Background: RelabotulinumtoxinA (relaBoNT-A) is a novel, complex-free, ready-to-use liquid BoNT-A for aesthetic use. Methods: This double-blind, Phase 3b study evaluated long-term (12-month) efficacy, satisfaction, safety, and time to onset of effect of relaBoNT-A for glabellar lines (GLs). Subjects were randomized 3:1 to a single dose of 50 U relaBoNT-A or placebo. Results: RelaBoNT-A was superior to placebo at Month 1 based on subject-reported Global Aesthetic Improvement Scale (GAIS) responder rates at maximum frown (primary endpoint), 92.9% (92/99 subjects) versus 9.1% (3/33 subjects), p<0.001. GAIS response after relaBoNT-A treatment remained high through Months 9 (42.7%) and 12 (37.8%), as did investigator-assessed GL severity (GL-ILA) ≥1-grade improvement at maximum frown at Months 6 (57.4%), 9 (28.1%), and 12 (12.2%). GAIS and GL-ILA showed onset of effect in 39.8% and 43.9% of relaBoNT-A-treated subjects within 1 day. Investigators reported increased confidence in dosing consistency with the ready-to-use product at baseline (98.0% relaBoNT-A vs. 100% placebo), and that they could achieve consistent (99.0% vs. 64.5%) and natural-looking results (98.0% vs. 64.5%) at Month 1. Subject satisfaction was higher for relaBoNT-A than placebo from Day 1 through Month 12. Two-thirds of subjects preferred treatment with relaBoNT-A to prior treatments with powder BoNT-As. Treatment-related adverse events (all mild) occurred in 8.1% of subjects. Conclusions: RelaBoNT-A showed rapid onset of effect from Day 1, with duration of effect through Month 6 for most subjects, and beyond 6 months for some. Injectors were highly satisfied with product usability, and subjects remained satisfied through Month 12. Treatment was well tolerated.
Background: Autologous fat transfer (AFT) has emerged as a promising technique for total breast reconstruction after mastectomy, particularly in cases unsuitable for other reconstruction methods. Evaluation of its efficacy, safety, and impact on quality of life (QoL) is essential. The authors assessed efficacy and safety outcomes of AFT as postmastectomy total breast reconstruction based on 12-month follow-up data from the BREAST-II trial. Methods: This multicenter nonrandomized clinical trial included women 18 years of age or older with a history of or planned mastectomy across 8 Dutch hospitals. Participants underwent multiple AFT sessions combined with external expansion using the Evebra device, with a maximum of 5 sessions over 12 months. The primary outcome was QoL measured by BREAST-Q and BODY-Q. Secondary outcomes included safety (eg, serious adverse events), operating time, hospital stay, and number of sessions. Results: A total of 229 women were included. At 12 months after AFT, significant improvements were observed in Psychosocial Well-Being (+5.72 +/- 16.79), Sexual Well-Being (+8.05 +/- 19.61), Physical Well-Being: Chest (+5.97 +/- 20.44), and Satisfaction with Chest (+17.22 +/- 27.27) (all P < 0.001). BODY-Q scores showed significant increases in satisfaction with the abdomen, back, body, hips/outer thighs, inner thighs, and scars (all P < 0.001). Among 805 AFT sessions, 52 adverse events occurred (6.46% complication rate). Hospital stays were less than 1 day per session. Conclusions: AFT is an effective and safe total breast reconstruction technique after mastectomy, significantly improving QoL with low complication rates. These findings support AFT as a valuable addition to breast reconstruction options.
Background: Most breast reconstructions are implant-based and performed in 2 stages using tissue expanders (TEs). Despite widespread indications for use, conventional TEs can present limitations, especially those containing metallic or magnetic ports. A new generation of TEs that incorporates nonmetallic radiofrequency identification systems (RFID TE) has been introduced. The authors assessed outcomes and risk factors for complications after implant-based reconstruction (IBR) with RFID TE systems.Methods: A retrospective cohort of patients who underwent IBR with RFID TEs was identified. The primary end point was occurrence of complications or identification of risk factors. The authors also evaluated the quality of magnetic resonance imaging scans (T1-weighted and T2-weighted sequences) taken for further diagnosis.Results: A total of 356 patients (mean age, 49.9 +/- 9.6 years) received 471 IBR RFID TE systems. The average follow-up was 29.4 +/- 16.6 months. A total of 77 patients (21.6%) experienced complications, most frequently seroma (7.8%). A greater number of complications were observed in older patients (P = 0.005), smokers (P = 0.009), patients who received radiotherapy (P = 0.005), and patients who received reconstruction using a premuscular pocket (P = 0.001). Multivariate regression found that older patients and smokers had odds ratios (ORs) of 2.12 (P = 0.013) and 2.30 (P = 0.024) for developing complications, respectively. Radiotherapy (OR, 2.29; P = 0.024) was also an independent risk factor for overall complications. Use of a submuscular pocket was associated with significantly lower odds of developing seroma (OR, 0.21; P = 0.08). Magnetic resonance imaging scans demonstrated excellent quality, with no artifact-related negative effects.Conclusions: Despite extensive research on IBR, previous studies on RFID TEs are limited and did not analyze predictive risk factors. These findings demonstrate that RFID TEs are reliable, with results similar to those of other series using different devices. The absence of significant imaging artifacts facilitates follow-up surveillance and represents an important advantage over traditional TEs.
Background: Secondary lymphedema in patients with breast cancer is a debilitating condition that adversely affects quality of life. Lymphovenous anastomosis (LVA) has shown promising results, but its long-term effectiveness is a subject of ongoing investigation. This study was performed to evaluate relapse to a presurgical condition and associated risk factors in patients with breast cancer-related lymphedema (BCRL) treated with LVA. This is the first study to analyze lymphedema relapse after LVA, providing valuable insights for managing patient expectations. Methods: Between 2018 and 2023, 90 patients who underwent LVA for BCRL were included in this retrospective study. The authors evaluated relapse and potential risk factors, along with changes in limb circumference, subjective improvement, and frequency of infection episodes. Results: Relapse to the presurgical condition occurred in 11 patients (12.2%), with a mean time to relapse of 27.4 months after surgery. Patients with International Society of Lymphology stage 3 lymphedema (hazard ratio, 9.88; P < 0.05) and a history of infections (hazard ratio, 3.99; P < 0.05) had a higher incidence of relapse. Two out of 3 patients without regular use of preoperative compressive therapy experienced relapse (P < 0.05). No significant associations were found between relapse and after surgery compression therapy, previous radiotherapy, duration of lymphedema, age, or body mass index. Conclusions: The low relapse rate suggests that LVA is an effective long-term treatment for BCRL. However, advanced stage lymphedema and history of infections in the affected limb may influence long-term effectiveness. Further studies are needed to identify additional risk factors for relapse.
Background: Deep inferior epigastric artery perforator (DIEP) flaps are commonly used in breast reconstruction due to their muscle-sparing nature. However, postoperative volume changes can affect long-term breast symmetry. This study evaluates the predictive value of intraoperative indocyanine green (ICG) angiography findings for postoperative volume changes in DIEP flaps. Methods: This retrospective cohort study included 44 patients who underwent unilateral breast reconstruction with unipedicled DIEP flaps between September of 2019 and February of 2024. Intraoperative flap perfusion was assessed using ICG angiography, and the ICG flow inset ratio was calculated. Flap volume was measured intraoperatively and about 1 year postoperatively using magnetic resonance imaging. Multivariable linear regression and receiver operating characteristic analysis were performed to identify predictors of volume preservation. Results: The average flap volume at 1 year was 85.2% of the initial volume. Higher ICG flow inset ratios were significantly associated with better volume preservation (beta = 0.083; P = 0.047); radiotherapy was correlated with increased volume loss (beta = -0.155; P < 0.001). The optimal ICG flow inset ratio cutoff for predicting above-average volume maintenance was 1.325 (area under the receiver operating characteristic curve = 0.700). Conclusions: ICG angiography can guide intraoperative decision-making to optimize postoperative volume outcomes in breast reconstruction. Higher intraoperative ICG flow inset ratios predict improved long-term volume preservation in DIEP flap breast reconstruction. Targeting a ratio above 1.325 and careful flap design may support better symmetry, particularly in patients undergoing radiotherapy.
