Lower Risk Of Adverse Outcomes Research Articles

Higher baseline lipid levels amplify the benefit of secondary prevention therapy with statins in Chinese patients with acute coronary syndrome.

ObjectiveStatins are recommended as the first-line treatments for reducing the risk of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome (ACS). The present study aimed to establish the baseline lipid levels associated with the greatest benefit from statin therapy in this population.MethodsThe study used a retrospective cohort methodology. In total, 636 patients with ACS were enrolled at Shaanxi Provincial People’s Hospital from 2011 to 2013. Participants were divided into four groups (group 1, hyperlipidemia with inconsistent statin use; group 2, no hyperlipidemia with inconsistent statin use; group 3, no hyperlipidemia with consistent statin use; and group 4, hyperlipidemia with consistent statin use).ResultsPatients in groups 3 (hazard ratio [HR] = 0.49, 95% confidence interval [CI] = 0.29–0.82) and 4 (HR = 0.21, 95% CI = 0.10–0.45) had lower risks of MACE than those in group 1. In subgroup analysis, patients in group 4 had a lower risk of MACE than those in group 3 (adjusted HR = 0.43, 95% CI = 0.21–0.89).ConclusionSustained statin therapy is associated with a lower risk of adverse outcomes in patients with ACS, especially in those with higher baseline lipid levels.

Gestational weight gain and adverse pregnancy outcomes by pre-pregnancy BMI category in women with chronic hypertension: A cohort study.

It is important to understand relationships of gestational weight gain with adverse pregnancy outcomes in women with chronic hypertension, given their high baseline risk of adverse outcomes. We assessed associations of gestational weight gain with adverse pregnancy outcomes in women with chronic hypertension by pre-pregnancy body mass index categories. We identified 14,369 women with chronic hypertension using electronic health records from 3 integrated health care delivery systems (2005-2014). Gestational weight gain-for-gestational age charts were used to calculate gestational weight gain z-scores, which account for gestational age. Modified Poisson regression models using generalized estimating equations were used to calculate relative risks and 95% confidence intervals, adjusted for sociodemographic and medical characteristics. Preeclampsia, preterm delivery, cesarean delivery, neonatal intensive care unit admission, birthweight (extracted from the electronic health record). In women with normal weight or overweight, low gestational weight gain (z-score<-1) was associated with 27-28% greater risk of preterm delivery and 48-82% greater risk of small-for-gestational age birthweight, while high gestational weight gain (z-score>1) was associated with 40-90% greater risk of preeclampsia and 59-113% greater risk of large-for-gestational age birthweight. In women with obesity, low gestational weight gain was associated with 27-54% lower risk of several adverse pregnancy outcomes, including preeclampsia and cesarean delivery. In women with chronic hypertension and normal weight or overweight, moderate gestational weight gain may confer the lowest risk of adverse outcomes. In women with chronic hypertension and obesity, low gestational weight gain may be necessary for the lowest risk of adverse pregnancy outcomes.

Predicting the risk for major bleeding in elderly patients with venous thromboembolism using the Charlson index. Findings from the RIETE.

Old patients receiving anticoagulant therapy for venous thromboembolism (VTE) are at an increased risk for bleeding. We used data from the RIETE registry to assess the prognostic ability of the Comorbidity Charlson Index (CCI) to predict the risk for major bleeding in patients aged > 75years receiving anticoagulation for VTE beyond the third month. We calculated the area under the receiver-operating characteristic curve (AUC), the category-based net reclassification index (NRI) and the net benefit (NB). We included 4303 patients with a median follow-up of 706days (interquartile range [IQR] 462-1101). Of these, 147 (3%) developed major bleeding (27 died of bleeding). The AUC was 0.569 (95% CI 0.524-0.614). Patients with CCI ≤ 4 points were at a lower risk for adverse outcomes than those with CCI > 10 (major bleeding 0.81 (95% CI 0.53-1.19) vs. 2.21 (95% CI 1.18-3.79) per 100 patient-years; p < 0.05; all-cause death 1.9 (95% CI 1.45-2.44) vs. 15.67 (95% CI 12.63-19.22) per 100 patient-years; p < 0.05). A cut-off point of 4 points (CCI4) had a sensitivity of 82% (95% CI 75-89) and a specificity of 30% (95% CI 29-31) to predict major bleeding beyond the third month. CCI4 reclassification improved the NB of the RIETE bleeding score to predict bleeding beyond the third month (CCI4 NB 1.78% vs. RIETE NB 0.44%). Although the AUC of the CCI to predict major bleeding was modest, it could become an additional help to select patients aged > 75years that obtain more benefit of extended anticoagulation, due to a lower risk for bleeding and better survival.

External Validation of the Oakland Score to Assess Safe Hospital Discharge Among Adult Patients With Acute Lower Gastrointestinal Bleeding in the US

Lower gastrointestinal bleeding (LGIB), which manifests as blood in the colon or anorectum, is a common reason for hospitalization. In most patients, LGIB stops spontaneously with no in-hospital intervention. A risk score that could identify patients at low risk of experiencing adverse outcomes could help improve the triage process and allow greater numbers of patients to receive outpatient management of LGIB. To externally validate the Oakland Score, which was previously developed using a score threshold of 8 points to identify patients with LGIB who are at low risk of adverse outcomes. This multicenter prognostic study was conducted in 140 US hospitals in the Hospital Corporation of America network. A total of 46 179 adult patients (aged ≥16 years) admitted to the hospital with a primary diagnosis of LGIB between June 1, 2016, and October 15, 2018, were initially identified using diagnostic codes. Of those, 51 patients were excluded because they were more likely to have upper gastrointestinal bleeding, leaving a study population of 46 128 patients with LGIB. For the statistical analysis of the Oakland Score, an additional 8061 patients were excluded because they were missing data on Oakland Score components or clinical outcomes, resulting in 38 067 patients included in the analysis. The study used area under the receiver operating characteristic curves with 95% CIs for external validation of the model. Sensitivity and specificity were calculated for each score threshold (≤8 points, ≤9 points, and ≤10 points). Data were analyzed from October 16, 2018, to September 4, 2019. Identification of patients who met the criteria for safe discharge from the hospital and comparison of the performance of 2 score thresholds (≤8 points vs ≤10 points). Safe discharge was defined as the absence of blood transfusion, rebleeding, hemostatic intervention, hospital readmission, and death. Among 46 128 adult patients with LGIB, the mean (SD) age was 70.1 (16.5) years; 23 091 patients (50.1%) were female. Of those, 22 074 patients (47.9%) met the criteria for safe discharge from the hospital. In this group, the mean (SD) age was 67.9 (18.1) years, and 11 056 patients (50.1%) were female. In the statistical analysis of the Oakland Score, which included only the 38 067 patients with complete data, the area under the receiver operating characteristic curve for safe discharge was 0.87 (95% CI, 0.87-0.87). An Oakland Score threshold of 8 points or lower identified 3305 patients (8.7%), with a sensitivity and specificity for safe discharge of 98.4% and 16.0%, respectively. Extension of the Oakland Score threshold to 10 points or lower identified 6770 patients (17.8%), with a sensitivity and specificity for safe discharge of 96.0% and 31.9%, respectively. In this study, the Oakland Score consistently identified patients with acute LGIB who were at low risk of experiencing adverse outcomes and whose conditions could safely be managed without hospitalization. The score threshold to identify low-risk patients could be extended from 8 points or lower to 10 points or lower to allow identification of a greater proportion of low-risk patients.

Watchman outcomes comparing post-implantation anticoagulation with warfarin versus direct oral anticoagulants.

As left atrial appendage occlusion devices (LAAO) implantation rates grow, continued evaluation on best patient practices is important. We report pooled Watchman outcomes at a multicenter Texas healthcare system with an emphasis on clinical outcomes and post-implantation anticoagulation with direct oral anticoagulants (DOACs) versus warfarin. Data for 163 patients with atrial fibrillation (AF) undergoing Watchman implantation was collected via retrospective chart review between June 2016 and June 2018. A Fisher's exact test was utilized to evaluate associations in bivariate comparisons of categorical data. Tests of non-inferiority, applied between DOACs and warfarin, utilized a ratio of 2. Outcomes were significant for similar rates of stroke, disabling stroke, major bleeds, and all-cause mortality when compared to published clinical trials. Most patients with cerebrovascular events were found to have >5mm peri-device leaks (PDLs), were on warfarin at the time of the event (75%), and all occurred within the first 6months post implant. A significant number of patients were discharged on DOACs (42%). DOACs were shown to be non-inferior to warfarin with respect to stroke (p = 0.0048), disabling stroke (p = 0.0383), gastrointestinal bleeding (p = 0.0287), mortality (p = 0.0165), and combined adverse outcomes (p = 0.0040). DOACs were associated with less combined adverse outcomes (p = 0.021). Our findings suggest that additional imaging or aggressive management of PDLs in Watchman recipients within the initial 6-month follow-up may aid in reducing stroke rates. Additionally, anticoagulation with DOACs' post Watchman implantation was found non-inferior to warfarin, with some evidence of lower risk for adverse outcomes favoring DOACs.

Mo1711 EXTERNAL VALIDATION OF THE OAKLAND SCORE IN 38,067 PATIENTS WITH ACUTE LOWER GASTROINTESTINAL BLEEDING

Most patients hospitalized with lower gastrointestinal bleeding (LGIB) require no in-hospital intervention nor experience adverse outcome. The Oakland Score (OS) was developed to identify patients with LGIB who can avoid hospitalization, using a threshold of ≤8, but requires further external validation. We assessed the operating properties of the OS amongst patients admitted to 140 hospitals in the United States. The discriminative ability of the OS to predict safe discharge, defined as the absence of transfusion, re-bleeding, hemostatic intervention, death and readmission was assessed using area under the receiver operator characteristic curves (AUROCs) with 95% confidence intervals (CI) and sensitivities were calculated for each score threshold. Overall 38,067 cases had complete data on outcomes, including 22,074 (58.0%) who met the criteria for safe discharge. The OS AUROC for safe discharge was 0.868 (95% CI 0.866 to 0.872). An OS of ≤8 applied to 3305 (8.7%) patients and had a sensitivity for safe discharge of 98.3%. Extending the threshold to ≤10 identified 6770 (17.8%) patients whilst maintaining a sensitivity of 96%. There was no difference between patients scoring ≤8 or ≤10 in terms of death (1.1% versus 1.4%, respectively, p=0.255) or in-hospital re-bleeding (4.6% versus 5.1%, p = 0.351), but more patients were re-admitted with further bleeding by 28 days (0.2% versus 0.6%, p < 0.05). The OS reliably identified LGIB patients at low risk of adverse outcomes who could safely be managed without hospital admission. The threshold to identify low risk patients could be extended to ≤10 to allow identification of a greater proportion of low risk patients.

P0694ALTERATION OF PHYSICAL ACTIVITY AND ITS ASSOCIATION WITH CARDIOVASCULAR OUTCOMES AMONG PRE-DIALYSIS CKD PATIENTS

Abstract Background and Aims Cardiovascular disease is major cause of mortality among chronic kidney disease (CKD) patients, and it is fundamental to focus on reducing the potential risk factors. Regular physical activity is known to reduce the risk of cardiovascular disease in general population. However, whether the change of physical activity habits is beneficial for pre-dialysis CKD patients had not been examined thoroughly. Method We performed a nationwide population based cohort study using the database of Korean National Health Insurance System. Among adult patients who received national health screening program ≥2 times between 2012 and 2016, CKD patients were identified using the serum creatinine and dipstick albuminuria measurements. Those who previously underwent dialysis or diagnosed cardiovascular disease were excluded. The frequency and the intensity of the physical activity were obtained at least twice, from self-reported questionnaire during the health examination. The study groups were divided according to the status of physical activity habit alteration; active, quit exercise, start exercise, and inactive group. Then, the development of myocardial infarction (MI), stroke or death was assessed using the multivariate Cox regression analysis. Results During the median follow up of 3.18 years, 549,187 CKD patients were examined for adverse outcomes. Compared to those who remained inactive, the active group patients who consistently continued physical activity exhibited lower risk of MI (hazard ratio (HR); 0.76, 95% confidence interval (95% CI); 0.69-0.85), stroke (HR (95%CI) 0.69 (0.62-0.78)), and death (HR (95%CI) 0.62 (0.57-0.67)). Moreover, those who newly started physical activity also showed lower risk of adverse outcomes, compared to the inactive group (HR (95%CI) 0.83 (0.76-0.89)). Conclusion Continuation of physical activity in pre-dialysis CKD patients is beneficial to reduce the risk of cardiovascular disease development. Therefore, clinicians should encourage even mild intensity of physical activity to CKD patients.

Timing and Outcomes of an Indication-Only Use of Intravenous Cannulation During Spontaneous Labor.

In the United States, most women presenting in spontaneous labor undergo intravenous (IV) cannulation on admission to hospital labor and birth units. There is limited evidence for this routine practice in pregnant women at low risk for adverse outcomes during labor or birth. A retrospective, exploratory, descriptive study of an indication-only practice of IV cannulation on admission for women presenting in spontaneous labor and cared for by a nurse-midwife service was performed. Descriptive data included the timing of IV cannula placement (admission, during labor or postpartum period, or not at all) and indications for placement. Maternal outcomes of interest were estimated blood loss, postpartum hemorrhage rates, and management; neonatal outcome was 5-minute Apgar scores. Records for 1069 women cared for by nurse-midwives who presented in spontaneous labor were reviewed. In this cohort, 445 (41.6%) had IV access established on admission, 325 (30.4%) had an IV cannula placed during labor or postpartum, and 299 (28%) never had IV access during their hospital stay. For the 325 women with IV cannulas placed after admission, 25 (7.7%) were placed urgently for excessive postpartum bleeding. Further analysis of the subset of women who had a postpartum hemorrhage after vaginal birth (defined as >500 mL estimated blood loss) indicated that urgent IV cannulation was not associated with a lower mean postpartum hemoglobin or hematocrit or an increase in blood transfusion rate when compared with women who had an IV cannula placed earlier in their labor course. Indication-only IV cannulation for women experiencing an uncomplicated labor and birth is a reasonable practice in settings where IV access can be established urgently if needed.

PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia

BackgroundPreeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB.MethodsThis is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded.DiscussionThe PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries.Trial registrationClinicalTrials.gov: NCT03073317.

Long-Term Prognosis of Cholecystocholedocholithiasis in Chinese Population

Introduction: Choledocholithiasis is usually treated with endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (CBDE) (LCBDE), or laparoscopic transcystic CBDE (LTCBDE). However, the comparative long-term prognosis of these methods in terms of adverse outcomes remains uncertain. Methods: In an ambispective, multicenter, observational, open cohort study, patients with cholecystocholedocholithiasis underwent one of three treatments (EST+laparoscopic cholecystectomy (LC), LCBDE+LC, and LTCBDE+LC).The primary outcome was adverse outcomes. Results: At a median follow-up period of 2.72 years among 2708 patients, the adverse outcome rate is 9.3%. Compared with LCBDE and LTCBDE groups, EST group displayed an increased risk for adverse outcomes (HR 1.25, 95% CI 0.93-1.69, P=0.146; HR 1.77, 95% CI 1.30-2.43, P<0.001) and stone-related outcomes (HR 1.43, 95% CI 0.99-2.06, P=0.054; HR 4.36, 95% CI 2.71-7.02, P<0.001) in the unadjusted Cox model. After adjustment in the multivariable analysis, EST group still displayed an increased risk of adverse outcomes (HR 1.43, 95% CI 1.05-1.95, P=0.021; HR 1.87, 95% CI 1.35-2.59, P<0.001) and stone-related outcomes (HR 1.64, 95% CI 1.13-2.37, P=0.010; HR 4.88, 95% CI 2.99-7.97, P<0.001). Compared with LTCBDE group, LCBDE group displayed an increased risk for a stone-related outcome in both the unadjusted Cox model (HR 3.05, 95% CI 1.89-4.90, P<0.001) and the adjusted multivariable analysis (HR 2.98, 95% CI 1.83-4.86, P <0.001). Conclusion: Compared with EST, the laparoscopic technique was associated with a lower risk of adverse outcomes and stone-related outcomes after adjustment for confounding factors. In laparoscopic techniques, the risk of stone-related outcomes after LTCBDE is reduced 66.4% than LCBDE. Clinical Trial Registration: CREST Choles ClinicalTrials.gov number, NCT02554097. Funding Statement: The author(s) disclose receipt of the following financial support for the research, authorship, and/or publication of this article: this program is sponsored by Capital Health Research and Special Development (No. 2016-1-1111), National Key Technologies R&D Program (No. 2015BAI13B09), and Beijing Municipal Administration of Hospitals Incubator Program (No. PX2016001 and No. PX2019004). Declaration of Interests: The author(s) declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Ethics Approval Statement: Ethical approval was obtained at all participating centers.

1409-P: Using Fasting Venous Plasma Glucose (FVPG) to Stratify Risk in Women with Gestational Diabetes (GDM)

Powe et al described variable “defects” (defined as parameter values &amp;lt;25th centile for non GDMs) in OGTT derived insulin secretion (Isecr) and sensitivity (Isens) estimates in GDM. They reported that pregnancy complications relate primarily to low Isens. To explore applicability to routine OGTT data, an analogous but simplified analysis was undertaken, classifying IADPSG GDM women according to FVPG &amp;lt; or ≥ 75th centile for non GDM women (cut-off 4.6 mmol/L - near the cohort mean (SD) of 4.5(0.4) mmol/L). Our multi-ethnic cohort included a diverse group of 6128 untreated women from 5 centers in the blinded epidemiologic HAPO study. Analyses compared outcome frequencies (LGA, excess neonatal (NN) adiposity, NN hypoglycemia, NN hyperinsulinemia, preterm birth, primary C section) with non GDM women and between GDM-FVPG groups using χ2 tests and logistic regression analyses adjusted for maternal age, height, smoking, FH diabetes, BMI at OGTT visit and ethnicity (Table 1). The 25% of GDM women with FVPG &amp;lt; 4.6 mmol/L were at much lower risk of adverse outcomes. Although “mechanistic” classification considering Isecr and Isens may offer insights for treatment, a simpler classification by FVPG performs better and appears simpler for routine use. A modified “two-step” approach for detection and classification of pregnancy hyperglycemia, using FVPG as the first step, deserves consideration. Disclosure D. McIntyre: None. K.S. Gibbons: None. L.R. Madsen: None. R.C. Ma: Advisory Panel; Self; Boehringer Ingelheim International GmbH. Research Support; Self; AstraZeneca, Bayer AG, Pfizer Inc. Stock/Shareholder; Self; GemVCare. Other Relationship; Self; AstraZeneca. D.A. Sacks: None. W.H. Tam: None. P. Catalano: None. Funding National Institutes of Health

Management of pulmonary embolism at a large academic hospital

The initial management of patients presenting with acute pulmonary embolism (PE) is individualized based on hemodynamic status and other prognostic factors. Patients at low risk of adverse outcomes are treated conservatively with anticoagulation, whereas high-risk and selected intermediate-risk patients should be considered for advanced interventions. Seeking to better understand local practice patterns, we retrospectively reviewed 196 cases of acute PE diagnosed in the emergency department of Baylor University Medical Center over a 12-month period. Given the available data, we classified 86 cases as low risk, 101 as intermediate risk, and 9 as high risk for early mortality. Four patients with high-risk PE and 11 patients with intermediate-risk PE were treated with thrombolytic therapy. Central embolus location, right ventricular dilation on computed tomography, and right ventricular strain on electrocardiogram were associated with the use of thrombolytic therapy in the intermediate-risk group. In total, 9 patients died and 11 suffered major bleeding. Patients with acute PE are a remarkably heterogeneous group with wide variations in workup, treatment, and outcomes.

New-onset atrial fibrillation after PCI and CABG for left main disease: insights from the EXCEL trial and additional studies.

To provide an up-to-date review of recent trials examining the incidence and prognostic impact of new-onset atrial fibrillation (NOAF) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) and the impact of postprocedural NOAF compared to nonsurgical atrial fibrillation. A recent analysis from the Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial demonstrated that NOAF is much more frequent following surgical compared with percutaneous revascularization for LMCAD, and is strongly associated with an increased 3-year risk of mortality and stroke. In a recent Danish registry-based, propensity score-matched analysis, postsurgical NOAF conferred a lower risk of adverse outcomes compared with nonsurgical nonvalvular atrial fibrillation. These new studies confirm that although postsurgical NOAF after left main revascularization may be of less clinical significance than nonvalvular atrial fibrillation, its occurrence still is strongly associated with subsequent stroke and mortality. Future efforts are warranted to prevent postsurgical NOAF and determine strategies for its optimal management should it occur.

Development, Validation, and Comparative Assessment of an International Scoring System to Determine Risk of Upper Gastrointestinal Bleeding

The Glasgow-Blatchford score (GBS) and pre-endoscopy Rockall score (pRS) are used in determining prognoses of patients with acute upper gastrointestinal bleeding, but neither predicts outcomes of patients with a high level of accuracy. A scoring system is needed to identify patients at risk of adverse outcomes and patients at low risk of harm. We pooled data from 5 data sets in Canada, the United Kingdom, and Australia on 12,711 patients with acute upper gastrointestinal bleeding. The GBS and pRS were calculated for each patient. We performed multivariable logistic regression modeling of data from 10,639 cases to develop the new scoring system Canada - United Kingdom - Adelaide (CANUKA). We performed area under the receiver operating characteristic analyses to test the ability of CANUKA to identify patients who died or had rebleeding within 30 days, surgical or radiologic intervention to control bleeding, need for therapeutic endoscopy, and transfusion-a poor outcome was defined as 1 or more of these outcomes. Patients at low risk of a poor outcome (safe for management as an outpatient) were identified based on lack of transfusion, rebleeding, therapeutic endoscopy, interventional radiology or surgery, or death. We validated in 2072 patients from a separate cohort compiled from 2 datasets. In the development data set there was no difference between GBS and pRS in identifying patients who died without 30 days of bleeding (area under the receiver operating characteristic curve [AUROC], 0.67; 95% CI, 0.62-0.72 for GBS; AUROC, 0.70; 95% CI, 0.66-0.74 for pRS; P=.21). The GBS was superior to the pRS in identifying patients with rebleeding, hemostatic interventions, and transfusions. In the validation data set, CANUKA had higher accuracy than the GBS in identifying patients who died within 30 days of bleeding (AUROC, 0.77 vs 0.74; P=.047), but there was no significant difference in the accuracy of these scoring systems in identifying patients who required hemostatic intervention. The GBS more accurately identified patients who required therapeutic endoscopy (AUROC, 0.78; 95% CI, 0.76-0.81 for GBS; AUROC, 0.77; 95% CI, 0.74-0.79 for CANUKA; P= .47). For patients classified as low-risk patients by CANUKA (score ≤1), 96.3% were safely discharged, whereas 16 patients with a GBS ≤1 had an adverse outcome (a 95.3% probability of safe discharge). In an international validation analysis of the GBS and pRS for patients with acute upper gastrointestinal bleeding, we found the GBS to more accurately identify those who later required hemostatic interventions and transfusions; the scoring systems identified 30-day mortality or rebleeding with equal levels of accuracy. We developed a scoring system (CANUKA) that had similar performance to the GBS in predicting patient outcomes and it more accurately identifies patients at low risk for adverse outcomes.

Improved Outcomes by Integrated Care of Anticoagulated Patients with Atrial Fibrillation Using the Simple ABC (Atrial Fibrillation Better Care) Pathway

BackgroundIntegrated care for the clinical management of atrial fibrillation patients is advocated as a holistic way to improve outcomes; the simple Atrial fibrillation Better Care (ABC) pathway has been proposed. The ABC pathway streamlines care as follows: ‘A’ Avoid stroke; ‘B’ Better symptom management; ‘C’ Cardiovascular and Comorbidity optimization. MethodsWe performed a post hoc analysis of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) trial. An ‘integrated care’ approach was defined according to the ABC pathway. Patients fulfilling all criteria were categorized as the ‘ABC’ group; those not fulfilling all criteria were the ‘non-ABC’ group. Trial-adjudicated all-cause death, composite outcome of stroke/major bleeding/cardiovascular death, and first hospitalization were the main study outcomes. ResultsAmong the 4060 patients in the original cohort, 3169 (78%) had available data to compare integrated care (ABC; n = 222; 7%) vs non-ABC (n = 2947; 93%) management. Over a median follow-up of 3.7 (interquartile range, 2.8-4.6) years, atrial fibrillation patients managed with integrated care (ABC group) had lower rates for all study outcomes (all P < .001) compared with the non-ABC group. A Cox multivariable regression analysis showed that atrial fibrillation patients managed in the ABC group had a significantly lower risk of all-cause death (hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.17-0.75), composite outcome (HR, 0.35; 95% CI, 0.18-0.68), and first hospitalization (HR, 0.65; 95% CI, 0.53-0.80). ConclusionsThe simple ABC pathway allows the streamlining of integrated care for atrial fibrillation patients in a holistic manner and is associated with a lower risk of adverse outcomes (including mortality, stroke/major bleeding/cardiovascular death, and hospitalization).

Kinesiology taping reduces the pain of finger osteoarthritis: a pilot single-blinded two-group parallel randomized trial.

ObjectivesOsteoarthritis (OA) is the most common arthropathy of the hand, and current treatments carry risks of adverse events. Supportive (kinesiology) tape may be analgesic and provide functional improvement, with a low risk of adverse outcomes. We experimented with supportive tape for OA of the proximal interphalangeal joint (PIPJ) of the finger in this pilot randomized trial.MethodsThis two-group parallel randomized trial recruited adults with OA of the PIPJ of the finger. We excluded patients lacking capacity or the ability to safely apply the tape. Participants were randomized to receive kinesiology tape on the dorsum of the finger, blind to grouping. Pain was the primary outcome, which was recorded on a visual analog scale (VAS). Secondary outcomes were hand function and adverse reactions. Bootstrapped between-group analyses are reported.ResultsTen patients were included and randomized and provided complete data. There was no significant difference in pain between the groups (mean difference of 0.4 VAS units [95% confidence interval {CI} –1.6, 0.7], p=0.4). Overall, the application of kinesiology tape reduced reported pain by 6% (mean reduction of 0.6 VAS units [95% CI 0, 1.2], p=0.04). Taping did not affect hand function or digital range of motion. There were difficulties in recruiting individuals owing to the lack of dedicated research staff.ConclusionKinesiology taping may reduce the pain of OA in the finger; however, whether this is a true effect, placebo effect, Hawthorne phenomenon, or due to a statistical error (ie, type 1 error due to underpowering) is unclear. Hence, further trials are required.

Index of Healthy Aging in Chinese Older Adults: China Health and Retirement Longitudinal Study.

To characterize the distribution of an index of healthy aging-the Chinese Healthy Aging Index (CHAI)-in Chinese adults aged 60 and older according to sociodemographic characteristics and geographic region and to examine the association between the CHAI and mortality, disability, and functional limitation over 4 years. Nationally representative cohort study. China Health and Retirement Longitudinal Study. Chinese adults aged 60 and older (N=3,740). Six CHAI components (systolic blood pressure, peak expiratory flow, Telephone Interview for Cognitive Status, estimated glomerular filtration rate, fasting glucose, C-reactive protein) were scored 0 (healthiest), 1, and 2 (unhealthiest) according to sex-specific tertiles or clinically relevant cut-points and summed to construct the CHAI (range 0-12). Mean CHAI score was 5.6; 5.7% had a score of 0 to 2 (healthiest), 23.0% a score of 3 or 4, 37.5% a score of 5 or 6, and 33.8% a score of 7 to 12 (unhealthiest). Participants who were younger, more educated, and married were much more likely to have an ideal CHAI profile (score 0-2). Age-adjusted prevalence of an ideal CHAI profile ranged from 1.7% in the south to 8.1% in the north. After multivariable adjustment, persons with a CHAI score of 3 to 12 had substantially higher odds of mortality, disability, and functional limitation than those with a score of 0 to 2. The CHAI further stratified outcomes for persons with no clinically recognizable comorbidities. Substantial variation exists in the CHAI according to sociodemographic characteristics and geographic regions. The CHAI could identify Chinese elderly adults with low risk of adverse outcomes and provide incremental value for risk prediction beyond clinically diagnosed comorbidities.

Standardization of surgical procedures to reduce risk of anastomotic leakage, reoperation, and surgical site infection in colorectal cancer surgery: a retrospective cohort study of 1189 patients.

Anastomotic leakage (AL) and surgical site infection (SSI) are prevalent complications of colorectal surgery. To lower this risk, we standardized our surgical procedures in 2012, with a preferential use of laparoscopic approach (LS) for both colon and rectal surgery, combined with triangulating anastomosis (TA) for colon surgery and defunctioning ileostomy (DI) for low anterior resection. Our aim was to evaluate the outcomes of our standardized procedures. The incidence rate of AL (primary outcome) and of reoperation and SSI (secondary outcome) was compared before (early period, n = 648) and after (late period, n = 541) standardization, through a retrospective analysis. The incidence rate of AL (6.6 versus 1.8%; P = 0.001), reoperation (3.5 versus 0.7%; P = 0.0012), and SSI (7.7 versus 4.6%; P = 0.029) was lower in late than in the early period. For colon cancer, TA and LS reduced the risk of AL (2.1 versus 0.3%, P = 0.020, for TA, and 3.2 versus 0.4%, P = 0.0027, for LS) and reoperation (2.9 versus 0.3%, P = 0.003, for TA, and 2.5 versus 0.2%, P = 0.0040, for LS). For rectal cancer, the incidence of all adverse outcomes (AL, reoperation, and SSI) was lower in cases treated by LS. However, the incidence of AL was lower in the late than in early period (P = 0.002) and with LS (P = 0.002). On multivariate analysis, late period and LS were independent factors of a lower risk of adverse outcomes. Our surgical standardization seems to be effective in lowering the risks of AL, reoperation, and SSI after colorectal cancer surgery.

Noninvasive encapsulated follicular variant of papillary thyroid carcinoma: Should it also be reclassified in children?

Noninvasive encapsulated follicular variant of papillary thyroid carcinoma (noniEFVPTC) has low risk of adverse outcome in adults, warranting reclassification as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP). In children, thyroid nodules have higher risk of malignancy and it is unknown if encapsulated FVPTC (EFVPTC) and infiltrative FVPTC (IFVPTC) tumors have different behavior. We analyzed the clinicopathologic features of follicular variant of papillary thyroid carcinoma (FVPTC) subtypes in our pediatric population to determine if noniEFVPTC has an indolent course as reported in adults. We retrospectively studied all patients diagnosed with FVPTC at our institution. The clinicopathologic characteristics of the histologic subtypes were compared. Eighteen patients were identified, all treated with total thyroidectomy. No significant differences in age, sex, tumor size, focality, or prior malignancy were detected between subtypes. Extrathyroidal extension had significantly higher incidence in IFVPTC (5/8) compared with EFVPTC (1/10, P=0.03), translating in significantly more T3 tumors within IFVPTC subtype (5/8), whereas most EFVPTC cases had T1 staging (6/10, T1 vs. T3, P=0.05). EFVPTC had significantly lower rate of lymph node involvement (N1 in 2/8) compared with IFVPTC (N1 in 8/8, P=0.003). Only one patient diagnosed with IFVPTC developed extranodal recurrence. When noniEFVPTC and iEFVPTC were separately compared, the noninvasive form showed no propensity for invasive growth (T3 staging: 0/4 vs. 2/6), lymph node metastasis (N1: 0/3 vs. 2/5) or extranodal recurrence. In children, noniEFVPTC/NIFTP has indolent behavior, warranting consideration of less aggressive management, similar to adults.

Pre-pregnancy BMI-specific optimal gestational weight gain for women in Japan.

BackgroundThe Institute of Medicine (IOM) guidelines are the most widely used guidelines on gestational weight gain; however, accumulation of evidence that body composition in Asians differs from other races has brought concern regarding whether their direct application is appropriate. We aimed to study to what extent optimal gestational weight gain among women in Japan differs by pre-pregnancy body mass index (BMI) and to compare estimated optimal gestational weight gain to current Japanese and Institute of Medicine (IOM) recommendations.MethodsWe retrospectively studied 104,070 singleton pregnancies among nulliparous women in 2005–2011 using the Japanese national perinatal network database. In five pre-pregnancy BMI sub-groups (17.0–18.4, 18.5–19.9, 20–22.9, 23–24.9, and 25–27.4 kg/m2), we estimated the association of the rate of gestational weight gain with pregnancy outcomes (fetal growth, preterm delivery, and delivery complications) using multivariate regression.ResultsWeight gain rate associated with the lowest risk of adverse outcomes decreased with increasing BMI (12.2 kg, 10.9 kg, 9.9 kg, 7.7 kg, and 4.3 kg/40 weeks) for the five BMI categories as described above, respectively. Current Japanese guidelines were lower than optimal gains, with the lowest risk of adverse outcomes for women with BMI below 18.5 kg/m2, and current IOM recommendations were higher than optimal gains for women with BMI over 23 kg/m2.ConclusionOptimal weight gain during pregnancy varies largely by pre-pregnancy BMI, and defining those with BMI over 23 kg/m2 as overweight, as proposed by the World Health Organization, may be useful when applying current IOM recommendations to Japanese guidelines.