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S78 www.annalsplasticsurgery.com Annals of Plastic Surgery • Volume 88, Supplement 1, March 2022
chemotherapy. All surgical plans were reviewed and performed by the a score ranging from 0 to 100. Higher scores indicated greater satisfac-
multidisciplinary team, including 3 senior breast surgeons and 5 plastic tion or QoL. All patients received surveys under an outpatient setting at
surgeons. least 6 months after completion of breast reconstruction and adjuvant
Clinical outcomes were defined as overall (any) complications. therapy. Patients who had reconstruction failure at any stage were ex-
Infection, seroma, capsular contracture, implant malposition, wound cluded from the survey.
complications, hematoma, implant rupture, and implant explantation were All data were analyzed by statistical database (IBM SPSS Version
evaluated, respectively, according to medical records. Infection was further 25.0; IBM Corp, Armonk, New York). To assess the association between
defined as minor or major infection. Minor infection was treated by oral an- risk factors and complications, univariate and multivariate analyses were
tibiotics under the outpatient setting, whereas major infection needed fur- performed with logistic regression model. P values <0.05 were statistical
ther intravenous antibiotics under hospitalization or surgical debridement. significance.
Seroma was also divided into early or late seroma by diagnosed at less than
12 months or more than 12 months. Only Baker grade 3 or 4 capsular con-
tracture was defined as complication. Wound complications were defined RESULTS
as skin flap necrosis due to noninfectious etiology or any poor wound A total of 237 patients with 247 breasts were finally enrolled in
healing. At last, nipple complications were also analyzed (ie, partial or total this cohort from 2006 to 2020. The mean follow-up time was 79.5 months.
necrosis) if the nipple-sparing mastectomy was performed. The patients of demographic characteristics revealed that the average age
Patient-reported outcomes were assessed via the BREAST-Q (re- was 45 years and the average BMI was 22.1 kg/m2. Eleven patients (4%)
construction module) Version 2.0 survey. It is a condition-specific PRO had a history of diabetes, and 13 patients (5%) had a history of smoking.
instrument that measures breast-related QoL and satisfaction in patients Bilateral breast reconstructions were performed in 10 patients (4%). Four-
undergoing breast reconstruction; details of its validation have been teen patients (5%) had a history of radiotherapy before reconstruction, and
published elsewhere.10,11 Six domains were independently calculated, 20 patients (8%) received postmastectomy radiotherapy. Thirty patients
including psychosocial well-being, physical well-being: chest, sexual (12%) and 96 patients (38%) received neoadjuvant and adjuvant chemo-
well-being, satisfaction with breasts, satisfaction with implants, and sat- therapy, respectively. About the timing of reconstructions, 234 (95%) were
isfaction with care. Each domain score was obtained by adding the re- immediate, and 13 (5%) were delayed. About the reconstruction type, 205
sponse items together and then converting the raw sum scale score to (83%) were 2-stage tissue expander-implant technique, but only 42 (17%)
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In this study, we revealed the risk factors of complications and infection.15 Thus, early detection and prompt management of seroma for-
PROs of implant-based breast reconstruction in an Asian population, mation could prevent further implant infection.
based on our preliminary results from 2009 to 2018.7 The complication In terms of capsular contracture, the mechanism of capsular
rate decreased from 37% to 34% compared with previous study, mostly contracture is not well known. However, it is theorized to be a local
involving infections. In multivariate analysis, smoking and nipple-sparing inflammatory reaction to the foreign body, caused by excessive fibrosis
mastectomy were still identified as significant risk factors for overall through collagen production in the tissue surrounding the implant.
complications. Diabetes mellitus, direct-to-implant procedures, periareolar Seroma, direct-to-implant and postmastectomy radiotherapy were inde-
incision, postmastectomy radiotherapy, and seroma were significant risk pendent risk factors for capsular contracture from our data. Because
factors for individual complications. The PRO questionnaire response rate seroma was related to the occurrence of infection as mentioned previ-
was 38% and yielded a total mean score of 69.78. ously, several studies also found associations between bacterial coloni-
From 2006 to 2020, alloplastic breast reconstruction (either single- zation and capsular contracture.16 The primary concern with seroma
stage or 2-stage) yielded a postoperative overall complication rate of 34% formation is the propensity to develop the further infection (0.2%–20%)
after a mean follow-up of 79.5 months. Only 2% reconstructive failure with and implant loss (6.7-fold). In our study, it also disclosed that direct-
implant explantation was found, which was slightly higher than previous to-implant reconstruction may increase the risk of seroma formation.
preliminary report.7 In the previous MROC data, the 2-year overall compli- Seroma formation might result from poor wound healing and skin flap
cation rate for 2-stage implant reconstruction was 26.6%, but single-stage necrosis, which remains a considerable wound issue after direct-to-
implant reconstruction had higher complication rate with 31.3%.5 In our implant reconstruction according to previous report.17 This might be
study, the 2-stage tissue expander-implant technique was used in 83% the reason why direct-to-implant reconstruction was also the indepen-
reconstruction, whereas only in 42 (17%), 1-stage direct-to-implant re- dent risk factor of capsular contracture. The last but not least, postmas-
constructions were performed. The overall complication rate of our tectomy radiotherapy increased the occurrence of capsular contracture
study was quite similar to other previous studies, even for a longer as well. Radiation toxicity induces vascular and soft tissue fibrosis,
follow-up time.12 which can lead to increased scarring, capsular contracture, a greater risk
Among all complications, infection (8%) was the most common of infection and skin necrosis, delayed wound healing, and pain. This
complication in our study. This finding was also consistent with our result is consistent with other studies on implant reconstruction followed
preliminary study.7 The MROC data, a total of 1637 alloplastic breast by postmastectomy radiotherapy.18 In addition to infection and radio-
reconstruction, showed an infection rate of 10.4% in 2-stage reconstruc- therapy, several clinical series have been published addressing the issue
tions and 15.2% in direct-to-implant procedures. However, some previ- of capsular contracture and surface texturing. Textured surface implants
ous reports demonstrated a lower infection rate in alloplastic breast re- have been shown to lower the risk of capsular contracture than smooth
constructions, ranging from 1% to 7.5%.2,3,13,14 Further multivariate surface implants. However, textured surface implants, compared with
analysis revealed that patient-related factors, such as a history of diabe- smooth surface implants, reduced the occurrence of capsular contrac-
tes (OR, 6.986; 95% CI, 1.63–29.89; P = 0.009) and smoking (OR, ture without statistical significance in our cohort.
9.331; 95% CI, 2.54–34.30; P = 0.001), significantly increased the risk Nipple-sparing mastectomy, even combined with single-stage
of developing postoperative infection in our cohort. Therefore, the ap- direct-to-implant reconstruction, may increase the overall complication
propriate patient selection of implant-based reconstruction was crucial rate and the occurrence of seroma and capsular contracture in our co-
to prevent postoperative infection. In addition, early seroma was also hort. The single-stage implant reconstruction also had a higher rate of
a significant risk factor for infection in our study (OR, 5.314; 95% implant malposition and revision from previous studies.17 Thus, the pa-
CI, 1.02–27.63; P = 0.047). The incidence of seroma after implant- tient selection plays an important role in single-stage implant recon-
based reconstruction varies from 0.2% to 20%. Seroma formation is struction. In the nipple-sparing mastectomy setting, nipple necrosis is
complicated by ischemic, proinflammatory environment of mastectomy the most frequent complication. Some risk factors for nipple necrosis
skin flap; the dead space; and the presence of a foreign body with poten- include smoking, large breast size, obesity, ptosis, old age, breast radi-
tial contamination and biofilm, which could induce further postoperative ation therapy, periareolar mastectomy incisions, mastectomy, and flap
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quality.2 Specifically, periareolar mastectomy incision was found to be a implant-based reconstruction had acceptable satisfaction in terms of
positive predictor for nipple-areola complex necrosis after nipple-sparing psychosocial well-being and the appearance of their breasts. In contrast
mastectomy (OR, 22.4). Comparatively, an inframammary fold incision to our study, many studies compared PRO between alloplastic and au-
was a negative predictor for nipple-areola complex necrosis (OR, tologous breast reconstructions, which disclosed higher satisfaction
0.0006).19 In our cohort, 28% of patients underwent nipple-sparing with breasts for autologous than alloplastic breast reconstructions.1,8
mastectomies, with nipple necrosis (partial or total) as the most com- Eltahir et al20 conducted a systematic review and meta-analysis to com-
mon complication (19%). From further risk factor analysis, patients pare BREAST-Q measurements between alloplastic and autologous
with smoking history and periareolar incisions may increase the breast reconstruction.20 Interestingly, when focusing on alloplastic breast
chances of nipple necrosis by directly cutting off the blood flow of reconstructions, the mean scores of satisfaction with the breast ranged
the nipple-areolar complex. from 53.8 to 65.5, which was similar to our result (mean [SD], 55.63
As for patient satisfaction, the literature on PROs of breast recon- [15.8]). It was clear that the similar complication rate resulted in the
struction is tremendously broad. Our study revealed that patients with similar patient satisfaction compared with our previous studies, although
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some cultural differences were present. Susarla et al3 compared patient sat- satisfaction with implants in single-stage reconstruction. Moreover, patients
isfaction between single-stage and 2-stage implant-based reconstructions who had nipple-sparing mastectomy had better satisfaction with breasts
and showed statistically equivalent scores of satisfaction with breasts. How- than those who had had non–nipple-sparing mastectomy (data not shown).
ever, this was slightly different from our results that demonstrated higher These results implied that nipple-sparing mastectomy or the direct-to-implant
technique would not compromise the satisfaction with breasts or im-
plants under appropriate patient selection.
TABLE 4. Summary of PRO Scores on BREAST-Q The limitations of this study included potential selection bias due
to retrospective enrollment and the issue of insurance imbursement. In
PROs Mean ± SD addition, the complication rate may be underestimated because of the
Psychosocial well-being 68.05 ± 16.11 retrospective review of the medical records, relatively small case num-
Physical well-being: chest 67.52 ± 17.49 bers, and short follow-up period. Moreover, some surgical variations
might still exist for different 5 plastic surgeons at our institute. Lastly,
Sexual well-being 53.63 ± 18.29
our response rate of questionnaire was relatively low and lack of preop-
Satisfaction with breasts 57.11 ± 15.43
erative baseline for comparison. The impact of various factors could
Satisfaction with outcome further be analyzed if comparison were provided.
Satisfaction with implants 5.85 ± 1.34
Satisfaction with care CONCLUSIONS
Satisfaction with information 63.17 ± 15.14 At a single institute in Taiwan from 2006 to 2020, alloplastic
Satisfaction with surgeon 79.55 ± 20.58 breast reconstruction, either single or 2-stage, has acceptable complica-
Satisfaction with medical team 83.51 ± 19.60 tion rates and good postoperative satisfactions based on PROs. Optimal
Satisfaction with office staff 84.07 ± 18.79 aesthetic outcomes can be achieved by precise patient selection and
comprehensive discussion between the patient and the physician.
© 2022 Wolters Kluwer Health, Inc. All rights reserved. www.annalsplasticsurgery.com S83
FIGURE 3. A 41-year-old woman with right breast ductal carcinoma in situ (upper row). Six-month follow-up after endoscopic-assisted
right nipple-sparing mastectomy and sentinel lymph node biopsy with direct-to-implant breast reconstruction (lower row).
FIGURE 4. A 53-year-old woman with right breast ductal carcinoma in situ (upper row). Six-month follow-up after right non–nipple-
sparing mastectomy and sentinel lymph node biopsy with 2-stage breast reconstruction and contralateral breast augmentation
(lower row).
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