Implant Based Breast Reconstruction With Acellular Dermal Matrix: Safety Data From an Open-label, Multicenter, Randomized, Controlled Trial in the Setting of Breast Cancer Treatment.

OBJECTIVE: To evaluate clinical outcomes of using acellular dermal matrix (ADM) with implant based breast reconstructions (IBBRs) in a randomized controlled trial. SUMMARY BACKGROUND DATA: The use of ADMs in IBBRs is widespread, but link between ADM and complications remain a controversial topic. In view of reports concerning harm, we present 6-months safety data of ADM-assisted IBBR in the setting of breast cancer treatment. METHODS: An open-label, randomized, controlled trial recruiting patients from 4 centers in Sweden and 1 in UK. Eligible were women with breast cancer planned for mastectomy with immediate IBBR. Participants were randomly allocated to IBBR with or without ADM (Strattice, Branchburg, NJ), with stratification by center in blocks of 6. Main primary endpoint was number of unplanned reoperations at 24 months, and safety expressed as the incidence of adverse events with a 6-month follow-up time for all participants. Analysis were done per protocol using Fisher exact test for complications and reoperations. RESULTS: From start of enrolment on April 24, 2014, to close of trial on May 10, 2017, 135 women were enrolled, of whom 64 with ADM and 65 without ADM were included in the final analysis. Four patients (6%) in each group had reconstructive failure with implant loss, but IBBR with ADM exhibited a trend of more overall complications and reoperations (difference 0·16, 95% CI, -0·01 to 0·32, P = 0·070), and with higher risk of wound healing problems (P = 0·013). CONCLUSIONS: With 6-months follow-up for all participants, immediate IBBR with ADM carried a risk of implant loss equal to conventional IBBR without ADM, but was associated with more adverse outcomes requiring surgical intervention. Further investigation of risk factors and patient selection in a long-term follow-up is warranted.

Radiotherapy in implant-based immediate breast reconstruction: risk factors, surgical outcomes, and patient-reported outcome measures in a large Swedish multicenter cohort.

The purpose of this large cohort study was to analyze the effects of prior and postoperative radiotherapy (RT) on surgical outcomes and patient-reported outcome measures (PROMs) in implant-based immediate breast reconstruction (IBR). All breast cancer patients (n = 725, of whom 29 had bilateral IBR) operated with implant-based IBR at four Stockholm hospitals from 2007 to 2011 were included. The median follow-up was 43 months. Three groups were compared: no RT (n = 386), prior RT (n = 64), and postoperative RT (n = 304). Outcomes were IBR failure (implant loss with or without secondary autologous reconstruction), unplanned reoperations, and PROMs, as measured by the BreastQ(®) questionnaire. IBR failure occurred in 22/386 (6 %) of non-irradiated cases, 16/64 (25 %) after prior and 45/304 (15 %) after postoperative RT (p < 0.001). Failure risk was higher after prior than postoperative RT (HR 9.28 vs. 3.08). Further risk factors were high BMI, less surgeon reconstructive experience, and postoperative infection, while the use of permanent implants lowered the risk of IBR failure. The estimated 5 years IBR failure rate was 10.4 % for non-irradiated, 28.2 % for previously and 25.2 % for postoperatively irradiated patients (p < 0.001). At least one unplanned reoperation occurred in 169/384 of non-irradiated (44 %), 42/64 (66 %) of previously, and 180/303 (59 %) of postoperatively irradiated breasts (p < 0.001). Further contributing factors were the use of one-stage expander and permanent implants, less surgeon reconstructive experience, and smoking. RT significantly impaired scores on all scales of the BreastQ(®). However, a clear majority of women in all groups would choose IBR again. Implant-based IBR remains a feasible option for women undergoing mastectomy as patient satisfaction levels are high. After prior RT, however, autologous alternatives should be considered.

Breast reconstruction patterns from a Swedish nation-wide survey.

OBJECTIVES: The overall aim of the Swedish Breast Reconstruction Outcome Study was to investigate national long-term outcomes after mastectomy with or without breast reconstruction. The current report evaluates breast reconstruction (BR) patterns in Sweden over time. MATERIALS AND METHODS: This is a cross-sectional, registry-based study where all women operated with mastectomy 2000, 2005, 2010 were identified (N = 5853). Geographical differences in type of BR were investigated using heatmaps. Distribution of continuous variables were compared using the Mann-Whitney U test, categorical variables were compared using the chi-square test. RESULTS: Mean age at survey was 69 years (SD=±11.4) and response rate was 50%, responders were on average six years younger than the non-responders and had a more favourable tumor stage (both p < 0.01). Of the 2904 responders, 31% (895/2904) had received a BR: implant-based in 58% (516/895)autologous in 31% (281/895). BR was immediate in 20% (176/895) and delayed in 80% (719/895) women. Women with BR were on average one year older, more often had a normal BMI, reported to be married or had a partner, had a higher educational level and a higher annual income when compared to those without BR (all p < 0.001). The independent factors of not receiving BR were older age and given radiotherapy. CONCLUSIONS: To our knowledge, this is the first national long-term follow-up study on women undergoing mastectomy with and without BR. Around 30% of the survey responders have had a BR with a significant geographical variation highlighting the importance of information, availability and standardisation of indications for BR.

The latissimus dorsi flap--still a valuable tool in breast reconstruction: report of 32 cases.

Breast reconstruction with a pedicled latissimus dorsi flap (LDF), with or without implants, is an established method. At the Breast Cancer Unit, Huddinge University Hospital, 32 patients with soft tissue deficiencies of the chest such as damaged skin or lack of pectoral muscle after the initial operation, or complications of radiotherapy had breasts reconstructed with a pedicled LDF during the years 2002-2004. We made a retrospective assessment of the results of this procedure, which showed that the pedicled LDF, usually combined with an implant, still should be considered as an option to microsurgery as it is safe, with great satisfaction and few complications.

Early experience with the crescent expander in immediate and delayed breast reconstruction.

Traditional breast expanders have known drawbacks, such as undesirable fullness at the upper pole, inadequate expansion of the residual breast tissue, and poor ptosis of the reconstructed breast. Crescent-shaped expanders are thought to improve the result in that expansion is concentrated at the basal breast pole. The aim of this prospective pilot study was to evaluate our results with the crescent-shaped expander in immediate and delayed breast reconstructions. Twenty-five patients, median age 51 (27-75) years, underwent 28 operations. The median follow-up time was 8 (4-15) months. Four patients developed complications including superficial infections, capsular contractions (Baker III-IV), and fullness of the upper pole. Three of these patients had been given irradiation. Breast reconstructions with the crescent-shaped expander allowed expansion of the lower pole and led to an anatomical breast shape. Patients' satisfaction during expansion was good. Our data indicate a correlation between complications and radiotherapy.

A prospective randomized study comparing two different expander approaches in implant-based breast reconstruction: one stage versus two stages.

BACKGROUND: Implant-based reconstruction is performed in the majority of women offered primary reconstruction for breast cancer. METHODS: Two different expander implants were compared prospectively. The primary endpoint was the number of operations needed in each group to obtain patient satisfaction. Secondary endpoints were evaluation of breast volume and shape and aspects of quality of life. Seventy consecutive breast cancer patients were randomized to either a one-stage reconstruction with a round permanent expander implant (Becker 25; n=35) or a two-stage reconstruction with a crescent-shaped expander (LV 133; n=35), later replaced by a form-stable anatomical implant. Thirty patients had to be excluded and 40 patients, 20 in each group, were evaluated. The median follow-up for both groups was 3.5 years (range, 1.5 to 5 years). Plastic cups, plastic casts, and two -and three-dimensional scanning techniques were used for objective assessment of breast volume and shape. The aesthetic outcome was evaluated by a panel of experts and lay people, and by the patients. Quality of life was evaluated with a validated questionnaire (36-Item Short Form Health Survey). RESULTS: Of the patients in the one-stage group, 70 percent had revision surgery, mostly because of upper pole fullness and poor ptosis. These findings agreed with the data from the two-dimensional scanning and from the expert panel and the patients' subjective judgment. Quality of life was similar in the two groups. CONCLUSIONS: The permanent expander method failed significantly as a one-stage procedure. The crescent two-stage method gave the most acceptable results both objectively and subjectively. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Evaluation of volume and shape of breasts: comparison between traditional and three-dimensional techniques.

There have been many attempts to evaluate the shape, volume, and contour of breasts both before and after operation. To evaluate and compare results objectively in a reproducible, low-cost way is difficult. The aim of this study was to compare three-dimensional techniques with traditional methods in evaluating the volume and shape of breasts. Twelve patients with breast cancer were evaluated, 6 patients preoperatively and 6 patients postoperatively, using plastic cups, thermoplastic casts, magnetic resonance imaging (MRI), and three-dimensional imaging techniques. Thermoplastic casts and plastic cups measured better accordance with the volume of the operated breast than either the three-dimensional technique or MRI, which resulted in significantly higher values. The three-dimensional technique offered a new possibility to evaluate the shape of breasts objectively.