Donor-Site Morbidity and Quality of Life after Autologous Breast Reconstruction with PAP versus TMG Flap

Round 1

Reviewer 1 Report

Dear authors,

I reviewed with interest the paper "Donor -site morbidity and quality of life after autologous breast reconstruction with PAP versus TMG flap".

I find it very interesting to compare the two methods. The article is well written and I my advise is to pubblish it after revision:

1) I have some concerns about the study design: you state that it is a prospective study, but no data were collected at the moment of srgery and no prospective evaluation is performed. To be honest I find it more appropriate to desctibe it as a retrospective study on patients who had undergone PAP flap.

2) I am wondering why the follow up of the PAP group is at 12 months, while in the article on TMG group it was at 10 months(and 58 months): do you feel that 2 months may make any difference?

3) On page 4/16 in table 2 " Complications breast" is 6 on 27 flaps, "secondary corrections brest" is 9 on 27 flaps, but in the paper on the same page you state that 1 free flap was lost, 6 reconstructed breasts had consecutive lipofillings(are these your 6 complications? what do you mean? where is the lost flap?) and 9 had secondary corrections. Please clarify what kind of corrections (obviousely not beeing lipofilling)and correct the numbers on the table in order to be consistent.

4) I advice to add in the limitations that the questionnaire that was administered was not one of the universally accepted and validated ones to test the quality of life, nore those accepted for breast reconstruction satisfaction /as Breast Q for example).

5) Please remove from the conclusion the new design you offer for PAP skin paddle, as conclusions should be driven by the presented research.

Kind regards,

The reviewer.

Author Response

We are thankful for your overall appreciation of our work and for your valuable comments. We attempted to integrate all feasible aspects into the revised version of this proposal. Additionally, we aim to address all comments in a detailed manner in order to explain our line of thoughts.

Point 1. Reviewer 1.

“I have some concerns about the study design: you state that it is a prospective study, but no data were collected at the moment of surgery and no prospective evaluation is performed. To be honest I find it more appropriate to describe it as a retrospective study on patients who had undergone PAP flap.”

Response 1. We thank you for your detailed and careful review! However, we decided to classify the study as prospective, since the questionnaire survey was conducted prospectively We agree, that patient’s medical data were collected from the medical chart retrospectively and therefore we now adapted the Section 2.1 Study Design to clarify the study setup.

Point 2. Reviewer 1.

“I am wondering why the follow up of the PAP group is at 12 months, while in the article on TMG group it was at 10 months (and 58 months): do you feel that 2 months may make any difference?”

Response 2. We updated the Section 2.2 Patients to provide the information about the follow-up of the TMG group in the paper. We included all patients with a minimum follow-up of 12 months, all others were excluded since we aimed to publish data on long term follow-up only. Twelve months is not only the time of our routinely performed post-op check-ups but also routine oncologic follow up is performed at this time point. Since most patients visit our clinic from far, we aimed to add to patient’s convenience and thus, also patient’s compliance in completing the study follow-up. Reflecting this fact, we recorded only two drop-outs. Concerning the changes in tissue quality from 10 to 12 months postoperatively, there is only negligible change in our experience.

Point 3. Reviewer 1.

“On page 4/16 in table 2 " Complications breast" is 6 on 27 flaps, "secondary corrections breast" is 9 on 27 flaps, but in the paper on the same page you state that 1 free flap was lost, 6 reconstructed breasts had consecutive lipofilling (are these your 6 complications? what do you mean? where is the lost flap?) and 9 had secondary corrections. Please clarify what kind of corrections (obviously not being lipofilling) and correct the numbers on the table in order to be consistent.”

Response 3. We are more than thankful for pointing out this fact and we apologize for causing confusion! We checked the data again and found the incosistency concerning the patient with the flap loss, however it might be seen as a point of discussion how to handle this: In our evaluation we differentiated between acute complications in the post-operative period in contrast to this, secondary revisions (staged corrections) due to aesthetic deficits or complaints in the field of surgery. Secondary corrections concerning the breast were, however, only evaluated in PAP-reconstructed breasts, therefore case number is reduced to n=26. Upon your excellent suggestion, correction of the table was done and a footnote was added for better understanding. Furthermore, lipofilling sessions were considered as secondary corrections and are included in the total number of 9, but information about the other corrections (scar corrections) was now added, to be more clear. Following your comment, we revised the clinical records and identified the error in our data collection. The patient with the flap loss underwent secondary lipofilling bilaterally, meaning the PAP-reconstructed breast as well as the breast were the flap loss occurred had secondary volume augmentation using autologous fat grafts. Since this patient was excluded in our data analysis for secondary corrections due to the flap loss, the lipofilling of the contralateral side was unfortunately missed. This mistake is now ruled out, so the total number of lipofilling now adds up to 7 / 26 reconstructed breasts. We thank you for helping in such a thoughtful manner!

Point 4. Reviewer 1.

“I advise to add in the limitations that the questionnaire that was administered was not one of the universally accepted and validated ones to test the quality of life, nor those accepted for breast reconstruction satisfaction /as Breast Q for example).”

Response 4. We totally agree that the questionnaire is not one of routine use in current literature. However, this questionnaire was chosen for a good reason, since the BREAST Q is so far not available for detailed evaluation of the thigh as donor region for autologous breast reconstruction (Copyright©2017 Memorial Sloan Kettering Cancer Center and The University of British Columbia. https://qportfolio.org/wp-content/uploads/2022/07/BREAST-Q-BREAST-CANCER-USER-GUIDE-1.pdf; accessed 1 August 2022).  Stocco et al. proposed questions enhancing autologous BREAST Q post-operative reconstruction questionnaire in case of PAP flap breast reconstruction in 2018, but these items have so far not been evaluated and validated[1]. For this reason and due to our study design, including the TMG cohort, we decided to use the same questionnaire again to keep the groups comparable for evaluation. The statement was added in the limitations as you suggested.

Point 5. Reviewer 1.

“Please remove from the conclusion the new design you offer for PAP skin paddle, as conclusions should be driven by the presented research.

Response 5. Thank you for your suggestion, as recommended, we now adapted the conclusion and clarified the suggestions for the design and placement of the skin paddle as our strategy to minimize the revealed wound healing disadvantages in our data of the PAP group. Evaluation of these adaptations will be part of a further study, and details have now been removed from the manuscript in order to respect your comment.

[1] Stocco C, Figus A, Razzano S. Upgrading the BREAST-Q questionnaire with donor site evaluation after PAP flap breast reconstruction. J Plast Reconstr Aesthet Surg. 2018;71(6):928-929. doi:10.1016/j.bjps.2018.01.025

Reviewer 2 Report

Introduction is all right, but the last sentence is redundant. I think that it shall be more concrete if it is supposed to be a part of the conclusion.

 

Were the senior plastic surgeons involved in these surgeries?.

 

Matherials and methods. It is not clear if the patients belonging to TMG group filled the questionnaire postoperatively and in which period. Authors shall develop it. Is it a questionnaire that is usually filled after reconstruction in your department of PRS?. Who standardized this questionnaire?.

 

 

In my opinion, the rate of complications is high, so you need to clarify that Clavied Dindo classification is very demanding.

I think that you need to explain that the flap volume that you can get in these cases is quite low, which explains that the BMI of patients is quite low and most of the required secondary surgeries….lipofilling.

 

Questions about donor area are precise and very descriptive. Good work.

 

Nice pictures. Congratulations for these fine results.

 

Conclusions. I am afraid that conclusions must be seriously reviewed. They do not correspond to what I have been reading along the manuscript. Advices are good and practical, but I don’t find any reference along results to conclude it.

Author Response

We highly appreciate the positive assessment of our study! Please see below the point-by-point response to the critical issues:

Point 1. Reviewer 2.

“Introduction is all right, but the last sentence is redundant. I think that it shall be more concrete if it is supposed to be a part of the conclusion.”

Response 1. Thank you for the suggestion! As requested, the sentence has been removed and is now, in an adapted version, moved to Section “2.1 Study design”. To avoid redundant information, the adaptation now also includes answers to Point 3.

Point 2. Reviewer 2.

“Were the senior plastic surgeons involved in these surgeries?”

Response 2. All autologous breast reconstructions at our department are conducted by or under the supervision of a senior plastic surgeon. Specification was added in Section “4. Discussion”, paragraph limitations.

 

Point 3. Reviewer 2. - Materials and methods.

“It is not clear if the patients belonging to TMG group filled the questionnaire postoperatively and in which period. Authors shall develop it. Is it a questionnaire that is usually filled after reconstruction in your department of PRS? Who standardized this questionnaire?”

Response 3. Thank you for this important question! In the historic TMG cohort 25 flaps and donor-sites in 22 patients had been evaluated using the questionnaire with a mean post-operative follow-up of 10 months. This information was added in the Section “2.2 Patients”. The questionnaire was developed in our clinic for the use in the TMG study and was very well accepted by the patients. The original questionnaire was designed by the authors of the TMG study that is cited in the paper. This questionnaire was chosen for a good reason, since validated forms, like for example the BREAST Q, are so far not available for detailed evaluation of the thigh as donor region for autologous breast reconstruction (Copyright©2017 Memorial Sloan Kettering Cancer Center and The University of British Columbia. https://qportfolio.org/wp-content/uploads/2022/07/BREAST-Q-BREAST-CANCER-USER-GUIDE-1.pdf; accessed 1 August 2022).  Stocco et al. proposed questions enhancing autologous BREAST Q post-operative reconstruction questionnaire in case of PAP flap breast reconstruction in 2018, but these items have so far not been evaluated and validated[1]. For this reason and due to our study design, including the TMG cohort, we decided to use the same questionnaire again to keep the groups comparable for evaluation. The statement was added in the limitations in Section “4 Discussion”.

Point 4. Reviewer 2.

“In my opinion, the rate of complications is high, so you need to clarify that Clavied Dindo classification is very demanding.

I think that you need to explain that the flap volume that you can get in these cases is quite low, which explains that the BMI of patients is quite low and most of the required secondary surgeries…. lipofilling.”

Response 4. Thank you for making this point. We considered only post-operative complications classified as Grade 3a or 3b after Clavien Dindo as relevant, meaning they had to be taken back to the theater for surgical management. Details about the type of complications and the reference to the Clavien-Dindo classification are given in the Section “3.1 Patient characteristics”; page 4: “Evaluation of complications showed in 29.6% (8/27) of operated thighs events classified as Grade 3 according to the Clavien-Dindo Classification (hematoma, seroma, wound dehiscence, wound infection) necessitating operative revision [21].”

We totally agree with your statement about the correlation between BMI, flap volume and correction rate. To point it out we added this statement in the Section “4. Discussion”, page 14: “Also the rather low BMI (21.6 ± 2.3 kg/m²; range 17.9 - 27.5 kg/m²) in the PAP group may explain a volume deficit in the reconstructed breasts due to the limited tissue available in the donor region.” However, the PAP advanced to the flap of choice for slim patients, that do not have the option to choose the DIEP flap in our clinic.

Point 5. Reviewer 2 - Conclusions.

“I am afraid that conclusions must be seriously reviewed. They do not correspond to what I have been reading along the manuscript. Advices are good and practical, but I don’t find any reference along results to conclude it.”

Response 5. We have adapted the conclusion and clarified the suggestions for the design and placement of the skin paddle as our strategy to minimize the wound healing disadvantages revealed in our data of the PAP group.  Evaluation of these adaptations will be part of a further study, and details have been removed.

[1] Stocco C, Figus A, Razzano S. Upgrading the BREAST-Q questionnaire with donor site evaluation after PAP flap breast reconstruction. J Plast Reconstr Aesthet Surg. 2018;71(6):928-929. doi:10.1016/j.bjps.2018.01.025

Reviewer 3 Report

 

The authors conducted a cohort study comparing the TMG flap to the PAP flap for breast reconstruction. It is the first study to conduct a comprehensive analysis of patient reported outcomes. The topic is crucial and the study is worth for publication However, there are some issues which I may ask the authors to clarify. Please comment on the following:

1.      This study compares a historic cohort (TMG flaps) to a recent cohort (PAP flap). Why did you not conduct a prospective comparative study of both cohorts? One possible explanation could be, that the PAP flap displaced the TMG flap in your institution. Please explain in the discussion section.

2.      One potential disadvantage of the PAP flap is reduced anatomical reliability compared to the TMG flap. Did you do some kind of imaging before PAP flap breast reconstruction? Did your PAP cohort include your first in-house PAP flaps, which might explain the higher rate of wound healing complications. Please report on your learning curve with the PAP flap in your discussion section.

3.      Validated patient reported outcome instruments exist, such as the BREAST-Q. Those allow for a reliable analysis of patient perceptions and statistical calculation. This is a limitation of the study and should be explained in the discussion section.

 

Author Response

We highly appreciate the positive evaluation of our study and valuable comments! Please see below the point-by-point response to the critical issues:

Point 1. Reviewer 3

“This study compares a historic cohort (TMG flaps) to a recent cohort (PAP flap). Why did you not conduct a prospective comparative study of both cohorts? One possible explanation could be, that the PAP flap displaced the TMG flap in your institution. Please explain in the discussion section.”

Response 1.The Reviewer is correct. With advances of skills and knowledge of perforator flap preparation, the PAP flap has almost completely displaced the TMG flap for autologous breast reconstruction with tissue from the thigh at our department. This replacement was one of the reasons why we aimed to conduct this study, in order to directly compare the technique, evaluate the patient reported outcome and gain information for future surgical decisions and patient counseling. Explanation was added in Section “4. Discussion” page 12.

Point 2. Reviewer 3

“One potential disadvantage of the PAP flap is reduced anatomical reliability compared to the TMG flap. Did you do some kind of imaging before PAP flap breast reconstruction? Did your PAP cohort include your first in-house PAP flaps, which might explain the higher rate of wound healing complications. Please report on your learning curve with the PAP flap in your discussion section.”

Response 2. This is an interesting point, we did not include all patients with a PAP flap breast reconstruction at our department but started evaluation only from 2016 when we had already gained 1 year of experience. During the early stage of PAP flap reconstructions high rates of donor-site complications turned out to be the biggest challenge

For surgical planning all our PAP patients underwent computed tomography of the donor site for perforator mapping preoperatively. (Details added in Section “4. Discussion”, page 13

Point 3. Reviewer 3

“Validated patient reported outcome instruments exist, such as the BREAST-Q. Those allow for a reliable analysis of patient perceptions and statistical calculation. This is a limitation of the study and should be explained in the discussion section.”

Response 3. We totally agree that the questionnaire is not one of routine use in current literature. However, this questionnaire was chosen for a good reason, since the BREAST Q is so far not available for detailed evaluation of the thigh as donor region for autologous breast reconstruction (Copyright©2017 Memorial Sloan Kettering Cancer Center and The University of British Columbia. https://qportfolio.org/wp-content/uploads/2022/07/BREAST-Q-BREAST-CANCER-USER-GUIDE-1.pdf; accessed 1 August 2022).  Stocco et al. proposed questions enhancing autologous BREAST Q post-operative reconstruction questionnaire in case of PAP flap breast reconstruction in 2018, but these items have so far not been evaluated and validated[1]. For this reason and due to our study design, including the TMG cohort, we decided to use the same questionnaire again to keep the groups comparable for evaluation. The statement was added in the limitations in Section “4. Discussion” as you suggested.

[1] Stocco C, Figus A, Razzano S. Upgrading the BREAST-Q questionnaire with donor site evaluation after PAP flap breast reconstruction. J Plast Reconstr Aesthet Surg. 2018;71(6):928-929. doi:10.1016/j.bjps.2018.01.025

Round 2

Reviewer 1 Report

Dear authors,

I reviewed the revised version of "Donor-site morbidity and quality of life after autologous breast reconstruction with PAP versus TMG flap".

Thank you for addressing all my concerns, the paper has improved after the requested revisions and in my opinion it is ready for publication.

Kind regards,

Rossella Sgarzani

Reviewer 3 Report

All questions were properly answered and discussed in the manuscript. The manuscript is of interest and worth for publication. Thank you.

This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.