Ultrasound-guided puncture reduces bleeding-associated complications, regardless of calcified plaque, after endovascular treatment of femoropopliteal lesions, especially using the antegrade procedure: A single-center study

Kentaro Fukuda; Shinya Okazaki; Masayuki Shiozaki; Iwao Okai; Akihisa Nishino; Hiroshi Tamura; Kenji Inoue; Masataka Sumiyoshi; Hiroyuki Daida; Tohru Minamino

doi:10.1371/journal.pone.0248416

Peer Review History

Original SubmissionOctober 30, 2020
27 Nov 2020 Decision Letter - Xianwu Cheng, Editor PONE-D-20-34172 Ultrasound-guided puncture reduces bleeding-associated complications, regardless of calcified plaque, after endovascular treatment of femoropopliteal lesions, especially using the antegrade procedure: A single-center study PLOS ONE Dear Dr Olazaki 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 January 5, 2021. 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. 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If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Xianwu Cheng, M.D., Ph.D., FAHA Academic Editor PLOS ONE Additional Editor Comments: Although the topic is interesting, as you will gather from the reviews, the referees identified substantive methodological problems/technical problems, statistical analysis, and data presentation. One reviewer has concerns the novelty of current study with raising the recent studies. The editorial broad member also concurs. You may resubmit a revised version but it will be re-reviewed and there exists no guarantee that even with revision it will necessarily be accepted. 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Please see the following video for instructions on linking an ORCID iD to your Editorial Manager account: https://www.youtube.com/watch?v=_xcclfuvtxQ [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: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: 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: 1 why is this report that ultrasound guidance is important in vascular catheterization novel given references 15 and 16 and why is this of general conceptual importance? a. is it calcification b. is it antegrade just not sure why these findings are so conceptually novel as to appeal to the broad readership of 2 should it not be incidence of bleeding when US guidance is used and when not rather than was US guidance used in bleeding or not. Can the authors please provide that analysis? Otherwise we are dealing with small numbers 3 can you report relative risk not just odds ratio? Reviewer #2: Comments:: 1. The primary endpoint is not well defined - what is a "bleeding complication?" You say "main outcome measure of bleeding-associated complications was defined as bleeding at the puncture site that required medical intervention" - what does this mean? What interventions were performed? This is poorly flushed out 2. How were these bleeding complications treated? 3. Overall tone of the text is very colloquial and should be revised ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. 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Revision 1
26 Dec 2020 Author Response Reviewer#1 1 why is this report that ultrasound guidance is important in vascular catheterization novel given references 15 and 16 and why is this of general conceptual importance? a. is it calcification b. is it antegrade just not sure why these findings are so conceptually novel as to appeal to the broad readership of Thank you very much for your comment. We apologize for the inadequate explanation. In references 15 and 16, many risk factors for bleeding-associated complications have been verified, but the antegrade approach and puncture site calcification have not been verified. Although ultrasonic-guided puncture is greatly affected by artifacts in puncture site calcifications, it is novel in that it reduces the risk of bleeding-associated complications, especially in an antegrade puncture. In previous studies showing that ultrasound guide puncture is useful, many of the cases are of retrograde approaches. In modern EVT, the antegrade approach is often required, and the purpose was to retroactively confirm whether the ultrasound guide is effective in the recent EVT situation. Therefore, we added the objective of this investigation in the Introduction section. (line 2-5, page 4) 2 should it not be incidence of bleeding when US guidance is used and when not rather than was US guidance used in bleeding or not. Can the authors please provide that analysis? Otherwise we are dealing with small numbers Thank you very much for your comment. The incidence of bleeding-associated complications with ultrasound-guided puncture was 0% (1/168), and the incidence without ultrasound-guided puncture was 14.4% (34/236). In this study, 236 (58%) of the total 404 cases did not undergo ultrasound-guided puncture. If ultrasound-guided puncture was performed in all cases, the incidence of complications is expected to decrease from the actual 35 cases to 2.4 cases. Therefore, we added the incidence of bleeding-associated complication in the Procedure section. (line 6-11, page 10) 3 can you report relative risk not just odds ratio?　 I would like to thank you for the constructive comment. The following data have been added to the revised manuscript. (line 2-6, page 12) (Age ≥ 80 years): relative risk is 2.04 (Ultrasound-guided puncture): relative risk is 0.04 Reviewer#2 1. The primary endpoint is not well defined - what is a "bleeding complication?" You say "main outcome measure of bleeding-associated complications was defined as bleeding at the puncture site that required medical intervention" - what does this mean? What interventions were performed? This is poorly flushed out Thank you for your comment. We apologize for the inadequate explanation. The medical interventions required are compression, an extension of the bed rest period, transfusion, and operation for hemostasis. I added it in the Endpoints section. (line 3-4, page 5) 2. How were these bleeding complications treated Thank you for your comment. Of the 35 patients with bleeding-associated complications, all required manual re-compression and extension of the bed rest period, and 15 patients were treated with blood transfusions and treated without sequelae. No cases required operation for hemostasis. Therefore, we added it in the Results section. (line 3-6, page 9) 3. Overall tone of the text is very colloquial and should be revised Thank you very much for your comment. I have revised the manuscript in accordance with your suggestion. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0248416.r002
19 Jan 2021 Decision Letter - Xianwu Cheng, Editor PONE-D-20-34172R1 Ultrasound-guided puncture reduces bleeding-associated complications, regardless of calcified plaque, after endovascular treatment of femoropopliteal lesions, especially using the antegrade procedure: A single-center study PLOS ONE Dear Dr Okazaki 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 March 1, 2021. 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Xianwu Cheng, M.D., Ph.D., FAHA Academic Editor PLOS ONE Additional Editor Comments (if provided): Although the original reviewer#1 has still concerned the novelty of current paper, this academic editors recommend the authors figure out the differences between previous and current studies in the discussion section. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: (No Response) Reviewer #2: All comments have been addressed Reviewer #3: All comments have been addressed ******** 2. 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: Yes Reviewer #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: No Reviewer #3: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. 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: Yes ****** 6. 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: The authors have answered my queries and yet I still remain unconvinced that there is much novel here or that there is a mechanistic, conceptual or scientific aspect to this study. Reviewer #2: All comments have been addressed. Ok to accept this paper. I have no further comments to add. Reviewer #3: (No Response) ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0248416.r003
Revision 2
9 Feb 2021 Author Response Reviewer #1: The authors have answered my queries and yet I still remain unconvinced that there is much novel here or that there is a mechanistic, conceptual or scientific aspect to this study. Thank you very much for your comment. We have added the following information to the revised manuscript (page 12, line 12): “Several previous studies have demonstrated that ischemia of the ipsilateral lower extremity is associated with hemostasis after femoral arterypuncture [18, 21]. Therefore, antegrade cannulation, which is a puncture of the lower limb on the lesion side, requires safe puncture without complications. Most of previous studies have demonstrated the usefulness of ultrasound-guided puncture; however, the rates of antegrade cannulation were as low as 0–16% [15, 16, 22, 23], which were not sufficient to evaluate the usefulness of ultrasound-guided puncture in antegrade cannulation. In this study, 48% of patients had antegrade cannulation, which indicates that ultrasound guidance is useful even in patients with a relatively high number of ipsilateral antegrade cannulations.“ Reviewer #2: All comments have been addressed. Ok to accept this paper. I have no further comments to add. Thank you very much for reviewing our manuscript. Reviewer #3: (No Response) Thank you very much for reviewing our manuscript. Attachments Attachment Submitted filename: Response_to_Reviewers.docx https://doi.org/10.1371/journal.pone.0248416.r004
26 Feb 2021 Decision Letter - Xianwu Cheng, Editor Ultrasound-guided puncture reduces bleeding-associated complications, regardless of calcified plaque, after endovascular treatment of femoropopliteal lesions, especially using the antegrade procedure: A single-center study PONE-D-20-34172R2 Dear Dr Okazaki 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, Xianwu Cheng, M.D., Ph.D., FAHA Academic Editor PLOS ONE Additional Editor Comments (optional): None. Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #2: All comments have been addressed ******** 2. 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 #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #2: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #2: Yes ****** 6. 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 #2: Ok to accept this paper. I have no further comments to add. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #2: No https://doi.org/10.1371/journal.pone.0248416.r005
Formally Accepted
3 Mar 2021 Acceptance Letter - Xianwu Cheng, Editor PONE-D-20-34172R2 Ultrasound-guided puncture reduces bleeding-associated complications, regardless of calcified plaque, after endovascular treatment of femoropopliteal lesions, especially using the antegrade procedure: A single-center study Dear Dr. Okazaki: 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 Associate Prof. Xianwu Cheng Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0248416.r006

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