Evidence map›Paper›PMID 36567000›Full record

ArticleJournal of vascular surgery2023

Evaluating national guideline concordance of recurrent interventions after radiocephalic arteriovenous fistula creation.

Patrick Heindel, James J Fitzgibbon, Jessica D Feliz, Dirk M Hentschel, Steven K Burke, Mohammed Al-Omran, Deepak L Bhatt, Michael Belkin, C Keith Ozaki, Mohamad A Hussain

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Journal of vascular surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02414841 (Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02414841 phase3completednot on this map

Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

TypeinterventionalSponsorProteon TherapeuticsRan2015 to 2019Enrolled696ConditionsChronic Kidney DiseaseArmsVonapanitase, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
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  8. Hemodialysis Access: US for Preprocedural Mapping and Evaluation of Maturity and Access Dysfunction.Radiographics : a review publication of the Radiological Society of North America, Inc · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Patrick HeindelDivision of Vascular and Endovascular Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
James J FitzgibbonDivision of Vascular and Endovascular Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Jessica D FelizDivision of Vascular and Endovascular Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Dirk M HentschelDepartment of Medicine, Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Steven K BurkeAkebia Therapeutics, Cambridge, MA.
Mohammed Al-OmranDivision of Vascular Surgery and Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada; Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Deepak L BhattMount Sinai Heart, Icahn School of Medicine at Mount Sinai Health System, New York, NY.
Michael BelkinDivision of Vascular and Endovascular Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
C Keith OzakiDivision of Vascular and Endovascular Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Mohamad A HussainDivision of Vascular and Endovascular Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: mhussain7@bwh.harvard.edu.

Funding

HARVARD-LONGWOOD RESEARCH TRAINING IN VASCULAR SURGERYT32HL007734 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI FERRAN, CHRISTIANE, LOGERFO, FRANK W · 1993 to 2023
$10.5M
NHLBI NIH HHS T32 HL007734
6 · The paper itself

Abstract

objectiveRadiocephalic arteriovenous fistulas have been historically perceived as requiring multiple follow-up procedural interventions to achieve maturation and maintain patency. Recent clinical practice guidelines from the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) emphasize a patient-centered hemodialysis access strategy with new maximum targets for intervention rates, potentially conflicting with concomitant recommendations to prioritize autogenous forearm hemodialysis access creation. The present descriptive study seeks to assess whether radiocephalic fistulas can meet the KDOQI guideline benchmarks for interventions following access creation, and to elucidate clinical and anatomic characteristics associated with the timing and frequency of interventions following radiocephalic arteriovenous fistula creation.

methodsProspective patient-level data from the multicenter PATENCY-1 and PATENCY-2 randomized trials, which enrolled patients undergoing new radiocephalic arteriovenous fistula creation, was analyzed (ClinicalTrials.govNCT02110901 and NCT02414841). The primary outcome was the rate of interventions at 1 year postoperatively. Incidence rates were calculated, and time to surgical or endovascular intervention following fistula creation was modeled using recurrent event extensions of the Cox proportional hazards model. Confidence intervals at the 95% level were calculated using nonparametric bootstrapping.

resultsThe cohort consisted of 914 patients; mean age was 57 years (standard deviation, 13 years), and 22% were female. Median follow-up was 707 days (interquartile range, 447-1066 days). The incidence of interventions per person-year was 1.04 (95% confidence interval [CI], 0.95-1.13) overall; 1.10 (95% CI, 0.98-1.21) before fistula use, and 0.96 (95% CI, 0.82-1.11) after fistula use. The most common interventions overall were balloon angioplasty (54.9% of all interventions), venous side-branch ligation (16.4%), and open revisions (eg, proximalization from snuffbox to wrist, 16.4%). The locations requiring balloon angioplasty included the juxta-anastomotic segment (51.7% of angioplasties), the outflow vein (29.2%), the inflow artery (14.8%), the central veins (3.8%), and the cephalic arch (0.5%). Common indications were to restore or maintain patency (75.6% of all interventions), assist maturation (14.9%), improve depth (4.4%), or improve augmentation (3.0%). In the multivariable regression analysis, female sex (adjusted hazard ratio [HR], 1.21; 95% CI, 1.05-1.45), diabetes (HR, 1.21; 95% CI, 1.01-1.46), and intraoperative vein diameter <3.0 mm (vs ≥4.0 mm: HR, 1.33; 95% CI, 1.02-1.66) were associated with earlier and more frequent interventions. Patients not on hemodialysis at the time of fistula creation underwent less frequent interventions (HR, 0.69; 95% CI, 0.59-0.81).

conclusionsPatients with radiocephalic arteriovenous fistulas can expect to undergo one intervention, on average, in the first year after creation, which aligns with current KDOQI guidelines. Patients already requiring hemodialysis, female patients, patients with diabetes, and patients with intraoperative vein diameters <3.0 mm were at increased risk for repeated intervention. No subgroup exceeded guideline-suggested maximum thresholds for recurrent interventions. Overall, the results demonstrate that creation of radiocephalic arteriovenous fistula remains a guideline-concordant strategy when part of an end-stage kidney disease life-plan in appropriately selected patients.

Indexed as

Arteriovenous FistulaArteriovenous Shunt, SurgicalDiabetes MellitusFemaleGraft Occlusion, VascularHumansMaleMiddle AgedProspective StudiesRadial ArteryRenal DialysisRetrospective StudiesRisk FactorsTreatment OutcomeVascular PatencyArteriovenous shuntchronicKidney failureRenal dialysisRenal replacement therapysurgicalVascular surgical procedures

Identifiers

PMID36567000
PMCPMC10038866

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.