Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Should laryngeal tubes or masks be used for out-of-hospital cardiac arrest patients?

Objective: Few studies have compared airway management via laryngeal masks (LM) or laryngeal tubes (LT) in patients with out-of-hospital cardiac arrest (OHCA). This study evaluated whether LT insertion by emergency medical service (EMS) personnel affected ventilation and outcomes in OHCA patients (vs. the standard LM treatment). Methods: This prospective, cluster-randomized, and open-label study evaluated data that were collected by the Sapporo Fire Department between June 2012 and January 2013. We selected the 14 EMS teams that treated the greatest number of OHCA patients in Sapporo, Japan during 2011, and randomized the teams into Groups A and B. In the first study period (June 2012 to September 2012), Group A treated OHCA patients via LT and Group B treated OHCA patients via LM. In the second period (October 2012 to January 2013), Group A treated OHCA patients via LM and Group B treated OHCA patients via LT. If necessary, both groups were allowed to use an esophageal obturator airway (EOA) kit. The primary endpoints were time from cardiopulmonary resuscitation to device insertion and the rate of successful pre-hospital ventilation. The secondary endpoints were return of spontaneous circulation and survival and favorable neurological outcomes at 1 month after cardiac arrest.Results: LT was used in 148 OHCA patients and LM was used in 165 OHCA patients. Our intention-to-treat analyses revealed no significant differences in the primary and secondary outcomes of the LT- and LM-treated groups. Conclusion: Prehospital advanced airway management via LT provides similar outcomes to those of LM in OHCA patients

Effect of annual hospital admissions of out-of-hospital cardiac arrest patients on prognosis following cardiac arrest

Background Although the prognosis of patients treated at specialized facilities has improved, the relationship between the number of patients treated at hospitals and prognosis is controversial and lacks constancy in those with out-of-hospital cardiac arrest (OHCA). This study aimed to clarify the effect of annual hospital admissions on the prognosis of adult patients with OHCA by analyzing a large cohort. Methods The effect of annual hospital admissions on patient prognosis was analyzed retrospectively using data from the Japanese Association for Acute Medicine OHCA registry, a nationwide multihospital prospective database. This study analyzed 3632 of 35,754 patients hospitalized for OHCA of cardiac origin at 86 hospitals. The hospitals were divided into tertiles based on the volume of annual admissions. The effect of hospital volume on prognosis was analyzed using logistic regression analysis with multiple imputation. Furthermore, three subgroup analyses were performed for patients with return of spontaneous circulation (ROSC) before arrival at the emergency department, patients admitted to critical care medical centers, and patients admitted to extracorporeal membrane oxygenation-capable hospitals. Results Favorable neurological outcomes 30 days after OHCA for patients overall showed no advantage for medium- and high-volume centers over low-volume centers; Odds ratio (OR) 0.989, (95% Confidence interval [CI] 0.562-1.741), OR 1.504 (95% CI 0.919-2.463), respectively. However, the frequency of favorable neurological outcomes in OHCA patients with ROSC before arrival at the emergency department at high-volume centers was higher than those at low-volume centers (OR 1.955, 95% CI 1.033-3.851). Conclusion Hospital volume did not significantly affect the prognosis of adult patients with OHCA. However, transport to a high-volume hospital may improve the neurological prognosis in OHCA patients with ROSC before arrival at the emergency department

Rapid Evaluation of Fibrinogen Levels Using the CG02N Whole Blood Coagulation Analyzer

Rapid evaluation of fibrinogen (Fbg) levels is essential for maintaining homeostasis in patients with massive bleeding during severe trauma and major surgery. This study evaluated the accuracy of fibrinogen levels measured by the CG02N whole blood coagulation analyzer (A&T Corporation, Kanagawa, Japan) using heparinized blood drawn for blood gas analysis (whole blood-Fbg). A total of 100 matched pairs of heparinized blood samples and citrated blood samples were simultaneously collected from patients in the intensive care unit. Whole blood-Fbg results were compared with those of citrated plasma (standard-Fbg). The whole blood coagulation analyzer measured fibrinogen levels within 2 minutes. Strong correlations between standard-Fbg and whole blood-Fbg were observed (ρ = 0.91, p < 0.001). Error grid analysis showed that 88% of the values were clinically acceptable, and 12% were in a range with possible effects on clinical decision-making; none were in a clinically dangerous range without appropriate treatment. Using a fibrinogen cutoff value of 1.5 g/L for standard-Fbg, the area under the receiver operating characteristic curve of whole blood-Fbg was 0.980 (95% confidence interval 0.951-1.000, p < 0.001). The whole blood coagulation analyzer can rapidly measure fibrinogen levels in heparinized blood and could be useful in critical care settings where excessive bleeding is a concern

The response time threshold for predicting favourable neurological outcomes in patients with bystander-witnessed out-of-hospital cardiac arrest

Objective: It is well established that the period of time between a call being made to emergency medical services (EMS) and the time at which EMS arrive at the scene (i.e., the response time) affects survival outcomes in patients who experienced out-of-hospital cardiac arrest (OHCA). However, the relationship between response time and favourable neurological outcomes remains unclear. We therefore aimed to determine a response time threshold in bystander-witnessed OHCA patients that is associated with positive neurological outcomes and to assess the relationship between response time and neurological outcomes in OHCA patients. Methods: This study was a retrospective, observational analysis of data from 204,277 episodes of bystander-witnessed OHCA between 2006 and 2012 in Japan. We used classification and regression trees (CARTs) and receiver operating characteristic (ROC) curve analysis to determine the threshold of response time associated with favourable neurological outcomes (Cerebral Performance Category 1 or 2) one month after cardiac arrest. Results: Both CARTs and ROC analyses indicated that a threshold of 6.5 min was associated with improved neurological outcomes in all bystander-witnessed OHCA events from cardiac origin. Furthermore, bystander cardiopulmonary resuscitation (CPR) prolonged the threshold of response time by 1 min (to 7.5 min). The adjusted odds ratios for favorable neurological outcomes in OHCA patients who received care within ≤ 6.5 min was 1.935 (95% confidential interval: 1.834-2.041, P<0.001). Conclusions: A response time ≤ 6.5 min was closely associated with favourable neurological outcomes in all bystander-witnessed OHCA patients. Bystander CPR prolonged the response time threshold by 1 min

Prediction and Implications of Edoxaban-Associated Bleeding in Patients after Critical Illness

In this retrospective study, we aimed to identify the risk factors for bleeding in patients after critical illness during edoxaban treatment. Data from patients who received edoxaban after critical illness at the Emergency Department at a tertiary care hospital were obtained from the hospital medical records. Multivariate analysis revealed the risk factors for edoxaban-associated bleeding. Additionally, we developed an edoxaban-associated bleeding score (EAB score) based on these results. The derived EAB score was compared with the HAS-BLED score using receiver operating characteristic (ROC) curve analysis. Bleeding was observed in 42 of 114 patients (36.8%). We identified the following bleeding predictors (odds ratios, 95% confidence interval, score points) using multivariate analysis: concomitant use of antiplatelet agents (6.759, 2.047-22.32, 2 points), concomitant use of P-glycoprotein inhibitors (3.825, 1.484-9.856, 1 point), prothrombin time (PT)% following edoxaban administration of = 60% (2.507, 0.788-7.970, 1 point), and PT% following edoxaban administration of <60% (11.23, 3.560-35.42, 3 points). The ROC curve analysis revealed an area under the curve of 0.826 for the EAB score and 0.625 for the HAS-BLED score. Under appropriate edoxaban dosing regimens in patients after critical illness, a combination of antiplatelet agents, P-gp inhibitors, and a low PT% following edoxaban administration were identified as strong risk factors for bleeding

Prediction and Implications of Edoxaban-Associated Bleeding in Patients after Critical Illness

In this retrospective study, we aimed to identify the risk factors for bleeding in patients after critical illness during edoxaban treatment. Data from patients who received edoxaban after critical illness at the Emergency Department at a tertiary care hospital were obtained from the hospital medical records. Multivariate analysis revealed the risk factors for edoxaban-associated bleeding. Additionally, we developed an edoxaban-associated bleeding score (EAB score) based on these results. The derived EAB score was compared with the HAS-BLED score using receiver operating characteristic (ROC) curve analysis. Bleeding was observed in 42 of 114 patients (36.8%). We identified the following bleeding predictors (odds ratios, 95% confidence interval, score points) using multivariate analysis: concomitant use of antiplatelet agents (6.759, 2.047&ndash;22.32, 2 points), concomitant use of P-glycoprotein inhibitors (3.825, 1.484&ndash;9.856, 1 point), prothrombin time (PT)% following edoxaban administration of &lt;75% and &ge;60% (2.507, 0.788&ndash;7.970, 1 point), and PT% following edoxaban administration of &lt;60% (11.23, 3.560&ndash;35.42, 3 points). The ROC curve analysis revealed an area under the curve of 0.826 for the EAB score and 0.625 for the HAS-BLED score. Under appropriate edoxaban dosing regimens in patients after critical illness, a combination of antiplatelet agents, P-gp inhibitors, and a low PT% following edoxaban administration were identified as strong risk factors for bleeding