Equivalence and endothelial safety of temporary intracoronary shunt device: Insights from preclinical porcine and rabbit models

Qi Chen; Yinfen Wang; Liuhuan Huang; Bin Li; Zhuo Chen; Ping Liu; Xin Jiang

doi:10.1371/journal.pone.0329864

Peer Review History

Original SubmissionApril 21, 2025
14 May 2025 Decision Letter - Redoy Ranjan, Editor PONE-D-25-20869Equivalence and Endothelial Safety of Temporary Intracoronary Shunt Device: Insights from Preclinical Porcine and Rabbit ModelsPLOS ONE Dear Dr. Jiang, 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. ============================== ACADEMIC EDITOR: While we found the work interesting, it would benefit from revision. Therefore, I invite you to respond to the reviewer's comments and submit a revised version of your article. ============================== Please submit your revised manuscript by Jun 28 2025 11:59PM. 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If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [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 Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know Reviewer #2: Yes Reviewer #3: 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 Reviewer #3: 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: Yes Reviewer #3: Yes ****** 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: Hello This is a good article The topic of the article is also well chosen. I think the quality of the article is relatively good. I hope we will see better quality articles from the authors in the future. Good luck. Reviewer #2: I read this paper with great interest because I used to do open chest research on dogs (40 years ago). The surgical technique is GREAT. All the conditions to do surgical research on animals were described and adhered rigorously. All documentations about hemodynamics and pathological specimens are GREAT. I could review the slides of the specimens of the coronary arteries This paper is concise, with great documentation. The ENglish language is perfect Reviewer #3: The authors present an interesting experimental study that evaluated the temporary intracoronary shunt (TICS) device while documenting patterns of endothelial repair and damage during the perioperative period. The manuscript is interesting, and has a clinically relevant question. It handles an unplorex research question in a very interesting and innovative way. The results are quite interesting.I enjoyed reading the manuscript. I only have a few comments: How was the sample size calculated? Does this study have enough power to suport the conclusions? Please describe within the manuscript. The word "procine" is written wrongly troughtout the manuscript, please replace with "porcine" What is the authors hypothesis? Please add a hypothesis to Introduction. Can the results from this study be extrapolated to shunts from other brands? Please discuss. ****** 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: Yes: Thach Nguyen MD FACC FSCAI Reviewer #3: Yes: Mateo Marin-Cuartas ******** [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.0329864.r001
Revision 1
30 Jun 2025 Author Response Response to Reviewers Reviewer #1: Hello This is a good article The topic of the article is also well chosen. I think the quality of the article is relatively good. I hope we will see better quality articles from the authors in the future. Good luck. Response�We deeply appreciate your encouraging feedback. Your recognition of our work's quality is immensely uplifting, fueling our drive to strive for even greater heights in current and future endeavors. Thank you for sharing your valuable time and insightful comments. Reviewer #2: I read this paper with great interest because I used to do open chest research on dogs (40 years ago). The surgical technique is GREAT. All the conditions to do surgical research on animals were described and adhered rigorously. All documentations about hemodynamics and pathological specimens are GREAT. I could review the slides of the specimens of the coronary arteries. This paper is concise, with great documentation. The ENglish language is perfect. Response�We are profoundly honored to receive your thoughtful review, especially given your extensive expertise in this field. Your personal experience with open-chest canine research lends exceptional weight to your feedback, and we deeply value your recognition of our surgical techniques, steadfast adherence to ethical standards, and comprehensive documentation, including hemodynamic and pathological analyses. We are particularly grateful you took the time to meticulously review the coronary artery specimens, and your validation of these findings is invaluable to our team. Your praise for the paper’s conciseness and linguistic precision is equally encouraging. Thank you for your enthusiasm and for sharing your unique perspective as a pioneer in this area. It has been a tremendous privilege to have our work evaluated by a reviewer with such profound knowledge. Reviewer #3: The authors present an interesting experimental study that evaluated the temporary intracoronary shunt (TICS) device while documenting patterns of endothelial repair and damage during the perioperative period. The manuscript is interesting, and has a clinically relevant question. It handles an unplorex research question in a very interesting and innovative way. The results are quite interesting. I enjoyed reading the manuscript. I only have a few comments: Comment 1: How was the sample size calculated? Does this study have enough power to support the conclusions? Please describe within the manuscript. The word "procine" is written wrongly throughout the manuscript, please replace with "porcine" Response: We deeply appreciate the reviewer's insightful comment. The sample size calculation was conducted in strict compliance with China’s regulatory requirements, specifically adhering to the "Regulatory Consideration for Animal Study of Medical Device" issued by the Center for Medical Device Evaluation of the National Medical Products Administration of China. This guiding document establishes mandatory minimum standards for large animal utilization in medical device research, including rigorous criteria for animal species selection, sample size determination, and experimental design methodology. Simultaneously, we strictly followed the Institutional Animal Care and Use Committee (IACUC) review standards, guaranteeing all animal experiments met ethical norms and adhered to international best practices. Throughout the study, we rigorously implemented the 3R principles (Replacement, Reduction, and Refinement) as a fundamental framework. This approach enhanced the reliability and significance of our statistical data without increasing animal numbers, thereby achieving a crucial balance between scientific rigor and animal welfare in our research. We have described this content in the revised manuscript (Line 96-101). We sincerely appreciate the reviewer’s careful reading and valuable feedback regarding the typographical errors in the original manuscript. We apologize for the typographical errors and have confirmed that all these errors have been corrected in the revised manuscript. The changes have been highlighted in the revised version for the reviewer’s convenience. Thank you for pointing this out and helping us improve the accuracy of our manuscript. Comment 2: What is the authors hypothesis? Please add a hypothesis to Introduction. Response�Thank you for this invaluable feedback. We fully concur that explicitly stating the hypothesis will significantly enhance the clarity of our study's rationale. In the present study, we hypothesized that the two devices exhibit substantial equivalence during surgery. And our findings revealed comparable intraoperative hemodynamic profiles during surgery and endothelial response patterns between PerMedos and Medtronic devices, providing evidence for the safety interchangeability of TICS devices in OPCABG. In the revised manuscript, we have incorporated the hypothesis into the Introduction section, and we are very grateful for the reviewer’s comment that has significantly enhanced the quality of our manuscript (Line 77-85). Comment 3: Can the results from this study be extrapolated to shunts from other brands? Please discuss. Response�We deeply appreciate the reviewer's insightful comment. This study conducted a rigorous clinical evaluation by comparing the target device with a control device that met equivalent safety and efficacy benchmarks. Our methodology adheres to the harmonized regulatory frameworks of both the FDA and China NMPA, specifically addressing devices with identical intended use and comparable technological characteristics. The preclinical validation demonstrated equivalence in critical performance endpoints, suggesting these findings may hold broader regulatory relevance for similarly classified devices [15]. However, brand-specific variations in material composition or design specifications may require additional verification when considering other manufacturers' products. We have incorporated this point into the revised Discussion section in the revised manuscript. And we are deeply grateful for the reviewer’s invaluable comment which has greatly improved the quality of our manuscript (Line 397-405). Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0329864.r002
23 Jul 2025 Decision Letter - Redoy Ranjan, Editor Equivalence and Endothelial Safety of Temporary Intracoronary Shunt Device: Insights from Preclinical Porcine and Rabbit Models PONE-D-25-20869R1 Dear Dr. Jiang, 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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. For questions related to billing, please contact billing support . 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, Dr Redoy Ranjan, MBBS, MRCSEd, Ch.M., MS (CV&TS), FACS Academic Editor PLOS ONE Additional Editor Comments (optional): Review Comments to the Author Reviewer #1: Hello This is a good article Many studies have been conducted in this field so far, and this article can complement previous articles and increase information in this field. Good luck. Reviewer #2: I review the manuscript and the surgical technique was described well. The results were shown in a scientific way, easy to read and to understand. The discussion section was great. The revised version is much better Reviewer #3: No further comments. All my comments were replied and my suggestions accurately addressed. Congratulations on an excellent manuscript. https://doi.org/10.1371/journal.pone.0329864.r003
Formally Accepted
Acceptance Letter - Redoy Ranjan, Editor PONE-D-25-20869R1 PLOS ONE Dear Dr. Jiang, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days to review your paper and let you know the next and final steps. Lastly, 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. You will receive an invoice from PLOS for your publication fee after your manuscript has reached the completed accept phase. If you receive an email requesting payment before acceptance or for any other service, this may be a phishing scheme. Learn how to identify phishing emails and protect your accounts at https://explore.plos.org/phishing. If we can help with anything else, please email us at customercare@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.0329864.r004

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