Keywords breast reconstruction - quality of life - BREAST-Q - breast implant - patient-reported
outcome
Introduction
Mastectomy is a common treatment for breast cancer and is increasingly being used
as a prophylactic measure in women at high risk of developing cancer. As a method
of reconstruction, direct-to-implant breast reconstruction (DIR) is gaining acceptance.[1 ] DIR has proven to be time-saving with both physical and financial advantages compared
to two-stage breast reconstructions.[2 ]
[3 ]
When performing DIR, two main approaches are being used; the implant is either placed
in a subpectoral pocket, under the pectoralis major muscle (PMM), or in a prepectoral
pocket leaving the PMM undisturbed. Regardless of the pocket plane, a biological or
synthetic mesh can be used to support the implant. In the subpectoral approach, one
sheet of the mesh is used to create a “hammock” to support the inferior and lateral
parts of the implant. This method was first described two decades ago.[4 ] When the prepectoral approach is used, the most common technique is to create a
full hammock of mesh that covers the implant. This technique was first described in
2015 and since then the benefits and drawbacks of the different pocket planes have
been described.[5 ]
Since the introduction of acellular dermal matrices in 2005, the dual-plane submuscular
pocket has been increasingly used worldwide.[6 ] This technique has proven to be a safe and effective way of reconstructing the breast,
the main benefits being a vascularized cover protecting the implant, reduced rippling
and implant visibility, as well as a lower incidence of capsular contracture.[7 ]
[8 ] Some of the disadvantages are related to muscle coverage which may cause breast
animation deformity (BAD). BAD is an unwanted movement of the PMM caused by a compressing
action on the underlying implant resulting in a superolateral movement of the whole
breast, breast skin, or nipple–areolar complex.[9 ] Besides being a cosmetic problem, some experience pain and discomfort in relation
to BAD.[10 ] After subpectoral breast reconstruction, it has been shown that all women experience
some degree of BAD.[9 ]
[10 ]
Recently there has been an increased focus on prepectoral breast reconstructions,[11 ] and it has been shown that the two pocket planes are comparable regarding postoperative
complication rates.[12 ] When leaving the PMM undisturbed, patients report less postsurgical pain, and the
degree of BAD can be reduced or even avoided.[13 ] For the reconstructed women, the main drawback of placing the implant prepectoral
with a subcutaneous tissue cover only is related to insufficient thickness of the
postmastectomy skin flaps. This seems to cause an increased risk of rippling and visibility
of the implants.[13 ]
When comparing sub- and prepectoral DIR focus has mainly been on assessing complications,
cosmetic outcomes, and avoidance of BAD. The final choice of pocket plane is often
based on the patient's preference along with the surgeon's experience. However, the
main reason for DIR is to restore a naturally appearing breast and thereby increase
patients' health-related quality of life (HRQOL). When evaluating breast reconstruction
regarding different pocket planes, we must therefore keep the patient's perception
in mind.
In health care, there has been a general shift towards patient-centered care. Patient-reported
outcome measures (PROMs) have gained more attention.[14 ] BREAST-Q is a reliable, tested, and psychometric-validated PROM developed to assess
HRQOL and patient satisfaction in women undergoing mastectomy, breast-conserving therapy,
and breast reconstruction.[15 ]
[16 ] Since the introduction of BREAST-Q, several studies have demonstrated improved HRQOL
in breast-reconstructed women compared to mastectomy alone.[17 ] Still, there is a lack of high-quality studies evaluating HRQOL between different
implant placement methods. Going through the literature, most studies comparing sub-
and prepectorally reconstructed women have used self-developed nonvalidated questionnaires.[18 ]
[19 ] Therefore, this randomized controlled study aimed to investigate the HRQOL of patients
undergoing DIR using the BREAST-Q to compare patients reconstructed with subpectoral
or prepectoral DIR.
Methods
The data presented in this paper were collected as part of a randomized controlled
(clinical) trial (RCT). The data presented in this are secondary outcomes and the
power calculations were not based on the PROM data entailed in this paper, but were
based on the risk of developing BAD in the two groups. The power calculations have
been published in detail and described with the primary outcome measure, a comparison
of the degree of BAD between the two groups.[20 ] This trial was primarily conducted to investigate differences in incidences and
degrees of BAD following DIR with either subpectoral or prepectoral implant placement.
A detailed description of the study design, data collection, and data management has
previously been published by the authors.[21 ]
We conducted an RCT in accordance with the Consolidated Standards of Reporting Trials
guidelines. Patients were enrolled from two departments of Plastic Surgery in Denmark.
Between April 2017 and March 2020, all women over 18 years eligible for unilateral
or bilateral DIR after a therapeutic or prophylactic skin- or nipple-sparing mastectomy,
were assessed for eligibility.[20 ]
[21 ] Those meeting the criteria were invited to participate in the trial and informed
consent was obtained prior to enrollment. Enrolled patients were evaluated at baseline
including interview and clinical examination. Each patient was informed that the final
screening for eligibility would be carried out during surgery, where the mastectomy
flaps were assessed for thickness and viability, ensuring the tissue was suitable
for prepectoral implant placement if randomized to this technique. When evaluated
as suitable, patients were allocated to DIR with either sub- or prepectoral implant
placement in a ratio of 1:1. The randomization was conducted by opening an envelope
containing the allocation to one of the two intervention groups. There was no blinding
of participants or investigators following surgery. The exclusion criteria were prior
or planned radiation therapy to the breast, tobacco usage, hypertension treated with
more than one drug, breast ptosis >2 measured by Regnault's ptosis scale,[22 ] body mass index (BMI) <22 or > 32 kg/m2 , dementia, or psychiatric disorders making patients incapable of providing informed
consent.
Breast reconstructions were performed in a standardized fashion as previously described
by the authors.[23 ] For the subpectoral reconstruction the PMM insertion was divided inferomedially
using monopolar cautery allowing partial muscle coverage of the implant. The inferior
part of the implant was covered by an acellular mesodermal matrix (Meso BioMatrix®
size 8 × 16 cm; AMM), which was sutured with vicryl 2.0 sutures to the edge of the
muscle and the inframammary crease. Two pieces of AMM sutured together by vicryl 2.0
sutures were used for prepectoral reconstructions and sutured with vicryl 2.0 sutures
circumferentially along the breast footprint to the PMM. The same postoperative regime
was used for all patients.
To evaluate the HRQOL of patients undergoing DIR, we used the validated Danish version
of the BREAST-Q.[22 ] At baseline evaluation in the outpatient clinic, the preoperative module of BREAST-Q
was handed out directly. At 3- and 12-month follow-ups, the postoperative module of
the BREAST-Q questionnaire for postmastectomy breast reconstruction (version 1.0)
was administered.[16 ] We selected the following scales of the postoperative BREAST-Q: (1) satisfaction
with breast, (2) satisfaction with breast implant, (3) satisfaction with outcome,
and the quality of life (QoL) domains; (4) psychosocial well-being, (5) sexual well-being,
and (6) physical well-being. We excluded scales regarding abdominal donor site, satisfaction
with information, and satisfaction with the surgeon. For each scale, the raw scores
were computed from the responses to the items, which were added together and converted
to a Rasch-transformed scale (ranging from 0 to 100).[24 ] The item responses were collected in paper forms and later entered into the secure
REDCap Database System by double data entry.[25 ] The trial was registered on clinicaltrials.gov (NCT03143335) and approved by The
Danish Committee on Health Research Ethics (S-20160160) as well as the Danish Data
Protection Agency (17/13640).
Statistical Analysis
Descriptive statistics were used to summarize demographic data and type of implant,
laterality of reconstruction, and mean volume of implants. Data are presented as means
and standard deviations (SDs) or median and interquartile ranges. For all BREAST-Q
scale items, raw scores were summed and converted to Rasch-transformed scores for
each scale from 0 (worst) to 100 (best). We used the Qscore Software BREAST-Q Version
1.0 (https://qportfolio.org/score-breast-q-breast-cancer-2/ ) for the preoperative and postoperative reconstruction modules. The Rasch-transformed
scores for each scale were compared between the prepectoral and subpectoral implant
placement group with an independent-sample t -test for normally distributed data or the Mann–Whitney U test for non-normally distributed
data. All scores were reported as means and SDs (normal distribution) or medians and
interquartile range (non-normal distribution). A p -value of 0.05 was deemed statistically significant. Preoperative scores from each
group (prepectoral and subpectoral, respectively) were compared with 3- and 12-month
postoperative scores of the same group with multiple comparison tests with Bonferroni
adjustment. All statistical analyses were performed using SPSS, version 26 (IBM SPSS
Statistics, Version 26.0. Armonk, NY: IBM Corp.), Qscore, and GraphPad Prism 7.0 (GraphPad
Software Inc., CA).
Results
Between April 2017 and March 2020, 69 women were assessed for eligibility. A total
of 53 patients were randomized and allocated to sub- or prepectoral DIR, and finally,
21 women in the subpectoral group and 21 in the prepectoral group completed the trial
and were eligible for analysis. A detailed description and flowchart of patient inclusion
have been previously published.[20 ] The completion of this study was challenged by the coronavirus disease 2019 (COVID-19)
pandemic as all our risk-reducing procedures were paused during the pandemic and the
inclusion period was extended from 1 to 3 years accordingly.
Baseline characteristics after randomization were similar in both groups ([Table 1 ]). In the subpectorally reconstructed group, the mean age was 50 ± 10.2 years and
the mean BMI was 26.8 ± 2.25 kg/m2 . For the prepectorally reconstructed group, the mean age was 49.4 ± 10.9 years and
the mean BMI was 25.5 ± 2.4 kg/m2 . In the subpectoral group, 28.6% had a bilateral reconstruction compared to 57.2%
in the prepectoral group. The duration of surgery was similar between groups: 176
(121–354) minutes in the subpectoral group and 184 (130–333) minutes in the prepectoral
group. The length of follow-up (days) was comparable between groups (399.4 vs. 390.4,
p = 0.42).
Table 1
Demographics
Characteristics
Descriptive statistics
Subpectoral
Prepectoral
p -Value
Number of patients, N
21
21
–
Age, mean ± SD, years
50.0 ± 10.2
49.4 ± 10.9
0.84
BMI, mean ± SD, kg/m2
26.8 ± 2.25
25.5 ± 2.4
0.08
Laterality of reconstruction, N (%)
Unilateral
15 (71.4)
9 (42.8)
0.12
Bilateral
6 (28.6)
12 (57.2)
–
Duration of surgery, median (range)
176 (121–354)
184 (130–333)
0.56
Length of follow-up, mean ± SD
399.4 ± 36.7
390.4 ± 34.5
0.42
Abbreviations: BMI, body mass index; SD, standard deviation.
Data regarding complications, implants, and indications for surgery are described
in a previous paper comparing the degree of BAD between groups.[20 ]
All the preoperative and postoperative BREAST-Q questionnaires were completed by all
patients (100%). When analyzing and comparing results between the sub- and prepectorally
reconstructed groups, we found no significant differences in any of the domains investigated,
neither in satisfaction nor in QoL ([Table 2 ]). There were no significant differences in the mean preoperative scores for satisfaction
with breasts between sub- and prepectorally reconstructed groups ([Table 2 ]). The same applied to the postoperative scores regarding satisfaction with breast,
satisfaction with implant, and satisfaction with outcome where no significant differences
could be found ([Table 2 ]).
Table 2
BREAST-Q scores
Preoperative (mean, SD)
Scale
Prepectoral (n = 21)
Subpectoral (n = 21)
Sig.
Satisfaction with breast
68.71 (19.96)
70.05 (19.67)
ns
Psychosocial well-being
79.76 (16.67)
72.43 (17.88)
ns
Physical well-being
86.90 (11.31)
83.90 (09.76)
ns
Sexual well-being
68.85 (20.63)
62.05 (15.92)
ns
Postoperative
Scale
Prepectoral (n = 21)
Subpectoral (n = 21)
Sig.
3 months postoperative
Satisfaction with breast
71.95 (18.51)
63.62 (15.87)
ns
Satisfaction with breast implant
71.33 (21.83)
73.48 (19.84)
ns
Satisfaction with outcome
80.86 (14.41)
75.95 (16.10)
ns
Psychosocial well-being
66.65 (21.03)
60.24 (25.81)
ns
Sexual well-being
82.14 (13.78)
74.67 (13.67)
ns
Physical well-being
89.90 (20.81)
86.48 (18.80)
ns
12 months postoperative
Satisfaction with breast
72.81 (16.62)
67.90 (17.21)
ns
Satisfaction with breast implant
77.67 (17.07)
73.57 (15.05)
ns
Satisfaction with outcome
85.14 (13.19)
75.00 (19.40)
ns
Psychosocial well-being
66.50 (13.89)
62.09 (20.12)
ns
Sexual well-being
84.38 (15.63)
77.80 (16.46)
ns
Physical well-being
89.90 (20.81)
87.09 (23.74)
ns
Abbreviations: ns, no statistically significant difference; SD, standard deviation;
Sig., level of significance (p ≤ 0.05).
BREAST-Q scores in the prepectoral and subpectoral groups: preoperatively, and 3 and
12 months postoperatively.
Correspondingly, when assessing HRQOL and comparing results between the sub- and prepectorally
reconstructed groups, we found no significant differences in either physical, psychosocial,
or sexual well-being ([Fig. 1 ]). When assessing each group independently we found, that the prepectoral group scored
significantly higher in sexual well-being 12 months postoperatively compared to the
preoperative scores (84.38 vs. 68.85, Bonferroni-adjusted p -value [0.03]). The same tendency was seen when comparing the preoperative scores
with the 3-month follow-up scores, however not significant (68.85 vs. 82.14), Bonferroni-adjusted
p -value (0.07; [Fig. 1 ]). In the subpectoral group, patients had significantly higher sexual well-being
scores at both 3- and 12 months postoperatively compared to preoperative scores (62.05
vs. 74.57), Bonferroni-adjusted p -value (0.03), and (62.05 vs. 77.8), Bonferroni-adjusted p -value (0.01), respectively. When assessing physical and psychosocial well-being in
each group separately, no statistically significant differences could be found ([Fig. 1 ]).
Fig. 1 Mean change in BREAST-Q scores between groups. OP, operative; PO, postoperatively.
* significant (p < 0.05).
Discussion
We achieved a 100% response rate and compared BREAST-Q scores assessed preoperatively,
3 and 12 months postoperatively from sub- and prepectorally DIR reconstructed women.
Overall, we found no significant differences in BREAST-Q scores between the two groups,
neither in patient satisfaction nor HRQOL after the reconstruction. Correspondingly,
we could not detect any significant differences in assessing each group separately
by comparing preoperative scores to 3- and 12-month postoperative scores, except in
the HRQOL scale of sexual well-being. Interestingly, patients scored significantly
higher in sexual well-being postoperatively compared to preoperative scores in both
groups.
Mundy et al reported normative scores of the general population and compared the scores
to previously published BREAST-Q scores. Our BREAST-Q preoperative scores were comparable to normative data published by Mundy et al,[17 ] except in the subtheme “physical well-being” where our scores were slightly below
the norm (83.90–86.90 vs. 93). The marginally lower preoperative scores may be explained
by pain following biopsy or sentinel lymph node dissection. Patients' physical well-being
might also be affected by anxiety, the circumstances of going through surgery soon,
and not knowing how everything will turn out in the end.
When comparing our postoperative scores to the same normative data by Mundy et al, patient satisfaction was above
the normative scores regarding subthemes “satisfaction with breast” and “sexual well-being”
and still slightly below in “physical well-being” (86.48–89.90 vs. 93). Postoperative
lower scores in “physical well-being” compared to normative scores can be explained
by multiple factors such as scar tissue, loss of feeling in the area, damage to the
PMM, and overall discomfort. Furthermore, physical limitations after breast reconstruction
could be a reason. Even though our findings in “physical well-being” were below the
normative scores by Mundy et al, our data corresponded to the previously published
BREAST-Q scores reported by the same authors that reported lower “physical well-being”
scores after implant-based breast reconstruction (76 vs. 93).[17 ]
If the low scores were solely related to discomfort and pain after reconstruction,
one would expect scores to be higher at the 12-month follow-up. However, this was
not the case as we found no significant differences between 3- and 12-month scores.
Regarding our small sample size of 42 patients, a type 2 error is possible; however,
we found our data on HRQOL between sub- and prepectoral groups comparable to findings
by other studies.[26 ]
[27 ]
[28 ]
[29 ]
[30 ] Li et al conducted a systematic review and meta-analysis in 2019 comparing sub-
and prepectorally reconstructed groups regarding complications, oncological safety,
patient-reported outcomes, and pain. Corresponding to our findings, they found no
significant differences between sub- and prepectorally reconstructed groups utilizing
the BREAST-Q to evaluate PROM by assessing 16 comparative studies.[27 ] Several other studies report no difference in HRQOL between sub- and prepectoral
groups; a prospective study by Baker et al aimed to compare differences in PROM between
sub- and prepectorally reconstructed groups. They included 40 patients and 31 returned
the BREAST-Q revealing no significant differences between groups.[28 ] Furthermore, a retrospective study by Walia et al aimed to compare HRQOL in patients
reconstructed with tissue expanders. They identified 26 in the prepectoral group and
109 in the subpectoral group, which completed the BREAST-Q questionnaire and found
no significant differences between groups.[29 ] Manrique et al also conducted a retrospective study evaluating BREAST-Q between
33 prepectorally reconstructed women and 42 subpectorally reconstructed women. After
20 months of follow-up, they found no significant differences in BREAST-Q scores.[26 ] Lastly, a retrospective study by Ng et al assessed HRQOL by BREAST-Q in 80 patients
after DIR and found patients in the prepectorally reconstructed group reporting a
significantly higher score in the “satisfaction with breast” subtheme (68.9 vs. 57.5;
p = 0.036), but no significant differences in the other subthemes.[30 ] Correspondingly, we found no significant differences comparing sub- to prepectorally
reconstructed groups in any of the applied BREAST-Q scales after reconstruction. There
was a trend towards slightly higher satisfaction in the prepectoral group but no significant
differences could be detected. Quite recently, a systematic review and meta-analysis
has been published regarding QoL and pain related to reconstruction using either prepectoral
and/or subpectoral implant placement.[31 ] In this study, patients reported higher BREAST-Q scores after prepectoral breast
reconstruction.
Surprisingly, when analyzing each group separately, we found higher sexual well-being
scores postoperatively compared to preoperative scores. The increased postoperative
sexual well-being scores found in this study might be a result of several things.
Patients might score low preoperatively when they are influenced by a recent cancer
diagnosis that can induce a vulnerability prior to surgery, and sex may very well
be the last thing on their minds. This vulnerability might disappear postoperatively
as the patients have survived and fought cancer, a sense of relief.[32 ] We do not know if the patients were sexually active pre- or postoperatively in our
population, nor do we know their marital status. However, our focus was to investigate
differences between sub- and prepectorally reconstructed groups, and with that in
mind, both groups were indifferent. More research is needed to investigate the change
in sexual well-being and sexual function postoperatively in women undergoing DIR.
In a previously published retrospective study, we found a significant difference between
the degree of BAD when comparing sub- and prepectorally reconstructed women.[9 ] With this in mind, and since BAD has previously been suggested to have a negative
impact on HRQOL,[10 ] we would have expected the nuisance of BAD to be reflected in the HRQOL scores in
our subpectorally reconstructed group. However, we found no significant difference
in HRQOL reflecting the choice of pocket plane. Thus, patients may not be as affected
by animation deformity as presumed by surgeons. A shift towards the prepectoral plane
might not be the answer to all problems, even though it eliminates BAD.[33 ] Baker et al found no significant differences in HRQOL between pre- and subpectorally
reconstructed groups corresponding to our findings. However, when analyzing outcomes
from individual questions, they found significantly more patients in the prepectoral
group either dissatisfied or very dissatisfied with the amount of rippling and visibility
of the implant.[28 ] Implant visibility and rippling increase the need for correctional surgery, including
fat grafting, which might negatively affect HRQOL with a risk of affecting all the
advantages of the prepectoral plane. Nevertheless, careful evaluation of postmastectomy
skin flaps is crucial when choosing the prepectoral plane.
In this RCT, it seems that both methods for DIR can be used with good satisfaction
and HRQOL. The data presented here are, however, secondary endpoints, and therefore
the power calculation is not performed for HRQOL as an outcome. The total number of
21 patients in each group could have insufficient power.
We did not examine if there was a difference in PROM between unilateral and bilateral
cases, the sample size is too small for that; however, this is an important topic
that could be interesting to look at in future and larger studies.
Conclusions drawn regarding pocket planes and their impact on satisfaction and HRQOL
should therefore be made carefully. If any differences between the two DIR methods
exist, they might be too insignificant to be detected in our small study sample (type
2 error). Furthermore, we cannot rule out that differences between groups would be
revealed after a longer follow-up time, but we did, however, not find any significant
differences between 3- and 12-month follow-up scores between the groups. This might
suggest that HRQOL does not change over time. Furthermore, our findings were comparable
to the previously mentioned meta-analysis by Li et al that correspondingly found no
significant differences between sub- and prepectorally reconstructed groups utilizing
the BREAST-Q.[27 ]
This is an RCT where we used the BREAST-Q questionnaire, a reliable, tested, and psychometric-validated
PROM.[16 ] Despite the limitations mentioned above, we conclude that women who undergo DIR
are likely to report high satisfaction and HRQOL and have increased sexual well-being
postoperatively. Nevertheless, HRQOL comparing implant-based reconstructions by different
techniques is a subject that needs further investigation. RCTs with larger sample
sizes and longer follow-ups are needed to accommodate deviations. We, as surgeons,
influence the operative recommendations and choice of the surgical method. Still,
in the end, the final and most important goal is to help our patients reach a high
degree of satisfaction with their surgical outcomes.
