A precise performance-based reimbursement model for the multi-centre NAPKON cohorts - development and evaluation.

Fair allocation of funding in multi-centre clinical studies is challenging. Models commonly used in Germany - the case fees ("fixed-rate model", FRM) and up-front staffing and consumables ("up-front allocation model", UFAM) lack transparency and fail to suitably accommodate variations in centre performance. We developed a performance-based reimbursement model (PBRM) with automated calculation of conducted activities and applied it to the cohorts of the National Pandemic Cohort Network (NAPKON) within the Network of University Medicine (NUM). The study protocol activities, which were derived from data management systems, underwent validation through standardized quality checks by multiple stakeholders. The PBRM output (first funding period) was compared among centres and cohorts, and the cost-efficiency of the models was evaluated. Cases per centre varied from one to 164. The mean case reimbursement differed among the cohorts (1173.21€ [95% CI 645.68-1700.73] to 3863.43€ [95% CI 1468.89-6257.96]) and centres and mostly fell short of the expected amount. Model comparisons revealed higher cost-efficiency of the PBRM compared to FRM and UFAM, especially for low recruitment outliers. In conclusion, we have developed a reimbursement model that is transparent, accurate, and flexible. In multi-centre collaborations where heterogeneity between centres is expected, a PBRM could be used as a model to address performance discrepancies.Trial registration: https://clinicaltrials.gov/ct2/show/NCT04768998 ; https://clinicaltrials.gov/ct2/show/NCT04747366 ; https://clinicaltrials.gov/ct2/show/NCT04679584 .

Impact of Advanced Therapy Centers on Characteristics and Outcomes of Heart Failure Admissions.

BACKGROUND: Although much attention has been paid to admission and transfer patterns for cardiogenic shock, contemporary data are lacking on decompensated heart failure (HF) admissions and transfers and the impact of advanced therapy centers (ATCs) on outcomes. METHODS: HF hospitalizations were obtained from the Nationwide Readmissions Database 2016 to 2019. Centers performing at least 1 heart transplant or left ventricular assist device were classified as ATCs. Patient characteristics, outcomes, and procedural volume were compared among 3 cohorts: admissions to non-ATCs, admissions to ATCs, and transfers to ATCs. A secondary analysis evaluated outcomes for severe HF hospitalizations (cardiogenic shock, cardiac arrest, and mechanical ventilation). Multivariable logistic regression was performed to adjust for the presence of HF decompensations and significant clinical variables during univariate analysis. RESULTS: A total of 2 331 690 hospitalizations (81.2%) were admissions to non-ATCs (94.5% of centers), 525 037 (18.3%) were admissions to ATCs (5.5% of centers), and 15 541 (0.5%) were transferred to ATCs. Patients treated at ATCs (especially those transferred) had higher rates of HF decompensations, procedural frequency, lengths of stay, and costs. Unadjusted mortality was 2.6% at non-ATCs and was higher at ATCs, both for directly admitted (2.9%, P<0.001) and transferred (11.2%, P<0.001) patients. However, multivariable-adjusted mortality was significantly lower at ATCs, both for directly admitted (odds ratio, 0.82 [95% CI, 0.78-0.87]; P<0.001) and transferred (odds ratio, 0.66 [95% CI, 0.57-0.78]; P<0.001) patients. For severe HF admissions, unadjusted mortality was 37.2% at non-ATCs and was lower at ATCs, both for directly admitted (25.3%, P<0.001) and transferred (25.2%, P<0.001) patients, with similarly lower multivariable-adjusted mortality. CONCLUSIONS: Patients with HF treated at ATCs were sicker but associated with higher procedural volume and lower adjusted mortality.

Predictors of non-recovery from fatigue and cognitive deficits after COVID-19: a prospective, longitudinal, population-based study.

Background: Despite the high prevalence and major disability associated with fatigue and cognitive deficits after SARS-CoV-2 infection, little is known about long-term trajectories of these sequelae. We aimed to assess long-term trajectories of these conditions and to identify risk factors for non-recovery. Methods: We analyzed longitudinal data from the population-based COVIDOM/NAPKON-POP cohort in Germany. Participants with confirmed SARS-CoV-2 infection were assessed at least 6 months (baseline) and again at least 18 months (follow-up) after infection using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale (cutoff ≤ 30) and the Montreal Cognitive Assessment (MoCA, cutoff ≤ 25). Predictors of recovery from fatigue or cognitive deficits between assessments were identified through univariate and multivariable logistic regression models. The COVIDOM study is registered at the German registry for clinical studies (DRKS00023742) and at ClinicalTrials.gov (NCT04679584). Findings: Between 15 November 2020 and 9 May 2023, a total of 3038 participants were assessed at baseline (median 9 months after infection) and 83% responded to invitations for follow-up (median 26 months after infection). At baseline, 21% (95% confidence interval (CI) [20%, 23%]) had fatigue and 23% (95% CI [22%, 25%]) had cognitive deficits according to cutoff scores on the FACIT-Fatigue or MoCA. Participants with clinically relevant fatigue (at baseline) showed significant improvement in fatigue scores at follow-up (Hedges' g [95% CI] = 0.73 [0.60, 0.87]) and 46% (95% CI [41%, 50%]) had recovered from fatigue. Participants with cognitive deficits showed a significant improvement in cognitive scores (g [95% CI] = 1.12 [0.90, 1.33]) and 57% (95% CI [50%, 64%]) had recovered from cognitive deficits. Patients with fatigue exhibiting a higher depressive symptom burden and/or headache at baseline were significantly less likely to recover. Significant risk factors for cognitive non-recovery were male sex, older age and <12 years of school education. Importantly, SARS-CoV-2 reinfection had no significant impact on recovery from fatigue or cognitive deficits. Interpretation: Fatigue and cognitive deficits are common sequelae after SARS-CoV-2 infection. These syndromes improved over time and about half of the patients recovered within two years. The identified risk factors for non-recovery from fatigue and cognitive deficits could play an important role in shaping targeted strategies for treatment and prevention. Funding: Funded by the German Federal Ministry of Education and Research (BMBF; grant number 01KX2121) and German Research Foundation (DFG) Excellence Cluster "Position Medicine in Information".

Analysis of acute COVID-19 including chronic morbidity: protocol for the deep phenotyping National Pandemic Cohort Network in Germany (NAPKON-HAP).

BACKGROUND: The severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) pandemic causes a high burden of acute and long-term morbidity and mortality worldwide despite global efforts in containment, prophylaxis, and therapy. With unprecedented speed, the global scientific community has generated pivotal insights into the pathogen and the host response evoked by the infection. However, deeper characterization of the pathophysiology and pathology remains a high priority to reduce morbidity and mortality of coronavirus disease 2019 (COVID-19). METHODS: NAPKON-HAP is a multi-centered prospective observational study with a long-term follow-up phase of up to 36 months post-SARS-CoV-2 infection. It constitutes a central platform for harmonized data and biospecimen for interdisciplinary characterization of acute SARS-CoV-2 infection and long-term outcomes of diverging disease severities of hospitalized patients. RESULTS: Primary outcome measures include clinical scores and quality of life assessment captured during hospitalization and at outpatient follow-up visits to assess acute and chronic morbidity. Secondary measures include results of biomolecular and immunological investigations and assessment of organ-specific involvement during and post-COVID-19 infection. NAPKON-HAP constitutes a national platform to provide accessibility and usability of the comprehensive data and biospecimen collection to global research. CONCLUSION: NAPKON-HAP establishes a platform with standardized high-resolution data and biospecimen collection of hospitalized COVID-19 patients of different disease severities in Germany. With this study, we will add significant scientific insights and provide high-quality data to aid researchers to investigate COVID-19 pathophysiology, pathology, and chronic morbidity.

Impact of Clinical Study Implementation on Data Quality Assessments - Using Contradictions within Interdependent Health Data Items as a Pilot Indicator.

INTRODUCTION: Contradiction is a relevant data quality indicator to evaluate the plausibility of interdependent health data items. However, while contradiction assessment is achieved using domain-established contradictory dependencies, recent studies have shown the necessity for additional requirements to reach conclusive contradiction findings. For example, the oral or rectal methods used in measuring the body temperature will influence the thresholds of fever definition. The availability of this required information as explicit data items must be guaranteed during study design. In this work, we investigate the impact of activities related to study database implementation on contradiction assessment from two perspectives including: 1) additionally required metadata and 2) implementation of checks within electronic case report forms to prevent contradictory data entries. METHODS: Relevant information (timestamps, measurement methods, units, and interdependency rules) required for contradiction checks are identified. Scores are assigned to these parameters and two different studies are evaluated based on the fulfillment of the requirements by two selected interdependent data item sets. RESULTS: None of the studies have fulfilled all requirements. While timestamps and measurement units are found, missing information about measurement methods may impede conclusive contradiction assessment. Implemented checks are only found if data are directly entered. DISCUSSION: Conclusive contradiction assessment typically requires metadata in the context of captured data items. Consideration during study design and implementation of data capture systems may support better data quality in studies and could be further adopted in primary health information systems to enhance clinical anamnestic documentation.

The Importance of Being FAIR and FAST - The Clinical Epidemiology and Study Platform of the German Network University Medicine (NUKLEUS).

The COVID-19 pandemic has urged the need to set up, conduct and analyze high-quality epidemiological studies within a very short time-scale to provide timely evidence on influential factors on the pandemic, e.g. COVID-19 severity and disease course. The comprehensive research infrastructure developed to run the German National Pandemic Cohort Network within the Network University Medicine is now maintained within a generic clinical epidemiology and study platform NUKLEUS. It is operated and subsequently extended to allow efficient joint planning, execution and evaluation of clinical and clinical-epidemiological studies. We aim to provide high-quality biomedical data and biospecimens and make its results widely available to the scientific community by implementing findability, accessibility, interoperability and reusability - i.e. following the FAIR guiding principles. Thus, NUKLEUS might serve as role model for FAIR and fast implementation of clinical epidemiological studies within the setting of University Medical Centers and beyond.

Fatigue and cognitive impairment after COVID-19: A prospective multicentre study.

Background: Reliable estimates of frequency, severity and associated factors of both fatigue and cognitive impairment after COVID-19 are needed. Also, it is not clear whether the two are distinct sequelae of COVID-19 or part of the same syndrome." Methods: In this prospective multicentre study, frequency of post-COVID fatigue and cognitive impairment were assessed in n = 969 patients (535 [55%] female) ≥6 months after SARS-CoV-2 infection with the FACIT-Fatigue scale (cut-off ≤30) and Montreal Cognitive Assessment (≤25 mild, ≤17 moderate impairment) between November 15, 2020 and September 29, 2021 at University Medical Center Schleswig-Holstein, Campus Kiel and University Hospital Würzburg in Germany. 969 matched non-COVID controls were drawn from a pre-pandemic, randomised, Germany-wide population survey which also included the FACIT-Fatigue scale. Associated sociodemographic, comorbid, clinical, psychosocial factors and laboratory markers were identified with univariate and multivariable linear regression models. Findings: On average 9 months after infection, 19% of patients had clinically relevant fatigue, compared to 8% of matched non-COVID controls (p < 0.001). Factors associated with fatigue were female gender, younger age, history of depression and the number of acute COVID symptoms. Among acute COVID symptoms, altered consciousness, dizziness and myalgia were most strongly associated with long-term fatigue. Moreover, 26% of patients had mild and 1% had moderate cognitive impairment. Factors associated with cognitive impairment were older age, male gender, shorter education and a history of neuropsychiatric disease. There was no significant correlation between fatigue and cognitive impairment and only 5% of patients suffered from both conditions. Interpretation: Fatigue and cognitive impairment are two common, but distinct sequelae of COVID-19 with potentially separate pathophysiological pathways. Funding: German Federal Ministry of Education and Research (BMBF).

Hospital readmission in systemic sclerosis associated pulmonary hypertension: Results from the PHAROS registry.

OBJECTIVE: To identify individual-level factors associated with hospital readmission among individuals with SSc-associated pulmonary hypertension (SSc-PH). METHODS: Individuals enrolled in the Pulmonary Hypertension Assessment and Recognition of Outcomes in Scleroderma (PHAROS) registry contributed clinical data related to SSc-PH disease severity and hospital admissions. Readmission was defined as a subsequent hospitalization within 12 months of any hospital discharge. Characteristics were compared between individuals with and without readmissions using Fisher's exact test, Wilcoxon rank-sum test, or Kruskal-Wallis test. Logistic regression was used to estimate associations between clinical predictors and likelihood of readmission. RESULTS: Of 572 individuals with SSc-PH enrolled in PHAROS, 54% had ≥1 hospitalizations between 2005 and 2016. Among individuals ever-hospitalized, 34% had ≥1 readmission. Individuals with vs without readmissions had shorter median (IQR) time between index hospitalization date and next PHAROS visit [37 (3, 80) vs 81 (42, 136) days, P <0.001]. Index admissions related to PH or SSc (vs non-PH/SSc related) were associated with an increased odds of 12-month readmission [aOR 6.6 (95% CI 3.2, 13.6) and aOR 2.2 (95% CI 1.1, 4.5), respectively]. Readmission was less likely among home oxygen users (vs non-users) (aOR 0.44; 95% CI 0.22, 0.89). Race, age, sex, disease duration and disease subtype were not associated with readmission. CONCLUSION: The strongest predictor for 12-month readmission was an index hospitalization reason related to PH. Home oxygen use was associated with lower odds of readmission. Future studies should determine whether testing for the need for home oxygen mediates the risk of readmission in SSc-PH.

Impact of hospital transfer to hubs on outcomes of cardiogenic shock in the real world.

AIMS: Cardiogenic shock (CS) is associated with significant mortality, and there is a movement towards regional 'hub-and-spoke' triage systems to coordinate care and resources. Limited data exist on outcomes of patients treated at CS transfer hubs. METHODS AND RESULTS: Cardiogenic shock hospitalizations were obtained from the Nationwide Readmissions Database 2010-2014. Centres receiving any interhospital transfers with CS in a given year were classified as CS transfer 'hubs'; those without transfers were classified as 'spokes.' In-hospital mortality was compared among three cohorts: (A) direct admissions to spokes, (B) direct admissions to hubs, and (C) interhospital transfer to hubs. Among hospitals treating CS, 70.6% were classified as spokes and 29.4% as hubs. A total of 130 656 (31.7%) hospitalizations with CS were direct admission to spokes, 253 234 (61.4%) were direct admissions to hubs, and 28 777 (7.0%) were transfer to hubs. CS mortality was 47.8% at spoke hospitals and was lower at hub hospitals, both for directly admitted (39.3%, P < 0.01) and transferred (33.4%, P < 0.01) patients. Hospitalizations at hubs had higher procedural frequency (including coronary artery bypass graft, right heart catheterization, mechanical circulatory support), greater length of stay, and greater costs. On multivariable analysis, direct admission to CS hubs [odds ratio (OR) 0.86, 95% confidence interval (CI) 0.84-0.89, P < 0.01] and transfer to hubs (OR 0.72, 95% CI 0.69-0.76, P < 0.01) were both associated with lower mortality. CONCLUSION: While acknowledging the limited ability of the Nationwide Readmissions Database to classify CS severity on presentation, treatment of CS at transfer hubs was associated with significantly lower mortality within this large real-world sample.

Thirty-day hospital readmission in systemic sclerosis associated pulmonary hypertension: A nationwide study.

OBJECTIVE: To identify risk-factors for 30-day hospital readmission in systemic sclerosis pulmonary hypertension (SSc-PH) and to compare trends and characteristics of 30-day readmissions in SSc-PH versus non-SSc pulmonary arterial hypertension (non-SSc PAH). METHODS: In this retrospective study, we identified SSc-PH and non-SSc PAH hospitalizations using ICD-9 codes within the Healthcare Cost and Utilization Project-National Readmission Database. Thirty-day readmission rates were calculated between 2010 and 2015. Characteristics were compared using chi-square, Wilcoxon rank-sum, or two-sample t-tests between (A) SSc-PH patients with versus without readmission and (B) patients with ≥1 readmission with SSc-PH versus non-SSc PAH. Adjusted logistic regression models were generated for readmission in SSc-PH. RESULTS: 4,846 of 22,420 (22%) with SSc-PH and 10,573 of 49,254 (21%) with non-SSc PAH had ≥1 30-day readmission. Between 2010-2015, readmission rate decreased in non-SSc PAH (23% to 20%; p<0.001) and was unchanged in SSc-PH (23% to 23%; p = 0.77). In SSc-PH, independent predictors of 30-day readmission include male sex, age <60, Medicare or Medicaid, higher Charlson/Deyo comorbidity index, and congestive heart failure (CHF). A higher proportion of patients with SSc-PH (vs. non-SSc PAH) died during index hospitalizations (p = 0.001) and readmissions (p <0.001). Readmitted patients with SSc-PH (vs. non-SSc PAH) were younger and less often had CHF. In SSc-PH, the most common readmission primary diagnosis was infection, followed by respiratory and heart failure. CONCLUSION: In SSc-PH, 30-day readmission is frequent, and in-hospital deaths occur at a higher rate compared to those with non-SSc PAH. This study identifies factors that may characterize those with SSc-PH at highest risk for readmission.

Outcomes of Hospitalizations for Cardiogenic Shock at Left Ventricular Assist Device Versus Non-Left Ventricular Assist Device Centers.

Background Cardiogenic shock (CS) is a complex syndrome associated with high morbidity and mortality. In recent years, many US hospitals have formed multidisciplinary shock teams capable of rapid diagnosis and triage. Because of preexisting collaborative systems of care, hospitals with left ventricular assist device (LVAD) programs may also represent "centers of excellence" for CS care. However, the outcomes of patients with CS at LVAD centers have not been previously evaluated. Methods and Results Patients with CS were identified in the 2012 to 2014 National Inpatient Sample. Clinical characteristics, revascularization rates, and use of mechanical circulatory support were analyzed in LVAD versus non-LVAD centers. The association between hospital type and in-hospital mortality was examined using multivariable logistic regression models. Of 272 075 hospitalizations, 26.0% were in LVAD centers. CS attributable to causes other than acute myocardial infarction represented most cases. In-hospital mortality was lower in LVAD centers (38.9% versus 43.3%; P<0.001). In multivariable analysis, the odds of mortality remained significantly lower for hospitalizations in LVAD centers (odds ratio, 0.89; P<0.001). In patients with CS secondary to acute myocardial infarction, revascularization rates were similar between LVAD and non-LVAD centers. The use of intra-aortic balloon pump (18.7% versus 18.8%) and Impella/TandemHeart (2.6% versus 1.9%) was similar between hospital types, whereas extracorporeal membrane oxygenation was used more frequently in LVAD centers (4.3% versus 0.2%; P<0.001). Conclusions Risk-adjusted mortality was lower in patients with CS who were hospitalized at LVAD centers. These centers likely represent specialized, shock team capable institutions across the country that may be best suited to manage patients with CS.

A case series on inflammatory cardiomyopathy and suspected cardiac sarcoidosis: role of cardiac PET in management.

BACKGROUND: Presentation of life-threatening arrhythmias concomitantly with a new-onset non-ischaemic cardiomyopathy raises concern for an inflammatory cardiomyopathy such as cardiac sarcoidosis or cardiac manifestations of connective tissue disease. Comprehensive workup for specific aetiologies may be unrevealing except for signs of myocardial inflammation identified on cardiac positron emission tomography (PET). Here, we present five cases of such subjects and their clinical course. CASE SUMMARY: We collected clinical, imaging, pathological, and follow-up data of five subjects presenting with arrhythmias and unexplained new-onset cardiomyopathy. Mean age was 56.2 ± 5.8 years. Three subjects presented with ventricular tachycardia and two with atrial arrhythmias. Echocardiography showed a mean left ventricular ejection fraction of 37 ± 9%. Significant coronary artery disease was ruled out in all cases as the cause of the cardiomyopathy. All patients underwent cardiac magnetic resonance imaging (MRI) and PET scan at presentation and follow-up. In all patients, cardiac MRI revealed hyperenhancement in epicardial and mid-myocardial pattern in a non-coronary distribution, while PET scan revealed fluorodeoxyglucose (FDG) mismatch defects in multiple foci in a non-coronary distribution. Right ventricular biopsy was obtained in all patients and revealed interstitial fibrosis and cardiomyocyte hypertrophy. On median follow-up of 210 days, all subjects had improvement in both heart failure symptoms and arrhythmias and repeat PET in four out of five patients showed decreased inflammation. DISCUSSION: A high level of suspicion for inflammatory cardiomyopathy is needed in patients presenting with new unexplained cardiomyopathy and arrhythmias. A cardiac FDG-PET should be considered for diagnosis if cardiac inflammation is in the differential. This can inform further decisions regarding targeted immunomodulation therapy that may be helpful in this cohort.

Transition of a Large Tertiary Heart Failure Program in Response to the COVID-19 Pandemic: Changes That Will Endure.

The coronavirus disease 2019 (COVID-19) pandemic imposed severe restrictions on traditional methods of patient care. During the pandemic, the heart failure program at New York-Presbyterian Hospital in New York, NY rapidly and comprehensively transitioned its care delivery model and administrative organization to conform to a new healthcare environment while still providing high-quality care to a large cohort of patients with heart failure, heart transplantation, and left ventricular assist device. In addition to the widespread adoption of telehealth, our program restructured outpatient care, initiating a shared clinic model and introducing a comprehensive remote monitoring program to manage patients with heart failure and heart transplant. All conferences, including administrative meetings, support groups, and educational seminars were converted to teleconferencing platforms. Following the peak of COVID-19, many of the new changes have been maintained, and the program structure will be permanently altered as a lasting effect of this pandemic. In this article, we review the details of our program's transition in the face of COVID-19 and highlight the programmatic changes that will endure.

Histopathologic Characterization of Myocarditis Associated With Immune Checkpoint Inhibitor Therapy.

CONTEXT.­: Cardiac complications of immune checkpoint inhibitor therapy are rare, but reports of myocarditis are increasing. The findings have been described in case reports as lymphocytic myocarditis, but its histopathology is underreported. OBJECTIVE.­: To review the histology of myocardial biopsy-proven cases of immune checkpoint-associated myocarditis and provide immunohistochemical characterization of the inflammatory infiltrate. DESIGN.­: We have encountered 6 patients with biopsy-proven myocarditis in conjunction with therapy using anti-programmed death receptor-1 (PD-1)/programmed death ligand-1 (PD-L1) agents with and without cytotoxic T-lymphocyte associated protein 4 (CTLA-4) inhibitors and characterized the histopathology and immune cell profile. RESULTS.­: The myocarditis was multifocal/diffuse and characterized by a predominant CD163-positive histiocytic infiltrate, with an associated CD8+ and PD-1+ T-lymphocytic infiltrate, some of which were granzyme B positive. Cardiac myocytes showed immunoreactivity for PD-L1 in areas of injury, confirmed using 2 different anti-PD-L1 clones. Four of 6 patients recovered from their cardiac injury. One patient had residual tachycardia-bradycardia syndrome and 1 patient expired. CONCLUSIONS.­: The diffuse lymphohistiocytic myocarditis associated with this therapy is relatively distinctive, and this diagnosis is strongly suggested based on the histopathologic findings in the correct clinical setting.

Prevalence and determinants of Hyperpolypharmacy in adults with heart failure: an observational study from the National Health and Nutrition Examination Survey (NHANES).

BACKGROUND: While an expanding armamentarium of pharmacologic therapies has contributed to improved outcomes among adults with heart failure (HF) over the past two decades, this has also been accompanied by an increase in the number of medications taken by adults with HF. The use of at least 10 medications, defined as hyperpolypharmacy, is particularly notable given its association with adverse outcomes. We aimed to assess the prevalence and identify determinants of hyperpolypharmacy among adults with HF. METHODS: We studied adults aged ≥50 years with self-reported HF from the National Health And Nutrition Examination Survey (NHANES) in 2003-2014. We calculated weighted means and percentages to describe patient characteristics. We conducted a multivariable Poisson regression analysis to identify factors independently associated with hyperpolypharmacy; we adjusted for survey sampling, socio-demographics, comorbidity, geriatric conditions, and health care utilization. We examined 947 participants, representing 4.6 million adults with HF. RESULTS: The prevalence of hyperpolypharmacy was 26%. In a multivariable regression analysis, comorbidity count, ≥10 ambulatory contacts, and ≥ 3 hospitalizations were independently associated with hyperpolypharmacy. Interestingly, functional impairment and cognitive impairment were not independently associated with hyperpolypharmacy; while low annual household income and low educational status were each associated with an almost 2-fold increase in hyperpolypharmacy. CONCLUSION: Hyperpolypharmacy is a common condition among adults with HF. We additionally found that low household income and low educational status are independently associated with hyperpolypharmacy, suggesting that non-medical factors may be contributing to this potentially harmful condition.

Characteristics of hospitalizations for cardiogenic shock after acute myocardial infarction in the United States.

BACKGROUND: Multiple studies have reported a decline in mortality for patients with cardiogenic shock after acute myocardial infarction (CS-AMI), a finding which has been attributed to an increase in revascularization over the past decade. However, other studies that have focused on CS-AMI patients treated with early percutaneous coronary intervention (PCI) have found no improvement in risk-adjusted mortality. To reconcile these discordances, we hypothesize that the clinical complexity of the PCI-population has changed over time, in ways not precisely adjusted for in previous studies. METHODS: We conducted a retrospective analysis of the 2005-2012 Nationwide Inpatient Sample. Patients with CS-AMI who underwent PCI within 24h of hospitalization were identified. Temporal trends in clinical characteristics and in-hospital mortality were analyzed. RESULTS: There was no significant change in un-adjusted in-hospital mortality (30% in 2005-2006 and 27.8% in 2011-2012, OR: 0.90; 95% CI: 0.79-1.01, p=0.07). There was an increase in the proportion of patients with ≥3 Elixhauser comorbidities and comorbidity scores ≥5. The population of patients that suffered from cardiac arrest or needed intubation on the first hospital day increased from 27.8% to 42.6% (ptrend<0.001). In a multivariate analysis, mortality rates in 2011-2012 versus 2005-2006 decreased significantly (OR: 0.75; 95% CI: 0.65-0.85, p<0.001). CONCLUSIONS: During a period that corresponds to expanded PCI use and improved prehospital survival, risk-adjusted mortality declined. Much of the survival benefit attributable to early revascularization has been neutralized by an increase in prevalence of "extreme-risk" patients. This may contribute to the null effect on in-hospital mortality.

Sex- and Race-Related Differences in Characteristics and Outcomes of Hospitalizations for Heart Failure With Preserved Ejection Fraction.

BACKGROUND: Sex and race have emerged as important contributors to the phenotypic heterogeneity of heart failure with preserved ejection fraction (HFpEF). However, there remains a need to identify important sex- and race-related differences in characteristics and outcomes using a nationally representative cohort. METHODS AND RESULTS: Data were obtained from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project-Nationwide Inpatient Sample files between 2008 and 2012. Hospitalizations with a diagnosis of HFpEF were included for analysis. Demographics, hospital characteristics, and age-adjusted comorbidity prevalence rates were compared between men and women and whites and blacks. In-hospital mortality was determined and compared for each subgroup. Multivariable regression analyses were used to identify and compare correlates of in-hospital mortality for each subgroup. A sample of 1 889 608 hospitalizations was analyzed. Men with HFpEF were slightly younger than women with HFpEF and had a higher Elixhauser comorbidity score. Men experienced higher in-hospital mortality compared with women, a finding that was attenuated after adjusting for comorbidity. Blacks with HFpEF were younger than whites with HFpEF, with lower rates of most comorbidities. Hypertension, diabetes, anemia, and chronic renal failure were more common among blacks. Blacks experienced lower in-hospital mortality compared with whites, even after adjusting for age and comorbidity. Important correlates of mortality among all 4 subgroups included pulmonary circulation disorders, liver disease, and chronic renal failure. Atrial fibrillation was an important correlate of mortality only among women and blacks. CONCLUSIONS: Differences in patient characteristics and outcomes reinforce the notion that sex and race contribute to the phenotypic heterogeneity of HFpEF.

Characteristics of Hospitalizations for Heart Failure with Preserved Ejection Fraction.

BACKGROUND: Hospitalizations for heart failure with preserved ejection fraction (HFpEF) are increasing. There are limited data examining national trends in patients hospitalized with HFpEF. METHODS: Using the Nationwide Inpatient Sample, we examined 5,046,879 hospitalizations with a diagnosis of acute heart failure in 2003-2012, stratifying hospitalizations by HFpEF and heart failure with reduced ejection fraction (HFrEF). Patient and hospital characteristics, in-hospital mortality, and length of stay were examined. RESULTS: Compared with HFrEF, those with HFpEF were older, more commonly female, and more likely to have hypertension, atrial fibrillation, chronic lung disease, chronic renal failure, and anemia. Over time, HFpEF comprised increasing proportions of men and patients aged ≥75 years. In-hospital mortality rate for HFpEF decreased by 13%, largely due to improved survival in those aged ≥65 years. Multivariable regression analyses showed that pulmonary circulation disorders, liver disease, and chronic renal failure were independent predictors of in-hospital mortality, whereas treatable diseases including hypertension, coronary artery disease, and diabetes were inversely associated. CONCLUSIONS: This study represents the largest cohort of patients hospitalized with HFpEF to date, yielding the following observations: number of hospitalizations for HFpEF was comparable with that of HFrEF; patients with HFpEF were most often women and elderly, with a high burden of comorbidities; outcomes appeared improved among a subset of patients; pulmonary hypertension, liver disease, and chronic renal failure were strongly associated with poor outcomes.