Balloon-expandable versus self-expanding transcatheter aortic valve replacement for bioprosthetic dysfunction: A systematic review and meta-analysis

Hsiu-An Lee; An-Hsun Chou; Victor Chien-Chia Wu; Dong-Yi Chen; Hsin-Fu Lee; Kuang-Tso Lee; Pao-Hsien Chu; Yu-Ting Cheng; Shang-Hung Chang; Shao-Wei Chen

doi:10.1371/journal.pone.0233894

Peer Review History

Original SubmissionFebruary 26, 2020
31 Mar 2020 Decision Letter - Corstiaan den Uil, Editor PONE-D-20-05542 Balloon-expandable versus self-expanding transcatheter aortic valve replacement for bioprosthetic dysfunction: a systematic review and meta-Analysis PLOS ONE Dear Dr Chen, 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. We would appreciate receiving your revised manuscript by May 15 2020 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols 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). This letter should be uploaded as separate file and labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. This file should be uploaded as separate file and labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. This file should be uploaded as separate file and labeled 'Manuscript'. Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out. We look forward to receiving your revised manuscript. Kind regards, Corstiaan den Uil 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 http://www.plosone.org/attachments/PLOSOne_formatting_sample_main_body.pdf and http://www.plosone.org/attachments/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. We noticed that the search of your systematic review was last performed in October 2018. Please ensure that the search is up to date and that the systematic review/meta-analysis includes any new studies published since then. 3. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. [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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A 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: Yes 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: This is a very interesting review and meta-analysis of VIV-treatment. However, there are some points to discuss: 1. Comparison of EOA between SEV and BEV: It should be better explained why the EOA of SEV is bigger than BEV. The used BEV-Size was smaller than the SEV-Sizes (THV size ≤ 23mm 65,7% vs 31,7%), this alone can explain the difference. How was the gradient-/EOA- difference in treated small surgical bioprosthesis (<21mm), are there data available? 2. There was a recent publication about measuring error of measured echo gradients in intra annular and supra annular valves (Abbas AE and Pibarot P, CCI 2019). Are there data about invasive measured gradients after VIV available. 3. For a recommendation which valve should be used in which situation, the coronary access possibility after VIV should be discussed, as there are differences between BEV and SEV. Reviewer #2: it is a very important subject that the authors have performed a metanalysis on given the sparse RCT data comparing these 2 valves. Some questions that need to be answered: 1. Why is there such a large difference between the % of baseline >=moderate MR between the 2 groups (25.5% vs 68.3%) 2. Could the higher number of stented valves in the BEV group explain the higher PVL after the procedures? 3. Given that transfemoral access is the most common modality why were there only 67.8% in the BEV group? Especially given that alternate access is associated with higher periprocedural complication rates. 4. Higher EOA and Lower gradients have been shown in prior studies with SEV, although they did not translate into lower mortality with SEV compared to BEV. Can the authors elaborate on that in their discussion? ****** 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 to be viewed.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0233894.r001
Revision 1
14 May 2020 Author Response The following is a point-by-point response to reviewers comments. _______________________________________________________________ 2. We noticed that the search of your systematic review was last performed in October 2018. Please ensure that the search is up to date and that the systematic review/meta-analysis includes any new studies published since then Response: We have updated the search to April 2020. Reviewer #1: This is a very interesting review and meta-analysis of VIV-treatment. However, there are some points to discuss: 1. Comparison of EOA between SEV and BEV: It should be better explained why the EOA of SEV is bigger than BEV. The used BEV-Size was smaller than the SEV-Sizes (THV size ≤ 23mm 65,7% vs 31,7%), this alone can explain the difference. How was the gradient-/EOA- difference in treated small surgical bioprosthesis (<21mm), are there data available? Response: Thanks for the great question. Regarding gradient-/EOA- difference in treated small surgical bioprostheses, a study using the Valve-in-Valve International Data Registry found that elevated postprocedural pressure gradient (mean ≥ 20mmHg) were more common with BEVs in comparison with SEVs; for small surgical valves (internal diameter [ID] < 20mm), 41.2% vs 23.4% (P = .04) and for intermediate-sized valves (≥20 and < 23), 35.8% vs 19.4% (P = .01), respectively [1](eFigure 2C). Moreover, 11.8% of Edwards SAPIEN VIV procedures performed inside small bioprosthesis had very high postprocedural gradients (mean ≥ 40mmHg), while no cases of CoreValve VIV procedures resulted in very high gradients (P = 0.005, eFigure 2D). We believe that the supra-annular design of Medtronic SEV allows a relatively larger size, while an intra-annular design of Edwards BEV results in marked leaflet distortion if the size is too large. This can explain why the ViV Aortic app suggests 20mm Edwards THVs inside19 or 21mm degenerated bioprosthesis, but 23mm Medtronic THVs inside same-sized bioprostheses. In conclusion, the supra-annular design of Medtronic CoreValve allows better expansion of the leaflets, and allows a relatively larger sized THV to be inserted inside a small bioprosthesis, hence results in better EOA/gradient. We have added the above explanation and citation in the revised manuscript. 2. There was a recent publication about measuring error of measured echo gradients in intra annular and supra annular valves (Abbas AE and Pibarot P, CCI 2019). Are there data about invasive measured gradients after VIV available. Response: Abbas et. al. demonstrated the catheterization/echocardiography discordance after native TAVR and after Valve-in-Valve TAVR[2]. The echocardiography mean gradient is significantly higher than catheterization gradient after both procedures. In all the studies we reviewed, only 1 reported postprocedural catheterization gradients[3]. The postprocedural mean echocardiographic gradient and mean invasive gradient were 22.8 and 13.6 mmHg, respectively (P < 0.001). 3. For a recommendation which valve should be used in which situation, the coronary access possibility after VIV should be discussed, as there are differences between BEV and SEV. Response: Yes, the coronary access possibility after VIV is a very important concern. Allali et. al. reported their experience of coronary intervention after TAVR[4]. However, the aim of the current meta-analysis is to collect evidences and analyze. Since we did not find sufficient data regarding coronary-related outcomes after ViV to perform meta-analysis, we did not include this point in our manuscript. Nevertheless, if you consider the point suitable for our article, we would like to add it in our manuscript according to your suggestion. _________________________________________________________________ Reviewer #2: it is a very important subject that the authors have performed a metanalysis on given the sparse RCT data comparing these 2 valves. Some questions that need to be answered: 1. Why is there such a large difference between the % of baseline >=moderate MR between the 2 groups (25.5% vs 68.3%) Response: In the original analysis, very few study reported the percentage of baseline ≥moderate AR. A single study of high or low % made a large difference in the results. After collecting more data, the % of baseline ≥moderate AR was 43.4% and 54.0 in the BEV and SEV groups, respectively. However, it should be noted that only a small portion of studies reported baseline ≥moderate AR, so the result does not well represent the whole population. 2. Could the higher number of stented valves in the BEV group explain the higher PVL after the procedures? Response: In studies comparing outcomes following VIV inside stentless versus stented bioprostheses, stentless bioprostheses appeared to be related to higher PVL than stented bioprostheses[5, 6]. Hence, the higher percentage of stentless valves in the SEV group in our study could contribute to the higher rates of postprocedural PVL. However, in the revised manuscript, after updating research with more recent data included in the meta-analysis, the difference of postprocedural PVL between BEV and SEV groups was no longer significant. 3. Given that transfemoral access is the most common modality why were there only 67.8% in the BEV group? Especially given that alternate access is associated with higher periprocedural complication rates. Response: The proportion of transfemoral (TF) access reported by the two largest registry regarding Edwards VIV, VIVID Registry and PARTNER 2 VIV Registry, were 66.7% and 75.4%, respectively[7, 8]. In VIVID Registry, the TF ratio of Sapien XT was only 58.5%. Although nowadays approximately 5% of TAVR candidates require a non-femoral access, in the earlier era, 10~20% of patients require non-femoral access because previous-generation devices had larger profile. Transapical access, which could only be performed using BEV, was the first-developed non-femoral access, and had been the most commonly used non-femoral access for quite a few years. This may explain the lower percentage of TF access in BEV group, especially in earlier era. After updating the search to April, 2020, the TF ratio of BEV group slightly increased to 68.5% 4. Higher EOA and Lower gradients have been shown in prior studies with SEV, although they did not translate into lower mortality with SEV compared to BEV. Can the authors elaborate on that in their discussion? Response: Thanks for the suggestion. We have discussed EOA and gradients in sections 4.3 and 4.4 of discussion in the original manuscript. We also added a sentence in the first paragraph of section 4.4 to emphasize that higher EOA and lower gradient of SEV did not translate into lower mortality. If there is any further suggestion from the reviewer, we will be glad to revise our manuscript accordingly. References 1. Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, et al. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA 2014;312(2):162-70. doi: 10.1001/jama.2014.7246. 2. Abbas AE, Mando R, Hanzel G, Gallagher M, Safian R, Hanson I, et al. Invasive Versus Echocardiographic Evaluation of Transvalvular Gradients Immediately Post-Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2019;12(7):e007973. Epub 2019/07/06. doi: 10.1161/CIRCINTERVENTIONS.119.007973. PubMed PMID: 31272227. 3. Scholtz S, Piper C, Horstkotte D, Gummert J, Ensminger SM, Borgermann J, et al. Valve-in-valve transcatheter aortic valve implantation with CoreValve/Evolut R((c)) for degenerated small versus bigger bioprostheses. J Interv Cardiol. 2018;31(3):384-90. Epub 2018/03/01. doi: 10.1111/joic.12498. PubMed PMID: 29490430. 4. Allali A, El-Mawardy M, Schwarz B, Sato T, Geist V, Toelg R, et al. Incidence, feasibility and outcome of percutaneous coronary intervention after transcatheter aortic valve implantation with a self-expanding prosthesis. Results from a single center experience. Cardiovasc Revasc Med. 2016;17(6):391-8. Epub 2016/07/12. doi: 10.1016/j.carrev.2016.05.010. PubMed PMID: 27396607. 5. Duncan A, Moat N, Simonato M, de Weger A, Kempfert J, Eggebrecht H, et al. Outcomes Following Transcatheter Aortic Valve Replacement for Degenerative Stentless Versus Stented Bioprostheses. JACC Cardiovasc Interv. 2019;12(13):1256-63. Epub 2019/06/17. doi: 10.1016/j.jcin.2019.02.036. PubMed PMID: 31202944. 6. Choi CH, Cheng V, Malaver D, Kon N, Kincaid EH, Gandhi SK, et al. A comparison of valve-in-valve transcatheter aortic valve replacement in failed stentless versus stented surgical bioprosthetic aortic valves. Catheter Cardiovasc Interv. 2019;93(6):1106-15. Epub 2018/12/28. doi: 10.1002/ccd.28039. PubMed PMID: 30588736; PubMed Central PMCID: PMCPMC6590419. 7. Seiffert M, Treede H, Schofer J, Linke A, Wöhrle J, Baumbach H, et al. Matched comparison of next- and early-generation balloonexpandable transcatheter heart valve implantations in failed surgical aortic bioprostheses. EuroIntervention. 2018;14(4):e397-e404. doi: 10.4244/EIJ-D-17-00546. 8. Webb JG, Mack MJ, White JM, Dvir D, Blanke P, Herrmann HC, et al. Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol. 2017;69(18):2253-62. Epub 2017/05/06. doi: 10.1016/j.jacc.2017.02.057. PubMed PMID: 28473128. Attachments Attachment Submitted filename: Response to Reviewers 20200512.docx https://doi.org/10.1371/journal.pone.0233894.r002
15 May 2020 Decision Letter - Corstiaan den Uil, Editor Balloon-expandable versus self-expanding transcatheter aortic valve replacement for bioprosthetic dysfunction: a systematic review and meta-analysis PONE-D-20-05542R1 Dear Dr. Chen, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. 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 enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and 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. With kind regards, Corstiaan den Uil Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0233894.r003
Formally Accepted
22 May 2020 Acceptance Letter - Corstiaan den Uil, Editor PONE-D-20-05542R1 Balloon-expandable versus self-expanding transcatheter aortic valve replacement for bioprosthetic dysfunction: a systematic review and meta-analysis Dear Dr. Chen: I am 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 notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Corstiaan den Uil Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0233894.r004

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .