Characterization of hemodialysis fistulas experienced abrupt thrombosis and determination of a proper follow-up protocol: A retrospective cohort study and an interventionist’s perspective

Matt Chiung-Yu Chen; Mei-Jui Weng; Lee-Hua Chao

doi:10.1371/journal.pone.0282891

Peer Review History

Original SubmissionJanuary 10, 2023
30 Jan 2023 Decision Letter - Redoy Ranjan, Editor PONE-D-23-00790Characterization of Hemodialysis Fistulas Experienced Abrupt Thrombosis and Determination of a Proper Follow-up Protocol: A Retrospective Cohort Study and an Interventionist’s PerspectivePLOS ONE Dear Dr. Chen, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Mar 16 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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If consent was waived for your study, please include this information in your statement as well. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Partly Reviewer #3: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: N/A Reviewer #3: I Don't Know ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? 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Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: No ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Very nicely organized paper with well defenition for the subgroups. The follwup is very good and suffecient for all groups No bias could be detedcted in the statistical nalaysis . Overall very informative reserch paper. Reviewer #2: The concept that artAVF has a lower patent rate can make sense, the reviewer has several comments: 1, The title is retrospective, but the method is prospective? 2, AVF and AVG are different, from the pathology viewpoint, the acute thrombosis has some difference, this data should be separated. 3, In the paper, the patent rat is 100% at the first year, and 98% at the 4th and 8th year, this is extremely higher than the commonly reported patent rate; and 8 years is a long time for CKD patient. 4, Are these patients received anticoagulation therapy? Should be present the data and discuss. 5, How could the authors discriminate the technique failures induced thrombosis? 6, What is the diameters of the artery and vein? 7, What is the diameter of the prosthetic graft? and what is the materials? Reviewer #3: The present manuscript has potentially important data on an interesting topic how to get better patency for failing artery - venous fistula. The cohort is reasonable sized 227 patients. The main issue with the manuscript is that it would have been easier to review if authors had finalized the manuscript little more. The order of presented issues could be more logical, results and observations should be more accurately presented, tables should have all appendixes explained and legends be more detailed and even figure legends were not on a file for the review. Also it would be interesting to have a demographic data correlated with the AVF requiring additional procedures and the ones that function just fine. Abstract: Some parts of the abstract are hard to follow and AVF both with and without thrombosis should be clearly defined when presenting results. Introduction: There should be a strong body of literature on AVF thrombosis and patency, relevant and as scientific base for the introduction. At present introduction lacks the scientific touch. Methods: Sample characteristics with the statement of ethical approval details etc. would define the work better? The methods could be better formulated to be easier to read and interpret. Also, some of the nice flow charts could be in supplement? Essentially at present methods is hard to follow and still does not include required details. Results: Over 500 VA and only little over 227 enrolled rationales? Figure 3 shows the explanation, but authors should either refer to figure 3 after stating 227 enrolled or explain briefly why half of the VA were excluded. It would be nice to have more detailed demographic data presented. Tables should have subheading containing the appendixes written out and be more comprehensive. Figures should have detailed legend? Now these legends seem to be missing. The discussion should be more fluent. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). 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Revision 1
5 Feb 2023 Author Response Author’s response to reviews Title: Characterization of hemodialysis fistulas experienced abrupt thrombosis and determination of a proper follow-up protocol: A retrospective cohort study and an interventionist’s perspective Authors: Matt Chiung-Yu Chen (jjychen@gmail.com) Mei-Jui Weng (mjweng@gmail.com) Lee-Hua Chao (y0053@yuanhosp.com.tw) Version: 1, Date 5th Feb 2023 Author’s response to reviews Manuscript number: PONE-S-23-01053. R1 Journal Requirements: 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming A: The manuscript has been thoroughly reviewed to ensure it meets PLOS ONE's style requirements. 2. In your revised cover letter, please address the following prompts: A: A paragraph addressing the data availability of this study has been added to the revised cover letter as follows: “The authors confirm that all data underlying the findings are fully available without restriction. All data have been deposited to Figshare (doi: 10.6084/m9.figshare.21996920).” 3. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well. A: A sub-section entitled "Patient population and study design" has been added to the Methods section as follows: “Between November 2020 and February 2021, patients referred to our institution for treatment of vascular access (VA) sites were enrolled in this study. All VA sites were treated and followed according to our routine protocols. After obtaining approval from our hospital's institutional review board committee (IRB number: 20220011B), the patients' electronic imaging and medical records were reviewed. Data for this study was collected prospectively and routinely recorded after each treatment was completed. To conduct this study, the collected data was retrieved and analyzed retrospectively.” Reviewer #2: 1. The title is retrospective, but the method is prospective? A: The authors are sorry for the ambiguity. The data in this study was collected prospectively, which was routinely recorded after each treatment was completed. To conduct this study, the collected data was retrieved analyzed retrospectively. 2. AVF and AVG are different, from the pathology viewpoint, the acute thrombosis has some difference, this data should be separated. What is the diameter of the prosthetic graft? and what is the materials? + A: We are sorry for the ambiguity. The study, as stated in the Methods section and shown in Fig 3, only autogenous AVFs were included. All AVGs were excluded per the exclusion criteria of this study. 3. In the paper, the assisted primary patency rate for n-abtAVF(periodic) is 100% at the first year, and 98% at the 4th and 8th year, this is extremely higher than the commonly reported patent rate; and 8 years is a long time for CKD patient. A: Thanks for your pertinent comments. A paragraph addressing this issue had been added into the Discussion section as follows:” In this study, AVFs without a history of abrupt thrombosis and under periodic follow-up (n-abtAVF(periodic)) had a high thrombosis-free or assisted primary patency of 100% at 1 year and 98% at 4 and 8 years. Aragoncillo et al. also reported a high assisted primary patency of 91% at 1 year (estimated from the survival plot) for AVFs under flow surveillance. Tessitore et al reported a lower assisted primary patency of 85% at 1 year and 75% at 4 years (estimated from the survival plot) when subclinical stenoses in AVFs were detected using flow surveillance and treated preemptively. However, 30% of the AVFs in their treatment group were failing AVFs (Qa≤350 or recirculation>5%), which might explain their relatively low assisted primary patency.” 4. Are these patients received anticoagulation therapy? Should be present the data and discuss. A: Thanks for your comments. The duration and types of anticoagulants vary for the patients in this study. The question is very difficult to answer. For example, if a patient takes anticoagulants only for a few days or weeks during a three-year follow-up period, yes, he received anticoagulation therapy but it is nearly impossible to assess the effect of such an anti-coagulation regimen on his AVF patency. Moreover, our aim is to discuss about AVF, and discussing the effect of anticoagulants on AVF patency would make the Discussion section out of focus. 5. How could the authors discriminate the technique failures induced thrombosis? A: Thanks for your comments. We didn’t mention technique failures induced thrombosis in this manuscript but technical failure for salvage of a thrombotic AVF, especially the salvage -challenging AVFs. 6. What are the diameters of the artery and vein? A: Thanks for your comments. For a given AVF, the diameter varies from the anastomosis to the outflow veins. Could you specify your question? Reviewer #3: 1. The order of presented issues could be more logical, results and observations should be more accurately presented. A: Thanks for your comments. The Methods section has been extensively rewritten and the order of its sub-sections have been re-arranged. 2. Tables should have all appendixes explained and legends be more detailed and even figure legends were not on a file for the review. Tables should have subheading containing the appendixes written out and be more comprehensive. Figures should have detailed legend? Now these legends seem to be missing. A: Thanks for your pertinent comments. The appendixes of Table 2 have been written out. Detailed figure legends were added to Figs 4~7. 3. Also it would be interesting to have a demographic data correlated with the AVF requiring additional procedures and the ones that function just fine. A: The authors agree with you that it would be interesting to correlate demographic data with AVFs that require additional procedures and those that functioning well without intervention. However, we do not have approval from the Institutional Review Board (IRB) to review those well-functioning AVFs that do not require any intervention. 4. Abstract: Some parts of the abstract are hard to follow and AVF both with and without thrombosis should be clearly defined when presenting results. A: Due to the word count limit of 300-500 words for the Abstract section, we cannot provide too much detail. Definitions have been included in the Definitions subsection of the Methods section. 5. Introduction: There should be a strong body of literature on AVF thrombosis and patency, relevant and as scientific base for the introduction. At present introduction lacks the scientific touch. A: Thank you for your insightful comments. The Introduction section has been thoroughly rewritten and the necessary scientific background has been provided. Three new paragraphs have been added: the first one addressed the "dysfunctional hypothesis", the second discussed the presence of subclinical stenosis, and the third focused on the thrombosis-high-risk stenosis and its implications for AVF abrupt thrombosis. 6. Methods: Sample characteristics with the statement of ethical approval details etc. would define the work better? The methods could be better formulated to be easier to read and interpret. A: Thanks for your comments. We have revised the Methods section to make it easier to read and interpret. 7. Also, some of the nice flow charts could be in supplement? Essentially at present methods is hard to follow and still does not include required details. A: Thanks for your suggestion. The authors prefer to keep Figures 1-3 in their current locations rather than moving them to the Supporting Information section. This would be convenient for readers, as they may want to view the detailed sub-protocol flow charts after reading the sub-protocol definitions, and they can access these flow charts easily. 8. Results: Over 500 VA and only little over 227 enrolled rationales? Figure 3 shows the explanation, but authors should either refer to figure 3 after stating 227 enrolled or explain briefly why half of the VA were excluded. A: Thanks for your comments. The paragraph has been rewritten as follows: “A total of 505 VA sites in 505 patients were treated during the study period. Of them, 227 AVFs were enrolled. The study flow diagram is shown in Figure 3. Most of the excluded VA sites were AVGs, n=149 (29.5%).” 9. The discussion should be more fluent. A: Thanks for your comments. We have added a paragraph to the Discussion section addressing the high thrombosis-free primary patency of the n-abtAVF(periodic) group, which should make the section easier to follow. Additionally, a professional editor has edited the manuscript.http://www.intervrad.net/shareCenter/proof.jpg Attachments Attachment Submitted filename: Point by point letter_PLOS ONE_r1.docx https://doi.org/10.1371/journal.pone.0282891.r002
27 Feb 2023 Decision Letter - Redoy Ranjan, Editor Characterization of Hemodialysis Fistulas Experienced Abrupt Thrombosis and Determination of a Proper Follow-up Protocol: A Retrospective Cohort Study and an Interventionist’s Perspective PONE-D-23-00790R1 Dear Dr. Chen, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Redoy Ranjan, MBBS, MRCSEd, Ch.M., MS (CV&TS), FACS Academic Editor PLOS ONE Additional Editor Comments (optional): Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: (No Response) Reviewer #2: The authors have addressed all of the reviewer's concerns. the quality of the paper is now improved, Reviewer #3: All given comments have been addressed. The present manuscript has been improved significantly after revision https://doi.org/10.1371/journal.pone.0282891.r003
Formally Accepted
2 Mar 2023 Acceptance Letter - Redoy Ranjan, Editor PONE-D-23-00790R1 Characterization of hemodialysis fistulas experienced abrupt thrombosis and determination of a proper follow-up protocol: A retrospective cohort study and an interventionist’s perspective Dear Dr. Chen: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Redoy Ranjan Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0282891.r004

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