Implant-based Breast Reconstruction Research Articles

Prospective Clinical Trial for Predicting Mastectomy Skin Flap Necrosis with Indocyanine Green Angiography in Implant-Based Prepectoral Breast Reconstruction.

Indocyanine green angiography (ICG-A) is a useful tool for evaluating mastectomy skin flap (MSF) perfusion during breast reconstruction. However, a standardized protocol for interpreting and applying MSF perfusion after mastectomy has not been established yet. The purpose of this study is to establish criteria for assessing MSF perfusion in immediate implant-based prepectoral breast reconstruction while correlating ICG-A findings with postoperative outcomes METHODS: This prospective observational study was conducted at a single institution and involved patients with breast cancer who underwent mastectomy and immediate implant-based prepectoral breast reconstruction between August 2021 and August 2023. The terms "hypoperfused flap" and "hypoperfused area" were defined according to ICG-A perfusion. MSF exhibited < 30% perfusion, excluding the nipple and the corresponding region, respectively. Data on the hypoperfused flap, hypoperfused area, and MSF necrosis were collected. Fifty-three breast cases were analyzed. Eight patients developed MSF necrosis (15.1%, 8/53). Of these, two patients underwent surgical debridement and revision within 3months (3.8%, 2/53). There were nine cases of a hypoperfused flap, eight of which developed MSF necrosis. The hypoperfused flap was a significant predictor of the occurrence of MSF necrosis (p < 0.001). There was a tendency for increased full-thickness necrosis with a wider hypoperfused area. The hypoperfused flap enabled the prediction of MSF necrosis with high sensitivity, specificity, positive predictive value, and negative predictive value. Considering the presumed correlation between the extent of the hypoperfused area and the need for revision surgery, caution should be exercised when making intraoperative decisions regarding the reconstruction method. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Autologous Fat Breast Reconstruction with Implant Completion-Experience with 29 Consecutive Cases and 33 Breasts.

Implant-based breast reconstruction is the most prevalent form of breast reconstruction. Autologous fat grafting (AFG) was conceptualized as an alternative to implant-based breast reconstruction and was found to be a reliable reconstruction modality. However, usually, a few grafting rounds are required to create the desired shape and size of the breast. Current literature describes ample experience with AFG as an adjunct to implant-based breast reconstruction for improving appearance. However, the utilization of breast implants following initial AFG has been sparingly described. The primary advantage of this study is the creation of new fat tissue as a breast mound. The reconstruction is then concluded by inserting an implant into this new mound. This approach reduces the overall number of fat injections needed to achieve the desired outcome, as well as the total volume of the implant. This IRB-approved retrospective study was conducted between January 2015 and December 2021. All women who underwent delayed breast reconstruction with AFG during this timeframe and wanted to complete it with a silicone implant as a last stage were included in the study. A total of 29 patients (33 breasts) underwent delayed breast reconstruction with AFG and a silicone implant as the final stage. In all cases, the results were satisfying without any major complications. Minor complications were observed with one patient and included an infection. The findings of this study have demonstrated the effectiveness of this procedure together with patient satisfaction, thus highlighting the potential advantages that this approach offers. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Abstract PO4-22-11: Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)

Abstract Background: The use of TiLOOP@ Bra in implant-based breast reconstruction (IBBR) becomes standard of care in mainland China. But evidence is limited about complication of one-stage and two-stage IBBR using TiLOOP@ Bra. A prospective randomized trial was conducted to compare the safety of immediate IBBR with that of immediate-delayed IBBR, both with TiLOOP@ Bra. Methods: We did an open label, randomized, controlled trial in eleven hospitals in the mainland China. Inclusion criteria: Women aged above 18 with cT0-T2N0M0 breast carcinoma which requires to undergo nipple or skin-sparing mastectomy (NSM or SSM) and immediate IBBR. Randomization was done electronically, stratified per center and in blocks of four of six to achieve approximately balanced groups of patients assigned to undergo one-stage or two-stage IBBR. Both procedures were undergone pectoralis major and TiLOOP@ Bra to build pockets. The primary endpoint of the present study was the incidence of postoperative complications (within 90 days after surgery), while the secondary endpoints were the quality of life at 18 months after surgery, satisfaction with breast appearance, aesthetic scores of reconstructed breasts, type of reoperation and TiLOOP@ Bra angiopathological assessment. This study is registered at clinicaltrials.gov, number NCT03589924. Findings: Between June 2018 and May 2022, a total of 418 eligible patients were randomly assigned to either two-stage implant reconstruction (n=194) group or immediate one-stage implant reconstruction (n=224) group. In terms of surgical procedures, NSM was more commonly (72.7%) chosen, with the two-stage implant reconstruction group having a lower proportion compared to the immediate one-stage implant reconstruction (66.3% vs. 78.3%; p=0.010). At 3 months after breast reconstruction surgery, the incidence of complications was lower in the two-stage implant reconstruction group than that in the immediate one-stage implant reconstruction group, with significant difference of 14.5% vs 23%; p=0.038. The incidence of nipple or areola necrosis was lower in the two-stage implant reconstruction group compared to the immediate one-stage implant reconstruction group, with statistically significant difference of 9.8% vs 17.1%; p=0.048. The implant loss rate was only 0.7%. It was discovered that the incidence of severe complications was lower in the two-stage implant reconstruction group than in the immediate one-stage implant reconstruction group (2.6% vs. 3.7%), and the difference was not statistically significant. Patients who experienced complications had a higher proportion of chemotherapy (69.2% vs. 38.9%; p&amp;lt; 0.001), endocrine therapy (74.4% vs. 53.9%; p=0.002), and targeted therapy (24.4% vs. 9.6%; p=0.001), and the differences were statistically significant. In terms of surgical procedures, 67 (85.9%) patients who experienced complications underwent NSM, while the proportion of NSM in patients who did not experience complications was lower at 69.6%, which were 231 patients, and the difference was statistically significant (p=0.011). In addition, the complication incidence of patients who received implants sizes of 300-400ml was higher than that of the group that did not (32.1% vs. 17.8%; p=0.012). Conclusion: Both one-stage and two-stage TiLOOP@-assisted IBBR demonstrated perioperative safety. The complication rate within three month of two-stage is lower than one-stage. The implant loss rate was only 0.7% perioperatively. Our results suggest that use of TiLOOP@ Bra be considered carefully for one-stage NSM with IBBR but can be considered for SSM patients. Citation Format: Benlong Yang, Jian Liu, Haibo Wang, Yiding Chen, Cuizhi Geng, Nanyan Rao, Siyuan Han, Antai Zhang, Jinping Shi, Qiang Zhang, Wenhe Zhao, Jiong Wu. Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-22-11.

Abstract PO4-27-11: Fat grafting is oncologically safe during implant-based breast reconstruction and mastectomy after radiotherapy for breast cancer or Hodgkin Lymphoma: results of a multicentric study

Abstract Background. Fat grafting during or after mastectomy could promote the regeneration of irradiated tissues, thus improving tissue softness, increasing patient comfort and ameliorating quality of life. However, there are no conclusive data about the oncological safety of fat grafting, especially in terms of risk of tumor recurrences. The most appropriate timing of adipose tissue transplant is also debated, especially in patients with locoregional breast cancer (BC) recurrence undergoing salvage mastectomy and implant-based breast reconstruction after breast conserving surgery and radiotherapy. Methods. We conducted a prospective, multicentric Italian study to investigate the oncological safety of fat grafting between June 2007 and March 2022. One hundred sixty-three patients who had previously received radiotherapy, either as adjuvant treatment after breast conservative surgery (N=154), or as a treatment of Hodgkin Lymphoma (N=9), underwent mastectomy (simple mastectomy, NAC-sparing and skin-sparing mastectomy) and implant-based, two-stage breast reconstruction. Inclusion criteria were: age between 25 and 75 years, absence of concomitant malignancies, grade 2 or 3 of Breast post Radiotherapy Reconstruction with ExpAnder Score Test (B.R.R.E.A.S.T. score) (Tab 1). Patient BMI, hypertension, smoking history, diabetes and having received neoadjuvant chemotherapy were not considered as exclusion criteria. Contextual mastectomy and expander positioning were performed during first stage (stage I), while substitution of the expander with definitive implant occurred during second stage (stage II). Fat grafting could be performed during stage I, between stage I and II surgery, or during stage II. Results. One hundred sixty-nine mastectomy procedures (six bilateral) and first-stage implant-based reconstructions with expander were performed either as prophylactic surgery (N=23) or for the treatment of primary or recurrent BC (N=146). Thirty-four patients had ductal carcinoma in situ, whereas 112 patients had invasive disease, including: 17 patients with Luminal A BC, 67 patients with Luminal B HER2-negative BC, 3 patients with Luminal B HER-2 positive BC, 7 patients with HER-2 positive BC and 18 patients had triple-negative BC. One hundred thirty-six (80.5%) patients received at least one fat grafting. Eighty-six patients (52.8%) have received second-stage definitive implant. With a median time of observation of 25.1 months, we observed four locoregional cancer recurrences (2.4%), one of which in axillary lymph nodes. All tumor recurrences occurred in patients who had received fat grafting. Eight patients (4.9%) developed distant metastases (liver, lung, lymph nodes, and bone metastases); of these, four patients (50%) had received fat grafting. No death events occurred. Conclusion. Fat grafting after radiotherapy of the breast is associated with a low incidence of locoregional tumor recurrences and distant metastases. Although our findings need to be confirmed in larger, multicentric clinical studies, fat grafting is a safe and useful technique that can be proposed for breast reconstruction after irradiation. Table. Breast post Radiotherapy Reconstruction with ExpAnder Score Test, B.R.R.E.A.S.T score. Based on our experience, we thought to include two tissue characteristics (Pinch test ≥ 0.5 cm and presence/absence of skin teleangectasia or severe dyscromia) in a pre-operative, clinically useful, and ready-to-use score to assess soft tissue adequacy as recommended by NCCN guidelines, that we called Breast post Radiotherapy Reconstruction with ExpAnder Score Test (B.R.R.E.A.S.T. score). In our study, two-stage implant-based breast reconstruction and adipose tissue transplant with regenerative intent were performed in patients with Pinch test ≥ 0.5 cm but moderate skin teleangectasia or dyscromia (B.R.R.E.A.S.T. score 2) and in patients with Pinch test ≥ 0.5 cm and absence of skin teleangectasia or severe dyscromia (B.R.R.E.A.S.T. score 3). Patients with skin teleangectasia or dyscromia and Pinch test &amp;lt; 0.5 cm (B.R.R.E.A.S.T. score 1) were not enrolled in our study as they did not undergo alloplastic breast reconstruction but they underwent autologous reconstruction (data not shown). Citation Format: Chiara Listorti, Claudio Vernieri, Francesco Barretta, Chiara Osio, Ilaria Maugeri, Federica Pilotta, Cristina Ferraris, Massimiliano Gennaro, Gabriele Martelli, Marco Visaggio, Giulia Valeria Bianchi, Serena Di Cosimo, Gianfranco Scaperrotta, Maria Carmen De Santis, Daniela Tognali, Antonino Romeo, Matteo Mingozzi, Francesco Marongiu, Annalisa Curcio, Secondo Folli. Fat grafting is oncologically safe during implant-based breast reconstruction and mastectomy after radiotherapy for breast cancer or Hodgkin Lymphoma: results of a multicentric study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-27-11.

Abstract PO3-23-05: Capsular contracture after post-mastectomy radiotherapy in the patients undergoing implant-based breast reconstruction: impact of implant positioning and two-stage surgery

Abstract Background Capsular contracture is a significant concern in patients undergoing post-mastectomy radiotherapy (PMRT) following implant-based breast reconstruction. It negatively impacts cosmetic outcomes and can have a profound effect on the individual's quality of life. Our study aimed to explore whether the degree of capsular contracture varies based on the placement of the inserted implant and the type of operation (one- or two-staged). Patients and Methods This retrospective study was conducted at a single center, Ganganm Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. Our study included patients who underwent PMRT following total mastectomy and implant-based breast reconstruction surgery between January 2017 and September 2022. To assess the degree of capsular contracture, we evaluated the presence of capsular contracture, particularly severe capsular contracture classified as Baker grade 3 or higher, as well as implant migration. The implants were placed either in the pre-or sub-pectoral position, and the surgical approach employed was either direct-to-implant (DTI) or two-staged operation. Results A total of 195 patients were included in the study, with 83 (42.6%) patients in the pre-pectoral group and 112 (57.4%) patients in the sub-pectoral group. In addition, 116 underwent a two-stage operation, while 79 underwent DTI surgery. There was a significant difference in the occurrence of capsular contracture based on the implant placement, with 16 patients (19.3%) in the pre-pectoral group and 46 patients (41.1%) in the sub-pectoral group experiencing this complication (OR 4.142 [1.973-8.698]). Furthermore, the severity of capsular contracture differed significantly between the two groups, with 5 patients (6.0%) in the pre-pectoral group and 16 patients (14.3%) in the sub-pectoral group affected (OR 3.434 [1.153-10.227]). The incidence of capsular contracture was lower in the two-stage operation group compared to the DTI group (28 [23.9%] vs 34 [38.6%]; OR 3.064 [1.528-6.141]), and the severity of capsular contracture was also reduced (9 [7.7%] vs 12 [14.5%]; OR 2.854 [1.092-7.455]). There were no significant differences in other complications such as seroma and infection. In addition, sub-pectoral placement was identified as a significant risk factor for implant upward migration (OR 2.531 [95% CI, 1.263-5.071]). Conclusions Our findings suggest that pre-pectoral reconstruction and the two-stage operation are beneficial for patients who may undergo PMRT based on their initial nodal stage. These approaches can help reduce the incidence of capsular contracture and abnormal implant migration following radiation, leading to improved aesthetic outcomes and greater patient satisfaction. Citation Format: Sohyun Moon, Kyunghyun Min, Jung Hwan Eom, Yoonwon Kook, Seung Ho Baek, Junghyun Kim, Min Ji Kim, Seung Eun Lee, In Sik Yun, Tai Suk Roh, Soong June Bae, Joon Jeong, Young Seok Kim, Sung Gwe Ahn. Capsular contracture after post-mastectomy radiotherapy in the patients undergoing implant-based breast reconstruction: impact of implant positioning and two-stage surgery [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-23-05.

Assessment of Patient Reported Outcomes for Closed Incision Negative Pressure Therapy with Wide-Coverage Dressings in Simple Mastectomy and Immediate Implant Based Breast Reconstruction.

A new configuration of closed incision negative pressure therapy (ciNPT) dressings now covers the incision and a broader area of peri-incisional tissues. We have implemented these ciNPT dressings following simple mastectomy (SM) or skin-sparing mastectomy with implant-based reconstruction (IBR). This study assesses patient-reported outcomes of this new protocol. Patients underwent SM or IBR for breast cancer. ciNPT with wide-coverage dressings were placed over the entire breast, and -125 mmHg was applied for 14 days. Upon dressing removal, patients rated their experience using the Wound-Q™ Suction Device Scale and recorded their satisfaction on a Likert scale ranging 1-5. Thirteen SM patients and 12 IBR patients were included in the study. The median age was 62 years, and SM patients were significantly older (p<0.01). Patients rated the ciNPT device highest on items relating to its function and appearance, and lowest on noise and interference with sleep and physical activity. The overall mean score for the combined cohort was 64.8/100. The mean score for SM patients (74.8±19.9) was significantly greater than for IBR patients (53.9±9.6, p<0.01). The mean overall patient satisfaction rating was 3.92 on a 5-point scale; 4.0 in the SM group and 3.8 in the IBR group. This study is the first to report on the patient experience with these novel, wide-coverage ciNPT dressings. Overall, the dressing was well tolerated by patients, and satisfaction was high. The positive reception of ciNPT with wide coverage dressings supports continued use at our hospital.

Abstract PO3-23-04: Patient-reported outcomes and complication profiles of implant-based breast reconstruction in patients with postmastectomy radiation therapy

Abstract Objective: This study aims to investigate the patient-reported outcomes (PROs) and complications of distinct implant-based breast reconstruction (IBBR) modality for patients with postmastectomy radiation therapy (PMRT). Methods: A retrospective review was conducted on breast cancer patients with stage II-III disease who performed IBBR following with PMRT between September 2016 and April 2022. The patients were categorized into two matched groups: (1) patients receiving prepectoral breast reconstruction (PBR) or subpectoral breast reconstruction (SBR) followed by PMRT; (2) patients undergoing PMRT with the tissue expander (PMRT-TE) or permanent implant (PMRT-PI) groups. PROs were measured with BREAST-Q questionnaire. Early and late complications were recorded and analysed. Results: A total of 55 eligible patients were recruited. For PROs, patients underwent PBR reported significantly higher Satisfaction with Breasts scores (P = 0.003) compared with SBR group, and PMRT-TE group presented higher Satisfaction with Breasts (P = 0.001) but lower Physical Well-being (P = 0.029) scores compared with PMRT-PI group. Moreover, Patients in SBR cohort had a higher risk of capsular contracture (Baker grade III or IV) (20.5% vs 6.3%) and implant dislocation (48.7% vs 12.5%) than patients in PBR cohort. Patients in PMRT-PI group had a slightly higher rate of capsular contracture (Baker grade III or IV) than PMRT-TE group (20.8% vs 12.9%). Conclusions: PBR was associated with lower rates of late complications, especially for implant dislocation, and higher Satisfaction with Breasts scores compared to SBR. In addition, compared to PMRT-TE with PMRT-PI, patients in PMRT-TE cohort reported superior patient-reported outcomes of Satisfaction with Breasts. Table 1. Patient and Tumor Characteristics of 55 Patients Stratified with Prepectoral/Subpectoral and PMRT-TE/PMRT-PI Reconstructive Procedure. XX- XX Table 2. Patient-Reported BREAST-Q Scores XX- XX Table 3. Association of Reconstruction Techniques with Late Complications. XX- XX Citation Format: Jian Liu, Cong Chen, Honggang Chen, Aizhai Xiang, Ruzhen Zheng, Shufang Hu, Jufeng Guo, Li Qu, Jun Zhou, Jiong Wu. Patient-reported outcomes and complication profiles of implant-based breast reconstruction in patients with postmastectomy radiation therapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-23-04.

Abstract PO3-22-12: Clinical feasibility of nipple sparing mastectomy (NSM) followed by immediate reconstruction based on direct-to-implant technique

Abstract [Background] The development of NSM approach combined with immediate implant-based breast reconstruction (IBBR) for patients with earlystage breast cancer (BC) preserve the natural skin envelope including nipple-areolar complex (NAC) to able to immediately reconstruct the breast with a permanent implant and simultaneously omit the skin expansion with a tissue expander. We retrospectively analyzed the clinical results of NSM+IBBR and compared the complication rate, outcome of patients who underwent immediate (one-stage) or delayed (two-stage) IBBR followed by standard TM or NSM. [Patients and Results] A total of 108 patients who underwent a TM that included SSM or NSM followed by one- or two-stage IBBR between January 2013 and April 2022. 53 patients underwent a total mastectomy (TM) and 32 patients underwent an NSM followed by two-stage IBBR, and 24 patients underwent an NSM followed by one-stage IBBR. The operation times were 236, 247.2, and 321 min, and the mean surgical bleeding was 60.4, 88.8, and 138 ml, respectively. The complications in the three groups included infection (2.7%, 11.1%, and 6.3%), seroma/hematoma (0%, 5.6%, and 6.3%), flap necrosis (2.7%, 11.1%, and 12.5%), and loss of tissue expander or implant (2.7%, 5.6%, and 6.3%), respectively. At the median 62-month follow-up after the NSM + IBBR, one patient was diagnosed with distant lymph node metastases at the 24-month follow-up and one patient had new primary breast cancer within the reconstructed breast at the 38-month follow-up. But no loco-regional recurrence at the NAC or other distant recurrence were detected in the patients undergone regardless TM or NSM + one-stage or two-stage IBBR. [Summary] Our results suggested that the use of one-stage IBRR tended to increase the operating time and the amount of bleeding compared to two-stage IBRR and the complication rate might be higher in cases in which an NSM is followed by IBBR. Oncological outcome was consistent with the studies showing that loco-regional recurrence is less likely at the NAC regardless of whether the patients underwent one-stage or two-stage IBBR following an NSM. Citation Format: Uhi Toh, Yuko Takao, Yuriko Katagiri, Rie Sugihara, Hidetaka Watanabe. Clinical feasibility of nipple sparing mastectomy (NSM) followed by immediate reconstruction based on direct-to-implant technique [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-22-12.

Abstract PO5-22-11: Radiotherapy-associated Complications in Breast Cancer patients treated with Nipple-Sparing Mastectomy: Results of the Reconstruction-after-Mastectomy AGO R02 Registry

Abstract Nipple-Sparing mastectomy (NSM) followed by implant-based breast reconstruction is an oncologically safe procedure increasingly used in patients with breast cancer. A proportion of patients treated with NSM will be receiving adjuvant radiotherapy according to contributing factors indicating radiotherapy use. Methods Data from six breast centers in Austria were entered in the AGO R02 Registry from women who underwent breast reconstruction after mastectomy between 2012 and 2022 to evaluate complications associated with surgical techniques and selection of patients. Univariate analysis was used to identify factors that may impact surgical outcome. Results The registry included a total of 744 female patients. Of 913 NSMs, 730 NSMs were followed by implant-based reconstruction. Adjuvant radiotherapy was administered in 132/730 patients (18%). In this group minor complications (infection, hematoma) were observed in 6 patients (4.5%) and major complications requiring additional surgery (wound breakdown, skin and/or nipple necrosis) were observed in 16 patients (12.1%) in a short term follow up of 4 months (mean). In the group of patients without adjuvant radiotherapy minor complications (infection, hematoma) were observed in 33 patients (4.5%) and major complications (wound breakdown, skin and/or nipple necrosis) were observed in 75 patients (10.3%). In both groups no statistically significant association was observed between complications and age, body mass index, diabetes, preoperative chemotherapy, implant position (pre/subpectoral), use of mesh. Smoking and chemotherapy were the only factors associated with higher proportion of minor complications in patients not receiving radiotherapy. Conclusions Women treated with adjuvant radiotherapy after NSM followed by implant-based reconstruction have a higher incidence of major complications requiring additional surgery in comparison with women treated without radiotherapy in a short term follow up. Considering new radiotherapy techniques/volumes and early multidisciplinary planning may optimize multimodal treatment in these patients. Supported by AGO Österreich Citation Format: Florentia Peintinger, Elisa Sieghartsleitner, Bernhard Pfeifer, Gunda Pristauz-Telsnigg, Georg Tsangarakis, Rüdiger Hochstätter, Rupert Koller, Ursula Denison, Christopher Hager, Roland Reitsamer. Radiotherapy-associated Complications in Breast Cancer patients treated with Nipple-Sparing Mastectomy: Results of the Reconstruction-after-Mastectomy AGO R02 Registry [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-22-11.

Abstract PO2-22-12: Patient-reported outcomes 3 and 18 months after prepectoral implant-based breast reconstruction: Results from the UK Pre-BRA multicentre prospective cohort study

Abstract Background: Prepectoral implant-based reconstruction (PPBR) with and without mesh is becoming the standard of care for prosthetic reconstruction in the UK. In addition to being easier and quicker to perform, the procedure is perceived to be associated with better patient-centred outcomes including decreased post-operative pain, avoidance of animation deformity and improved cosmesis. Evidence to support these benefits, however, is lacking. The UK PreBRA prospective multicentre cohort study (ISRCTN11898000) aimed to assess patient-reported outcomes (PROs) before and 3 and 18 months following PPBR to provide much needed evidence to support the effectiveness of the technique. Methods: Women aged 18 or over undergoing mastectomy for breast cancer or risk-reduction who opted to have PPBR between July 2019 and December 2020 were eligible to participate in the study. Demographic, operative, oncology and three-month complication data were collected. Participants were asked to complete the validated BREAST-Q questionnaire at before surgery and at 3 and 18 months following the procedure. Questionnaires were scored according to the developers’ instructions and scores compared over time. Exploratory analysis of covariance, adjusting for baseline scores was performed to explore factors impacting PROs following PPBR. Results: 347 women underwent PPBR at 40 centres across the UK. Of these, 334 (96.3%) completed PROMs at baseline with 237 (68.3%) completing at least two of the three main BREAST-Q scales at both 3 and 18 months. The median age of the cohort was 49 (range 23-74). Most women (n=291, 87.1%) had mastectomy for malignancy with a quarter (n=82, 24.6%) undergoing bilateral surgery. Approximately a fifth (n=68, 20.4%) had a body mass index &amp;gt;30 and 12% (n=40) were active smokers at the time of surgery. At 3 months, 68 (20.4%) had experienced a complication requiring readmission and/or re-operation and 27 (8.1%) experienced an implant loss. In the cohort overall, women undergoing PPBR reported slight increases in their ‘Satisfaction with Breasts’ scores from baseline to 3 months after surgery but by 18 months, their scores had fallen below baseline values (Table 1). ‘Physical well-being’ scores decreased from baseline to 3 months but then remained stable. No changes were seen in ‘Psychosocial well-being’ scores across the three timepoints. At 18 months, after adjusting for baseline BREAST Q scores, women having surgery for risk-reduction reported scores that were 10-16 points lower than those having surgery for malignancy across all four main domains for the BREAST-Q. This exceeded the minimum clinically meaningful difference and was highly statistically significant. Women with high mastectomy weights ( &amp;gt;600g) reported lower scores for ‘Physical’, ‘Psychosocial’ and ‘Sexual’ well-being but not ‘Satisfaction with Breasts’. Smoking adversely impacted ‘Psychosocial well-being’ and ‘Satisfaction with Breasts’ and women with BMI &amp;gt;30 reported lower ‘Physical well-being’ scores at 18 months. Having a major complication requiring readmission/re-operation did not affect BREAST-Q scores, but when considered separately, implant loss dramatically impacted all BREAST-Q domains Conclusions: Women having PPBR report short-term improvements in ‘Satisfaction with Breasts’ scores but these are not maintained over time and decrease to below baseline 18 months after surgery. ‘Physical well-being’ also decreased after PPBR despite no disruption to the pectoralis muscle. Women having surgery for risk-reduction reported the worse PROs. Further work is needed to establish the long-term patient-reported outcomes of PPBR and factors impacting these. Citation Format: Leigh Johnson, Kate Harvey, Parisa Sinai, Nicola Mills, Paul White, Chris Holcombe, Shelley Potter. Patient-reported outcomes 3 and 18 months after prepectoral implant-based breast reconstruction: Results from the UK Pre-BRA multicentre prospective cohort study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-22-12.

3D Lipogluing: Preliminary Results of a Novel Technique for Direct Three-dimensional Fat Grafting in Breast Reconstruction Surgery.

Lipofilling has emerged as an effective technique in breast reconstruction for enhancing aesthetic outcomes and addressing residual deformities. Traditionally, fat grafting has been performed as a secondary step in implant-based breast reconstruction during the replacement of the expander with a breast implant or as a revisional procedure. Our study investigates the technical feasibility and presents preliminary results of a new promising technique for delivering fat grafting in a three-dimensional (3D) shape, directly during mastectomy with immediate breast reconstruction or in delayed breast reconstructive procedures. Our new 3D lipogluing technique involves securing the fat tissue in a 3D manner using fibrin glue. This method enhances the coverage of soft tissues and provides improved volume and shape supplementation. In selected cases between December 2015 and September 2023, we treated 24 patients using the 3D lipogluing technique and five patients using 3D lipocubing (without use of fibrin glue).The patient cohort consisted of different indications for breast reconstructions: direct-to-implant, expander-based breast reconstruction, and "conservative" surgery. Preliminary findings suggest the technique is a safe and effective approach that can enhance the soft-tissue envelope of reconstructed breasts by acting as an autologous scaffold, owing to its regenerative properties. This technique not only improves the overall aesthetic outcome but also has the potential to reduce implant-related complications. Furthermore, ongoing studies are investigating methods to optimize the results and explore the potential application of 3D lipogluing and 3D lipocubing in breast-conserving oncoplastic surgery, cosmetic breast surgery, and other areas of plastic reconstructive and aesthetic surgery.

Association of Neoadjuvant Chemotherapy With Postoperative Outcomes in Immediate Prepectoral Prosthetic Breast Reconstruction.

Neoadjuvant chemotherapy (NACT) followed by total mastectomy and immediate reconstruction has become an important strategy in the treatment of breast cancer. Although the safety of subpectoral implant-based breast reconstruction with NACT has been extensively evaluated, the safety in prepectoral reconstruction has not been clearly elucidated. We aimed to evaluate the association of NACT with immediate prepectoral breast reconstruction outcomes. A retrospective review of patients who underwent total mastectomy and immediate implant-based prepectoral breast reconstruction between May and December 2021 was conducted. Patients were categorized into 2 groups: those receiving NACT and those not receiving it. Postoperative complication rates were compared between the 2 groups. The independent association between NACT and the complication profiles was evaluated. Propensity score matching was also conducted. We analyzed 343 cases, including 85 who received NACT treatment and 258 who did not. Compared with the non-NACT group, the NACT group was younger, had a higher body mass index, and a higher rate of adjuvant radiotherapy. There were no differences in the rates of overall complications or type of complication between the 2 groups. In the multivariable logistic analyses, NACT did not show a significant association with the development of adverse outcomes. Similar results were observed in propensity score matching analyses. Our results suggest that receiving NACT may not have a significant detrimental effect on the postoperative outcomes of immediate prepectoral prosthetic reconstructions. Conducting prepectoral implant-based reconstruction in the setting of NACT might be safe and provide acceptable outcomes.

Prepectoral versus Subpectoral Breast Reconstruction after Nipple-sparing Mastectomy: A Systematic Review and Meta-Analysis.

Implant-based breast reconstruction after nipple-sparing mastectomy (NSM) presents unique benefits and challenges. The literature has compared outcomes among total submuscular (TSM), dual-plane (DP), and prepectoral (PP) planes; however, a dedicated meta-analysis relevant to NSM is lacking. We conducted a systematic review of studies on immediate breast reconstruction after NSM using TSM, DP, or PP prosthesis placement in PubMed, Embase, and Cochrane databases. In total, 1317 unique articles were identified, of which 49 were included in the systematic review and six met inclusion criteria for meta-analysis. Pooled descriptive outcomes were analyzed for each cohort for all 49 studies. Fixed-effects meta-analytic methods were used to compare PP with subpectoral (TSM and DP) reconstructions. A total of 1432 TSM, 1546 DP, and 1668 PP reconstructions were identified for descriptive analysis. Demographics were similar between cohorts. Pooled descriptive outcomes demonstrated overall similar rates of reconstructive failure (3.3%-5.1%) as well as capsular contracture (0%-3.9%) among cohorts. Fixed-effects meta-analysis of six comparative studies demonstrated a significantly lower rate of mastectomy flap necrosis in the PP cohort compared with the subpectoral cohort (relative risk 0.24, 95% confidence interval [0.08-0.74]). All other consistently reported outcomes, including, hematoma, seroma, infection, mastectomy flap necrosis, nipple -areola complex necrosis, and explantation were comparable. A systematic review of the literature and meta-analysis demonstrated the safety of immediate prepectoral breast reconstruction after NSM, compared with submuscular techniques. Submuscular reconstruction had a higher risk of mastectomy flap necrosis, though potentially influenced by selection bias.

P8. Comparative Outcomes of Proton versus Photon Post-Mastectomy Radiation Therapy in Pre-pectoral Implant Based Breast Reconstruction

P8. Comparative Outcomes of Proton versus Photon Post-Mastectomy Radiation Therapy in Pre-pectoral Implant Based Breast Reconstruction

P14. Are Prophylactic Post-operative Antibiotics Indicated For Implant-based Breast Reconstruction?: A Randomized-controlled Pilot Study

P14. Are Prophylactic Post-operative Antibiotics Indicated For Implant-based Breast Reconstruction?: A Randomized-controlled Pilot Study

Bilateral Implant-based Breast Reconstruction with Unilateral Radiotherapy: A Matched Cohort Study Comparing Nipple-sparing Mastectomy and Skin-sparing Mastectomy.

Nipple-sparing mastectomy (NSM) preserves the natural nipple-areola complex and entire native breast skin, with the goal of better cosmetic outcomes in breast reconstruction. In bilateral TE/implant-based reconstruction requiring unilateral postmastectomy radiotherapy (PMRT), progressive radiation-induced fibrosis can lead to increasing nipple asymmetry with cosmetic dissatisfaction. Thus, PMRT may ultimately negate the intended positive cosmetic value of NSM compared with skin-sparing mastectomy (SSM). This study compares (1) surgical complications, (2) patient satisfaction, and (3) aesthetic outcomes between NSM versus SSM in bilateral implant-based reconstruction with unilateral PMRT. This retrospective matched cohort study included consecutive NSM patients with bilateral TE/implant breast reconstruction + unilateral PMRT matched 1:2 to SSM group. Patients completed PMRT and TE exchange to implants. Demographics, oncologic stage, comorbidities, and complications were collected. Patient satisfaction was evaluated by BREAST-Q. Aesthetic outcomes were assessed by blinded reviewers with a five-point Likert scale. Among 58 patients who underwent bilateral TE/implant reconstruction with unilateral PMRT, 17 NSM patients were matched to 41 SSM patients by age, body mass index, and comorbidities. No significant differences existed in overall surgical complications and individual BREAST-Q questionnaire scores between cohorts. However, aesthetic outcomes scores were higher in SSM compared with NSM. Although NSM is generally associated with superior cosmetic outcomes compared with SSM, it has far less impact in bilateral implant-based breast reconstruction with unilateral PMRT due to the negative postradiotherapy effect on nipple symmetry.

25. Investigating The Impact Of Prophylactic Oral Antibiotics On The Gut Microbiome And Infectious Outcomes In Post-mastectomy Implant-based Breast Reconstruction: Pilot Data From A Prospective Randomized-controlled Trial

25. Investigating The Impact Of Prophylactic Oral Antibiotics On The Gut Microbiome And Infectious Outcomes In Post-mastectomy Implant-based Breast Reconstruction: Pilot Data From A Prospective Randomized-controlled Trial

Retrospective comparative analysis of short-term surgical outcomes of immediate prepectoral implant-based breast reconstruction with polyurethane implants alone Vs microtextured implants with acellular dermal matrix

Retrospective comparative analysis of short-term surgical outcomes of immediate prepectoral implant-based breast reconstruction with polyurethane implants alone Vs microtextured implants with acellular dermal matrix

Immediate Unilateral Subpectoral Implant-Based Breast Reconstruction does not Impair Pulmonary Functions: A Preliminary Prospective Study.

Implant-based breast reconstruction is one of the most common procedures among women with breast cancer undergoing mastectomy. Prosthetic devices may be positioned either beneath or above the pectoralis major muscle, which is considered an accessory muscle of ventilation. This preliminary prospective study aimed to investigate whether subpectoral unilateral implant-based breast reconstruction has any effect on patients' pulmonary functions. A prospective study of fourteen women who underwent immediate unilateral implant-based subpectoral breast reconstruction by a single surgeon over 10months was conducted. Spirometry and maximal voluntary ventilation tests were conducted 1day prior to surgery, and 1- and 3months following breast reconstruction. ANOVA or Friedman test were used to compare pulmonary function tests before and after surgery. Fourteen patients completed the study protocol. No statistically significant differences were found when comparing spirometry parameters in the three time points. Pectoralis muscle release does not impair pulmonary function among patients undergoing immediate unilateral implant-based breast reconstruction following mastectomy. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The wide base bipedicled (WIBB) flap in nipple-sparing skin-reducing mastectomy

In this article, we present a modification of the NS/SRM technique in which the mastopexy design for skin reduction is undertaken with a wide-base bipedicled (WIBB) flap. The WIBB flap can be applied in both autologous and implant-based breast reconstruction. Our reconstructive algorithm is also presented. The clinical data of patients operated on from June 2017 to November 2022 were collected: 51 patients for a total of 71 breasts. Personal data, BMI, type and volume of implants used, and major and minor complications were analyzed by descriptive statistics. The mean age was 48.3 years. BMI ranged between 21.5 and 30.9 kg/m2. Thirty-one patients underwent unilateral mastectomy, while twenty patients underwent bilateral surgery. In 25 breasts, immediate reconstruction was performed with implants and ADM. In 40 breasts, reconstruction was performed with a subpectoral tissue expander, and in 6 breasts, reconstruction was performed with a DIEP flap. We observed only one case (1.4%) of periprosthetic infection requiring implant removal under general anesthesia. Minor complications occurred in 14.1% of patients. The use of both the WIBB flap and our algorithm maintained a low complication rate in our series, ensuring oncological radicality and a good aesthetic result at the same time.