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. 2024 Mar 8;103(10):e37365. doi: 10.1097/MD.0000000000037365

Risk factors for severe complications and salvage management in direct-to-implant immediate breast reconstruction: A retrospective study

Meizhen Zhu a,*, Jiefei Mao a, Jun Fang b, Daobao Chen a
PMCID: PMC10919468  PMID: 38457600

Abstract

Controversies regarding the risk factors affecting direct-to-implant (DTI) immediate breast reconstruction still exist. This study aimed to evaluate the risk factors for severe complications in DTI breast reconstruction and explore potential salvage management strategies. We conducted a retrospective review of 238 patients (240 breasts) who underwent DTI immediate breast reconstruction between 2011 and 2020. Multivariate logistic regression analyses were used to identify the risk factors predicting severe complications. Seventeen (7.08%) reconstructed breasts experienced severe complications, of which only 5 were successfully salvaged through surgical revision, while the others failed and resulted in implant removal. Multivariate analyses demonstrated that mesh use [odds ratio (OR) = 4.054, 95% confidence interval: 1.376–11.945, P = .011] and post-mastectomy radiotherapy (odds ratio = 4.383, 95% confidence interval 1.142–16.819, P = .031) were independent predictors of severe complications. Mesh use and post-mastectomy radiotherapy for breast reconstruction increase the risk of severe complications. Despite positive surgical treatment, the successful salvage rate was poor.

Keywords: breast reconstruction, implant, mesh, radiotherapy

1. Introduction

Breast cancer is the most common carcinoma among females in China, and 70% of the patients are younger than 60 years of age.[1] Along with significant improvements in comprehensive treatment and a multidisciplinary team approach, the mortality rate of breast cancer is decreasing.[2] Moreover, with the development of the economy and improvement in living conditions in China, the demand for a better body image and quality of life has also been increasing, particularly among younger patients. Breast reconstruction following mastectomy can help patients modify local deformities and improve cosmetic outcomes, and thus increase self-confidence and satisfaction in social and psychological aspects.[3]

Immediate breast reconstruction has shown satisfactory aesthetic results and overall psychological well-being compared with delayed breast reconstruction.[4] Moreover, previous studies support the oncological safety of immediate breast reconstruction following total mastectomy.[5,6] Similar to the United States, implant-based breast reconstruction (IBR) is the most prevalent form of breast reconstruction in China, partly because of minimal donor site sacrifice and thus faster postoperative recovery, as well as a shorter learning curve, which is favored by more doctors and patients.[7] However, IBR is often associated with a higher incidence of complications including infection, implant exposure, capsular contracture, and malposition. Adjuvant therapy, such as chemotherapy and post-mastectomy radiation therapy (PMRT), further increases the risk of complications.[8]

Direct-to-implant (DTI) breast reconstruction, which involves a single-stage operation, is a reasonably preferred choice for patients who desire aesthetic benefits and minimal costs. However, the DTI approach has not been popularized because severe complications, including flap necrosis, wound dehiscence, and implant/mesh exposure, still occur.[9] Furthermore, 17.6% of breast reconstructions result in implant removal, despite positive surgical treatment.[10] Implant removal is not only a financial loss but also frustrating for both surgeons and patients. Surgeons may experience feelings of guilt, and their self-confidence may be undermined, while patients may experience several physical and psychosocial impacts.[11] However, many controversies remain regarding the risk factors for severe complications.[12] Thus, the purpose of the present study was to evaluate the risk factors for severe complications in immediate IBR procedures from the perspectives of patient characteristics, surgical techniques, and adjuvant therapies, to prevent severe complications, and to explore better salvage management.

2. Materials and methods

2.1. Study design

Patients with breast cancer who underwent breast reconstruction at our single center between January 2011 and December 2020 were retrospectively reviewed following the approval of the Zhejiang Cancer Hospital Clinical Research Ethics Committee (IRB-2020-327). The eligibility criteria were as follows: female patients with histologically confirmed in situ or invasive breast cancer in the primary or after neoadjuvant chemotherapy (NACT); patients who underwent immediate DTI breast reconstruction. Patients were excluded if they met any of the following criteria: delayed breast reconstruction; immediate autologous breast reconstruction, 2-stage immediate IBR, contralateral prophylactic mastectomy followed by reconstruction, history of ipsilateral breast radiotherapy, and local recurrence and/or distant metastasis.

2.2. Data collection

Patient characteristics, including age, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), smoking status, comorbidities (diabetes, hypertension), breast size, and pathological TNM stage, according to the 8th edition of the AJCC TNM staging system,[13] were recorded. Data on mastectomy types, such as skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM), incision type, sentinel lymph node biopsy or axillary lymph node dissection (ALND), device coverage, and mesh use were also collected. Adjuvant therapy details, such as NACT, adjuvant chemotherapy (ACT), PMRT, and perioperative antibiotics were recorded. Severe complications were defined as flap necrosis, wound dehiscence, implant and/or mesh exposure.

2.3. Surgical techniques

Patients undergoing NACT were expected to undergo surgery at least 2 weeks after the last chemotherapy. For patients with clinically suspected and/or pathologically confirmed nipple involvement, a transverse ellipse incision to remove the nipple-areola complex (NAC) was chosen for performing SSM, while lateral transverse with or without semicircle periareolar or inframammary fold were common incisions for NSM. In the subpectoral group, the implant was inserted into a pocket combined with the pectoralis major and either a mesh (TiLoop® Bra, Germany, Titanium-coated polypropylene mesh) or the serratus anterior muscle. Prepectoral group was divided into 2 groups. In the skin envelop group, the implant was wrapped around by the mesh and placed into the prepectoral space, properly positioned by suturing on the chest wall. The other latissimus dorsi envelop group, the implant was covered by part of latissimus dorsi, and the covering was total muscular without mesh use. Multidisciplinary treatment was performed for ACT and/or PMRT, according to the final pathology. Perioperative antibiotic prophylaxis was administered for 48 hours, and second-generation cephalosporins were preferred, while lincosamides may be another choice for allergic patients. Once severe complications occurred, positive salvage management would be given immediately. Based on our single-center experience, timely surgical revision was effective for small area flap necrosis or delayed healing. In cases of wound dehiscence, tension sutures, such as Z-shaped skin flap technique was necessary.

2.4. Statistical analysis

Categorical variables were analyzed using the chi-squared test or Fisher exact test. Logistic regression analysis was performed, and potential prognostic factors (P < .1) by univariate analysis were further entered into multivariate analysis to identify odds ratios (OR) and 95% confidence intervals (CI). Statistical analysis was performed using SPSS software (version 25.0; IBM Corporation, Armonk, NY, USA). All reported p values were 2-sided, and statistical significance was set at P < .05.

3. Results

A total of 238 patients (240 breasts) who underwent immediate DTI breast reconstruction from 2011 to 2020 in our single center were retrospectively reviewed. The median follow-up time after breast reconstruction surgery was 60 months (33–135) months.

3.1. Characteristics of study cohort

None of the patients had a history of smoking (present or former) and no patient had comorbidities of diabetes or hypertension (perhaps surgeons in our center were relatively more cautious and preferred patients without comorbidities for DTI operation). The characteristics of the patients, surgical techniques, and adjuvant therapies, stratified by severe complications, are shown in Table 1. Among 238 patients (240 breasts), 17 (7.08%) experienced severe complications. Significant differences were found in BMI, lymph node management, breast size, mesh use, pTNM stage, PMRT between the 2 groups (P < .05). However, other variables such as age, mastectomy type, incision type, pocket coverage, NACT, ACT, and perioperative antibiotics were not significant (P > .05).

Table 1.

Comparisons of characteristics in severe complication and non-severe complication groups undergoing breast reconstruction.

Variables Severe complication group Non-severe complication group P
(n = 17) (n = 223)
Age .885
 ≤ 40 yr 9 (52.94) 114 (51.12)
 > 40 yr 8 (47.06) 109 (48.88)
BMI .026
 ≤ 24 kg/m2 10 (58.82) 184 (82.51)
 > 24 kg/m2 7 (41.18) 39 (17.49)
Breast size .036
 ≤280 mL 6 (35.29) 141 (63.23)
 >280 mL 11 (64.71) 82 (36.77)
pTNM/ypTNM .011
 0 3 (17.65) 27 (12.11)
 I 2 (11.76) 99 (44.40)
 II 7 (41.18) 74 (33.18)
 III 5 (29.41) 23 (10.31)
Mastectomy type .120
 SSM 7 (41.18) 139 (62.33)
 NSM 10 (58.82) 84 (37.67)
Incision type 1.000
 Without periareolar 17 (100.00) 215 (96.41)
 Periareolar 0 (0.00) 8 (3.59)
Lymph node management .008
 SLNB 5 (29.41) 143 (64.13)
 ALND 12 (70.79) 80 (35.87)
Coverage of pocket .897
 Skin 0 (0.00) 11 (4.93)
 Pectoralis major muscle 13 (76.47) 167 (74.89)
 Latissimus dorsi 4 (23.53) 45 (20.18)
Mesh use .003
 No 7 (41.18) 170 (76.23)
 Yes 10 (58.82) 53 (23.77)
NACT .732
 No 14 (82.35) 189 (84.75)
 Yes 3 (17.65) 34 (15.25)
ACT .315
 No 5 (29.41) 97 (43.50)
 Yes 12 (70.59) 126 (56.50)
PMRT .031
 No 11 (64.71) 192 (86.10)
 Yes 6 (35.29) 31 (13.90)
Perioperative antibiotics .097
 Lincosamides 4 (23.53) 22 (9.87)
 Cephalosporins 13 (76.47) 201 (90.13)
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ACT = adjuvant chemotherapy, ALND = axillary lymph node dissection, BMI = body mass index, NACT = neoadjuvant chemotherapy, NSM = nipple-sparing mastectomy, PMRT = postmastectomy radiation therapy, SLNB = sentinel lymph node biopsy, SSM = skin-sparing mastectomy.

3.2. Predictors of severe complication

Univariate logistic regression analysis showed that BMI, lymph node management, breast size, mesh use, and PMRT were possible factors associated with severe complications (P < .01). Further multivariate analysis revealed that mesh use [OR = 4.054, 95% CI: 1.376–11.945, P = .011] and PMRT (OR = 4.383, 95% CI: 1.142–16.819, P = .031) were independent risk factors (Table 2).

Table 2.

Multivariate logistic regression analysis for predictors of severe complications.

Variables OR (95% CI) P
BMI
 >24 vs ≤ 24 kg/m2 1.844 (0.558–6.100) .316
Lymph node management
 ALND vs SLNB 1.648 (0.397–6.844) .492
Breast size
 >280 vs ≤ 280 mL 1.683 (0.514–5.513) .389
Mesh use
 Yes vs no 4.054 (1.376–11.945) .011
PMRT
 Yes vs no 4.383 (1.142–16.819) .031
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ALND = axillary lymph node dissection, BMI = body mass index, CI = confidence interval, OR = odds ratio, PMRT = post-mastectomy radiation therapy, SLNB = sentinel lymph node biopsy.

3.3. Implant salvage

Severe complications occurred in 17 (7.08%) of the reconstructed breasts, including flap necrosis, wound dehiscence, implant exposure, and mesh exposure (Fig. 1). Once these severe complications occur, adequate wound disinfection is performed, and antibiotics are administered empirically. Surgical salvage was then performed if necessary to revise the flap and ensure adequate drainage. However, only 5 of them were successfully salvaged by surgical revision, while the others failed and resulted in implant removal. The characteristics of the patients with severe complications are summarized in Table 3.

Figure 1.

Figure 1.

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(A) Flap necrosis occurred in a left SSM with DTI reconstruction; (B) wound dehiscence occurred in a left NSM with DTI reconstruction; (C) implant exposure occurred in a right NSM with DTI reconstruction; (D) mesh exposure occurred in a right NSM with DTI reconstruction enveloped by mesh. DTI = direct-to-implant, NSM = nipple-sparing mastectomy, SSM = skin-sparing mastectomy.

Table 3.

Characteristics of patients who experienced severe complications.

Patient No. Age BMI Lymph node management Breast size > 280ml Mesh use PMRT Complication Salvage result
1 43 24.98 ALND Yes No Yes Flap necrosis Removal
2 43 21.09 ALND No No No Wound dehiscence Success
3 39 23.05 ALND No No No Implant exposure Removal
4 44 25.16 ALND Yes No No Wound dehiscence Success
5 44 25.30 ALND Yes Yes Yes Flap necrosis Removal
6 46 24.11 SLNB No Yes Yes Flap necrosis Removal
7 44 23.46 SLNB Yes Yes No Wound dehiscence Success
8 36 18.29 SLNB No Yes No Implant exposure Removal
9 29 19.84 ALND Yes Yes Yes Mesh exposure Removal
10 48 23.23 ALND Yes No Yes Wound dehiscence Removal
11 39 25.35 SLNB Yes Yes No Implant exposure Success
12 51 19.53 ALND No Yes Yes Implant exposure Removal
13 31 28.63 ALND Yes Yes No Wound dehiscence Success
14 30 24.78 ALND Yes Yes Yes Mesh exposure Removal
15 33 23.74 SLNB Yes No No Implant exposure Removal
16 30 17.93 ALND No No Yes Implant exposure Removal
17 32 23.62 ALND Yes Yes Yes Mesh exposure Removal
Open in a new tab

ALND = axillary lymph node dissection, BMI = body mass index, NSM = nipple-sparing mastectomy, PMRT = post-mastectomy radiation therapy, SLNB = sentinel lymph node biopsy, SSM = skin-sparing mastectomy.

4. Discussion

With the rising trend of immediate IBR and advancements in surgical technology, DTI reconstruction has become an increasingly popular approach for restoring an acceptable aesthetic breast contour in a single operation.[14] However, DTI is associated with a higher likelihood of revision surgery because of its severe complications.[15] Our results revealed that 17 (7.08%) reconstructive breasts experienced severe complications, with only 5 successfully salvaged by surgical revision, while the others failed, resulting in implant removal. Multivariate analyses demonstrated that mesh use and PMRT were independent predictors of severe complications.

Old age and higher BMI are well-established risk factors for complications in immediate IBR from the patient perspective.[16] Furthermore, many studies have indicated that obesity is associated with reconstructive failure in both implant-based and autologous breast reconstruction.[17,18] Some studies have proposed a theory to explain why women with a higher BMI might have larger breasts, leading to longer operative times, longer mastectomy flaps, and more ischemia flaps.[8,19] Most patients in our study were younger than 40 years, and age was not found to be a risk factor. In contrast, higher BMI and larger breast size were significantly associated with severe complications. However, neither factor was an independent risk factor for severe complications.

Flap perfusion is closely associated with delayed wound healing in IBR. Yang et al quantified the tension-perfusion relationship and proved that flap perfusion deteriorated as skin tension increased from a larger implant.[20] SSM is a widespread technique in breast reconstruction surgery for patients clinically suspected and/or pathologically confirmed to have nipple involvement, which preserves the native skin envelope and inframammary fold.[8] However, in the case of SSM techniques, whose skin envelope is reduced owing to NAC dissection, further stress on the skin envelope is inherently created.[11] In contrast, NSM is an improved surgical technique with proven oncological safety in appropriately selected patients.[21,22] However, different incision locations in the NSM procedure are associated with different rates of NAC necrosis. Previous studies have demonstrated that periareolar incisions have a higher NAC necrosis rate, which may result in severe complications.[23] 94 (39.17%) breasts in the present study retained NAC, and 8 (3.33%) breasts received periareolar incisions. Nevertheless, the mastectomy type and incision were not risk factors for severe complications.

Significant differences were observed in axillary lymph node management between the severe and non-severe complication groups. However, ALND was not an independent risk factor in multivariate analysis. The removal of axillary lymph nodes affects lymph drainage and wound healing, which results in postoperative complications such as flap lymphedema, wound infection, and delayed healing.[24] Some studies have demonstrated that seroma formation was the most likely reason for wound infection after ALND, and minimizing dead space through fixation of axillary flaps with underlying muscles can lower the incidence of seroma.[25,26]

In our study, the coverage of the implant was either skin, total muscular, or muscular combined with a mesh. Total muscular coverage provides a protective pocket for the prosthesis in cases of flap necrosis or wound disruption.[27] Covering the pocket was not associated with severe complications. The mesh was generally placed and sutured to the pectoralis major muscle edges to support and cover the prosthesis. Mesh has many advantages, such as reducing muscle sacrifice, reducing prosthesis migration, improving the upper pole of the breast, and resulting in a natural inframammary fold, specifically in cases of larger breast size or insufficient muscle coverage.[11] Nevertheless, mesh use significantly increased the risk of complications compared with total muscular coverage in IBR.[27] A titanium-coated polypropylene mesh, which was approved for use in 2008 and had an implant loss rate of 8.7% in a previous report,[28] was popularly used in our center. Our study showed that mesh use was associated with a higher risk of severe complications and was an independent predictor in multivariate analysis.

Chemotherapeutic agents and irradiation have been proven to reduce local recurrence and improve patient survival outcomes in advanced breast cancer.[29] However, many studies have demonstrated that ACT is associated with cytotoxic effects and immunosuppression, which can cause wound infections and delayed healing.[30] Similarly, PMRT on a prosthesis may increase complications and compromise aesthetic outcomes.[31] The failure rate of IBR treated with PMRT was 18.7%.[32] In the present study, ACT was not found to be a risk factor for severe complications, whereas PMRT was associated with severe complications, which is consistent with previous studies. Moreover, PMRT was considered an independent predictor in multivariate analysis. In addition, 6 (16.22%) of the reconstructed breasts treated with PMRT experienced severe complications, and none of them were successfully salvaged.

Many studies have demonstrated that 24 hours of antibiotic prophylaxis is warranted,[33] and infectious disease guidelines recommend cephalosporins against gram-positive organisms as appropriate for non-allergic patients.[34] All patients in our study received antibiotic prophylaxis for 48 hours during the perioperative period, with second-generation cephalosporins prescribed for non-allergic patients and lincosamides for others. Furthermore, we found that perioperative antibiotic use was not associated with severe complications.

Once severe complications occurred, the success rate was still poor, despite positive salvage management. Only 5 reconstructed breasts were successfully salvaged by surgical revision in the present study, while the others were compromised and required implant removal. In our single-center experience, extensive skin flap necrosis was difficult to successfully revise. Keep the crust dry, trim it when it separates from the surface of the wound, and fall off gradually. However, when flap necrosis was in a small area or the wound was slow to heal, timely positive surgical revision was effective. When an implant or mesh is exposed due to wound dehiscence, it usually occurs at home. The patient should be instructed to cover the wound with sterile gauze immediately, and then come to the hospital for revision surgery. Replacing a smaller implant or revising the wound using tension sutures may be effective. Excise the necrotic portion of the skin flap or the original dehiscence at the incision site, and then suture it anew utilizing a Z-shaped skin flap technique to diminish tension. Crucially, ensure that the muscle layer incision overlying the implant is staggered in relation to the skin incision, avoiding any overlap. All surgical salvage management procedures require empirical antibiotic treatment, confirmation of bacterial culture, and adequate drainage. Severe complications caused by PMRT usually demonstrate extensive flap redness and swelling, accompanied by skin ulcer necrosis, resulting in exposure of the implant or mesh, which is difficult to salvage.

The main limitation of present study is the retrospective nature and single center design. Nonetheless, it offers a unique contribution by analyzing the factors leading to the failure of DTI breast reconstruction over the past decade from the perspective of a tertiary care institution in a developing country. This study also shares insights into salvage surgical procedures, an aspect not extensively reported in prior research. These insights have been gleaned through academic exchanges among domestic breast reconstruction surgeons and through the exploratory work conducted at our institution. To gain a more comprehensive understanding of salvage management strategies for severe complications in breast reconstruction, multicenter prospective clinical trials are warranted.

5. Conclusion

Ideally, patients suitable for DTI breast reconstruction should have a relatively low BMI and small breast size. In contrast, patients with larger breasts who require mesh coverage of the prosthesis or patients who require PMRT are more likely to develop serious complications, which would be difficult to salvage despite positive management.

Acknowledgments

We gratefully acknowledge the valuable cooperation of Dr Hong-jian Yang (Department of Breast Surgery, Zhejiang Cancer Hospital; Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences; Cancer Hospital of the University of Chinese Academy of Sciences at China) for preparing this application note.

Author contributions

Conceptualization: Meizhen Zhu, Daobao Chen.

Data curation: Jiefei Mao.

Formal analysis: Jiefei Mao, Daobao Chen.

Funding acquisition: Meizhen Zhu.

Investigation: Jiefei Mao.

Methodology: Jiefei Mao, Jun Fang, Daobao Chen.

Resources: Jiefei Mao, Jun Fang.

Software: Jun Fang.

Supervision: Meizhen Zhu, Daobao Chen.

Validation: Jun Fang.

Visualization: Jun Fang.

Writing – original draft: Meizhen Zhu.

Writing – review & editing: Meizhen Zhu, Daobao Chen.

Abbreviations:

ACT
adjuvant chemotherapy
ALND
axillary lymph node dissection
BMI
body mass index
CI
confidence intervals
DTI
direct-to-implant
IBR
implant-based breast reconstruction
NAC
nipple-areola complex
NACT
neoadjuvant chemotherapy
NSM
nipple-sparing mastectomy
PMRT
post-mastectomy radiotherapy
OR
odds ratios
SSM
skin-sparing mastectomy

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

All patient data were retrospectively reviewed following approval from the Zhejiang Cancer Hospital Clinical Research Ethics Committee (IRB-2020-327). Written informed consent from participants was not required in accordance with local and national guidelines.

The authors have no conflicts of interest to disclose.

This study was funded by grants from the Medical Science and Technology Project of Zhejiang Province (2021RC045) and Zhejiang Traditional Chinese Medicine Administration (2020ZB035).

How to cite this article: Zhu M, Mao J, Fang J, Chen D. Risk factors for severe complications and salvage management in direct-to-implant immediate breast reconstruction: A retrospective study. Medicine 2024;103:10(e37365).

Contributor Information

Jiefei Mao, Email: maojf2062@zjcc.org.cn.

Jun Fang, Email: fangjun1391@zjcc.org.cn.

Daobao Chen, Email: chendb@zjcc.org.cn.

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