INTRODUCTION
Immediate breast reconstruction after mastectomy has undeniable benefits, both
aesthetic and psychological, avoiding a stigmatizing procedure with clear
repercussions on the quality of life of cancer patients or women at high risk of
developing breast cancer1.
Approximately one in eight women in the United States develops breast cancer,
with 200,000 new cases diagnosed per year2. Following the trend towards more frequent conservative
surgery, there is also an increasing trend for immediate breast reconstruction
following mastectomy. Reconstruction rates increased from 11.6% to 36.4% for
unilateral mastectomies and 36.0% to 57.2% regarding bilateral mastectomies
between 1998 and 2011, respectively3. The American Society of Plastic Surgeons estimated that
109,256 women underwent breast reconstruction in 2016 in the USA alone4. The most frequent immediate
breast reconstruction is alloplastic. Alloplastic reconstruction includes
two-stage with the use of tissue expanders and direct-to-implant (DTI)
reconstruction5.
Major complications implying reoperation and reconstruction failure are reported
to be as high as 20% to 35%4.
Therefore, quality assessment and evaluation of surgical outcomes are mandatory
to improve clinical practice. Patient’s risk factors such as obesity,
smoking, radiation, and the use of acellular dermal matrices influence the rate
of complications6. The pandemic
and increasing proportion of obesity mean that a significant number of these
patients will have an additional risk of postoperative complications, as pointed
in literature, with a commitment to the feasibility of reconstruction6.
Evaluating breast reconstruction outcomes in this population is a challenge due
to the length of time necessary to complete the reconstruction process and the
number of variables that may interfere with the long-term results.
The most frequent complications related to implant-based breast reconstruction
are skin necrosis and infection, frequently leading to additional surgeries and
compromising the optimal timing of adjuvant therapies2.
The overall 5-year survival rate after mastectomy is 98.7%. Yet and, according to
English literature, most women submitted to mastectomy still do not undergo
breast reconstruction7.
OBJECTIVE
The purpose of the study is to evaluate immediate and late postoperative
outcomes, comparing different types of immediate reconstruction and identifying
risk factors for complications of immediate alloplastic reconstruction in
Hospital and University Center of Coimbra (CHUC - Centro Hospitalar e
Universitário de Coimbra), Portugal.
These results represent an important step to improve the quality of care for
women undergoing breast reconstruction.
METHODS
This retrospective study evaluated women who underwent immediate alloplastic
reconstruction following mastectomy at a tertiary faculty medical center over
five years between 2015 and 2019. Patients were selected if they had undergone
mastectomy with implant-based reconstruction (DTI or two-stage with tissue
expander). Patients who underwent delayed breast reconstruction were excluded
from this study.
Clinical data including age, comorbidities, smoking status, neoadjuvant
chemotherapy and body mass index (BMI) were collected from medical records.
Comorbidities included obesity, hypertension, coronary artery disease, and
diabetes.
Surgical collected variables were the type of reconstruction (two-stage versus
DTI), laterality (unilateral or bilateral procedure), and acellular dermal
matrix. Surgical teams were composed of gynecologic oncologists and plastic
surgeons.
Clinically relevant early and late complications were analyzed and compared
according to the type of reconstruction. Early complications included infection,
necrosis of mastectomy flaps/nipple-areolar complex (NAC), hematoma, seroma or
extrusion/dehiscence. Late complications comprised late seroma, malposition or
rotation of the implant, capsular contracture, chronic pain, and lymphedema.
Seroma was defined as any fluid collection that developed after drain removal or
daily output above 30cc during more than ten days. Infection was defined as any
patient receiving antibiotics beyond the expected postoperative course or
restarting antibiotics for a suspected infection or erythema. Capsular
contracture was defined as Baker capsular contracture classification of grade
III and IV8.
Breast reconstruction failure was defined as a complication resulting in the
removal of an implant or tissue expander. The need for implant removal was
evaluated based on the cause. Further reconstructive options were later given to
these patients.
Trend data on BMI, categorized as normal, overweight and obese, were analyzed
using logistic regression.
Statistical analysis was performed using SPSS version 23.0. Categorical variables
were analyzed using the chi-square test and continuous variables with
Student’s t-test. The significance level was set at α=0.05 (95%
confidence interval).
This observational study was developed in Hospital and University Center of
Coimbra (CHUC - Centro Hospitalar e Universitário de
Coimbra), submitted to the CHUC ethics commission with the
reference number 210/CES.
RESULTS
Our assay comprises a retrospective study of immediate alloplastic breast
reconstruction in CHUC in 5 years, from 2015 to 2019. In this period, a total of
500 patients underwent breast reconstruction by the plastic surgery department.
From this sample, 132 women underwent immediate breast reconstruction after
undergoing mastectomy for breast cancer or in a preventive manner by the
gynecology oncology team.
Most of these patients underwent immediate alloplastic reconstruction comprising
a sample of 105 patients selected for this article. Therefore, immediate
alloplastic reconstruction comprised about 80% of total immediate reconstruction
(with 20% being autologous) and about 21% of total breast reconstruction in our
department. The average patient age was 48.5±8.2 [27-71] years. 87.6%
(n=92) underwent therapeutic mastectomy for breast cancer, predominant invasive
ductal carcinoma (44,8%, n=47), followed by ductal carcinoma in situ (24.8%,
n=26), and invasive lobular carcinoma (13.3%, n=14). Additionally, five women
were submitted to contralateral prophylactic mastectomy in the same operative
time of total therapeutic mastectomy. 12.4% (n=13) had risk-reducing
(prophylactic) mastectomy.
Most patients had unilateral breast reconstruction (84.8% [n=89]). Bilateral
reconstruction was performed in 16 women (15.2%); 6 were risk-reducing
mastectomies, 5 had bilateral breast cancer, and the remaining five were
performed in a context of contralateral risk-reducing mastectomy.
Total mastectomy was performed in 66 patients (62.9%), of which three were
bilateral; skin-sparing mastectomy in 17 cases (16.2%), of which 2 were
bilateral, both risk-reducing; and nipple-sparing mastectomy in 16 (15.2%), of
which five were bilateral. In addition, six women were submitted to total
mastectomy and contralateral nipple-sparing mastectomy.
41.9% (n=44) of patients underwent immediate breast reconstruction using
direct-to-implant technique, while 58.1% (n=61) underwent 2-stage reconstruction
with expander. Acellular dermal matrix (ADM) was used in 26.7% (n=27) of breast
reconstructions. The statistical comparison showed a significant increase in
direct-to-implant technique vs. expander over the years (from 19.0% in 2015 to
52.4% in 2019).
Secondary/complementary procedures
43% (n=45) patients had undergone secondary procedures on the reconstructed
breast alone or in combination. There were 26 NAC reconstruction, 24
lipofilling, 2 cases of mastopexy, and four scar revisions. 40% (n=42) of
our patients underwent contralateral symmetrization either by reduction
mammoplasty or mastopexy (n=39) or by breast augmentation (n=3).
Most common indications for revisions included improving soft-tissue contour
irregularities. Lipofilling has become a common adjunct to enhance contours
and camouflage the periphery of the implant (n=25).
Complications
The average patient admission time was days 9.5±5.0 [2-28]. The
overall complications rate was 47.6% (n=50).
Early complications occurred in 32.3% (n=34) and included infection (n=10),
partial necrosis of mastectomy flaps (n=6) and complete necrosis (n=4),
hematoma (n=8), seroma (n=12), and extrusion/dehiscence (n=5). Total failure
of reconstruction occurred in 8 cases.
Late complications were less frequent, affecting 20.0% (n=21) patients.
Comprised late seroma (n=3), malposition or rotation of the implant (n=2),
capsular contracture (n=7), chronic pain (n=6), and lymphedema (n=2).
Implant replacement was required in 3 cases.
Overall complication rates, both early and delayed, are stated in Table 1.
Table 1 - Breast reconstruction complications.
| Early complications |
N |
% |
| Seroma/prolonged drainage |
12 |
11.4 |
| Hematoma |
8 |
7.6 |
| Necrosis of mastectomy flaps or NAC |
10 |
9.5 |
| Extrusion |
5 |
4.7 |
| Infection |
10 |
9.5 |
| Late complications |
N |
% |
| Late seroma |
3 |
2.8 |
| Malposition, rotation of the implant |
2 |
1.8 |
| Capsular contracture |
7 |
6.6 |
| Chronic pain |
6 |
5.7 |
| Lymphedema |
2 |
1.8 |
Table 1 - Breast reconstruction complications.
Minor complications such as suture exposure, delayed healing and
epidermolysis were usually self-resolving with conservative treatment.
Two patients were managed by revision of the implant, and three required
implant exchange. Twenty patients had a complete failure of the alloplastic
reconstruction. Of these, 12 were offered autologous reconstruction (4 deep
inferior epigastric artery perforator (DIEP), 5 atissimus dorsi (LD), 2
thoracodorsal artery perforator (TDAP), and 1 transverse rectus abdominis
myocutaneous (TRAM). In addition, eight women did not want further
reconstruction, and 2 had a recurrence of the oncologic disease.
Statistical comparison showed a significant increase in overall complications
for patients in the direct-to-implant technique versus two-stage tissue
expander-based immediate reconstruction (59.1% [n=26] vs. 39.3% [n=24],
p=0.046).
The average BMI was 24.8±4.0 [18-37] kg/m2. 59.1% of women
had normal weight (BMI 18.5-24.9kg/m2), 24.7% were overweight
(BMI 25.0-29.9kg/m2), and 16.1% were obese
(BMI≥30.0kg/m2).
The rate of complications was significantly higher in the group of obese
women compared to women with normal weight (80.0% vs. 40.0%,
p=0.006) and overweight (80% vs. 43.5%,
p=0.026), mainly at the expense of initial
complications (66.7% vs. 23.6%, p=0.002; 66.7 vs. 26.1%,
p=0.013). Overweight women had no more complications
compared to women of normal weight. The incidence of late complications was
also not significantly different among all groups. BMI as a predictive
factor for complications did not reach statistical significance, but the
cutoff of 23.5kg/m2 was associated with better sensitivity
(56.8%) and specificity (53.1%) together. The cutoff for obesity
(BMI>30kg/m2) was associated with a specificity of
95.9%, despite a reduced sensitivity value (15.9%). Comparison of
complications across BMI indexes is stated in Table 2.
DISCUSSION
As stated above, immediate alloplastic reconstruction can be either
direct-to-implant or two-stage with the use of an expander and implant.
Direct-to-implant
In selected patients, this approach offers benefits over the two-stage breast
reconstruction such as good symmetry with small breasts, fewer surgeries,
faster return to everyday life, and avoidance of the period of expansion. It
also adds psychological benefits9 - the feeling that the patient never wholly lost the
breast and overall cost savings - do it all in one procedure10-12. The limitations of DTI are breast size, higher
risk for skin or nipple necrosis is technically more demanding to make it
right in one procedure, and the risk of postoperative radiation negatively
affecting the outcome.
Table 2 - Comparing complications across BMI indexes. BMI - average
24.9±4.0 [18-37]kg/m2
| Comparing weight to complications: |
| Normal weight vs. Excess weight -> p=0.799 |
| Normal weight vs. Obesity
--> p=0.006 ---> Statistically
significant
|
| Excess weight vs. Obesity --> p=0.026 --->
Statistically significant
|
| Comparing weight to early
complications: |
| Normal weight vs. Excess weight
--> p=0.498
|
| Normal weight vs. Obesity -> p=0.001 --->
Statistically significant
|
| Excess weight vs. Obesity
-> p=0.02 ---> Statistically significant
|
| Comparing weight to late
complications: |
| Normal weight vs. Excess weight --> p=0.966 Normal
weight vs. Obesity --> p=0.791 Excess weight vs.
Obesity --> p=0.785
|
Table 2 - Comparing complications across BMI indexes. BMI - average
24.9±4.0 [18-37]kg/m2
The ideal candidate is a healthy non-smoker with small cup breasts who
desires a similar or slightly larger size, with minimal ptosis, to do a
prophylactic mastectomy or to treat an early-stage disease with a low
likelihood for postoperative adjuvant therapy.
The main limitation in DTI is providing adequate, stable soft-tissue coverage
for an implant in a new mastectomy pocket.
Women with larger size and ptotic breasts may be candidates for skin
reduction mastectomy (usually in T pattern) with direct-to-implant
reconstruction; this procedure increases the risk of NAC necrosis.
In our center, patients with a history of breast radiation and those likely
to require post-mastectomy radiation have traditionally been offered
autologous reconstruction.
The plane chosen in our center mainly was the partial submuscular coverage
using ADM to cover the lower pole in a dual-plane fashion.
Usually, after creating the pocket for the implant, the muscle is advanced
inferiorly until the desired upper pole contour is achieved. The matrix is
then trimmed to create a tight and supportive pocket and sutured to the
lower pole to function as a pectoral expansion down to the inframammary fold
(IMF) in a dual-plane fashion.
ADM has been routinely used in DTI reconstruction. The two brands of ADM that
were most often employed in our department/hospital were Strattice®
and Native®.
Some patients with well-vascularized mastectomy flaps were given a
subcutaneous or pre-pectoral reconstruction usually combined with ADM
wrapped around the implant. For this technique, Surgimend® was chosen
as the preferred ADM due to its increased flexibility and support compared
to the former. However, this technique can cause significant stress to the
lower pole mastectomy flaps leading to soft-tissue necrosis in the short
term and significant thinning in the long term.
Total submuscular coverage is usually challenging to achieve because it
limits the size of an implant that can be placed and does not allow for a
natural fill of the lower pole. Therefore, it was reserved for expander
placement and not for DTI.
Clinical case 1 depicts a 45 years old patient diagnosed with an invasive
carcinoma on the left breast. The patient had a previous breast augmentation
20 years before and had a left breast capsular contraction (preoperative -
Figure 1). The patient underwent
bilateral NAC sparing mastectomy and an axillary lymphadenectomy on the left
side. Immediate DTI reconstruction was performed with 460cc implants and ADM
in a dual-plane fashion. Figure 2
depicts the final result 1-year after.
Figure 1 - Pre-DTI reconstruction.
Figure 1 - Pre-DTI reconstruction.
Figure 2 - Post-DTI reconstruction.
Figure 2 - Post-DTI reconstruction.
Clinical case 1: immediate DTI breast reconstruction
Two-stage immediate reconstruction
Because it involves two surgical procedures, this technique increases the
chances of creating a better result. It is technically more
straightforward and has broader indications. It causes less strain on
the mastectomy flaps due to lower expansion volumes and, therefore, less
risk of skin necrosis. Compared with the DTI, its disadvantages are a
delayed outcome due to the expansion period and the need for one more
surgery.
The ideal patients are healthy non-smokers who have good quality
expandable chest wall skin and soft tissues.
Its absolute contraindications are the lack of available expandable skin
or underlying bony support to withstand the forces of the overlying
process of expansion. Therefore, we do not routinely offer this
reconstruction to patients that underwent or will undergo radiotherapy.
Instead, these patients were offered autologous reconstruction.
Markings
Markings are made with the patient in the sitting position, with both
oncologic and reconstructive teams present. Anatomic landmarks that must
be drawn on the patient include the chest midline, medial, and superior
breast borders, and lateral mammary fold (LMF) and IMF.
The chosen incision is based on various factors, including the
preoperative size and shape of the breast, the desired postoperative
breast size and position, and the location of pre-existing scars.
Despite helping to achieve the desired reconstructive result, markings
should allow the surgeon to carry out a safe oncologic mastectomy.
Plane chosen
The plane chosen in our center was preferably total submuscular coverage
to cover the expander.
Dual-plane was occasionally used. When chosen, the dual plane technique
was usually combined with ADM to cover the inferior pole.
Pre-pectoral was only seldom used as an expansion of the lower pole can
cause significant stress to the mastectomy flaps leading to soft-tissue
necrosis in the short term and significant thinning in the long
term.
Due to losing the lateral border because of the large mastectomy pocket,
anterior serratus flaps are frequently used to control the lateral
position of the expander and define the LMF or anterior axillary
line.
Incision
The most often used incision is a transverse ellipse, which provides the
opportunity to decrease the size of the skin envelope with minimal risk for
skin flap compromise. It also helps to conceal the scar under the
brassiere.
In nipple-sparing mastectomies, most often, an inferior periareolar incision
was used. The type of mastectomy, the importance of gentle tissue handling,
preservation of the IMF and the serratus fascia, and minimizing unnecessary
lateral dissection of the breast pocket are crucial factors to consider.
Drains
In our center, we usually place a drain within the submuscular/ADM
pocket. A second drain is placed along the inframammary crease in the
subcutaneous plane and brought out through a separate incision in the
anterior axillary line. Drains are maintained until output decreases
below 30cc. Antibiotics are routinely prescribed for one week after or
until the drains are removed.
Expansion period
Expansion usually begins one month after surgery, and volumes are limited
by discomfort and signs of stress to the skin (blanching). Expansion is
generally made in 3 to 5 visits to the outpatient clinic. Exchange to
implant is usually performed from 6 months to 1-year post-surgery.
Implant choice
Size selection begins during the initial consultation. First, chest wall
dimensions must be accurately measured, focusing on breast width,
height, and projection, allowing the surgeon to estimate breast
volume.
According to literature, a small overcorrection from the mastectomy
weight is suggested to accommodate the laxity created in the skin
envelope due to the mastectomy13. Mostly high-profile implants were used for
maximal projection.
An example of a patient that underwent two-stage immediate reconstruction
is depicted in clinical case 2, a 46 years old patient diagnosed with an
invasive ductal carcinoma on the right breast (preoperative - Figure 3). The patient underwent a
total mastectomy and two-stage immediate reconstruction with an expander
and later a 270cc implant. The left breast was augmented with a 180cc
implant. Figure 4 depicts the
result 2-years after. The patient did not wish to reconstruct the
NAC.
Figure 3 - Pre-two-stage reconstruction.
Figure 3 - Pre-two-stage reconstruction.
Figure 4 - Post-two-stage reconstruction.
Figure 4 - Post-two-stage reconstruction.
Clinical case 2: two-stage immediate reconstruction
Comparing complications to literature
In some articles, major complications have been reported with an overall
incidence as low as 6% each13,14.
In other series, individual complications including implant loss, skin
necrosis requiring re-operation, infection, hematoma, seroma, and
capsular contracture were as low as 2%13,14. In our department, complication rates were
somewhat like some literature series, with slightly higher percentage of
seroma formation, infections (9.5%), and hematoma formation (7.6%).
Comparing the reconstructions after NAC-sparing mastectomy
After NAC-sparing mastectomies, another series of 500 consecutive
one-stage and two-stage reconstructions showed overall low complication
rates and lower than 10% nipple loss. In addition, the risk of infection
was 3.3%12.
In our center, there were two cases of total nipple necrosis and one case
of infection hence making a prevalence of 9.5 % and 4.5%, respectively,
for each complication.
The most extensive multi-institutional report comparing early
complications of direct-to-implant reconstruction with two-stage
reconstruction found a higher rate of overall complications (6.8%
compared with 5.4%) and prosthesis failure (1.4% compared with 0.8%) in
direct-to implant reconstruction. However, no significant difference was
found concerning infection, re-operation, or major medical
complications14.
In our center, despite the occurrence of a higher percentage of
complications with the one-stage reconstruction (56.8%) versus the
two-stage reconstruction (39.3%), we have failed to demonstrate any
statistical significance between expander and implant reconstruction in
terms of complications: expander (two-stage) vs. DTI 39.3% vs. 56.8%,
p=0.077 (ns).
Special considerations
Patients treated in 2019 have yet to develop late complications. Some
complications like seroma and even late complications like lymphedema
and chronic pain may not have been registered in our records, leading to
underestimating the number of cases.
Lymphedema is not a complication of breast reconstruction but instead a
complication of mastectomy. Still, the authors decided it was relevant
to register the number of occurrences.
CONCLUSION
Regardless of its many advantages, immediate breast reconstruction is not a
straightforward procedure and has some limitations compared with delayed
reconstruction.
Factors like skin flap viability are of extreme importance to the
procedure’s success. In addition, patients should be aware that the
surgical team ultimately decides whether to perform immediate reconstruction in
the operating theatre.
Signed consent should always be obtained previously, explaining that immediate
alloplastic reconstruction may not be possible and consequently deferred to a
delayed setting.
Occasionally the reconstructive team might decide to perform a two-stage
immediate reconstruction instead of a DTI reconstruction when mastectomy flaps
are of dubious viability. Consent should always include the possibility of
partial or complete necrosis of NAC and mastectomy flaps, and failure of
reconstruction.
Despite being widely performed, it remains a high-risk procedure with a high
likelihood of developing complications. In our series, 47% of patients developed
some complication, even if a minor one.
Our higher rate of revisions compared to literature (40.5%) was partly due to
considering the revisions and the secondary procedures altogether. These include
reconstruction of NAC, lipofilling, revisions of scar, liposuction and
mastopexy, and usually were performed in the same surgery.
Managing complications
Postoperative complications must be managed aggressively and in a timely
fashion. Seromas and hematomas must be drained immediately to prevent excess
tension on the overlying skin flaps and minimize long-term implant
malposition.
Skin flap necrosis must be followed closely and, if not healing quickly,
should be excised and closed primarily to avoid the possibility of implant
exposure. Skin edge necrosis (2-5mm) can often be managed with debridement
and closure under local anesthesia. Larger areas usually require the removal
of the implant.
What to improve?
There is a statistically significant p-value when comparing
the incidence of early complications in the obese population with a BMI
above 30. However, that was not true for overweight patients with a BMI
between 25 and 30. Therefore, one way to decrease the complication rates is
to select patients with a BMI below 30.
Further selecting patients with normal or lower than 30 BMI might be a way to
decrease the percentage of complications. Overweight and obese patients
should be encouraged to lose weight and can more safely undergo delayed
reconstruction. Further investigation still must be done to discover a
proper cutoff of BMI.
Other behavioral factors such as smoking, hypertension, and diabetes mellitus
cause a negative impact on complication rates. Patients should be encouraged
to cease smoking as vasoconstriction causes a deleterious effect on the
mastectomy flaps and wound healing. Blood glucose levels should also be
strictly controlled. Hypertension and especially poorly controlled
hypertensive patients are at increased risk of developing a hematoma.
Unfortunately, not enough data was available to assess the statistical
significance of these risk factors in this essay.
The authors’ opinion is that patients previously submitted to
radiotherapy or who will likely receive adjuvant radiotherapy should not be
candidates for alloplastic immediate reconstruction. It should be offered
delayed autologous reconstruction instead.
New trends favoring alloplastic reconstruction in these patients after
improving the quality of flaps with lipofilling are beyond this
article’s scope. Due to fenestrations in the ADM and permeability of
the mastectomy pocket, the submuscular drain may not be necessary. Many
centers are using only one drain. Reducing the number of drains might play a
role in decreasing the rate of infection.
Regarding ADM use, and even though most infected/extruded implants in DTI
reconstruction were associated with ADM13,14, there is
not sufficient data for this fact to be statistically significant.
In conclusion, alloplastic reconstruction remains the gold standard in
immediate breast reconstruction. It allows achieving aesthetically
satisfying results that endure many years of the patient’s life.
However, this is not without its limitations, especially when treating young
women with long life expectancies. These women are expected to undergo
multiple procedures throughout their life, such as implant replacement, and
many will eventually develop capsular contracture.
Other complications might also arise, such as the breast implant-associated
anaplastic large cell lymphoma (BIA-ALCL), a malignancy though very rare
that is gaining the spotlight in plastic surgery conferences all over the
world once was most certainly overlooked and underdiagnosed. These
complications are part of the burden of carrying a breast implant for
life.
Because of all this, it is essential to further invest in immediate
autologous reconstruction and routinely offering this option to younger
patients, especially with the state-of-the-art DIEP flap.
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1. Hospital and University Center of Coimbra,
Coimbra, Portugal, Portugal.
Corresponding author: João Baltazar
Ferreira, Rua Av Bissaya Barreto, Unidade Queimados, Blocos de Celas
HUC, Coimbra, Portugal, Zip Code 3000-075, E-mail:
joao_cbf@msn.com
Article received: February 21, 2021.
Article accepted: April 19, 2021.
Conflicts of interest: none.
Institution: Hospital and University Center of Coimbra, Coimbra,
Portugal.
