Dataset Information

The effect of post mastectomy radiation therapy on breast reconstruction with and without acellular dermal matrix: a systematic review and meta-analysis protocol.

ABSTRACT:

Background

The widespread implementation of acellular dermal matrix (ADM) has broadened the reconstructive repertoire for alloplastic breast reconstruction. ADM's role in the context of postoperative radiation therapy remains unclear. The present review will evaluate whether ADM reduces complication rates in patients undergoing post-mastectomy radiation therapy (PMRT).

Methods

A healthcare librarian assisted in performing a search strategy of electronic databases MEDLINE (via Ovid), EMBASE, and CENTRAL. A combination of the keywords and Medical Subject Headings (MESH) to describe the various commercially available ADMs and terms for radiation therapy will be used. The search strategy will identify patients undergoing postoperative radiation following implant-based breast reconstruction and compare outcomes between those with and without ADM. Extracted data will include patient demographics, intraoperative data, and postoperative complications. Data on patient satisfaction and resource utilization will also be extracted if available. The references of selected works will be reviewed for additional studies meeting study criteria. Only peer-reviewed papers written in English will be included. The study data will be assessed for risk of bias and heterogeneity. Providing that sufficient studies can be identified, a meta-analysis will be performed. This review has been registered with PROSPERO (CRD42017056495).

Conclusions

To date, the short- and long-term performance of ADM in the context of postoperative radiation remains unclear. The objective of the present review will be to critically evaluate the literature with the intention of improving postoperative outcomes in the context of mastectomy and radiation.

SUBMITTER: Chung AM

PROVIDER: S-EPMC6383242 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Publications

The effect of post mastectomy radiation therapy on breast reconstruction with and without acellular dermal matrix: a systematic review and meta-analysis protocol.

Chung Amy M AM Stein Michael J MJ Ghumman Ammara A Zhang Jing J

Systematic reviews 20190221 1

<h4>Background</h4>The widespread implementation of acellular dermal matrix (ADM) has broadened the reconstructive repertoire for alloplastic breast reconstruction. ADM's role in the context of postoperative radiation therapy remains unclear. The present review will evaluate whether ADM reduces complication rates in patients undergoing post-mastectomy radiation therapy (PMRT).<h4>Methods</h4>A healthcare librarian assisted in performing a search strategy of electronic databases MEDLINE (via Ovid ...[more]

PMID: 30791946

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Project description:ImportanceThe use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking.ObjectiveTo evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM.Design, setting, and participantsThis was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017.InterventionsParticipants were allocated to immediate IBBR with or without ADM.Main outcomes and measuresThe primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire.ResultsFrom start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11).Conclusions and relevanceImmediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits.Trial registrationClinicalTrials.gov Identifier: NCT02061527.

Project description:PurposeThe goal of this study was to explore the perspectives and practice of radiation oncologists who treat breast cancer patients who have had breast reconstruction.MethodsIn 2010, an original electronic survey was sent to all physician members of the American Society of Radiation Oncology, National Cancer Research Institute-Breast Cancer Studies Group in the United Kingdom, Thai Society of Therapeutic Radiology and Oncology, Swiss Society of Radiation Oncology, and Turkish Radiation Oncology Society. We identified factors associated with radiation oncologists who treat breast cancer patients with reconstruction performed prior to radiation and obtained information regarding radiation management of the breast reconstruction.Results358 radiation oncologists responded, and 60% of the physicians were from the United States. While 64% of participants agree or strongly agree that breast image affects a woman's quality of life during radiation, 57% feel that reconstruction challenges their ability to deliver effective breast radiation. Compared with other countries, treatment within the United States was associated with a high reconstruction rate (>/= 50% of mastectomy patients) prior to radiation (p < 0.05). Delayed-immediate reconstruction with a temporary tissue expander was more common in the United States than in other countries (52% vs. 23%, p = 0.01). Among physicians who treat patients with tissue expanders, the majority (60%) prefer a moderately inflated implant with 150-250 cc of fluid rather than a completely deflated (13%) or inflated expander (28%) during radiation. Among radiation oncologists who treat reconstructions, 49% never use bolus and 40% never boost a breast reconstruction. United States physicians were more likely than physicians from other countries to boost or bolus the reconstruction irrespective of the type of reconstruction seen in their clinic patients (p < 0.01).ConclusionsGreat variation in practice is evident from our study of radiation treatment for breast cancer patients with reconstruction. Further research on the impact and delivery of radiation to a reconstructed breast may validate some of the observed practices, highlight the variability in treatment practice, and help create a treatment consensus.

Project description:The two-stage tissue expander/implant (TE/I) reconstruction is currently the gold standard method of implant-based immediate breast reconstruction in North America. Recently, however, there have been numerous case series describing the use of one-stage direct to implant reconstruction with the aid of acellular dermal matrix (ADM). In order to rigorously investigate the novel application of ADM in one-stage implant reconstruction, we are currently conducting a multicentre randomized controlled trial (RCT) designed to evaluate the impact on patient satisfaction and quality of life (QOL) compared to the two-stage TE/I technique.The MCCAT study is a multicenter Canadian ADM trial designed as a two-arm parallel superiority trial that will compare ADM-facilitated one-stage implant reconstruction compared to two-stage TE/I reconstruction following skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) at 2 weeks, 6 months, and 12 months. The source population will be members of the mastectomy cohort with stage T0 to TII disease, proficient in English, over the age of 18 years, and planning to undergo SSM or NSM with immediate implant breast reconstruction. Stratified randomization will maintain a balanced distribution of important prognostic factors (study site and unilateral versus bilateral procedures). The primary outcome is patient satisfaction and QOL as measured by the validated and procedure-specific BREAST-Q. Secondary outcomes include short- and long-term complications, long-term aesthetic outcomes using five standardized photographs graded by three independent blinded observers, and a cost effectiveness analysis.There is tremendous interest in using ADM in implant breast reconstruction, particularly in the setting of one-stage direct to implant reconstruction where it was previously not possible without the intermediary use of a temporary tissue expander (TE). This unique advantage has led many patients and surgeons alike to believe that one-stage ADM-assisted implant reconstruction should be the procedure of choice and should be offered to patients as the first-line treatment. We argue that it is crucial that this technique be scientifically evaluated in terms of patient selection, surgical technique, complications, aesthetic outcomes, cost-effectiveness, and most importantly patient-reported outcomes before it is promoted as the new gold standard in implant-based breast reconstruction.ClinicalTrials.gov: NCT00956384.

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:Background and Objective: Prepectoral implant placement in breast reconstruction is currently a must-have in the portfolios of breast surgeons. The introduction of new tools and conservative mastectomies is a game changer in this field. The prepectoral plane usually goes hand-in-hand with the ADM wrapping of the implant. It is a cell-free dermal matrix comprising a structurally integrated basement membrane complex and an extracellular matrix. The literature reports that ADMs may be useful, but proper patient selection, surgical placement, and post-operative management are essential to unlock the potential of this tool, as these factors contribute to the proper integration of the matrix with surrounding tissues. Materials and Methods: A total of 245 prepectoral breast reconstructions with prostheses or expanders and ADMs were performed in our institution between 2016 and 2022. A retrospective study was carried out to record patient characteristics, risk factors, surgical procedures, reconstructive processes, and complications. Based on our experience, we developed a meticulous reconstruction protocol in order to optimize surgical practice and lower complication rates. The DTI and two-stage reconstruction were compared. Results: Seroma formation was the most frequent early complication (less than 90 days after surgery) that we observed; however, the majority were drained in outpatient settings and healed rapidly. Secondary healing of wounds, which required a few more weeks of dressing, represented the second most frequent early complication (10.61%). Rippling was the most common late complication, particularly in DTI patients. After comparing the DTI and two-stage reconstruction, no statistically significant increase in complications was found. Conclusions: The weakness of prepectoral breast reconstruction is poor matrix integration, which leads to seroma and other complications. ADM acts like a graft; it requires firm and healthy tissues to set in. In order to do so, there are three key steps to follow: (1) adequate patient selection; (2) preservative and gentle handling of intra-operative technique; and (3) meticulous post-operative management.

Dataset Information

The effect of post mastectomy radiation therapy on breast reconstruction with and without acellular dermal matrix: a systematic review and meta-analysis protocol.

Background

Methods

Conclusions

Publications

The effect of post mastectomy radiation therapy on breast reconstruction with and without acellular dermal matrix: a systematic review and meta-analysis protocol.

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