Treatment and Outcomes of 844 Cases of Pneumothorax in Heritable Connective Tissue Disorders.

BACKGROUND: Characteristics, practice patterns, and clinical outcomes of secondary spontaneous pneumothorax (SSP) with heritable connective tissue disorders (Marfan, Ehlers-Danlos, and Birt-Hogg-Dubé syndromes) are unclear. METHODS: A nationwide Japanese inpatient database that included data of 524 patients with SSP (884 hospitalizations) and 137,821 with primary spontaneous pneumothorax between July 2010 and March 2020 was used in this study. Hospitalization for SSP (n = 884) was categorized into surgical (n = 459) and nonsurgical (n = 425) groups, and the patient characteristics, treatment, and outcomes were compared between the groups. Multivariable analyses were performed to evaluate risk factors for pneumothorax recurrence. We also compared the characteristics of patients with different underlying heritable connective tissue disorders. RESULTS: Compared with the nonsurgical group, the surgical group had less frequent readmission for pneumothorax (26% vs 44%; hazard ratio, 0.47; 95% CI, 0.38-0.58). Young patients (2.46; 1.83-3.32) or those with Birt-Hogg-Dubé syndrome (2.53; 1.77-3.63) had a high risk of recurrence. Pneumothorax occurred frequently in teenagers with Marfan syndrome, in those aged 20 to 39 years with Ehlers-Danlos syndrome, and in those aged ≥40 years with Birt-Hogg-Dubé syndrome. CONCLUSIONS: Detailed information on the characteristics and clinical course of SSP in heritable connective tissue disorders will aid in the clinical decision-making process.

Outcomes of nonrejection in weakly fluorescent intestine detected by indocyanine green fluorescence angiography: a case series of infants.

BACKGROUND: Indocyanine green fluorescence angiography, a validated noninvasive imaging technique, is used to assess tissue vascularization. Here, we report three infant patients who underwent intraoperative indocyanine green fluorescence angiography and suffered from postoperative complications caused by the lack of weak fluorescent intestinal resection and assessed residual intestinal perfusion. CASE PRESENTATION: We observed the clinical characteristics and operative findings of patients treated from January 2022 to December 2022. Indocyanine green (0.5 mg/kg) was intravenously injected. The first patient was a 29-day-old girl with surgical necrotizing enterocolitis who underwent intraoperative indocyanine green fluorescence angiography at the first- and second-look operations. The proximal jejunum was difficult to diagnose to detect blood flow during the second-look operation. The second patient was a 32-day-old boy with surgical necrotizing enterocolitis. A part of the antimesenteric mucosa of the patient that exhibited weak fluorescence was preserved; however, it formed postoperative hematomas. The third patient was a 30-day-old boy with midgut volvulus. Weak fluorescence in the intestinal wall was observed 5 cm of the small intestine from the ileocecal valve was preserved, but it formed a stricture, and the patient underwent ileocecal resection after 30 days. CONCLUSIONS: Weak fluorescence in the intestine in infants by performing indocyanine green fluorescence angiography is associated with a high risk of non-recovering ischemic lesions and postoperative complications.

Comparison of Postoperative Respiratory Function Between Patients After Thoracoscopic and Open Lobectomy.

Purpose: This study aimed to compare respiratory functions of patients after thoracoscopic lobectomy (TS) with those after thoracotomy (TR). Methods: This retrospective study was conducted in two centers, one of which adapted TS as a standard procedure in 2009 and the other performs it via TR. Data on patients who underwent lobectomy for congenital lung disease between 2009 and 2021 and underwent pulmonary function test (spirometry) were collected. Results: Ten patients underwent TS and 36 underwent TR. Distribution based on sex, prenatal diagnosis, pathological diagnosis, and resected lobe were similar between the two groups. The median [interquartile range] age at procedure in the TR group was significantly smaller than that in the TS group (13 [11-18] months versus 38 [13-79] months, P = .03). The procedure duration in the TR group was significantly shorter than that in the TS group (230 [171-264] minutes versus 264 [226-420] minutes, P = .02). Pulmonary function test was conducted at the age of eight in both groups, but the interval between the procedure, and the test was significantly shorter in the TS group (TR: 7 [5-8] years versus TS: 5 [2-7] years, P = .03). The ratio of forced vital capacity compared to predicted one (TR: 86.6 [76.6-95.3] versus TS: 88.7 [86.8-89.1], P = .58) and the ratio of forced expiratory volume in 1 second against that predicted (TR: 84.0 [80.5-88.7] versus TS: 88.7 [86.8-89.1], P = .08) were not significantly different between the two groups. Conclusions: Although TR was performed earlier than TS, respiratory function was similar between the two groups.

Influence of surgical volume on the mortality and morbidity of gastrointestinal perforation in children.

PURPOSE: To clarify the influence of surgical volume on the mortality and morbidity of gastrointestinal perforation in children in Japan. METHODS: We collected data on pediatric patients with gastrointestinal perforation between 2017 and 2019, from the National Clinical Database. The surgical volumes of various institutions were classified into three groups: low (average number of surgeries for gastrointestinal perforation/year < 1), medium (≥ 1, < 6), and high (≥ 6). The observed-to-expected (o/e) ratios of 30-day mortality and morbidity were calculated for each group using an existing risk model. RESULTS: Among 1641 patients (median age, 0.0 years), the 30-day mortality and morbidity rates were 5.2% and 37.7%, respectively. The 30-day mortality rates in the low-, medium-, and high-volume institutions were 4.9%, 5.3%, and 5.1% (p = 0.94), and the 30-day morbidity rates in the three groups were 26.8%, 39.7%, and 37.7% (p < 0.01), respectively. The o/e ratios of 30-day mortality were 1.05 (95% confidence interval [CI] 0.83-1.26), 1.08 (95% CI 1.01-1.15), and 1.02 (95% CI 0.91-1.13), and those of 30-day morbidity were 1.72 (95% CI 0.93-2.51), 1.03 (95% CI 0.79-1.28), and 0.95 (95% CI 0.56-1.33), respectively. CONCLUSION: Surgical volume does not have significant impact on the outcomes of pediatric gastrointestinal perforation in Japan.

Treatment courses and outcomes of oesophageal atresia in patients with trisomy 18: a case series of 271 patients from a nationwide database in Japan.

OBJECTIVE: To describe characteristics, treatments and clinical outcomes of patients with trisomy 18 and oesophageal atresia, using a nationwide database in Japan. DESIGN: Descriptive study using a retrospective cohort. SETTING: A nationwide inpatient database including 90% of hospitals with neonatal intensive care units in Japan. PATIENTS: Patients hospitalised within a day after birth for both oesophageal atresia and trisomy 18 between July 2010 and March 2020. INTERVENTIONS: Radical surgery for oesophageal atresia. MAIN OUTCOME MEASURES: Characteristics, treatment course and outcomes. RESULTS: Among 271 patients with both oesophageal atresia and trisomy 18, 70 patients underwent radical surgery for oesophageal atresia. Patients who underwent radical surgery were less likely to have severe cardiac anomalies (17% vs 32%; p=0.020), but more likely to undergo cardiac surgery (21% vs 9.5%; p=0.012) than those who did not. The overall in-hospital mortality was lower (54% vs 79%; p<0.001) and the median age at death was higher (210 days vs 39 days; p<0.001) in patients who underwent radical surgery than the others. Postoperative mortality within 30 days after radical surgery was 5.7%. Patients who underwent radical surgery were likely to be discharged to home (50% vs 18%; p<0.001), whereas the age at home discharge (median 314 days vs 216 days; p=0.19) and the requirement for each home treatment did not differ significantly by radical surgery. CONCLUSION: This study provides information that will aid the clinical decision-making process for patients with oesophageal atresia and trisomy 18. Radical surgery may be a safe and feasible treatment option.

Outcomes Following Laparoscopic Versus Open Surgery for Pediatric Intussusception: Analysis Using a National Inpatient Database in Japan.

BACKGROUND: Laparoscopic surgery for pediatric intussusception has recently become more common as an alternative to open surgery. However, the differences in outcomes between laparoscopic and open surgery remain unclear. Thus, this study aimed to compare short-term surgical outcomes and recurrence rates between patients treated with laparoscopic and open surgery for pediatric intussusception. METHODS: Patients aged <18 years who underwent laparoscopic (n = 192) and open (n = 416) surgery for intussusception between April 2016 and March 2021 were retrospectively identified using a Japanese nationwide inpatient database. Propensity-score overlap weighting analyses were conducted to compare the outcomes between the laparoscopic and open surgery groups. The outcomes included in-hospital morbidity, reoperation, readmission for intussusception, bowel resection, the diagnosis of Meckel's diverticulum, duration of anesthesia, postoperative length of hospital stay, and total hospitalization costs. RESULTS: The laparoscopic surgery group was older, heavier, and had fewer congenital malformations and emergency admissions than the open surgery group did. Overlap weighting analyses showed no significant differences in in-hospital morbidity (odds ratio [95% confidence interval], 0.88 [0.35-2.23]), reoperation (1.88 [0.24-14.9]), readmission for intussusception within 30 days (0.80 [0.12-5.30]) and 1 year (0.90 [0.28-2.93]), bowel resection (0.69 [0.46-1.02]), the diagnosis of Meckel's diverticulum (0.97 [0.50-1.90]), duration of anesthesia (difference, 11 [-1-24] minutes), postoperative length of stay (difference, -1.9 [-4.2-0.4] days), or total hospitalization costs (difference, 612 [ -746-1970] US dollars) between the groups. CONCLUSIONS: In this large nationwide cohort, no significant differences in outcomes were observed between laparoscopic and open surgery. Laparoscopic surgery is an acceptable treatment option for pediatric intussusception. LEVELS OF EVIDENCE: Level III.

Impact of the National Action Plan for Antimicrobial Resistance on Antibiotic Use for Mastitis Using a Japanese Nationwide Database.

Introduction: Mastitis is the inflammation of the mammary gland that mainly occurs during the lactation period and requires antibiotic treatment with little evidence for its efficacy. We investigated the effect of the National Action Plan for antimicrobial resistance aiming for appropriate antimicrobial stewardship on broad-spectrum antibiotics administration for mastitis despite the lack of a disease-specific antimicrobial agents manual. Methods: Using a large nationwide database, an interrupted time-series analysis was performed using data from 34,340 female patients who received antibiotics for mastitis between April 2012 and March 2020. This study compared the trend of outcomes before and after the publication date of the National Action Plan (April 2016). The outcomes were the proportion of broad-spectrum and first-choice narrow-spectrum antibiotic administration and surgical drainage within 30 days after the administration. Results: Broad-spectrum antibiotics were administered in 70% of the cases before and 67% of the cases after the National Action Plan publication date. The trend of broad-spectrum antibiotics administration significantly changed at the publication (-2.6% [95% confidence interval, -3.9% to -1.3%], p < 0.001) and the administration decreased after the publication (1.9% annual decrease, Ptrend < 0.001). The trend of first-choice antibiotics administration also changed at the publication (1.3% [0.1-2.4%], p = 0.028) and the administration increased after the publication (1.3% annual increase, Ptrend < 0.001). The occurrence of surgical drainage was stable during the study period. Conclusion: Despite the lack of a disease-specific antimicrobial manual, the publication of the National Action Plan improved antimicrobial stewardship for mastitis without any impact on a surgical treatment course.

Respiratory Virus-Specific Nasopharyngeal Lipidome Signatures and Severity in Infants With Bronchiolitis: A Prospective Multicenter Study.

BACKGROUND: In infant bronchiolitis, recent evidence indicates that respiratory viruses (eg, respiratory syncytial virus [RSV], rhinovirus [RV]) contribute to the heterogeneity of disease severity. Of the potential pathobiological molecules, lipids serve as signaling molecules in airway inflammation. However, little is known about the role of the airway lipidome in between-virus heterogeneity and disease severity. METHODS: In this multicenter prospective study of 800 infants hospitalized for RSV or RV bronchiolitis, we analyzed nasopharyngeal lipidome data. We examined discriminatory lipids between RSV and RV infection and the association of the discriminatory lipids with bronchiolitis severity, defined by positive pressure ventilation (PPV) use. RESULTS: We identified 30 discriminatory nasopharyngeal lipid species and 8 fatty acids between RSV and RV infection. In the multivariable models adjusting for patient-level confounders, 8 lipid species-for example, phosphatidylcholine (18:2/18:2) (adjusted odds ratio [aOR], 0.23 [95% confidence interval {CI}, .11-.44]; false discovery rate [FDR] = 0.0004) and dihydroceramide (16:0) (aOR, 2.17 [95% CI, 1.12-3.96]; FDR = 0.04)-were significantly associated with the risk of PPV use. Additionally, 6 fatty acids-for example, eicosapentaenoic acid (aOR, 0.27 [95% CI, .11-.57]; FDR = 0.01)-were also significantly associated with the risk of PPV use. CONCLUSIONS: In infants hospitalized for bronchiolitis, the nasopharyngeal lipidome plays an important role in the pathophysiology of between-virus heterogeneity and disease severity.

Risk factors for postoperative anastomotic leakage after repair of esophageal atresia: a retrospective nationwide database study.

PURPOSE: Postoperative anastomotic leakage is the most frequent short-term complication of esophageal atresia repair in neonates. We conducted this study using a nationwide surgical database in Japan to identify the risk factors for anastomotic leakage in neonates undergoing esophageal atresia repair. METHODS: Neonates diagnosed with esophageal atresia between 2015 and 2019 were identified in the National Clinical Database. Postoperative anastomotic leakage was compared among patients to identify the potential risk factors, using univariate analysis. Multivariable logistic regression analysis included sex, gestational age, thoracoscopic repair, staged repair, and procedure time as independent variables. RESULTS: We identified 667 patients, with an overall leakage incidence of 7.8% (n = 52). Anastomotic leakage was more likely in patients who underwent staged repairs than in those who did not (21.2% vs. 5.2%, respectively) and in patients with a procedure time > 3.5 h than in those with a procedure time < 3.5 h (12.6% vs. 3.0%, respectively; p < 0.001). Multivariable logistic regression analysis identified staged repair (odds ratio [OR] 4.89, 95% confidence interval [CI] 2.22-10.16, p < 0.001) and a longer procedure time (OR 4.65, 95% CI 2.38-9.95, p < 0.001) as risk factors associated with postoperative leakage. CONCLUSION: Staged procedures and long operative times are associated with postoperative anastomotic leakage, suggesting that leakage is more likely after complex esophageal atresia repair and that such patients require refined treatment strategies.

Oral Antibiotics and Organ Space Infection after Appendectomy and Intravenous Antibiotics Therapy for Complicated Appendicitis in Children.

BACKGROUND: There is little consensus regarding management after appendectomy for complicated appendicitis in children. Recent literature suggests that patients may be safely discharged without oral antibiotics after adequate intravenous antibiotics therapy. We conducted a nationwide retrospective cohort study comparing the proportion of postoperative organ space infection between patients discharged with and without oral antibiotics after appendectomy followed by intravenous antibiotics therapy for complicated appendicitis. METHODS: Using the Diagnosis Procedure Combination database, we identified patients between 3 and 18 years of age who had undergone appendectomy for complicated appendicitis between July 2010 and March 2018. Propensity score-matched analyses were performed to compare outcomes between the groups with and without oral antibiotics. The primary outcome was readmission due to organ space infection within 60 days of discharge and the secondary outcome was 60-day readmission due to any reason. Additionally, we conducted a stabilized inversed probability of treatment weighting analysis as a sensitivity analysis. RESULTS: We identified 13,100 eligible patients who had received oral antibiotics (n = 3,501) and who had not received oral antibiotics (n = 9,599). Propensity score matching created 2,769 pairs. Readmissions due to organ space infection were 3.4% and 5.2% in the nonusers and users of oral antibiotics, respectively (p = 0.007). The oral antibiotics users also had a significantly higher proportion of readmission due to any reason than the nonusers (5.5 vs. 7.4%, p = 0.004). The sensitivity analyses demonstrated consistent results. CONCLUSION: Among children who had undergone appendectomy for complicated appendicitis, oral antibiotics following discharge after adequate intravenous antibiotics therapy may increase organ space infection.

Perioperative outcomes of thyroid cancer surgery in children and adults: a nationwide inpatient database study in Japan.

BACKGROUND: Little is known about perioperative outcomes after pediatric thyroidectomy. This study was performed to compare perioperative outcomes between children and adults undergoing thyroid cancer surgery using a nationwide inpatient database in Japan. METHODS: Using the Japanese Diagnosis Procedure Combination database, we identified patients aged 0 to 40 years with thyroid cancer who underwent thyroidectomy from July 2010 to March 2020. To compare the occurrence of in-hospital morbidities including local complications (e.g., recurrent laryngeal nerve paralysis, postoperative bleeding), duration of anesthesia, postoperative length of stay, and total hospitalization costs between children (0-18 years) and adults (19-40 years), we used multivariable logistic regression analysis for the occurrence of in-hospital morbidities and linear regression for other outcomes. RESULTS: For 16,016 eligible patients (666 children vs. 15,350 adults), no significant differences between the two groups were found in any in-hospital morbidity (5.4% vs. 5.9%; adjusted odds ratio [OR], 0.80; 95% confidence interval [CI], 0.57-1.14; P = 0.23), local complications (5.0% vs. 5.5%; OR, 0.80; 95% CI, 0.55-1.15; P = 0.22), recurrent laryngeal nerve paralysis (2.1% vs. 2.4%; OR, 0.78; 95% CI, 0.45-1.35; P = 0.37), or postoperative bleeding (1.7% vs. 1.4%; OR, 0.99; 95% CI, 0.53-1.87; P = 0.98). Children showed a longer duration of anesthesia (difference, 20 minutes; 95% CI, 13-27; P < 0.001) and higher total costs (difference, 445 US dollars; 95% CI, 239-651; P < 0.001) than adults. CONCLUSION: This large nationwide cohort study showed no significant difference in perioperative complications between children and adults undergoing thyroid cancer surgery.

Infantile Kaposiform hemangioendothelioma in a female patient complicated with severe obstructed jaundice: a case report.

BACKGROUND: Kaposiform hemangioendothelioma (KHE) is a rare locally aggressive vascular neoplasm that occurs mainly in the pediatric population. KHE usually originates just underneath the skin and affects deeper tissues through infiltrative growth; however, visceral tissue involvement is quite rare. CASE PRESENTATION: An 8-month-old girl with jaundice and acholic stool was referred to our hospital for further evaluation of a hepatoduodenal ligament tumor. A blood examination revealed high bilirubin and liver enzyme levels, but no signs of coagulopathy. The first attempt at a diagnostic surgical procedure did not provide sufficient diagnostic information. However, the histopathological diagnosis of the cystic duct excised in the second surgery indicated KHE. Therefore, in our case, KHE was considered a cause of obstructive jaundice. Sirolimus (rapamycin) was initiated, and the patient was discharged 7 months after admission. CONCLUSIONS: In cases of atypical hypervascular lesions in the abdominal cavity, especially in the pediatric population, it is important to consider the possibility of KHE, and surgical intervention with proper strategies is required for diagnosis, followed sequentially by promising treatments.

Perioperative outcomes of laparoscopically assisted anorectoplasty versus conventional procedures for anorectal malformation: a retrospective nationwide database study.

PURPOSE: This study aimed to compare the perioperative outcomes of laparoscopically assisted anorectoplasty (LAARP) and conventional procedures (CPs) for anorectal malformation (ARM) using a national inpatient database in Japan. METHODS: Using the Diagnosis Procedure Combination database, we identified patients who underwent anorectoplasty for high- or intermediate-type ARMs from 2010 to 2019. Primary outcomes were postoperative rectal prolapse, anal stenosis, and general complications. Secondary outcomes were the duration of anesthesia and length of hospital stay. We performed 1:2 propensity score-matched analyses to compare the outcomes between the LAARP and CP groups. RESULTS: We identified 1005 eligible patients, comprising 286 and 719 patients who underwent LAARP and CP, respectively. The propensity score-matched groups included 281 patients with LAARP and 562 with CP. The LAARP group showed a higher proportion of rectal prolapse (21.4% vs. 8.5%; odds ratio, 2.91; 95% confidence interval [CI], 1.89-4.48; p < 0.001) and longer duration of anesthesia (462 min vs. 365 min; difference, 90 min; 95% CI 43-137; p < 0.001) than the CP group. No significant differences were found in other outcomes. CONCLUSION: LAARP had worse outcomes than CP in terms of rectal prolapse. Thus, we propose that LAARP may require technical refinement to improve patient outcomes.

Risk Factors for Postoperative Bleeding Following Breast Cancer Surgery: A Nationwide Database Study of 477,108 Cases in Japan.

BACKGROUND: Although postoperative bleeding is a common and serious complication in breast cancer surgery, the risk factors remain unclear. Therefore, we examined the risk factors using a Japanese nationwide database. METHODS: Patients who underwent breast cancer surgery between July 2010 and March 2020 were identified from a Japanese nationwide database. Multivariable analyses for 47 candidate risk factors (4 patient characteristics, 32 comorbidities, 5 tumor characteristics, 3 preoperative drug uses, and 3 surgical procedures) were conducted to investigate risk factors associated with postoperative bleeding requiring reoperation. Two sensitivity analyses were conducted: an analysis for postoperative bleeding with or without reoperation and an analysis for patients who underwent total mastectomy without breast reconstruction. RESULTS: Among the 477,108 patients included, 7048 (1.5%) developed postoperative bleeding and 2357 (0.5%) underwent reoperation for postoperative bleeding. Male sex, old age, body mass index ≥ 25.0 kg/m2, several comorbidities (deficiency anemia, cardiac arrhythmias, hypertension, liver disease, psychoses, and valvular disease), preoperative heparin use, and several procedures were identified as risk factors. Deficiency anemia showed the highest odds ratio among the risk factors (4.41 [95% confidence interval, 3.63-5.36]). High odds ratios were also observed in total mastectomy (2.32 [2.10-2.56]), flap reconstruction (1.93 [1.55-2.40]), and preoperative heparin use (1.64 [1.26-2.14]). The results corresponded with the sensitivity analyses. CONCLUSIONS: This study identified several risk factors for postoperative bleeding in breast cancer surgery, such as high body mass index, anemia, cardiovascular diseases, liver diseases, psychoses, preoperative heparin use, and surgical procedures.

Association of Operative Day of the Week with the Length of Stay and Total Hospitalization Costs in Patients with Partial Mastectomy: A Nationwide Database Study in Japan.

Introduction: Length of stay (LOS) is a major concern while optimizing medical resources and costs. Hence, factors influencing LOS should be investigated. In Japan, breast cancer surgery generally involves several days of hospitalization for observation, despite few complications. We hypothesized that the day of surgery (weekday; Monday-Friday) affects LOS. Methods: Using a Japanese nationwide database, we retrospectively identified 146,610 patients who underwent partial mastectomy for stage 0-III breast cancer from July 2010 to March 2017. We conducted multivariable linear and logistic regression analyses adjusting for background characteristics (such as comorbidities and hospital characteristics) with a generalized estimating equation for within-hospital clustering to compare postoperative and total LOS, total hospitalization costs, and postoperative complications between the groups for whom the surgery was performed on different days of the week. Results: In total, whereas the median postoperative LOS was 4 days (interquartile range, 3-6 days), the median total LOS was 6 days (5-8 days). The median total hospitalization cost was 6,189 US dollars (5,609-6,668 US dollars), and postoperative complications occurred in 3.3% of cases. Despite no significant difference in postoperative complications, Monday-Wednesday surgeries showed significantly shorter postoperative LOS than Friday surgeries (-0.11 days [95% confidence interval, -0.14 to -0.07] on Monday with reference to Friday). Nevertheless, Monday surgeries showed significantly increased total LOS (0.69 days [0.64-0.74]) and hospitalization costs (93 US dollars [71-116]) in comparison with Friday surgeries. Conclusions: The operative day of the week was associated with increased LOS and cost, with no difference in postoperative complications after partial mastectomy. Surgeries on Monday involved longer preoperative hospital stays and higher total hospitalization costs than those on other weekdays.

Integrated relationship of nasopharyngeal airway host response and microbiome associates with bronchiolitis severity.

Bronchiolitis is a leading cause of infant hospitalizations but its immunopathology remains poorly understood. Here we present data from 244 infants hospitalized with bronchiolitis in a multicenter prospective study, assessing the host response (transcriptome), microbial composition, and microbial function (metatranscriptome) in the nasopharyngeal airway, and associate them with disease severity. We investigate individual associations with disease severity identify host response, microbial taxonomical, and microbial functional modules by network analyses. We also determine the integrated relationship of these modules with severity. Several modules are significantly associated with risks of positive pressure ventilation use, including the host-type I interferon, neutrophil/interleukin-1, T cell regulation, microbial-branched-chain amino acid metabolism, and nicotinamide adenine dinucleotide hydrogen modules. Taken together, we show complex interplays between host and microbiome, and their contribution to disease severity.

Surgical and obstetric outcomes of breast cancer surgery during pregnancy: a nationwide database study in Japan.

PURPOSE: Although the incidence of breast cancer during pregnancy is increasing, little is known about short-term outcomes following breast cancer surgery during pregnancy. We aimed to compare the characteristics and outcomes of breast cancer surgery with and without pregnancy, and describe the obstetric outcomes following surgery. METHODS: The data of 249,257 female patients aged < 60 years who underwent breast cancer surgery between July 2010 and March 2020 were analyzed using a nationwide Japanese database; we generated a 1:10 matched-pair cohort (260 and 2597 patients with and without pregnancy, respectively) matched according to age and treatment year. We conducted multivariable analyses to compare surgical procedures and outcomes, adjusting for potential confounders in the matched-pair cohort. Additionally, we described the obstetric outcomes of patients with pregnancy. RESULTS: Patients with pregnancy were more likely to undergo total mastectomy [odds ratio: 1.48 (95% confidence interval: 1.13-1.94)] and axillary dissection [1.62 (1.17-2.24)], but less likely to undergo reconstruction [0.14 (0.07-0.31)], than patients without; however, postoperative complications, postoperative length of stay, and total hospitalization costs did not differ significantly with pregnancy. Additionally, some pregnant patients experienced premature delivery [n = 18 (6.9%)] and miscarriage [n = 4 (1.5%)], and 31 of 101 patients in the third trimester at breast cancer surgery underwent a cesarean section. CONCLUSION: This study demonstrated significant differences regarding surgical procedures; however, there were no significant differences regarding surgical outcomes between patients who underwent breast cancer surgery with and without pregnancy. Obstetric outcomes following breast cancer surgery were also reported.

Cost-effectiveness analysis of trastuzumab monotherapy versus adjuvant chemotherapy plus trastuzumab in elderly patients with HER2-positive early breast cancer.

BACKGROUND: In elderly patients with human epidermal growth factor 2-positive breast cancer, adjuvant chemotherapy was associated with decreased quality of life, with relatively small benefits for prognosis. We examined the cost-effectiveness of trastuzumab monotherapy versus adjuvant chemotherapy plus trastuzumab in elderly patients with human epidermal growth factor 2-positive breast cancer. METHODS: A Markov model was developed to evaluate the costs and benefits of trastuzumab monotherapy over adjuvant chemotherapy plus trastuzumab for elderly patients with human epidermal growth factor 2-positive breast cancer. We built the model with a yearly cycle over a 20-year time horizon and five health states: disease-free, relapse, post-relapse, metastasis and death. The parameters in the model were based on a previous randomized controlled trial and a nationwide administrative database in Japan. The incremental cost-effectiveness ratio, expressed as Japanese yen per the quality-adjusted life-years, was estimated from the perspective of health care payers. One-way deterministic sensitivity analysis and probabilistic sensitivity analysis with Monte-Carlo simulations of 10 000 samples were conducted. RESULTS: The incremental cost-effectiveness ratio of trastuzumab monotherapy over adjuvant chemotherapy plus trastuzumab was $\sim$1.8 million Japanese yen /quality-adjusted life-year. The one-way deterministic sensitivity analysis showed that transition probability from disease-free to metastasis status and cost of metastasis status had the greatest influence on the incremental cost-effectiveness ratio. More than half the estimates in the probabilistic sensitivity analysis were located below a threshold of willingness-to-pay of 5 million Japanese yen /quality-adjusted life-year. CONCLUSION: In this first comparative cost-effectiveness analysis of adjuvant chemotherapy plus trastuzumab versus trastuzumab monotherapy in the elderly, the latter was found favorable for elderly patients with human epidermal growth factor 2-positive breast cancer.