Autologous versus implant-based breast reconstruction: A systematic review and meta-analysis of Breast-Q patient-reported outcomes

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Autologous versus implant based breast reconstruction: A systematic review and meta-analysis of Breast-Q patient reported outcomes Navid Mohamadpour Toyserkani MD, PhD , Mads Gustaf Jørgensen MD , Siavosh Tabatabaeifar MD , Tine Damsgaard MD, PhD , Jens Ahm Sørensen MD, PhD PII: DOI: Reference:

S1748-6815(19)30443-7 https://doi.org/10.1016/j.bjps.2019.09.040 PRAS 6267

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Journal of Plastic, Reconstructive & Aesthetic Surgery

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1 August 2019 20 September 2019

Please cite this article as: Navid Mohamadpour Toyserkani MD, PhD , Mads Gustaf Jørgensen MD , Siavosh Tabatabaeifar MD , Tine Damsgaard MD, PhD , Jens Ahm Sørensen MD, PhD , Autologous versus implant based breast reconstruction: A systematic review and meta-analysis of BreastQ patient reported outcomes, Journal of Plastic, Reconstructive & Aesthetic Surgery (2019), doi: https://doi.org/10.1016/j.bjps.2019.09.040

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Autologous versus implant based breast reconstruction: A systematic review and meta-analysis of Breast-Q patient reported outcomes Running title: Autologous versus implant breast reconstruction Navid Mohamadpour Toyserkani, MD, PhD1 , Mads Gustaf Jørgensen, MD2, Siavosh Tabatabaeifar, MD2, Tine Damsgaard MD, PhD1, Jens Ahm Sørensen MD, PhD2 1

Department of Plastic Surgery and Burns Treatment, Rigshospitalet, Copenhagen, Denmark Department of Plastic Surgery, Odense University Hospital, Odense, Denmark

2

Correspondence: Navid Toyserkani [email protected] Department of Plastic Surgery and Burns Treatment, Rigshospitalet Blegdamsvej 9, København Ø Denmark Authorship NMT: Conception and design. Acquisition, analysis and interpretation of data. Drafting and revising manuscript. Given final approval. Agreed to be accountable for all aspects. MGJ: Acquisition, analysis and interpretation of data. Drafting and revising manuscript. Given final approval. Agreed to be accountable for all aspects. ST: Acquisition, analysis and interpretation of data. Drafting and revising manuscript. Given final approval. Agreed to be accountable for all aspects. TD: Analysis and interpretation of data. Drafting and revising manuscript. Given final approval. Agreed to be accountable for all aspects. JAS: Acquisition, analysis and interpretation of data. Drafting and revising manuscript. Given final approval. Agreed to be accountable for all aspects.

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Abstract Objective Breast reconstruction following mastectomy can increase quality of life of patients. Reconstruction methods can broadly be divided in implant-based and autologous tissue reconstruction. Patient reported outcomes following breast reconstruction is one of the most important success parameters and in this systematic review and meta-analysis we aimed to compare the two methods using the recognized Breast-Q questionnaire. Methods We performed a systematic search in PubMed and EMBASE databases. Meta-analysis was performed on the five most commonly reported Breast-Q modules. RevMan 5.3 was used for statistical analysis. Methodological quality of the included studies was assessed using the Newcastle-Ottawa Quality Assessment Form for Cohort Studies. Results The search strategy resulted in 219 studies of which nine studies were included in the analysis, yielding 2129 implant-based and 825 autologous breast reconstructions. Overall satisfaction with outcome as well as satisfaction with the breast were significantly higher among patients with autologous breast reconstructions (mean Breast-Q difference between the two groups was 9.82 [3.09, 16.54], p=0.004, and 10.33 [95% CI 5.93, 14.74], p<0.00001, respectively). Sexual and psychosocial well-being was higher among autologous breast reconstructions. There was no difference in physical well-being. Conclusion This is the first systematic review and meta-analysis to compare patient reported outcomes of implantbased and autologous breast reconstruction. We found that autologous reconstruction yields a higher satisfaction with overall outcome and breast. These findings can aid clinicians when discussing breast reconstruction options with patients. Keywords Breast reconstruction, implant, meta-analysis, systematic review

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Introduction Breast reconstruction following either prophylactic or therapeutic mastectomy may increase quality of life [1]. Trends in breast reconstruction services suggest that breast reconstruction demand is rising and that especially implant-based reconstructions are increasing [2]. Breast reconstructions can be performed either immediately or delayed. In both instances, an implantbased reconstruction method can be used utilizing either a single-stage or a two-stage expander/implant approach. For autologous breast reconstruction the main work horse today is the Deep Inferior Epigastric Perforator (DIEP) flap but many other abdominal, gluteal, upper thigh and upper and lower back based flaps are described and in use as well [3]. Many factors play a role when deciding on the optimal breast reconstruction such as oncologic breast cancer therapy (radiotherapy and/or chemotherapy), age, body mass index, patient wishes and reconstructive methods available [4, 5]. Patient reported outcomes (PRO) are vital in comparing different reconstructive modalities as breast reconstruction primarily aims at increasing quality of life. Few patients make well informed decisions regarding reconstruction method [6, 7]. To some extent, this i attributed to prior lack of well-developed tools to evaluate PRO following breast reconstruction. Breast-Q is a newly validated PRO instrument that is specific for patients undergoing surgery for breast cancer, breast reconstruction, as well as other types of breast surgery and therefore able to detect differences in specific procedure types and in patients over time [8]. Several authors have presented their data with Breast-Q in recent years. The aim of this systematic review and meta-analysis was to compare PRO following breast reconstruction with autologous and implant-based reconstructions.

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Methods The primary study question, framed in the PICO (Population, Intervention, Comparison, and Outcome) format, was the following: in patients who underwent breast reconstruction after mastectomy how do PRO compare between implant-based and autologous reconstructions. The systematic meta-analysis was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement [9]. We performed a systematic search in PubMed and EMBASE databases. The search string (breast reconstruction and (implant) and (autologous or autogenous or diep or "abdominal flap") and (satisfaction or "qol" or "quality of life" or "breast-q" or "patient reported outcome" or "patient-reported outcomes" or "patient-reported outcome) was used. Covidence was used for the paper selection process. Search results were imported to Covidence (Covidence systematic review software, Veritas Health Innovation, Melbourne, Australia. Available at www.covidence.org). Imported citations were screened for relevance using title and abstract by two authors and relevant articles were then assessed in full text. Any disagreement between the two authors was settled by consensus. We included only English language papers directly comparing any autologous with any form of implant based breast reconstruction. The outcome of interest was Breast-Q data so all studies without Breast-Q data were excluded. All study authors with Breast-Q data, but with insufficient data presentation (i.e. means without standard deviations or only graphic presentation of data) were contacted and asked for missing details. We sent a reminder four weeks after the initial request. None of the authors replied. We excluded all conference abstracts. We extracted the following data from each paper: Study type (cross-sectional or cohort), Number of patients/respondents per group, Breast reconstruction setting (immediate, delayed or mixed), Follow-up time (in months), implant-based reconstruction type (one or two stage reconstruction), autologous reconstruction type (abdominal, other or mixed) and Breast-Q data. Data were pooled with random-effects meta-analysis to determine the mean differences, and 95% confidence intervals (CIs). We used RevMan 5.3 (2014) for statistical analysis [10]. Methodological quality of the included studies was assessed using the Newcastle-Ottawa Quality Assessment Form for Cohort Studies, which is recommended by Cochrane for evaluation of nonrandomized cohort studies [11]. The form uses a star rating for evaluating bias within 3 bias domains: selection of study groups, comparability of study groups and outcome assessment. Bias analysis was conducted by two independent authors (MGJ and ST). Discrepancies in rating were resolved consensus.

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Results The search strategy resulted in 219 studies of which 54 were included for full text screening and finally nine studies were included in the analysis (Figure 1) [12–20]. All study authors with insufficient but relevant Breast-Q data were contacted to obtain the necessary data for inclusion but no one replied and did not submit the requested data. Table 1 summarizes the characteristics of each included study. The sample size of included studies ranged from to 543 and 22 to 1490 for autologous and implant-based breast reconstructions, respectively, yielding a total of 825 autologous breast reconstructions and 2129 implantbased reconstructions. Studies were either cross-sectional or cohort studies and no randomized controlled trials were identified. Satisfaction with breast Eight of the included studies presented data regarding “satisfaction with breast” yielding 751 autologous breast reconstructions and 1988 implant based breast reconstructions. The difference between the two groups was statistically significant in favor of autologous breast reconstruction (Figure 2A). The mean difference between the two groups was 10.33 [95% CI 5.93, 14.74], p<0.00001. There was high heterogeneity. Satisfaction with outcome Five of the included studies presented data regarding “satisfaction with outcome” yielding 121 autologous breast reconstructions and 369 implant based reconstructions. The difference between the two groups was statistically significant in favor of autologous breast reconstruction (Figure 2B). The mean difference between the two groups was 9.82 [3.09, 16.54], p=0.004. There was moderate heterogeneity. Psychosocial well-being Seven of the included studies presented data regarding “psychosocial well-being” yielding 730 autologous breast reconstructions and 1966 implant based reconstructions. The difference between the two groups was statistically significant in favor of autologous breast reconstruction (Figure 2C). The mean difference between the two groups was 5.59 [2.00, 9.19], p=0.002. There was moderate heterogeneity. Sexual well-being Seven of the included studies presented data regarding “sexual well-being” yielding 730 autologous breast reconstructions and 1966 implant based reconstructions. The difference between the two groups was

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statistically significant in favor of autologous breast reconstruction (Figure 2D). The mean difference between the two groups was 4.72 [1.49, 7.95], p=0.004. There was moderate heterogeneity. Physical well-being, chest Eight of the included studies presented data regarding “physical well-being” yielding 804 autologous breast reconstructions and 2107 implant based reconstructions. There was no statistically significant difference between the two groups. (Figure 2E). The mean difference between the two groups was 0.08 [-0.13, 0.29], p=0.48. There was high heterogeneity. Bias evaluation According to the New castle-Ottawa Quality Assessment Form, four studies scored eight points, two studies scored seven points, two studies scored six points and one study scores five points (Table 2). Usually the maximum score that can be achieved using this form is nine points; however, as the purpose of our analysis was to asses self-reported Breast-Q outcomes, the “assessment of outcome” score was excluded due to “self-report” scoring zero points resulting in a maximum score of eight points. Five studies scored points for representative exposed and unexposed cohorts, secure records for ascertainment of exposures, controlled for disease specific confounders, linked surgical records for assessment of outcomes, comparability of the cohorts, adequate length and completeness of follow-up for outcomes to occur [12, 15, 16, 19, 20]. Four studies did not compare differences or similarities on the basis of design or analysis between the cohorts [13, 14, 17, 18], and one of these studies did not have any statement of follow-up, although based on the duration of patient inclusion a time range could be estimated [17].

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Discussion The aim of breast reconstruction is ultimately to increase the quality of life of the patient [21]. Therefore, the most important measure of success is patient satisfaction. Well-developed PRO measure tools such as the Breast-Q has made it possible to analyze PRO following breast reconstruction across multiple domains. The tool also allows for direct comparison between different breast reconstruction types. This is the first systematic review and meta-analysis comparing Breast-Q data between autologous and implant-based breast reconstructions. We find that patients undergoing autologous breast reconstruction have higher satisfaction with the reconstructed breast and overall outcome. We also find that these patients to a smaller extent have better psychosocial and sexual well-being but that the physical well-being is similar between the two reconstruction methods. Both groups were heterogeneous as implant based reconstructions included both direct to implant reconstructions in immediate breast reconstruction cases but also delayed reconstructions with two-stage expander implants. The PRO based on these two different methods however has been shown not be different when looking at satisfaction with outcome and breast [1, 22]. Neither the introduction of acellular dermal matrices in immediate breast reconstruction has been shown to increase PRO compared to twostage expander implant breast reconstruction [23]. Likewise, the autologous breast reconstruction group was heterogeneous, as several abdominally based flaps as well as some latissimus dorsi and thigh-based flaps were included, although the abdominally based flaps dominated the overall group of autologous reconstructions. The heterogeneous nature of the studies is also likely the explanation for the medium to high heterogeneity seen in the meta-analysis as patient composition and procedures varied between the two groups across different studies. The follow-up time in the included studies varied between less than a year to more than ten years with most studies having a follow-up between 2-4 years. Patient reported outcomes following breast reconstruction can change over time and studies have suggested that perhaps autologous breast reconstructions are more time stable compared to implant based reconstructions where it has been shown that satisfaction deteriorates in the long term [24]. One often cited benefit of autologous reconstructions is the ability of the reconstructed breast to evolve over time and undergo ptosis and thereby maintaining better symmetry with the contralateral breast [25]. Therefore, the results found in this meta-analysis if anything underestimates the true difference and superiority of autologous breast reconstruction in the long term.

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Breast reconstruction should be discussed with patients undergoing mastectomy. It has been shown that surgical oncologists and plastic surgeons differ in their approach towards patient information when informing about immediate breast reconstruction [26], and inclusion of plastic surgeons in multidisciplinary oncoplastic meetings can increase the rate of breast reconstructions, thus suggesting that some patients perhaps are not undergoing reconstruction due to insufficient information [27]. Implant based reconstructions outnumber autologous reconstructions 10:1 but in our meta-analysis we show that better PRO are achieved with autologous breast reconstruction [2]. Several studies have also documented that autologous breast reconstruction is cost-effective compared to implant reconstructions and therefore efforts should be made to increase the availability of autologous breast reconstruction to patients undergoing mastectomy [28–30]. Physician reimbursement per hour for breast reconstruction is much higher for implant-based reconstruction compared to autologous breast reconstructions and this disparity is increasing [31]. Also, travel distance to breast reconstruction has been shown to affect breast reconstruction rates and types of reconstructions chosen/offered to patients [32, 33]. Lastly, optimal autologous breast reconstruction requires microsurgical expertise and setup, and it has been shown that less than a quarter of plastic surgeons offer any microsurgical breast reconstruction as part of their service [34]. Solutions to these hurdles must be found in order to increase the availability of autologous breast reconstruction. This review has certain limitations. All studies were non-randomized and most were cross-sectional in design. Thus, it is highly likely that patients in the two groups were not all candidates for both types of breast reconstruction. The cross-sectional study design in most studies also resulted in lack of sufficient preoperative Breast-Q data and therefore only the postoperative data were used in the meta-analysis but Breast-Q is developed to be able to detect change from pre- to postoperative status. Many of the included studies had significant differences in baseline characteristics between the groups such as immediate versus delayed breast reconstruction and radiotherapy and studies previously have suggested that these details influence breast reconstruction outcomes. Data were too limited to allow for subgroup analyses. The results should therefore be viewed with caution and any true comparison of PRO between autologous and implant-based breast reconstruction should be conducted in a randomized controlled trial including patients that are eligible for both reconstruction types.

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Conclusion In this meta-analysis, we find that autologous breast reconstruction results in significantly better patient reported outcomes compared to implant-based reconstructions. Several inherent biases of the included studies however, mean that randomized controlled trials including patients eligible for both types of reconstruction are needed to verify our findings. Until then, the results of this study can aid surgeons when consulting patients prior to breast reconstruction.

Funding No funding applicable. Conflict of interest statement None of the authors has conflicts of interest.

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Liu C, Zhuang Y, Momeni A, Luan J, Chung MT, Wright E, Lee GK (2014) Quality of life and patient satisfaction after microsurgical abdominal flap versus staged expander/implant breast reconstruction: a critical study of unilateral immediate breast reconstruction using patient-reported outcomes instrument BREAST-Q. Breast Cancer Res Treat 146:117–26

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Figure legends

Figure 1. Study selection flow chart.

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Figure 2. Forest plot for Satisfaction with breast (A), Satisfaction with outcome (B), Psychosocial well-being (C), Sexual well-being (D) and Physical well-being (E).

14

Satisfaction with outcome

Psychosocial well-being

Physical well-being of chest and upper body

Sexual well-being

★

★

-

-

-

0.5

57

69

?

?

★

-

★

★

★

Netherland

5

72

38

?

?

★

-

★

★

★

Liu 2014

China

4

48

26

Abdominal

Two-stage

★

★

★

★

★

McCarthy

United

2014

States

2

141

74

?

Two-stage

-

-

-

★

-

4-11

157

18

Mixed

Mixed

★

★

★

★

★

1-4

34

31

Abdominal

Two-stage

★

★

★

★

★

2

1490

523

Abdominal

Mixed

★

-

★

★

★

2

108

25

Abdominal

Two-stage

★

★

★

★

★

2019

Arabia

3

Dean 2016

Australia

Lagendijk 2018

Moberg 2018 Pirro 2017

Norway Czech Republic

Santosa

United

2018

States

Weichman 2015

Germany

Implant Method

0.5-

Autologous (No.)

Saudi

Autologous method

Mixed

Alshammari

Implant (No.)

Mixed

Follow-up (years. Mean or range)

21

Country

22

Study (year)

Satisfaction with breast

Table 1

Table 1. Study characteristics and reported Breast-Q scales. Abdominal: Abdominal flap breast reconstruction. Mixed (Autologous method): Both abdominal and back or thigh flaps. Mixed (Implant Method): Both one-stage and two-stage. ?: Not described. ★: Breast-Q scale reported. -: Breast-Q scale not reported.

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Table 2

Selection† Study

Representati veness of the exposed cohort

Selection of the nonexposed cohort

Outcome†

Comparabili ty‡

Ascertain ment of exposure

Outcome of interest not present at start of study

Comparabilit y of cohorts on the basis of the design or analysis

Assessme nt of outcome *

Followup long enough

Total score Adequa cy of followup

Alshammari 2019

★

★

★

★

★★

-

★

★

Dean 2016

★

★

★

★

0

-

★

★

Lagendijk 2018

★

★

★

★

0

-

★

★

Liu 2014

★

★

★

★

★★

-

★

★

★

★

★

★

★★

-

★

★

★

★

★

★

0

-

0

★

★

★

★

★

0

-

★

★

★

★

★

★

★

-

★

★

★

★

★

★

★★

-

★

★

McCarthy 2014 Moberg 2018 Pirro 2017 Santosa 2018 Weichman 2015

Maximum: 8

8 6 6 8 8 5 6 7 8

Table 2. Newcastle-Ottawa Quality Assessment Form for Cohort Studies. †Maximum score is 1, ‡Maximum score is 2. *All included studies are self-reported outcomes using BreastQ making the score irrelevant.

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