The influence of a previous implant-based breast reconstruction on postoperative sensation of the deep inferior epigastric artery perforator flap.

BACKGROUND: Implants and DIEP flaps have different outcomes regarding postoperative breast sensation. When compared to the preoperative healthy breast, implant-based breast reconstruction (IBBR) negatively influences postoperative breast sensation. However, it is currently unknown whether a prior IBBR also influences postoperative sensation of a replacing DIEP flap. The goal of this cohort study is to evaluate the influence of an IBBR on the postoperative sensation of a replacing DIEP flap. METHODS: Women were included if they received a DIEP flap reconstruction after mastectomy, with or without prior tissue expander (TE) and/or definitive breast implant. Sensation was measured at four intervals in 9 areas of the breast with Semmes-Weinstein monofilaments: T0 (preoperative, implant/no reconstruction), T1 (2-7 months postoperative, DIEP), T2 (± 12 months postoperative, DIEP), Tmax (maximum follow-up, DIEP). Linear mixed-effects models were used to investigate the relationship between an implant/TE prior to the DIEP flap and recovery of breast sensation. RESULTS: 142 women comprising 206 breasts were included. 48 (23.3%) breasts did, and 158 (76.7%) breasts did not have a TE/IBBR prior to their DIEP. No statistically significant or clinically relevant relationships were found between a prior implant/TE and recovery of DIEP flap breast sensation for the flap skin, native skin, or total breast skin at T1, T2, or Tmax. There were also no relationships found after adjustment for the confounders radiation therapy, BMI, diabetes, age, flap weight, follow-up, and nerve coaptation. CONCLUSIONS: An implant/TE prior to a DIEP flap does not influence the recovery of postoperative breast sensation of the DIEP flap.

Risk factors for unplanned reoperation during the expansion phase in two-stage breast reconstruction in the Dutch Breast Implant Registry.

BACKGROUND: The majority of postmastectomy breast reconstructions (PMBRs) are currently performed in two stages using a tissue expander (TE). However, complications during the expansion phase occur regularly, leading to unplanned reoperations and/or reconstruction failure. This study aimed to identify risk factors for unplanned reoperation after TE placement, assessed the time until unplanned and planned reoperation, and investigated indications for unplanned reoperation. METHODS: Patient and surgery-related characteristics of patients who underwent two-stage PMBR between 2017 and 2021 were collected from the Dutch Breast Implant Registry (DBIR). Unplanned reoperation was defined as TE explantation followed by either no replacement or replacement with the same or a different TE. Co-variate adjusted characteristics associated with unplanned reoperation were determined using backward stepwise selection and multivariable logistic regression analyses. RESULTS: In total, 2529 patients (mean age, 50.2 years) were included. Unplanned reoperation occurred in 19.4 percent of all registered TEs (n=3190). Independent factors associated with unplanned reoperation were BMI≥25 kg/m 2 (adjusted Odds Ratio [aOR]=1.63;99% Confidence Interval [99%CI]=1.20-2.57 for BMI 25-29.9 kg/m2, aOR=2.57;99%CI=1.74-3.78 for BMI≥30 kg/m 2), low institutional volume (aOR=1.51;99%CI=1.06-2.18), no drains (aOR=2.06;99%CI=1.15-3.60), subcutaneous TE placement (aOR=5.71;99%CI=3.59-9.10), and partial pectoralis major muscle coverage (aOR=1.35;99%CI=1.02-1.79). Age<40 years (aOR=0.49;99%CI=0.32-0.74) and delayed PMBR (aOR=0.35;99%CI=0.19-0.60) reduced the risk of unplanned reoperation. Median time until reoperation was 97 days for unplanned and 213 days for planned reoperation. Deep wound infections were most often registered as indication for unplanned reoperation (34.4 percent). CONCLUSION: This study identified several risk factors for unplanned reoperation which may be used to reduce complications in expander-based PMBR.

Replacing an Implant-Based with a DIEP Flap Breast Reconstruction: Breast Sensation and Quality of Life.

BACKGROUND: In this cohort study, the authors compared breast sensation and quality of life (QoL) after replacement of an implant-based breast reconstruction with a deep inferior epigastric perforator (DIEP) flap reconstruction in a singular sample of women. METHODS: Women with implant-based breast reconstruction before their DIEP flap were included. Women formed their own control. Breast sensation was measured using Semmes-Weinstein monofilaments. QoL was evaluated using BREAST-Q questionnaires. Preoperative (T0) sensation and QoL were compared with postoperative values at 6 months (T1), at 12 months (T2), and at maximum follow-up (Tmax, sensation only). A linear mixed effects regression was used for Semmes-Weinstein monofilaments measurements; a paired samples t test was used for BREAST-Q scores. Most women chose replacement of their implant by a DIEP flap because of implant-related complaints. RESULTS: Postoperative sensation decreased significantly compared with preoperative sensation after T1 (mean, 5.1 months), T2 (mean, 14.6 months), and Tmax (mean, 17.6 months) for the total breast but recovers to preoperative levels for the native skin after an average of 1.5 years. Nerve coaptation positively influenced recovery of sensation. BREAST-Q scores increased significantly after 6 and 12 months over the domains Satisfaction with Breasts, Psychosocial Well-Being, Physical Well-Being of the Chest, and Sexual Well-Being. Scores decreased significantly in Physical Well-Being of the Abdomen after 6 months. CONCLUSION: Replacing an implant with a DIEP flap initially causes a decrease in overall breast sensation, gradually recovering to preoperative levels for native skin, and can significantly increase QoL with the right indication. Superior recovery of sensation and QoL may be obtained by accompanying the DIEP flap with nerve coaptation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Variation in the use of infection control measures and infection-related revision incidence after breast implant surgery in the Netherlands.

Background: The use and effect of most infection control measures (ICMs) in breast implant surgery are still debated, likely resulting in undesired variation in current practices. Objectives: This study investigated the relationship between the number and combinations of ICMs used and the infection-related revision incidence after breast implant surgery. Additionally, national variation between Dutch healthcare institutions in ICM use was evaluated. Methods: For this multicentre, population-based study, all patients who received a primary breast implant or tissue expander for breast augmentation or reconstruction between 2015 and 2019 were identified from the Dutch Breast Implant Registry. Seven prospectively collected ICMs were investigated: preoperative antibiotics, implant and/or pocket irrigation, glove change, nipple guards, insertion sleeve, postoperative drains, and postoperative antibiotics. Results: This study included 52,415 implants (85% augmentation, 15% reconstruction).The median (IQR) number of ICMs used was 3 (3-4) for augmentation and 4 (4-5) for reconstruction. Median follow-up was 30 months for augmentation and 34 months for reconstruction. Infection-related revision incidence was 0.1% for augmentation and 2.1% for reconstruction. Most infection-related revisions occurred within 2 months for augmentation and 2.5 months for reconstruction. The impact of ICM use on infection-related revision incidence remained unclear, given its low incidence. A significant variation was observed between institutions in the use of postoperative antibiotics and drains. Conclusions: Although the use of different ICMs varied considerably between institutions, the infection-related revision incidence after breast implant surgery was generally low. Most surgeons used four ICMs for breast reconstruction and three ICMs for breast augmentation. Further studies on the causes and effects of the observed variation are needed.

Using a Digital Implant Catalog Improves Data Quality and Reduces Administrative Burden in the Dutch Breast Implant Registry.

BACKGROUND: Correct registration of implant characteristics is essential to monitor implant safety within implant registries. Currently, in the nationwide Dutch Breast Implant Registry (DBIR), these characteristics are being registered manually by plastic surgeons, resulting in administrative burden and potentially incorrect data entry. OBJECTIVES: This study evaluated the accuracy of manually registered implant data, possible consequences of incorrect data, and the potential of a Digital Implant Catalog (DIC) on increasing data quality and reducing the administrative burden. METHODS: Manually entered implant characteristics (fill, shape, coating, texture) of newly inserted breast implants in the DBIR, from 2015 to 2019, were compared with the corresponding implant characteristics in the DIC. Reference numbers were employed to match characteristics between the 2 databases. The DIC was based on manufacturers' product catalogs and set as the gold standard. RESULTS: A total of 57,361 DBIR records could be matched with the DIC. Accuracy of implant characteristics varied from 70.6% to 98.0%, depending on the implant characteristic. The largest discrepancy was observed for "texture" and the smallest for "coating." All manually registered implant characteristics resulted in different conclusions about implant performance compared with the DIC (P < 0.01). Implementation of the DIC reduced the administrative burden from 14 to 7 variables (50%). CONCLUSIONS: Implementation of a DIC increases data quality in the DBIR and reduces the administrative burden. However, correct registration of reference numbers in the registry by plastic surgeons remains key for adequate matching. Furthermore, all implant manufacturers should be involved, and regular updates of the DIC are required.

Immediate Breast Reconstruction in The Netherlands and the United States: A Proof-of-Concept to Internationally Compare Quality of Care Using Cancer Registry Data.

BACKGROUND: Studies based on large-volume databases have made significant contributions to research on breast cancer surgery. To date, no comparison between large-volume databases has been made internationally. This is the first proof-of-concept study exploring the feasibility of combining two existing operational databases of The Netherlands and the United States, focusing on breast cancer care and immediate breast reconstruction specifically.313/291 METHODS:: The National Breast Cancer Organization The Netherlands Breast Cancer Audit (NBCA) (2011 to 2015) and the U.S. Surveillance, Epidemiology, and End Results (SEER) database (2010 to 2013) were compared on structure and content. Data variables were grouped into general, treatment-specific, cancer-specific, and follow-up variables and were matched. As proof-of-concept, mastectomy and immediate breast reconstruction rates in patients diagnosed with invasive breast cancer or ductal carcinoma in situ were analyzed. RESULTS: The NBCA included 115 variables and SEER included 112. The NBCA included significantly more treatment-specific variables (n = 46 versus 6), whereas the SEER database included more cancer-specific variables (n = 74 versus 26). In patients diagnosed with breast cancer or ductal carcinoma in situ, immediate breast reconstruction was performed in 19.3 percent and 24.0 percent of the breast cancer cohort and 44.0 percent and 35.3 percent of the ductal carcinoma in situ cohort in the NBCA and SEER, respectively. Immediate breast reconstruction rates increased significantly over time in both data sets. CONCLUSIONS: This study provides a first overview of available registry data on breast cancer care in The Netherlands and the United States, and revealed limited data on treatment in the United States. Comparison of treatment patterns of immediate breast reconstruction showed interesting differences. The authors advocate the urgency for an international database with alignment of (treatment) variables to improve quality of breast cancer care for patients across the globe.

The Dutch Breast Implant Registry: Registration of Breast Implant-Associated Anaplastic Large Cell Lymphoma-A Proof of Concept.

BACKGROUND: The Dutch Breast Implant Registry (DBIR) was established in April of 2015 and currently contains information on 38,000 implants in 18,000 women. As a clinical registry, it evaluates the quality of breast implant surgery, including adverse events such as breast implant-associated (BIA) anaplastic large cell lymphoma (ALCL). To examine the efficacy of the DBIR, the capture rate of BIA-ALCL was compared to the registration of BIA-ALCL in the Dutch Nationwide Network and Registry of Histo- and Cytopathology (PALGA) as a gold standard, in combination with matching these databases to obtain complementary information. METHODS: All BIA-ALCL patients diagnosed and registered in The Netherlands in 2016 and 2017 were identified separately in the PALGA and DBIR databases. In addition, both databases were matched using indirect key identifiers. Pathologic information from the PALGA and clinical and device characteristics from the DBIR were obtained for all patients. RESULTS: Matching of both databases gave a capture rate of BIA-ALCL in the DBIR of 100 percent (n = 6) in 2016 and 70 percent (n = 7) in 2017. In total, 17 patients were identified in the PALGA, of which 14 patients were also identified in the DBIR; three patients were not registered; and 10 patients were registered false-positive. Of all confirmed patients, symptoms, staging results, treatment, and implant information were registered. CONCLUSIONS: Currently, the DBIR contains 2 full registration years and captures most of the BIA-ALCL patients despite overestimation. Therefore, pathology confirmation remains essential. By matching these databases, complementary clinical and implant information could be retrieved, establishing the DBIR as an essential postmarketing surveillance system for health risk assessments.

European Survey Study Among Plastic/Breast Surgeons on the Use of and Opinion Toward Autologous Fat Transfer: With Emphasis on Breast Surgery.

Objective. The aim of this study is to examine the experience of European surgeons on autologous fat transfer (AFT) and highlight differences between countries and levels of experience. Background Data. The popularity of AFT causes an increase in sophisticated scientific research and clinical implementation. While results from the former are well-documented, important aspects of the latter are far less recognized. Methods. An international survey study about surgeon background, besides AFT familiarity, technique, and opinion, was distributed among surgeons from 10 European countries. The differences between countries and levels of experience were analyzed using a logistic regression model. Results. The mean respondent age, out of the 358 completed questionnaires, was 46 years. Ninety-seven percent of the respondents were plastic surgeons, who practiced AFT mostly in breast surgery and considered themselves experienced with the technique. The thigh and abdomen were less favored harvest locations by the Belgium and French respondents, respectively, and both the French and Austrian respondents preferred manual aspiration over liposuction in harvesting the fat. Despite minor differences between countries and experience, the intraglandular space was injected in all subgroups. Conclusions. The expanding use of AFT in Europe will lead to more experience and heterogeneity regarding the technique. However, despite an obvious adherence to Coleman's method, deviations thereof become more apparent. An important example of such a deviation is the ongoing practice of intraglandular AFT despite being a contraindication in various European guidelines. These unsafe practices should be avoided until scientific clarification regarding oncological safety is obtained and should therefore be the focus of surgeon education in Europe.

Autologous Fat Transfer After Augmentation and Reconstruction of the Female Breast: An International, Cross-Sectional Photo-Comparison Study Among Different Physician and Laymen Study Groups.

OBJECTIVE: The aim of this study is to compare the cosmetic evaluation of autologous fat transfer (AFT) for various indications between surgeons and different laymen groups. BACKGROUND DATA: Despite the upsurge in AFT scientific/clinical interest, objectifying satisfaction has only recently progressed beyond simple Likert-type/Visual Analog Scales. Furthermore, differences in satisfaction between laymen and surgeons has not been thoroughly studied. METHOD: A photo comparison study between European plastic surgeons and different laymen groups was conducted to investigate agreement on cosmetic evaluation of AFT. Three sets of preoperative/postoperative photographs illustrating patients treated with External Vacuum Expansion (EVE) + AFT for various indications in breast surgery were scored according to the Harris Scale, and the interrater agreement was analyzed using Cohen's κ. RESULTS: The overall agreement between the surgeons and the groups of former augmentation, control group, and deep inferior epigastric artery perforator patients was fair, moderate, and substantial, respectively. Interrater agreements among different laymen groups and surgeons from different countries among themselves was substantial to almost perfect. Finally, we found that laymen are generally more optimistic about postoperative results than surgeons. CONCLUSION: In our study, former augmentation patients showed the lowest agreement with surgeons, in the cosmetic appreciation of EVE + AFT and this group might benefit from a more thorough preoperative consultation regarding expectations when choosing AFT. However, overall laymen tend to be more optimistic about postoperative results and surgeon education in general does not seem influenced by surgeon nationality. The significant differences between surgeons and laymen in the cosmetic evaluation of EVE + AFT justifies further studies that focus on the qualitative aspects of these differences to further balance patients' and surgeons' expectations.

Autologous Fat Transfer for Facial Rejuvenation: A Systematic Review on Technique, Efficacy, and Satisfaction.

BACKGROUND: Parallel to the steady decline in surgical aesthetic procedures to the face, dermal fillers seem to have gained a more prominent place in facial rejuvenation over the last couple of years. As a dermal, facial filler, autologous fat transfer (AFT) seems to have real potential because of the biocompatibility of adipose tissue besides being a procedure with few and primarily minor complications. This systematic review aims to evaluate the available evidence regarding the safety and effectiveness of AFT for facial rejuvenation. METHOD: A systematic review after the Preferred-Reporting-Items-for-Systematic-Reviews-and-Meta-Analysis (PRISMA) statement was conducted. MEDLINE, Embase, and Cochrane Library were searched up to December 2016, with no language restrictions imposed. Case series, cohort studies, and randomized controlled trials (RCTs) reporting on relevant outcomes were included. RESULTS: Eighteen clinical articles were included, reporting on 3,073 patients in total over a mean follow-up period of 13.9 months. Meta-analysis showed an overall complication rate of 6% (95% CI 3.0-14.0), with hematoma/ecchymosis (5%), fat necrosis/oil cysts (2%), and irregular fat distribution and scars (both 2%) being among the most reported. No major complications were reported, and the overall patient satisfaction rate was 81%. CONCLUSION: Although the evidence in this systematic review is still limited and plagued by heterogeneity between studies, AFT seems to be a promising method in facial rejuvenation with fewer complications than other fillers and high patient satisfaction rates. Further large-cohort, preferably multicenter, RCTs should substantiate these results through quantifiable volumetric assessment tools and validated patient questionnaires, while adhering to predetermined nomenclature in terms of complications.