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Autologous therapies using adipose-derived stromal vascular fraction (AD-SVFs) and adult adipose-derived mesenchymal stem cells (AD-MSCs) warrant careful preparation of the harvested adipose tissue. Currently, no standardized technique for this preparation exists. Processing quantitative standards (PQSs) define manufacturing quantitative variables (such as time, volume, and pressure). Processing qualitative standards (PQLSs) define the quality of the materials and methods in manufacturing. The purpose of the review was to use PQSs and PQLSs to report the in vivo and in vitro results obtained by different processing kits that use different procedures (enzymatic vs. non-enzymatic) to isolate human AD-SVFs/AD-MSCs. PQSs included the volume of fat tissue harvested and reagents used, the time/gravity of centrifugation, and the time, temperature, and tilt level/speed of incubation and/or centrifugation. PQLSs included the use of a collagenase, a processing time of 30 min, kit weight, transparency of the kit components, the maintenance of a closed sterile processing environment, and the use of a small centrifuge and incubating rocker. Using a kit with the PQSs and PQLSs described in this study enables the isolation of AD-MSCs that meet the consensus quality criteria. As the discovery of new critical quality attributes (CQAs) of AD-MSCs evolve with respect to purity and potency, adjustments to these benchmark PQSs and PQLs will hopefully isolate AD-MSCs of various CQAs with greater reproducibility, quality, and safety. Confirmatory studies will no doubt need to be completed.

Autologous therapies using platelet-rich plasma (PRP) need meticulous preparation—currently, no standardised preparation technique exists. Processing Quantitative Standards (PQSs) define manufacturing quantitative variables (such as time, volume and pressure). Processing Qualitative Standards (PQLSs) define the quality of the materials and methods of manufacturing. The aim of this review is to use existing PQSs and PQLs to report the in vivo/in vitro results obtained by using different Kits, that utilise different procedures (classified as Closed-Technique and Opened-Technique) to isolate autologous human activated (AA-PRP) or non-activated PRP (A-PRP). PQSs included the volumes of blood collected as well as the reagents used, the time/gravity of centrifugation, and the duration, temperature and tilt level/speed of centrifugation. PQLSs included the use of Calcium Chloride CaCl2, Kit weight, transparency of Kit components, the maintenance of a closed sterile processing environment and the use of a small centrifuge. Eight CE marked devices for PRP extraction were evaluated: Angel®, Biomed®, Cascade® and Selphyl®, Mag-18®, i-Stem®, MyCells® and Regenlab®. Using a Kit with the PQSs and PQLSs described in this study enables the isolation of A-PRP, thereby meeting consensus quality criteria. As our understanding of Critical Quality Attributes (CQAs) of A-PRP continues to evolve, especially with respect to purity and potency, adjustments to these benchmark PQSs and PQLs will hopefully help isolate A-PRP of desired CQAs with greater reproducibility, quality, and safety. Confirmatory studies will no doubt need to be completed.

IntroductionIn women undergoing breast-conserving surgery (BCS), 20–25% require a re-operation as a result of incomplete tumour resection. An intra-operative technique to assess tumour margins accurately would be a major advantage. A novel method for intraoperative margin assessment was developed by applying a thin flexible scintillating film to specimens—flexible autoradiography (FAR) imaging. A single-arm, multi-centre study was conducted to evaluate the feasibility of intraoperative [18F]FDG FAR for the assessment of tumour margins in BCS. MethodsEighty-eight patients with invasive breast cancer undergoing BCS received ≤ 300 MBq of [18F]FDG 60–180 min pre-operatively. Following surgical excision, intraoperative FAR imaging was performed using the LightPath® Imaging System. The first 16 patients were familiarisation patients; the remaining 72 patients were entered into the main study. FAR images were analysed post-operatively by three independent readers. Areas of increased signal intensity were marked, mean normalised radiances and tumour-to-tissue background (TBR) determined, agreement between histopathological margin status and FAR assessed and radiation dose to operating theatre staff measured. Subgroup analyses were performed for various covariates, with thresholds set based on ROC curves.ResultsData analysis was performed on 66 patients. Intraoperative margin assessment using FAR was completed on 385 margins with 46.2% sensitivity, 81.7% specificity, 8.1% PPV, 97.7% NPV and an overall accuracy of 80.5%, detecting both invasive carcinoma and DCIS. A subgroup analysis based on [18F]FDG activity present at time of imaging revealed an increased sensitivity (71.4%), PPV (9.3%) and NPV (98.4%) in the high-activity cohort with mean tumour radiance and TBR of 126.7 ± 45.7 photons/s/cm2/sr/MBq and 2.1 ± 0.5, respectively. Staff radiation exposure was low (38.2 ± 38.1 µSv).Conclusion[18F]FDG FAR is a feasible and safe technique for intraoperative tumour margin assessment. Further improvements in diagnostic performance require optimising the method for scintillator positioning and/or the use of targeted radiopharmaceuticals.Trial registration: Identifier: NCT02666079. Date of registration: 28 January 2016. URL: https://clinicaltrials.gov/ct2/show/NCT02666079.ISRCTN registry: Reference: ISRCTN17778965. Date of registration: 11 February 2016. URL: http://www.isrctn.com/ISRCTN17778965.

Background Breast augmentation-mastopexy can yield an aesthetically attractive breast, but the 1-stage procedure is prone to unsatisfactory outcomes, including poor wound healing. Objectives The authors evaluated whether postsurgical application of a polyurethane bra cup coated with oxygen-enriched olive oil (NovoX Cup; Moss SpA, Lesa, Novara, Italy) would decrease pain associated with augmentation-mastopexy and improve the quality of the surgical scar. Methods This retrospective study was conducted at a single center from January 2016 to June 2019. All patients underwent 1-stage augmentation-mastopexy with the inverted T incision. For 2 weeks postsurgically, wounds were dressed either with the oxygen-enriched olive oil bra or with Fitostimoline (Farmaceutici Damor SpA, Naples, Italy). Patients indicated their pain intensity on postoperative days 2, 3, and 10, and patients and independent observers scored scar quality on the Patient and Observer Scar Assessment Scale (POSAS) 6 and 12 months after the procedure. Results A total of 240 women (120 per study arm) completed the study. All the patients had satisfactory aesthetic results, and there were no tolerability concerns with either postoperative dressing. Compared with patients in the Fitostimoline group, patients who received the oxygen-enriched olive oil bra cup had significantly lower pain levels, and their surgical scars were given better scores on the POSAS. Conclusions The results suggest that maintenance of the surgical wound in a film of oxygen-enriched olive oil for 2 weeks is a safe, effective modality for suppressing pain and promoting healing following augmentation-mastopexy. Level of Evidence: 2

Background The SentiMAG Multicentre Trial evaluated a new magnetic technique for sentinel lymph node biopsy (SLNB) against the standard (radioisotope and blue dye or radioisotope alone). The magnetic technique does not use radiation and provides both a color change (brown dye) and a handheld probe for node localization. The primary end point of this trial was defined as the proportion of sentinel nodes detected with each technique (identification rate). Methods A total of 160 women with breast cancer scheduled for SLNB, who were clinically and radiologically node negative, were recruited from seven centers in the United Kingdom and The Netherlands. SLNB was undertaken after administration of both the magnetic and standard tracers (radioisotope with or without blue dye). Results A total of 170 SLNB procedures were undertaken on 161 patients, and 1 patient was excluded, leaving 160 patients for further analysis. The identification rate was 95.0 % (152 of 160) with the standard technique and 94.4 % (151 of 160) with the magnetic technique (0.6 % difference; 95 % upper confidence limit 4.4 %; 6.9 % discordance). Of the 22 % (35 of 160) of patients with lymph node involvement, 16 % (25 of 160) had at least 1 macrometastasis, and 6 % (10 of 160) had at least a micrometastasis. Another 2.5 % (4 of 160) had isolated tumor cells. Of 404 lymph nodes removed, 297 (74 %) were true sentinel nodes. The lymph node retrieval rate was 2.5 nodes per patient overall, 1.9 nodes per patient with the standard technique, and 2.0 nodes per patient with the magnetic technique. Conclusions The magnetic technique is a feasible technique for SLNB, with an identification rate that is not inferior to the standard technique.

The heterogeneous group of B3 lesions in the breast harbors lesions with different malignant potential and progression risk. As several studies about B3 lesions have been published since the last Consensus in 2018, the 3rd International Consensus Conference discussed the six most relevant B3 lesions (atypical ductal hyperplasia (ADH), flat epithelial atypia (FEA), classical lobular neoplasia (LN), radial scar (RS), papillary lesions (PL) without atypia, and phyllodes tumors (PT)) and made recommendations for diagnostic and therapeutic approaches. Following a presentation of current data of each B3 lesion, the international and interdisciplinary panel of 33 specialists and key opinion leaders voted on the recommendations for further management after core-needle biopsy (CNB) and vacuum-assisted biopsy (VAB). In case of B3 lesion diagnosis on CNB, OE was recommended in ADH and PT, whereas in the other B3 lesions, vacuum-assisted excision was considered an equivalent alternative to OE. In ADH, most panelists (76%) recommended an open excision (OE) after diagnosis on VAB, whereas observation after a complete VAB-removal on imaging was accepted by 34%. In LN, the majority of the panel (90%) preferred observation following complete VAB-removal. Results were similar in RS (82%), PL (100%), and FEA (100%). In benign PT, a slim majority (55%) also recommended an observation after a complete VAB-removal. VAB with subsequent active surveillance can replace an open surgical intervention for most B3 lesions (RS, FEA, PL, PT, and LN). Compared to previous recommendations, there is an increasing trend to a de-escalating strategy in classical LN. Due to the higher risk of upgrade into malignancy, OE remains the preferred approach after the diagnosis of ADH.

Background: Surgical excision of a non-palpable breast lesion requires a localization step. Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have been developed in the last two decades with the aim of improving outcomes and logistics. Methods: We performed a systematic review on localization techniques for non-palpable breast cancer. Results: For most techniques, oncological outcomes such as lesion identification and clear margin rate seem either comparable with or better than for WGL, but evidence is limited to small cohort studies for some of the devices. Intraoperative ultrasound is associated with significantly higher negative margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons’ and radiologists’ attitudes towards these techniques. Conclusions: Large studies with an additional focus on patient, surgeon, and radiologist preference are necessary. This review aims to present the rationale for the MELODY (NCT05559411) study and to enable standardization of outcome measures for future studies.

The authors report that grade 3 adverse events occurred in 26 (29%) of 91 operated breasts in the one-stage group, leading to implant, ADM, or both ADM and implant removal in 24 (26%) of the 91 breasts.1 At Guy's Hospital Breast Unit, London, UK, between January, 2013, and December, 2016, we performed skin-sparing mastectomies and nipple-sparing mastectomies with single stage direct-to-implant and ADM reconstruction in 184 patients (288 breasts). References 1 REG Dikmans, VL Negenborn,...

IntroductionIndia’s progress in reducing maternal and neonatal mortality since the 1990s was faster than the regional average. We systematically analysed how national health policies, services for maternal and newborn health, and socioeconomic contextual changes, drove these mortality reductions.MethodsThe study’s mixed-methods design integrated quantitative trend analyses of mortality, intervention coverage and equity since the 1990s, using the sample registration system and national surveys, with interpretive understandings from policy documents and 13 key informant interviews.ResultsIndia’s maternal mortality ratio (MMR) declined from 412 to 103 maternal deaths per 100 000 live births between 1997–1998 and 2017–2019. The neonatal mortality rate (NMR) declined from 46 to 22 per 1000 live births between 1997 and 2019. The average annual rate of mortality reduction increased over time. During this period, coverage of any antenatal care (57%–94%), quality antenatal care (37%–85%) and institutional delivery (34%–90%) increased, as did caesarean section rates among the poorest tertile (2%–9%); these coverage gains occurred primarily in the government (public) sector. The fastest rates for increasing coverage occurred during 2005–2012.The 2005–2012 National Rural Health Mission (which became the National Health Mission in 2012) catalysed bureaucratic innovations, additional resources, pro-poor commitments and accountability. These efforts occurred alongside smaller family sizes and improvements in macroeconomic growth, mobile and road networks, women’s empowerment, and nutrition. These together reduced high-risk births and improved healthcare access, particularly among the poor.ConclusionRapid reduction in NMR and MMR in India was accompanied by increased coverage of maternal and newborn health interventions. Government programmes strengthened public sector services, thereby expanding the reach of these interventions. Simultaneously, socioeconomic and demographic shifts led to fewer high-risk births. The study’s integrated methodology is relevant for generating comprehensive knowledge to advance universal health coverage.

Currently, about 8% of deaths worldwide are maternal or neonatal deaths, or stillbirths. Maternal and neonatal mortality have been a focus of the Millenium Development Goals and the Sustainable Development Goals, and mortality levels have improved since the 1990s. We aim to answer two questions: What were the key drivers of maternal and neonatal mortality reductions seen in seven positive-outlier countries from 2000 to the present? How generalisable are the findings?We identified positive-outlier countries with respect to maternal and neonatal mortality reduction since 2000. We selected seven, and synthesised experience to assess the contribution of the health sector to the mortality reduction, including the roles of access, uptake and quality of services, and of health system strengthening. We explored the wider context by examining the contribution of fertility declines, and the roles of socioeconomic and human development, particularly as they affected service use, the health system and fertility. We analysed government levers, namely policies and programmes implemented, investments in data and evidence, and political commitment and financing, and we examined international inputs. We contextualised these within a mortality transition framework.We found that strategies evolved over time as the contacts women and neonates had with health services increased. The seven countries tended to align with global recommendations but could be distinguished in that they moved progressively towards implementing their goals and in scaling-up services, rather than merely adopting policies. Strategies differed by phase in the transition framework—one size did not fit all.