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One-step prepectoral breast reconstruction with porcine dermal matrix-covered implant: a protective technique improving the outcome in post-mastectomy radiation therapy setting.

ABSTRACT: Background:Post-mastectomy radiotherapy (PMRT) applied on implant-assisted immediate breast reconstruction (IBR) involves a marked increase in complication rate. The recent opportunity of performing an ADM-assisted prepectoral breast reconstruction (PPBR) raised the hypotesis of a protective interaction between ADM and periprosthetic tissues under PMRT. Methods:We performed a retrospective monocentric analysis of a cohort of consecutively treated patients undergone one-step PPBR between January 2015 and September 2018. The aim is to examine complication rate and aesthetic satisfaction of patients, in order to evaluate if this reconstructive technique could be recommendable in PMRT setting. Group 1 comprised 158 patients not submitted to PMRT and Group 2 twenty-eight patients undergone PMRT. Results:All post-operative complications were not statistically different between the two groups, except for capsular contracture (P=0.011). We obtained very high percentages in all BREAST-Q categories in Group 2 patients: satisfaction with breasts 86.8±13.9, satisfaction with implants 6.5±3.0, high satisfaction for no adverse effects of radiation 15.7±6.8. According to multivariate analysis no risk factor was significantly associated with complications. Conclusions:We may conclude that one-step PPBR with porcine ADM followed by PMRT is well tolerated, with no significant risk of adverse outcomes, at least in the short-term follow-up. These promising outcomes warrant further studies to examine the existence of a protective effect due to ADM integration with subcutaneous tissue.

SUBMITTER: Polotto S

PROVIDER: S-EPMC7225454 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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One-step prepectoral breast reconstruction with porcine dermal matrix-covered implant: a protective technique improving the outcome in post-mastectomy radiation therapy setting.

Polotto Susanna S Bergamini Maria Luisa ML Pedrazzi Giuseppe G Arcuri Maria F MF Gussago Francesca F Cattelani Leonardo L

Gland surgery 20200401 2

<h4>Background</h4>Post-mastectomy radiotherapy (PMRT) applied on implant-assisted immediate breast reconstruction (IBR) involves a marked increase in complication rate. The recent opportunity of performing an ADM-assisted prepectoral breast reconstruction (PPBR) raised the hypotesis of a protective interaction between ADM and periprosthetic tissues under PMRT.<h4>Methods</h4>We performed a retrospective monocentric analysis of a cohort of consecutively treated patients undergone one-step PPBR b ...[more]

PMID: 32420245

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Project description:BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques.Methods and analysisBest-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques.The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients.Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial.Ethics and disseminationThe study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.Trial registration numberISRCTN10081873.

Project description:BackgroundSeveral studies have discussed various methods of prepectoral direct-to-implant (DTI) breast reconstruction using an acellular dermal matrix (ADM) prosthesis to achieve full coverage. However, methods for anterior coverage have rarely been reported. In this study, prepectoral DTI breast reconstruction with complete anterior implant coverage was performed using a square piece of ADM. This study aimed to introduce our prepectoral DTI technique and determine its functional and cosmetic outcomes as well as compare them with those of existing subpectoral DTI techniques.MethodsThis prospective comparative study focused on 29 patients (35 breasts) and 34 patients (35 breasts) who underwent breast reconstruction via subpectoral implant insertion (control group) and anterior coverage prepectoral implant insertion (anterior coverage group), respectively. Postoperative complications were noted, and breast symmetry was evaluated using the Vectra H2 three-dimensional scanner. The modified Kyungpook National University Hospital Breast-Q (KNUH Breast-Q) scale was used to assess the patient's subjective satisfaction with the reconstruction and postoperative quality of life.ResultsNo remarkable differences in terms of complications (seroma, skin necrosis, nipple-areola complex necrosis, hematoma, capsular contracture, and infection) were noted in both groups. Compared with controls, considerably better results were observed among those in the anterior coverage group in terms of the mean drain removal period. Furthermore, those in the anterior coverage group showed greater symmetry on three-dimensional scans than the controls; however, this was not statistically significant. Subjective satisfaction and postoperative quality of life measured using the KNUH Breast-Q scale were not significantly different between both groups.ConclusionsConsidering its stability, faster recovery time, and cosmetic benefit, prepectoral breast reconstruction with anterior implant coverage using a single, large ADM is a good choice to perform breast reconstruction with implant insertion in patients who have undergone mastectomy.Level of evidenceII.

Project description:IntroductionThe emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions.Methods and analysisInternational, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm).Ethics and disseminationThis study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). 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 and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles.Trial registration numberNCT04293146.

Dataset Information

One-step prepectoral breast reconstruction with porcine dermal matrix-covered implant: a protective technique improving the outcome in post-mastectomy radiation therapy setting.

Publications

One-step prepectoral breast reconstruction with porcine dermal matrix-covered implant: a protective technique improving the outcome in post-mastectomy radiation therapy setting.

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