BREAST SURGERY

Direct-To-Implant and 2-Stage Breast Reconstruction After Nipple

Sparing Mastectomy
Results of a Retrospective Comparison
Tiziano Pallara, MD,* Barbara Cagli, MD, PhD,* Lucio Fortunato, MD,† Vittorio Altomare, MD, PhD,‡
Andrea Loreti, MD,§ Antonella Grasso, MD,‡ Elena Manna, MD,† and Paolo Persichetti, MD, PhD*

with single-stage implant placement has become increasingly popular,

Abstract: Breast reconstruction after nipple sparing mastectomy (NSM) plays,
particularly with the advent of acellular dermal matrices (ADM) and en-
nowadays, a fundamental role in breast cancer management. There is no consen-
dorsement of surgical techniques that allow sparing of the skin
sus on the best implant-based reconstruction technique, considering 2 stages
envelope.4–9 Direct-to-implant (DTI) reconstruction has several poten-
(expander-prosthesis) or direct-to-implant (DTI). A retrospective review of con-
tial advantages, because it avoids a second-stage exchange procedure
secutive adult female patients who underwent NSM with breast reconstruction
and numerous office visits required for completion of the expansion
over a 3-year period (January 2013 to December 2015) was performed. Patients
process, and it allows a quicker restoration of breast shape. However,
were divided into 2 groups according to the type of reconstruction: expander/
DTI reconstruction has also potential disadvantages, because it relies
prosthesis (group A) and DTI (group B). Anamnestic data were collected. Num-
more heavily on the quality of the mastectomy skin flaps, it does not
ber and type of procedures, complications and esthetic satisfaction were regis-
classically allow for any postoperative volume control of the definitive
tered and compared. Fifty-six patients were included in group A (34.6%) and
prosthesis,10 the quantity of the skin envelope may ultimately limit the
106 in group B (65.4%). Complications associated with the 2 types of breast re-
size of the implant that can be safely placed in a single-stage fashion,
construction were not different (P = 0.2). Patients in group A received a higher
and this may interfere with the patients' reconstructive expectations.
number of total surgical procedures (considering revisions, lipostructures and
Although many investigators have previously reported success-
contralateral symmetrizations) than those in group B (2.5 ± 0.69 and 1.88 ± 1.02,
ful clinical outcomes following either 2-stage or single-stage implant-
P = 0.0001). Satisfaction with breast reconstruction resulted higher in group A
based BRs, there is a paucity of large-scale studies comparing directly
(7.5 ± 2.6 and 6 ± 1.9, P = 0.0004). At the multivariate analysis, chemotherapy
these 2 reconstructive approaches.11–15
and radiotherapy were not correlated with complications, regardless of the group
The purpose of the present study is to identify and compare pa-
(odds ratio, 0.91 and 2.74, respectively). Radiotherapy and chemotherapy did not
tient satisfaction, postoperative complication rates, and need for opera-
even influence the esthetic result, regardless of the group (P = 0.816 and
tive revision, between DTI and 2-stage implant-based BR after NSM.
P = 0.521, respectively). Prosthetic breast reconstructions, both in a single and
in 2 stages, are welcomed by patients and have relatively low and almost equiv-
alent complication rates, independent of other factors such as chemotherapy, ra- PATIENTS AND METHODS
diotherapy, lymphadenectomy, smoking and age. In our experience, 2-stage
This study was approved by the respective institutional review
breast reconstruction, although requiring more operations, is associated with a
boards, and data were deidentified and analyzed in aggregate.
higher esthetic satisfaction. Patients who perform a DTI breast reconstruction af-
A retrospective review of consecutive adult (18 years or older)
ter NSM should be informed of the high probability of surgical revision.
female patients who underwent NSM with BR over a 3-year period
Key Words: breast reconstruction, nipple sparing mastectomy, (January 2013 to December 2015) was performed at 2 accredited Breast
implant-based breast reconstruction Units in Rome (San Giovanni-Addolorata Hospital and Campus Bio-
(Ann Plast Surg 2019;83: 392–395)
Medico University of Rome). Only BRs after NSMs performed for breast
cancer were considered in the present study, and cases performed for pro-
phylaxis were excluded to allow a more homogeneous group of patients.
T he current literature suggests that nipple sparing mastectomy (NSM)
is oncologically safe, if the retroareolar margin is negative,1,2 and
that it provides a significant improvement in quality of life after recon-
Each breast unit performed weekly multidisciplinary meetings,
where all cases were thoroughly discussed both in the preoperative and
struction compared with non–nipple-sparing mastectomy.3 the postoperative periods. Multicentric tumors without nipple-areola
Reconstructive techniques after mastectomy continue to evolve, complex (NAC) involvement were the main indications for NSM.
with the goal of optimizing esthetics while minimizing morbidity. Patients were divided into 2 groups according to the type of re-
Among the available methods of breast reconstruction (BR), implant- construction: expander-prosthesis (E-P) (group A) and DTI (group B).
based BR is the most widely used, and traditionally, it has been per- The following information were available: age at diagnosis, stage
formed in a 2-stage fashion. More recently, immediate reconstruction of disease, history of radiation therapy, and history of chemotherapy,
body mass index, smoking status, medical comorbidities (ie, diabetes
Received October 9, 2018, and accepted for publication, after revision January 21, 2019.
mellitus, hypertension, coronary artery disease), and surgical variables
From the *Plastic and Reconstructive Surgery Unit, Campus Bio-Medico, University (ie, type of skin incision and use of ADM).
of Rome; †Breast Unit, San Giovanni-Addolorata Hospital; ‡Breast Unit, Campus The skin flaps were carefully dissected with a low-voltage elec-
Bio-Medico, University of Rome; and §Plastic and Reconstructive Surgery Unit, tric scalpel, maintaining a thickness about 3 mm. The technique of the
San Giovanni-Addolorata Hospital, Rome, Italy.
Conflicts of interest and sources of funding: none declared.
hydrodissection of the NAC with saline solution was performed to facil-
No sources of support require acknowledgment. itate retroareolar dissection, and to increase the distance between the
Reprints: Tiziano Pallara, MD, Plastic and Reconstructive Surgery Unit, Università surgical plane and the epidermis minimize the thermal damage.15
Campus, Bio-Medico di Roma, Via A. del Portillo 200, 00128, Rome, Italy. E-mail: After the completion of mastectomy, the viability of the mastec-
t.pallara@gmail.com.
Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
tomy skin flaps was first checked. Excision of the nonviable skin flap
ISSN: 0148-7043/19/8304–0392 was done if no bleeding was observed in the skin margin and definite
DOI: 10.1097/SAP.0000000000001893 compromise of skin circulation was confirmed. After assessing the skin

392 www.annalsplasticsurgery.com Annals of Plastic Surgery • Volume 83, Number 4, October 2019

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Annals of Plastic Surgery • Volume 83, Number 4, October 2019 Breast Reconstruction

The normality criteria for each continuous variable were veri-

TABLE 1. Patients' Charactheristics fied. Normal variables were analyzed using parametric statistical tests
such as Student t test. Nonparametric variables, on the other hand, were
Group A (E-P), Group B (DTI), analyzed using nonparametric tests such as the Mann-Whitney U test.
N = 162 (n = 56–35%) (n = 106–65%) P Discrete variables were analyzed with the χ2 test. Logistic regression
Age, y 50 48 0.1 (for complications) and ordinal (for qualitative measures) were used
BMI 23 22.7 NS to assess the influence of chemotherapy, radiotherapy and axillary
Smoking habit 21 (37.5%) 14 (13%) NS lymph node dissection on the outcomes. All statistical analyses were
carried out using the STATA SE 13.0 program. All values of P less than
Diabetes 1 (2%) 3 (3%) NS
0.05 were considered meaningful.
Hypertension 10 (18%) 16 (15%) NS
pTis 7 (12.5%) 10 (9%) NS RESULTS
pT1 30 (54%) 56 (53%) NS
One hundred sixty-two patients met the inclusion criteria. Fifty-six
pT2 19 (34%) 35 (33%) NS patients were included in group A (34.6%), and 106 in group B (65.4%).
pT3 0 5 (5%) NS An ADM or a synthetic mesh was used only in 2 patients (both in Group
N0 34 (60%) 80 (75%) 0.1 B). In 90% of cases a radial incision in the outer quadrants was performed.
N1 18 (32%) 20 (19%) 0.1 Patients' characteristics are shown in Table 1. There were no sta-
N2 2 (4%) 5 (5%) NS tistically significant differences between the 2 groups. Complications
N3 2 (4%) 1 (1%) NS associated with the 2 types of BR were not different (P = 0.2) (Table 2)].
Adjuvant CT 25 (45%) 35 (33%) NS Patients in group A received a higher number of total surgical
Neoadjuvant CT 5 (9%) 11 (10%) NS procedures (considering revisions, lipostructures, and contralateral
PMRT 8 (14%) 1 (1%) 0.1 symmetrizations) than those in group B (2.5 ± 0.69 and 1.88 ± 1.02,
P = 0.0001) (Table 3). A contralateral breast adjustment was performed
ADM/mesh 0 2 (2%) NS
in 43 (76.79%) of 56 patients in group A and in 52 (49.06%) of 106 patients
SLB 28 (50%) 48 (45%) NS in group B (P = 0.001).
ALND 28 (50%) 58 (55%) NS A prosthetic replacement was performed at different times in the
Median F-U, mo 37 33 NS course of the postoperative period in 4 (7.1%) of 56 patients in group A,
BMI, body mass index; CT, chemotherapy; PMRT, postmastectomy radiation and in 39 (36.8%) of 106 patients in group B (P = 0.0001), usually for
therapy; SLNB, sentinel lymph node biopsy; ALND, axillary lymph node dissection. capsular contracture or malposition. The incidence of capsular contrac-
ture was the same between the 2 groups.
At the multivariate analysis chemotherapy and radiotherapy were
flap, the defect size was reevaluated to decide between expander im- not correlated with complications, regardless of the group (OR, 0.91
plant or DTI reconstruction. Prosthesis were implanted under the mus- and 2.74, respectively). Radiotherapy and chemotherapy did not even
cular layer, composed of the pectoralis major and serratus. Acellular influence the esthetic result, regardless of the group (P = 0.816 and
dermal matrices were used to provide coverage for the inferior pole of P = 0.521, respectively).
the implant, when muscle could not cover completely the implant. In 3 (2.8%) patients of group B, the NAC was removed in the
Radiotherapy was always performed after definitive postoperative period for diagnosis of a positive retro-areolar margin
implant positioning. on definitive histological examination, whereas no such cases were re-
Any complication, such as partial or full thickness necrosis of the corded in group A.
NAC, scar dehiscence, flap necrosis, capsular contracture, infection, seroma, Only 1 case of local recurrence was found in both (1.79% for
and hematoma, were registered. For each patient, the number and type group A and 0.94% for group B) at a median follow-up of 35 months.
of reoperations (ie, contralateral breast surgeries, breast lipostructure, Satisfaction with BR resulted higher in group A (7.5 ± 2.6 and
prosthesis removal/revision) after NSM were also recorded. 6 ± 1.9, P = 0.0004) (Fig. 1).
Additionally, during the month of January 2018 patients were
asked to answer anonymously regarding their satisfaction with the DISCUSSION
whole reconstruction process and with the final esthetic results, giving The study evidences that 2-stage BR requires, as natural, more
a score from 0 to 10 and considering the following parametric ranges: procedures to reach the definitive result. Furthermore, in this setting,
0–2 insufficient, 3–4 sufficient, 5–6 good, 7–8 great, 9–10 excellent. contralateral breast surgery is most often performed. However, 2-stage

TABLE 2. Overall Complications

Complications Group A (n = 56, [34.6%]) Group B (n = 106, [65.4%]) P

Partial necrosis of NAC 2 (3.6%) 11 (10.4%) 0.13
Total necrosis of NAC 3 (5.4%) 4 (3.8%) NS
Scar dehiscence/minor necrosis of mastectomy flaps 2 (3.6%) 11 (10.4%) 0.13
Major necrosis of mastectomy flaps 1 (1.8%) 6 (5.7%) NS
Capsular contracture grade I/II 46 (82,1%) 86 (81,1%) NS
Capsular contracture grade III/IV 10 (17.9%) 20 (18.9%) NS
Infection requiring expander/implant removal 3 (5,4%) 11 (10.4%) NS
Hematoma 1 (1,8%) 0 0.16
Seroma 2 (3.6%) 6 (5.7%) NS

© 2019 Wolters Kluwer Health, Inc. All rights reserved. www.annalsplasticsurgery.com 393

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

Pallara et al
TABLE 3. Total Surgical Procedures
GROUP A (E-P) GROUP B (DTI)
Operations n = 56 (35%) n = 106 (65%) P stages. An important advantage of a 2-stage reconstruction is the oppor-
Contralateral breast surgery 43 (77%) 52 (49%) 0.001
Lipostructure 10 (18%) 14 (13%) NS
EP change 4 (7%) 39 (37%) 0.0001
EP removal 3 (5%) 8 (7.5%) NS
Total (mean value) 2.5 1.9 0.0001
BR showed higher values in esthetic results. The 2 techniques have the
same rate of complications.
Although a variety of choices are currently available for post-
mastectomy reconstruction, implant-based techniques remain the most
common.16 Among these procedures, DTI reconstruction has become
an attractive option for both patients and surgeons because it offers mul-
tiple advantages.17 By opting for a single-stage approach, patients un-
dergoing mastectomy can forego the multiple visits required for
expansions and the disability time from a second operation. Whether
because of surgical complications or because of adjuvant cancer thera-
pies, the interval between expander placement and its exchange may be
prolonged for some patients. Although patients are requesting single-
stage procedures, surgeons may be hesitant to perform DTI reconstruc-
tion because of a perceived higher risk of complications, compared with
traditional expander-implant technique.11 Previous investigators have
analyzed outcomes for DTI and expander-/implant-based reconstruc-
tion, but these studies have been limited by single-center designs or rel-
atively short lengths of follow-up.12–14,18
In our study, when controlling for these covariates, we found no
statistically significant differences between the procedure types for rates
of complications. We agree with the review of Endara et al,19 in which it
is stated, although with higher percentages, that the incidence of the
NAC necrosis is slightly higher with DTI reconstruction (4.5% vs 18%
and 3.6% vs. 10.4% in our study, respectively in the E-P reconstruction
and DTI). The highest percentage of complications in group B is presum-
ably to be linked to the fact that this reconstructive method has been pro-
posed to a large cohort of patients (eg, T3 patients), not considering the
selection criteria disseminated in the literature, such as young and no
smoker patients with medium/small and non ptotic breasts.
FIGURE 1. Outcomes of esthetic satisfaction.
394 www.annalsplasticsurgery.com
Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Annals of Plastic Surgery • Volume 83, Number 4, October 2019
As it was clear to expect, patients in group A performed more
operations than those in group B. However, it was found that patients
undergoing direct-to-implant reconstruction had significantly higher
prosthetic replacement rates than those undergoing reconstruction in 2
tunity of breast pocket revision when replacing the breast expander with
the final prosthesis, as well as to perform a contralateral breast sym-
metrization. In more than 76% of cases, in fact, patients performed a
breast symmetrization in group A. In the middle of the cases, how-
ever, this procedure was performed in group B. Therefore, in 50%
of cases, in group B, DTI reconstruction was already able to make
the breasts symmetric. Many surgeons exploit the second-time re-
constructive procedure to make adjustments in the position of the
periprosthetic pocket and the submammary sulcus or for a better profile
and symmetry.
The fact that DTI reconstructions have a likelihood of requiring
additional surgical revisions almost 5 times higher probably reflects the
limitations of working with fresh mastectomy skin flaps and having lim-
ited pocket control. These are important factors for obtaining the best
cosmetic result.
The high rate of revisions of BR could affect the overall judgment.
This is can also be reconnected to the learning curve which, of
course, is created for a more recent technique than the 2-stage recon-
struction. The resulting result is in line with the randomized prospective
study conducted by Eriksen et al20 in which, comparing results and sat-
isfaction after BR, they showed a 70% revision rate with DTI recon-
struction due to an unacceptable cosmetic appearance, compared with
only 10% of the 2-stage reconstructions. Therefore, patients requiring
immediate reconstruction with permanent prosthesis should be ade-
quately informed at preoperative visit with regard to the need for further
revisions. This stage could lead to a further selection of patients who are
candidates for the different types of BR.
One of the most common cosmetic problems in implant-based
BR is the dislocation of the NAC. Some authors argue that its lateraliza-
tion is related to the prosthetic device, the size and degree of breast pto-
sis, the disjunction between the musculocutaneous layers and the
prosthesis.21,22 In our opinion, the type of skin incision may be essential
in causing malposition of the NAC as a result of scar contraction after a
radial incision. Therefore, we believe that the most effective way to pre-
vent the lateralization of the NAC is the use of an incision located on the
inframammary fold, and we have adopted this approach in our clinical
practice for most cases.
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
Annals of Plastic Surgery • Volume 83, Number 4, October 2019
Our study has several limitations. First, it a retrospective review,
and this may include selection bias. Second, the number of patients was
not large compared to multicenter studies. Third, the groups had a dif-
ferent sample size.
CONCLUSIONS
Prosthetic BRs, both in a single and in 2 stages, are welcomed by
patients and have relatively low and almost equivalent complication
rates, independent of other factors, such as chemotherapy, radiotherapy,
lymphadenectomy, smoking, and age.
In our experience, 2-stage BR, although requiring more opera-
tions, is associated with a higher esthetic satisfaction. Patients who per-
form a DTI BR after NSM should be informed of the high probability of
surgical revision.
However, DTI reconstruction is associated with a lower number of
total surgical interventions, multiple office visits for expansion are avoided,
and this can be particularly valuable in the oncologic setting. Thus, DTI
reconstruction should continue to be offered to patients in whom a good
shape and volume of the breasts are expected to be achieved in 1 step.
REFERENCES
1. Fortunato L, Loreti A, Andrich R, et al. When mastectomy is needed: is the nipple-
sparing procedure a new standard with very few contraindications? J Surg Oncol.
2013;108:207–212.
2. Coopey SB, Smith BL. The nipple is just another margin. Ann Surg Oncol. 2015;
22:3764–3766.
3. Bailey CR, Ogbuagu O, Baltodano PA, et al. Quality-of-life outcomes improve
with nipple-sparing mastectomy and breast reconstruction. Plast Reconstr Surg.
2017;140:219.
4. Lee BT, Duggan MM, Keenan MT, et al. Commonwealth of Massachusetts Board
of registration in medicine expert panel on immediate implant-based breast recon-
struction following mastectomy for cancer: executive summary, June 2011. J Am
Coll Surg. 2011;213:800–805.
5. D'Souza N, Darmanin G, Fedorowicz Z. Immediate versus delayed reconstruction
following surgery for breast cancer. Cochrane Database Syst Rev. 2011;7:CD008674.
6. Ganske I, Verma K, Rosen H, et al. Minimizing complications with the use of acel-
lular dermal matrix for immediate implant-based breast reconstruction. Ann Plast Surg.
2013;71:464–470.
7. Ho G, Nguyen TJ, Shahabi A, et al. A systematic review and meta-analysis of
complications associated with acellular dermal matrix-assisted breast reconstruction.
Ann Plast Surg. 2012;68:346–356.
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Breast Reconstruction
8. Vardanian AJ, Clayton JL, Roostaeian J, et al. Comparison of implant-based imme-
diate breast reconstruction with and without acellular dermal matrix. Plast Reconstr
Surg. 2011;128:403e–410e.
9. Venturi ML, Mesbahi AN, Boehmler JH 4th, et al. Evaluating sterile human acel-
lular dermal matrix in immediate expander-based breast reconstruction: a multi-
center, prospective, cohort study. Plast Reconstr Surg. 2013;131:9e–18e.
10. Fischer JP, Wes AM, Tuggle CT 3rd, et al. Risk analysis of early implant loss after
immediate breast reconstruction: a review of 14,585 patients. J Am Coll Surg.
2013;217:983–990.
11. Dikmans RE, Negenborn VL, Bouman MB, et al. Two-stage implant-based breast
reconstruction compared with immediate one-stage implant-based breast recon-
struction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre,
randomised, controlled trial. Lancet Oncol. 2017;18:251–258.
12. De Vita R, Zoccali G, Buccheri EM, et al. Outcome evaluation after 2023
nipple-sparing mastectomies: our experience. Plast Reconstr Surg. 2017;139:
335e–347e.
13. Jensen JA, Orringer JS, Giuliano AE. Nipple-sparing mastectomy in 99 patients
with a mean follow-up of 5 years. Ann Surg Oncol. 2011;18:1665–1670.
14. Susarla SM, Ganske I, Helliwell L, et al. Comparison of clinical outcomes and pa-
tient satisfaction in immediate single-stage versus two-stage implant-based breast
reconstruction. Plast Reconstr Surg. 2015;135:1e–8e.
15. Folli S, Curcio A, Buggi F, et al. Improved sub-areolar breast tissue removal in
nipple-sparing mastectomy using hydrodissection. Breast. 2012;21:190–193.
16. ASPS. Reconstructive procedures by demographic, 2013. Available at: https://
www.plasticsurgery.org/documents/News/Statistics/2013/reconstructive-breast-
procedures-age-2013.pdf. Accessed July 2017.
17. Colwell AS, Damjanovic B, Zahedi B, et al. Retrospective review of 331 consec-
utive immediate single-stage implant reconstructions with acellular dermal matrix:
indications, complications, trends, and costs. Plast Reconstr Surg. 2011;128:
1170–1178.
18. Han HH, Kim HB, Kim EK, et al. Direct-to-implant as a frontline option for im-
mediate breast reconstruction: a comparative study with 2-stage reconstruction.
Ann Plast Surg. 2018;81:274–279.
19. Endara M, Chen D, Verma K, et al. Breast reconstruction following nipple-sparing
mastectomy: a systematic review of the literature with pooled analysis. Plast
Reconstr Surg. 2013;132:1043–1054.
20. Eriksen C, Lindgren EN, Frisell J, et al. A prospective randomized study compar-
ing two different expander approaches in implant-based breast reconstruction: one
stage versus two stages. Plast Reconstr Surg. 2012;130:254e–264e.
21. Nahabedian MY, Tsangaris TN. Breast reconstruction following subcutaneous
mastectomy for cancer: a critical appraisal of the nipple-areola complex. Plast
Reconstr Surg. 2006;117:1083–1090.
22. Spear SL, Hannan CM, Willey SC, et al. Nipple-sparing mastectomy. Plast Reconstr
Surg. 2009;123:1665–1673.
www.annalsplasticsurgery.com 395