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1.
Am Heart J ; 243: 77-86, 2022 01.
Article in English | MEDLINE | ID: covidwho-1536405

ABSTRACT

BACKGROUND: Regulatory agencies have endorsed more limited approaches to clinical trial site monitoring. However, the impact of different monitoring strategies on trial conduct and outcomes is unclear. METHODS: We conducted a patient-level block-randomized controlled trial evaluating the effect of intensive versus limited monitoring on cardiovascular clinical trial conduct and outcomes nested within the CoreValve Continued Access and Expanded Use Studies. Intensive monitoring included complete source data verification of all critical datapoints whereas limited monitoring included automated data checks only. This study's endpoints included clinical trial outcome ascertainment as well as monitoring action items, protocol deviations, and adverse event ascertainment. RESULTS: A total of 2,708 patients underwent transcatheter aortic valve replacement (TAVR) and were randomized to either intensive monitoring (n = 1,354) or limited monitoring (n = 1,354). Monitoring action items were more common with intensive monitoring (52% vs 15%; P < .001), but there was no difference in the percentage of patients with any protocol deviation (91.6% vs 90.4%; P = .314). The reported incidence of trial outcomes between intensive and limited monitoring was similar for mortality (30 days: 4.8% vs 5.5%, P = .442; 1 year: 20.3% vs 21.3%, P = .473) and stroke (30 days: 2.8% vs 2.4%, P = .458), as well as most secondary trial outcomes with the exception of bleeding (intensive: 36.3% vs limited: 32.0% at 30 days, P = .019). There was a higher reported incidence of cardiac adverse events reported in the intensive monitoring group at 1 year (76.7% vs 72.4%; P = .019). CONCLUSIONS: Tailored limited monitoring strategies can be implemented without influencing the integrity of TAVR trial outcomes.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Stroke , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Heart Valve Prosthesis/adverse effects , Humans , Incidence , Risk Factors , Stroke/epidemiology , Stroke/etiology , Stroke/prevention & control , Transcatheter Aortic Valve Replacement/methods , Treatment Outcome
3.
Am J Med ; 134(11): 1380-1388.e3, 2021 11.
Article in English | MEDLINE | ID: covidwho-1397151

ABSTRACT

BACKGROUND: Whether the volume of coronavirus disease 2019 (COVID-19) hospitalizations is associated with outcomes has important implications for the organization of hospital care both during this pandemic and future novel and rapidly evolving high-volume conditions. METHODS: We identified COVID-19 hospitalizations at US hospitals in the American Heart Association COVID-19 Cardiovascular Disease Registry with ≥10 cases between January and August 2020. We evaluated the association of COVID-19 hospitalization volume and weekly case growth indexed to hospital bed capacity, with hospital risk-standardized in-hospital case-fatality rate (rsCFR). RESULTS: There were 85 hospitals with 15,329 COVID-19 hospitalizations, with a median hospital case volume was 118 (interquartile range, 57, 252) and median growth rate of 2 cases per 100 beds per week but varied widely (interquartile range: 0.9 to 4.5). There was no significant association between overall hospital COVID-19 case volume and rsCFR (rho, 0.18, P = .09). However, hospitals with more rapid COVID-19 case-growth had higher rsCFR (rho, 0.22, P = 0.047), increasing across case growth quartiles (P trend = .03). Although there were no differences in medical treatments or intensive care unit therapies (mechanical ventilation, vasopressors), the highest case growth quartile had 4-fold higher odds of above median rsCFR, compared with the lowest quartile (odds ratio, 4.00; 1.15 to 13.8, P = .03). CONCLUSIONS: An accelerated case growth trajectory is a marker of hospitals at risk of poor COVID-19 outcomes, identifying sites that may be targets for influx of additional resources or triage strategies. Early identification of such hospital signatures is essential as our health system prepares for future health challenges.


Subject(s)
Bed Occupancy/statistics & numerical data , COVID-19 , Hospital Bed Capacity/statistics & numerical data , Intensive Care Units/statistics & numerical data , Mortality , Quality Improvement/organization & administration , COVID-19/mortality , COVID-19/therapy , Civil Defense , Health Care Rationing/organization & administration , Health Care Rationing/standards , Hospital Mortality , Hospitalization/statistics & numerical data , Humans , Outcome Assessment, Health Care , Registries , Risk Assessment , SARS-CoV-2 , Triage/organization & administration , United States/epidemiology
4.
Circulation ; 143(24): 2346-2354, 2021 06 15.
Article in English | MEDLINE | ID: covidwho-1304328

ABSTRACT

BACKGROUND: Cardiovascular deaths increased during the early phase of the COVID-19 pandemic in the United States. However, it is unclear whether diverse racial/ethnic populations have experienced a disproportionate rise in heart disease and cerebrovascular disease deaths. METHODS: We used the National Center for Health Statistics to identify heart disease and cerebrovascular disease deaths for non-Hispanic White, non-Hispanic Black, non-Hispanic Asian, and Hispanic individuals from March to August 2020 (pandemic period), as well as for the corresponding months in 2019 (historical control). We determined the age- and sex-standardized deaths per million by race/ethnicity for each year. We then fit a modified Poisson model with robust SEs to compare change in deaths by race/ethnicity for each condition in 2020 versus 2019. RESULTS: There were a total of 339 076 heart disease and 76 767 cerebrovascular disease deaths from March through August 2020, compared with 321 218 and 72 190 deaths during the same months in 2019. Heart disease deaths increased during the pandemic in 2020, compared with the corresponding period in 2019, for non-Hispanic White (age-sex standardized deaths per million, 1234.2 versus 1208.7; risk ratio for death [RR], 1.02 [95% CI, 1.02-1.03]), non-Hispanic Black (1783.7 versus 1503.8; RR, 1.19 [95% CI, 1.17-1.20]), non-Hispanic Asian (685.7 versus 577.4; RR, 1.19 [95% CI, 1.15-1.22]), and Hispanic (968.5 versus 820.4; RR, 1.18 [95% CI, 1.16-1.20]) populations. Cerebrovascular disease deaths also increased for non-Hispanic White (268.7 versus 258.2; RR, 1.04 [95% CI, 1.03-1.05]), non-Hispanic Black (430.7 versus 379.7; RR, 1.13 [95% CI, 1.10-1.17]), non-Hispanic Asian (236.5 versus 207.4; RR, 1.15 [95% CI, 1.09-1.21]), and Hispanic (264.4 versus 235.9; RR, 1.12 [95% CI, 1.08-1.16]) populations. For both heart disease and cerebrovascular disease deaths, Black, Asian, and Hispanic populations experienced a larger relative increase in deaths than the non-Hispanic White population (interaction term, P<0.001). CONCLUSIONS: During the COVID-19 pandemic in the United States, Black, Hispanic, and Asian populations experienced a disproportionate rise in deaths caused by heart disease and cerebrovascular disease, suggesting that these groups have been most impacted by the indirect effects of the pandemic. Public health and policy strategies are needed to mitigate the short- and long-term adverse effects of the pandemic on the cardiovascular health of diverse populations.


Subject(s)
COVID-19/pathology , Cerebrovascular Disorders/mortality , Health Status Disparities , Heart Diseases/mortality , Adult , African Americans/statistics & numerical data , Aged , Asian Americans/statistics & numerical data , COVID-19/complications , COVID-19/epidemiology , COVID-19/virology , Cerebrovascular Disorders/complications , Cerebrovascular Disorders/ethnology , Cerebrovascular Disorders/pathology , Female , Heart Diseases/complications , Heart Diseases/ethnology , Hospital Mortality/ethnology , Humans , Male , Middle Aged , Pandemics , Risk , SARS-CoV-2/isolation & purification , United States/epidemiology , /statistics & numerical data
5.
Circulation ; 143(24): 2346-2354, 2021 06 15.
Article in English | MEDLINE | ID: covidwho-1232383

ABSTRACT

BACKGROUND: Cardiovascular deaths increased during the early phase of the COVID-19 pandemic in the United States. However, it is unclear whether diverse racial/ethnic populations have experienced a disproportionate rise in heart disease and cerebrovascular disease deaths. METHODS: We used the National Center for Health Statistics to identify heart disease and cerebrovascular disease deaths for non-Hispanic White, non-Hispanic Black, non-Hispanic Asian, and Hispanic individuals from March to August 2020 (pandemic period), as well as for the corresponding months in 2019 (historical control). We determined the age- and sex-standardized deaths per million by race/ethnicity for each year. We then fit a modified Poisson model with robust SEs to compare change in deaths by race/ethnicity for each condition in 2020 versus 2019. RESULTS: There were a total of 339 076 heart disease and 76 767 cerebrovascular disease deaths from March through August 2020, compared with 321 218 and 72 190 deaths during the same months in 2019. Heart disease deaths increased during the pandemic in 2020, compared with the corresponding period in 2019, for non-Hispanic White (age-sex standardized deaths per million, 1234.2 versus 1208.7; risk ratio for death [RR], 1.02 [95% CI, 1.02-1.03]), non-Hispanic Black (1783.7 versus 1503.8; RR, 1.19 [95% CI, 1.17-1.20]), non-Hispanic Asian (685.7 versus 577.4; RR, 1.19 [95% CI, 1.15-1.22]), and Hispanic (968.5 versus 820.4; RR, 1.18 [95% CI, 1.16-1.20]) populations. Cerebrovascular disease deaths also increased for non-Hispanic White (268.7 versus 258.2; RR, 1.04 [95% CI, 1.03-1.05]), non-Hispanic Black (430.7 versus 379.7; RR, 1.13 [95% CI, 1.10-1.17]), non-Hispanic Asian (236.5 versus 207.4; RR, 1.15 [95% CI, 1.09-1.21]), and Hispanic (264.4 versus 235.9; RR, 1.12 [95% CI, 1.08-1.16]) populations. For both heart disease and cerebrovascular disease deaths, Black, Asian, and Hispanic populations experienced a larger relative increase in deaths than the non-Hispanic White population (interaction term, P<0.001). CONCLUSIONS: During the COVID-19 pandemic in the United States, Black, Hispanic, and Asian populations experienced a disproportionate rise in deaths caused by heart disease and cerebrovascular disease, suggesting that these groups have been most impacted by the indirect effects of the pandemic. Public health and policy strategies are needed to mitigate the short- and long-term adverse effects of the pandemic on the cardiovascular health of diverse populations.


Subject(s)
COVID-19/pathology , Cerebrovascular Disorders/mortality , Health Status Disparities , Heart Diseases/mortality , Adult , African Americans/statistics & numerical data , Aged , Asian Americans/statistics & numerical data , COVID-19/complications , COVID-19/epidemiology , COVID-19/virology , Cerebrovascular Disorders/complications , Cerebrovascular Disorders/ethnology , Cerebrovascular Disorders/pathology , Female , Heart Diseases/complications , Heart Diseases/ethnology , Hospital Mortality/ethnology , Humans , Male , Middle Aged , Pandemics , Risk , SARS-CoV-2/isolation & purification , United States/epidemiology , /statistics & numerical data
6.
J Am Coll Cardiol ; 77(2): 159-169, 2021 01 19.
Article in English | MEDLINE | ID: covidwho-1014576

ABSTRACT

BACKGROUND: Although the direct toll of COVID-19 in the United States has been substantial, concerns have also arisen about the indirect effects of the pandemic. Hospitalizations for acute cardiovascular conditions have declined, raising concern that patients may be avoiding hospitals because of fear of contracting severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2). Other factors, including strain on health care systems, may also have had an indirect toll. OBJECTIVES: This investigation aimed to evaluate whether population-level deaths due to cardiovascular causes increased during the COVID-19 pandemic. METHODS: The authors conducted an observational cohort study using data from the National Center for Health Statistics to evaluate the rate of deaths due to cardiovascular causes after the onset of the pandemic in the United States, from March 18, 2020, to June 2, 2020, relative to the period immediately preceding the pandemic (January 1, 2020 to March 17, 2020). Changes in deaths were compared with the same periods in the previous year. RESULTS: There were 397,042 cardiovascular deaths from January 1, 2020, to June 2, 2020. Deaths caused by ischemic heart disease increased nationally after the onset of the pandemic in 2020, compared with changes over the same period in 2019 (ratio of the relative change in deaths per 100,000 in 2020 vs. 2019: 1.11, 95% confidence interval: 1.04 to 1.18). An increase was also observed for deaths caused by hypertensive disease (1.17, 95% confidence interval: 1.09 to 1.26), but not for heart failure, cerebrovascular disease, or other diseases of the circulatory system. New York City experienced a large relative increase in deaths caused by ischemic heart disease (2.39, 95% confidence interval: 1.39 to 4.09) and hypertensive diseases (2.64, 95% confidence interval: 1.52 to 4.56) during the pandemic. More modest increases in deaths caused by these conditions occurred in the remainder of New York State, New Jersey, Michigan, and Illinois but not in Massachusetts or Louisiana. CONCLUSIONS: There was an increase in deaths caused by ischemic heart disease and hypertensive diseases in some regions of the United States during the initial phase of the COVID-19 pandemic. These findings suggest that the pandemic may have had an indirect toll on patients with cardiovascular disease.


Subject(s)
COVID-19 , Cardiovascular Diseases/mortality , Cohort Studies , Humans , Time Factors , United States/epidemiology
7.
Health Aff (Millwood) ; 39(11): 1984-1992, 2020 11.
Article in English | MEDLINE | ID: covidwho-732986

ABSTRACT

Massachusetts has one of the highest cumulative incidence rates of coronavirus disease 2019 (COVID-19) cases in the US. Understanding which specific demographic, economic, and occupational factors have contributed to disparities in COVID-19 incidence rates across the state is critical to informing public health strategies. We performed a cross-sectional study of 351 Massachusetts cities and towns from January 1 to May 6, 2020, and found that a 10-percentage-point increase in the Black non-Latino population was associated with an increase of 312.3 COVID-19 cases per 100,000 population, whereas a 10-percentage-point increase in the Latino population was associated with an increase of 258.2 cases per 100,000. Independent predictors of higher COVID-19 rates included the proportion of foreign-born noncitizens living in a community, mean household size, and share of food service workers. After adjustment for these variables, the association between the Latino population and COVID-19 rates was attenuated. In contrast, the association between the Black population and COVID-19 rates persisted but may be explained by other systemic inequities. Public health and policy efforts that improve care for foreign-born noncitizens, address crowded housing, and protect food service workers may help mitigate the spread of COVID-19 among minority communities.


Subject(s)
Coronavirus Infections/epidemiology , Health Status Disparities , Pneumonia, Viral/epidemiology , Adult , Betacoronavirus/isolation & purification , COVID-19 , Female , Humans , Incidence , Male , Massachusetts/epidemiology , Middle Aged , Minority Groups/statistics & numerical data , Morbidity , Pandemics , SARS-CoV-2
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