In a randomized trial, 2287 patients with coronary artery disease and evidence of ischemia were assigned to receive optimal medical therapy with or without percutaneous coronary intervention (PCI). ...At a median of 4.6 years, the rates of death and myocardial infarction were 19.0% in the PCI group and 18.5% in the medical-therapy group. The PCI group had lower rates of angina and repeat revascularization.
Patients with coronary artery disease and evidence of ischemia were assigned to receive optimal medical therapy with or without percutaneous coronary intervention (PCI). At a median of 4.6 years, the rates of death and myocardial infarction were 19.0% in the PCI group and 18.5% in the medical-therapy group.
During the past 30 years, the use of percutaneous coronary intervention (PCI) has become common in the initial management strategy for patients with stable coronary artery disease in North America, even though treatment guidelines advocate an initial approach with intensive medical therapy, a reduction of risk factors, and lifestyle intervention (known as optimal medical therapy).
1
,
2
In 2004, more than 1 million coronary stent procedures were performed in the United States,
3
and recent registry data indicate that approximately 85% of all PCI procedures are undertaken electively in patients with stable coronary artery disease.
4
PCI reduces the incidence of death and . . .
Summary
Background
Cardiac involvement is a major cause of mortality in patients with thrombotic thrombocytopenic purpura (TTP). However, diagnosis remains underestimated and delayed, owing to ...subclinical injuries. Cardiac troponin‐I measurement (cTnI) on admission could improve the early diagnosis of cardiac involvement and have prognostic value.
Objectives
To assess the predictive value of cTnI in patients with TTP for death or refractoriness.
Patients/Methods
The study involved a prospective cohort of adult TTP patients with acquired severe ADAMTS‐13 deficiency (< 10%) and included in the registry of the French Reference Center for Thrombotic Microangiopathies. Centralized cTnI measurements were performed on frozen serum on admission.
Results
Between January 2003 and December 2011, 133 patients with TTP (mean age, 48 ± 17 years) had available cTnI measurements on admission. Thirty‐two patients (24%) had clinical and/or electrocardiogram features. Nineteen (14.3%) had cardiac symptoms, mainly congestive heart failure and myocardial infarction. Electrocardiogram changes, mainly repolarization disorders, were present in 13 cases. An increased cTnI level (> 0.1 μg L−1) was present in 78 patients (59%), of whom 46 (59%) had no clinical cardiac involvement. The main outcomes were death (25%) and refractoriness (17%). Age (P = 0.02) and cTnI level (P = 0.002) showed the greatest impact on survival. A cTnI level of > 0.25 μg L−1 was the only independent factor in predicting death (odds ratio OR 2.87; 95% confidence interval CI 1.13–7.22; P = 0.024) and/or refractoriness (OR 3.03; 95% CI 1.27–7.3; P = 0.01).
Conclusions
A CTnI level of > 0.25 μg L−1 at presentation in patients with TTP appears to be an independent factor associated with a three‐fold increase in the risk of death or refractoriness. Therefore, cTnI level should be considered as a prognostic indicator in patients diagnosed with TTP.
To identify factors predictive of a large labral tear at the time of shoulder instability surgery.
As part of the Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Instability cohort, patients ...undergoing open or arthroscopic shoulder instability surgery for a labral tear were evaluated. Patients with >270° tears were defined as having large labral tears. To build a predictive logistic regression model for large tears, the Feasible Solutions Algorithm was used to add significant interaction effects.
After applying exclusion criteria, 1235 patients were available for analysis. There were 222 females (18.0%) and 1013 males (82.0%) in the cohort, with an average age of 24.7 years (range 12 to 66). The prevalence of large tears was 4.6% (n = 57), with the average tear size being 141.9°. Males accounted for significantly more of the large tears seen in the cohort (94.7%, P = .01). Racquet sports (P = .01), swimming (P = .02), softball (P = .05), skiing (P = .04), and golf (P = .04) were all associated with large labral tears, as was a higher Western Ontario Shoulder Instability Index (WOSI; P = .01). Age, race, history of dislocation, and injury during sport were not associated with having a larger tear. Using our predictive logistic regression model for large tears, patients with a larger body mass index (BMI) who played contact sports were also more likely to have large tears (P = .007).
Multiple factors were identified as being associated with large labral tears at the time of surgery, including male sex, preoperative WOSI score, and participation in certain sports including racquet sports, softball, skiing, swimming, and golf.
I, prognostic study.
Following the 2010 Deepwater Horizon accident of a massive blow-out in the Gulf of Mexico, scientists from government, industry, and academia collaborated to advance oil spill modeling and share best ...practices in model algorithms, parameterizations, and application protocols. This synergy was greatly enhanced by research funded under the Gulf of Mexico Research Initiative (GoMRI), a 10-year enterprise that allowed unprecedented collection of observations and data products, novel experiments, and international collaborations that focused on the Gulf of Mexico, but resulted in the generation of scientific findings and tools of broader value. Operational oil spill modeling greatly benefited from research during the GoMRI decade. This paper provides a comprehensive synthesis of the related scientific advances, remaining challenges, and future outlook. Two main modeling components are discussed: Ocean circulation and oil spill models, to provide details on all attributes that contribute to the success and limitations of the integrated oil spill forecasts. These forecasts are discussed in tandem with uncertainty factors and methods to mitigate them. The paper focuses on operational aspects of oil spill modeling and forecasting, including examples of international operational center practices, observational needs, communication protocols, and promising new methodologies.
Noninvasive monitoring of tumor therapy response helps in developing personalized treatment strategies. Here, we performed sequential PET and diffusion-weighted MRI to evaluate changes induced by a ...FOLFOX-like combination chemotherapy in colorectal cancer xenografts, to identify the cellular and molecular determinants of these imaging biomarkers.
Tumor-bearing CD1 nude mice, engrafted with FOLFOX-sensitive Colo205 colorectal cancer xenografts, were treated with FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) weekly. On days 1, 2, 6, 9, and 13 of therapy, tumors were assessed by in vivo imaging and ex vivo analyses. In addition, HCT116 xenografts, which did not respond to the FOLFOX treatment, were imaged on day 1 of therapy.
In Colo205 xenografts, FOLFOX induced a profound increase in uptake of the proliferation PET tracer 3'-deoxy-3'-
F-fluorothymidine (
F-FLT) accompanied by increases in markers for proliferation (Ki-67, thymidine kinase 1) and for activated DNA damage response (γH2AX), whereas the effect on cell death was minimal. Because tracer uptake was unaltered in the HCT116 model, these changes appear to be specific for tumor response.
We demonstrated that
F-FLT PET can noninvasively monitor cancer treatment-induced molecular alterations, including thymidine metabolism and DNA damage response. The cellular or imaging changes may not, however, be directly related to therapy response as assessed by volumetric measurements.
To use data from a large, prospectively- acquired regional collaborative database to compare the risk of infectious complications associated with three American Urologic Association- recommended ...antibiotic prophylaxis pathways, including culture-directed or augmented antibiotics, following prostate biopsy.
Data on prostate biopsies and outcomes were collected from the Pennsylvania Urologic Regional Collaborative, a regional quality collaborative working to improve the diagnosis and treatment of prostate cancer. Patients were categorized as receiving one of three prophylaxis pathways: culture-directed, augmented, or provider-discretion. Infectious complications included fever, urinary tract infections or sepsis within one month of biopsy. Odds ratios of infectious complication by pathway were determined, and univariate and multivariate analyses of patient and biopsy characteristics were performed.
11,940 biopsies were included, 120 of which resulted in infectious outcomes. Of the total biopsies, 3246 used “culture-directed”, 1446 used “augmented” and 7207 used “provider-discretion” prophylaxis. Compared to provider-discretion, the culture-directed pathway had 84% less chance of any infectious outcome (OR= 0.159, 95% CI = 0.074, 0.344, P < 0.001). There was no difference in infectious complications between augmented and provider-discretion pathways.
The culture-directed pathway for transrectal prostate biopsy resulted in significantly fewer infectious complications compared to other prophylaxis strategies. Tailoring antibiotics addresses antibiotic-resistant bacteria and reduces future risk of resistance. These findings make a strong case for incorporating culture-directed antibiotic prophylaxis into clinical practice guidelines to reduce infection following prostate biopsies.
Orthopedic injuries are the leading cause of hospital admissions in the USA, and many of these patients transition into chronic pain. Currently, there are no evidence-based interventions targeting ...prevention of chronic pain in patients with orthopedic injuries. We iteratively developed a four-session intervention "The Toolkit for Optimal Recovery" (TOR) which we plan to subsequently test for efficacy in a phase III hybrid efficacy-effectiveness multi-site clinical trial. In order to prevent methodological weaknesses in the subsequent trial, we conducted a feasibility pilot to evaluate the TOR delivered via secure live video versus usual care (UC) in patients with orthopedic injuries from an urban, level I trauma clinic, who screen in as at risk for chronic pain and disability. We tested the feasibility of recruitment, acceptability of screening, and randomization methods; acceptability of the intervention, treatment adherence, and treatment fidelity; satisfaction with the intervention; feasibility of the assessment process at all time points; acceptability of outcome measures for the definitive trial; and within-treatment effect sizes.
We aimed to recruit 50-60 participants, randomize, and retain them for ~ 4 months. Assessments were done electronically via REDCap at baseline, post-intervention (approximately 5 weeks after baseline), and 3 months later. We followed procedures we intend to implement in the full-scale hybrid efficacy-effectiveness trial.
We recruited 54 participants and found that randomization and data collection procedures were generally acceptable. The majority of participants were white, educated, and employed. Warm hand-off referrals were more effective than research assistants directly approaching patients for participation without their providers' engagement. Feasibility of recruitment, acceptability of screening, and randomization were good. Satisfaction with the program, adherence to treatment sessions, and treatment fidelity were all high. There were no technical issues associated with the live video delivery of the TOR. There was minimal missing data and outcome measures were deemed appropriate. Effect sizes for improvement after participation in TOR were moderate to large. There were many lessons learned for future trials.
This study provided evidence of the feasibility of the planned hybrid efficacy-effectiveness trial design when implemented at our home institution. Establishing feasibility of the intervention and study procedures at other trauma centers with more diverse patient populations and different clinical practices is required before a multi-site phase III efficacy-effectiveness trial.
ClinicalTrials.gov ID: NCT03405610. Registered on January 28, 2018-retrospectively registered.
To estimate the incidence, risk factors, and outcomes associated with in-hospital cardiac arrest and cardiopulmonary resuscitation in critically ill adults with coronavirus disease 2019 (covid-19).
...Multicenter cohort study.
Intensive care units at 68 geographically diverse hospitals across the United States.
Critically ill adults (age ≥18 years) with laboratory confirmed covid-19.
In-hospital cardiac arrest within 14 days of admission to an intensive care unit and in-hospital mortality.
Among 5019 critically ill patients with covid-19, 14.0% (701/5019) had in-hospital cardiac arrest, 57.1% (400/701) of whom received cardiopulmonary resuscitation. Patients who had in-hospital cardiac arrest were older (mean age 63 (standard deviation 14)
60 (15) years), had more comorbidities, and were more likely to be admitted to a hospital with a smaller number of intensive care unit beds compared with those who did not have in-hospital cardiac arrest. Patients who received cardiopulmonary resuscitation were younger than those who did not (mean age 61 (standard deviation 14)
67 (14) years). The most common rhythms at the time of cardiopulmonary resuscitation were pulseless electrical activity (49.8%, 199/400) and asystole (23.8%, 95/400). 48 of the 400 patients (12.0%) who received cardiopulmonary resuscitation survived to hospital discharge, and only 7.0% (28/400) survived to hospital discharge with normal or mildly impaired neurological status. Survival to hospital discharge differed by age, with 21.2% (11/52) of patients younger than 45 years surviving compared with 2.9% (1/34) of those aged 80 or older.
Cardiac arrest is common in critically ill patients with covid-19 and is associated with poor survival, particularly among older patients.
Purpose
Etomidate and ketamine are hemodynamically stable induction agents often used to sedate critically ill patients during emergency endotracheal intubation. In 2015, quality improvement data ...from our hospital suggested a survival benefit at Day 7 from avoidance of etomidate in critically ill patients during emergency intubation. In this clinical trial, we hypothesized that randomization to ketamine instead of etomidate would be associated with Day 7 survival after emergency endotracheal intubation.
Methods
A prospective, randomized, open-label, parallel assignment, single-center clinical trial performed by an anesthesiology-based Airway Team under emergent circumstances at one high-volume medical center in the United States. 801 critically ill patients requiring emergency intubation were randomly assigned 1:1 by computer-generated, pre-randomized sealed envelopes to receive etomidate (0.2–0.3 mg/kg,
n
= 400) or ketamine (1–2 mg/kg,
n
= 401) for sedation prior to intubation. The pre-specified primary endpoint of the trial was Day 7 survival. Secondary endpoints included Day 28 survival.
Results
Of the 801 enrolled patients, 396 were analyzed in the etomidate arm, and 395 in the ketamine arm. Day 7 survival was significantly lower in the etomidate arm than in the ketamine arm (77.3% versus 85.1%, difference − 7.8, 95% confidence interval − 13, − 2.4,
p
= 0.005). Day 28 survival rates for the two groups were not significantly different (etomidate 64.1%, ketamine 66.8%, difference − 2.7, 95% confidence interval − 9.3, 3.9,
p
= 0.294).
Conclusion
While the primary outcome of Day 7 survival was greater in patients randomized to ketamine, there was no significant difference in survival by Day 28.
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