Implantable cardioverter-defibrillator therapy after resuscitation from cardiac arrest in vasospastic angina: A retrospective study

Kazuya Tateishi; Yusuke Kondo; Yuichi Saito; Hideki Kitahara; Kenichi Fukushima; Hidehisa Takahashi; Daichi Yamashita; Koichi Ohashi; Ko Suzuki; Osamu Hashimoto; Yoshiaki Sakai; Yoshio Kobayashi

doi:10.1371/journal.pone.0277034

Peer Review History

Original SubmissionJune 15, 2022
4 Sep 2022 Decision Letter - Shukri AlSaif, Editor PONE-D-22-17097Implantable cardioverter-defibrillator therapy after resuscitation from cardiac arrest in vasospastic angina: a retrospective studyPLOS ONE Dear Dr. Tateishi, 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 13 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. 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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: Yes 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: No Reviewer #2: 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: The paper by Kazuya Tateishi et al. relies on the prognosis of patients with variant angina and sudden cardiac death. They compare implanted patients with VSA with other ICD patients implanted after SCD. Major comments : - VSA group (n=51) and non-VSA group (n=229) is rather intriguing since VSA are more excpetional in Europe and 229 non VSA ICD patients over a rather long time is not a so important number of implanted patienst. Could the authors comment on that ? - the results are mainly presented as tables. A more detailed presentation in the text is probably more readable - details about the appropriate ICD therapies in the VSA group are mandatory. Did VT/VF occur in relation with other vasospastic events ? or with acute coornary trhombosis ? How many VF and VT ? did some patients experience several events ? what was the anti arrhythmic drug regimen at the time of the recurrence and therafter ? - where are the comparisons between VSA patients and subtypes of other ICD patients ? (seen in figure 3 but anaysis should be provided) - Factors associated with death and recurrent ventricular arrhythmias should be separately analyzed for VSA patients - A better comarison would be with a third group of VSA with cardiac arrest but non implanted. Did the authors have such group of patients to be studied ? Reviewer #2: Well written paper that acknowledges the limitations involved in a retrospective analysis and is soundly written. Furthermore, the paper highlights a possibly under-diagnosed representation of VSA amongst patients that have survived a sudden cardiac arrest. ****** 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? 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Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0277034.r001
Revision 1
11 Oct 2022 Author Response Responses to the comments of Reviewer #1 We appreciate the careful and comprehensive review of our manuscript. In response to the Reviewer’s comments and recommendations, we have answered the questions in a point-by-point fashion and revised our manuscript as follows. The changes we made are shown in red font in the revised manuscript. 1. VSA group (n=51) and non-VSA group (n=229) is rather intriguing since VSA are more exceptional in Europe and 229 non VSA ICD patients over a rather long time is not a so important number of implanted patient. Could the authors comment on that? As the Reviewer pointed out, the patients with VSA accounted for 18% of the entire population (patients who received ICD implantation for secondary prophylaxis) in the present study. This high prevalence was probably because we are encouraged to perform ACh provocation tests for patients with cardiac arrest of an unknown etiology at our institutions. However, since this is a retrospective study, further prospective studies will be needed to investigate the exact prevalence of VSA in patients with cardiac arrest. We have accordingly added the following sentence to the Study limitations section of the manuscript: “Therefore, further prospective studies will be needed to investigate the precise prevalence of VSA in patients resuscitated from SCA.” (page 20, lines 6–7) 2. The results are mainly presented as tables. A more detailed presentation in the text is probably more readable. We appreciate the Reviewer’s meaningful comment. We have accordingly revised the Results section as follows: “Of the patients with VSA, 37 (73%) were diagnosed using the intracoronary acetylcholine provocation test, 13 (25%) by spontaneous ST-segment elevation on ECG, and 1 (2%) by spontaneous coronary vasospasm on emergent coronary angiography.” (page 10, lines 10–13). “Among patients without VSA, ischemic cardiomyopathy was the leading cause of SCA (38%), followed by non-ischemic cardiomyopathies (18%) and Brugada syndrome (7%) (Table 1).” (page 10, lines 16–18) “There was no significant difference in the composite endpoint during the study period between the VSA and non-VSA groups (24% vs. 33%, p=0.19).” (page 12, line 12 to page 13, line 1) “One patient (2%) in the VSA group died of a cardiac cause compared to 10 patients (4%) in the non-VSA group.” (page 13, lines 2–3) 3. Details about the appropriate ICD therapies in the VSA group are mandatory. Did VT/VF occur in relation with other vasospastic events? or with acute coronary thrombosis? How many VF and VT? did some patients experience several events? what was the anti-arrhythmic drug regimen at the time of the recurrence and thereafter? Of the 11 patients in the VSA group who received appropriate ICD therapy, 5 had VF and 6 had sustained VT. Although coronary angiography was not routinely performed for patients without ST-segment elevation who had undergone appropriate ICD therapy, there were no patients with acute coronary thrombosis in this cohort. Since the routine check-up and further examinations performed on re-admission could not reveal any other reason for the recurrent VT/VF in these patients, we believe that coronary vasospasm is one of the major causes of recurrent lethal arrhythmia. Actually, 2 patients in the VSA group had undergone several appropriate ICD therapies in the present study. For the patients with VSA who had undergone appropriate ICD therapy, we usually added CCBs (both dihydropyridine and non-dihydropyridine) and long-active nitrate and subsequently escalated them up to the maximum dose. However, since we discontinued follow-up when the first event occurred in this study, we could not obtain detailed information about the changes in anti-arrhythmic medication in these 2 patients. As this point is clinically important, further studies are needed. Therefore, we have added the following sentence to the revised Results section: “In the VSA group, 11 (22%) patients had undergone ICD therapy (7 patients received shock and 4 anti-tachycardia pacing only), and further examinations on re-admission did not reveal another reason for the recurrent, lethal ventricular arrhythmias.” (page 12, lines 9–12) 4. Where are the comparisons between VSA patients and subtypes of other ICD patients? (seen in figure 3 but analysis should be provided) We have added the patient characteristics and outcomes according to each etiology to Table S2. Although patient characteristics differed notably among the groups, there was no significant difference in any outcomes. Thus, we have revised the Results section as follows: “Although patient characteristics differed widely according to etiology, the incidence of the primary endpoint was not significantly different (Table S2, Fig 3).” (page 13, lines 5–7) 5. Factors associated with death and recurrent ventricular arrhythmias should be separately analyzed for VSA patients. As the Reviewer suggested, we have analyzed some factors associated with the primary endpoint (all-cause death and appropriate ICD therapy) in patients with VSA (n=51). However, probably because of the limited sample size, no significant predictors were found (Table S3). We have accordingly added the following sentence to the Results: “We also analyzed predictors of all-cause death and appropriate ICD therapy in patients with VSA, but no significant factors were found (Table S3).” (page 13, lines 8–10) 6. A better comparison would be with a third group of VSA with cardiac arrest but non implanted. Did the authors have such group of patients to be studied? According to the Reviewer’s suggestion, we have added an analysis of a supplemental cohort, which includes SCA survivors with VSA who did not receive ICD therapy at the four hospitals between January 2012 and November 2019, to the revised manuscript, in addition to the main study cohort (Figure 1). There were 88 SCA survivors with VSA managed during this period at the participating hospitals. After excluding patients who died during the index hospitalization and those with cardiomyopathy or reduced left ventricular ejection fraction, 24 patients were identified as the supplemental cohort. The characteristics of VSA patients with or without ICD therapy are shown in Table S4. Kaplan–Meier curve analysis showed a lower rate of cardiac death in patients with ICD than in those without during the follow-up period (Figure S1); however, the patients’ baseline characteristics differed notably between the two groups (Table S4). We have added Figure 1 and S1, Table S4, and have revised the Methods and Results accordingly. “SCA survivors with VSA who did not receive ICD therapy from January 2012 to November 2019 at the four hospitals were also included as a supplemental cohort (Fig 1).” (page 5, lines 9–11) “In the comparison of patients with VSA according to ICD implantation, 24 of 75 (32%) patients did not receive ICD after SCA (Fig 1). Although there were notable differences in patient characteristics according to ICD implantation after SCA (Table S4), Kaplan–Meier curve analysis showed a lower rate of cardiac death in patients with ICD than in those without (Fig S1).” (page 16, lines 11–14) Responses to the comments of Reviewer #2 Thank you for your time and input. We sincerely appreciate your comprehensive comments. Attachments Attachment Submitted filename: Responses_to_reviewer.docx https://doi.org/10.1371/journal.pone.0277034.r002
19 Oct 2022 Decision Letter - Shukri AlSaif, Editor Implantable cardioverter-defibrillator therapy after resuscitation from cardiac arrest in vasospastic angina: a retrospective study PONE-D-22-17097R1 Dear Dr. Tateishi, 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, Shukri AlSaif Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0277034.r003
Formally Accepted
21 Oct 2022 Acceptance Letter - Shukri AlSaif, Editor PONE-D-22-17097R1 Implantable cardioverter-defibrillator therapy after resuscitation from cardiac arrest in vasospastic angina: a retrospective study Dear Dr. Tateishi: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Shukri AlSaif Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0277034.r004

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