The use of laser lead extraction sheath in the presence of supra-cardiac occlusion of the central veins for cardiac implantable electronic device lead upgrade or revision

Sameer Al-Maisary; Gabriele Romano; Matthias Karck; Raffaele De Simone; Jamila Kremer

doi:10.1371/journal.pone.0251829

Peer Review History

Original SubmissionMarch 15, 2021
14 Apr 2021 Decision Letter - Giuseppe Coppola, Editor PONE-D-21-08523 The use of Laser lead extraction sheath in the presence of supra-cardiac occlusion of the central veins for cardiac implantable electronic device lead upgrade or revision. PLOS ONE Dear Dr. Sameer Al-Maisary, 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 29 2021 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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We note you have included tables to which you do not refer in the text of your manuscript. Please ensure that you refer to Tables 2 and 3 in your text; if accepted, production will need this reference to link the reader to each Table. [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: Yes Reviewer #2: Yes Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 3. 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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: The implantation of cardiac implantable electronic devices (CIED) has very increased in the last decades, reducing mortality and improvement the quality of life of patients with cardiac rhythm disorders. In this scenario the use of laser-assisted lead extraction (LLE) is a is a very useful technique, particularly in the presence of bilateral subclavian, innominate or superior vena cava obstruction, that is a major limitation to device revision and/or upgrade. I would like congratulate all the authors contributing to this good article and research work. The article is presented in an intelligible fashion. In conclusion, given the overall work, I recommend minor revision concerning a implementation of bibliography, reporting for example the group of Prof Curnis A, who direct a center of great experience in this field (see the paper "Curnis A, Bontempi L, et al. Active-fixation coronary sinus pacing lead extraction: a hybrid approach. Int J Cardiol. 2012 May 3;156(3):e51-2. doi: 10.1016/j.ijcard.2011.08.016"). Reviewer #2: NO COMMENT TO ADD. IT'S A GOOD REVIEW OF PATEINTS FOR A CENTER. I CAN ADD THAT IN SAME CASESE IS USEFUL TO HAVE A WIRE FROM FEMORAL VEIN TO RIGHT ATRIUM, IN CASE TOU NEED IN EMERGENCY TO INSERT A BALOON Reviewer #3: I have read with interest the paper entitled “The use of Laser lead extraction sheath in the presence of supra-cardiac occlusion of the central veins for cardiac implantable electronic device lead upgrade or revision.” The paper is a retrospective analysis of patients who underwent transvenous lead extraction (TLE) requiring Laser. The Authors conclude that this approach has good results in terms of safety and efficacy. Some specific comments are: -The section “conclusion” in the abstract is a repetition of the results and not a real conclusion. Please add that data in the section results and rearrange the section conclusion with correct form. -It is not well described the method used for demonstration of vein occlusion (venography? CT scan, other?). Please better explain this in the method section and in the results section (how many patients performed a unilateral or bilateral venography? A CT scan?). - It could be of interest to know how many leads had an active or a passive fixation system. - It could be of interest the median duration of the follow up - line 229 (discussion): you say that Lead laser extraction has shown good results. In proof of this, you report the results of the ELECTRA. It is misunderstanding, because you do not explain that only a minority of patients of the ELECTRA underwent Laser extraction (19.3%). Additionally, a sub analysis of the ELECTRA revealed that the use of mechanical dilatation was a predictor of lower incidence of major complications, compared with powered sheaths. I think that you have to explain better data from ELECTRA and extend the discussion also with an analysis of the other non-laser approach. -In conclusion, the topic is of interest, and the paper could be suitable for the publication with the correction of these major revisions. ****** 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 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.0251829.r001
Revision 1
2 May 2021 Author Response Rebuttal Plos one Journal Dear Sir or Madam, We are pleased to resubmit a major revision of the enclosed manuscript entitled: “The use of Laser lead extraction sheath in the presence of supra-cardiac occlusion of the central veins for cardiac implantable electronic device lead upgrade or revision. ” for publication in the Journal of Cardiothoracic Surgery. We would like to express our appreciation for giving us the opportunity and the motivation to improve this paper with very valuable suggestions and elaborate comments. The manuscript underwent substantial revision. Details of each change to the original manuscript are reported below along with each issue raised by the Reviewers. In the manuscript, modified text passages are marked in red. We thank you for helping us to substantially improve this paper. Sameer Al-Maisary and Co-Authors Comments from Reviewer #1: The implantation of cardiac implantable electronic devices (CIED) has very increased in the last decades, reducing mortality and improvement the quality of life of patients with cardiac rhythm disorders. In this scenario the use of laser-assisted lead extraction (LLE) is a is a very useful technique, particularly in the presence of bilateral subclavian, innominate or superior vena cava obstruction, that is a major limitation to device revision and/or upgrade. I would like congratulate all the authors contributing to this good article and research work. The article is presented in an intelligible fashion. In conclusion, given the overall work, I recommend minor revision concerning a implementation of bibliography, reporting for example the group of Prof Curnis A, who direct a center of great experience in this field (see the paper "Curnis A, Bontempi L, et al. Active-fixation coronary sinus pacing lead extraction: a hybrid approach. Int J Cardiol. 2012 May 3;156(3):e51-2. doi: 10.1016/j.ijcard.2011.08.016"). Response: We thankfully acknowledge the compliments of Reviewer 1. We read the work of Curnis et al and found it interesting. We added it to our conclusion section to mark the complexity of some Lead extractions. We thank you again for suggesting this reference to enrich our paper. Comments from Reviewer #2: NO COMMENT TO ADD. IT'S A GOOD REVIEW OF PATEINTS FOR A CENTER. I CAN ADD THAT IN SAME CASESE IS USEFUL TO HAVE A WIRE FROM FEMORAL VEIN TO RIGHT ATRIUM, IN CASE TOU NEED IN EMERGENCY TO INSERT A BALOON Response: Thank you for your comments. You have raised an important point here. We agree that inserting a wire from the femoral vein is helpful but because of the cost of the balloon we are not using it. We try to get enough financial support to be able to use it but for the time being we cannot afford it. Comments from Reviewer #3: I have read with interest the paper entitled “The use of Laser lead extraction sheath in the presence of supra-cardiac occlusion of the central veins for cardiac implantable electronic device lead upgrade or revision.” The paper is a retrospective analysis of patients who underwent transvenous lead extraction (TLE) requiring Laser. The Authors conclude that this approach has good results in terms of safety and efficacy. Some specific comments are: -The section “conclusion” in the abstract is a repetition of the results and not a real conclusion. Please add that data in the section results and rearrange the section conclusion with correct form. Answer: We thank the reviewer for pointing this out. We have revised the conclusion completely. -It is not well described the method used for demonstration of vein occlusion (venography? CT scan, other?). Please better explain this in the method section and in the results section (how many patients performed a unilateral or bilateral venography? A CT scan?). Answer: This observation is correct. We have changed the sentences and made it more clear that Venography was used to make the diagnosis of venous obstruction in 23 patients. We made it also more clear in the methods section, that Venography was used for the diagnosis. We also added the word bilateral to venography as all patient with obstruction of an access vein undergo venography of the contralateral side. - It could be of interest to know how many leads had an active or a passive fixation system. Answer: We thank the reviewer for pointing this out. We are sorry to tell you, that we don’t have recording of the LV-Lead type (active or passive) - It could be of interest the median duration of the follow up Answer: We appreciate the reviewer’s insightful suggestion and agree that it would be useful to demonstrate that. However, trying to get these data again well need a lot of time and mostly we want be able to get the whole data. Because of that we concentrated on the first 30 days. - line 229 (discussion): you say that Lead laser extraction has shown good results. In proof of this, you report the results of the ELECTRA. It is misunderstanding, because you do not explain that only a minority of patients of the ELECTRA underwent Laser extraction (19.3%). Additionally, a sub analysis of the ELECTRA revealed that the use of mechanical dilatation was a predictor of lower incidence of major complications, compared with powered sheaths. I think that you have to explain better data from ELECTRA and extend the discussion also with an analysis of the other non-laser approach. Answer: We thank the reviewer for pointing this out. We have revised our discussion and adapted your suggestions. We added that 19.3 % of the patients underwent laser lead extraction. We also added the Wazni et al paper to support the benefits of laser lead extraction to the discussion. We also discussed the role of the mechanical extraction and that we still have to improve it, to avoid the risks of laser lead extraction. -In conclusion, the topic is of interest, and the paper could be suitable for the publication with the correction of these major revisions. Answer: Thank you for your assessment. We hope that through our correction, we reach your expectations. Once again, we thank you for the time you put in reviewing our paper and look forward to meeting your expectations. Your inputs have been precious. We look forward to hearing from you regarding our submission and to respond to any further questions and comments you may have. The authors’ Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0251829.r002
4 May 2021 Decision Letter - Giuseppe Coppola, Editor The use of Laser lead extraction sheath in the presence of supra-cardiac occlusion of the central veins for cardiac implantable electronic device lead upgrade or revision. PONE-D-21-08523R1 Dear Dr. Sameer Al-Maisary, 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, Giuseppe Coppola Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0251829.r003
Formally Accepted
6 May 2021 Acceptance Letter - Giuseppe Coppola, Editor PONE-D-21-08523R1 The use of Laser lead extraction sheath in the presence of supra-cardiac occlusion of the central veins for cardiac implantable electronic device lead upgrade or revision. Dear Dr. Al-Maisary: 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. Giuseppe Coppola Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0251829.r004

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