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.

Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial).

INTRODUCTION: Two-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants. METHODS AND ANALYSIS: The Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed. ETHICS AND DISSEMINATION: The trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals. TRIAL REGISTRATION: NTR7265.

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.

Optimal High-Dose-Rate Brachytherapy Fractionation Scheme After Keloid Excision: A Retrospective Multicenter Comparison of Recurrence Rates and Complications.

PURPOSE: To determine the optimal brachytherapy dose and fractionation scheme for keloid treatment. METHODS AND MATERIALS: Patient cohorts from 3 centers treated with keloid excision followed by 2 × 9 Gy, 3 × 6 Gy, or 2 × 6 Gy high-dose-rate brachytherapy were retrospectively compared regarding recurrence (after at least 12 months' follow-up) and complications (after at least 1 month's follow-up), using logistic regression analyses. RESULTS: A total of 238 keloids were treated. An overall full recurrence rate of 8.3% was found. After correction for confounders (sex, skin color, keloid location, keloid duration) no statistically significant differences in recurrence rates could be discerned between fractionation schemes. There were 12.8% major and 45.6% minor complication rates. Lower radiation dose resulted in significantly fewer complications (odds ratio 0.35, P=.015). CONCLUSIONS: After excision of resistant keloids, high-dose-rate brachytherapy with a biological equivalent dose of approximately 20 Gy is recommended, on the basis of low recurrence and complication rates.