Background: This meta-analysis was conducted to evaluate the effect of fractional flow reserve (FFR) on clinical outcomes after coronary artery bypass grafting (CABG).Methods: Five online databases were searched for studies that (1) enrolled patients who underwent isolated CABG or CABG with aortic valve replacement and (2) demonstrated the effect of an FFR-guided strategy on major adverse cardiac events (MACE) after surgery based on a randomized controlled trial or adjusted analysis.MACE included cardiac death, acute myocardial infarction (MI), and repeated revascularization.The primary outcomes were all MACE outcomes and a composite of all-cause death and MI, and the secondary outcomes were the individual MACE outcomes.Publication bias was assessed using a funnel plot and the Egger test.Results: Six articles (3 randomized and 3 non-randomized studies: n=1,027) were selected.MACE data were extracted from 4 studies.The pooled analyses showed that the risk of MACE was not significantly different between patients who underwent FFR-guided CABG and those who underwent angiography-guided CABG (hazard ratio [HR], 0.80; 95% CI, 0.57-1.12).However, the risk of the composite of death or MI was significantly lower in patients undergoing FFR-guided CABG (HR, 0.62; 95% CI, 0.41-0.94).The individual MACE outcomes were not significantly different between FFR-guided and angiography-guided CABG.Conclusion: FFR-guided CABG might be beneficial in terms of the composite outcome of death or MI compared with angiography-guided CABG although data are limited.
The objective of this study was to investigate the physicochemical properties, drug release and in situ depot-forming behavior of alginate hydrogel containing poorly water-soluble aripiprazole (ARP) for achieving free-flowing injectability, clinically accessible gelation time and sustained drug release. The balanced ratio of pyridoxal phosphate (PLP) and glucono-delta-lactone (GDL) was crucial to modulate gelation time of the alginate solution in the presence of calcium carbonate. Our results demonstrated that the sol state alginate hydrogel before gelation was free-flowing, stable and readily injectable using a small 23 G needle. In addition, the ratio (w/w) of PLP and GDL altered the gelation time, which was longer as the PLP content increased but shorter as the GDL content increased. The alginate hydrogel with a ratio of PLP to GDL of 15:9 had the optimal physicochemical properties in terms of a clinically acceptable gelation time (9.1 min), in situ-depot formation with muscle-mimicking stiffness (3.55 kPa) and sustained release over a two-week period. The alginate hydrogel, which is tunable by varying the ratio of PLP and GDL, could provide a controllable pharmaceutical preparation to meet the need for long-acting performance of antipsychotic drugs like ARP.
Background Otitis media (OM) is a major reason for children’s visits to physicians and a major cause of their being treated with antibiotics. It not only causes economic burdens but also influences hearing, speech, and education. To our knowledge, no nationwide population-based study has assessed the association between air pollution and OM. Therefore, this study evaluated the association between air pollution levels and the incidence of OM. Methods We identified cases of OM that occurred in South Korea between January 2011 and December 2012 from the Korea National Health Insurance Service-National Sample Cohort database, and evaluated its relationship with five air pollutants: particulate matter (PM10, particulates ≤10 μm in diameter), nitrogen dioxide (NO2), ozone (O3), sulfur dioxide, and carbon monoxide. Associations between the weekly incidence of OM and the five air pollutants were analyzed using generalized estimating equations. Conditional logistic regression analysis was used to obtain odds ratios (ORs) and their 99.9% Bonferroni-corrected confidence intervals after adjusting for gender, age, season, and region. Results We based our analysis on 160,875 hospital visits for OM by children aged <15 years. Correlations with higher concentrations of the five pollutants showed higher ORs than did the reference values at most time lags. PM10 had the largest influence on the OM incidence at a time lag of 0 weeks, whereas NO2 and O3 had the largest impacts on OM incidence at time lags of 1 and 4 weeks, respectively. Conclusion These findings support the notion that the incidence of OM is associated with ambient air pollution.
4075 Background: While overall survival (OS) is the most important survival endpoint in oncology clinical trials, it can be affected by sequential treatment after progression or by crossover from control to experimental arms and requires longer follow up duration compared to surrogate endpoints. Because death resulting from liver cirrhosis might confound the treatment outcome, time to progression (TTP) is suggested as a reliable surrogate endpoint compared to progression free survival (PFS) in the clinical trials of hepatocellular carcinoma (HCC). However, the correlation between TTP/PFS and OS has never been studied. Methods: We searched Pubmed and Embase data to obtain data source. Eligible studies were randomized controlled phase III trials which evaluated the efficacy of systemic chemotherapy or molecular targeted therapy in advanced HCC. The association between TTP/PFS and OS was assessed by Spearman rank correlation coefficient (rs) and linear regression analysis. The association of treatment effects as shown by the hazard ratio (HR) of TTP/PFS and OS in each trial was also investigated. Results: Ten studies with a total of 20 treatment arms and 6689 patients were included. Median TTP/PFS was significantly correlated with median OS. The rs value between TTP/PFS and OS was 0.74 (95% confidence index (CI) 0.45 – 0.89, p < 0.001) and the corresponding R2 was 0.47. There was no difference in rs value (0.72 vs. 0.69) and R2 value (0.38 vs. 0.35) between TTP and OS, and PFS and OS. Incremental benefit from the study treatment in TTP/PFS from each trial was correlated with incremental benefit in OS. The rs value and R2 value between log (HRTTP/PFS ) and log (HROS ) was 0.76 (95% CI 0.25 – 0.94, p = 0.009) and 0.61. Conclusions: Our study results suggest that either TTP or PFS could serve as a surrogate marker for OS in the clinical trials of advanced HCC. TTP was not a superior surrogate marker compared to PFS. In addition, this trial level analysis shows that the gain of TTP/PFS leads to the gain of OS.
Abstract Particulate matter (PM) is the main component of air pollution. Children are vulnerable to PM and acute otitis media (AOM), which is one of the most common diseases in children. However, studies on the relationship between AOM in children and PM are rare and their results are inconsistent. The aim of this study is to investigate the effect of PM on AOM in children on the basis of the Korea National Health Insurance service (NHIS) claims data. NHIS claim data from 2008 to 2015 was used to identify outpatient visits, antibiotic use to treat AOM, and demographic data. This data was combined with the data on PM 2.5 (≤ 2.5 μm) and PM 10 (≤ 10 μm according to its aerodynamic diameter) level extracted from air pollution data from Korean National Institute of Environmental Research for 16 administrative regions. The children with AOM were divided into three age groups (< 2, 2–4, 5–10 years). Generalized linear Poisson regression model was used to estimate the association between AOM and PM using daily counts of AOM and daily mean PM concentrations. It was adjusted to temperature, wind, humidity, season, year, age, and region. With an increase in PM 2.5 of 10 μg/m 3 , the relative risk of OM increased by 4.5% in children under 2 years of age. The effect of PM 2.5 was strongest influence on the day of exposure. The exposure to PM 10 was related to the incidence of AOM on the day of exposure and the following seven days in all three age groups. The PM concentrations did not strongly affect either AOM duration or the use of antibiotics to cure AOM. The RR in the each lag day after exposure to PM 10 was diverse according to the age groups. Regardless of PM size and children’s age, the PM levels are positively related to the incidence of AOM. Both PM 2.5 and PM 10 have the most adverse effects on children under 2 years of age and on the day of exposure.
To compare the outcomes of digital breast tomosynthesis (DBT) screening combined with ultrasound (US) with those of digital mammography (DM) combined with US in women with dense breasts.A retrospective database search identified consecutive asymptomatic women with dense breasts who underwent breast cancer screening with DBT or DM and whole-breast US simultaneously between June 2016 and July 2019. Women who underwent DBT + US (DBT cohort) and DM + US (DM cohort) were matched using 1:2 ratio according to mammographic density, age, menopausal status, hormone replacement therapy, and a family history of breast cancer. The cancer detection rate (CDR) per 1000 screening examinations, abnormal interpretation rate (AIR), sensitivity, and specificity were compared.A total of 863 women in the DBT cohort were matched with 1726 women in the DM cohort (median age, 53 years; interquartile range, 40-78 years) and 26 breast cancers (9 in the DBT cohort and 17 in the DM cohort) were identified. The DBT and DM cohorts showed comparable CDR (10.4 [9 of 863; 95% confidence interval {CI}: 4.8-19.7] vs. 9.8 [17 of 1726; 95% CI: 5.7-15.7] per 1000 examinations, respectively; P = 0.889). DBT cohort showed a higher AIR than the DM cohort (31.6% [273 of 863; 95% CI: 28.5%-34.9%] vs. 22.4% [387 of 1726; 95% CI: 20.5%-24.5%]; P < 0.001). The sensitivity for both cohorts was 100%. In women with negative findings on DBT or DM, supplemental US yielded similar CDRs in both DBT and DM cohorts (4.0 vs. 3.3 per 1000 examinations, respectively; P = 0.803) and higher AIR in the DBT cohort (24.8% [188 of 758; 95% CI: 21.8%-28.0%] vs. 16.9% [257 of 1516; 95% CI: 15.1%-18.9%; P < 0.001).DBT screening combined with US showed comparable CDR but lower specificity than DM screening combined with US in women with dense breasts.
ArtiSential, a new articulating laparoscopic instruments, addresses the limited movement associated with conventional laparoscopic instruments. This study was conducted to assess the clinical effectiveness of ArtiSential in detailed steps of various renal surgery. This study was approved by the Institutional Review Board of our institution and registered on the Clinical Research Information Service site of the Korea Disease Control and Prevention Agency. Participants meeting all inclusion and exclusion criteria were included in the clinical trial and underwent renal surgery. The clinical effectiveness of ArtiSential was assessed in terms of the feasibility and objective and subjective parameters across 9 detailed steps. Of the 15 potential candidates enrolled from October 2021 to November 2021, 1 patient dropped out due to anaphylaxis from an anesthetic agent, and 14 patients underwent laparoscopic surgery using ArtiSential. Of the 14 patients, 2 patients were converted to laparoscopic surgery using straight-shaped instruments due to the ischemia time exceeding 30 min, and 1 patient due to excessive bleeding. The feasibility for most steps was more than 90%, except the renorrhaphy step. The median total operation time and ischemia time were 161 and 23 min, respectively. The median estimated blood loss was 58.5 mL. Two cases of venous injury occurred during renal pedicle dissection step. The accuracy of the procedure judged by reviewers and usability judged by the operator were acceptable in all steps. The surgeon's quantitatively measured stress score was the highest during renorrhaphy step. Laparoscopic surgery using ArtiSential is feasible for most steps except the renorrhaphy step. The difficulty of performing renorrhaphy is attributed to prolonged ischemia time, which could be addressed by overcoming the learning curve. Clinical Research Information Service site of the Korea Disease Control and Prevention Agency, KCT0006532. Registered 03/09/2021, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24071 .
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