Sex-Related Differences in Patient Characteristics, Risk Factors, and Symptomatology in Older Adults with Pulmonary Embolism: Findings from the SERIOUS-PE Study.

Sex-specific factors are implicated in pulmonary embolism (PE) presentation in young patients, as indicated by increased risk in pregnancy. Whether sex differences exist in PE presentation, comorbidities, and symptomatology in older adults, the age group in which most PEs occur, remains unknown. We identified older adults (aged ≥65 years) with PE in a large international PE registry replete with information about relevant clinical characteristics (RIETE registry, 2001-2021). To provide national data from the United States, we assessed sex differences in clinical characteristics and risk factors of Medicare beneficiaries with PE (2001-2019). The majority of older adults with PE in RIETE (19,294/33,462, 57.7%) and in the Medicare database (551,492/948,823, 58.7%) were women. Compared with men, women with PE less frequently had atherosclerotic diseases, lung disease, cancer, or unprovoked PE, but more frequently had varicose veins, depression, prolonged immobility, or history of hormonal therapy (p < 0.001 for all). Women less often presented with chest pain (37.3 vs. 40.6%) or hemoptysis (2.4 vs. 5.6%) but more often with dyspnea (84.6 vs. 80.9%) (p < 0.001 for all). Measures of clot burden, PE risk stratification, and use of imaging modalities were comparable between women and men. PE is more common in elderly women than in men. Cancer and cardiovascular disease are more common in men, whereas transient provoking factors including trauma, immobility, or hormone therapy are more common in elderly women with PE. Whether such differences correlate with disparities in treatment or differences in short- or long-term clinical outcomes warrants further investigation.

Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism: Rationale and design of the SERIOUS-PE study.

BACKGROUND: Sex is an important factor associated with pulmonary embolism (PE) disease presentation and outcomes, which may be related to pathobiological, social, and treatment-based differences. We are seeking to illuminate sex differences in pulmonary embolism presentation, care, and outcomes using an international registry and a national US database of people 65 years and older, the age group in which the majority of these events occur. METHODS: The Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism (SERIOUS-PE) study has been designed to address knowledge gaps in this area. This study will use data from the Registro Informatizado Enfermedad TromboEmbolica (RIETE) registry and the US Medicare Fee-For-Service beneficiaries. RIETE is a large international registry of patients with venous thromboembolism with data collected on PE presentation, risk factors, co-morbidities, drug and interventional therapies, as well as 30-day and 1-year outcomes (including recurrent VTE, major bleeding, and mortality). Data from US Medicare Fee-For-Service beneficiaries will be used to understand the sex differences in PE hospitalizations, advanced therapies, and outcomes at 30-day and 1-year follow-up. Assessment of outcomes in both databases will be performed in unadjusted models, as well as those adjusted for demographics, co-morbidities, and treatments, to understand whether the potential sex differences in outcomes are related to differences in risk factors and co-morbidities, potential disparities in treatment, or a plausible biological difference in women versus men. Linear trends will be assessed over time. RESULTS: RIETE data from March 2001 through March 2021 include 33,462 elderly patients with PE, of whom 19,294 (57.7%) were women and 14,168 (42.3%) were men. In the Medicare Fee-For-Service database, between January 2001 and December 31, 2019, 1,030,247 patients were hospitalized with a principal discharge diagnosis of PE, of whom 599,816 (58.2%) were women and 430,431 (41.8%) were men. CONCLUSIONS: Findings from the SERIOUS-PE study will help address important knowledge gaps related to sex differences in presentation and risk factors, treatment patterns, and outcomes of older adults with PE. The results may guide changes in prognostic prediction rules based on sex-specific findings, identify sex-based disparities in care delivery that should be addressed by quality improvement, or uncover potential differences in response to available therapies that warrant testing in dedicated randomized trials.

Randomised controlled trial of a prognostic assessment and management pathway to reduce the length of hospital stay in normotensive patients with acute pulmonary embolism.

BACKGROUND: The length of hospital stay (LOS) for acute pulmonary embolism (PE) varies considerably. Whether the upfront use of a PE prognostic assessment and management pathway is effective in reducing the LOS remains unknown. METHODS: We conducted a randomised controlled trial of adults hospitalised for acute PE: patients were assigned either to a prognostic assessment and management pathway involving risk stratification followed by predefined criteria for mobilisation and discharge (intervention group) or to usual care (control group). The primary end-point was LOS. The secondary end-points were the cost of prognostic tests and of hospitalisation, and 30-day clinical outcomes. RESULTS: Of 500 patients who underwent randomisation, 498 were included in the modified intention-to-treat analysis. The median LOS was 4.0 days (interquartile range (IQR) 3.7-4.2 days) in the intervention group and 6.1 days (IQR 5.7-6.5 days) in the control group (p<0.001). The mean total cost of prognostic tests was EUR 174.76 in the intervention group, compared with EUR 233.12 in the control group (mean difference EUR -58.37, 95% CI EUR -84.34- to -32.40). The mean total hospitalisation cost per patient was EUR 2085.66 in the intervention group, compared with EUR 3232.97 in the control group (mean difference EUR -1147.31, 95% CI EUR -1414.97- to -879.65). No significant differences were observed in 30-day readmission (4.0% versus 4.8%), all-cause mortality (2.4% versus 2.0%) or PE-related mortality (0.8% versus 1.2%) rates. CONCLUSIONS: The use of a prognostic assessment and management pathway was effective in reducing the LOS for acute PE.

National and Regional Trends in Deep Vein Thrombosis Hospitalization Rates, Discharge Disposition, and Outcomes for Medicare Beneficiaries.

INTRODUCTION: Older adults are at increased risk of developing deep vein thrombosis. Little is known about national trends of deep vein thrombosis hospitalizations in the context of primary and secondary prevention efforts. METHODS: Medicare standard analytic files were analyzed from 2015-2017 to identify Fee-For-Service patients aged ≥65 years who had a principal discharge diagnosis for deep vein thrombosis from 1999 to 2010. We reported the deep vein thrombosis hospitalization rates per 100,000 person-years as well as 30-day and 1-year mortality rates. We used mixed-effects models to calculate adjusted outcomes. RESULTS: Overall, there were 726,423 deep vein thrombosis hospitalizations in Medicare Fee-for-Service from 1999 to 2010. Deep vein thrombosis hospitalization rate adjusted for age, sex, and race decreased from 264 per 100,000 person-years in 1999 to 167 per 100,000 person-years in 2010, a relative decline of 36.7% (P < .0001). Hospitalizations decreased for all subgroups by age, sex, and race with the exception of black patients (316 to 382 per 100,000 person-years, a relative increase of 20.8%) (P < .0001). Hospital length of stay decreased from 6.1 days in 1999 to 5.0 days in 2010, and the proportion of patients discharged to home decreased from 57.2% to 44.1%. Risk-adjusted 30-day, 6-month, and 1-year mortality and 30-day readmission rates remained relatively stable across the study period, but were highest among women in recent years. CONCLUSIONS: The overall deep vein thrombosis hospitalization rate decreased from 1999 to 2010, except for black patients. Decreases in hospitalizations may reflect changes in clinical practice with increased outpatient rather than inpatient management, and faster transitions to outpatient care for management of deep vein thrombosis.

Assessment of coexisting deep vein thrombosis for risk stratification of acute pulmonary embolism.

BACKGROUND: In patients with acute pulmonary embolism (PE), studies have shown an association between coexisting deep vein thrombosis (DVT) and short-term prognosis. It is not known whether complete compression ultrasound testing (CCUS) improves the risk stratification of their disease beyond the recommended prognostic models. METHODS: We included patients with normotensive acute symptomatic PE and prognosticated them with the European Society of Cardiology (ESC) risk model for PE. Subsequently, we determined the prognostic significance of coexisting DVT in patients with various ESC risk categories. The primary endpoint was a complicated course after the diagnosis of PE, defined as death from any cause, haemodynamic collapse, or adjudicated recurrent PE. RESULTS: According to the ESC model, 37% of patients were low-risk, 56% were intermediate-low risk, and 6.7% were intermediate-high risk. CCUS demonstrated coexisting DVT in 375 (44%) patients. Among the 313 patients with low-risk PE, coexisting DVT (46%) did not show a significant increased risk of complicated course (2.8%; 95% confidence interval [CI], 0.8%-7.0%), compared with those without DVT (0.6%; 95% CI, 0%-3.2%), (P = 0.18). Of the 478 patients with intermediate-low risk PE, a complicated course was 14% and 6.8% for those with and without DVT, respectively (P = 0.01). Of the 57 patients that had intermediate-high risk PE, a complicated course occurred in 17% and 18% for those with and without DVT, respectively (P = 1.0). CONCLUSIONS: In normotensive patients with PE, testing for coexisting DVT might improve risk stratification of patients at intermediate-low risk for short-term complications.

Vena Caval Filter Utilization and Outcomes in Pulmonary Embolism: Medicare Hospitalizations From 1999 to 2010.

BACKGROUND: Inferior vena caval filters (IVCFs) may prevent recurrent pulmonary embolism (PE). Despite uncertainty about their net benefit, patterns of use and outcomes of these devices in contemporary practice are unknown. OBJECTIVES: The authors determined the trends in utilization rates and outcomes of IVCF placement in patients with PE and explored regional variations in use in the United States. METHODS: In a national cohort study of all Medicare fee-for-service beneficiaries ≥65 years of age with principal discharge diagnoses of PE between 1999 and 2010, rates of IVCF placement per 100,000 beneficiary-years and per 1,000 patients with PE were determined. The 30-day and 1-year mortality rates after IVCF placement were also investigated. RESULTS: Among 556,658 patients hospitalized with PE, 94,427 underwent IVCF placement. Between 1999 and 2010, the number of PE hospitalizations with IVCF placement increased from 5,003 to 8,928, representing an increase in the rate per 100,000 beneficiary-years from 19.0 to 32.5 (p < 0.001 for both). As the total number of PE hospitalizations increased (from 31,746 in 1999 to 54,392 in 2010), the rate of IVCF placement per 1,000 PE hospitalizations did not change significantly (from 157.6 to 164.1, p = 0.11). Results were consistent across demographic subgroups, although IVCF use was higher in blacks and patients ≥85 years of age. IVCF utilization varied widely across regions, with the highest rate in the South Atlantic region and the lowest rate in the Mountain region. CONCLUSIONS: In a period of increasing PE hospitalizations among Medicare fee-for-service beneficiaries, IVCF placement increased as utilization rates in patients with PE remained greater than 15%. Mortality associated with PE hospitalizations is declining, regardless of IVCF use.

National Trends in Pulmonary Embolism Hospitalization Rates and Outcomes for Adults Aged ≥65 Years in the United States (1999 to 2010).

Little is known about national trends of pulmonary embolism (PE) hospitalizations and outcomes in older adults in the context of recent diagnostic and therapeutic advances. Therefore, we conducted a retrospective cohort study of 100% Medicare fee-for-service beneficiaries hospitalized from 1999 to 2010 with a principal discharge diagnosis code for PE. The adjusted PE hospitalization rate increased from 129/100,000 person-years in 1999 to 302/100,000 person-years in 2010, a relative increase of 134% (p <0.001). Black patients had the highest rate of increase (174 to 548/100,000 person-years) among all age, gender, and race categories. The mean (standard deviation) length of hospital stay decreased from 7.6 (5.7) days in 1999 to 5.8 (4.4) days in 2010, and the proportion of patients discharged to home decreased from 51.1% (95% confidence interval [CI] 50.5 to 51.6) to 44.1% (95% CI 43.7 to 44.6), whereas more patients were discharged with home health care and to skilled nursing facilities. The in-hospital mortality rate decreased from 8.3% (95% CI 8.0 to 8.6) in 1999 to 4.4% (95% CI 4.2 to 4.5) in 2010, as did adjusted 30-day (from 12.3% [95% CI 11.9 to 12.6] to 9.1% [95% CI 8.5 to 9.7]) and 6-month mortality rates (from 23.0% [95% CI 22.5 to 23.4] to 19.6% [95% CI 18.8 to 20.5]). There were no significant racial differences in mortality rates by 2010. There was no change in the adjusted 30-day all-cause readmission rate from 1999 to 2010. In conclusion, PE hospitalization rates increased substantially from 1999 to 2010, with a higher rate for black patients. All mortality rates decreased but remained high. The increase in hospitalization rates and continued high mortality and readmission rates confirm the significant burden of PE for older adults.

Trends in hospitalization rates and outcomes of endocarditis among Medicare beneficiaries.

OBJECTIVES: The aim of this study was to determine the hospitalization rates and outcomes of endocarditis among older adults. BACKGROUND: Endocarditis is the most serious cardiovascular infection and is especially common among older adults. Little is known about recent trends for endocarditis hospitalizations and outcomes. METHODS: Using Medicare inpatient Standard Analytic Files, we identified all fee-for-service beneficiaries age ≥65 years with a principal or secondary diagnosis of endocarditis from 1999 to 2010. We used Medicare Denominator Files to report hospitalizations per 100,000 person-years. Rates of 30-day and 1-year mortality were calculated using Vital Status Files. We used mixed-effects models to calculate adjusted rates of hospitalization and mortality and to compare the results before and after 2007, when the American Heart Association revised their recommendations for endocarditis prophylaxis. RESULTS: Overall, 262,658 beneficiaries were hospitalized with endocarditis. The adjusted hospitalization rate increased from 1999 to 2005, reaching 83.5 per 100,000 person-years in 2005, and declined during 2006 to 2007. After 2007, the decline continued, reaching 70.6 per 100,000 person-years in 2010. Adjusted 30-day and 1-year mortality rates ranged from 14.2% to 16.5% and from 32.6% to 36.2%, respectively. There were no consistent changes in adjusted rates of 30-day and 1-year mortality after 2007. Trends in rates of hospitalization and outcomes were consistent across demographic subgroups. Adjusted rates of hospitalization and mortality declined consistently in the subgroup with a principal diagnosis of endocarditis. CONCLUSIONS: Our study highlights the high burden of endocarditis among older adults. We did not observe an increase in adjusted rates of hospitalization or mortality associated with endocarditis after publication of the 2007 guidelines.

Most important outcomes research papers on treatment of stable coronary artery disease.

The following are highlights from the new series, Circulation: Cardiovascular Quality and Outcomes Topic Review. This series will summarize the most important manuscripts, as selected by the Editor, that have been published in the Circulation portfolio. The objective of this series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes, and general cardiology audience. The studies included in this article represent the most significant research related to treatment of stable coronary artery disease (CAD).

Comparison of three risk assessment methods for venous thromboembolism prophylaxis.

Venous thromboembolism (VTE) is a major problem for hospitalized patients. Nevertheless, adherence to VTE prophylaxis guidelines is suboptimal, partly because of physicians' neglect due to excessive workload. Simplified risk assessment methods (RAMs) facilitate timely risk stratification and thromboprophylaxis. However, the accuracy of such RAMs has not been extensively studied. Using the prospectively collected data from hospitalized patients of Masih-Daneshvari Hospital, we tested the accuracy of the Goldhaber RAM and the Harinath and St. John RAM for VTE prophylaxis, compared with the eighth edition of the American College of Chest Physicians (ACCP) recommendations. We evaluated 1091 patients. With reference to the ACCP recommendations, both RAMs had high specificities for detection of patients at risk of VTE (97.33 and 99.11%, respectively); however, we found significant interdepartment differences. The Goldhaber RAM had superior accuracy in medical oncology patients (P = 0.03), whereas the Harinath and St. John method was superior among surgical patients (P < 0.001). Overall accuracies of Goldhaber RAM for appropriate VTE risk assessment and for proper detection of at-risk patients were close to 60%. Corresponding figures were close to 70% for the Harinath and St. John method. Simplified VTE prophylaxis RAMs are valuable, especially for transmitting electronic alerts and for timely risk assessment and thromboprophylaxis. Both of the studied RAMs had high specificities and positive-predictive values, minimizing the risk of overprophylaxis. Improving the sensitivity of such RAMs can help for timely risk assessment for a greater array of real-world patients.

Most important outcomes research papers on anticoagulation for cardiovascular disease.

The following are highlights from the new series, Circulation: Cardiovascular Quality and Outcomes Topic Review. This series will summarize the most important manuscripts, as selected by the Editor, that have been published in the Circulation portfolio. The objective of this new series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes, and general cardiology audience. The studies included in this article represent the most significant research in the area of anticoagulation for cardiovascular disease.

Most important articles on cardiovascular disease among racial and ethnic minorities.

The following are highlights from the new series, Circulation: Cardiovascular Quality and Outcomes Topic Review. This series will summarize the most important manuscripts, as selected by the Editor, that have published in the Circulation portfolio. The objective of this new series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes, and general cardiology audience. The studies included in this article represent the most significant research in the area of cardiovascular disease among racial and ethnic minorities.

Most important papers in health costs, cost-effectiveness, and resource utilization.

The following are highlights from the new series, Circulation: Cardiovascular Quality and Outcomes Topic Review. This series will summarize the most important manuscripts (as selected by the Editor) that have published in the Circulation portfolio. The objective of this new series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes, and general cardiology audience. The studies included in this article represent the most significant research in the area of health costs, cost-effectiveness, and resource utilization.

AssessMent of ProphylAxis for VenouS ThromboembolIsm in hospitalized patients: the MASIH study.

BACKGROUND: Venous thromboembolism (VTE) accounts for several cases of in-hospital mortality (over 100 000 deaths annually in the West). Despite the existence of effective prophylaxis guidelines for at-risk patients, the guidelines adherence is missing. METHODS: We evaluated the thromboprophylaxis reception and appropriateness based on the eighth edition of the American College of Chest Physicians (ACCP) guidelines on VTE prophylaxis, among hospitalized patients of a World Health Organization (WHO)-collaborating teaching hospital in a 3-month period. RESULTS: From the 904 evaluated cases, 481 entered the study. Appropriate decision on whether to prophylaxe or not, was made in 305 (63.40%), however, complete appropriateness (considering correct regimen type, dosing, and duration) was seen only in 229 patients (47.60%). The ACCP risk for VTE was the strongest predictor of thromboprophylaxis prescription (odds ratio [OR]: 2.62, 95% confidence interval [CI]: 1.35-5.05). CONCLUSIONS: Our thromboprophylaxis results were comparable to that of Western countries. Improved thromboprophylaxis appropriateness, which requires improving the physicians' thromboprophylaxis awareness and knowledge, could reduce the rate of in-hospital VTE and translate into better patient care.