Background and Aims The efficacy of palliative biliary drainage by using bilateral or unilateral self-expandable metal stents (SEMSs) for a malignant hilar biliary stricture (MHS) remains ...controversial. This prospective, randomized, multicenter study investigated whether bilateral drainage by using SEMSs is superior to unilateral drainage in patients with inoperable MHSs. Methods Patients with inoperable high-grade MHSs who underwent palliative endoscopic insertion of bilateral or unilateral SEMSs were enrolled. The main outcome measurements were the rate of primary reintervention for malfunction after successful placement of SEMSs, stent patency, technical and clinical success rates, adverse events, and survival duration. Results A total of 133 pathology-diagnosed patients were randomized to the bilateral group (n = 67) or the unilateral group (n = 66). The primary technical success rates were 95.5% (64/67) and 100% (66/66) in the bilateral and unilateral groups, respectively ( P = .244). The clinical success rates were 95.3% (61/64) and 84.9% (56/66), respectively ( P = .047). The primary reintervention rates based on the per-protocol analysis were 42.6% (26/61) in the bilateral group and 60.3% (38/63) in the unilateral group ( P = .049). The median cumulative stent patency duration was 252 days in the bilateral group and 139 days in the unilateral group. The risk of stent patency failure was significantly higher in the unilateral group (log-rank test; P < .01). In a multivariate Cox proportional hazard model to assess stent patency, bilateral SEMS placement was a favorable factor (adjusted hazard ratio 0.30, 95% confidence interval, 0.172-0.521; P < .001). Survival probability and late adverse events were not different between the 2 groups. Conclusions Unilateral and bilateral drainage strategies by using SEMSs had similar technical success rates, but bilateral drainage resulted in fewer reinterventions and more durable stent patency in patients with inoperable high-grade MHSs. (Clinical trial registration number: NCT02166970.)
Abstract Background Dedicated intensive care unit (ICU) physician staffing is associated with a reduction in ICU mortality rates in general medical and surgical ICUs. However, limited data are ...available on the role of a cardiac intensivist in the cardiac intensive care unit (CICU). Objectives This study investigated the association of cardiac intensivist–directed care with clinical outcomes in adult patients admitted to the CICU. Methods This study analyzed 2,431 patients admitted to the CICU at Samsung Medical Center in Seoul, South Korea, from January 2012 to December 2015. In January 2013 the CICU was changed from a low-intensity staffing model to a high-intensity staffing model managed by a dedicated cardiac intensivist. Eligible patients were divided into either a low-intensity management group (n = 616) or a high-intensity management group (n = 1,815). One-to-many (1:N) propensity score matching with variable matching ratios was also performed. The primary outcome was death in the CICU. Results Death in the CICU occurred in 55 patients (8.9%) in the low-intensity group versus 74 patients (4.1%) in the high-intensity group (p < 0.001). Of 135 patients who underwent extracorporeal membrane oxygenation, the CICU mortality rate in the high-intensity group was also lower than that in the low-intensity group (54.5% vs. 22.5%; p = 0.001). On propensity score matching, high-intensity staffing was found associated with a lower CICU mortality rate in the matched cohort of patients (7.5% vs. 3.7%; adjusted odds ratio: 0.53; 95% confidence interval: 0.32 to 0.86; p = 0.010). In overall and propensity-matched patients, there were no substantive differences in either median length of CICU stay or readmission rates between the 2 groups. Conclusions The presence of a dedicated cardiac intensivist was associated with a reduction in CICU mortality rates in patients with cardiovascular disease who required critical care.
Loss-of-function (LOF) variants of cytochrome P450 2C19 (CYP2C19) have been hypothesized to be associated with lesser degrees of platelet inhibition and increased risk for recurrent ischemic events ...in patients with coronary artery disease on clopidogrel therapy; however, studies from Western countries have yielded mixed results. We aimed to assess the impact of CYP2C19 LOF variants on clinical outcomes from different ethnic groups. Sixteen prospective cohort studies including 7,035 patients carrying ≥1 CYP2C19 LOF allele and 13,750 patients with the wild-type genotype were included in this meta-analysis. Carriers of ≥1 CYP2C19 LOF allele were at significantly higher risk for adverse clinical events compared to noncarriers during clopidogrel therapy (odds ratio OR 1.42, 95% confidence interval CI 1.13 to 1.78). The summary OR showed a significant association between CYP2C19 LOF variants and an increased risk of cardiac death (OR 2.18, 95% CI 1.37 to 3.47), myocardial infarction (OR 1.42, 95% CI 1.12 to 1.81), and stent thrombosis (OR 2.41, 95% CI 1.76 to 3.30). Stratified analysis by ethnicity of study population suggested higher odds of adverse clinical events in the Asian population with LOF variants of CYP2C19 (OR 1.89, 95% CI 1.32 to 2.72) compared to Western populations (OR 1.28, 95% CI 1.00 to 1.64). In conclusion, carrier status for LOF CYP2C19 is associated with an increased risk of adverse clinical events in patients with coronary artery disease on clopidogrel therapy despite differences in clinical significance according to ethnicity.
Objectives We investigated whether statin therapy could be beneficial in patients with acute myocardial infarction (AMI) who have baseline low-density lipoprotein cholesterol (LDL-C) levels below 70 ...mg/dl. Background Intensive lipid-lowering therapy with a target LDL-C value <70 mg/dl is recommended in patients with very high cardiovascular risk. However, whether to use statin therapy in patients with baseline LDL-C levels below 70 mg/dl is controversial. Methods We analyzed 1,054 patients with AMI who had baseline LDL-C levels below 70 mg/dl and survived at discharge from the Korean Acute MI Registry between November 2005 and December 2007. They were divided into 2 groups according to the prescribing of statins at discharge (statin group n = 607; nonstatin group n = 447). The primary endpoint was the composite of 1-year major adverse cardiac events, including death, recurrent MI, target vessel revascularization, and coronary artery bypass grafting. Results Statin therapy significantly reduced the risk of the composite primary endpoint (adjusted hazard ratio HR: 0.56; 95% confidence interval CI: 0.34 to 0.89; p = 0.015). Statin therapy reduced the risk of cardiac death (HR: 0.47; 95% CI: 0.23 to 0.93; p = 0.031) and coronary revascularization (HR: 0.45, 95% CI: 0.24 to 0.85; p = 0.013). However, there were no differences in the risk of the composite of all-cause death, recurrent MI, and repeated percutaneous coronary intervention rate. Conclusions Statin therapy in patients with AMI with LDL-C levels below 70 mg/dl was associated with improved clinical outcome.
Background Tumor location is a prognostic factor for survival in patients with T2 gallbladder cancer. However, the optimal extent of resection according to tumor location remains unclear. Methods We ...reviewed the records of 192 patients with T2 gallbladder cancer who underwent R0 or R1 resection at 6 institutions. Perioperative and oncologic outcomes were compared according to the extent of resection between hepatic-sided ( n = 93) and peritoneal-sided ( n = 99) tumors. Results After a median follow-up of 30 months, the 5-year overall survival (84.9% vs 71.8%, P = .048) and recurrence-free survival (74.6% vs 62.2%, P = .060) were greater in T2P patients than in hepatic-sided T2 patients. Among hepatic-sided T2 patients, the 5-year overall survival was greater in patients who underwent radical cholecystectomy including lymph node dissection with liver resection than in patients who underwent lymph node dissection without liver resection (80.3% vs 30.0%, P = .032), and the extent of liver resection was not associated with overall survival ( P = .526). Lymph node dissection without liver resection was an independent prognostic factor for overall survival in hepatic-sided T2 gallbladder cancer (hazard ratio 5.009, 95% confidence interval 1.512–16.596, P = .008). In peritoneal-sided T2 patients, the 5-year overall survival was not significantly different between the lymph node dissection with liver resection and the lymph node dissection without LR subgroups (70.5% vs 54.8%, P = .111) and the extent of lymph node dissection was not associated with overall survival ( P = .395). Conclusion In peritoneal-sided T2 gallbladder cancer, radical cholecystectomy including lymph node dissection without liver resection is a reasonable operative option. Radical cholecystectomy including lymph node dissection with liver resection is suitable for hepatic-sided T2 gallbladder cancer.
Despite the increasing use of biologics in severe asthma, there is limited research on their use in asthma-chronic obstructive pulmonary disease overlap (ACO). We compared real-world treatment ...responses to biologics in ACO and asthma.
We conducted a multicenter, retrospective, cohort study using data from the Precision Medicine Intervention in Severe Asthma (PRISM). ACO was defined as post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <0.7 and a smoking history of >10 pack-years. Physicians selected biologics (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) based on each United States Food & Drug Administration (FDA) approval criteria.
After six-month treatment with biologics, both patients with ACO (N = 13) and asthma (N = 81) showed positive responses in FEV1 (10.69 ± 17.17 vs. 11.25 ± 12.87 %, P = 0.652), Asthma Control Test score (3.33 ± 5.47 vs. 5.39 ± 5.42, P = 0.290), oral corticosteroid use (-117.50 ± 94.38 vs. -115.06 ± 456.85 mg, P = 0.688), fractional exhaled nitric oxide levels (-18.62 ± 24.68 vs. -14.66 ± 45.35 ppb, P = 0.415), sputum eosinophils (-3.40 ± 10.60 vs. -14.48 ± 24.01 %, P = 0.065), blood eosinophils (-36.47 ± 517.02 vs. -363.22 ± 1294.59, P = 0.013), and exacerbation frequency (-3.07 ± 4.42 vs. -3.19 ± 5.11, P = 0.943). The odds ratio for exacerbation and time-to-first exacerbation showed no significant difference after full adjustments, and subgroup analysis according to biologic type was also showed similar results.
Biologics treatment response patterns in patients with ACO and asthma were comparable, suggesting that biologics should be actively considered for ACO patients as well.
Background Limited data exist regarding the long-term outcomes of EMR compared with gastrectomy. Objective To compare the long-term outcomes after EMR and surgery. Design Retrospective analysis with ...propensity-score matching. Setting Tertiary care center. Patients This study involved 215 patients with intramucosal gastric cancer completely removed by EMR and 843 patients who underwent curative surgical resection between January 1997 and August 2002. Propensity-score matching yielded 551 matched patients. Interventions EMR versus surgery. Main Outcome Measurements Death and recurrence. Results In the matched cohort, there were no significant between-group differences in the risk of death (hazard ratio HR for the EMR group 1.39; 95% CI, 0.87-2.23) or recurrence (HR 1.18; 95% CI, 0.22-6.35). Although patients who underwent EMR had higher risk of metachronous gastric cancers (HR 6.72; 95% CI, 2.00-22.58), all recurrent or metachronous gastric cancers after EMR were successfully re-treated without affecting overall survival. Although complication rates were similar (odds ratio 0.84; 95% CI, 0.41-1.70), there were no mortalities in the EMR group compared with 2 in the surgery group. The EMR group had a significantly shorter hospital stay (median 8 days, interquartile range IQR 6-11 days vs 15 days, IQR 12-19 days; P < .001) and lower cost of care ($2049, IQR $1586-2425 vs $4042, IQR $3458-4959; P < .001). Limitations Retrospective, nonrandomized study. Conclusions EMR was comparable to surgery in terms of risk of death and recurrence. Because of its lower medical costs and shorter duration of hospital stay, EMR has advantages over surgery.
Background Current guidelines for endoscopic management such as EMR and endoscopic submucosal dissection (ESD) in early gastric cancer (EGC) are in evolution, with broader indication criteria. ...Objective To determine the clinical outcomes of endoscopic treatment, based on absolute indication and extended indication criteria and endoscopic methods. Design Retrospective study. Setting Tertiary-care, academic medical center. Patients EMR or ESD was performed on 1627 cases of EGC in 1447 patients from July 1994 to January 2009. Intervention EMR and ESD. Main Outcome Measurements Clinical outcomes of EGC after EMR or ESD, based on the indication criteria. Results Although the complete resection rate was higher (95.9% vs 88.4%; P < .001), and the complication rate was lower (6.8% vs 9.8%; P = .054) in the absolute than in the extended indication group, there was no between-group difference in the local recurrence rate (0.9% vs 1.1%; P = .783) at a median follow-up period of 32 months (interquartile range 22-48 months). In the extended indication group, ESD resulted in a significantly higher complete resection rate than EMR (83.0% vs 91.1%; P = .006). Limitations Retrospective study. Conclusion ESD in the extended indication group showed acceptable clinical outcomes with a relatively high complete resection rate and a low local recurrence rate.
Tiotropium, a long-acting muscarinic antagonist, is recommended for add-on therapy to inhaled corticosteroids (ICS)-long-acting beta 2 agonists (LABA) for severe asthma. However, real-world studies ...on the predictors of response to tiotropium are limited. We investigated the real-world use of tiotropium in asthmatic adult patients in Korea and we identified predictors of positive response to tiotropium add-on.
We performed a multicenter, retrospective, cohort study using data from the Cohort for Reality and Evolution of Adult Asthma in Korea (COREA). We enrolled asthmatic participants who took ICS-LABA with at least 2 consecutive lung function tests at 3-month intervals. We compared tiotropium users and non-users, as well as tiotropium responders and non-responders to predict positive responses to tiotropium, defined as 1) increase in forced expiratory volume in 1 s (FEV1) ≥ 10% or 100 mL; and 2) increase in asthma control test (ACT) score ≥3 after 3 months of treatment.
The study included 413 tiotropium users and 1756 tiotropium non-users. Tiotropium users had low baseline lung function and high exacerbation rate, suggesting more severe asthma. Clinical predictors for positive response to tiotropium add-on were 1) positive bronchodilator response (BDR) odds ratio (OR) = 6.8, 95% confidence interval (CI): 1.6–47.4, P = 0.021 for FEV1 responders; 2) doctor-diagnosed asthma-chronic obstructive pulmonary disease overlap (ACO) OR = 12.6, 95% CI: 1.8–161.5, P = 0.024, and 3) initial ACT score <20 OR = 24.1, 95% CI: 5.45–158.8, P < 0.001 for ACT responders. FEV1 responders also showed a longer exacerbation-free period than those with no FEV1 increase (P = 0.014), yielding a hazard ratio for the first asthma exacerbation of 0.5 (95% CI: 0.3–0.9, P = 0.016).
The results of this study suggest that tiotropium add-on for uncontrolled asthma with ICS-LABA would be more effective in patients with positive BDR or ACO. Additionally, an increase in FEV1 following tiotropium may predict a lower risk of asthma exacerbation.
Abstract Objectives The authors sought to identify whether a coronary side branch (SB) is supplying a myocardial mass that may benefit from revascularization. Background The amount of subtending ...myocardium and physiological stenosis is frequently different between the main vessel (MV) and SB. Methods In this multicenter registry, 482 patients who underwent coronary computed tomography angiography and fractional flow reserve (FFR) measurement were enrolled. The % fractional myocardial mass (FMM), the ratio of vessel-specific myocardial mass to whole myocardium, was assessed in 5,860 MV or SB consisting of 2,930 bifurcations. Physiological stenosis was defined by fractional flow reserve (FFR) <0.80. Myocardial mass that may benefit from revascularization was defined by %FMM ≥10%. Results In per-bifurcation analysis, MV supplied a 1.5- to 9-fold larger myocardial mass compared with SB. Unlike left main bifurcation (n = 482), only 1 of every 5 non-left main SB (n = 2,448) supplied %FMM ≥10% (97% vs. 21%; p < 0.001). SB length ≥73 mm could estimate %FMM ≥10% (c-statistic = 0.85; p < 0.001). In 604 vessels interrogated by FFR, diameter stenosis was similar (p = NS), but %FMM ≥10%, FMM/minimal luminal diameter, and frequency of FFR <0.80 was higher in MV compared with SB (p < 0.001, all). Generalized estimating equations modeling demonstrate that vessel diameter, left myocardial mass, and FFR were not (p = NS), but SB length ≥73 mm and left main bifurcation were significant predictors for %FMM ≥10% (p < 0.001). Conclusions Compared with MV, SB supplies a smaller myocardial mass and showed less physiological severity despite similar stenosis severity. SB supplying a myocardial mass of %FMM≥10%, which may benefit revascularization could be identified by vessel length ≥73 mm. Pre-procedural recognition of these findings may guide optimal revascularization strategy for bifurcation.
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