Development and implementation of a decision aid for post-mastectomy breast reconstruction for Japanese women with breast cancer: a field-testing study.

INTRODUCTION: Surgical options for post-mastectomy breast reconstruction (PMBR) have increased and become more diverse. These options may cause difficulty and stress for patients in making the best choice, and this also increases the likelihood of postoperative regret over a particular decision. To solve this issue, implementation of shared decision-making (SDM) using a decision aid (DA) has become of increasing interest. We have created the first prototype DA in Japan. The aim of the current field study was to assess the usability of this DA in promoting effective SDM and avoiding regret over a decision to undergo reconstructive surgery. METHODS: A total of 25 consecutive patients who underwent BR were enrolled in the study, including 13 with SDM using the decision aid (DA + group) and 12 who received standard information (DA- group) before their choice of surgery. The Decision Regret Scale (DRS) were completed after PMBR, whereas SDM Questionnaire (SDM-Q-9) was completed before PMBR. Descriptive and summary statistics were compared to identify differences between the two groups to assess the usability of the DA. RESULTS: The DA + group had significantly higher mean total scores on the SDM-Q-9 (90.2 ± 5.3 vs. 84.1 ± 3.5, P = 0.0034) and DRS (90.3 ± 3.8 vs. 84.3 ± 6.7, P = 0.023), compared to those in the DA- group. CONCLUSION: Use of the DA may cause patients to have a higher level of perceived SDM and less regret, which suggests that the DA helps to facilitate smooth and effective implementation of SDM. We conclude that this type of decision-making approach should be recommended for choice of surgery for PMBR.

Characteristics and distribution of chronic pain after mastectomy and breast reconstruction: a long-term prospective cohort study.

PURPOSE: Chronic pain following breast surgery is a concern for breast cancer survivors; however, few studies have investigated the localization of persistent postoperative pain. We conducted this study to identify the location of pain following breast reconstruction. METHODS: A total of 213 Japanese women undergoing mastectomy only or breast reconstruction with a tissue expander/implant (TE/Imp) or a deep inferior epigastric perforator (DIEP) flap were enrolled in the study. Questionnaires related to pain location were sent to patients at the end of postoperative year (POY) 1 and POY 5. Multiple comparisons of the types of operation and cross-tabulation were made between the two time points. RESULTS: Surveys were completed by 107 of the women. Severe pain in the upper medial breast was significantly more common in POY 1 after DIEP reconstruction than after mastectomy only (P = 0.01), whereas abdominal pain was worse in POY 5 after DIEP reconstruction than after mastectomy only (P = 0.04). Pain in the medial arm and axilla had resolved better after TE/Imp (P = 0.03) and DIEP reconstruction (P = 0.01) than after mastectomy only by POY 5, but the difference between TE/Imp and DIEP reconstruction was not significant. CONCLUSIONS: These results show that localization of prolonged postoperative pain following breast reconstruction differs depending on the surgical strategy.

Prophylactic Application of Human Adipose Tissue-Derived Products to Prevent Radiation Disorders.

BACKGROUND: Radiation therapy is a mainstay treatment for malignancies, but it can induce deterministic adverse effects in surrounding healthy tissues, including atrophy, fibrosis, ischemia, and impaired wound healing. This exploratory study investigated whether prophylactic administration of products containing adipose tissue-derived stem cells immediately after radiotherapy could prevent the development of long-term functional disorders in irradiated tissues. METHODS: A total irradiation dose of 40 Gy (10 Gy, four times weekly) was delivered to the dorsal skin of nude mice. Subsequently, a prophylactic treatment with vehicle, fat tissue, stromal vascular fraction, or micronized cellular adipose matrix was injected subcutaneously into the irradiated area. Six months after these prophylactic treatments, a cutaneous punch wound was created to evaluate histologic changes and wound healing. RESULTS: Histologic assessments demonstrated dermal thickening, atrophy, and increased collagen deposits in the subcutaneous fatty layer 6 months after radiotherapy. In addition, wound healing was significantly delayed. The prophylactic treatments with three different types of human adipose tissue-derived products significantly prevented radiation-induced histologic changes and accelerated wound healing compared with the vehicle-treated irradiated group. CONCLUSIONS: This is the first study to demonstrate potential for prophylactic treatments after radiotherapy, which could prevent the progression of chronic radiation therapy disorders. The results could have a substantial impact on current anticancer radiotherapies; a next-generation radiation therapy may need to be always combined with a stem cell therapy. Such prophylactic treatments have the potential to improve wound healing of irradiated tissue and clinical outcomes of reconstructive surgery required after cancer radiotherapy. CLINICAL RELEVANCE STATEMENT: The results of this study suggest that it is clinically possible to prevent the development of radiation disorders using stem cell therapies. This study may provide a new concept of prophylactic treatment, which would be a paradigm shift in radiotherapy.

Micronized Cellular Adipose Matrix Promotes the Therapeutic Effect of an Artificial Nerve Conduit in Peripheral Nerve Gap Injury.

BACKGROUND: Stromal vascular fraction (SVF) isolated from adipose tissue has been shown to be beneficial for treating peripheral nerve injuries. Micronized cellular adipose matrix (MCAM) is an SVF-rich micronized fat tissue obtained by a series of simple mechanical processes. This study assessed the therapeutic effect of MCAM for peripheral nerve injury. METHODS: Microscopic evaluation of the cell phenotype and functions was performed to determine the adipose-derived stem cell content of the MCAM. An artificial nerve conduit (ANC) filled with MCAM was implanted into a sciatic nerve defect in immunodeficient mice. Comparisons of this treatment with an autograft, an ANC filled with SVF cells, and an ANC alone were made based on electrophysiologic characteristics, Sciatic Functional Index, and histologic analyses of regenerated nerve fiber and myelination using electron microscopy, and the preventive effect on innervated muscle atrophy. RESULTS: MCAM contained many cells with a phenotype and differentiation potency similar to those of ADSCs. The implantation experiment indicated that MCAM enhanced the efficiency of functional and structural recovery and prevented atrophy of the innervated muscle. These effects were significantly improved compared with the control group (ANC only) and comparable to those in the SVF group, whereas the improvement did not reach the same level of the autograft group. CONCLUSION: Injection of MCAM into an ANC accelerated nerve regeneration compared with use of an ANC alone, which indicates that MCAM is a promising transplant material for treatment of peripheral nerve injury and an alternative to use of SVF cells. CLINICAL RELEVANCE STATEMENT: Micronized cellular adipose matrix, which can be harvested and isolated from adipose tissue with a simple device, has been shown for the first time to be highly useful as an implantable material for new peripheral nerve regeneration.

Patient-Reported Outcomes After Autologous Fat Grafting in Prosthetic Breast Reconstruction: Prospective Cohort Study Using a Multivariate Analysis.

INTRODUCTION: There is widespread recognition of the importance of assessment of patient satisfaction and well-being after breast reconstruction. However, few studies of fat grafting performed simultaneously with implant-based breast reconstruction (IBBR) have accounted for confounding factors, such as patient background and information bias. The aim of this study was to examine patient satisfaction and well-being using multivariate analysis of BREAST-Q scores in patients treated with IBBR combined with fat grafting. METHODS: Seventy-one consecutive patients who underwent IBBR with silicone breast implants were enrolled for a prospective cohort study. Among these patients, 56 responded to the BREAST-Q questionnaire, including 24 who underwent fat grafting at the same time as IBBR (FAT+ group) and 32 who underwent IBBR alone (FAT- group). The BREAST-Q questionnaire was completed 1 year after surgery. Statistical analysis was performed using descriptive and summary statistics to identify differences between the 2 groups. RESULTS: Logistic regression analysis showed that the FAT+ group was significantly more likely than the FAT- group to have satisfaction with breasts (P = 0.0201) and satisfaction with outcome (P = 0.0364). CONCLUSIONS: Multivariate analysis with consideration of confounding factors indicated that addition of fat grafting to IBBR improves outcomes of breast reconstruction. These results suggest that a minor surgical procedure of fat grafting can improve patient satisfaction and outcomes after breast reconstruction.

Long-term survey of sexual well-being after breast reconstruction using the BREAST-Q in the Japanese population.

BACKGROUND: The objective of this study was to identify response patterns related to sexual well-being following breast operations in the Japanese population. METHODS: Patient-reported outcomes were analyzed at 1 year and 5 years after breast operations, including breast reconstruction, for Japanese women at a single center, with a focus on "Sexual well-being" in BREAST-Q. Response analysis and multiple regression analysis were performed. The scores at years 1 and 5 were also compared across three types of operation: mastectomy only, TE/Imp, and DIEP. RESULTS: The response rate for Sexual well-being on BREAST-Q in the prospective cohort of patients with breast cancer dropped from 60.0% in postoperative year 1-34.3% in year 5. The mean score for Sexual well-being increased from 32 (year 1) to 38 (year 5). There were significant differences between respondents and non-respondents in age at year 1 (P = 0.007) and for mastectomy only (P = 0.01) and TE/Imp (P = 0.03) at year 5. In regression analysis, only DIEP was positively associated with Sexual well-being at year 1 (p < 0.001) and there were no significant factors at year 5. Among the operative procedures, scores after DIEP were significantly better than those after mastectomy only at year 1 (p < 0.001), but there was no difference at year 5. There were no significant changes from year 1 to year 5 for each operation. CONCLUSIONS: A low response rate for Sexual well-being on BREAST-Q was found in Japanese women at 5 years postoperatively. This suggests the need for development of a modified evaluative scale that avoids nonresponse bias and considers ethnic differences.

Risk factors associated with chronic pain after mastectomy: a prospective study with a 5-year follow-up in Japan.

BACKGROUND: Chronic pain is a major complication following breast surgery including breast reconstruction. We previously examined prospective patient-specific and medical/surgical factors that predict chronic pain a year after breast surgery in the Japanese population. Five-year survivorship is essential for breast cancer patients. This report is a 4-year follow-up study following the previous research. METHODS: A follow-up observation study was performed 5 years after breast operations. The subjects were patients who underwent breast surgery, including tissue expander/implant (TE/implant), DIEP procedures and mastectomy only. Pain at 5 years was assessed using the Japanese Version of the Short-Form McGill Pain Questionnaire (SF-MPQ-JV). A multiple linear regression model was used to examine the relationships of clinical factors with chronic pain. RESULTS: Questionnaires were completed by 132 subjects. No factor related to chronic pain was significantly related to the MPQ pain ratings. Among patient characteristics, a psychotic or neurological medical history was related to significantly lower visual analog scale (p = 0.02) and present pain index (p = 0.04) scores. A history of chemotherapy and/or hormone therapy was significantly associated with the frequency of use of pain medication postoperatively (p = 0.05) and effect on the social life of the patients (p = 0.02). CONCLUSIONS: A psychotic or neurological history and a history of chemotherapy and/or hormone therapy were identified as risk factors for chronic pain after breast surgery, but the type of operation was not associated with chronic pain.

Long-Term Patient Satisfaction and Quality of Life Following Breast Reconstruction Using the BREAST-Q: A Prospective Cohort Study.

Background: Breast reconstruction is a promising surgical technique to improve health-related quality of life (HRQoL) in patients with breast cancer. However, the long-term risk factors associated with HRQoL after breast surgery are still unclear. Our aim was to evaluate breast satisfaction and HRQoL following breast reconstruction to identify clinical factors associated with each domain of BREAST-Q in the long-term. Methods: Patient-reported BREAST-Q outcomes were analyzed 1 and 5 years after breast reconstruction in a single-blinded, prospective study. Multiple regression analysis was performed to identify the risk and protective factors associated with BREAST-Q scores. These scores at 1 and 5 years were also compared across three types of operation: mastectomy only, tissue expander/implant (TE/Imp), and a deep inferior epigastric perforator (DIEP) flap. Results: Surveys were completed by 141 subjects after 1 year and 131 subjects after 5 years. Compared to mastectomy only, breast reconstruction was significantly associated with greater "Satisfaction with breasts" (TE/Imp, p < 0.001; DIEP, p < 0.001) and "Psychosocial well-being" (TE/Imp, p < 0.001; DIEP, p < 0.001), higher body mass index (BMI) resulted in lower "Satisfaction with breasts" (p = 0.004), and a history of psychiatric or neurological medication was significantly associated with "Physical well-being" at 1-year postoperatively (p = 0.02). At 5 years, reconstructive procedures were significantly positively associated with greater "Satisfaction with breasts" (TE/Imp, p < 0.001; DIEP, p < 0.001) and "Psychosocial well-being" (TE/Imp, p = 0.03; DIEP, p < 0.001), and a bilateral procedure was a significant risk factor for lower "Psychosocial well-being" (p = 0.02). Conclusions: The results of this study show that breast reconstruction improves "Satisfaction with Breasts" and "Psychosocial well-being" compared to mastectomy. Among all three types of operation, DIEP gave the best scores at 5 years postoperatively. Thus, autologous reconstruction is recommended for promotion of long-term HRQoL after breast surgery.

Breast Splint for Prevention of Nipple-areolar Complex Malposition after Direct-to-implant Breast Reconstruction.

Breast reconstruction with immediate placement of breast implants (direct-to-implant methods) following nipple-sparing mastectomy has increased because of the low burden on the patient and good aesthetic results. However, nipple-areolar complex (NAC) malposition after this surgery remains a common complication that has yet to be entirely resolved. Here, we introduce an approach using Duoactive CGF to prevent postoperative NAC malposition. Immediate postoperative fixation of Duoactive CGF cranially to the NAC of the operated breast was applied for 2-4 weeks. This is referred to as a breast splint. In the study, nine patients who received breast splints and 15 patients who did not were enrolled. The NAC position on the splint-treated breast was compared with that on the healthy side within 6 months after surgery. A case with little visual malposition was defined as having a good outcome, based on the deviation in the cranial direction not exceeding the position of the contralateral NAC. Our preliminary data demonstrated that the rate of good outcomes was significantly higher (P = 0.028) in cases in which a breast splint was used, compared with those that were not treated with a breast splint (7/9, 78.8% versus 4/15, 26.7%). Postoperative application of a breast splint using Duoactive CGF is a simple and useful method to prevent NAC malposition after breast reconstruction, using a direct-to-implant method.

Medial Upper Lip Vermillion Reconstruction with a Labial Artery-based Cross-lip Vermillion Flap.

A defect of the central upper lip vermillion generally requires "like for like" reconstruction because this part of the upper lip can attract attention and has a unique structure and color. In this article, we report use of a labial artery-based horizontal long cross-lip flap for central upper lip vermillion reconstruction. In the first stage of surgery, a horizontal long vermillion flap from the lower lip starting at the left commissure with a vascular pedicle containing an inferior labial artery was raised and transposed to the upper vermillion defect. In the second stage, 12 days later, the pedicle was divided to complete the reconstruction. There were no postoperative complications in articulation or eating, and the patient was satisfied with the esthetic outcome. This surgical technique reduces microstomia and inconvenience in eating and speaking compared with a common horizontal cross-lip flap and provides better color- and texture-matched tissue compared to reconstruction using a tongue flap or mucosal flap. The technique is simple, requires a relatively short surgical time, has minimum donor-site morbidity and permits good esthetic and functional reconstruction of the central upper lip vermillion for a relatively small defect.

Preventive Effect on Seroma of Use of PEAK PlasmaBlade after Latissimus Dorsi Breast Reconstruction.

Postoperative seroma is still the main complication after a latissimus dorsi (LD) flap procedure. The etiology of seroma is currently thought to comprise tissue fluids resulting from inflammatory reactions in affected tissue caused by the use of monopolar electrocautery (EC). It is possible that seroma formation can be reduced by using alternative devices such as the PEAK PlasmaBlade (PPB), which provides atraumatic scalpel-like cutting precision while the blade temperature remains close to body temperature. The subjects were 44 patients who underwent breast reconstruction with LD flaps from August 2015 to April 2017. They were retrospectively split into groups treated with a PPB (n = 21) and with conventional EC (n = 23). Outcomes such as rate of seroma formation, total drain discharge volume, indwelling period of drainage at the donor site, length of hospital stay, and operation time were compared between the 2 groups. The incidence of seroma was significantly lower in the PPB group (19.0%) than in the EC group (47.8%). The total drain discharge volume was significantly lower and the indwelling period of drainage and length of hospital stay were significantly shorter in the PPB group. In summary, use of PPB in an LD flap procedure can reduce seroma formation and the lengths of the drainage period and the hospital stay.