Contralateral Breast Screening with Preoperative MRI: Long-Term Outcomes for Newly Diagnosed Breast Cancer.

Background The diagnostic value of screening the contralateral breast with MRI in patients with newly diagnosed breast cancer is poorly understood. Purpose To assess the impact of MRI for screening the contralateral breast on long-term outcomes in patients with newly diagnosed breast cancer and to determine whether subgroups with unfavorable prognoses would benefit from MRI in terms of survival. Materials and Methods Data on consecutive patients with newly diagnosed breast cancer seen from January 2008 to December 2010 were reviewed retrospectively. Patients with neoadjuvant chemotherapy, previous breast cancer, distant metastasis, absence of contralateral mammography at diagnosis, and no planned surgical treatment were excluded. Groups that did and did not undergo preoperative MRI were compared. Survival analysis was performed using the Kaplan-Meier method for propensity score-matched groups to estimate cause-specific survival (CSS) and overall survival (OS). A marginal Cox proportional hazards model was used to evaluate association of MRI and clinicopathologic variables with OS. Results Of 1846 patients, 1199 fulfilled the inclusion criteria. Median follow-up time was 10 years (range, 0-14 years). The 2:1 matched sample comprised 705 patients (470 in the MRI group and 235 in the no-MRI group); median ages at surgery were 59 years (range, 31-87 years) and 64 years (range, 37-92 years), respectively. MRI depicted contralateral synchronous disease more frequently (27 of 470 patients [5.7%] vs five of 235 patients [2.1%]; P = .047) and was associated with a higher OS (hazard ratio [HR], 2.51; 95% CI: 1.25, 5.06; P = .01). No differences were observed between groups in metachronous disease rate (MRI group: 21 of 470 patients [4.5%]; no-MRI group: 10 of 235 patients [4.3%]; P > .99) or CSS (HR, 1.34; 95% CI: 0.56, 3.21; P = .51). MRI benefit was greater in patients with larger tumor sizes (>2 cm) (HR, 2.58; 95% CI: 1.11, 5.99; P = .03) and histologic grade III tumors (HR, 2.94; 95% CI: 1.18, 7.32; P = .02). Conclusion Routine MRI screening of the contralateral breast after first diagnosis of breast cancer improved overall survival; the most pronounced benefit was found in patients with larger primary tumor size and primary tumors of histologic grade III. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Taourel in this issue.

Evaluation of the Number of Progressive Tension Sutures Needed to Prevent Seroma in Abdominoplasty with Drains: A Single-Blind, Prospective, Comparative, Randomized Clinical Trial.

BACKGROUND: Seroma formation has become the most reported complication after abdominoplasties. In 2000, progressive tension sutures (PTS) were described and reported to be associated with a seroma rate of 0.1%. Surgeons worldwide use PTS to prevent seroma; however, there are discrepancies in the number of PTS commonly used, starting from five up to 35 sutures. The absence of standardization may cause a lack of seroma prevention, increased surgical time, and general hesitation to perform the technique. OBJECTIVE: To determine whether 11 PTS are sufficient to prevent seroma in abdominoplasties. METHODS: We performed a single-blind, prospective, comparative, randomized clinical trial of 63 healthy patients from January to December 2017. Patients were divided into groups: group 1, classic abdominoplasty without the use of PTS and drains; group 2, abdominoplasty with the use of 11 PTS and drains; and group 3, abdominoplasty with the use of 22 PTS and drains. The duration of the surgical technique, presence of clinical seroma, number of aspirations, and days to drain removal were evaluated. The Cochran-Armitage, Fisher exact, Kruskal-Wallis, and t tests were used in the statistical analyses. RESULTS: PTS reduced the rate of seroma formation to 3.5%. Results showed that there is a benefit in using 11 PTS instead of 22 PTS because using more sutures led to an increased surgical time (30 min vs. 13 min) and possible complications. Compared to patients with PTS, those without PTS underwent more seroma aspirations and delayed drain removal. CONCLUSIONS: Eleven PTS should be used in classic abdominoplasties. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Strength of clinical evidence leading to approval of novel cancer medicines in Europe: A systematic review and data synthesis.

We aimed to evaluate the quality of clinical evidence that substantiated approval of cancer medicines by the European Medicines Agency (EMA) in the last decade. We performed a systematic review and data synthesis of EMA documents in agreement with PRISMA guidelines. We included the European Public Assessment Reports, Summaries of Product Characteristics, and published randomized controlled trials (RCTs) on anti-cancer drugs approved by EMA from 2010 to 2019, and excluded drugs not indicated for targeting solid or hematological tumors and non-innovative treatments. We synthesized frequencies of approvals differentiating between unblinded and blinded RCTs with and without overall survival (OS) as a predefined primary outcome measure. We assessed the frequency of post-approval RCTs for indications without at least one RCT at the time of approval. Of 199 approvals, 159 (80%) were supported by at least one RCT, 63 (32%) by at least one RCT having OS as the primary or co-primary endpoint, 74 (37%) by at least one blinded RCT, and 30 (15%) by at least one blinded RCT having OS as the primary or co-primary endpoint. Whereas 40 approvals (20%) were not supported by any RCT and, of those, 9 (22%) were followed by a post-approval RCT. While the majority of approvals of cancer medicines approved by EMA was supported by at least one RCT, we noted substantial methodological heterogeneity of the studies. Clinical trial registration: PROSPERO registration number CRD42020206669.

Risk of Adverse Clinical Outcomes in Hyponatremic Adult Patients Hospitalized for Acute Medical Conditions: A Population-Based Cohort Study.

CONTEXT: Hyponatremia has been associated with excess long-term morbidity and mortality. However, effects during hospitalization are poorly studied. OBJECTIVE: The objective of this work is to examine the association of hyponatremia with the risk of in-hospital mortality, 30-day readmission, and other short-term adverse events among medical inpatients. DESIGN AND SETTING: A population-based cohort study was conducted using a Swiss claims database of medical inpatients from January 2012 to December 2017. PATIENTS: Hyponatremic patients were 1:1 propensity-score matched with normonatremic medical inpatients. MAIN OUTCOME MEASURE: The primary outcome was a composite of all-cause in-hospital mortality and 30-day hospital readmission. Secondary outcomes were intensive care unit (ICU) admission, intubation rate, length-of-hospital stay (LOS), and patient disposition after discharge. RESULTS: After matching, 94 352 patients were included in the cohort. Among 47 176 patients with hyponatremia, 8383 (17.8%) reached the primary outcome compared with 7994 (17.0%) in the matched control group (odds ratio [OR] 1.06 [95% CI, 1.02-1.10], P = .001). Hyponatremic patients were more likely to be admitted to the ICU (OR 1.43 [95% CI, 1.37-1.50], P < .001), faced a 56% increase in prolonged LOS (95% CI, 1.52-1.60, P < .001), and were admitted more often to a postacute care facility (OR 1.38 [95% CI 1.34-1.42, P < .001). Of note, patients with the syndrome of inappropriate antidiuresis (SIAD) had lower in-hospital mortality (OR 0.67 [95% CI, 0.56-0.80], P < .001) as compared with matched normonatremic controls. CONCLUSION: In this study, hyponatremia was associated with increased risk of short-term adverse events, primarily driven by higher readmission rates, which was consistent among all outcomes except for decreased in-hospital mortality in SIAD patients.

Influence of vascularized lymph node transfer (VLNT) flap positioning on the response to breast cancer-related lymphedema treatment. / Influência do posicionamento do retalho linfonodal vascularizado na resposta ao tratamento cirúrgico do linfedema secundário ao câncer de mama.

OBJECTIVE: to evaluate the initial therapeutic experience of transplantation of vascularized lymph nodes in patients with lymphedema of the upper limbs secondary to the treatment of breast cancer, and to verify if the positioning of the transplant influences the surgical result. METHODS: we conducted a prospective, comparative test of two therapeutic modalities, with 24 patients with lymphedema of the upper limb after breast cancer treatment, classified as grades 2 and 3, according to the International Lymphedema Society. The two types of procedures performed were: 1) total breast reconstruction with - deep inferior epigastric perforator (DIEP) flap associated with lymph node flap, in patients with no previous breast reconstruction or loss of previous reconstruction (axillary positioning); 2) isolated inguinal lymph node flap performed in patients with completed breast reconstruction or without the desire to perform the breast reconstruction (wrist positioning). RESULTS: the reduction percentage of the affected limb volume was 20.1% (p=0.0370). The number of infectious episodes (cellulites) also decreased significantly, from 41% in the preoperative period to 12.5% in the postoperative one (p=0.004). There were no differences between the proximal and distal groups. CONCLUSION: the transplantation of lymph nodes positively affected the postoperative evolution of patients with lymphedema secondary to breast cancer. We observed no differences in relation to flap positioning.

OBJETIVO: analisar a experiência terapêutica inicial do transplante de linfonodos vascularizados em pacientes portadoras de linfedema de membros superiores secundário ao tratamento do câncer de mama e verificar se o posicionamento do transplante influencia o resultado cirúrgico. MÉTODOS: ensaio prospectivo, comparativo, de duas modalidades terapêuticas em 24 pacientes portadoras de linfedema de membro superior após tratamento de câncer mamário, classificados como graus 2 e 3, segundo a Sociedade Internacional de Linfedema. Os dois tipos de procedimentos realizados foram: 1) reconstrução total da mama com retalho de perfurante da artéria epigástrica inferior (DIEP- deep inferior epigastric perforator flap) associado ao retalho linfonodal, em pacientes sem reconstrução mamária prévia ou com histórico de perda da reconstrução (posicionamento axilar); 2) retalho linfonodal inguinal isolado foi realizado em pacientes com reconstrução mamária finalizada ou sem o desejo de realizar a reconstrução da mama (posicionamento no punho). RESULTADOS: a porcentagem de redução do volume do membro afetado foi de 20,1% (p=0,0370). O número de episódios infecciosos (celulites) também sofreu redução significativa, de 41% no período pré-operatório para 12,5% no pós-operatório (p=0,004). Não foram observadas diferenças entre os grupos proximal e distal. CONCLUSÃO: o transplante de linfonodos afetou positivamente a evolução pós-operatória de pacientes portadoras de linfedema secundário ao câncer de mama. Não foram observadas diferenças em relação ao posicionamento do retalho.

Influência do posicionamento do retalho linfonodal vascularizado na resposta ao tratamento cirúrgico do linfedema secundário ao câncer de mama / Influence of vascularized lymph node transfer (VLNT) flap positioning on the response to breast cancer-related lymphedema treatment

RESUMO Objetivo: analisar a experiência terapêutica inicial do transplante de linfonodos vascularizados em pacientes portadoras de linfedema de membros superiores secundário ao tratamento do câncer de mama e verificar se o posicionamento do transplante influencia o resultado cirúrgico. Métodos: ensaio prospectivo, comparativo, de duas modalidades terapêuticas em 24 pacientes portadoras de linfedema de membro superior após tratamento de câncer mamário, classificados como graus 2 e 3, segundo a Sociedade Internacional de Linfedema. Os dois tipos de procedimentos realizados foram: 1) reconstrução total da mama com retalho de perfurante da artéria epigástrica inferior (DIEP- deep inferior epigastric perforator flap) associado ao retalho linfonodal, em pacientes sem reconstrução mamária prévia ou com histórico de perda da reconstrução (posicionamento axilar); 2) retalho linfonodal inguinal isolado foi realizado em pacientes com reconstrução mamária finalizada ou sem o desejo de realizar a reconstrução da mama (posicionamento no punho). Resultados: a porcentagem de redução do volume do membro afetado foi de 20,1% (p=0,0370). O número de episódios infecciosos (celulites) também sofreu redução significativa, de 41% no período pré-operatório para 12,5% no pós-operatório (p=0,004). Não foram observadas diferenças entre os grupos proximal e distal. Conclusão: o transplante de linfonodos afetou positivamente a evolução pós-operatória de pacientes portadoras de linfedema secundário ao câncer de mama. Não foram observadas diferenças em relação ao posicionamento do retalho.

ABSTRACT Objective: to evaluate the initial therapeutic experience of transplantation of vascularized lymph nodes in patients with lymphedema of the upper limbs secondary to the treatment of breast cancer, and to verify if the positioning of the transplant influences the surgical result. Methods: we conducted a prospective, comparative test of two therapeutic modalities, with 24 patients with lymphedema of the upper limb after breast cancer treatment, classified as grades 2 and 3, according to the International Lymphedema Society. The two types of procedures performed were: 1) total breast reconstruction with - deep inferior epigastric perforator (DIEP) flap associated with lymph node flap, in patients with no previous breast reconstruction or loss of previous reconstruction (axillary positioning); 2) isolated inguinal lymph node flap performed in patients with completed breast reconstruction or without the desire to perform the breast reconstruction (wrist positioning). Results: the reduction percentage of the affected limb volume was 20.1% (p=0.0370). The number of infectious episodes (cellulites) also decreased significantly, from 41% in the preoperative period to 12.5% in the postoperative one (p=0.004). There were no differences between the proximal and distal groups. Conclusion: the transplantation of lymph nodes positively affected the postoperative evolution of patients with lymphedema secondary to breast cancer. We observed no differences in relation to flap positioning.