METHODS
Patients
A retrospective chart review was conducted on breast cancer patients who underwent BCS with multiple layers of ADM between August 2016 and December 2019. All patients included in the study had a minimum postoperative follow-up of 3 years and had received postoperative radiation therapy. Data collected included patients’ demographic information, medical history, tumor stage, type and location, weight of tissue resected, and other relevant details, all of which were extracted from their medical records. The ADM used in all surgical procedures was SureDerm (Han’s BioMed).
Anticipated postoperative complications included breast deformities, seromas, hematomas, and infections. Breast deformities encompass breast asymmetry, skin irregularities, and surgical site depression. Specifically, our study aimed to determine if the incidence of breast deformity varied depending on the breast quadrant where the tumor was located. Seromas were defined as those present on follow-up imaging studies at least 6 months post-surgery.
All participants provided written informed consent for the storage of their medical information in the database and for the use of this information in research. The study protocol received approval from the Institutional Review Board at Pusan National University (approval number: 05-2023-181).
Surgical technique
Before the surgery, the incision line was planned based on the tumor’s location while the patient was seated. Typically, this line extended around the areola, but if the tumor was near the premaxillary area or the inframammary fold (IMF), the incision was adjusted accordingly. The tumor was then removed along this line. After determining the extent of the area needing reconstruction, the dissection boundaries were marked. Once it was confirmed that the depth of the defect approached the pectoralis major (PM) fascia, the skin flap was carefully separated from the glandular flap within the designated dissection area. The dissection technique was adjusted so that the skin flap increased in thickness as it moved away from the defect. Additionally, we ensured that the glandular flap was repositioned towards the defect to minimize tension.
Once the flap was repositioned over the defect, any potential depressions along the flap’s margins were marked. These areas were then augmented with additional ADMs to ensure a smooth contour. For all patients, the ADM was prepared from a 7 ×12 cm SureDerm (Han’s BioMed) product weighing 30 g. Typically, the weight of the excised tissue was matched with the weight of the ADM used to fill the defect. In some cases, an ADM weighing up to twice as much as the removed tissue was used for excessive correction. After the glandular flap was dissected, the size of the dead space between the PM fascia and the glandular flap was measured. Approximately three to four layers of ADM, cut to various sizes and slightly overlapping, were layered and sutured into place within the defect (
Fig. 1). Whenever feasible, the ADM was cut slightly larger than the defect to avoid the need for sutures.
If the defect was near the subareolar area, the ADM was wedged between the glandular flap and sutured to prevent excessive depression of the nipple-areolar complex (NAC). In cases of dense breasts where the glandular flap could not be sufficiently slid, the ADM was sutured between the glandular flaps. If the glandular flap could be sufficiently slid, several layers of ADM were inserted between the PM fascia and the glandular flap before suturing the glandular flaps together. After suturing the glandular flaps together, ADM was placed between the skin flap and the glandular flap along the dissection area before suturing. A 100-cc drainage bag was positioned deep beneath the ADM and maintained for at least 5 days post-surgery. The drainage bag was removed when the output remained below 10 cc for three consecutive days. Postoperative management included restricting upper body muscle training until 2 months post-surgery and delaying the start of high-intensity workouts until at least 6 to 12 months post-surgery. Patients began full-range stretching 1-week post-surgery and were advised to lie on their sides, avoiding lying prone until 2 months post-surgery to prevent pressure on the surgical site.
RESULTS
This study included a total of 84 cases involving 74 patients, all of whom received postoperative radiation therapy. The mean age of the patients was 59 years, with a mean follow-up period of 52 months.
Table 1 presents the clinical characteristics of the patients. Regarding the reconstruction sites, the distribution was as follows: 35 cases involved the upper outer quadrant, 20 cases the upper inner quadrant, 15 cases the lower outer quadrant, 10 cases the lower inner quadrant, and four cases involved NAC reconstruction (
Fig. 2).
Table 2 details the excised weight of tissue resected from each breast segment.
The mean number of ADM layers used varied by the location of the defect. The NAC area utilized the most layers, averaging 6.5, followed by the lower outer quadrant with 5.5 layers, the lower inner quadrant with 4.8 layers, and the upper inner quadrant with 4.7 layers. The upper outer quadrant used the fewest layers, averaging 3.3.
During the follow-up period, breast deformation necessitating surgical correction occurred in 10 of the 84 cases (11.9%). Additionally, one patient (1.2%) experienced severe breast deformity and required re-operation to remove the ADM. Seromas were detected in follow-up imaging studies for at least 6 months post-surgery in four cases (4.8%), with one of these cases (1.2%) developing contracture. There were also two cases of fat necrosis (2.4%) (
Table 3).
In terms of the incidence of breast deformity by surgical site, the highest occurrence was noted when the ADM was placed around the NAC, with deformities arising in two out of four cases. In upper outer reconstruction, deformities occurred in four out of 35 cases (11.4%), while in upper inner reconstruction, three out of 20 cases (15%) experienced deformities. Lower inner reconstruction saw deformities in one out of 10 cases (10%), with the severity in one case necessitating the removal of the ADM. No instances of breast deformity were reported in lower outer reconstruction cases where ADM was used (
Table 4).
The patient who underwent ADM removal exhibited severe skin irregularities along the ADM margin 1 year after surgery, accompanied by discharge from the NAC. This patient had the ADM removal surgery 22 months following the initial breast reconstruction, yet medial atrophy and contracture deformity remained. Four patients displayed seroma on ultrasounds conducted 6 months post-surgery. All four continued to exhibit fluid collection on magnetic resonance imaging scans performed at the 1-year and 2-year follow-up appointments, with one patient developing capsular contracture.
DISCUSSION
BCS has emerged as a novel approach for tumor removal that preserves the natural shape of the breast. It is primarily categorized into two concepts: volume displacement and volume replacement [
2-
5].
Volume displacement entails the removal of the tumor accompanied by procedures such as glandular reapproximation, deepithelialization, and repositioning of the NAC. Techniques like superior pedicle mammoplasty or V-mammoplasty, which utilize either an inverted T scar or a vertical scar, are selected based on the tumor’s location and the volume of tissue resected [
2,
7-
9]. Volume replacement involves reconstructive strategies using autologous tissue flaps, including latissimus dorsi (LD) flaps, lateral thoracodorsal flaps, or intercostal artery perforator (ICAP) flaps, or synthetic materials such as ADM. This approach is used when the remaining breast tissue is inadequate for reconstruction by repositioning alone [
10-
12].
In this study, we chose a method that involves repositioning the breast tissue using a local glandular flap and augmenting the deficient volume with multiple layers of tailored ADM pieces. This technique effectively combines displacement and replacement strategies. The procedure not only facilitates faster recovery and higher patient satisfaction but also features a relatively smaller surgical scope and shorter operation time compared to other flap techniques such as the LD flap and ICAP flap, without the risk of donor site complications. In contrast, reconstructions using the LD flap in BCS have been associated with complications at both the flap and donor sites, with a reported complication rate including seroma, wound dehiscence, and partial flap loss of 33.3% [
13]. Moreover, it significantly reduces the risk of flap necrosis, a common issue with procedures like the thoracodorsal artery perforator flap [
14,
15].
The technique of maintaining breast shape and reconstructing it after BCS using ADM has been previously reported. In these cases, commercially available diced ADM is used to fill the defect [
16]. However, this study is distinguished by the surgeon personally cutting and layering the ADM to precisely match the volume and shape of the tumor, and then reconstructing it in conjunction with the glandular flap. This method offers the advantage of a more natural restoration of breast shape. Similar to other reconstruction techniques, the location and size of the tumor are critical factors, with subtle variations in the methods and outcomes accordingly.
For the excision of upper outer breast tissues in BCS, favorable outcomes were observed when the tissues were removed close to the PM fascia, particularly in cases where a small amount of tissue was excised from patients with moderately large or large breasts weighing 300 g or more. Conversely, complications such as atrophic deformities tended to occur when the skin flap was too thin, the distance between the nipple and IMF was narrow, or there was significant tissue removal in the medial area. This is attributed to the fact that thinner skin flaps are more prone to pigmentation following radiation therapy, and significant medial resections can lead to inadequate movement of the glandular flap, thereby increasing the risk of atrophic deformities.
In patients with a narrow nipple-to-IMF distance, noticeable changes in breast shape were more evident when the tumor resection included the subareolar area or extended below the NAC. This observation is consistent with previous research, which suggests that in cases involving lower tumors, the remaining tissue post-resection is often insufficient, leading to increased risks of unfavorable distortion, skin contraction, and inaccuracies in the lower positioning of the NAC [
2]. Consequently, when resecting the medial boundary of the breast or the IMF area, it is beneficial to overcorrect by adding more than four layers of ADM to compensate for the resection volume and to ensure that the flap is sufficiently thick. This approach aligns with findings that the thickest ADM layer used for reconstructing defects in the NAC and IMF areas yields favorable outcomes.
Fig. 3 shows a follow-up photograph taken 3 years after reconstruction with ADM in the medial area.
In addition, overcorrection with ADM relative to the resection volume offers cosmetic benefits because ADM is resistant to radiation and consists of cells that have already been exposed to radiation, making it particularly useful in breast reconstruction where radiation therapy is anticipated [
17]. Consequently, we minimized the dissection between the PM and the glandular flap while enhancing the dissection between the skin flap and the glandular flap. This allowed for the insertion of ADM between these layers. This technique helped prevent breast atrophy, shape deformation, and fat necrosis that could result from subsequent radiation therapy (
Fig. 4).
A persistent seroma over an extended period may increase the risk of breast atrophy deformity.
Fig. 5 illustrates a seroma observed 18 months post-surgery following the insertion of ADM. When multiple layers of ADM are used, suturing them together can help minimize dead space and reduce the incidence of seroma [
18]. Therefore, it is advisable to suture the layers of ADM when they are inserted in multiple layers (
Fig. 1). Additionally, the risk of seroma tends to be lower when ADMs are placed between glandular flaps or are fixed in such a way that they overlap minimally, ensuring maximal contact with the flaps while minimizing contact between the ADM layers themselves.
With increased experience, the incidence of complications diminished. Among the 10 patients who experienced breast deformity, seven cases occurred in those who underwent surgery in 2016 and 2017, coinciding with the initial adoption of this surgical procedure.
This study has several limitations. First, it was conducted by a single plastic surgeon and designed as a longitudinal study, which may result in variations due to the surgical technique used. Second, the evaluation of patient satisfaction and aesthetic outcomes is largely subjective. Finally, most patients experienced hard palpation due to the ADM placed at the defect site, and postoperative breast deformity complications were observed in 10 out of 74 patients (13.5%), suggesting that improvements are necessary. Therefore, when choosing this surgical approach, it is crucial to thoroughly assess the patient’s condition, the location of the tumor, and individual preferences.
In conclusion, using a glandular flap and a multilayered ADM for BCS provides several advantages, including reduced surgical time, simplicity of the procedure, and the elimination of the need for a donor site. Although there is a risk of breast deformity depending on the location of the defect, and the palpable presence of the inserted ADM may prevent achieving a perfectly natural reconstruction, it is anticipated that referencing this study’s findings and accumulating additional cases will enhance outcomes with this new surgical technique.