Long-Term Patient-Reported Outcomes following Oncological Facial Reconstructive Surgery using the FACE-Q Skin Cancer Module.

Background: Long-term patient-reported outcomes (PROs) of oncological facial reconstructive surgery are unknown. Objective: The present study aimed to assess long-term PROs and to identify possible correlations between patient and treatment characteristics and long-term PROs. Methods & Materials: Between 2006 and 2011, 202 patients underwent facial reconstruction after Mohs micrographic surgery for non-melanoma skin cancer at our institution. After 10 years of follow-up, 96 out of the remaining 122 patients completed the FACE-Q Skin Cancer Module. Results: Patients who were surgically treated for squamous cell carcinoma reported poorer scores on the satisfaction with facial appearance (p=0.038), appraisal of scars (p=0.039) and appearance-related psychosocial distress scales (p=0.036) compared to patients with basal cell carcinoma and lentigo maligna. Finally, female patients reported significantly higher scores on the Cancer Worry Scale than male patients (p=0.047). Conclusion: Long-term patient satisfaction with respect to their facial appearance and scars after reconstructive surgery for skin cancer was comparable to short-term patient satisfaction, whereas Cancer Worry Scale and psychosocial distress appeared to be slightly higher. Our results can be used to better inform patients on the long-term effects of facial reconstructive surgery on patient satisfaction and quality of life, which are important to improve patient counselling, patient expectation management and shared decision-making.

Health-related quality of life (HRQoL) after different axillary treatments in women with breast cancer: a 1-year longitudinal cohort study.

PURPOSE: As life expectancy continues to rise, post-treatment health-related quality of life (HRQoL) of breast cancer patients becomes increasingly important. This study examined the one-year longitudinal relation between axillary treatments and physical, psychosocial, and sexual wellbeing and arm symptoms. METHODS: Women diagnosed with breast cancer who received different axillary treatments being axilla preserving surgery (APS) with or without axillary radiotherapy or full axillary lymph node dissection (ALND) with or without axillary radiotherapy were included. HRQoL was assessed at baseline, 6- and 12-months postoperatively using the BREAST-Q and the European Organization for Research and Treatment of Cancer QoL Questionnaire Breast Cancer Module (EORTC QLQ-BR23). Mixed regression models were constructed to assess the impact of axillary treatment on HRQoL. HRQoL at baseline was compared to HRQoL at 6- and at 12-months postoperatively. RESULTS: In total, 552 patients were included in the mixed regressions models. Except for ALND with axillary radiotherapy, no significant differences in physical and psychosocial wellbeing were found. Physical wellbeing decreased significantly between baseline and 6- and 12-months postoperatively (p < 0.001, p = 0.035) and psychosocial wellbeing decreased significantly between baseline and 12 months postoperatively (p = 0.028) for ALND with axillary radiotherapy compared to APS alone. Arm symptoms increased significantly between baseline and 6 months and between baseline and 12 months postoperatively for APS with radiotherapy (12.71, 13.73) and for ALND with radiotherapy (13.93, 16.14), with the lowest increase in arm symptoms for ALND without radiotherapy (6.85, 7.66), compared to APS alone (p < 0.05). CONCLUSION: Physical and psychosocial wellbeing decreased significantly for ALND with radiotherapy compared to APS alone. Shared decision making and expectation management pre-treatment could be strengthened by discussing arm symptoms per axillary treatment with the patient.

Decision making in breast implant selection for breast reconstruction: A mixed-method study among plastic surgeons.

Background: Breast implants and the (dis)advantages of their characteristics (shape, filling, surface, and brand) have been studied extensively. When selecting a specific breast implant, a plastic surgeon makes a trade-off between the various (dis)advantages. However, the factors affecting the choice of their preferred breast implant have not been studied in detail. Methods: This is a mixed-method study. First, five plastic surgeons were interviewed to identify factors that influence their choice of a breast implant in a reconstructive setting. Second, 42 plastic surgeons were asked to state their preferred implant, weigh the collected factors, and indicate when they would deviate from their preferred implant. Results: The interviews produced a varied list of factors that influenced the choice of breast implant, including complication rates, marketing, economic, and logistic factors. The results from the survey showed variation in preferred implant and substantial variations in the weighing of these factors. The two most important factors were "study outcomes" and "brand reputation". Ninety percent of the respondents were willing to deviate from their preferred implant, with the patient's preference being the main indication to deviate. Conclusions: The list of factors that influence the plastic surgeons' choice of a breast implant in a reconstructive setting is extensive and their weighing showed substantial variation. Implant choice was not based solely on scientific evidence. Brand reputation was valued highly, implying that media and marketing may have considerable influence. Therefore, patients must be informed extensively about all aspects of breast implants during shared decision making to obtain true informed consent.

Near-infrared fluorescence angiography with indocyanine green for perfusion assessment of DIEP and msTRAM flaps: A Dutch multicenter randomized controlled trial.

Background: A common complication after a DIEP flap reconstruction is the occurrence of fat necrosis due to inadequate flap perfusion zones. Intraoperative identification of ischemic zones in the DIEP flap could be optimized using indocyanine green near-infrared fluorescence angiography (ICG-NIR-FA). This randomized controlled trial aims to determine whether intraoperative ICG-NIR-FA for the assessment of DIEP flap perfusion decreases the occurrence of fat necrosis. Design/methods: This article describes the protocol of a Dutch multicenter randomized controlled clinical trial: the FAFI-trial. Females who are electively scheduled for autologous breast reconstruction using DIEP or muscle-sparing transverse rectus abdominis muscle (msTRAM) flaps are included. A total of 280 patients will be included in a 1:1 ratio between both study arms. In the intervention arm, the intraoperative assessment of flap perfusion will be based on both regular clinical parameters and ICG-NIR-FA. The control arm consists of flap perfusion evaluation only through the regular clinical parameters, while ICG-NIR-FA images are obtained during surgery for which the surgeon is blinded. The main study endpoint is the difference in percentage of clinically relevant fat necrosis between both study arms, evaluated two weeks and three months after reconstruction. Conclusion: The FAFI-trial, a Dutch multicenter randomized controlled clinical trial, aims to investigate the clinical added value of intraoperative use of standardized ICG-NIR-FA for assessment of DIEP/msTRAM flap perfusion in the reduction of fat necrosis. Clinical trial registration number: NCT05507710; NL 68623.058.18.

Neuropathic Donor-Site Pain following Radial Forearm Free Flap Harvest: A Multicenter Study on Incidence, Prognostic Factors, and Quality of Life.

BACKGROUND: The radial forearm free flap (RFFF) is widely used and is considered one of the workhorse flaps in oncologic head and neck reconstructions. However, the potential for significant donor-site morbidity remains a major drawback. Although various donor-site problems have been reported, the incidence of neuropathic pain and possible predicting factors remain unclear. This study aimed to identify the incidence, prognostic factors, and impact on quality of life of neuropathic pain following RFFF harvest. METHODS: In this multicenter, cross-sectional study, 167 patients who underwent an RFFF reconstruction between 2010 and 2020 were included. Baseline characteristics were collected by medical charts. All patients received questionnaires to measure patient's pain (Doleur Neuropathique 4 and visual analog scale, pain), hand function (Patient-Reported Wrist and Hand Evaluation), and quality of life (EuroQol 5D). Multiple logistic regression was used to identify prognostic factors associated with outcomes. RESULTS: A total of 114 patients (68%) completed the questionnaire. Neuropathic pain was present in 18% of all patients. Donor-site wound problems, mostly tendon exposure, occurred in 32% and was significantly correlated with neuropathic pain (p = 0.003). Neuropathic pain was significantly associated with poorer quality of life (p < 0.001) and poorer hand function (p < 0.001). CONCLUSION: Almost one-fifth of all patients deal with neuropathic pain following RFFF harvest. Neuropathic pain is significantly correlated with poorer hand function and a poorer quality of life. Therefore, future research should focus on analyzing surgical factors such as the management of wound problems and primary denervation to improve hand function and quality of life of these patients.

Nation-wide validation of a multicenter risk model for implant loss following implant-based breast reconstruction.

INTRODUCTION: Implant loss following breast reconstruction is a devastating complication, which should be prevented as much as possible. This study aimed to validate a previously developed multicenter risk model for implant loss after implant-based breast reconstructions, using national data from the Dutch Breast Implant Registry (DBIR). METHODS: The validation cohort consisted of patients who underwent a mastectomy followed by either a direct-to-implant (DTI) or two-stage breast reconstruction between September 2017 and January 2021 registered in the DBIR. Reconstructions with an autologous adjunctive and patients with missing data on the risk factors extracted from the multicenter risk model (obesity, smoking, nipple preserving procedure, DTI reconstruction) were excluded. The primary outcome was implant loss. The predicted probability of implant loss was calculated using beta regression coefficients extracted from the multicenter risk model and compared to the observed probability. RESULTS: The validation cohort consisted of 3769 reconstructions and implant loss occurred after 307 reconstructions (8.1%). Although the observed implant loss rate increased when the risk factors accumulated, the predicted and observed probabilities of implant loss did not match. Of the four risk factors in the multicenter risk model, only obesity and smoking were significantly associated to implant loss. CONCLUSION: The multicenter risk model could not be validated using nationwide data of the DBIR and is therefore not accurate in Dutch practice. In the future, the risk model should be improved by including other factors to provide a validated tool for the preoperative risk assessment of implant loss.

An analysis of complication rates and the influence on patient satisfaction and cosmetic outcomes following oncoplastic breast surgery.

INTRODUCTION: This study aimed to evaluate complication rates, patient satisfaction, and cosmetic outcomes after oncoplastic breast-conserving surgery (OPS). Furthermore, outcome differences between volume displacement and volume replacement techniques and the effect of postoperative complications on outcomes were evaluated. METHODS: This was a prospective single-center study addressing patients who underwent OPS from 2017 to 2020. The BREAST-Q was used to measure patient satisfaction, and cosmetic outcomes were assessed by patient self-evaluation and panel evaluation based on medical photographs. RESULTS: A total of 75 patients were included. The overall complication rate was 18.7%, of which 4% required invasive interventions. Median BREAST-Q scores ranged from 56 to 100 and cosmetic outcomes were scored good to excellent in 60-86%. No differences in complications were observed between volume replacement and volume displacement techniques. Following volume displacement techniques, patients-reported higher BREAST-Q scores for the domain "physical well-being of the chest" and lower cosmetic outcomes scores for "mammary symmetry." Patients with complications scored significantly lower on several domains of the BREAST-Q and in various cosmetic outcome categories. CONCLUSION: In this cohort, an overall complication rate of 18.7% was observed. Patients were generally satisfied, and most cosmetic outcomes were good to excellent. Volume displacement or replacement techniques were performed for different indications and generally showed comparable results. Expected differences in physical discomfort and symmetry between both techniques were observed. In addition, the occurrence of complications resulted in lower patient satisfaction and cosmetic outcomes. These findings emphasize the importance of thorough preoperative counselling.

Quantification of near-infrared fluorescence imaging with indocyanine green in free flap breast reconstruction.

BACKGROUND: One of the complications of free flap breast reconstruction is the occurrence of skin and fat necrosis. Intra-operative use of near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG) has the potential to predict these complications. In this study, the quantification of the fluorescence intensity measured in free flap breast reconstruction was performed to gain insight into the perfusion patterns observed with ICG NIR fluorescence imaging. METHODS: ICG NIR fluorescence imaging was performed in patients undergoing free flap breast reconstruction following mastectomy. After completion of the arterial and venous anastomosis, 7.5 mg ICG was administered intravenously. The fluorescence intensity over time was recorded using the Quest Spectrum Platform®. Four regions of interest (ROI) were selected based on location and interpretation of the NIR fluorescence signal: (1) The perforator, (2) normal perfusion, (3) questionable perfusion, and (4) low perfusion. Time-intensity curves were analyzed, and two parameters were extracted: Tmax and Tmax slopes. RESULTS: Successful ICG NIR fluorescence imaging was performed in 13 patients undergoing 17 free flap procedures. Region selection included 16 perforators, 17 normal perfusions, 8 questionable perfusions, and 5 low perfusion ROIs. Time-intensity curves of the perforator ROIs were comparable to the ROIs of normal perfusion and demonstrated a fast inflow. No outflow was observed for the ROIs with questionable and low perfusion. CONCLUSION: This study provides insight into the perfusion patterns observed with ICG NIR fluorescence imaging in free flap breast reconstruction. Future studies should correlate quantitative parameters with clinical perfusion assessment and outcome.

Higher incidences of neuropathic pain and altered sensation following radial forearm free flap: A systematic review.

BACKGROUND: The radial forearm free flap (RFFF) has been used extensively for complex tissue defect reconstructions; however, the potential for significant donor-site morbidity remains a major drawback. Despite an abundance of literature on donor-site morbidities, no consensus has been reached on exact incidences of sensory morbidities that vary largely between 0% and 46%. Incidences of neuropathic pain in the donor site following RFFF still lack, even though clinical experience shows it often occurs. Therefore, the purpose of this systematic review was to identify the incidence of neuropathic pain and altered sensation in the hand following harvesting of a RFFF. METHODS: A systematic search was performed in multiple databases (Embase, Medline, Cochrane, Web of Science, and Google Scholar). Studies from 1990 onwards that reported donor-site morbidities following harvest of the RFFF were included. Analyzed parameters included hand pain, hypoesthesia, cold intolerance, hyperesthesia, neuroma formation, paresthesia, sharp sensation loss, light sensation loss, and defect closure. RESULTS: Of the 987 selected studies, 51 eligible articles were selected. The mean level of evidence was 3 (SD 0.6). Twenty articles reported pain as a donor-site morbidity, and the mean incidence of pain reported was 23% (SD 7.8). Hypoesthesia was reported by 37 articles and had a mean incidence of 34% (SD 25). Locations of pain and hypoesthesia included, amongst others, the area of the radial sensory nerve and the skin graft area. The mean incidences of cold intolerance and hyperesthesia were 13% (SD 13) and 16% (SD 15), respectively. CONCLUSION: The results of this systematic review suggest that 23% of all patients are dealing with neuropathic pain in the donor-site following harvest of an RFFF. Future studies should therefore focus on the prognostic factors and preventive measures of neuropathic pain to further improve clinical outcomes of this widely used flap.

Predictors of delayed breast reconstruction in the Netherlands: a 5-year follow-up study in stage I-III breast cancer patients.

PURPOSE: Delayed breast reconstruction (DBR) is a valid option for postmastectomy breast cancer patients who have a desire for breast reconstruction but are not considered suitable for immediate breast reconstruction (IBR). The objective of this study was to investigate the clinical practice and predictors of the use of DBR in the Netherlands. METHODS: Stage I-III breast cancer patients diagnosed from January to March 2012 and treated with mastectomy were selected from the Netherlands Cancer Registry. Routinely collected patient, tumor, treatment and hospital characteristics were complemented with data about DBR up to 2018. Multivariable logistic regression analyses were performed to identify factors independently associated with postmastectomy DBR. Factors associated with time to DBR were identified through Cox regression analyses. RESULTS: Of all patients who underwent mastectomy (n = 1,415), 10.2% underwent DBR. DBR patients more often received autologous reconstruction compared to IBR patients (37.5% vs 6.2%, p < 0.001). Age below 50 years (age < 35 OR 15.55, age 35-49 OR 4.18) and neoadjuvant and adjuvant chemotherapy (OR 2.59 and OR 2.83, respectively) were significantly associated with DBR. Mean time to DBR was 2.4 years [range 1-6 years]. Time to DBR was significantly associated with age < 35 years (HR 2.22), and a high hospital volume (HR 1.87). DISCUSSION: The use of DBR after mastectomy could not be fully explained by age below 50 years, chemotherapy, and hospital volume. Treatment with radiotherapy and adjuvant chemotherapy increased time to DBR. More information about patient preferences is needed to understand the use and timing of reconstruction.

Socioeconomic status significantly contributes to the likelihood of immediate postmastectomy breast reconstruction in the Netherlands: A nationwide study.

BACKGROUND: Previous studies have shown that breast cancer patients with a low socioeconomic status (SES) are less likely to undergo postmastectomy immediate breast reconstruction (IBR). However, these studies were performed in countries with unequal access to healthcare. Therefore, the aim of this study was to investigate whether SES also contributes to the likelihood of receiving IBR in a country with equal access to healthcare. MATERIALS AND METHODS: Patients with stage I or II breast cancer diagnosed between 2011 and 2018 who underwent mastectomy were selected from the Netherlands Cancer Registry. SES was calculated from the average incomes of each postal code which were divided into 10-deciles. Primary outcome was the effect of SES on the likelihood of receiving IBR, controlled for patient, tumour and hospital characteristics expressed as Odds Ratio (OR) with 95% confidence interval (CI). RESULTS: Higher SES significantly increased the probability of undergoing postmastectomy IBR (OR 1.05 per 10% SES stratum), just as larger hospital volume (average volume OR 1.89 and large volume 2.58), oestrogen positive tumours (OR 1.19) and neo-adjuvant therapy (OR 1.42). In contrast, factors significantly reducing the likelihood of receiving IBR were older age (OR 0.92 per year), stage II (OR 0.61 compared to stage I) and adjuvant therapy (OR 0.56). CONCLUSION: Women with lower SES undergoing mastectomy were less likely to receive postmastectomy IBR. More research is warranted to study whether lifestyle factors associated with lower SES such as smoking and higher BMI, language barrier, illiteracy and less access to internet explain these differences.

Rates of re-excision and conversion to mastectomy after breast-conserving surgery with or without oncoplastic surgery: a nationwide population-based study.

BACKGROUND: There is no consensus regarding the impact of oncoplastic surgery (OPS) on rates of re-excision and conversion to mastectomy following breast-conserving surgery (BCS). Here these two outcomes after BCS and OPS were compared in a nationwide population-based setting. METHODS: In Denmark, all OPS is registered and categorized into volume displacement, volume reduction or volume replacement. Patients who underwent BCS or OPS between 2012 and 2018 were selected from the Danish Breast Cancer Group database. Multivariable analyses were performed to adjust for confounders, and propensity score matching to limit potential confounding by indication bias. RESULTS: A total of 13 185 patients (72·5 per cent) underwent BCS and 5003 (27·5 per cent) OPS. Volume displacement was used in 4171 patients (83·4 per cent), volume reduction in 679 (13·6 per cent) and volume replacement in 153 (3·1 per cent). Re-excision rates were 15·6 and 14·1 per cent after BCS and OPS respectively. After adjusting for confounders, patients were less likely to have a re-excision following OPS than BCS (odds ratio (OR) 0·80, 95 per cent c.i. 0·72 to 0·88), specifically after volume displacement and reduction. The rate of conversion to mastectomy was similar after OPS and BCS (3·2 versus 3·7 per cent; P = 0·105), but with a lower risk in adjusted analysis (OR 0·69, 0·58 to 0·84), specifically after volume displacement and reduction procedures. Findings were similar after propensity score matching. CONCLUSION: A modest decrease in re-excision rate and less frequent conversion to mastectomy were observed after OPS compared with BCS.

ANTECEDENTES: No existe consenso con respecto al impacto de la cirugía oncoplástica (oncoplastic surgery, OPS) en las tasas de re-exéresis y conversión a mastectomía tras la cirugía conservadora de la mama (breast conserving surgery, BCS). En este estudio se compararon los dos resultados después de BCS y OPS en una base de datos poblacional de ámbito nacional. MÉTODOS: En Dinamarca, todas las OPS se registran y clasifican en procedimientos que incluyen 1) desplazamiento (o remodelación) de volumen, 2) reducción de volumen o 3) restitución de volumen. Todas las pacientes sometidas a BCS o OPS entre 2012 y 2018 fueron seleccionadas de la base de datos del Grupo de Cáncer de Mama Danés. Se realizaron análisis multivariables para ajustar por factores de confusión y un emparejamiento por puntaje de propensión para limitar las variables de confusión potenciales por el sesgo en la indicación. RESULTADOS: Un total de 13.185 (72,5%) pacientes fueron sometidos a BCS y 5.003 (27,5%) a OPS. Se utilizó el desplazamiento de volumen en 4.171 (83,4%) pacientes, reducción de volumen en 679 (13,6%) pacientes y restitución de volumen en 153 (3,1%) pacientes. Las tasas de re-exéresis fueron del 15,6% y 14,1% tras BCS y OPS, respectivamente. Tras ajustar por factores de confusión, las pacientes tuvieron menos probabilidad (razón de oportunidades, odds ratio, OR 0,80, i.c. del 95%. 0,72-0,88) de requerir re-exéresis tras OPS, específicamente después de desplazamiento y reducción de volumen, en comparación con BCS. La tasa de conversión a mastectomía fue inferior (3,2% versus 3,7%, P = 0,04) y menos probable (OR 0,71, i.c. del 95% 0,58-0,87) tras OPS, específicamente en el desplazamiento y reducción de volumen, en comparación con BCS. Los resultados fueron similares después del emparejamiento por puntuación de propensión. CONCLUSIÓN: Se observó un descenso modesto en las tasas de re-exéresis y una menor frecuencia de conversiones a mastectomía después de la cirugía oncoplástica cuando se comparó con la cirugía conservadora de la mama.

The added value of immediate breast reconstruction to health-related quality of life of breast cancer patients.

BACKGROUND: Postmastectomy immediate breast reconstruction (IBR) may improve the quality of life (QoL) of breast cancer patients. Guidelines recommend to discuss the option IBR with all patients undergoing mastectomy. However, substantial hospital variation in IBR-rates was previously observed in the Netherlands, influenced by patient, tumour and hospital factors and clinicians' believes. Information provision about IBR may have a positive effect on receiving IBR and therefore QoL. This study investigated patient-reported QoL of patients treated with mastectomy with and without IBR. METHODS: An online survey, encompassing the validated BREAST-Q questionnaire, was distributed to a representative sample of 1218 breast cancer patients treated with mastectomy. BREAST-Q scores were compared between patients who had undergone mastectomy either with or without IBR. RESULTS: A total of 445 patients were included for analyses: 281 patients with and 164 without IBR. Patients who had received IBR showed significantly higher BREAST-Q scores on "psychosocial well-being" (75 versus 67, p < 0.001), "sexual well-being" (62 versus 52, p < 0.001) and "physical well-being" (77 versus 74, p = 0.021) compared to patients without IBR. No statistically significant difference was found for "satisfaction with breasts" (64 versus 62, p = 0.21). Similar results were found after multivariate regression analyses, revealing IBR to be an independent factor for a better patient-reported QoL. CONCLUSIONS: Patients diagnosed with breast cancer with IBR following mastectomy report a better QoL on important psychosocial, sexual and physical well-being domains. This further supports the recommendation to discuss the option of IBR with all patients with an indication for mastectomy and to enable shared decision-making.

Virtual and augmented reality for preoperative planning in plastic surgical procedures: A systematic review.

BACKGROUND: Virtual and augmented reality (VR and AR) are fast-developing technologies that allow the three-dimensional visualization of digital information. OBJECTIVE: This systematic review aimed to compare the application of VR and AR to conventional methods in preoperative planning of plastic surgical procedures. METHOD: A systematic literature search was conducted in Embase, Medline (Ovid), Web-of-Science, Cochrane, and Google Scholar databases on October 11, 2019. All literature comparing AR and/or VR with conventional methods for preoperative planning was collected. Only articles that studied at least one of the following outcomes were included: technical accuracy of the procedure, operative time, complications, and costs of total intervention. RESULTS: No articles on VR were found. Six articles were found on interventions performed with AR assistance. AR showed to be significantly better for the accuracy of osteotomies in mandibular angle osteotomies and intraoral mandible distraction compared to conventional methods. For synostotic plagiocephaly and orbital hypertelorism correction, the use of AR demonstrated a precise osteotomy. Intraoperative perforator identification in DIEP flap procedures was more accurate with AR compared to Doppler ultrasound. Harvesting time (p < 0.012) and operative time (p < 0.01) in DIEP-flap procedures and mandibular angle osteotomies, respectively, were significantly reduced if AR was used. No articles were found regarding the costs of using AR for preoperative planning. CONCLUSION: AR technology has the potential to assist the plastic surgeon in operating more accurately, safely, and fast. Studies on VR technology for preoperative planning in plastic surgery are lacking. More comparative studies are necessary, including data on clinical outcomes and cost-effectiveness.

Breast-contour preserving procedures for early-stage breast cancer: a population-based study of the trends, variation in practice and predictive characteristics in Denmark and the Netherlands.

PURPOSE: Breast-contour preservation (BCP) is possible for most women treated for early-stage breast cancer. BCP can be defined as primary breast-conserving treatment (BCT), neoadjuvant chemotherapy (NAC) followed by BCT and immediate postmastectomy breast reconstruction (IBR). This study provides insight in current BCP strategies in Denmark and the Netherlands and aims to identify opportunities for improvement within both countries. METHODS: A total of 92,881 patients with early-stage breast cancer who were operated in Denmark and the Netherlands between 2012 and 2017 were selected from the Danish Breast Cancer Group and the Dutch National Breast Cancer Audit databases. BCP procedures and predictive factors were analyzed within and between both countries. RESULTS: BCP was achieved in 76.7% (n = 16,355) of the Danish and in 74.5% (n = 53,328) of the Dutch patients. While BCP rate did not change significantly over time in Denmark (p = 0.250), a significant increase in BCP rate from 69.5% in 2012 to 78.5% in 2017 (p < 0.001) was observed in the Netherlands. In both countries, variation in BCP rates between hospitals decreased over time. NAC followed by BCT and postmastectomy IBR was substantially more often used in the Netherlands compared to Denmark, specifically in patients younger than 50 years. CONCLUSIONS: In more than 75% of all Danish and Dutch patients, surgically treated for early-stage breast cancer, the breast-contour was preserved. The different use of BCP strategies within Denmark and the Netherlands and the differences observed between hospitals in both countries emphasize the need for more (inter)national consensus on treatment modalities.

Patient-Reported Outcome Measures may optimize shared decision-making for cancer risk management in BRCA mutation carriers.

PURPOSE: The aim of this study was to compare patient-reported outcomes (PROs) of BRCA1/2 mutation carriers, either after bilateral prophylactic mastectomy (BPM) or during breast surveillance, to improve shared decision-making in their cancer risk management. METHODS: Unaffected BRCA1/2 mutation carriers at least one year after BPM followed by immediate breast reconstruction (BPM-IBR) or one year under surveillance were eligible. After informed consent, the Hospital Anxiety and Depression Scale (HADS) and BREAST-Q were administered and compared between the different strategies. PROs were also compared to available normative data. RESULTS: Ninety-six participants were analyzed in this study and showed significant differences between strategies in age, age at genetic testing, and time since BPM or starting breast surveillance. All HADS scores were below 8 suggesting no signs of anxiety or depression in both groups. Higher mean 'Q-physical well-being' scores were reported by the surveillance group (81.78 [CI 76.99-86.57]) than the BPM group (76.96 [CI 73.16 - 80.75]; p = 0.011). Overall, for both questionnaires better scores were seen when compared to age-matched normative data. CONCLUSIONS: No signs of anxiety or depression were seen in the surveillance or BPM-IBR group. Slightly better mean BREAST-Q scores were seen for the surveillance group in comparison to BPM-IBR, except for 'Q-psychological well-being'. The difference in 'Q-physical well-being' was significantly worse for BPM-IBR. Approaches to obtain longitudinal PROs and reference values should be explored in the future, which could add value to shared decision-making in regards to breast cancer risk management in this specific patient population.

Nationwide population-based study of the impact of immediate breast reconstruction after mastectomy on the timing of adjuvant chemotherapy.

BACKGROUND: Initiation of adjuvant chemotherapy within 6-12 weeks after mastectomy is recommended by guidelines. The aim of this population-based study was to investigate whether immediate breast reconstruction (IBR) after mastectomy reduces the likelihood of timely initiation of adjuvant chemotherapy. METHODS: All patients with breast cancer who had undergone mastectomy and adjuvant chemotherapy between 2012 and 2016 in the Netherlands were identified. Time from surgery to adjuvant chemotherapy was categorized as within 6 weeks or after more than 6 weeks, within 9 weeks or after more than 9 weeks, and within 12 weeks or after more than 12 weeks. The impact of IBR on the initiation of adjuvant chemotherapy for these three scenarios was estimated using propensity score matching to adjust for treatment by indication bias. RESULTS: A total of 6300 patients had undergone primary mastectomy and adjuvant chemotherapy, of whom 1700 (27·0 per cent) had received IBR. Multivariable analysis revealed that IBR reduced the likelihood of receiving adjuvant chemotherapy within 6 weeks (odds ratio (OR) 0·76, 95 per cent c.i. 0·66 to 0·87) and 9 weeks (0·69, 0·54 to 0·87), but not within 12 weeks (OR 0·75, 0·48 to 1·17). Following propensity score matching, IBR only reduced the likelihood of receiving adjuvant chemotherapy within 6 weeks (OR 0·95, 0·90 to 0·99), but not within 9 weeks (OR 0·97, 0·95 to 1·00) or 12 weeks (OR 1·00, 0·99 to 1·01). CONCLUSION: Postmastectomy IBR marginally reduced the likelihood of receiving adjuvant chemotherapy within 6 weeks, but not within 9 or 12 weeks. Thus, IBR is not contraindicated in patients who need adjuvant chemotherapy after mastectomy.

ANTECEDENTES: Las guías clínicas recomiendan iniciar la quimioterapia adyuvante entre las 6 y las 12 semanas después de la mastectomía. El objetivo de este estudio de base poblacional fue investigar si la reconstrucción inmediata de la mama (immediate breast reconstruction, IBR) tras mastectomía reduce la posibilidad de iniciar la quimioterapia adyuvante en el momento adecuado. MÉTODOS: Se identificaron todas las pacientes con cáncer de mama a las que se había realizado mastectomía y quimioterapia adyuvante entre el 2012 y el 2016 en los Países Bajos. El tiempo transcurrido entre la cirugía y la quimioterapia adyuvante se clasificó en tres grupos: ≤ 6 versus > 6 semanas, ≤ 9 versus > 9 semanas y ≤ 12 versus > 12 semanas. El impacto de la IBR en el inicio de la quimioterapia adyuvante en estos tres escenarios se estimó mediante un análisis de emparejamiento por puntaje de propensión para ajustar el tratamiento por sesgo de indicación. RESULTADOS: Se realizó una mastectomía primaria y quimioterapia adyuvante en 6.300 pacientes, de las que a 1.700 (27%) se hizo una IBR. El análisis multivariable demostró que la IBR redujo la probabilidad de recibir quimioterapia adyuvante dentro de las 6 y 9 semanas (razón de oportunidades, odds ratio, OR 0,76; i.c. del 95% 0,66-0,87 y OR 0,69; i.c. del 95% 0,54-0,87, respectivamente), pero no dentro de las 12 semanas (OR 0,75, i.c. del 95% 0,48-1,17). Al emparejar mediante el análisis de puntaje de propensión, la IBR solo redujo la probabilidad de recibir quimioterapia adyuvante dentro de las 6 semanas (OR 0,95; i.c. del 95%: 0,90 a 0,99), pero no dentro de las 9 ó 12 semanas (OR 0,97; i.c. del 95%: 0,95 a 1,00 y OR 1,00, i.c. del 95% 0,99-1,01). CONCLUSIÓN: La IBR postmastectomía disminuyó marginalmente la probabilidad de recibir quimioterapia adyuvante dentro de las 6 semanas, pero no más allá de las 9 ó 12 semanas. Por lo tanto, la IBR postmastectomía no está contraindicada en pacientes que necesitan tratamiento con quimioterapia adyuvante.

How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch Breast Implant Registry (2015-2017).

BACKGROUND: Although the use of breast implants is generally considered to be safe, breast implants are associated with short- and long-term complications. To evaluate and improve the quality of breast implant surgery, and increase our knowledge of implant performance, the national Dutch Breast Implant Registry (DBIR) was established in 2015. DBIR is one of the first up-and-running breast implant registries worldwide and follows an opt-out structure. OBJECTIVE: This article provides an overview of the first outcomes and experiences of the DBIR. METHODS: The national coverage of DBIR was studied using data from the Dutch Health and Youth Care Inspectorate. The incidence rate of breast implants was calculated for 2016 and 2017, and patient, device, and surgery characteristics were compared between cosmetic breast augmentations or reconstructive indications. Four infection control, measures were selected to demonstrate the variation in the Dutch clinical practice. RESULTS: In 2016, 95% of the hospitals and 78% of the private clinics participated in DBIR. Between 2015 and 2017, a total of 15,049 patients and 30,541 breast implants were included. A minimum breast implant incidence rate of 1 per 1,691 women could be determined for 2017. The majority of devices were inserted for a cosmetic indication (85.2%). In general, patient, device, and surgery characteristics differed per indication group. Substantial variation was seen in the use of infection control measures (range 0-100%). CONCLUSION: Preliminary results obtained from DBIR show high national participation rates and support further developments toward the improvement of breast implant surgery and patient safety.

Short-term cost-effectiveness of one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage expander-implant reconstruction from a multicentre randomized clinical trial.

BACKGROUND: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure and its economic impact is significant. This study aimed to analyse whether a direct one-stage IBBR with use of an acellular dermal matrix (ADM) is more cost-effective than two-stage (expander-implant) breast reconstruction. METHODS: The BRIOS (Breast Reconstruction In One Stage) study was an open-label multicentre RCT in which women scheduled for skin-sparing mastectomy and immediate IBBR were randomized between one-stage IBBR with ADM or two-stage IBBR. Duration of surgery and hospital stay, and visits for the primary surgery, unplanned and cosmetic procedures were recorded. Costs were estimated at an institutional level. Health status was assessed by means of the EuroQol Five Dimensions 5L questionnaire. RESULTS: Fifty-nine patients (91 breasts) underwent one-stage IBBR with ADM and 62 patients (92 breasts) two-stage IBBR. The mean(s.d.) duration of surgery in the one-stage group was significantly longer than that for two-stage IBBR for unilateral (2·52(0·55) versus 2·02(0·35) h; P < 0·001) and bilateral (4·03(1·00) versus 3·25(0·58) h; P = 0·017) reconstructions. Costs were higher for one-stage compared with two-stage IBBR for both unilateral (€12 448 (95 per cent c.i. 10 722 to 14 387) versus €9871 (9373 to 10 445) respectively; P = 0·025) and bilateral (€16 939 (14 887 to 19 360) versus €13 383 (12 414 to 14 669); P = 0·002) reconstructions. This was partly related to the use of relatively expensive ADM. There was no difference in postoperative health status between the groups. CONCLUSION: One-stage IBBR with ADM was associated with higher costs, but similar health status, compared with conventional two-stage IBBR. Registration number: NTR5446 ( http://www.trialregister.nl).