PONE-D-22-26350Octogenarian patients and laser-assisted lead extraction: should we put a limit?PLOS ONE

Dear Dr. Al-Maisary,

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Redoy Ranjan, MBBS, MRCSEd, Ch.M., MS (CV&TS), FACS

Academic Editor

PLOS ONE

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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: No

Reviewer #2: No

Reviewer #3: Yes

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

Reviewer #1: I Don't Know

Reviewer #2: No

Reviewer #3: I Don't Know

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3. Have the authors made all data underlying the findings in their manuscript fully available?

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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 study is a single center experience in transvenous lead extraction. The message the authors are trying to give is that age should not be the barrier. This message has been seen in other contemporary publications (see below).The study is retrospective. We are not told if there was patients who had an indication for lead extraction and were not done for whatever reason. Retrospective studies have inherent bias to what was essentially successful.

The problem with this paper is the small number of patients who are older than 80 years.

The authors have not done an appropriate literature search before writing their manuscript. Their most recent reference was dated 2019.

I strongly advice the authors look at similar publications on the topic with significantly larger numbers.

Some of the recent published manuscripts on this subject are below. After reading these the authors need to see if they can add to the literature anything else that has not been observed in these publications

Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort.

Akhtar Z, Elbatran AI, Starck CT, Gonzalez E, Al-Razzo O, Mazzone P, Delnoy PP, Breitenstein A, Steffel J, Eulert-Grehn J, Lanmüller P, Melillo F, Marzi A, Leung LWM, Domenichini G, Sohal M, Gallagher MM.

Pacing Clin Electrophysiol. 2021 Sep;44(9):1540-1548. doi: 10.1111/pace.14310. Epub 2021 Aug 5.

PMID: 34235772

Transvenous lead extraction in patients with systemic cardiac device-related infection-Procedural outcome and risk prediction: A GALLERY subgroup-analysis.

Chung DU, Burger H, Kaiser L, Osswald B, Bärsch V, Nägele H, Knaut M, Reichenspurner H, Gessler N, Willems S, Butter C, Pecha S, Hakmi S; GALLERY investigators.

Heart Rhythm. 2022 Oct 11:S1547-5271(22)02489-4. doi: 10.1016/j.hrthm.2022.10.004. Online ahead of print.

PMID: 36240993

Safe and effective transvenous lead extraction for elderly patients utilizing non-laser and laser tools: a single-center experience in Japan.

Okada A, Tabata H, Shoda M, Shoin W, Kobayashi H, Okano T, Yoshie K, Kato K, Saigusa T, Ebisawa S, Motoki H, Kuwahara K.

Heart Vessels. 2021 Jun;36(6):882-889. doi: 10.1007/s00380-020-01761-3. Epub 2021 Jan 4.

PMID: 33394103

Indications for transvenous lead extraction and its procedural and early outcomes in elderly patients: a single-center experience.

Ząbek A, Boczar K, Dębski M, Pfitzner R, Ulman M, Holcman K, Kostkiewicz M, Musiał R, Lelakowski J, Małecka B.

Pol Arch Intern Med. 2020 Mar 27;130(3):216-224. doi: 10.20452/pamw.15182. Epub 2020 Feb 10.

PMID: 32041927

Risk Factors and Long-Term Survival of Octogenarians and Nonagenarians Undergoing Transvenous Lead Extraction Procedures.

Jacheć W, Polewczyk A, Segreti L, Bongiorni MG, Kutarski A.

Gerontology. 2021;67(1):36-48. doi: 10.1159/000511358. Epub 2020 Nov 26.

PMID: 33242867

Reviewer #2: I read your article with great interest. The study was a retrospective study of 270 patients who underwent lead extraction between 2013-2020. The research question is reasonable; however, it is not uncommon for the patients with the age between 80-90 to undergo lead extraction procedure with the reasonable indications and thorough benefit-risk discussion with the patients and their family.

1. It would be an interesting descriptive study if the authors describe more in detail regarding the reasons of “partial success or failure” in the OG group. This is important because it reflects the bias of treatment leading to the favorable outcome. For example, the procedure was aborted in the OG group after stucking at the SVC level in extracting. This surely would make the procedure safe for the patients and there was no mortality in the OG group. In such a case, that OG patient did not truly undergo extraction to its entirety. It therefore does not support the conclusion the authors made that it is safe for octogenarians to undergo this high-risk procedure. If so, it should be mentioned in the discussion part. For CS lead and dual-coiled ICD, they pose significant risks if the lead has been dwelling in the body for more than 10 years, but it might not have a significant risk or be too difficult to extract if the duration of the implantation was less than that.

2. Table 1 should provide more detail in comorbidities e.g. prior PCI, CABG (might lower the risk of extraction in some patients due to the lower risk of cardiac tamponade esp if the tear occurred at the SVC level where pericardium still covers).

3. In the discussion part, the limitation of the study should be discussed more in detail as this is a singer-centered experience which may not be generalizable to other centers with different setup/experience in extraction procedure.

4. The statement: Only one patient suffered from SVC tier [the authors might misspell it; should be “tear”??]. Please describe in detail about this case; OG or YG group, dual-coil ICD lead or other types of the lead, how old the lead was, etc.

5. One patient died due to pulmonary embolism; this one is in the OG or YG group? Please describe in detail how/when it happened in the postoperative period and what was a likely etiology of this mortality.

Reviewer #3: Major issues:

1-Tables can be arranged in a simpler form. Inclusion of graphs and charts would be more effective in providing a visual comparison between the groups. This is specifically in reference to tables 3 and 4.

2- How do you explain the difference in death rates between your study and 0.3% in previous studies?

3-Where does your study account for risk factors of complications mentioned in discussion? Risk factors mentioned included body mass index, female sex. Were they accounted for during the selection process for the study? Were pts with lower mass index, female and having longer ICD implants excluded from selection for a laser extraction?

Minor issues:

Grammatical Errors

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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PONE-D-22-26350R1

Octogenarian patients and laser-assisted lead extraction: should we put a limit?

PLOS ONE

Dear Dr. 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.

ACADEMIC EDITOR:

The authors are thanked for this submission to PLOS ONE. After a critical external peer review by three experts and considering the overall reviewers' comments, I reinforce improving your paper's clarity and presentation of the discussion section based on recent literature with a large sample and acknowledgement of concerns raised by reviewers. PLOS ONE's publication criteria considered methodological rigour and ethical standards, regardless of the paper's novelty.

Please see the attached reviewer comments detail below.

Please submit your revised manuscript by Apr 20 2023 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,

Redoy Ranjan, MBBS, MRCSEd, Ch.M., MS (CV&TS), FACS

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.

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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 #4: All comments have been addressed

Reviewer #5: All comments have been addressed

Reviewer #6: (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 #4: Yes

Reviewer #5: Yes

Reviewer #6: Partly

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

Reviewer #4: Yes

Reviewer #5: N/A

Reviewer #6: I Don't Know

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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 #4: Yes

Reviewer #5: Yes

Reviewer #6: No

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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 #4: Yes

Reviewer #5: Yes

Reviewer #6: No

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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 #4: The topic of the study is important because, according to the common opinion, TLE in patients > 80 years old may be more dangerous and some patients are disqualified for TLE only because of their age. There are many publications on this topic, many of which use more conventional lead extraction techniques, but with similar results. The study is based on the small number of patients >80y (38 patients), however, a certain advantage of it is a uniform (laser) extraction technique and performing procedures in organizational conditions ensuring maximum safety. In everyday practice, the stepwise approach and cross-over strategy (from simple traction, utility polypropylene sheaths of different sizes, and in the absence of progress of lead dilatation – up to utility mechanical rotational threaded tip sheaths or laser sheaths) are more often used. The authors' results confirm previous reports, enriching our knowledge that also extraction of leads using the laser technique is not more dangerous in octogenarians than in younger patients.

TLE appears to be easier in the elderly. Other authors explain this by a weaker reaction of the endothelium of veins and heart structures to the presence of leads, less intensive development of connective tissue scar around the lead and less intense processes of its mineralization and calcification.

It seems that if the available material is modest, the discussion should be based on publications containing a much larger number of 80- and 90-year-olds.

I suggest that you pay attention to such reports as:

Jacheć W, Polewczyk A, Segreti L, Bongiorni MG, Kutarski A. Risk Factors and Long-Term Survival of Octogenarians and Nonagenarians Undergoing Transvenous Lead Extraction Procedures. Gerontology. 2021;67:36-48. (80-90y -549 patients and over 90 years of age -35 patients).

Giannotti Santoro M, Segreti L, Zucchelli G, Barletta V, Fiorentini F, Di Cori A, De Lucia R, Bongiorni MG. Transvenous lead extraction: Efficacy and safety of the procedure in octogenarian patients. Pacing Clin Electrophysiol. 2020;43:382-387 (202 patients >80)

Kutarski A, Polewczyk A, Boczar K, Ząbek A, Polewczyk M. Safety and effectiveness of transvenous lead extraction in elderly patients. Cardiol J. 2014;21:47-52. (192 patients over 80y)

Burger H, Hakmi S, Petersen J, Yildirim Y, Choi YH, Willems S, Reichenspurner H, Ziegelhoeffer T, Pecha S. Safety and efficacy of transvenous lead extraction in octogenarians using powered extraction sheaths. Pacing Clin Electrophysiol. 2021;44:601-606 (71 patients over 80y)

Reviewer #5: Lead extraction procedures have increased in recent years due to the augmented number of cardiac implantable electronic devices, a term which includes implantable cardioverter-defibrillators (ICDs)

and permanent pacemakers (PMs). The main reasons for lead extraction are infection and malfunction of the device and/or catheters either after a first implant or a substitution/upgrade procedure.

The paper is a interesting paper. Is ok the remember that the indication for the lead extraction in not relatel to the age of the patients. Is possible to accept with the corrections.

Reviewer #6: In this manuscript authors report a retrospective comparison of two population (one of octogenarian patients, one of patients < 80 years old) undergoing TLE for various indications. Study aims are potentially interesting as the target demographics for this kind of procedure has progressively aged in recent decades. However, this manuscript holds several significant flaws in study ideation, conduction and reporting. English language needs major revision before consideration. Study population, especially for the target demographics (patients < 80 years old) is small, significantly reducing result generalizability.

Evidence regarding this topic is broadly available in papers with higher standards and larger populations:

- https://www.sciencedirect.com/science/article/pii/S0914508719302953

- https://pubmed.ncbi.nlm.nih.gov/23799557/

- https://pubmed.ncbi.nlm.nih.gov/33394103/

- https://www.ahajournals.org/doi/full/10.1161/CIRCEP.111.964270

- https://www.karger.com/Article/Abstract/511358

Minor:

ABSTRACT:

- Methods: “Consecutive 270 patients” should say “270 consecutive patients”

- Results: apart from mortality, briefly, other complications should be cited

- Conclusion: “In octogenarian” should say “In octogenerians”

MAIN:

- Methods:

- “Consecutive 270 patients” should say “270 consecutive patients”

- “The of redness” should be rephrased

- Statistical analysis should include all statistical tests used

- Please define “renal insufficiency”

- Results:

- “Lead demographics” table should be renamed to “Lead characteristics”, are numbers relative to dwelling time in months? There is no description or legend.

- Figure 1-2-3: please add numerical values, graphs are not useful as presented.

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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 #4: Yes: Andrzej Kutarski

Reviewer #5: No

Reviewer #6: No

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Octogenarian patients and laser-assisted lead extraction: should we put a limit?

PONE-D-22-26350R2

Dear Dr. 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.

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Kind regards,

Redoy Ranjan, MBBS, MRCSEd, Ch.M., MS (CV&TS), FACS

Academic Editor

PLOS ONE

Additional Editor Comments (optional): The authors are thanked for this submission to PLOS ONE. After a critical external peer review by the experts and considering the overall reviewers' comments and authors' responses, your manuscript meets PLOS ONE's publication criteria, i.e. fulfils the methodological rigour and ethical standards.

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 #4: The manuscript has been revised and supplemented. All reviewer’s suggestions were completed. I have no more critical comments.

Reviewer #5: Dear Authors, the paper is OK but is necessary to note that the safety of the lead extraction procedures un the elderly patients has been evaluated also with others techniques. Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort.

Akhtar Z, Elbatran AI, Starck CT, Gonzalez E, Al-Razzo O, Mazzone P, Delnoy PP, Breitenstein A, Steffel J, Eulert-Grehn J, Lanmüller P, Melillo F, Marzi A, Leung LWM, Domenichini G, Sohal M, Gallagher MM.

Pacing Clin Electrophysiol. 2021 Sep;44(9):1540-1548

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