Abstract
Background:
For arteriovenous fistula (AVF) presence of a venous segment with adequate diameter is essential which is lacking in many patients. To find the optimal augmentation technique in patients with small-caliber cephalic vein (i.e., cephalic vein diameter <3 mm), studies compared primary balloon angioplasty (PBA) versus hydrostatic dilation (HD); however, it remained debatable. This systematic review seeks to determine which technique is preferable.
Methods:
We searched MEDLINE, PubMed, Embase, and Google Scholar. Primary outcomes were 6-month primary patency, reintervention, and working AVF. Secondary outcomes were immediate success, the AVF’s maturation time (day), and surgical site infection.
Results:
Three randomized controlled trials yielding 180 patients were included, of which 89 patients were in the PBA group. The odds ratio (OR) of primary patency was significantly higher in the PBA group (OR 6.09, 95% confidence interval [CI], 2.36–15.76, P = 0.0002), the OR of reintervention was significantly lower in the PBA group (OR 0.16, 95% CI, 0.06–0.42, P = 0.0002), and the OR of working AVF was greater in PBA group (OR 4.22, 95% CI, 1.31–13.59, P = 0.02). The OR of immediate success was significantly greater in the PBA group (OR 11.42, 95% CI, 2.54–51.42, P = 0.002), and the AVF maturation time was significantly shorter in patients who underwent PBA (mean difference −20.32 days, 95% CI, −30.12 to −10.52, P = 0.0001). The certainty of the evidence was high.
Conclusions:
PBA of small cephalic veins with diameter ≤2.5 cm is a safe, feasible, and efficacious augmentation method for AVF creation. This technique achieves favorable maturation outcomes, and PBA is superior to the standard hydrostatic dilatation technique.
INTRODUCTION
According to the United States Renal Data System 2020 annual data report, the adjusted prevalence of end-stage renal disease (ESRD) patients has increased to 2,242 cases per million population, greater than 70% of them undergo dialysis, of which hemodialysis continues to be the most common modality of kidney replacement therapy (KRT).1 The quality of hemodialysis depends on the hemodialysis vascular access efficacy.2 Autogenous arteriovenous fistula (AVF) is preferable to other vascular access modalities in terms of efficacy, morbidities, and mortalities.2–5
Considering the average 132 days of AVF maturation time,1 the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) announced that the AVF should be created in the ESRD patients 4–6 months before starting hemodialysis. However, 20–60% of the AVFs failed to mature.2 It has been shown that the major limiting factor of fistula functional maturation is vein diameter.6–8 Cephalic veins smaller than 3 mm in diameter faced higher failure and lower primary patency rates.9–12 Therefore, patients with the small-caliber cephalic vein (i.e., <3 mm) should undergo careful assessments before AVF creation.2 Despite routine use of duplex ultrasound in the multicenter Dialysis Access Consortium Fistula study, the primary failure rate remained as high as 60%.13 Other techniques including angioplasty, thrombectomy, stent placement, venous branch ligation, fistula superficialization, banding, interposition vein grafts, and transposition have been used to enhance fistula function.14–17 However, the outcomes have not met expectations, because none of these techniques addressed the vein size at the time of AVF creation.
To upgrade the venous diameter at the time of AVF creation, scholars used primary balloon angioplasty (PBA), which showed promising results relative to traditional hydrostatic dilation (HD).18,19 However, a recent larger trial failed to show a significant difference between the PBA and HD. Therefore, this systematic review and meta-analysis sought to determine which approach is superior and grade the level of existing evidence.20
METHODS
Study Design and Eligibility Criteria
This systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.21 Studies that met the following PICO (i.e., patient, intervention, comparison, outcome) criteria were considered eligible for inclusion:
Patient: ESRD individuals who were a candidate for AVF creation and had small-caliber cephalic vein (i.e., cephalic vein diameter <3 mm).
Intervention: Primary balloon angioplasty.
Comparator: Hydrostatic dilation
Outcome: The primary outcomes at 6 months of follow-up include primary patency (intervention-free access survival) defined as the interval from dialysis access placement to date of one of the following events (whichever comes first): thrombosis or any intervention to facilitate, maintain, or re-establish patency2; reintervention defined as any intervention to facilitate, maintain, or establish the patency; and working AVF (i.e., AVF useful for hemodialysis access). The secondary outcomes include immediate success, defined as the presence of a thrill and a bruit associated with intraoperative duplex ultrasound finding of peak systolic velocity <200 cm/sec at the site of anastomosis, AVF maturation time (per day) as the interval period from AVF creation to the first successful hemodialysis, and surgical site infection. We excluded single-arm studies, case reports, non–full-text articles, non-English studies, and review articles.
Search Strategy
We searched MEDLINE, PubMed, Embase, and Google Scholar with the appropriate Medical Subject Heading terms, Emtree terms, and potential keywords from the inception to September 26, 2021. MEDLINE and PubMed were searched with the keywords “arteriovenous fistula, cephalic vein, and angioplasty.” Embase was searched using the terms (“arteriovenous fistula”/exp OR “arteriovenous fistula”) AND (“angioplasty”/exp OR “angioplasty”) AND (“cephalic vein”/exp OR “cephalic vein”), and Google Scholar was searched with the keywords “arteriovenous fistula, cephalic vein, balloon angioplasty, and hydrostatic dilatation.” We further supplemented our search by screening the texts and references of the eligible studies.
Data Extraction
Two authors (S.A.S. and A.R.S.) independently reviewed the included articles and extracted data in 2 separate sheets, and then the sheets were cross-checked. In case of any disagreement, the senior author (M.W.A.) would adjudicate. The following data were extracted: study first author name, publication year, the origin country of studies, study design, number of patients in each treatment arm, age, sex, the proportion of patients with diabetes mellitus, hypertension, peripheral arterial disease, and active smoking, the proportion of hemodialysis cases, and the outcomes of interest.
Risk-of-Bias Assessment
The Cochrane risk-of-bias tool (RoB2)22 was used for risk-of-bias assessment of the included studies.
Certainty in Evidence
Certainty in evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach23 and was demonstrated by using GRADEpro GDT Software, 2021, McMaster University, and Evidence Prime Inc, Ontario, Canada.
Statistical Analysis
Baseline demographic and clinical characteristics of the included studies were presented using descriptive statistics. The meta-analyses of outcomes were performed using the Review Manager, version 5.4.1. The odds ratio (OR) of dichotomous data and the mean difference (MD) of continuous data with associated 95% confidence interval (CI) were calculated by the Mantel-Haenszel method and the generic inverse-variance method, respectively. Considering the clinical diversities and methodological differences between included studies, the random effect model was applied. The heterogeneities between studies were detected using the I2 test statistic, which reflects the proportion of total variation attributed to the differences between studies rather than sampling error.24 All statistical tests were 2-sided, and a P-value <0.05 was considered statistically significant.
RESULTS
Study Selection
The applied search strategy resulted in 350 records (53 from MEDLINE and PubMed, 121 from Embase, and 176 from Google Scholar), of which 23 non-English records were removed. The remaining 327 records were screened by title and abstract and 318 records were excluded due to unrelated subject matter. The remaining 9 publications were reviewed in detail for potential eligibilities, in which 6 publications were excluded due to non–full-text articles (n = 2), non–comparative studies (n = 3), and case reports (n = 1). Therefore, we enrolled 3 comparative studies which were randomized controlled trials (RCTs; Fig. 1).18–20
Fig. 1.

PRISMA flow diagram for the study search and inclusion.
Characteristics of the Included Studies
The included studies were published between 2013 and 2021 and were performed in Italy (n = 1) and India (n = 2). These 3 RCTs yielded 180 patients, of which 89 patients underwent PBA-mediated AVF creation. In the included studies, the patients’ age ranges from 37 to 73 years, 122 (67.7%) cases were male, 77 (42.7%) were diabetic, 139 (77.2) had hypertension, 60 (50%) patients were smokers, 43 (35.8%) cases had the peripheral arterial disease, and 126 (70%) cases were on hemodialysis (Table I).
Table I.
Baseline demographic characteristics of the included studies
| Study and year | Design | Country | Total number of patients and treatment groups | Mean (SD) or range of age (year) | Male, n (%) | DM, n (%) | HTN, n (%) | Smoker, n (%) | PAD, n (%) | Dialysis, n (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| Veroux et al., 201318 | RCT | Italy | Total 40 | 54.5 | 19 (47.5) | 10 (25) | 40 (100) | 22 (55) | 14 (35) | 17 (42) |
| PBA 19 | 55 (18) | 13 (68) | 6 (32) | 19 (100) | 11 (58) | 8 (42) | 13 (68) | |||
| HD 21 | 54 (8) | 16 (76) | 4 (19) | 21 (100) | 11 (52) | 6 (29) | 4 (19) | |||
| Khan et al., 201719 | India | Total 60 | 51–60 | 44 (73) | 19 (32) | 37 (62) | NR | NR | 48 (80) | |
| PBA 30 | 21 (70) | |||||||||
| HD 30 | 23 (76) | |||||||||
| Tiwari et al., 202120 | India | Total 80 | 40–70 | 59 (73) | 48 (60) | 62 (77) | 38 (47) | 29 (36) | 61 (76) | |
| PBA 40 | 28 (70) | 23 (57) | 29 (72) | 20 (50) | 16 (40) | 31 (77) | ||||
| HD 40 | 31 (77) | 25 (62) | 33 (82) | 18 (45) | 13 (32) | 30 (75) |
DM, diabetes mellitus; HTN, hypertension; NR, not reported; PAD, peripheral arterial disease; SD, standard deviation.
Risk-of-Bias Assessment
Apart from performance and detection bias due to lack of blinding, the risk of bias was low in terms of election bias, attrition bias, and reporting bias (Fig. 2).
Fig. 2.

Cochrane risk-of-bias graph (left) and summary (right).
PICO
Table II outlines the details of patients’ enrollment, surgical techniques, outcomes, and follow-up duration regarding each included study.
Table II.
Surgical techniques, outcomes, and follow-up of the included studies
| Study and year | Sample | PICO | ||||
|---|---|---|---|---|---|---|
| Size | Patients | Intervention: PBA | Comparison: HD | Outcomes | Follow-up | |
| Veroux et al., 201318 | T 40 I 19 C 21 |
ESRD patients with normal radial artery on DUS and cephalic vein’s diameter ≤2 mm All patients received acetylsalicylic acid per day from 1 week before to 4 weeks after the procedure All patients received systemic anticoagulation using 2,500 IU of heparin 3 min before clamping the cephalic vein and the radial artery |
After isolation of 3–4 cm of the cephalic vein, a guidewire 0.018 inches was introduced through the cephalic vein and advanced up to the elbow under direct palpation, or DUS in cases of the deep cephalic vein A non–compliant balloon, 4 mm × 150 mm was introduced and gently inflated to 12 atmospheres of pressure for 60 sec, from the elbow to the level of the anastomosis, to achieve the final diameter of 4 mm. The anastomosis was performed end-to-side with 7/0 polypropylene running sutures |
After isolation of about 5 cm of cephalic vein at the wrist with ligation of collateral veins, the vein was dilated by injection of high-pressure sterile solution through a syringe 20 mL and 16-gauge plastic cannula to achieve the final diameter of 4 mm The anastomosis was performed end-to-side with the radial artery, with 7/0 polypropylene running sutures |
Primary: primary patency, reinterventions, and functioning AVF Secondary: immediate success rate and maturation time |
7 months |
| Khan et al., 201719 | T 60 I 30 C 30 |
ESRD patients with normal radial or brachial arteries on DUS and cephalic vein’s diameter ≤2 mm All patients received acetylsalicylic acid per day for 4 weeks after the procedure All patients received systemic anticoagulation using 2,500 IU of heparin 3 min before clamping the cephalic vein and the radial artery |
Same as the above technique was applied at the wrist (radiocephalic AVF) and elbow (brachiocephalic AVF) and a non–compliant balloon, 4 mm × 120 was used | Same as the above technique was applied at the wrist (radiocephalic AVF) and elbow (brachiocephalic AVF) and 18- or 20-gauge plastic cannula was used | Primary: primary patency, reinterventions, and functioning AVF Secondary: immediate success rate and maturation time |
6 months |
| Tiwari et al., 202120 | T 80 I 40 C 40 |
ESRD patient with normal radial artery on DUS and cephalic vein’s diameter ≤2.5 mm All patients received acetylsalicylic acid per day for 6 months after the procedure |
Same as the above technique was applied at elbow and a non–compliant balloon, 4 × 150 mm was used and finally the anastomosis was performed end-to-side with 6–0 polypropylene running suture | After isolation of about 5 cm of cephalic vein at the elbow, the vein was dilated with a 20-mL sterile heparinized saline solution injection. Then, segmental HD was done at 5, 10, and 15 cm and the anastomosis was performed end-to-side, with 6–0 polypropylene suture | Primary: primary patency, reinterventions, and functioning AVF Secondary: immediate success rate, maturation time, and surgical site infection |
6 months |
C, comparison; DUS, duplex ultrasonography; I, intervention; T, total.
Meta-Analysis of the Outcomes
Primary outcomes (in 6-months of follow-up)
Primary patency.
Eighty-three of 89 PBA cases versus 62 of 91 HD patients achieved primary patency. The meta-analysis concluded that the odds of primary patency were significantly higher following PBA (93.2% vs. 64.5%; OR 6.09, 95% CI, 2.36–15.76, P = 0.0002; I2 = 0, P = 0.55; Fig. 3). The certainty of the evidence was high.
Fig. 3.

Forest plots show odds of primary patency (A), reintervention (B), and working AVF (C) following PBA versus HD.
Reintervention.
Six of 89 PBA patients versus 29 of 91 HD cases underwent interventions to maintain or re-establish the patency. The meta-analysis showed that the risk of reintervention was significantly lower in the PBA group (6.7% vs. 31.8%; OR 0.16, 95% CI, 0.06–0.42, P = 0.0002; I2 = 0, P = 0.55; Fig. 3). The certainty of the evidence was high.
Working arteriovenous fistula.
Eighty-six (96.6%) of PBA-created AVFs versus 77 (84.6%) of HD-created AVFs remained functional for dialysis, and the meta-analysis concluded that the likelihood of the PBA-made AVF was significantly greater (OR 4.22, 95% CI, 1.31–13.59, P = 0.02; I2 = 0, P = 0.89; Fig. 3). The certainty of the evidence was high.
Secondary outcomes
Technical immediate success.
Eighty-eight (98.8%) of PBA-created AVFs versus 71 (78%) of HD-created AVFs showed immediate success. The meta-analysis concluded that the odds of immediate success were significantly greater following PBA (OR 11.42, 95% CI, 2.54–51.42, P = 0.002; I2 = 0, P = 0.67 Fig. 4). The certainty of the evidence was high.
Fig. 4.

Forest plots show immediate success (A) and AVF maturation time (B) following PBA versus HD.
Arteriovenous fistula maturation time (day).
The meta-analysis concluded that the MD of AVF maturation time was significantly shorter following PBA relative to HD (MD = −20.32 days, 95% CI, −30.12 to −10.52, P < 0.0001; I2 = 0, P = 0.95; Fig. 4). The certainty of the evidence was high.
Surgical site infection.
One study reported the surgical site infection (SSI), and there was no significant difference between PBA and HD in terms of SSI risk (5% vs. 10%; OR 0.47, 95% CI, 0.08–2.75. P = 0.4). The certainty of the evidence was low.
Certainty of Evidence
The GRADE approach was used to estimate the strength of evidence of outcomes.23 The included studies were RCTs with serious risk of bias due to lack of blinding. In our perspective, the results were consistent as no level of heterogeneity was identified. Directness was given because all included studies directly compared PBA to HD for AVF creation in patients with small-caliber cephalic veins. In terms of primary and secondary outcomes (except SSI), precision was given because the optimal information size (OIS) criterion was met, and the 95% CI excluded the null value. One point was added for primary and secondary outcomes (except SSI) because the pooled magnitude of the effect was large. One point was decreased for the SSI because the OIS criterion was not met (Table III).
Table III.
Summary of findings
| Primary balloon angioplasty compared to hydrostatic dilation for AVF creation in ESRD patients with small-caliber cephalic vein | ||||||
|---|---|---|---|---|---|---|
| Patient or population: AVF creation in ESRD patients with small-caliber cephalic vein | ||||||
| Setting: Hospitals in Italy and India | ||||||
| Intervention: Primary balloon angioplasty | ||||||
| Comparison: Hydrostatic dilation | ||||||
| Anticipated absolute effectsa (95% CI) | ||||||
| Outcomes | Risk with hydrostatic dilation | Risk with primary balloon angioplasty | Relative effect (95% CI) | No. of participant (studies) | Certainty of the evidence (GRADE) | Comments |
| Primary patency | 681 per 1,000 | 929 per 1,000 (835–971) | OR 6.09 (2.36–15.76) | 180 (3 RCTs) | ⨁⨁⨁⨁ Highb,c | A higher score indicates the greater chance of primary patency at the 6-month follow-up |
| Reintervention | 319 per 1,000 | 70 per 1,000 (27–164) | OR 0.16 (0.06–0.42) | 180 (3 RCTs) | ⨁⨁⨁⨁ Highb,c | A lower score indicates the lower risk of intervention at the 6-month follow-up |
| Working AVF | 846 per 1,000 | 959 per 1,000 (878–987) | OR 4.22 (1.31–13.59) | 180 (3 RCTs) | ⨁⨁⨁⨁ Highb,c | A higher score indicates the greater chance of working AVF at the 6-month follow-up |
| Immediate success | 780 per 1,000 | 976 per 1,000 (900–995) | OR 11.42 (2.54–51.42) | 180 (3 RCTs) | ⨁⨁⨁⨁ Highb,c | A higher score indicates the greater chance of intraoperative immediate success |
| AVF maturation time | The mean AVF maturation time was 51.16 days | MD 20.32 days lower (30.12 lower to 10.52 lower) | - | 180 (3 RCTs) | ⨁⨁⨁⨁ Highb,c | A lower score indicates the shorter AVF maturation time following primary balloon angioplasty versus hydrostatic dilation |
| Surgical site infection | 100 per 1,000 | 50 per 1,000 (9–234) | OR 0.47 (0.08–2.75) | 80 (1 RCT) | ⨁⨁◯◯ Lowb,d | A lower score indicates a lesser risk of surgical site infection |
GRADE Working Group grades of evidence: High certainty: we are very confident that the true effect lies close to that of the estimate of the effect; Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different; Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect; Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
Downgraded due to lack of blinding.
Upgraded due to large magnitude of effect.
Downgraded as the optimal information size was not reached.
DISCUSSION
According to the NKF-KDOQI guideline, patients with estimated glomerular filtration rate ≤30 cc/min/1.73 m2 and progressive decline in kidney function should be educated on KRT modalities. Therefore, prompt referral for the appropriate KRT modality allows adequate time for the creation of functional dialysis access, if indicated. Ideally, ESRD patients should initiate dialysis through a mature native fistula.2 This goal requires a coordinated care cycle involving timely referral by the nephrologist, meticulous access creation by the surgeon, monitoring the fistula for adequate maturation, and proper fistula cannulation by the dialysis nurse. Any disruption in the care cycle potentiates the risk of initiating dialysis with the central venous catheter. Although autogenous fistula is optimal dialysis access, 20–60% of AVFs fail to mature,25,26 with the vein diameter being the major limiting factor.6–8
It has been hypothesized that dilation of veins improves blood flow and enhances AVF creation.27–29 Therefore, various procedures and surgical techniques have been used to enhance AVFs including PBA and HD.18–20,27,30–32 To the best of our knowledge, this is the first systematic review and meta-analysis that compared the efficacy of PBA versus HD for AVF creation in ESRD patients with the small-caliber cephalic vein. The meta-analysis showed that PBA is preferable to HD in terms of 6-month favorable outcomes.
Efficacy
At the 6-month follow-up, PBA-augmented AVFs had greater primary patency, required lesser reinterventions, and remained more functional, relative to HD series. The AVFs’ primary patency rate has been reported at 60% at 1 year, with the vein diameter being the major determining factor of the patency.8,12,33 In the subcategory of patients, the meta-analysis revealed that PBA-augmented AVFs attained 93% primary patency at 6-month follow-up. Following AVF creation, the anastomosis and venous segment are being exposed to hemodynamic changes and undergo adaptive outward remodeling and vessel wall thickening.34 During this process, the venous diameter expansion is a critical element predicting clinical success.35–37 It seems that PBA can exert sufficient circumferential force against the venous wall, while the HD employs less effective radial force; therefore, those of HD were more susceptible to failure.
To reach the optimal outcome, it does matter to balloon the long segment of the cephalic vein (i.e., from wrist to elbow) rather than the short segment of the vein (i.e., from mid-forearm to wrist). For instance, in studies used primary ballooning of the short segment of the cephalic vein; about 15% of the AVFs failed initially, and the rest of the patients underwent multiple balloon-assisted maturation (BAM) at 2, 4, and 6 weeks, of which nearly 85% remained functional by 3 months.26,38 Apart from higher rate of radiocephalic fistula in these studies, it seems that poor venous outflow at the high resistant portion of the non–dilated cephalic vein (i.e., from mid-forearm to elbow) contributed to maturation failure. In contrast, the included studies performed ballooning of the long segment of the cephalic vein and achieved the medium-term primary patency and working AVFs of 93% and 96%, respectively. There are other concerns regarding BAM. Exposure to repeated angiography increases the risk of kidney function deterioration due to contrast-induced nephropathy, and thromboembolism. In addition, the repeated intimal injury during BAM sessions can intensify the underlying neointimal hyperplasia, which furthers fistula failure risk.39,40 Furthermore, BAM is expensive and not affordable by many patients.
Technical Feasibility
Despite anticoagulation, 1 of 5 fistulae created in the HD series were complicated by thrombus formation. This early thrombosis occurred due to persistent high-resistance venous outflow, indicating that HD failed to sufficiently dilate the lumen of veins. In contrast, nearly 99% of the PBA-augmented fistula showed signs of technical success intraoperatively, and few numbers of patients required reinterventions during maturation and follow-up.
Arteriovenous Fistula Maturation
To initiate dialysis with a native fistula, the AVF should be created 4–6 months before the anticipation date of the hemodialysis. An expert member of the vascular team should evaluate for maturity at 4–6 weeks after fistula creation, and any concern must be referred promptly for further investigation.2 The predialysis period is a golden time to give patients an autogenous fistula. It seems that venous augmentation expedites outward remodeling and thereby accelerates the maturation time. Of note, this meta-analysis showed that the mean fistula maturation time following PBA was 20 days less than conventional HD. It is worth saving about 3 weeks to achieve the NKF-KDOQI goal in this subcategory of patients.
Limitations
We acknowledge several limitations in this systematic review. Despite a comprehensive literature search, 3 eligible studies were found and enrolled in the meta-analysis. However, the OIS has been reached for the primary and secondary outcomes; therefore, the meta-analysis had sufficient power to detect the true effect measure. Second, although the risk of SSI was comparable between PBA and HD techniques, this event needs a greater sample size to be evaluated. Furthermore, 120 (70%) of reviews’ population were on dialysis before fistula creation; however, the included studies neither provided information about the site of the prior fistula or dialysis catheter nor determined site of fistula relative to hand dominancy. Finally, the existing literature reported the medium-term outcomes, and future studies with longer follow-up duration are still needed.
CONCLUSION
PBA is a safe, feasible, and efficacious augmentation technique for autogenous AVF creation in patients with small-caliber cephalic veins with diameter ≤2.5 cm, and it is preferable to the HD method. We recommend the PBA augmentation technique for this category of patients.
Type of Research
Systematic review and meta-analysis.
Key Findings
Three studies were included. At 6-month follow-up, the odds of primary patency was significantly higher in the primary balloon angioplasty group relative to hydrostatic dilation (odds ratio 6.09, 95% confidence interval, 2.36–15.76, P = 0.0002), and the odds of working arteriovenous fistula was higher in the primary balloon angioplasty group (odds ratio 4.22, 95% confidence interval, 1.31–13.59, P = 0.02).
Footnotes
Presentation: The abstract of this paper was presented orally at the Florida Vascular Society (FVS) 35th annual scientific session.
Conflict of interest: None.
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