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There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR. This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446. Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17·0 months [SD 7·8]) in the one-stage group and 44 women (17·2 months [SD 6·7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78·0 [SD 14·1] vs two-stage 79·3 [12·2], p=0·60), psychosocial wellbeing (72·6 [17·3] vs 72·8 [19·6], p=0·95), and sexual wellbeing (58·0 [17·0] vs 57·1 [19·5], p=0·82), or in the patient-reported satisfaction domains: satisfaction with breasts (63·4 [15·8] vs 60·3 [15·4], p=0·35) and satisfaction with outcome (72·8 [19·1] vs 67·8 [16·3], p=0·19). Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis. Pink Ribbon, Nuts-Ohra, and LifeCell.

The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67–5·43, p<0·001), reoperation (3·38, 2·10–5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24–9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. Pink Ribbon, Nuts-Ohra, and LifeCell.

IntroductionBreast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients’ own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area.Methods and analysisUK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm).Ethics and disseminationThis study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23/SC/0302; IRAS Project ID: 301 423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs.Trial registration numbersNCT06112977; ISRCTN17470747.

IntroductionAlthough breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. Randomised controlled trials (RCTs) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The objective of this study is to compare implant-based and autologous breast reconstruction in non-irradiated patients. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction.Methods and analysisThe study design partially randomised patient preference trial might be a way to overcome the aforementioned challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose the method. The study is designed as a superiority trial based on the patient-reported questionnaire BREAST-Q and 124 participants will be randomised. In the preference cohort, patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60 months. Embedded qualitative studies and within-trial economic evaluation will be performed. The primary outcome is patient-reported breast-specific quality of life/satisfaction, and the secondary outcomes are complications, factors affecting satisfaction and cost-effectiveness.Ethics and disseminationThe study has been approved by the Swedish Ethical Review Authority (2023-04754-01). Results will be published in peer-reviewed scientific journals and presented at peer-reviewed scientific meetings.Trial registration numberNCT06195865.

Background Acellular dermal matrix (ADM) in implant‐based breast reconstructions (IBBRs) aims to improve cosmetic outcomes. Six‐month data are presented from a randomized trial evaluating whether IBBR with ADM provides higher health‐related quality of life (HRQoL) and patient‐reported cosmetic outcomes compared with conventional IBBR without ADM. Methods In this multicentre open‐label RCT, women with breast cancer planned for mastectomy with immediate IBBR in four centres in Sweden and one in the UK were allocated randomly (1 : 1) to IBBR with or without ADM. HRQoL, a secondary endpoint, was measured as patient‐reported outcome measures (PROMs) using three validated instruments (EORTC‐QLQC30, QLQ‐BR23, QLQ‐BRR26) at baseline and 6 months. Results Between 24 April 2014 and 10 May 2017, 135 women were enrolled, of whom 64 with and 65 without ADM were included in the final analysis. At 6 months after surgery, patient‐reported HRQoL, measured with generic QLQ‐C30 or breast cancer‐specific QLQ‐BR23, was similar between the groups. For patient‐reported cosmetic outcomes, two subscale items, cosmetic outcome (8·66, 95 per cent c.i. 0·46 to 16·86; P = 0·041) and problems finding a well‐fitting bra (−13·21, −25·54 to −0·89; P = 0·038), yielded higher scores in favour of ADM, corresponding to a small to moderate clinical difference. None of the other 27 domains measured showed any significant differences between the groups. Conclusion IBBR with ADM was not superior in terms of higher levels of HRQoL compared with IBBR without ADM. Although two subscale items of patient‐reported cosmetic outcomes favoured ADM, the majority of cosmetic items showed no significant difference between treatments at 6 months. Registration number: NCT02061527 ( www.clinicaltrials.gov). Antecedentes Se ha propuesto la utilización de mallas dérmicas acelulares (acellular dermal matrix, ADM) en las reconstrucciones mamarias con prótesis (implant’based breast reconstructions, IBBR) como forma de mejorar los resultados estéticos. Se presentan los resultados a 6 meses de un ensayo aleatorizado, que evaluó si la IBBR con ADM proporcionaba mejor calidad de vida relacionada con la salud (health’related quality of life, HRQOL) y mejores resultados estéticos percibidos por la paciente en comparación con la IBBR convencional sin ADM. Métodos Se ha propuesto la utilización de mallas dérmicas acelulares (acellular dermal matrix, ADM) en las reconstrucciones mamarias con prótesis (implant’based breast reconstructions, IBBR) como forma de mejorar los resultados estéticos. Se presentan los resultados a 6 meses de un ensayo aleatorizado, que evaluó si la IBBR con ADM proporcionaba mejor calidad de vida relacionada con la salud (health’related quality of life, HRQOL) y mejores resultados estéticos percibidos por la paciente en comparación con la IBBR convencional sin ADM. Resultados Entre el 24 de abril de 2014 y el 10 de mayo de 2017, se consideraron 135 mujeres, de las que se incluyeron en el análisis final 64 con ADM y 65 sin ADM. A los 6 meses de la intervención, la HRQOL medida con los cuestionarios QLQ‐C30 (genérico) y QLQ‐BR23 (específico para el cáncer de mama) fue similar en los dos grupos. Con respecto a los resultados estéticos percibidos por la paciente, se obtuvieron mejores puntuaciones a favor de la ADM en dos sub‐escalas: “resultado estético” (8,66, i.c. del 95%, 0,46‐16,86, P = 0,041) y “problemas para encontrar un sujetador que se ajuste bien” −13,21 (i.c. del 95% −25, 54 a −0,89, P = 0,038), lo que representa una diferencia clínica pequeña‐moderada. No hubo diferencias significativas entre los dos grupos en ninguno de los otros 27 dominios medidos. Conclusión No se pudo demostrar la superioridad de la IBBR con ADM mediante variables relacionadas con la calidad de vida. Aunque se obtuvieron mejores puntuaciones con la ADM en dos sub‐escalas de los PROMs, no hubo diferencias entre ambos tratamientos en la mayoría de las variables estéticas a los 6 meses. Implant‐based breast reconstruction (IBBR) with acellular dermal matrix (ADM) after mastectomy is common practice. A randomized trial was conducted to evaluate health‐related quality of life and patient‐reported cosmetic outcomes after ADM‐assisted IBBR in the setting of breast cancer treatment. Early results from this trial do not indicate a benefit for IBBR when supported with ADM. Acellular dermal matrix does not influence quality of life.

Background Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of breast animation deformity (BAD) has been reported. Besides the nuisance that BAD can cause, lifting of the pectoralis major muscle (PMM) can result in a more extended postoperative recovery period. When placing the implant solely prepectorally leaving the PMM undisturbed, the incidence and severity of BAD might be mitigated. However, new challenges may occur because of thinner skin cover. Methods/design A prospective, multi-centre, randomised controlled trial will be carried out with the primary aim of assessing and comparing the incidence and degree of BAD in women having a direct-to-implant breast reconstruction with either a prepectorally or a subpectorally placed implant. The secondary outcomes are shoulder and arm function, quality of life, aesthetic evaluation, length of stay, complications, need for surgical corrections, and development of capsular contracture. A total of 70 included patients will be followed under admittance and at clinical check-ups 3 months and 1 year after surgery. Discussion To our knowledge, this trial is the first randomised controlled trial evaluating and comparing subpectoral and prepectoral implant placement when performing direct-to-implant breast reconstruction following skin-sparing mastectomy. The results will hopefully provide us with a broader knowledge of the outcomes of immediate breast reconstruction, making better preoperative planning possible in the future by providing our patients with a more objective information. Trial registration ClinicalTrials.gov, ID: NCT03143335 . Prospectively registered on 8 May 2017.

As the use of breast reconstruction and postmastectomy radiotherapy (PMRT) has increased over the past decade, the typical approach to integrating radiotherapy with breast reconstruction has provoked intense controversy in the management of breast cancer. PMRT can lead to an increased frequency of complications in the reconstructed breast. Conversely, the reconstructed breast can increase the complexity of radiotherapy delivery. How to minimise the frequency of complications without compromising oncological or cosmetic outcomes of the reconstructed breast is an important shared multidisciplinary goal for oncologists and their patients. Several questions remain, however, regarding the type of reconstruction that should be used with PMRT, when reconstruction should be done relative to PMRT and whether radiotherapy treatment should be directed towards the tissue expander or the implant for women who opt for a two-stage expander–implant reconstruction. Following advances in the planning of radiotherapy treatment, new questions about the application of these technologies in the setting of breast reconstruction have arisen. In this Review, we address these questions by reviewing contemporary evidence on the optimal integration of radiotherapy and breast reconstruction in the management of breast cancer.

Background During the last decades transaxillary breast augmentation (TBA) has gained worldwide acceptance. Breast augmentation via transaxillary access endoscopically assisted in the subglandular, subfascial, and submuscular planes has been previously described. Although TBA is a well-studied procedure, few reports exist concerning the subfascial plane of implant insertion and none exist comparing the three different planes of insertion by TBA. Methods A perspective study to evaluate the outcomes, complications, and patient satisfaction of TBA using the three different planes of implant insertion was performed during 2004-2005. Fifty-three patients fulfilled the inclusion criteria. They were randomly divided into three groups corresponding to the three planes of silicone insertion. All patients had a silicone texturized implant that ranged from 190 to 300 cc. Overall satisfaction with the breast appearance after TBA was rated on a scale of 1-5, where 1 is poor, 2 is fair, 3 is good, 4 is very good, and 5 is excellent. The evaluation was made at the follow-up times of 6 months and 3 years. Results There were 18 patients enrolled for the subcutaneous TBA (Group A), 18 for the subfascial TBA (Group B), and 17 for the submuscular TBA (Group C). Axillary incision-related complications occurred in 9% of the patients and included formation of a hypertrophic scar and small-wound dehiscence. There was no hematoma formation and no case of infection. There was one patient from Group A who developed seroma and was treated conservatively. Twenty-seven months postoperatively the same patient developed Baker III capsule contracture, which required silicone implant replacement in the subfascial plane. One case of stretch marks in a young nulliparous woman from Group B did not need treatment. One patient from Group A underwent implant exchange because of implant size dissatisfaction. Three patients in Group C had mild distortion of the implant during pectoral contracture. A meta-analysis of patient satisfaction 6 months and 3 years after TBA is presented. Conclusion Transaxillary breast augmentation provides consistent, satisfactory results with ease of dissection, when properly indicated. Although the subfascial augmentation mammaplasty has all the advantages of the subpectoral and subglandular augmentation mammaplasties and eliminates the disadvantages of increased postoperative discomfort, implant visibility, and distortion, patients of all three groups had similar rates of satisfaction. Further follow-up is needed in order to compare the long-term effects of the three different planes of insertion.

Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction—breast reconstruction with implants or expanders at the time of mastectomy—but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques. In this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281. Between Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 (99%) patients. Of these patients, 182 (9%, 95% CI 8–10) experienced implant loss, 372 (18%, 16–20) required re-admission to hospital, and 370 (18%, 16–20) required return to theatre for complications within 3 months of their initial surgery. 522 (25%, 95% CI 23–27) patients required treatment for an infection. The rates of all of these complications are higher than those in the National Quality Standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection). Complications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomised clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction. National Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons.

Capsular contracture is a common adverse outcome following implant breast reconstruction, often associated with radiation treatment. The authors hypothesize that muscle fibrosis is the main contributor of breast reconstruction contracture after radiation. Retrospective chart review identified patients that underwent DTI reconstruction with pre-or post-operative breast irradiation. Signs of capsular contracture were assessed using clinic notes and independent graders reviewing two-dimensional images and anatomic landmarks. Capsular contracture rate was greater in the subpectoral vs. prepectoral group (n = 28, 51.8% vs. n = 12, 30.0%, p = 0.02). When compared to prepectoral DTI reconstruction in irradiated patients, subpectoral implant placement was nearly 4 times as likely to result in capsular contracture (p < 0.01). Rates of explantation, infection, tissue necrosis, and hematoma were comparable between groups. We also found that when subpectoral patients present with breast contracture, chemoparalysis of the muscle alone can resolve breast asymmetry, corroborating that muscle is a key contributor to breast contracture. As prepectoral breast reconstruction is gaining popularity, there have been questions regarding outcome following radiation treatment. This study suggest that prepectoral breast reconstruction is safe in an irradiated patient population, and in fact compares favorably with regard to breast contracture.