Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review.

BACKGROUND: Major adverse cardiovascular events (MACE) are increasingly used as composite outcomes in randomized controlled trials (RCTs) and observational studies. However, it is unclear how observational studies most commonly define MACE in the literature when using administrative data. METHODS: We identified peer-reviewed articles published in MEDLINE and EMBASE between January 1, 2010 to October 9, 2020. Studies utilizing administrative data to assess the MACE composite outcome using International Classification of Diseases 9th or 10th Revision diagnosis codes were included. Reviews, abstracts, and studies not providing outcome code definitions were excluded. Data extracted included data source, timeframe, MACE components, code definitions, code positions, and outcome validation. RESULTS: A total of 920 articles were screened, 412 were retained for full-text review, and 58 were included. Only 8.6% (n = 5/58) matched the traditional three-point MACE RCT definition of acute myocardial infarction (AMI), stroke, or cardiovascular death. None matched four-point (+unstable angina) or five-point MACE (+unstable angina and heart failure). The most common MACE components were: AMI and stroke, 15.5% (n = 9/58); AMI, stroke, and all-cause death, 13.8% (n = 8/58); and AMI, stroke and cardiovascular death 8.6% (n = 5/58). Further, 67% (n = 39/58) did not validate outcomes or cite validation studies. Additionally, 70.7% (n = 41/58) did not report code positions of endpoints, 20.7% (n = 12/58) used the primary position, and 8.6% (n = 5/58) used any position. CONCLUSIONS: Components of MACE endpoints and diagnostic codes used varied widely across observational studies. Variability in the MACE definitions used and information reported across observational studies prohibit the comparison, replication, and aggregation of findings. Studies should transparently report the administrative codes used and code positions, as well as utilize validated outcome definitions when possible.

Elevated bands as a predictor of bloodstream infection and in-hospital mortality.

OBJECTIVE: Although >10% bands on a CBC has been a part of the definition for sepsis, scant data exists regarding the clinical significance of lower percentages of bands. Our aim was to determine whether any associations exist between percentage of bands on an initial CBC and likelihood of a bloodstream infection and in-hospital mortality. METHODS: We performed a retrospective study of emergency department adults from January 1, 2016 to September 1, 2019 who had a CBC with manual differential and blood cultures obtained during their initial evaluation. Band percentages were grouped into zero (0% bands), minimal (1-2% bands), mild (3-4% bands), moderate (5-10% bands) and high (>10% bands). The primary outcomes were bloodstream infections and in-hospital mortality. RESULTS: Increasing rates of bloodstream infections were observed as bands went from zero (95% CI: 9.3%-10.5%) to minimal (17.5%-19.1%, p < 0.0001), minimal to mild (19.2%-22.0%, p = 0.0039), mild to moderate (23.5%-26.7%, p < 0.0001), and moderate to high (33.0%-37.4%, p < 0.0001). Similar observations were seen when comparing mortality. The most common bloodstream infections were due to Gram-negative bacilli. CONCLUSION: Elevated bands on an initial CBC were correlated with the likelihood of a concurrent bloodstream infection and in-hospital mortality, even at levels below 10%. Our results suggest that clinical suspicion for a bloodstream infection due to Gram-negative bacilli should rise if bands are elevated on an initial CBC. Therefore, clinicians should consider obtaining blood cultures if bands are elevated on an initial CBC.

Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis.

BACKGROUND: We sought to determine whether there are differences in enrolled patients' risk factors in published percutaneous coronary intervention (PCI) trials between various continents. METHODS: We systematically identified clinical trials evaluating PCI interventions through PubMed. We reviewed 701 studies between 1990 and 2014 from North America (N=135), Europe (N=403), and Asia (N=163), examining the prevalence of cardiovascular risk factors-hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HL), smoking, sex, and body mass index. We performed meta-regression with random- and mixed-effects models to compare patient baseline characteristics between continents and linear meta-regression analysis to test trends over time. RESULTS: In meta-regression with random-effects model, North American trials recruited the lowest proportion of male participants (71.32%), followed by Asian (74.41%) and European trials (76.47%; P<.0001). North American trials enrolled the highest proportion of patients with HTN (63.17%, P=.0035) and HL (63.72%, P<.0001), whereas Asia enrolled the highest proportion of DM patients (29.64%, P<.0001) and smoking (38.41%, P=.0144). When adjusting for other moderators such as publication date, body mass index, and sex in meta-regression with mixed-effects model, age was significantly positively correlated with HTN, HL, DM, and smoking (P<.001). Body mass index was significantly higher in Europe and North America than in Asia. All enrollment risk factors demonstrated (ß<0.02) statistically significant temporal trends over time, except for sex. CONCLUSIONS: There are major continental differences in risk factors among patients enrolled in PCI trials from various continents. Clinical trial results may not be applicable to patient populations from another region.

High-dose influenza vaccines for the prevention of hospitalization due to cardiovascular events in older adults in the nursing home: Post-hoc analysis of a cluster-randomized trial.

Older adults are at high risk of major acute cardiovascular events (MACE) linked to influenza illness andpreventable by influenza vaccination. It is unknown whether high-dose vaccine might incrementally reduce the risk of MACE.We conducted a post-hoc analysis of data collected from a pragmatic cluster randomized study of 823 nursing homes (NH) randomized to standard-dose (SD) or high-dose (HD) influenza vaccine in the 2013-14 season. Adults age 65 year or older who are Medicare-enrolled long-stay residents were included in the analysis.There were no statistically significant differences in hospitalization for MACE, acute coronary syndromes (ACS), stroke or heart failure between the HD and SD arms. However, in the fee-for-service group, participants in the HD arm had significantly decreased risk of hospitalization for respiratory problems, which was not observed in the Medicare Advantage group.High-dose influenza vaccine was not shown to be incrementally protective against MACE relative to standard-dose vaccine.

Periprocedural Peritonitis Prophylaxis: A Summary of the Microbiology and the Role of Systemic Antimicrobials.

BACKGROUND: Peritonitis is a leading complication of peritoneal dialysis (PD). One strategy that the International Society for Peritoneal Dialysis (ISPD) has used to help mitigate the morbidity and mortality associated with peritonitis is through prevention, including antibiotic prophylaxis utilization in high-risk situations. The aim of this study is to summarize our current understanding of postprocedural peritonitis and discuss the existing data behind periprocedural antibiotic prophylaxis, focusing primarily on PD catheter insertion, dental procedures, colonoscopies, upper endoscopies with gastrostomy, and gynecologic procedures. SUMMARY: The ISPD currently recommends intravenous antibiotics prior to PD catheter insertion, colonoscopies, and invasive gynecologic procedures, though prophylaxis has only demonstrated benefit in a prospective, randomized control setting for PD catheter insertion. However, multiple retrospective studies exist that support the use of antibiotic prophylaxis for the other 2 procedures. No specific antibiotic regimen has been established as most optimal to prevent peritonitis for any of the 3 procedures. Antibiotic coverage should include the Enterobacteriaceae family, as well as Gram-positive organisms commonly found on the skin flora for PD catheter insertion, anaerobes for colonoscopies, and common organisms from the urogenital flora in gynecologic procedures. Additionally, the ISPD currently recommends oral amoxicillin prior to dental procedures. There is currently no ISPD recommendation to provide antibiotic prophylaxis prior to an upper endoscopy with or without gastrostomy, though this is a potential area for research. KEY MESSAGES: PD patients are at high risk for developing peritonitis after typical procedures. Antibiotic prophylaxis is a potential strategy that the ISPD utilizes to prevent these infections. However, further research needs to be done to determine the optimal antibiotic regimen.

Abdominal Pain Due to Renal Infarction: An Unexpected Presentation of COVID-19.

Although respiratory symptoms dominate the clinical presentation of COVID-19, atypical, misleading non-pulmonary complaints can occur. Here we present a case of an otherwise healthy 28-year-old cisgender woman whose initial presentation of COVID-19 was unexplained acute abdominal pain, which was later found to be due to renal infarction. She was treated with anti-coagulation and was discharged after a short hospital stay. This case demonstrates the heterogeneous presentations that are associated with COVID-19. Medical providers must be aware that this virus may mimic a diverse array of disorders, even in the absence of respiratory symptoms.

A rare case of Actinomyces skin and soft tissue infection in an end-stage kidney disease patient with a review of the literature.

End-stage kidney disease (ESKD) patients are a commonly overlooked immunocompromised population that places them at risk for rare infections. We describe the case of a 78-year-old man with a history of ESKD managed with thrice weekly in-center hemodialysis who had a prolonged episode of left elbow pain and drainage and was eventually found to have a skin and soft tissue infection from Actinomyces radingae. We review the bacteriology of Actinomyces spp. and the experiences of other providers who have treated actinomycosis in individuals with ESKD. The anatomic sites and demographics of these individuals are heterogeneous, but they all generally require a long antibiotic course with a beta-lactam and portend to a good prognosis. High index of suspicion is needed to identify rare and atypical infections in the ESKD population.

Shared Decision-Making in Femoral Versus Radial Cardiac Catheterization.

Shared decision-making is a strategy to assist with patient involvement in medical decisions. One of its pillars is patient knowledge and understanding of the risks and benefits associated with specific procedures. We studied patient knowledge about transradial (TRA) and transfemoral (TFA) cardiac catheterization. A prospective study was conducted in 100 patients hospitalized following diagnostic and therapeutic cardiac catheterization-TRA in 71% of patients and remaining TFA. All patients were presented a standard balanced informed consent outlining risks and benefits. Following catheterization, patients were verbally administered an 11-item open-ended questionnaire to assess knowledge of cardiac catheterization and the associated risks and benefits. A patient knowledge index (PKI) was developed with 1 point given for: identifying the procedure; correctly describing the procedure; identifying at least 1 risk of TRA; and/or TFA; and at least 1 benefit of TRA; and/or TFA. Maximum PKI score was 6. The mean PKI score was 2.6 ± 1.1. A PKI score ≥4 was observed in 21% of patients with only 1 patient obtaining the maximum 6 points. Over 80% of patients were unable to recall procedure risks provided at the time of informed consent. The majority of patients were unable to discriminate between TRA and TFA risks and benefits, PKI 2.52 versus 2.60, respectively (p = 0.718). On multivariate analysis, higher education levels were correlated with increased PKI scores (odds ratio = 0.65, p = 0.014) whereas black race was associated with lower PKI scores (odds ratio = -0.48, p = 0.045). In conclusion, patient retention of information from the informed consent was low. The majority of patients had no preference or deferred to their physician's expertise when deciding TRA compared with TFA. This study identifies challenges with implementing shared decision-making and the need for improved patient education and involvement regarding cardiac catheterization.