Breast Reconstruction Outcomes with and without Strattice: Long-Term Outcomes of a Multicenter Study Comparing Strattice Immediate Implant Breast Reconstruction with Submuscular Implant Reconstruction.

BACKGROUND: Over half of immediate implant-based breast reconstructions (IBBR) are performed with an acellular dermal matrix, despite limited long-term outcome data. METHODS: The Breast Reconstruction Outcomes with and without Strattice, or BROWSE, study was a retrospective multicenter cohort study comparing consecutive patients who had undergone immediate Strattice IBBR with those who had undergone immediate IBBR with a submuscular technique between January of 2009 and December of 2015. RESULTS: This study compared 553 Strattice reconstructions with 242 submuscular reconstructions, with a median follow-up of 4.3 years (range, 2 to 9.3 years) and 5.7 years (range, 2 to 8.1 years), respectively, demonstrating an equivalent total complication rate [Strattice, n = 204 (36.9%); submuscular, n = 77 (31.8%); P = 0.17] and implant loss rate (8.5% versus 5.4%, respectively; P = 0.12). Infection rates and wound dehiscence rates were higher in the Strattice cohort [ n = 114 (20.6%) versus n = 31 (12.8%), P = 0.009; and n = 90 (16.3%) versus n = 25 (10.4%), P = 0.03, respectively]. Overall revision rates were comparable [ n = 226 (46.7%) versus n = 79 (41.1%); P = 0.2], but significantly fewer Strattice reconstructions required revision surgery for capsular contracture (5.3% versus 15.6%; P < 0.001). CONCLUSION: Although the risk of complications associated with Strattice reconstruction is numerically higher than that for submuscular coverage, the difference is small and not statistically significant, and likely outweighed by the clear reduced rate of revision surgery because of capsular contracture when Strattice is used. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

BROWSE: A multicentre comparison of nine year outcomes in acellular dermal matrix based and complete submuscular implant-based immediate breast reconstruction-aesthetics, capsular contracture and patient reported outcomes.

Approximately 60% of implant-based breast reconstructions (IBBR) are performed with an acellular dermal matrix (ADM), for which, reliable, good quality long-term outcome data is limited. In a retrospective multicentre cohort study, we aimed to determine long-term aesthetic and quality of life outcomes of IBBR with ADM (Strattice™) compared to a submuscular technique. METHODS: Capsular contracture (Baker III/IV capsule) was determined by clinical examination by an independent researcher. Quality of life was assessed using BREAST-Q and aesthetic outcome by photographic assessment from a breast surgeon, breast care nurse and lay person, blinded to reconstruction type. RESULTS: We recruited 117 (51 bilateral) patients with ADM reconstructions, median follow-up 62 months (range 29-113) and 49 patients (16 bilateral) with submuscular reconstructions, median follow-up 76 months (range 38-111). 17 (10.1%) ADM reconstructions were Baker 3/4 compared to six (9.2%) submuscular (p = 0.85). Of the Baker 1/2 reconstructions six (3.6%) ADM and eight (13.6%) submuscular had previously undergone revision surgery to correct capsular contracture (p = 0.01). Combining both findings gave an estimated rate of capsular contracture of 13.6% in the ADM group and 21.2% in the submuscular (p = 0.14). A higher mean score for satisfaction with breasts was demonstrated when comparing ADM to submuscular (62 and 55, respectively; p = 0.01) but no significant difference in other BREAST-Q domains. The mean 'general satisfaction' score was higher in the ADM group for all three photograph assessors. CONCLUSION: This study provides evidence of improved aesthetic outcome and reduction in capsular contracture with ADM reconstruction when compared to submuscular, consistent over long-term follow-up.

Protocol for a national cohort study to explore the long-term clinical and patient-reported outcomes and cost-effectiveness of implant-based and autologous breast reconstruction after mastectomy for breast cancer: the brighter study.

INTRODUCTION: Breast reconstruction (BR) is offered to improve quality of life for women with breast cancer undergoing mastectomy. As most women will be long-term breast cancer survivors, high-quality information regarding the long-term outcomes of different BR procedures is essential to support informed decision-making. As different techniques vary considerably in cost, policymakers also require high-quality cost-effectiveness evidence to inform care. The Brighter study aims to explore the long-term clinical and patient-reported outcomes (PROs) of implant-based and autologous BR and use health economic modelling to compare the long-term cost-effectiveness of different reconstructive techniques. METHODS AND ANALYSIS: Women undergoing mastectomy and/or BR following a diagnosis of breast cancer between 1 January 2008 and 31 March 2009 will be identified from hospital episode statistics (HES). Surviving women will be contacted and invited to complete validated PRO measures including the BREAST-Q, EQ-5D-5L and ICECAP-A, or opt out of having their data included in the HES analysis. Long-term clinical outcomes will be explored using HES data. The primary outcome will be rates of revisional surgery between implant-based and autologous procedures. Secondary outcomes will include rates of secondary reconstruction and reconstruction failure. The long-term PROs of implant-based and autologous reconstruction will be compared using BREAST-Q, EQ-5D-5L and ICECAP-A scores. Multivariable regression will be used to examine the relationship between long-term outcomes, patient comorbidities, sociodemographic and treatment factors. A Markov model will be developed using HES and PRO data and published literature to compare the relative long-term cost-effectiveness of implant-based and autologous BR. ETHICS AND DISSEMINATION: The Brighter study has been approved by the South-West -Central Bristol Research Ethics Committee (20/SW/0020), and the Confidentiality Advisory Group (20/CAG/0021). Results will be published in peer-reviewed journals and presented at national meetings. We will work with the professional associations, charities and patient groups to disseminate the results.

Breast imaging for aesthetic surgery: British Society of Breast Radiology (BSBR), Association of Breast Surgery Great Britain & Ireland (ABS), British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS).

This is an overview of the guidelines for breast imaging before and after aesthetic (cosmetic) breast surgery, which includes but is not limited to implants, lipomodelling and mammoplasty procedures. The guidelines are based on a review of the literature and consensus of breast imaging and aesthetic breast surgery specialists. 1. Pre-aesthetic surgery 2. Post-aesthetic surgery If breast imaging or breast assessment is required, it should be performed in a designated breast facility with access to specialist breast imaging and a complete breast multidisciplinary team in accordance with national guidelines and recommendations.

Donor-Site Hernia Repair in Abdominal Flap Breast Reconstruction: A Population-Based Cohort Study of 7929 Patients.

BACKGROUND: The authors investigated hernia repair rates following pedicled transverse rectus abdominis myocutaneous (TRAM), free TRAM, and deep inferior epigastric perforator (DIEP) flap breast reconstruction in English National Health Service hospitals. METHODS: Women diagnosed with breast cancer who underwent pedicled TRAM, free TRAM, or DIEP flap breast reconstruction procedures in English National Health Service hospitals between April of 2006 and March of 2012 were identified using the Hospital Episode Statistics database. Women who underwent mastectomy without reconstruction acted as controls, and hernia repair rates were calculated for all four groups. Multiple Cox regression was performed to estimate the relative risk of hernia repair among the reconstruction groups, adjusted for age, obesity, previous abdominal surgery, reconstruction year, and bilateral flap harvest. RESULTS: Between 2006 and 2012, 7929 women had a DIEP or TRAM flap breast reconstruction. The overall hernia repair rate within 3 years was 2.45 percent after abdominal flap breast reconstruction, and 0.28 percent among the 15,679 women who had mastectomy only. Mean time to hernia repair following an abdominal flap harvest was 17.7 months. Compared with DIEP flaps, free and pedicled TRAM flap procedures were associated with adjusted hazard ratios of 1.81 (95 percent CI, 1.24 to 2.64) and 2.89 (95 percent CI, 1.91 to 4.37), respectively. The only independent risk factor for hernia repair was age older than 60 years (p = 0.039). CONCLUSIONS: Abdominally based autologous breast reconstruction carries a small risk of subsequent donor-site hernia repair. The rates herein can be used to inform patients and to assess quality of care across service providers. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

An analysis of the motivating and risk factors for conversion from implant-based to total autologous breast reconstruction.

BACKGROUND: Problems with implant-based breast reconstructions can lead to patient dissatisfaction and a request for total autologous reconstruction. This 12-year study aimed to determine the rate of conversion from implant-based to autologous reconstruction, to identify potential risk factors, compare the rate of conversion in implant-only and latissimus dorsi/implant reconstructions, and assess patient satisfaction following conversion. METHODS: Implant-based reconstructions performed between 2000 and 2008 were reviewed. The cohort was then followed prospectively until 2012. RESULTS: One hundred thirty-nine implant-based reconstructions were performed in 118 patients. Sixty-nine patients underwent latissimus dorsi/implant (80 breasts) and 49 underwent implant-only reconstructions (59 breasts). Twenty-one underwent bilateral reconstructions following risk-reduction surgery. Sixteen percent (19 of 118) of patients and 14 percent of breasts (19 of 139) underwent conversion to autologous tissue. None of the 21 bilateral cases converted (hazard ratio, 4.6; p < 0.05). Median time to conversion was 64 months (range, 18 to 142 months). The main motivating factors for conversion included poor aesthetic result (36.8 percent), capsular contracture (31.6 percent), change in weight (21.1 percent), and implant infection/extrusion (10.5 percent). Implant-only reconstructions were more likely to convert (hazard ratio, 3.6; p < 0.05) and at an earlier stage (p < 0.05) than latissimus dorsi/implant reconstructions. Neither radiotherapy (p = 0.68) nor capsular contracture (p = 0.94) significantly increased the risk of conversion. The BREAST-Q demonstrated high patient satisfaction after conversion. CONCLUSIONS: Autologous tissue conversion offers a definitive means of improving the quality of the result, patient satisfaction, and quality of life in troublesome implant-based breast reconstructions. Latissimus dorsi coverage of implants and bilateral reconstructions appear to be protective. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.