlled trial enrolling patients with an AVF with subclinical stenosis and Qa > 500 mL/min, to see how elective stenosis repair [treatment group (TX)] influenced access failure (thrombosis or impending thrombosis requiring access revision), or loss and the related cost compared with stenosis correction according to the guidelines, i.e. after the onset of access dysfunction or a Qa < 400 mL/min [control group (C)]. An interim analysis was performed in July 2012, by which time the trial had enrolled 58 patients (30 C and 28 TX). Results. TX led to a relative risk of 0.47 [95% confidence interval (CI): 0.17-1.15] for access failure (P = 0.090), 0.37 [95% CI: 0.12-0.97] for thrombosis (P = 0.033) and 0.36 [95% CI: 0.09-0.99] for access loss (P = 0.041). In the setting of our study (in which all surgery was performed as in patient procedure) no significant differences in costs emerged between the two strategies. The mean incremental cost-effectiveness ratio for TX was €282 or €321 to avoid one episode of thrombosis or access loss, respectively. Conclusions. Our interim analysis showed that elective repair of subclinical stenosis in AVFs with Qa > 500 mL/min cost-effectively reduces the risk of thrombosis and access loss in comparison with the approach of the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, raising the question of whether the currently recommended criteria for assessing and treating stenosis should be reconsidered.

Preemptive Correction of Arteriovenous Access Stenosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials

American Journal of Kidney Diseases, 2016

Background: Preemptive correction of a stenosis in an arteriovenous (AV) access (fistula or graft) that is adequately providing hemodialysis (functional AV access) may prolong access survival as compared to waiting for signs of access dysfunction to intervene (deferred salvage). However, the evidence in support of preemptive intervention is controversial. We evaluated benefits and harms of preemptive versus deferred correction of AV access stenosis. Study Design: Systematic review and meta-analysis of randomized controlled trials. Setting & Population: Adults receiving hemodialysis by a functional AV access. Selection Criteria for Studies: We searched the Cochrane Kidney and Transplant Specialised Register and EMBASE to October 15, 2015. Intervention: Active access surveillance (flow measurement and Doppler or venous pressure) and preemptive correction of a newly identified stenosis versus routine clinical monitoring and deferred salvage, or preemptive correction of a known stenosis versus deferred salvage. Outcomes: Access loss (primary outcome) and thrombosis (overall and by access type), infection, mortality, hospitalization, and access-related procedures. Results: We included 14 trials (1,390 participants; follow-up, 6-38 months). Relative to deferred salvage, preemptive correction of AV access stenosis had a nonsignificant effect on risk for access loss (risk ratio [RR], 0.81; 95% CI, 0.65-1.02; I 2 5 0%) and a significant effect on risk for thrombosis (RR, 0.79; 95% CI, 0.65-0.97; I 2 5 30%). Treatment effects were larger in fistulas than in grafts for both risk for access loss (subgroup difference, P 5 0.05) and risk for thrombosis (subgroup difference, P 5 0.002). Results were heterogeneous or imprecise for mortality, rates of access-related infections or procedures, and hospitalization. Limitations: Small number and size of primary studies limited analysis power. Conclusions: Preemptive stenosis correction in a functional AV access does not improve access longevity. Although preemptive stenosis correction may be promising in fistulas, existing evidence is insufficient to guide clinical practice and health policy.

Secondary interventions in patients with autologous arteriovenous fistulas strongly improve patency rates

Journal of Vascular Surgery, 2011

Background: Nowadays, as a result of more liberal selection criteria, dialysis-dependent patients have become substantially older, more likely to be female and diabetic, and have more comorbidity. The 1-year primary patency rates of arteriovenous fistulas (AVFs) are poor. To improve these results, several secondary interventions can be performed. The aim of this study was to evaluate the results after secondary interventions in patients with an upper extremity AVF. Methods: Between January 2000 and December 2008, all consecutive patients who underwent construction of an autologous upper extremity AVF were included. Patient characteristics were collected retrospectively from digital patient files and a prospectively recorded database on hemodialysis patients. Results: Between January 2000 and December 2008, 736 hemodialysis access procedures were performed. A total of 347 autologous arteriovenous fistulas (AVFs) were created in 294 patients. The mean age was 62.1 ؎ 14.7 years, and the majority (66%) of the patients was male. Mean follow-up of all 347 fistulas was 21.9 ؎ 21.6 months. During follow-up, failure occurred in 209 (60%) of the AVFs. A total of 133 of these failures were followed by a secondary intervention, of which 78 (59%) were endovascular interventions. Twenty-nine patients developed a third failure, and 25 of these patients underwent another intervention, of which 22 were percutaneous transluminal angioplasty for stenosis. Fifteen patients developed a fourth failure, and all of them underwent an intervention. One patient had 11 interventions. The 1-and 2-year primary patency rates were 46% and 36.8%, respectively. The 1-and 2-year primary assisted patency rates were 74.6% and 71.2%, respectively. The 1-and 2-year secondary patency rates were 79.2% and 77.8%, respectively. Conclusion: The primary patency rate of AVFs is disappointing. However, due to mostly endovascular secondary interventions, 2-year primary assisted and secondary patency rates of more than 70% can be obtained. ( J Vasc Surg 2011; 54:1095-9.)

Inferiority of arteriovenous grafts, in comparison to autogenous fistulas, is underestimated by standard survival measures alone

ANZ Journal of Surgery, 2020

Background: It has been argued that a prosthetic arteriovenous graft (AVG) is a reasonable alternative to an arteriovenous fistula (AVF) for dialysis. We aimed to compare the patency rates and requirements for the intervention of newly formed AVF and AVG. Methods: A retrospective analysis was undertaken of AVF and AVG formed between 1 January 2013 and 31 December 2015 at two tertiary referral centres and followed up until 31 December 2017. Outcome measures included successful use for dialysis, patency rates and the number of interventions required to maintain dialysis access per patient-year (PPY). Results: Four hundred and seventy AVF and 92 AVG were constructed. Of 470 AVF, 324 (68.9%) were used compared to 80 of 92 (87%) AVG. One year assisted primary patency of AVF was 75% (confidence interval 71-79%) compared to 47% (confidence interval 36-57%) for AVG. Secondary patency rates for AVF at 1, 2 and 3 years were 77%, 71% and 69%, respectively. At the same time points, secondary patency rates for AVG were 77%, 60% and 46%, respectively (log rank P = 0.034). AVG required 2.4 times the number of interventions PPY than AVF. Surgical thrombectomy of AVG was at a rate of 0.49 PPY compared with 0.042 PPY for AVF. Conclusion: AVG have a substantially higher rate of thrombosis than AVF, evident from early in the life of the graft. AVF demonstrate superior patency rates to AVG throughout the life of the access, with far fewer interventions PPY than grafts.

Sentinel vascular access monitoring after endovascular intervention predicts access outcome

The Journal of Vascular Access, 2018

Background and objectives: The vascular access pressure ratio test identifies dialysis vascular access dysfunction when three consecutive vascular access pressure ratios are >0.55. We tested whether the magnitude of the decline in vascular access pressure ratio 1-week post-intervention could alert of subsequent access failure. Design, setting, participants, and measurements: The retrospective study included all vascular access procedures at one institution from March 2014 to June 2016. Data included demographics, comorbidities, vascular access features, %ΔVAPR = ((Pre-Post)/Pre] × 100% assessed within the first 2 weeks post-percutaneous transluminal balloon angioplasty, time-to-next procedure, and patency. The log-rank test compared the area under the curve, receiver operating curve, Kaplan-Meier arteriovenous graft and arteriovenous fistula survival curves. A multivariable Cox proportional hazard (CP) model was used to determine the association of %ΔVAPR with access patency. Results: Analysis of 138 subjects (females 51%; Black 87%) included 64 arteriovenous fistulas with 104 angioplasties and 74 arteriovenous grafts with 134 angioplasties. The area under the receiver operating characteristic curve for fistula failure at 3 months was 0.59, with optimal screening characteristics of 33.3%, sensitivity of 56.1%, and specificity of 63.2%. Arteriovenous fistula with <33.3% decline compared to >33.3% required earlier subsequent procedure (136 vs 231 days), lower survival on Kaplan-Meier analysis (P = 0.01), and twofold greater risk of failure (P = .006). Area under the receiver operating characteristic for arteriovenous graft failure at 3 months had a sensitivity of 52.3% and specificity of 67.4%. Arteriovenous graft with a post-intervention vascular access pressure ratio decline of <28.8% also required earlier subsequent procedure (144 vs 189 days), lower survival on Kaplan-Meier (P = 0.04), and a 59% higher risk for failure. The area under the receiver operating characteristic curve for combined access failure (arteriovenous fistula + arteriovenous graft) at 3 months had an optimal cut-point value of 31.2%, a sensitivity of 54.6%, and a specificity of 63.1%. Access with a <31.2% drop had a 62% increase in the risk of failure (hazard ratio 1.62; confidence interval 1.16, 2.27; P = 0.005). Conclusion: The magnitude of post-intervention reduction in vascular access pressure ratio provides a novel predictive measure of access outcomes.

Reduction in arteriovenous graft impairment: Results of a vascular access surveillance protocol

American Journal of Kidney Diseases, 1998

Impairment of hemodialysis (HD) vascular access, remains a frustrating problem for both the patient who possesses an arteriovenous graft (AVG) and the nephrologist who cares for the patient. We instituted a vascular access surveillance protocol intended to detect and correct evolving stenosis in patients with AVGs. The principal screen was the observation of dynamic venous pressure (VP) at a blood flow rate of 200 mL/min during the first 5 minutes of each HD session. If VP at a blood flow rate of 200 mL/min was 140 mm Hg or greater in three of six consecutive readings, recirculation greater than 15% on two observations, graft-arm swelling observed, or prolonged bleeding postdialysis observed, then the patient was referred for angiography and then angioplasty or surgery if a vascular stenosis of greater than 50% was documented. Sixty-four patients with a synthetic AVG comprised the study group. Seventy-two episodes of AVG impairment (56 with stenosis H 50% on angiography, 16 with thrombosis) occurred in these patients during the study period. In 63 of 72 impairment episodes, the preceding vascular access screening test was positive. The calculated sensitivity and specificity of the vascular access protocol was 88% and 81%, respectively. Calculation of the sensitivity and specificity for the VP alone was 81% and 85%, respectively. Comparison of the study group with a similar historical control group (55 patients) showed a significantly lower thrombosis rate (P ‫؍‬ 0.03; 95% confidence interval [CI], 0.025 to 0.375) in the study group (0.29 thrombotic episodes/graft-year at risk) versus the historical control group (0.49 thrombotic episodes/graft-year at risk). In summary, a vascular access surveillance protocol is a useful tool to predict patients at risk for AVG venous stenosis and/or thrombosis. A dynamic VP of 140 mm Hg or greater appears to be the optimal threshold pressure. A decrease in synthetic AVG thrombosis rate resulted from the use of this surveillance protocol. 1998 by the National Kidney Foundation, Inc.

Improving arteriovenous fistula rate: Effect on hemodialysis quality

Hemodialysis International, 2014

Vascular access (VA) is the lifeline for patients with end-stage renal disease on regular hemodialysis (HD). Tunneled catheters have been associated with increased risk of luminal thrombosis, infection, hospitalization, and high cost. Our aims were to follow the "Fistula First Initiative," avoid or reduce the rate of catheter insertion, improve the rate of arteriovenous fistula (AVF) use, and study the effect of increased AVF use on quality of dialysis and patient's outcome. A VA program has been established in collaboration with an enthusiastic and professional vascular surgery team to manage 358 patients who have been on regular HD treatment for a period ranging from 1 to 252 months. The mean ± standard deviation age of patients was 52 ± 15 years with 62% male patients. Over a period of 2 years, 408 procedures were performed. These include 293 AVFs and 56 arteriovenous grafts (AVGs). Other procedures include 39 permanent catheter insertions, 8 AVF aneurysmectomy, removal of 6 AVGs, embolectomy of 4 AVGs, excision of 1 AVG lymphocele, and ligation of 1 AVF. This program resulted in significant increase in AVF rate from 35% to 82%; reduction in catheter rate from 62% to 10.9%; infection rate down from 6.6% to 0.6%; VA clotting down from 5.1% to 1.0%; and increase in average blood flow rate from 214 ± 32 to 298 ± 37 mL/min (P < 0.01). These results have been associated with improved average single pool Kt/V from 0.88 ± 0.19 to 1.28 ± 0.2 (P < 0.01); increased hemoglobin from 9.2 ± 1.2 to 10.9 ± 0.9 g/dL (P < 0.01); improved serum albumin from 3.2 ± 0.5 to 3.7 ± 0.4 g/dL (P < 0.05); reduction in administered erythropoietin dose by 19%; and significant drop in hospitalization rate from 6.1% to 3.8%. These results confirm the great benefits of AVF on quality of HD and patient outcome, and clearly affirm that AVF should always be considered first.

Predictors of Arteriovenous Fistula Failure: A Post Hoc Analysis of the FAVOURED Study

Kidney360, 2020

Background An autologous arteriovenous fistula (AVF) is the preferred hemodialysis vascular access, but successful creation is hampered by high rates of AVF failure. This study aimed to evaluate patient and surgical factors associated with AVF failure to improve vascular access selection and outcomes. Methods This is a post hoc analysis of all participants of FAVOURED, a multicenter, double-blind, multinational, randomized, placebo-controlled trial evaluating the effect of fish oil and/or aspirin in preventing AVF failure in patients receiving hemodialysis. The primary outcome of AVF failure was a composite of fistula thrombosis and/ or abandonment and/or cannulation failure at 12 months post-AVF creation, and secondary outcomes included individual outcome components. Patient data (demographics, comorbidities, medications, and laboratory data) and surgical factors (surgical expertise, anesthetic, intraoperative heparin use) were examined using multivariable logistic regression analyses to evaluate associations with AVF failure. Results Of 536 participants, 253 patients (47%) experienced AVF failure during the study period. The mean age was 55614.4 years, 64% were male, 45% were diabetic, and 4% had peripheral vascular disease. Factors associated with AVF failure included female sex (odds ratio [OR], 1.79; 95% confidence interval [CI], 1.20 to 2.68), lower diastolic BP (OR for higher DBP, 0.85; 95% CI, 0.74 to 0.99), presence of central venous catheter (OR, 1.49; 95% CI, 1.02 to 2.20; P50.04), and aspirin requirement (OR, 1.60; 95% CI, 1.00 to 2.56). Conclusions Female sex, requirement for aspirin therapy, requiring hemodialysis via a central venous catheter, and lower diastolic BP were factors associated with higher odds of AVF failure. These associations have potential implications for vascular access planning and warrant further studies.

Development and validation of a risk score to prioritize patients for evaluation of access stenosis

Seminars in Dialysis, 2021

Background: Access flow dysfunction, often associated with stenosis, is a common problem in hemodialysis access and may result in progression to thrombosis. Timely identification of accesses in need of evaluation is critical to preserving a functioning access. We hypothesized that a risk score using measurements obtained from the Vasc-Alert surveillance device could be used to predict subsequent interventions. Methods: Measurement of five factors over the preceding 28 days from 1.46 million hemodialysis treatments (6163 patients) were used to develop a score associated with interventions over the subsequent 60 days. The score was validated in a separate dataset of 298,620 treatments (2641 patients). Results: Interventions in arteriovenous fistulae (AVF; n = 4125) were much more common in those with the highest score (36.2%) than in those with the lowest score (11.0). The score also was strongly associated with interventions in patients with an arteriovenous graft (AVG; n = 2,038; 43.2% vs. 21.1%). There was excellent agreement in the Validation datasets for AVF (OR = 2.67 comparing the highest to lowest score) and good agreement for AVG (OR = 1.92). Conclusions: This simple risk score based on surveillance data may be useful for prioritizing patients for physical examination and potentially early referral for intervention.