PONE-D-21-26425

Percutaneous Pericardial Catheter Drainage for Symptomatic Uremic Pericardial Effusions with Narrow Safety Margins

PLOS ONE

Dear Dr. Shin,

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 Jun 03 2022 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.

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: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Arturo Cesaro, MD

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at 

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and 

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. 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. 

Additional Editor Comments (if provided):

You are invited to consider the reviewers' comments, reported at the end of this letter, and to revise your manuscript accordingly. In the letter accompanying your resubmission, please explain your response to each of the comments. Please observe the word count and citation style. For further details, please consult the Instructions for Authors on the website

[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: Partly

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: N/A

**********

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: Authors describe a case series of patients with symptomatic large uremic pericardial effusion with narrow safety margins for pericardiocentesis with subxyphoid access. Patients underwent pericardiocentesis under echocardiographic and fluoroscopic guidance. The manuscript is written in clear standard English. It is a retrospective decription of the cases.

There are some major revisions required: to provide echocardiographic data on the absence/presence of tamponade/pre-tamponade diagnostic signs; to better explain indications to procede to pericardiocentesis even in the absence of tamponade or of the demostration of resistance to treatment (why intensive dialysis wasn't the prefferred first line strategy in all the cases? - Am J Med Sci. 2003 Apr;325(4):228-36); to explain why it was not considered to use approach other than subxyphoid, since with echocardiographic guidance it is possibile to perform safely apical and parasternal approaches to reach the maximum amount of fluid to overcome the absence of standard safety margins in the subxyphoid approach; to remove references to UpToDate website and specifically cite papers that support the statements.

Reviewer #2: Dear Authors,

I read your article with great interest. Pericardial effusion can occur in many metabolic and oncological diseases. It is a condition with a high risk of recurrence if not treated with an appropriate approach. We have interventional and surgical options for intervention. There are many studies comparing these two methods in terms of safety and effectiveness. I would like to explain my criticisms about the study you have done, item by item, in the continuation of the article:

1) In the study, you have presented the results of seven patients. It means that two patients had to be re-intervented with PCD. In addition to that, the 8th patient had undergone surgery one month after PCD. Actually, these outcomes indicate that PCD was a permanent solution for only four patients. In your article, you mentioned that the cardiologists had rejected the PCD because of the narrow safety margin. Cardiologists and Cardiothoracic Surgeons are the professionals who manage the process of heart-related medical conditions. Cardiologists might reject the PCD because of the high risk but they ought to suggest a better and less risky way to fix the problem. In your study, you did not mention what their suggestions were instead of PCD.

Every high-risk intervention could be performed successfully by some talented medical associates. Having abilities to perform high-risk interventions is not a scientific justification to do it. Patients' safety and permanency of the therapy must be the main goals of every healthcare professional.

2) In the guideline, the recommendation for pericardial effusion with a known etiology is primarily to treat the underlying disease. Pericardial effusion is expected to decrease in this way. It was stated in your study that 3 patients did not receive any renal replacement therapy prior to PCD. One of these patients had also anasarca. Why didn’t you perform dialysis for these three patients primarily?

3) The guideline recommends intervention for chronic (>3 months) and large pericardial effusions. There are only two patients who showed signs of pericardial tamponade(IVC plethora, 2 and 9). Dyspnea, hemoptysis, and orthopnea occur in pulmonary edema due to volume overload. These are not specific findings of pericardial tamponade.

How long was the pericardial effusion followed in these patients? How long was the medical treatment given? Was the intervention planned as soon as pericardial effusion was detected? Were there other findings for pericardial tamponade, such as an inspiratory change in blood pressure?

4) In echocardiographic measurements, the distribution of pericardial effusion is highly variable in a few cases. Was further examination(CT or CMR) performed considering the possibility of loculations? Because the presence of loculation further reduces the chance of success of percutaneous interventions.

5) Finally, I think that a 9-case study is not sufficient to recommend a high-risk intervention as "safely feasible". If you could increase the number of cases and datas, it might be a considerable study.

**********

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. 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.

PONE-D-21-26425R1Percutaneous Pericardial Catheter Drainage for Symptomatic Uremic Pericardial Effusions with Narrow Safety MarginsPLOS ONE

Dear Dr. Shin,

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 Oct 15 2022 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.

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: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Wisit Kaewput, MD

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. 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.

Additional Editor Comments:

I really appreciate your hard work and tremendous improvement on methods and results. All comments had appropriate addressed. However some minor concern should be address as following. I invite you therefore to respond to the reviewer(s)' comments and revise your manuscript accordingly. I hope you will take the opportunity to revise your manuscript

[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 #2: (No Response)

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 #2: Partly

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

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 #2: Yes

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 #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 #2: Dear Authors,

Thank you for your response. In your study, there are still some sections that must be revised.

1- In your revised paper, I couldn't find the answer to "what was the cardiologists' suggestion instead of the PCD?". In my opinion, surgery(pericardial window) would have been a safer and more permanent treatment option for all the patients in your study. I think that the cardiologists suggested the surgery instead of PCD.

2- Patient 1 had a large pericardial effusion upon admission (Posterior of LV, 37mm). Surgery would be the option for treatment. The PCD is not a feasible method for this case.

Patient 2 didn't have pericardial effusion that needed an aggressive intervention.

In pre-mortem echo findings, you have mentioned massive pericardial effusion. What are your measurements?

These two patients are not similar cases. They can't be a medical basis for your study.

3- Could you please mention the post-interventional echo findings in Table 2?

Reviewer #3: Authors have addressed the reviewers' comments a properly. I have one minor change to suggest - the date format in table 1 and table 2 (yearmonthdate) are not in universal format. In fact, presenting the exact date in the manuscript might not be appropriate because this is patient identifiable information.

**********

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

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.

Percutaneous Pericardial Catheter Drainage for Symptomatic Uremic Pericardial Effusions with Narrow Safety Margins

PONE-D-21-26425R2

Dear Dr. Shin,

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,

Wisit Kaewput, MD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The authors addressed all previous comments. I have no additional concern.

Reviewers' comments: