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Key Points: Question: How many excess deaths and years of potential life lost for the Black population, compared with the White population, occurred in the United States from 1999 through 2020? Findings: Based on Centers for Disease Control and Prevention data, excess deaths and years of potential life lost persisted throughout the period, with initial progress followed by stagnation of improvement and substantial worsening in 2020. The Black population had 1.63 million excess deaths, representing more than 80 million years of potential life lost over the study period. Meaning: After initial progress, excess mortality and years of potential life lost among the US Black population stagnated and then worsened, indicating a need for new approaches. Importance: Amid efforts in the US to promote health equity, there is a need to assess recent progress in reducing excess deaths and years of potential life lost among the Black population compared with the White population. Objective: To evaluate trends in excess mortality and years of potential life lost among the Black population compared with the White population. Design, setting, and participants: Serial cross-sectional study using US national data from the Centers for Disease Control and Prevention from 1999 through 2020. We included data from non-Hispanic White and non-Hispanic Black populations across all age groups. Exposures: Race as documented in the death certificates. Main outcomes and measures: Excess age-adjusted all-cause mortality, cause-specific mortality, age-specific mortality, and years of potential life lost rates (per 100 000 individuals) among the Black population compared with the White population. Results: From 1999 to 2011, the age-adjusted excess mortality rate declined from 404 to 211 excess deaths per 100 000 individuals among Black males (P for trend <.001). However, the rate plateaued from 2011 through 2019 (P for trend =.98) and increased in 2020 to 395—rates not seen since 2000. Among Black females, the rate declined from 224 excess deaths per 100 000 individuals in 1999 to 87 in 2015 (P for trend <.001). There was no significant change between 2016 and 2019 (P for trend =.71) and in 2020 rates increased to 192—levels not seen since 2005. The trends in rates of excess years of potential life lost followed a similar pattern. From 1999 to 2020, the disproportionately higher mortality rates in Black males and females resulted in 997 623 and 628 464 excess deaths, respectively, representing a loss of more than 80 million years of life. Heart disease had the highest excess mortality rates, and the excess years of potential life lost rates were largest among infants and middle-aged adults. Conclusions and relevance: Over a recent 22-year period, the Black population in the US experienced more than 1.63 million excess deaths and more than 80 million excess years of life lost when compared with the White population. After a period of progress in reducing disparities, improvements stalled, and differences between the Black population and the White population worsened in 2020. This study focuses on differences in mortality and years of potential life lost between Black and White populations to understand recent trends. [ABSTRACT FROM AUTHOR]

Key Points: Question: When medical devices that had been cleared under the FDA's 510(k) pathway are subject to Class I recalls, how often did the predicates for these devices also have a history of recalls? Findings: In this cross-sectional analysis of 156 cases of 510(k)–authorized devices with Class I recalls from 2017 through 2021, 44.1% used predicates with Class I recalls. In addition, 48.1% of these devices were subsequently used as predicates to authorize descendant devices later subject to Class I recalls. The risk of a Class I recall was 6.40 times higher for descendants that used predicates with Class I recalls than for devices using Class I recall–free predicates. Meaning: Stronger safeguards are needed to prevent problematic predicate selection and ensure patient safety. Importance: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall—the FDA's most serious designation indicating a high probability of adverse health consequences or death—as predicates for new devices. The consequences for patient safety are not known. Objective: To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway. Design and Setting: In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA's annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. Main Outcomes and Measures: Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls. Results: Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 [95% CI, 3.59-11.40]; P<.001). Conclusions and Relevance: Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety. This cross-sectional study evaluates the frequency of new devices receiving US Food and Drug Administration approval through its 510(k) pathway based on predicate devices that had been subject to a Class 1 recall. [ABSTRACT FROM AUTHOR]

The correlation existing between the automated external defibrillators (AEDs) and survival after in-hospital cardiac arrest is analyzed. The application of AEDs is not shown to enhance the survival of such patients.

A study was conducted to evaluated the association between length of stay and short-term outcomes among Medicare older patients hospitalized for heart failure. Results indicated that with a reduced length of hospital stay 30-day mortality decreased; however, posthospital readmission and mortality risk increased.

A study was conducted to investigate the association between a lack of health insurance and financial constraints on accessing care among those with health insurance and the time taken from onset to hospital admission in acute myocardial infarction (AMI). Results indicated that such factors did contribute to delays in seeking emergency care for AMI.

The study attempts to investigate the profile of US General surgery residents and highlight their attitudes, training experiences and professional expectations as well as differences due to sex and training years. The results indicate that general surgery residents undergo a wide variety of emotions including satisfaction as well as strain and do vary.

The study attempts to estimate racial differences in survival for patients following in-hospital cardiac arrests and the factors associated with it. The results indicate that African-American patients were less likely to survive discharge as compared to white patients and also that most of the racial differences were associated with the hospital in which African-American patients received care.

The study attempts to evaluate the hospital 30-day risk-standardized mortality rates (RSMRs) for those patients that have been discharged with acute myocardial infarction (AMI). The results indicate that there was a significant decrease in hospital mortality rate for patients with AMI.

A study was conducted to evaluate whether patients receiving an implantable cardioverter-defibrillator (ICD) from nonelectrophysiologists had more negative outcomes as compared to implants done by electrophysiologists who were certified for the procedure. Results indicated that implants done by nonelectrophysiologists had a higher risk of procedural complications.

The study aims to compare the mortality risk associated with hypoglycemia among patients with acute myocardial infarction who develop hypoglycemia spontaneously as against those who develop it as a result of insulin therapy. The results indicate that iatrogenic hypoglycemia after insulin therapy had much lower mortality rates as compared to spontaneous hypoglycemia.

Importance: Patient safety is a US national priority, yet lacks a comprehensive assessment of progress over the past decade.Objective: To determine the change in the rate of adverse events in hospitalized patients.Design, Setting, and Participants: This serial cross-sectional study used data from the Medicare Patient Safety Monitoring System from 2010 to 2019 to assess in-hospital adverse events in patients. The study included 244 542 adult patients hospitalized in 3156 US acute care hospitals across 4 condition groups from 2010 through 2019: acute myocardial infarction (17%), heart failure (17%), pneumonia (21%), and major surgical procedures (22%); and patients hospitalized from 2012 through 2019 for all other conditions (22%).Exposures: Adults aged 18 years or older hospitalized during each included calendar year.Main Outcomes and Measures: Information on adverse events (abstracted from medical records) included 21 measures across 4 adverse event domains: adverse drug events, hospital-acquired infections, adverse events after a procedure, and general adverse events (hospital-acquired pressure ulcers and falls). The outcomes were the total change over time for the observed and risk-adjusted adverse event rates in the subpopulations.Results: The study sample included 190 286 hospital discharges combined in the 4 condition-based groups of acute myocardial infarction, heart failure, pneumonia, and major surgical procedures (mean age, 68.0 [SD, 15.9] years; 52.6% were female) and 54 256 hospital discharges for the group including all other conditions (mean age, 57.7 [SD, 20.7] years; 59.8% were female) from 3156 acute care hospitals across the US. From 2010 to 2019, the total change was from 218 to 139 adverse events per 1000 discharges for acute myocardial infarction, from 168 to 116 adverse events per 1000 discharges for heart failure, from 195 to 119 adverse events per 1000 discharges for pneumonia, and from 204 to 130 adverse events per 1000 discharges for major surgical procedures. From 2012 to 2019, the rate of adverse events for all other conditions remained unchanged at 70 adverse events per 1000 discharges. After adjustment for patient and hospital characteristics, the annual change represented by relative risk in all adverse events per 1000 discharges was 0.94 (95% CI, 0.93-0.94) for acute myocardial infarction, 0.95 (95% CI, 0.94-0.96) for heart failure, 0.94 (95% CI, 0.93-0.95) for pneumonia, 0.93 (95% CI, 0.92-0.94) for major surgical procedures, and 0.97 (95% CI, 0.96-0.99) for all other conditions. The risk-adjusted adverse event rates declined significantly in all patient groups for adverse drug events, hospital-acquired infections, and general adverse events. For patients in the major surgical procedures group, the risk-adjusted rates of events after a procedure declined significantly.Conclusions and Relevance: In the US between 2010 and 2019, there was a significant decrease in the rates of adverse events abstracted from medical records for patients admitted for acute myocardial infarction, heart failure, pneumonia, and major surgical procedures and there was a significant decrease in the adjusted rates of adverse events between 2012 and 2019 for all other conditions. Further research is needed to understand the extent to which these trends represent a change in patient safety. [ABSTRACT FROM AUTHOR]

A study to evaluate the strategy of Merck and Co Inc. using guest authorship and ghost writers for promotion of rofecoxib was conducted. Results showed that it was difficult to error either guest or ghost writers without determining the extent of research carried out by them on the report.

Several states have laws mandating disclosure of payments made to physicians by pharmaceutical companies, and an investigation was made to determine the accessibility and quality of the available data, to describe the prevalence and magnitude of disclosed payments. Payments of $100 or more were made to physicians by pharmaceutical companies, but the laws did not provide easy access to public, and the quality of data accessed was not satisfactory.

The financial barriers to health care services or medication among individuals following acute myocardial infarction (AMI) and their association with subsequent health care outcomes are evaluated. The results have shown that the financial barriers to health care services and medications are increasingly associated with worse recovery after AMI, manifested as more angina, poorer quality of life and higher risk of rehospitalization.

A study was conducted among Medicare beneficiaries to determine whether the opening of specialty cardiac hospitals was associated with greater population-based rates of coronary revascularization. Results revealed that opening a specialty cardiac hospital within a hospital referral region (HRR) was associated with increasing use of coronary revascularization among Medic are beneficiaries.

A study evaluated whether the Medicare reimbursement policy changes that provide coverage for screening colonoscopies for all individuals are associated with an increase in either colonoscopy use or early stage colon cancer diagnosis in older patients. Results revealed that expansion of reimbursement to cover colon cancer screening is associated with an increased use of colonoscopy for Medicare beneficiaries and also an increased possibility of early stage diagnosis of colon cancer.

A study was conducted to quantify the representation of patients with renal disease in randomized controlled trials for interventions proven efficacious for cardiovascular disease. It was found that major cardiovascular disease trials frequently exclude patients with renal disease and do not provide adequate information on the renal function of enrollees or the effect of interventions on patients with renal disease.

A study was conducted to determine correlations among acute myocardial infarction (AMI) core process measures and the degree to which they explain the variation in hospital-specific, risk-standardized, 30-day mortality rates. The results indicated that the publicly reported AMI process measures capture a small proportion of the variation in hospital's risk-standardized short-term mortality rates.

A study was conducted to evaluate the effect of blinded peer review on the association between abstract characteristics and likelihood of abstract acceptance at a national research meeting. The study provided evidence of bias in the open review of abstracts, favoring authors from the United States, English-speaking countries outside the U.S. and prestigious academic institutions.

Concerns about the rationale for regionalized acute coronary syndromes (ACS) care are presented and some potential unintended consequences are outlined. Proponents contend that regionalized ACXS would save lives by improving access to new technologies, specialist physicians, and higher-quality care not available at other centers.

Race and ethnicity differences in door-to-drug and door-to-balloon times for patients receiving primary reperfusion for ST-segment elevation myocardial infarction are estimated. The results revealed that a substantial portion of the racial and ethnic disparity in time to treatment was accounted for by the specific hospital to which patients were admitted, in contrast to differential treatment by race and ethnicity inside the hospital.

The representation of various groups with regard to race, ethnicity, age, and sex in the cancer trial, despite its diversity in the participants are discussed. The representation of racial and ethnic minorities, the elderly, and women in cancer trials sponsored by the National Cancer Institute are characterized.

About one-fourth of all patients with both diabetes and heart failure are taking a diabetes drug that should not be given to these patients, according to a study of 12,505 patients surveyed in 1998-1999 and 13,158 surveyed in 2000-2001. Twenty-four percent received a prescription for metformin or a thiazolidinedione drug even though the FDA warns against giving these two drugs to patients with both diabetes and heart failure. In medical terms, these two drugs are contraindicated in patients with both diabetes and heart failure.

Elderly African-Americans who have heart failure receive the same quality of care that white patients do, according to a study of 29,732 Medicare patients. The African-American patients were hospitalized more frequently but had lower death rates than the white patients. African-Americans are more likely to develop heart failure than whites.

There is little evidence that low-carbohydrate diets are effective in producing long-term weight loss, according to researchers who analyzed 107 studies involving 3,268 people. Only five of the studies followed the participants for longer than three months. The weight loss that occurs from this diet occurs primarily from the reduced calories rather than the low-carbohydrate content of the diet. The Atkins diet is a well-known example of a low-carbohydrate diet.

Patients with congestive heart failure who are taking digoxin should have the dose adjusted to produce a blood level between 0.5 and 0.8 nanograms per milliliter. Blood levels higher than that may increase their risk of death, according to a study of 3,782 patients. All of the men in the study had a left ventricular ejection fraction of 45% or less.

Beta blockers do not increase the risk of depression, fatigue, or sexual problems, according to researchers who analyzed 15 studies involving more than 35,000 patients who took beta blockers to treat heart attack, heart failure, or hypertension. This is important because beta blockers can benefit many patients, but many doctors do not prescribe them., Context: [beta]-Blocker therapy remains substantially underused in cardiac patients despite its proven mortality benefits. Reluctance to prescribe these agents may derive from concerns about their association with symptoms of depression, fatigue, and sexual dysfunction. Objective: To determine the association of [beta]-blockers with depressive symptoms, fatigue, and sexual dysfunction by performing a quantitative review of randomized trials that tested [beta]-blockers in myocardial infarction, heart failure, and hypertension. Data Sources: Randomized trials of [beta]-blockers used in the treatment of myocardial infarction, heart failure, or hypertension were identified by searching the MEDLINE database for English-language articles (1966-2001). In addition, we searched the reference lists of previously published trials and reviews of [beta]-blockers for additional studies. Study Selection: Criteria for inclusion of trials in the review were: random allocation of study treatments, placebo control, noncrossover design, enrollment of at least 100 patients, and a minimum of 6 months of follow-up. The initial search produced 475 articles, 42 of which met these criteria. Fifteen of these trials reported on depressive symptoms, fatigue, or sexual dysfunction and were selected for inclusion. Data Extraction: For each trial, 1 author abstracted the frequency of adverse events in the [beta]-blocker and placebo groups and the numbers of patients randomized to the treatment groups. Two other authors verified the counts of events, and all authors adjudicated any discrepancies. Two different types of information on adverse events were abstracted: patient-reported symptoms and withdrawal of therapy due to a specified symptom. We categorized the tested [beta]-blockers by generation (early vs late) and lipid solubility (high vs low to moderate). Data Synthesis: The 15 trials involved more than 35000 subjects. [beta]-Blocker therapy was not associated with a significant absolute annual increase in risk of reported depressive symptoms (6 per 1000 patients; 95% confidence interval [CI], -7 to 19). [beta]-Blockers were associated with a small significant annual increase in risk of reported fatigue (18 per 1000 patients; 95% CI, 5-30), equivalent to 1 additional report of fatigue for every 57 patients treated per year with [beta]-blockers. [beta]-Blockers were also associated with a small, significant annual increase in risk of reported sexual dysfunction (5 per 1000 patients; 95% CI, 2-8), equivalent to one additional report for every 199 patients treated per year. None of the risks of adverse effects differed significantly by degree of [beta]-blocker lipid solubility. The risk associated with reported fatigue was significantly higher for early-generation than for late-generation [beta]-blockers (P=.04). Conclusion: The conventional wisdom that [beta]-blocker therapy is associated with substantial risks of depressive symptoms, fatigue, and sexual dysfunction is not supported by data from clinical trials. There is no significant increased risk of depressive symptoms and only small increased risks of fatigue and sexual dysfunction. The risks of these adverse effects should be put in the context of the documented benefits of these medications.

Internet-based report cards may not be the best way to rate hospitals. In a study of 141,914 Medicare patients admitted to 3,363 hospitals for treatment of a heart attack, report cards on HealthGrades.com did not accurately discriminate between hospitals that provided the best care and hospitals that provided the worst care., Context: Health care "report cards" have attracted significant consumer interest, particularly publicly available internet health care quality rating systems. However, the ability of these ratings to discriminate between hospitals is not known. Objective: To determine whether hospital rating for acute myocardial infarction (AMI) mortality from a prominent Internet hospital ratir g system accurately discriminate between hospitals&apos; performance based on process of care and outcomes. Design, Setting, and Patients: Data from the Cooperative Cardiovascular Project, a retrospective systematic medical record review of 141914 Medicare fee-for-service beneficiaries 65 years or older hospitalized with AMI at 3363 US acute care hospitals during a 4- to 8-month period between January 1994 and February 1996 were compared with ratings obtained from HealthGrades.com (1-star: worse outcomes than predicted, 5-star: better outcomes than predicted) based on 1994-1997 Medicare data. Main Outcome Measures: Quality indicators of AMI care, including use of acute reperfusion therapy, aspirin, [beta]-blockers, angiotensin-converting enzyme inhibitors; 30-day mortality. Results: Patients treated at higher-rated hospitals were significantly more likely to receive aspirin (admission: 75.4% 5-star vs 66.4% 1-star, P for trend = .001; discharge: 79.7% 5-star vs 68.0% 1-star, P = .001 and [beta]-blockers (admission: 54.8% 5-star vs 35.7% 1-star, P = .001; discharge: 63.3% 5-star vs 52.1% 1-star, P = .001), but not angiotensin-converting enzyme inhibitors (59.6% 5-star vs 57.4% 1-star, P = .40). Acute reperfusion therapy rates were highest for patients treated at 2-star hospitals (60.6%) and lowest for 5-star hospitals (53.6% 5-star, P =.008). Risk-standardized 30-day mortality rates were lower for patients treated at higher-rated than lower-rated hospitals (21.9% 1-star vs 15.9% 5-star, P = .001). However, there was marked heterogeneity within rating groups and substantial overlap of individual hospitals across rating strata for mortality and process of care; only 3.1% of comparisons between 1-star and 5-star hospitals had statistically lower risk-standardized 30-day mortality rat es in 5-star hospitals. Similar findings were observed in comparisons of 30-day mortality rates between individual hospitals in all other rating groups and when comparisons were restricted to hospitals with a minimum of 30 cases during the study period. Conclusion Hospital ratings published by a prominent Internet health care quality rating system identified groups of hospitals that, in the aggregate, differed in their quality of care and outcomes. However, the ratings poorly discriminated between any 2 individual hospitals&apos; process of care or mortality rates during the study period. Limitations in discrimination may undermine the value of health care quality ratings for patients or payers and may lead to misperceptions of hospitals&apos; performance.

Beta blockers can lower the mortality rate in patients with heart failure and also reduce the number of hospitalizations, according to research on over 10,000 patients. The FDA has approved metoprolol and carvedilol for use in heart failure., Context: Care of patients with heart failure has been revolutionized throughout the past decade. A paradigm shift in the strategy for treating heart failure caused by systolic dysfunction is in progress. Despite the initial perception about [beta]-blockers&apos; safety, they are now the most extensively studied class of agents in the treatment of heart failure and have emerged as an important intervention to improve the clinical outcomes of heart failure patients. Objective: To provide scientific rationale for the use of [beta]-blockers for patients with heart failure. Data Sources: All English-language articles of large, randomized controlled clinical trials assessing the mortality benefits of [beta]-blockers in patients with heart failure were identified to provide the scientific rationale for the use of [beta]-blockers in heart failure. Basic science studies were reviewed to provide an overview of the potential physiologic role of [beta]-blockers in heart failure. Finally, clinical guidelines for the treatment of patients with heart failure were assessed to determine current recommendations for the use of these agents. Study Selection and Data Extraction: Randomized controlled clinical trials of [beta]-blockers that included more than 300 subjects and assessed mortality as a primary end point. Data Synthesis: Of the 4 [beta]-blockers tested in large randomized controlled clinical trials of patients with heart failure, 3 are available in the United States, bisoprolol, carvedilol, and metoprolol; 2 of these, carvedilol and metoprolol, have Food and Drug Administration indications for the treatment of heart failure. Compared with placebo treatment, [beta]-blocker use is associated with a consistent 30% reduction in mortality and a 40% reduction in hospitalizations in patients with class II and III heart failure. Conclusions: Tested in more than 10 000 patients, [beta]-blockers reduce morbidity and mortality in class II through IV heart failure. Along with angiotensin-converting enzyme inhibitors, digoxin, and diuretics, [beta]-blockers have strengthened the armamentarium to improve clinical outcomes of heart failure patients. The science supporting [beta]-blockers must be translated into practice safely and rationally if the agents are to achieve their full potential.

Tips for using beta blockers to treat heart failure are provided, including patient selection, dosage, and adverse effects. Beta-blockers were once believed to be harmful for these patients, but studies have shown they can reduce mortality rates and the number of hospitalizations.

Women who have had a heart attack are less likely than men to have cardiac catheterization even when the woman's doctor is also a woman. This means that bias on the part of male doctors is not responsible for the lower rate of cardiac catheterization in female cardiac patients., Context Many studies indicate that women are less likely than men to undergo cardiac procedures after an acute myocardial infarction (AMI), raising concerns of sexual bias in clinical care. However, no data exist regarding the relationship between patient sex, physician sex, and use of cardiac procedures. Objective To determine whether sex differences in cardiac catheterization after AMI were greater when patients were treated by male attending physicians compared with female attending physicians. Design, Setting, and Patients Analysis of data from the Cooperative Cardiovascular Project, a retrospective medical record review. A total of 104231 Medicare fee-for-service beneficiaries who were hospitalized in US acute care hospitals for an AMI between January 1994 and February 1995. Main Outcome Measure Use of cardiac catheterization within 60 days of admission, compared between the 4 groups of patient sex-physician sex combinations. Results Women underwent fewer cardiac catheterizations than men when treated by either male physicians (38.6% vs 50.8%; P=.001) or female physicians (34.8% vs 45.8%; P=.001). Sex differences in procedure use were not greater when a patient and physician were of different sexes (P for interaction=.85). After potential confounders in multivariable analysis were accounted for, women were less likely to undergo cardiac catheterization (risk ratio, 0.90 [95% confidence interval {CI}, 0.880.92]), regardless of the treating physician&apos;s sex. Patients treated by male physicians were more likely to undergo cardiac catheterization (risk ratio, 1.06 [95% CI, 1.02-1.10]) than those treated by female physicians, regardless of patient sex. Conclusions Women who have had an AMI undergo a cardiac catheterization less often than men, whether treated by a male or female physician. These results suggest that factors other than sexual bias by male physicians toward women account for sex differences in cardiac procedure use.

This study describes the degree to which blood draws occurred among hospitalized patients during traditional sleep hours and investigates trends over time. [ABSTRACT FROM AUTHOR]