Management of DOAC in Patients Undergoing Planned Surgery or Invasive Procedure: Italian Federation of Centers for the Diagnosis of Thrombotic Disorders and the Surveillance of the Antithrombotic Therapies (FCSA) Position Paper.

Patients on anticoagulant treatment are constantly increasing, with an estimated prevalence in Italy of 2% of the total population. About a quarter of the anticoagulated patients require temporary cessation of direct oral anticoagulants (DOACs) or vitamin K antagonists for a planned intervention within 2 years from anticoagulation inception. Several clinical issues about DOAC interruption remain unanswered: many questions are tentatively addressed daily by thousands of physicians worldwide through an experience-based balancing of thrombotic and bleeding risks. Among possible valuable answers, the Italian Federation of Centers for the diagnosis of thrombotic disorders and the Surveillance of the Antithrombotic therapies (FCSA) proposes some experience-based suggestions and expert opinions. In particular, FCSA provides practical guidance on the following issues: (1) multiparametric assessment of thrombotic and bleeding risks based on patients' individual and surgical risk factor, (2) testing of prothrombin time, activated partial thromboplastin time, and DOAC plasma levels before surgery or invasive procedure, (3) use of heparin, (4) restarting of full-dose DOAC after high risk bleeding surgery, (5) practical nonpharmacological suggestions to manage patients perioperatively. Finally, FCSA suggests creating a multidisciplinary "anticoagulation team" with the aim to define the optimal perioperative management of anticoagulation.

Systems controls are needed to reduce mistaken tests for hemophagocytic lymphohistiocytosis, results of a prospective quality-improvement cohort study.

ABSTRACT: Medical diagnosis and therapy often rely on laboratory testing. We observed mistaken testing in evaluations for hemophagocytic lymphohistiocytosis (HLH) that led to delays and adverse outcomes. Physicians were mistakenly ordering interleukin-2 and quantitative natural killer cell flow cytometry, rather than soluble interleukin 2 receptor (sIL2R) or qualitative natural killer functional tests in the evaluation of patients suspected to have HLH.We initiated a prospective quality improvement project to reduce mistaken testing, reduce delays in correct testing due to mistaken ordering, and improve HLH evaluations. This consisted of provider education, developing an evaluation algorithm, and ultimately required systems interventions such as pop-ups and removal of the mistaken tests from the electronic ordering catalog.Active education reduced mistaken testing significantly in HLH evaluations from baseline (73.3% vs 33.3%, P = .003, relative risk reduction (RRR) 54.5%), but failed to meet the pre-specified RRR cutoff for success (70%). Education alone did not significantly reduce the proportion of HLH evaluations with delays in sIL2R testing (23.3% vs 7.4%, P = .096). Mistaken testing increased after the active intervention ended (33.3% vs 43.5%, P = .390, with RRR 40.7% from baseline. Mistaken test removal was successful: mistaken testing dropped to 0% (P < .001, RRR 100%), saved $14,235 yearly, eliminated delays in sIL2R testing from mistaken testing (23.3% vs 0%, P = .008), and expedited sIL2R testing after admission for HLH symptoms (14.6 days vs 3.8 days, P = .0012). These data show systems controls are highly effective in quality improvement while education has moderate efficacy.

COVID-19 Vaccine for Elderly: Should We Be Reactive or Proactive?

It has been a year since the Indonesian government announced its first COVID-19 identified in Jakarta. Since then, there have been more than 900,000 cases in Indonesia with case fatality rate (CFR) of 2.9%. The number of new cases per day is now ranging from 9,000 cases to almost 13,000 cases. Not only in Indonesia, but the number of new cases along with the mortality rate in other countries, such as Malaysia, Japan, United States, and Europe region also increased dramatically. COVID-19 vaccines are being investigated and the world hopes that vaccines will be the answer to tackle this pandemic. Is it really so? Immunization is an effort to induce immunity in individuals to prevent a disease or the complication related to the diseases that may be catastrophic. Immunization can be divided into passive, which is by giving certain type of antibody and active, which means that either we get the disease, or we get the antigen injected into our body.Having prior vaccination or past COVID-19 does not mean that someone is totally immune to COVID-19 as a recent study suggested that the antibody related to COVID-19 past infection is significantly decreasing after 3 months post-infection. Compliance to implementation of health protocol remained the most crucial strategy during this pandemic.

Access to cardiac surgery centers for cardiac and non-cardiac hospitalizations in adolescents and adults with congenital heart defects- a descriptive case series study.

BACKGROUND: Individuals with congenital heart defects (CHDs) are recommended to receive all inpatient cardiac and noncardiac care at facilities that can offer specialized care. We describe geographic accessibility to such centers in New York State and determine several factors associated with receiving care there. METHODS: We used inpatient hospitalization data from the Statewide Planning and Research Cooperative System (SPARCS) in New York State 2008-2013. In the absence of specific adult CHD care center designations during our study period, we identified pediatric/adult and adult-only cardiac surgery centers through the Cardiac Surgery Reporting System to estimate age-based specialized care. We calculated one-way drive and public transit time (in minutes) from residential address to centers using R gmapsdistance package and the Google Maps Distance Application Programming Interface (API). We calculated prevalence ratios using modified Poisson regression with model-based standard errors, fit with generalized estimating equations clustered at the hospital level and subclustered at the individual level. RESULTS: Individuals with CHDs were more likely to seek care at pediatric/adult or adult-only cardiac surgery centers if they had severe CHDs, private health insurance, higher severity of illness at encounter, a surgical procedure, cardiac encounter, and shorter drive time. These findings can be used to increase care receipt (especially for noncardiac care) at pediatric/adult or adult-only cardiac surgery centers, identify areas with limited access, and reduce disparities in access to specialized care among this high-risk population.

Risk stratification and secondary prevention post-myocardial infarction: insights from the EYESHOT Post-MI study.

AIMS: Clinical management of patients more than 1 year after acute myocardial infarction (MI) is challenging. Patient risk stratification may help to establish therapeutic priorities. We aimed to describe the comprehensive risk profile and management of patients with prior MI. METHODS: We analyzed data from the EYESHOT Post-MI study, which evaluated the management of patients 1-3 years after MI. The risk profile of participants was defined according to the qualifying high-risk features of the PEGASUS-TIMI 54 trial (history of diabetes, history of recurrent MI, angiographic evidence of multivessel coronary disease, chronic kidney disease with estimated glomerular filtration rate <60 ml/min, age ≥65 years). Patients were classified into five subgroups according to the presence of zero, one, two, three, or more than three features. RESULTS: Of the 1633 patients in the EYESHOT Post-MI study, 1008 could be stratified according to PEGASUS-TIMI 54 high-risk features. About 22% of patients had no high-risk features, whereas 25% showed at least three features. The prevalence of patients with specific clinical severity indicators was progressively higher with the increasing number of high-risk features. Dual antiplatelet therapy and oral anticoagulation were more frequently used in patients with an increasing number of high-risk features (P for trend <0.0001). Lipid-lowering therapies were less frequently prescribed in patients with a higher number of features (P for trend 0.006 for statins; P for trend 0.007 for ezetimibe). CONCLUSION: Higher-risk post-MI patients, identified by PEGASUS-TIMI 54 high-risk features, showed an increased prevalence of major clinical severity indicators. Secondary prevention therapies were not adequately implemented in higher-risk patients.

Cardiovascular Medications in Pregnancy: A Primer.

Cardiovascular disease and cardiovascular disease-related disorders remain among the most common causes of maternal morbidity and mortality in the United States. Due to increased rates of obesity, delayed childbearing, and improvements in medical technology, greater numbers of women are entering pregnancy with preexisting medical comorbidities. Use of cardiovascular medications in pregnancy continues to increase, and medical management of cardiovascular conditions in pregnancy will become increasingly common. Obstetricians and cardiologists must familiarize themselves with the pharmacokinetics of the most commonly used cardiovascular medications in pregnancy and how these medications respond to the physiologic changes related to pregnancy, embryogenesis, and lactation.

Pregnancy in Women with Adult Congenital Heart Disease.

Women with congenital heart disease are pursuing pregnancy in increasing numbers. Counseling about genetic transmission, medication management, maternal and fetal risks, and maternal longevity should be initiated well before pregnancy is considered. Although preconception medical and surgical optimization as well as coordinated multidisciplinary care throughout pregnancy decrease maternal and fetal risks, the rate of complications remains increased compared with the general population. Lesion-specific risk stratification and care throughout pregnancy further improve outcomes and decrease unnecessary interventions.

Why Did the ACA Co-Op Program Fail? Lessons for the Health Reform Debate.

The ACA created a new type of nonprofit health insurance entity, the "Consumer Operated and Oriented Plan" ("co-op"). Most of the newly created co-ops soon lost money, and only 4 of the original 23 remain. We interviewed key stakeholders and conducted in-depth case studies of 3 of these co-ops. We discovered that politicians and regulators made it unlikely the program could succeed, that most of the co-ops did not have the management capacity to overcome these political obstacles, and that even those with good managers lacked the needed fiscal resilience. We also considered lessons suggested for those proposing a newly created "public option." The main one is that a successful public option requires a supportive political environment, strong management, and significant fiscal capacity, none of which comes easily. A better route may be a quasi-public option in which the government subcontracts the operation of its newly created plan to a private firm. Although it is uncertain whether federal regulators have the capacity to hold such private for-profit firms accountable, pragmatism suggests that a combination of public-sector regulation and private-sector implementation may be the most direct path toward a US version of affordable universal coverage.

Endoscopy during the Covid-19 outbreak: experience and recommendations from a single center in a high-incidence scenario.

A dramatic SARS-Cov-2 outbreak is hitting Italy hard. To face the new scenario all the hospitals have been re-organised in order to reduce all the outpatient services and to devote almost all their personnel and resources to the management of Covid-19 patients. As a matter of fact, all the services have undergone a deep re-organization guided by: the necessity to reduce exams, to create an environment that helps reduce the virus spread, and to preserve the medical personnel from infection. In these days a re-organization of the endoscopic unit, sited in a high-incidence area, has been adopted, with changes to logistics, work organization and patients selection. With the present manuscript, we want to support gastroenterologists and endoscopists in the organization of a "new" endoscopy unit that responds to the "new" scenario, while remaining fully aware that resources, availability and local circumstances may extremely vary from unit to unit.

Analysis of situation of acute coronary syndrome based on the date of the Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome (CCC-ACS) project: single-centre observational study.

BACKGROUND: We are currently faced with an increasing burden of cardiovascular disease in China and the inadequacy of the application of guidelines in clinical practice. In the past decade, China has been strengthening the healthcare system, but it still lacked a national performance measurement system and an appropriate quality improvement strategy. Therefore, in order to improve the implementation of guideline recommendations in clinical practice, China has learnt from the successful experience of Get With The Guidelines project in 2014. Under the guidance of the Medical and Health Hospital of the National Health and Family Planning Commission, the Chinese Society of Cardiology and the American Heart Association jointly launched the Improving Care for Cardiovascular Disease in China (CCC) project. The project team provided an analysis report on the completion of key medical quality evaluation indicators of each hospital every month, supplied guidance through education, training, experience exchange and on-site investigation for problems, and certified hospitals with outstanding performance and obvious progress. The circle pattern, including evaluation, training, improvement and re-evaluation, will boost the guidelines compliance on clinical practice in China and improve the quality of medical services. METHODS: This study was conducted in a centre of the Third Xiangya Hospital of Central South University. It included patients with ACS from December 2009 to December 2011 (n=225), patients with ACS in the Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome project coming from the Third Xiangya Hospital of Central South University (n=665), 12 hospitals in Hunan Province (n=4333) and 150 hospitals in China (n=63 641) from November 2014 to April 2017. It assessed the situation of drug therapy, hospitalisation day, mortality during hospitalisation, median of door-to-needle (D-to-N) time and median of door-to-balloon (D-to-B) time of patients with ST-segment elevation myocardial infarction (STEMI), the proportion of D-to-N within 30 min and D-to-B within 90 min, and the proportion of reperfusion therapy. Patients with ACS from the centre from November 2014 to April 2017 were divided into five groups (every 6 months as a group according to time). The study observed change trends in all the above-mentioned indexes. RESULTS: Compared with before participating in the CCC project, there were increases after participating in the CCC project in the drug usage rates of aspirin, P2Y12 inhibitor (clopidogrel or ticagrelor), ß-blocker, statin and angiotensin converting enzyme inhibitor (ACEI)/angiotensin-receptor blocker (ARB). Hospitalisation day and mortality during hospitalisation were shortened. D-to-N and D-to-B times of patients with STEMI were shorter. Compared with Hunan Province and China, the drug usage rates were higher; hospitalisation day and D-to-N time were shorter; D-to-B time was longer; and the proportion of reperfusion therapy was higher. The trend of drug usage rates was on the rise. There was no significant change in the hospitalisation day and D-to-N and D-to-B times. The mortality during hospitalisation showed a downward trend. The proportion of D-to-N within 90 min and reperfusion therapy showed upward trends. CONCLUSION: Quality of care for patients with ACS improved over time in the CCC project, including taking medicine following the guidelines, increased use of reperfusion therapy and faster time to treatment. Although overall mortality has improved, we also should attach importance to high-risk patients. The influence of the CCC project, which is based on guidelines on prognosis of ACS in the centre, presents an important clinical implication that it is necessary to enhance adherence to the guidelines in the treatment of ACS.

Long-term colorectal cancer incidence after adenoma removal and the effects of surveillance on incidence: a multicentre, retrospective, cohort study.

OBJECTIVE: Postpolypectomy colonoscopy surveillance aims to prevent colorectal cancer (CRC). The 2002 UK surveillance guidelines define low-risk, intermediate-risk and high-risk groups, recommending different strategies for each. Evidence supporting the guidelines is limited. We examined CRC incidence and effects of surveillance on incidence among each risk group. DESIGN: Retrospective study of 33 011 patients who underwent colonoscopy with adenoma removal at 17 UK hospitals, mostly (87%) from 2000 to 2010. Patients were followed up through 2016. Cox regression with time-varying covariates was used to estimate effects of surveillance on CRC incidence adjusted for patient, procedural and polyp characteristics. Standardised incidence ratios (SIRs) compared incidence with that in the general population. RESULTS: After exclusions, 28 972 patients were available for analysis; 14 401 (50%) were classed as low-risk, 11 852 (41%) as intermediate-risk and 2719 (9%) as high-risk. Median follow-up was 9.3 years. In the low-risk, intermediate-risk and high-risk groups, CRC incidence per 100 000 person-years was 140 (95% CI 122 to 162), 221 (195 to 251) and 366 (295 to 453), respectively. CRC incidence was 40%-50% lower with a single surveillance visit than with none: hazard ratios (HRs) were 0.56 (95% CI 0.39 to 0.80), 0.59 (0.43 to 0.81) and 0.49 (0.29 to 0.82) in the low-risk, intermediate-risk and high-risk groups, respectively. Compared with the general population, CRC incidence without surveillance was similar among low-risk (SIR 0.86, 95% CI 0.73 to 1.02) and intermediate-risk (1.16, 0.97 to 1.37) patients, but higher among high-risk patients (1.91, 1.39 to 2.56). CONCLUSION: Postpolypectomy surveillance reduces CRC risk. However, even without surveillance, CRC risk in some low-risk and intermediate-risk patients is no higher than in the general population. These patients could be managed by screening rather than surveillance.

Problematic Risk Adjustment in National Healthcare Safety Network Measures.

This article reviews the risk-adjustment models underpinning the National Healthcare Safety Network (NHSN) standardized infection ratios. After first describing the models, the authors focus on hospital intensive care unit (ICU) designation as a variable employed across the various risk models. The risk-adjusted frequency with which ICU services are reported in Medicare fee-for-service claims data was compared as a proxy for determining whether reporting of ICU days is similar across hospitals. Extreme variation was found in the reporting of ICU utilization among admissions for congestive heart failure, ranging from 25% in the lowest admission hospital quartile to 95% in the highest. The across-hospital variation in reported ICU utilization was found to be unrelated to patient severity. Given that such extreme variation appears in a designation of ICU versus non-ICU utilization, the NHSN risk-adjustment models' dependence on nursing unit designation should be a cause for concern.

Rational planning of operating lists: a prospective comparison of 'booking to the mean' vs. 'probabilistic case scheduling' in urology.

The efficient use of operating theatres requires accurate case scheduling. One common method is 'booking to the mean'. Here, the mean times for individual operations are summed to approximate the time allocated to the list. An alternative approach is 'probabilistic scheduling'. Here, the means and standard deviation of the individual case times are combined to estimate the probability that the planned list will finish on time. This study assessed how probabilistic booking would have changed list utilisation, over-running and case cancellations in 60 urology lists during eight months that had been 'booked to the mean'. Booking to the mean resulted in 53/60 (88%) lists over-running and correctly predicted the finish times in just 13% of lists. Out of 264 patients, 36 (14%) were cancelled on the day due to over-runs in 24/60 (40%) lists. In contrast, probabilistic scheduling correctly predicted an over-run or under-run in 77% of lists, which would have allowed the case mix to be adjusted to prevent cancellation and optimise utilisation.

Suitability of the German version of the Manchester Triage System to redirect emergency department patients to general practitioner care: a prospective cohort study.

OBJECTIVES: To investigate the suitability of the German version of the Manchester Triage System (MTS) as a potential tool to redirect emergency department (ED) patients to general practitioner care. Such tools are currently being discussed in the context of reorganisation of emergency care in Germany. DESIGN: Prospective cohort study. SETTING: Single centre University Hospital Emergency Department. PARTICIPANTS: Adult, non-surgical ED patients. EXPOSURE: A non-urgent triage category was defined as a green or blue triage category according to the German version of the MTS. PRIMARY AND SECONDARY OUTCOME MEASURES: Surrogate parameters for short-term risk (admission rate, diagnoses, length of hospital stay, admission to the intensive care unit, in-hospital and 30-day mortality) and long-term risk (1-year mortality). RESULTS: A total of 1122 people presenting to the ED participated in the study. Of these, 31.9% (n=358) received a non-urgent triage category and 68.1% (n=764) were urgent. Compared with non-urgent ED presentations, those with an urgent triage category were older (median age 60 vs 56 years, p=0.001), were more likely to require hospital admission (47.8% vs 29.6%) and had higher in-hospital mortality (1.6% vs 0.8%). There was no significant difference observed between non-urgent and urgent triage categories for 30-day mortality (1.2% [n=4] vs 2.2% [n=15]; p=0.285) or for 1-year mortality (7.9% [n=26] vs 10.5% [n=72]; p=0.190). Urgency was not a significant predictor of 1-year mortality in univariate (HR=1.35; 95% CI 0.87 to 2.12; p=0.185) and multivariate regression analyses (HR=1.20; 95% CI 0.77 to 1.89; p=0.420). CONCLUSIONS: The results of this study suggest the German MTS is unsuitable to safely identify patients for redirection to non-ED based GP care. TRIAL REGISTRATION NUMBER: U1111-1119-7564; Post-results.

Adjusting for social risk factors impacts performance and penalties in the hospital readmissions reduction program.

OBJECTIVE: Medicare's Hospital Readmissions Reduction Program (HRRP) does not account for social risk factors in risk adjustment, and this may lead the program to unfairly penalize safety-net hospitals. Our objective was to determine the impact of adjusting for social risk factors on HRRP penalties. STUDY DESIGN: Retrospective cohort study. DATA SOURCES/STUDY SETTING: Claims data for 2 952 605 fee-for-service Medicare beneficiaries with acute myocardial infarction (AMI), congestive heart failure (CHF) or pneumonia from December 2012 to November 2015. PRINCIPAL FINDINGS: Poverty, disability, housing instability, residence in a disadvantaged neighborhood, and hospital population from a disadvantaged neighborhood were associated with higher readmission rates. Under current program specifications, safety-net hospitals had higher readmission ratios (AMI, 1.020 vs 0.986 for the most affluent hospitals; pneumonia, 1.031 vs 0.984; and CHF, 1.037 vs 0.977). Adding social factors to risk adjustment cut these differences in half. Over half the safety-net hospitals saw their penalty decline; 4-7.5 percent went from having a penalty to having no penalty. These changes translated into a $17 million reduction in penalties to safety-net hospitals. CONCLUSIONS: Accounting for social risk can have a major financial impact on safety-net hospitals. Adjustment for these factors could reduce negative unintended consequences of the HRRP.