PONE-D-24-58174Risk assessment of temporary pacing for cardiac arrest after cardiopulmonary bypass assisted cardiovascular surgery: a case-control studyPLOS ONE

Dear Dr. Wang,

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.

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Kind regards,

Eyüp Serhat Çalık

Academic Editor

PLOS ONE

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2. Thank you for stating the following financial disclosure:

“The accumulation of cases and data was supported in part by Shanghai Pudong New Area Health Commission Special Program for Clinical Research in the Health Industry [PW2010D-2, PW2015D-2, PW2021E-04]; Three-year Action Plan to Promote Clinical Skills and Clinical Innovation Capabilities in Municipal Hospitals, Shanghai Shenkang Hospital Development Center [SHDC2020CR6013]; Clinical Innovation and Training Funding of Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital [RJPY-DZX-005].”

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If this statement is not correct you must amend it as needed.

Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf.

3. Thank you for stating the following in the Competing Interests section:

“Potential competing interests are declared that Dr. Song Xue received financial supports from Shanghai Pudong Health Commission Special Program for Clinical Research in the Health Industry [PW2010D-2, PW2015D-2, PW2021E-04]; Three-year Action Plan to Promote Clinical Skills and Clinical Innovation Capabilities in Municipal Hospitals, Shanghai Shenkang Hospital Development Center [SHDC2020CR6013]; Clinical Innovation and Training Funding of Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital [RJPY-DZX-005]. Other authors declare that they have no conflict of interest.”

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Additional Editor Comments:

I would like to thank the esteemed authors for presenting their work on this important topic for cardiac surgery. The manuscript was reviewed by 5 valuable referees, and their comments are below. We look forward to your point-by-point responses to the suggestions and your re-uploading of your manuscript after appropriate revisions.

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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: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Partly

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

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: N/A

Reviewer #5: No

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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: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

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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

Reviewer #4: Yes

Reviewer #5: No

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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: The abstract does not provide sufficient background to contextualize the importance of studying temporary pacing.

Suggestion: Add 1-2 sentences explaining the clinical implications of temporary pacing and its relevance to postoperative outcomes.

The results section is data-heavy, with numerous ORs and CIs presented in a dense format that might overwhelm readers.

While the abstract mentions the scoring system, it does not explain how the scoring system was developed or validated.

Lack of Specificity in the Conclusion:

The conclusion reiterates findings but does not address the scoring system’s potential for clinical implementation or its limitations.

Ambiguity in Results Interpretation:

Terms like "long CPB time" are vague and lack specific thresholds, which might limit reproducibility.

No Mention of Limitations:

The abstract does not acknowledge any study limitations, which could affect the interpretation of findings.

Terminology: Replace "Odd ratio" with "Odds ratio" for accuracy.

Scoring System AUC: While the ROC curve AUC of 0.7402 is acceptable, its clinical significance is not addressed. How well does the scoring system perform in different patient populations?

Preoperative Atrial Fibrillation: This is identified as a major risk factor. The abstract could mention its prevalence in the study cohort for context.

Reviewer #2: The study makes an important contribution, highlighting key risk factors for the need for temporary pacing upon CPB-assisted cardiovascular surgery and by developing a scoring system that could be clinically useful. However, the study could benefit from a deeper exploration of the mechanisms behind the identified risk factors. To enhance the clinical application and the robustness of the study, the following areas should be addressed:

1. This study provides clear exclusion criteria, there is a potential risk of collection bias, given that the data was collected by specific team members during working hours. The authors should clarify if there are inherent biases like selection bias, recall bias, and missing data issues, which could have affected the comprehensiveness of their findings.

2. While the authors report an AUC of 0.7400 for their scoring system, external validation is critical. In this case, where no external validation exists, caution must be emphasized, as validation in an independent cohort would test the robustness and generalizability of the scoring system. For example, the clinical effectiveness of this model needs to be evaluated prospectively in other hospitals or surgical settings. Furthermore, while the scoring system’s sensitivity (59.26%) and specificity (80.16%) are reported, it would be helpful to provide additional details on the performance of the model at different score cutoffs. How does the model perform in different patient subgroups (e.g., those with comorbidities, and specific valve surgeries)?

3. The authors highlight that non-CABG operations (e.g., MVR, DVR) are independent risk factors for temporary pacing. However, the paper does not discuss how the complexity or specific technical aspects of these procedures may increase the likelihood of pacing. For instance, does mitral valve replacement inherently cause more myocardial stress or post-operative arrhythmias? Further discussion could provide a more mechanistic understanding of these findings.

4. The study focuses on the need for temporary pacing, including other postoperative outcomes such as mortality, long-term arrhythmias, and recovery times. These additional outcomes would provide a more comprehensive assessment of the clinical implications of temporary pacing. The authors didn’t mention if temporary pacing leads to a need for permanent pacing in some patients. Including this information would be valuable, as it would indicate whether the need for temporary pacing might signal a higher risk for long-term pacing requirements.

Reviewer #3: Major Comments:

Study Design and Patient Selection:

The retrospective design is appropriate given the clinical context; however, additional clarification on the selection criteria (and potential selection biases) would strengthen the manuscript.

The exclusion of patients with incomplete information or preoperative pacing is clearly justified, but the manuscript should discuss how these exclusions might affect generalizability.

Statistical Analysis and Model Development:

The logistic regression analysis appears robust, and the identification of independent risk factors is supported by appropriate statistical tests.

The development of the scoring system is innovative; however, external validation in an independent cohort is necessary to confirm its clinical utility.

The manuscript would benefit from a more detailed discussion of the model’s calibration (beyond the Hosmer-Lemeshow test) and discrimination metrics.

Clinical Implications:

The authors effectively argue that temporary pacing is an important intervention with non-negligible risks, and that predicting its necessity could optimize patient management.

It would be useful to elaborate on how the scoring system might be integrated into clinical practice and whether it might reduce unnecessary temporary pacing wire insertions.

Minor Comments:

Some sections of the Methods and Results could be more concise; consider streamlining the text to focus on the most critical details.

The description of the risk factors (e.g., CPB time, preoperative rhythm) is clear, but providing a table that summarizes baseline characteristics between the pacing and non-pacing groups would enhance clarity.

Figures and supplementary materials (such as the ROC curve and distribution of scores) are helpful; ensure they are of high resolution and fully referenced in the text.

There are a few typographical errors and minor formatting issues that should be corrected prior to publication.

Reviewer #4: Review of the Manuscript: Risk Assessment of Temporary Pacing for Cardiac Arrest After Cardiopulmonary Bypass-Assisted Cardiovascular Surgery: A Case-Control Study

The manuscript presents a case-control study on the risk assessment of temporary pacing for cardiac arrest following cardiopulmonary bypass (CPB)-assisted cardiovascular surgery. The study addresses an important clinical question, offering a scoring system to evaluate risk factors. However, there are areas that require revision, including the clarity of the methodology, statistical justification, and overall presentation of results. Below are specific comments regarding strengths and areas for improvement.

Strengths:

1. Clinical Relevance: The study addresses a significant clinical concern, providing a risk assessment for temporary pacing after cardiac surgery.

2. Large Sample Size: The study includes 2,326 patients, which strengthens the statistical power.

3. Clear Identification of Risk Factors: Independent risk factors such as age, preoperative atrial fibrillation, and prolonged CPB time are well-identified and explained.

4. Development of a Scoring System: The creation of a risk stratification model adds practical value for clinical decision-making.

Major Concerns:

1. Abstract Clarity and Precision

• The abstract should explicitly state the statistical methods used to determine independent risk factors and scoring system development.

• Clarify the meaning of “certain indications” in the methods section.

• The conclusion should emphasize the clinical applicability of the scoring system.

2. Methodology and Statistical Analysis

• The description of how patients were categorized into case and control groups lacks clarity. The inclusion and exclusion criteria need refinement, particularly regarding preoperative ventricular arrhythmia.

• The statistical justification for using specific cut-offs in logistic regression models should be provided.

• The rationale for choosing coronary artery bypass grafting (CABG) as the reference category in operation type comparisons should be explained.

• Multiple logistic regression: The criteria for stepwise elimination should be described in greater detail.

• The scoring system parameters need validation against an external dataset. If not feasible, a discussion on its limitations should be included.

3. Presentation of Results

• Tables 1 and 2 should be reformatted for clarity. Consider summarizing key findings in the text.

• Figure 2D requires additional explanation to clarify how likelihood ratios were determined.

• Sensitivity and specificity should be interpreted in a clinical context—what constitutes an acceptable threshold?

4. Discussion and Clinical Implications

• The study should compare findings with existing literature on temporary pacing after CPB.

• Potential confounding factors such as perioperative medications, patient comorbidities, and intraoperative hemodynamics should be acknowledged.

• The limitations section should expand on how surgical techniques and institutional practices may affect generalizability.

5. Language and Formatting

• Several grammatical errors and awkward phrasings are present. A professional language review is recommended.

• Consistency in terminology: The manuscript alternates between “temporary pacing” and “temporary pacemaker use” without clear distinction.

• Reference formatting should follow journal guidelines.

Minor Comments:

1. Define abbreviations upon first use.

2. Ensure figures are high resolution and appropriately labeled.

3. The ethical approval statement should be moved to the methods section.

This study presents valuable findings on temporary pacing after CPB-assisted cardiovascular surgery. However, revisions are necessary to enhance methodological clarity, statistical justification, and the clinical interpretation of results. Addressing these concerns will significantly strengthen the manuscript's impact and readability.

Reviewer #5: Abstract:

Spell out the numbers two thousand three hundred twenty-six and one hundred eight as they appear at the start of the sentence.

Rephrase: A scoring formula was developed, achieving an area under the receiver operating characteristic (ROC) curve (AUC) of 0.7402 (95% CI: 0.6939–0.7865, P < 0.0001).

Revise: A scoring system incorporating age, preoperative rhythm, and CPB time can quantitatively assess the associated risk.

Methods:

Since this is a case-control study, explicitly state the inclusion and exclusion criteria for both cases and controls.

Justify why this study is not classified as a retrospective cohort study.

Revise the statistical analysis section: Specify where the D’Agostino & Pearson test, Mann-Whitney test, chi-square test or Fisher’s exact test, and Baptista-Pike method were applied in the results.

Results:

Spell out the numbers two thousand four hundred forty-six and one hundred nine as they appear at the start of the sentence.

Report p-values to three decimal places, percentages to one decimal place, and other values to two decimal places.

Table 1:

-This table should report results from simple logistic regression.

-Replace "statistics" with p-values.

-Reclassify some variables where necessary.

-Ensure the reference category is reported first (e.g., "male" followed by "female").

Table 3: Clearly state the variable selection method used.

Revise:

-The incidence of temporary pacing increased with the score. When the score was below 2, the incidence remained below 5% (Fig. 2C).

-With an interval of 0.002, cutoff values ≤1.138 or ≥3.474 corresponded to negative likelihood ratios <0.1 and positive likelihood ratios >10 (Fig. 2D).

Discussion:

Expand this section as it is currently too brief.

Revise the use of the term "incidence" to ensure accuracy.

Discuss why the type of operation was not included in the scoring system.

Address the exclusion of several key factors and how this impacts the scoring system.

References:

Additional references should be included where relevant.

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Reviewer #1: Yes:  Aram Baram

Reviewer #2: Yes:  Victory Ashonibare

Reviewer #3: No

Reviewer #4: Yes:  Juliana Aggrey

Reviewer #5: No

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Attachments

Attachment

Submitted filename: Comments for 58174.docx

PONE-D-24-58174R1Risk assessment of temporary pacing for cardiac arrest after cardiopulmonary bypass-assisted cardiovascular surgery: a case-control studyPLOS ONE

Dear Dr. Wang,

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 May 23 2025 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,

Eyüp Serhat Çalık

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 would like to thank the authors for their point-by-point responses to the reviewers' suggestions and for their appropriate revisions. We recommend a small revision for additional suggestions. Good luck.

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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

Reviewer #4: All comments have been addressed

Reviewer #5: (No Response)

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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

Reviewer #4: Yes

Reviewer #5: Partly

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

Reviewer #2: Yes

Reviewer #4: Yes

Reviewer #5: No

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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 #4: Yes

Reviewer #5: Yes

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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 #4: Yes

Reviewer #5: Yes

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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: (No Response)

Reviewer #4: General Overview

This study aims to assess the risk of temporary pacing in patients experiencing cardiac arrest after CPB-assisted cardiovascular surgery. The authors employ multiple logistic regression (MLR) to identify independent risk factors and develop a scoring system for clinical application. While the study is methodologically sound and clinically relevant, several areas require refinement to enhance clarity, validity, and applicability.

Strengths

1. Relevance and Novelty

o The topic addresses an important clinical dilemma: balancing the benefits of temporary pacing with the risks of unnecessary pacing wire insertion.

o The study attempts to fill a gap in current literature by providing a quantitative assessment model.

2. Methodological Rigor

o The study includes a large sample size (n=2326), enhancing statistical power.

o The use of MLR is appropriate for identifying independent risk factors.

o Sensitivity analysis and subgroup analysis strengthen the robustness of findings.

3. Development of a Practical Tool

o The scoring system offers a structured approach for identifying patients at low risk of requiring pacing, potentially reducing unnecessary interventions.

o The chosen cutoff (score ≤1) minimizes false negatives, ensuring that high-risk patients are not overlooked.

Areas for Improvement

1. Clarity in Presentation

o The manuscript presents results in a highly technical manner. Simplifying the text and using clearer tables or graphical representations (such as summary tables of key findings) would improve readability.

o The replacement of Table 2 with forest plots is helpful, but further effort is needed to make the statistical findings more accessible to clinicians.

2. Validation of the Scoring System

o The absence of external validation is a significant limitation. While the authors acknowledge this, they should provide a more detailed discussion on the necessity of validating the model in independent cohorts.

o The current validation approach (testing the scoring system within the same dataset) may introduce bias and overestimate model performance.

3. Consideration of Confounding Factors

o The study does not fully explore perioperative factors (e.g., medication use, intraoperative hemodynamics, and surgeon expertise) that may influence pacing needs.

o A more detailed discussion on how the type of surgery affects pacing risk is necessary. For example, why do non-CABG procedures increase the likelihood of pacing?

4. Limitations and Bias

o The manuscript acknowledges selection bias but does not sufficiently elaborate on recall bias, missing data issues, or potential inaccuracies in data collection.

o The retrospective design limits causal inference, which should be explicitly stated in relation to future prospective studies.

5. Clinical Implementation

o The discussion should elaborate on how the scoring system could be integrated into clinical workflows.

o Exploring the potential for incorporation into electronic health records (EHRs) for automated decision support would enhance practical utility.

Conclusion

This study contributes valuable insights into the risk assessment of temporary pacing post-CPB-assisted cardiovascular surgery. While the methodology is sound and the scoring system has potential clinical utility, improvements in clarity, external validation, and discussion of confounding factors would further strengthen its impact. Addressing these aspects would make the research more applicable to a broader cardiovascular surgical audience.

Reviewer #5: (No Response)

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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: Yes:  Victory Ashonibare

Reviewer #4: Yes:  Juliana Aggrey

Reviewer #5: No

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[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.

Attachments

Attachment

Submitted filename: Comments for 58174 R1.docx

Risk assessment of temporary pacing for cardiac arrest after cardiopulmonary bypass-assisted cardiovascular surgery: a case-control study

PONE-D-24-58174R2

Dear Dr. Wang,

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.

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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,

Eyüp Serhat Çalık

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: