3.1. Study Design and Setting
This retrospective observational cohort study was conducted at Imam Khomeini Hospital, a tertiary academic center affiliated with Urmia University of Medical Sciences, Urmia, Iran, between March 2020 and March 2024. The research protocol was reviewed and approved by the Ethics Committee of Urmia University of Medical Sciences (IR.UMSU.HIMAM.REC.1403.017). Patient confidentiality was maintained throughout the study. Owing to the retrospective design, the requirement for direct informed consent was waived. All patient data were de-identified and handled in accordance with the Declaration of Helsinki.
3.2. Study Population
The target population comprised adult hemodialysis patients referred to the vascular surgery service for vascular access creation. The study population included patients who underwent either tBBAVF creation or placement of an upper-extremity prosthetic AVG at Imam Khomeini Hospital between March 2020 and March 2024.
3.2.1. Inclusion Criteria
1) Confirmed anatomical unsuitability or exhaustion of the cephalic vein on preoperative duplex ultrasonography.
2) Underwent either tBBAVF creation or placement of an arm prosthetic AVG using ePTFE.
3.2.2. Exclusion Criteria
1) Concomitant central venous stenosis or occlusion ipsilateral to the planned access site.
2) Prior complex vascular access reconstruction or proximal bypass in the target extremity.
3) Requirement for an early-cannulation-specific graft to standardize the comparison with standard ePTFE.
4) Follow-up of less than 6 months, unless the access failed or the patient died before this endpoint.
3.3. Preoperative Evaluation
All patients underwent comprehensive preoperative vein mapping using high-resolution duplex ultrasonography. The minimum anatomical criteria for tBBAVF creation were a continuous basilic vein diameter > 3.0 mm under a tourniquet and an ipsilateral brachial artery diameter ≥ 2.0 mm without severe continuous calcification. In the AVG group (n = 30), treatment allocation was based on prespecified clinical and anatomical constraints:
1) Anatomical unsuitability: n = 21 (70.0%) had inadequate basilic vein caliber (< 3.0 mm) or localized venous sclerosis.
2) Clinical urgency/catheter avoidance: n = 6 (20.0%) required rapid access cannulation to avoid prolonged central venous catheter (CVC) dependence because of active catheter-related bloodstream infection or poor tolerance.
3) Limited life expectancy/medical frailty: n = 3 (10.0%) had severe systemic comorbidities for which a multistage surgical maturation process was clinically contraindicated.
3.4. Surgical Techniques
All procedures were performed under regional anesthesia (brachial plexus block) or local anesthesia with intravenous sedation by board-certified vascular surgeons.
tBBAVF: Depending on vein caliber, tBBAVF was performed as either a single-stage or two-stage procedure. In the two-stage approach, the first stage involved an end-to-side anastomosis of the native basilic vein to the brachial artery. After 4 - 6 weeks of maturation to allow venous dilation, second-stage superficialization was performed. The arterialized vein was mobilized through a longitudinal or skip-incision approach, transposed anteriorly into a subcutaneous tunnel, and superficialized to permit safe repetitive cannulation.
Prosthetic AVG: ePTFE grafts (standard 6-mm or 4 - 7-mm tapered configurations) were implanted. The specific configuration (straight arm, loop forearm, or loop arm) was determined by individual anatomy and available outflow veins, typically the deep brachial or axillary veins. Anastomoses were constructed using standard running nonabsorbable monofilament sutures.
3.5. Postoperative Care and Surveillance
Postoperative access surveillance included clinical examinations for thrill, bruit, and edema at 2 weeks, 6 weeks, and every 3 months thereafter. For tBBAVF, initial cannulation was permitted only after clinical clearance by the surgical team. Clinical maturation was typically defined as a vein diameter > 6 mm, depth < 6 mm from the skin surface, and access flow > 600 mL/min, consistent with the KDOQI "Rule of 6s." Standard ePTFE AVGs were typically cleared for cannulation 14 - 21 days postoperatively.
3.6. Outcome Assessment and Blinding
Because of the retrospective observational cohort design, formal prospective blinding of outcome assessment was not performed. Primary outcome and complication data were extracted through systematic medical record review of standardized clinical evaluations, routine hemodialysis nursing access reports, and duplex ultrasonography studies performed by board-certified vascular surgeons.
3.7. Endpoints and Definitions
Clinical endpoints were defined according to the recommended Society for Vascular Surgery (SVS) reporting standards.
Primary patency failure: Primary patency was defined as the interval, in months, from access creation until any intervention intended to maintain or re-establish patency, access thrombosis, or final follow-up (up to 6 months). Patency failure was defined as any of the following prespecified events: 1) total acute or subacute access thrombosis confirmed by absent pulse/thrill and duplex ultrasonography; 2) hemodynamically significant stenosis (> 50% luminal narrowing on duplex ultrasonography associated with a peak systolic velocity ratio > 2.0 or clinical dysfunction during hemodialysis); 3) inability to achieve successful two-needle cannulation for hemodialysis (maturation failure); or 4) any endovascular or surgical intervention performed to maintain flow.
Secondary patency: The interval from access creation until access abandonment, surgical ligation, or replacement, including time supported by endovascular or surgical interventions such as thrombectomy or angioplasty.
Maturation failure: Inability to successfully use the autogenous access for two-needle hemodialysis for at least two-thirds of dialysis sessions over a 30-day period.
Complications: Recorded postoperative complications included surgical-site infection, graft/fistula infection requiring explantation or systemic antibiotics, steal syndrome (hemodialysis access-induced distal ischemia), hematoma, and seroma.
Censoring framework: Patients who maintained a functioning, unintervened vascular access at the end of the 6-month study period were censored at 6 months. Patients who died with a patent access or were lost to follow-up before 6 months without access failure were censored at the date of their last documented clinical contact. Access failure or the requirement for surgical/endovascular intervention was treated as an event.
Steal syndrome/HAIDI diagnosis and grading: Hemodialysis access-induced distal ischemia (HAIDI), clinically manifesting as steal syndrome, was diagnosed based on clinical symptoms (distal extremity coldness, pain, paresthesia, or diminished distal pulses during hemodialysis) and confirmed by duplex ultrasonography demonstrating retrograde flow in the distal native artery or dampening of distal arterial signals. Cases were graded using the SVS clinical severity scale: Grade 1 (mild), pale or cool limb or mild paresthesia during dialysis without pain, managed conservatively; Grade 2 (moderate), intermittent pain during hemodialysis or exercise, managed conservatively or monitored closely; and Grade 3 (severe), rest pain or continuous tissue ischemia/neurologic deficit requiring surgical or endovascular intervention.
3.8. Sample Size and Sampling Method
A census sampling strategy was used. All medical records of adult hemodialysis patients who underwent either tBBAVF or ePTFE prosthetic AVG placement at the study center between March 2020 and March 2024 were reviewed. The final cohort included 60 patients, with 30 patients in each group.
3.9. Sample Size and Precision Framing
Because the retrospective sample size was fixed, statistical inference was presented using effect estimates with 95% confidence intervals to convey precision and sample uncertainty, rather than formal post hoc power calculations. Confidence intervals were used to assess whether clinically meaningful differences could be ruled out.
3.10. Statistical Analysis
Data extraction and statistical analyses were performed using SPSS version 21 (IBM Corp., Armonk, NY). Continuous variables were summarized using measures of central tendency and dispersion, including means, medians, and standard deviations (SDs). Categorical variables were analyzed using chi-square (χ2) or Fisher exact tests, as appropriate, and are presented as frequencies and percentages (n, %).
Cumulative 6-month primary patency over time was estimated using the Kaplan-Meier method. Differences in patency distributions between the tBBAVF and AVG groups were evaluated using the log-rank (Mantel-Cox) test. Discrete 6-month patency rates were also examined using chi-square cross-tabulations to calculate risk differences (RDs) and odds ratios (ORs) with 95% confidence intervals (CIs). All tests were 2-tailed, and P < 0.05 was considered statistically significant.
To evaluate potential confounding, baseline comparability between the tBBAVF and AVG groups was assessed across clinical, demographic, and anatomical parameters. Given the constrained sample size (N = 60) and event counts (29 patency losses and 28 cases of steal syndrome), full multivariable logistic regression was limited by the events-per-variable (EPV) rule. Applying standard EPV guidance (≥ 10 - 15 events per candidate predictor) restricted the candidate pool to a maximum of 2 predictors to reduce overfitting, coefficient instability, and inflated type I error.
Accordingly, parsimonious multivariable logistic regression models were constructed for 1) primary patency, adjusted for access type (tBBAVF vs. AVG) and sex; and 2) steal syndrome, adjusted for access type and diabetes mellitus. Unadjusted cross-tabulations, crude ORs (cORs), adjusted ORs (aORs), and 95% CIs were reported.