All-cause Hospitalization Rates Research Articles

Coronavirus Disease 2019 Convalescent Plasma Outpatient Therapy to Prevent Outpatient Hospitalization: A Meta-Analysis of Individual Participant Data From 5 Randomized Trials.

Outpatient monoclonal antibodies are no longer effective and antiviral treatments for coronavirus disease 2019 (COVID-19) disease remain largely unavailable in many countries worldwide. Although treatment with COVID-19 convalescent plasma (CCP) is promising, clinical trials among outpatients have shown mixed results. We conducted an individual participant data meta-analysis from outpatient trials to assess the overall risk reduction for all-cause hospitalizations by day 28 in transfused participants. Relevant trials were identified by searching Medline, Embase, medRxiv, World Health Organization COVID-19 Research Database, Cochrane Library, and Web of Science from January 2020 to September 2022. Five included studies from 4 countries enrolled and transfused 2620 adult patients. Comorbidities were present in 1795 (69%). The virus neutralizing antibody dilutional titer levels ranged from 8 to 14 580 in diverse assays. One hundred sixty of 1315 (12.2%) control patients were hospitalized, versus 111 of 1305 (8.5%) CCP-treated patients, yielding a 3.7% (95% confidence interval [CI], 1.3%-6.0%; P = .001) absolute risk reduction and 30.1% relative risk reduction for all-cause hospitalization. The hospitalization reduction was greatest in those with both early transfusion and high titer with a 7.6% absolute risk reduction (95% CI, 4.0%-11.1%; P = .0001) accompanied by at 51.4% relative risk reduction. No significant reduction in hospitalization was seen with treatment >5 days after symptom onset or in those receiving CCP with antibody titers below the median titer. Among outpatients with COVID-19, treatment with CCP reduced the rate of all-cause hospitalization and may be most effective when given within 5 days of symptom onset and when antibody titer is higher.

Applicability of Vericiguat to Patients Hospitalized for Heart Failure in the United States

BackgroundIn January 2021, vericiguat, a soluble guanylate cyclase stimulator, was approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of cardiovascular death and heart failure (HF) hospitalization among patients with a recent worsening HF event based on the VICTORIA (VerICiguaT Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial. ObjectivesThis study sought to leverage a contemporary U.S. registry of patients hospitalized for heart failure (HF) to characterize patients who may be candidates for vericiguat based on FDA label and the VICTORIA trial eligibility criteria. MethodsThe authors studied patients hospitalized for HF with ejection fraction (EF) <45% across 525 sites in the GWTG-HF (Get With The Guidelines–Heart Failure) registry between January 2014 and December 2020. Approximate FDA label criteria (excluding estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m2, dialysis, or patients with heart transplantation or durable mechanical circulatory support) and eligibility criteria for the VICTORIA trial were applied to the GWTG-HF cohort. ResultsAmong 241,057 patients with EF <45% in the GWTG-HF registry, 221,730 (92%) could be candidates for vericiguat under the FDA label and 92,249 (38%) would have been eligible for the VICTORIA trial. The most frequent reasons for ineligibility for the FDA label were eGFR <15 mL/min/1.73 m2 (5.7%) and dialysis (1.6%). Although there were greater proportions of women and Black patients in the GWTG-HF registry, most clinical characteristics were qualitatively similar with patients enrolled in the VICTORIA trial. Among Medicare beneficiaries in the GWTG-HF registry eligible for vericiguat by either FDA label or VICTORIA trial criteria, 12-month postdischarge rates of mortality (36%-37%), HF hospitalization (33%-35%), all-cause hospitalization (64%-66%), and mean health care expenditure (U.S. $25,106-$25,428) were high. ConclusionsData from a large, contemporary U.S. registry of patients actively hospitalized for HF with EF <45% suggest that approximately 4 in 10 patients meet the criteria of the VICTORIA trial and that more than 9 in 10 patients are potential candidates for vericiguat based on the FDA label. Contemporary Medicare beneficiaries hospitalized for HF with EF <45% and eligible for vericiguat face high rates of postdischarge mortality and readmission and accrue substantial health care costs.

Clinical characteristics and outcomes of COVID-19 in patients with autoimmune hepatitis: A population-based matched cohort study.

Patients with autoimmune hepatitis (AIH) require life-long immunosuppressive agents that may increase the risk of poor coronavirus disease 2019 (COVID-19) outcomes. There is a paucity of large data at the population level to assess whether patients with AIH have an increased risk of severe diseases. To evaluate the impact of pre-existing AIH on the clinical outcomes of patients with COVID-19. We conducted a population-based, multicenter, propensity score-matched cohort study with consecutive adult patients (≥ 18 years) diagnosed with COVID-19 using the TriNeTx research network platform. The outcomes of patients with AIH (main group) were compared to a propensity score-matched cohort of patients: (1) Without chronic liver disease (CLD); and (2) Patients with CLD except AIH (non-AIH CLD) control groups. Each patient in the main group was matched to a patient in the control group using 1:1 propensity score matching to reduce confounding effects. The primary outcome was all-cause mortality, and secondary outcomes were hospitalization rate, need for critical care, severe disease, mechanical ventilation, and acute kidney injury (AKI). For each outcome, the risk ratio (RR) and confidence intervals (CI) were calculated to compare the association of AIH with the outcome. We identified 375 patients with AIH, 1647915 patients with non-CLD, and 15790 patients with non-AIH CLD with COVID-19 infection. Compared to non-CLD patients, the AIH cohort had an increased risk of all-cause mortality (RR = 2.22; 95%CI: 1.07-4.61), hospitalization rate (RR = 1.78; 95%CI: 1.17-2.69), and severe disease (RR = 1.98; 95%CI: 1.19-3.26). The AIH cohort had a lower risk of hospitalization rate (RR = 0.72; 95%CI: 0.56-0.92), critical care (RR = 0.50; 95%CI: 0.32-0.79), and AKI (RR = 0.56; 95%CI: 0.35-0.88) compared to the non-AIH CLD patients. Patients with AIH are associated with increased hospitalization risk, severe disease, and all-cause mortality compared to patients without pre-existing CLD from the diagnosis of COVID-19. However, patients with AIH were not at risk for worse outcomes with COVID-19 than other causes of CLD.

Postpartum navigation decreases severe maternal morbidity most among Black women

Postpartum care is crucial for addressing conditions associated with severe maternal morbidity and mortality. Examination of programs that affect these outcomes for women at high risk, including disparate populations, is needed. This study aimed to examine whether a postpartum navigation program decreases all-cause 30-day postpartum hospitalizations and hospitalizations because of severe maternal morbidity identified using the US Centers for Disease Control and Prevention guidelines. The effect of this program was explored across patient demographics, including race and ethnicity. This was a retrospective cohort study that used health records of women who delivered at 3 large hospitals in the New York metropolitan area (Queens and Long Island) between April 2020 and November 2021 and who were at high risk of severe maternal morbidity. The incidence rates of 30-day postpartum all-cause hospitalization and hospitalization because of severe maternal morbidity were compared between women who were and were not enrolled in a novel postpartum transitional care management program. Navigation included standardized assessments, development of care plans, clinical management, and connection to clinical and social services that would extend beyond the postpartum period. Because the program prioritized enrolling women of the greatest risk, the risk-adjusted incidence was estimated using multivariate Poisson regression and stratified across patient demographics. Patient health records of 5819 women were included for analysis. Of note, 5819 of 19,258 deliveries (30.2%) during the study period were identified as having a higher risk of severe maternal morbidity. This was consistent with the incidence of high-risk pregnancies for tertiary hospitals in the New York metropolitan area. The condition most identified for risk of severe maternal morbidity at the time of delivery was hypertension (3171/5819 [54.5%]). The adjusted incidence of all-cause rehospitalization was 20% lower in enrollees than in nonenrollees (incident rate ratio, 0.80; 95% confidence interval, 0.67-0.95). Rehospitalization was decreased the most among Black women (incident rate ratio, 0.57; 95% confidence interval, 0.42-0.80). The adjusted incidence of rehospitalization because of indicators of severe maternal morbidity was 56% lower in enrollees than in nonenrollees (incident rate ratio, 0.44; 95% confidence interval, 0.24-0.77). Furthermore, it decreased most among Black women (incident rate ratio, 0.23; 95% confidence interval, 0.07-0.73). High-risk medical conditions at the time of delivery increased the risk of postpartum hospitalization, including hospitalizations because of severe maternal morbidity. A postpartum navigation program designed to identify and resolve clinical and social needs reduced postpartum hospitalizations and racial disparities with hospitalizations. Hospitals and healthcare systems should adopt this type of care model for women at high risk of severe maternal morbidity. Cost analyses are needed to evaluate the financial effect of postpartum navigation programs for women at high risk of severe maternal morbidity or mortality, which could influence reimbursement for these types of services. Further evidence and details of novel postpartum interventional models are needed for future studies.

SARS-CoV-2 Infection, Hospitalization, and Death in Vaccinated and Infected Individuals by Age Groups in Indiana, 2021‒2022

Objectives. To assess the effectiveness of vaccine-induced immunity against new infections, all-cause emergency department (ED) and hospital visits, and mortality in Indiana. Methods. Combining statewide testing and immunization data with patient medical records, we matched individuals who received at least 1 dose of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines with individuals with previous SARS-CoV-2 infection on index date, age, gender, race/ethnicity, zip code, and clinical diagnoses. We compared the cumulative incidence of infection, all-cause ED visits, hospitalizations, and mortality. Results. We matched 267 847 pairs of individuals. Six months after the index date, the incidence of SARS-CoV-2 infection was significantly higher in vaccine recipients (6.7%) than the previously infected (2.9%). All-cause mortality in the vaccinated, however, was 37% lower than that of the previously infected. The rates of all-cause ED visits and hospitalizations were 24% and 37% lower in the vaccinated than in the previously infected. Conclusions. The significantly lower rates of all-cause ED visits, hospitalizations, and mortality in the vaccinated highlight the real-world benefits of vaccination. The data raise questions about the wisdom of reliance on natural immunity when safe and effective vaccines are available. (Am J Public Health. 2023;113(1):96-104. https://doi.org/10.2105/AJPH.2022.307112).

Long-Term Outcomes for Living Kidney Donors With Early Guideline-Concordant Follow-up Care: A Retrospective Cohort Study.

Current guidelines recommend that living kidney donors receive lifelong annual follow-up care to monitor kidney health. In the United States, the reporting of complete clinical and laboratory data for kidney donors has been mandated for the first 2 years post-donation; however, the long-term impact of early guideline-concordant care remains unclear. The primary objective of this study was to compare long-term post-donation follow-up care and clinical outcomes of living kidney donors with and without early guideline-concordant follow-up care. Retrospective, population-based cohort study. Linked health care databases were used to identify kidney donors in Alberta, Canada. Four hundred sixty living kidney donors who underwent nephrectomy between 2002 and 2013. The primary outcome was continued annual follow-up at 5 and 10 years (adjusted odds ratio with 95% confidence interval, LCLaORUCL). Secondary outcomes included mean change in estimated glomerular filtration rate (eGFR) over time and rates of all-cause hospitalization. We compared long-term follow-up and clinical outcomes for donors with and without early guideline-concordant care, defined as annual physician visit and serum creatinine and albuminuria measurement for the first 2 years post-donation. Of the 460 donors included in this study, 187 (41%) had clinical and laboratory evidence of guideline-concordant follow-up care throughout the first 2 years post-donation. The odds of receiving annual follow-up for donors without early guideline-concordant care were 76% lower at 5 years (aOR 0.180.240.32) and 68% lower at 10 years (aOR 0.230.320.46) compared with donors with early care. The odds of continuing follow-up remained stable over time for both groups. Early guideline-concordant follow-up care did not appear to substantially influence eGFR or hospitalization rates over the longer term. We were unable to confirm whether the lack of physician visits or laboratory data in certain donors was due to physician or patient decisions. Although policies directed toward improving early donor follow-up may encourage continued follow-up, additional strategies may be necessary to mitigate long-term donor risks.

Rapid Detection of Influenza Outbreaks in Long Term Care Facilities Reduces Emergency Room Visits and Hospitalization.

Context: Influenza is a significant respiratory pathogen for residents of long-term care facilities (LTCFs). Rapid influenza detection tests (RIDT) may enable early outbreak detection allowing a timely response. Objective: We assessed whether RIDT for LTCF residents with acute respiratory infection is associated with increased antiviral use and decreased healthcare utilization. Study Design and Analysis: Non-blinded, pragmatic, randomized controlled trial (clinicaltrials.gov: NCT0296487). Setting: Wisconsin LTCFs. Population Studied: Residents of 20 LTCFs matched by bed capacity and geographic location. Intervention: (1) modified case identification criteria and (2) nursing-staff initiated collection of nasal swab specimen for on-site RIDT. Outcome Measures: Primary outcome measures, expressed as events per 1000 resident-weeks, included antiviral treatment courses, aniviral prophylaxis courses, total emergency department (ED) visits, ED visits for respiratory illness, total hospitalization, hospitalization for respiratory illness, hospital length of stay, total deaths, and deaths due to respiratory illness over three influenza seasons. Results: Oseltamivir use for prophylaxis was higher at intervention LTCFs (2.6 vs 1.9 courses per 1000 person-weeks; rate ratio: 1.38; 95%CI: 1.24-1.54; p<0.001); rates of oseltamivir use for treatment were not different. Rates of total ED visits (7.6 vs 9.8/1000 person-weeks; RR=0.78; 95%CI: 0.64-0.92; p=0.004), total hospitalizations (8.6 vs 11.0/1000 person-weeks; RR=0.79; 95%CI: 0.67-0.93; p=0.004), and hospital length of stay (35.6 days vs 55.5 days/1000 person-weeks; RR=0.64; 95%CI: 0.0.59-0.69; p<0.001) were lower at intervention as compared to control LTCFs. No significant differences were noted for respiratory-related ED visits or hospitalizations or in rates for all-cause or respiratory-associated mortality. Conclusions: The use of low threshold criteria to trigger nursing staff-initiated testing for influenza with RIDT resulted in increased prophylactic use of oseltamivir. There were significant reductions in the rates of all-cause ED visits (22% decline), hospitalizations (21% decline), and hospital length of stay (36% decline) across three combined influenza seasons. No significant differences were noted in respiratory-associated and all-cause deaths between intervention and control sites. This feasible, and low-cost intervention may provide significant benefit and should be further tested in other settings.

The outcome of “non-urgent'' patients diverted by triage at an emergency department

No universal definitions have been proposed for non-urgent emergency department (ED) patients. Robust evidence on safety issues and the subsequent utilisation of health care services among diverted patients is insufficient. The aim of this study was to establish the revisit rate within 7 days, as well as the 30-day mortality and outcome of patients diverted by triage. An observational single-centre retrospective study was conducted at the Tampere University Hospital ED for the full calendar year of 2019. The primary outcomes were a revisit within 7 days and 30-day mortality. A total of 92,406 ED visits were registered. Of these patients, 7.8% (7216 visits) were diverted by triage. Among the diverted patients, the hospital revisit rate within 7 days was 10.1%, and a diagnostic or therapeutic intervention was performed on 81.4% of the readmitted patients. The all-cause 30-day mortality, hospitalisation and intensive care unit admission rates of diverted patients were 0.07%, 1.7% and 0.1%, respectively. Diverting non-urgent patients reduces ED visits. The current study showed a revisit rate of 10.1% and a 30-day mortality rate of 0.07% for diverted patients. There were more unanticipated adverse outcomes than reported previously, and the strategy may thus be suitable only for some groups of patients without increasing risks. Therefore, further investigation is needed to determine the factors associated with readmissions and adverse outcomes to enhance the performance of triage in the future.

Burden of all-cause and organism-specific parapneumonic empyema hospitalization rates prior to the SARS-CoV-2 pandemic in the United States

Background and aimsParapneumonic empyema, a severe pneumonia complication, decreased shortly after 13-valent pneumococcal conjugate vaccine (PCV13) introduction in US children, though the long-term impact remains poorly described. It is also unclear whether PCV13 introduction in 2010 or the 2014 US recommendation for PCV13 use in older adults was associated with declines in empyema among adults. We examined overall and organism-specific parapneumonic empyema rates among US children and adults from 2006 to 2019, prior to the SARS-CoV-2 pandemic and the updated recommendations for PCV15 and PCV20 in the US. MethodsWe used the National Inpatient Sample and US Census Data to calculate national annual all-cause and pneumococcal empyema hospitalization rates by age group (2006–2019). We examined rates during the late-PCV13 era (October 2015–2019) after transition to ICD10 codes compared to rates in the late-PCV7 (2006–2009) and early-PCV13 era (2011–September 2015). We also examined the rate of empyema with thoracentesis-related procedures and according to the causative organism type. ResultsCompared to the late-PCV7 era, all-cause empyema hospitalization rates were lower among child age groups (<1, 1, 2–4 and 5–17 years) in the late-PCV13 era. In contrast, among most adult age groups (18–34, 50–64, 65+ years), all-cause empyema rates were higher in the late-PCV13 era compared to the late-PCV7 era. ConclusionEarly declines in all-cause empyema-related hospitalizations observed right after PCV13 introduction among children in 2010 were sustained through 2019, though rates did not decline among adults.

Meta-Analysis on Drug and Device Therapy of New York Heart Association Functional Class IV Heart Failure With Reduced Ejection Fraction

Heart failure with reduced ejection fraction (HFrEF) is associated with significant morbidity and mortality, particularly in patients with New York Heart Association (NYHA) functional class IV symptoms. Decades of discovery have heralded significant advancements in the pharmacologic management of HFrEF. However, patients with NYHA IV symptoms remain an under-represented population in almost every clinical trial to date, leaving clinicians with limited evidence with which to guide drug treatment decisions in this patient group with severe heart failure. Randomized controlled trials of adult patients with NYHA IV symptoms of HFrEF randomized to current guideline-recommended medical therapy were included in this systematic review and meta-analysis. The outcomes of interest included the rate of all-cause mortality, cardiovascular mortality, and heart failure hospitalization. A total of 39 randomized controlled trials were included. A total of 6 studies examined angiotensin converting enzyme inhibitors, with meta-analyses of 2 demonstrating a reduced risk of all-cause mortality (relative risk (RR) 0.76, 95% confidence interval 0.59 to 0.97, p=0.03). A total of 11 studies examined β blockers, with meta-analysis of 6 demonstrating a reduced risk of all-cause mortality (risk ratio 0.74, 95% confidence interval 0.60 to 0.92, p=0.008). A study examined the mineralocorticoid antagonist spironolactone, reporting a reduced risk of all-cause mortality in the NYHA IV subgroup. A total of 6 studies examined device therapy, demonstrating the benefit of cardiac resynchronization therapy with or without an implantable cardiac defibrillator in reducing hospitalization in the NYHA IV subgroup. Although trial evidence exists for angiotensin converting enzyme inhibitors, β-blockers, and mineralocorticoid antagonist therapy in the NYHA IV population, the role of angiotensin receptor blockers is unclear. Ivabradine, angiotensin receptor neprilysin inhibitors, and sodium-glucose transport protein 2 inhibitors remain underinvestigated and have not been proved to provide any benefit above standard heart failure therapy in patients with HFrEF and NYHA IV symptoms.

Health care resource utilization patterns among patients with Parkinson’s disease psychosis: analysis of Medicare beneficiaries treated with pimavanserin or other-atypical antipsychotics

Background Pimavanserin (PIM) is the only FDA-approved atypical antipsychotic (AAP) for hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Comparative real-world analyses demonstrating its benefits are needed. Objectives To evaluate health care resource utilization (HCRU) outcomes among PDP patients treated with PIM vs. other-AAPs. Methods Retrospective cohort analysis of Parts A, B, and D claims from 100% Medicare sample from 01 January 2013–31 December 2019 was conducted. PDP Patients initiating (i.e. index date) continuous monotherapy (PIM vs. other-AAPs) for ≥12-months during 01 January 2014–31 December 2018 without 12-months pre-index AAP use were selected after 1:1 propensity score matching (PSM) on 31 variables (sex, race, region, age, and 27 Elixhauser comorbidities). HCRU outcomes included: annual all-cause and psychiatric hospitalization (short-term stay, long-term stay, and SNF-stay [skilled nursing facility]) rates, annual all-cause and psychiatric-ER visit rates, mean per-patient-per-year (PPPY) hospitalizations, and average length of stay (ALOS). PIM and other-AAPs were compared using generalized linear models (GLM) controlled for demographic characteristics, comorbidities, coexisting-dementia, and coexisting insomnia. Results Of 12,164 PDP patients, 48.41% (n = 5,889) were female, and mean age was 77 (±8.14) years. Among 1:1 matched patients (n = 842 in each), 37.8% (n = 319) on PIM vs. 49.8% (n = 420) on other-AAPs (p < .05) reported ≥1 all-cause hospitalizations, respectively. Specifically, short-term and SNF-stay among PIM patients vs. other-AAPs were: 34% (n = 286) vs. 46.2% (n = 389) and 20.2% (n = 170) vs. 31.8% (n = 267) (p < .05), respectively. Similarly, 9.6% (n = 81) of PIM vs. 14.6% (n = 123) of other-AAPs patients had ≥1 psychiatric hospitalization (p < .05). Furthermore, ≥1 all-cause and psychiatric ER visit among PIM vs. other-AAPs were 61.6% (n = 519) vs. 69.4% (n = 584) and 5.2% (n = 43) vs. 10.2% (n = 86) (p < .05), respectively. PIM also had significantly lower ALOS, and mean PPPY short-term hospitalization and SNF-stays. Conclusions In this analysis of PDP patients, PIM monotherapy resulted in nearly 12% and 7% lower all-cause hospitalizations and ER visits vs. other-AAPs.

Real-World Evidence Comparing Vedolizumab and Ustekinumab in Antitumor Necrosis Factor-Experienced Patients With Crohn's Disease.

Many patients with Crohn's disease (CD) lose response or become intolerant to antitumor necrosis factor (TNF) therapy and subsequently switch out of class. We compared the effectiveness and safety of ustekinumab to vedolizumab in a large, geographically diverse US population of TNF-experienced patients with CD. We conducted a retrospective cohort study using longitudinal claims data from a large US insurer (Anthem, Inc.). We identified patients with CD initiating vedolizumab or ustekinumab with anti-TNF treatment in the prior 6 months. Our primary outcome was treatment persistence for >52 weeks. Secondary outcomes included (i) all-cause hospitalization, (ii) hospitalization for CD with surgery, (iii) hospitalization for CD without surgery, and (iv) hospitalization for infection. Propensity score fine stratification was used to control for demographic and baseline clinical characteristics and prior treatments. Among 885 new users of ustekinumab and 490 new users of vedolizumab, we observed no difference in treatment persistence (adjusted risk ratio 1.09 [95% confidence interval 0.95-1.25]). Ustekinumab was associated with a lower rate of all-cause hospitalization (adjusted hazard ratio 0.73 [0.59-0.91]), nonsurgical CD hospitalization (adjusted hazard ratio 0.58 [0.40-0.83]), and hospitalization for infection (adjusted hazard ratio 0.56 [0.34-0.92]). This real-world comparative effectiveness study of anti-TNF-experienced patients with CD initiating vedolizumab or ustekinumab showed similar treatment persistence rates beyond 52 weeks, although secondary outcomes such as all-cause hospitalizations, nonsurgical CD hospitalizations, and hospitalizations for infection favored ustekinumab initiation. We, therefore, advocate for individualized decision making in this medically refractory population, considering patient preference and other factors such as cost and route of administration.

The relationship between glucose intolerance status and risk of hospitalization during two decades of follow-up: Tehran lipid and glucose study

Objective To assess the relationship between glucose intolerance statuses at baseline defined as normal glucose tolerance (NGT), pre-diabetes, newly diagnosed (NDM) and known diabetes mellitus (KDM) and all-cause hospitalization among Iranian men and women during 20 years of follow-up. Research design and methods This study included 8,014 individuals (3,836 men) ≥30 years from the cohort of Tehran Lipid and Glucose Study. Incidence rate ratios (IRRs) and (95% confidence interval (95% CI) for three groups of pre-diabetes, NDM and KDM was estimated using the Negative Binomial regression model, considering NGT group as reference group. Regression models were adjusted for age, body mass index, hypertension, chronic kidney disease, and cardiovascular disease (CVD). Results Among men, compared with NGT group, those with pre-diabetes, NDM and KDM had higher incidence rate for hospitalization, with IRRs (95% CI) of 1.08 (0.96–1.20), 1.38 (1.20–1.57) and 1.96 (1.66–2.26), respectively, after adjusting for confounders. The corresponding values were 1.07 (0.96–1.17), 1.40 (1.21–1.59) and 2.07 (1.72–2.42) for women. Men with diabetes, generally had a higher rate of hospitalization for CVD rather than their female counterparts (IRRs: 1.46; 1.17–1.74). In patients with diabetes, the most common causes of hospitalization were macrovascular complications (i.e. coronary heart disease and stroke). Moreover, among the individuals with diabetes, those with poor glycaemic control (fasting plasma glucose (FPG) >10 mmol/l) had 39% higher rate of hospitalization than those with fair glycaemic control (FPG <10 mmol/l) (1.39; 1.12–1.65), adjusted for confounders. Conclusion Pre-diabetes, NDM, and KDM were associated with increased hospitalization rates during long-term follow-up. Interventions such as lifestyle modification or pharmacological therapies aiming to slow down the pre-diabetes and fair control of diabetes might potentially decrease the rate of hospitalization. Key messages NDM and KDM status both increased rate of all-cause hospitalization. CVD and T2DM complication were the most common cause of hospitalization among patients with diabetes. Hospitalization due to recurrent CHD was significantly higher in men with diabetes than their female counterparts.

Abstract 14643: Benefits and Risks of Single- vs. Dual- Chamber Implantable Cardioverter Defibrillators for Primary Prevention of Sudden Cardiac Death

Introduction: Implantable cardioverter defibrillator (ICD) is the more effective and safer treatment for the primary prevention of sudden cardiac death. It remains unclear whether dual-chamber ICD offers the clinical benefits over single-chamber ICD without increasing complications. Hypothesis: The study aimed to evaluate the benefits and risks of dual-chamber ICD compared with single-chamber ICD for primary prevention of sudden cardiac death in clinical practice. Methods: Using the Korean National Health Insurance Service database from January 2008 to December 2019, we include patients with primary prevention ICD and no documented indication for pacing. The propensity score matching method was used to balance covariates across single- and dual-chamber ICDs. Primary outcomes were all-cause mortality, hospitalization of heart failure, and hospitalization of cardiovascular cause. Results: Among 1,929 patients, 1,098 (56.9%) received a single-chamber ICD and 831 (43.1%) received a dual-chamber ICD. In 752 pairs of patients after propensity matching baseline characteristics were balanced between the 2 groups (median age 62 years; male 72%). Over a mean follow-up of 2.7±2.4 years, 1- and 5-year all-cause mortality (5.5% vs. 5.6%, P=0.910; 19.4% vs. 19.3%, P=0.948), 1- and 5-year hospitalization for cardiovascular cause (14.9% vs. 14.9%, P=1.000; 23.9% vs. 22.6%, P=0.542), and 1- and 5-year hospitalization for heart failure (10.8% vs. 8.6%, P=0.163; 16.8% vs. 14.0%, P=0.133) were similar in both groups. However, cardiac tamponade in the rates of device-related complications was 0.1% in the single-chamber ICD vs. 1.1% in dual-chamber ICD groups (P=0.013). Conclusions: In the real-world population receiving a primary prevention ICD, dual-chamber ICD was associated with higher rates of cardiac tamponade than single-chamber ICD. One and five-year rates of all-cause mortality and hospitalization did not differ significantly between the two groups.

Abstract 15615: The Association of Acute Kidney Injury With Angiotensin Converting Enzyme Inhibitor and Angiotensin Ii Receptor Blockers Use in Patients With Sars-cov-2

Introduction: Previous studies have suggested that SARS-CoV-2 causes microvascular inflammation and thrombosis, leading to microvascular angiopathy. A downstream sequela of microvascular angiopathy is AKI. Literature extensively describes the renoprotective effects of ACEI and ARB. Hypothesis: We hypothesize that using an ACEI/ARB in patients with SARS-CoV-2 is negatively associated with AKI. Methods: We conducted a retrospective chart review of patients 18 years and older who tested positive for SARS- CoV-2 using a polymerase chain reaction test between March 2020 and April 2021. Patients were divided into two groups, AKI, and non-AKI. The primary outcomes were all-cause mortality and hospitalization rate. The secondary outcomes were myocardial infarction, hypotension, intubation, use of vasopressors and ventricular tachycardia (VT). We used multivariate logistic regression to adjust for baseline characteristics. Results: We identified a total of 1,212 patients with AKI and 21,887 without AKI who tested positive for SARS-CoV-2. Incidence was 539 (44%) for all-cause mortality, 1144 (94.2%) for hospitalization, and 413 (34.6%) for patients taking ACEI/ARB. After logistic regression analysis, OR was 3.006 (95% Confidence Interval [CI]: 2.342-3.858; p&lt;0.001) for hospitalization, 7.359 (95% CI:5.191-10.433, p &lt;0.001) for all-cause mortality, and 1.034 (95% CI: 0.784-1.365; p&lt; 0.810) for patients taking ACEI/ARB. The AKI group had significantly increased adjusted OR for hypotension (p&lt; 0.001), calcium channel (p&lt;0.001) and beta-blocker (p&lt;0.038) use. Adjusted OR for all other secondary outcomes were not increased but not significant, including myocardial infarction (p&lt;0.697), VT (p&lt;0.184), vasopressor use (p&lt;0.113), and intubation (p&lt;0.096). Conclusions: This study suggests that ACEI/ARB use was not positively associated with AKI in patients with SARS-CoV-2, while calcium channel blocker and beta-blocker use were. A positive association between BB and CCB with AKI suggests that there should be a preference for ACEI/ARB in patients where all three medications are possible therapy options. Further studies are needed to confirm the association between ACE/ARB and AKI and rule out potential confounding variables.

Abstract 11096: Impact of Rhythm versus Rate Control in Atrial Fibrillation on All-Cause Mortality, Hospitalization and Stroke: A Systematic Review and Meta-Analysis

Introduction: Many randomized controlled trials (RCTs) compared rate control vs rhythm control therapy in patients with atrial fibrillation (AF). In this study, we systematically reviewed these RCTs and performed a meta-analysis of the outcomes comparing the two therapies. Methods: We searched PubMed, Medline, EMBASE, and SCOPUS databases until April 30, 2022 for all RCTs investigating AF rate vs rhythm control. We used the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) for constructing and reporting this review. We assigned I 2 &gt;50% as an indicator of statistical heterogeneity among the RCTs. We analyzed all-cause mortality, stroke rate, heart failure (HF) hospitalization, and total hospitalization between the two groups. We estimated the risk ratios (RR) with a random-effects model using the Mantel-Haenszel technique and calculated the 95% confidence intervals (CI). A P-value &lt;0.05 was considered significant. All analyses were performed using Review Manager 5.3. Results: Twenty-one RCTs comprising 11,547 patients (77% male) were included. Between the two therapy groups, there was no significant difference in all-cause mortality (RR 1.02 [0.90-1.16], P=0.75 ), HF hospitalization (RR 1.04 [0.83-1.32], P=0.72 ), or stroke rate (RR 1.15 [0.88-1.50], P=0.32 ). Nonetheless, rate control was associated with reduced total hospitalizations (RR 0.77 [0.64-0.94], P=0.01 ). (Figure 1) Conclusions: Atrial fibrillation rate control therapy has similar outcomes to rhythm control in terms of all-cause mortality, HF hospitalization, and stroke rates, but a lower rate of total hospitalizations. Findings are consistent with multiple prior studies showing noninferiority of rate control to rhythm control. Figure 1 - Forest plots highlighting the outcomes of both treatment strategies on AF: A) All-cause mortality, B) Heart failure hospitalization, C) Stroke, and D) Total hospitalization.

Abstract 13338: Clinical Profile of Patients Hospitalized for Heart Failure With Severely Reduced Ejection Fraction: From the GWTG-HF Registry

Introduction: Many patients with heart failure (HF) have severely reduced ejection fraction but do not meet threshold for consideration of advanced therapies (i.e., stage D HF). The clinical profile, outcomes, and management of these patients in US practice is not well described. Methods: We studied patients hospitalized for worsening chronic HF with reduced ejection fraction (HFrEF) ≤40% across 423 sites in the Get With The Guidelines® (GWTG)-HF registry admitted 2014 -2019. We excluded patients with heart transplantation or durable mechanical circulatory support, severe kidney disease (eGFR&lt;20 mL/min/1.73 m 2 or dialysis), or missing critical data elements. Patients were grouped by EF (≤30% vs. 31-40%) and data were compared using absolute standardized differences. Results: Among 113,348 patients with HFrEF ≤40%, 78,589 (69%) had an EF≤30%. Compared with EF 31-40%, patients with EF≤30% tended to be younger, were less likely to be female, and more likely to be Black (Table). Patients with EF ≤30% had lower systolic blood pressure, but modestly higher eGFR and lower rates of atrial fibrillation and diabetes. Rates of guideline-directed medical therapy (GDMT) use at discharge were generally higher among those with EF≤30%, including greater use of triple therapy (ACEI/ARB/ARNI + beta-blocker + MRA). Among 20,387 patients age ≥65 years linked to Medicare, compared with patients with EF 31-40%, patients with EF≤30% faced higher rates of 12-month mortality and HF hospitalization, but similar rates of all-cause hospitalization. Conclusions: Among patients hospitalized for worsening chronic HFrEF in US clinical practice, most patients have severely reduced EF≤30%. Despite modestly higher use of GDMT at discharge and younger age, patients with severely reduced EF face heightened post-discharge risk of death and HF hospitalization.

Abstract 11607: In-Hospital and Readmission Outcomes With Percutaneous Balloon Mitral Valvuloplasty

Introduction: Percutaneous balloon mitral valvuloplasty (PBMV) is primarily performed for rheumatic mitral stenosis (MS). Therefore, limited data exist on PBMV in countries with a low incidence of rheumatic disease. We sought to examine in-hospital and readmission outcomes for PBMV in the U.S. Methods: Using the Nationwide Readmission Database, hospitalizations in which patients received PBMV for rheumatic and non-rheumatic MS were identified. In-hospital mortality and 30-day readmission rate were examined, and multivariable logistic regression was performed for risk adjustment. Additionally, McNemar's test was used to examine the change in 90-day hospitalization rate before vs. after PBMV. Results: Between 2016-2019 there were 1109 hospitalizations in which patients received PBMV for rheumatic (n= 955, 86.1%) vs non-rheumatic MS (n=154, 13.9%) (Figure). In-hospital mortality (odds ratio (OR) 0.67, 95% confidence interval (CI): 0.19-2.25; p=0.52) and 30-day all-cause readmission rate (OR 1.05, 95% CI: 0.54-2.04; p=0.88) were similar with rheumatic vs non-rheumatic MS, respectively. There was no change in 90-day all-cause hospitalization rate after PBMV for rheumatic and non-rheumatic MS (25.5% to 21.8%; p=0.14, and 24.0% to 33.7%; p=0.19, respectively), and similarly among key subgroups except for male and patients &lt;65 years old; (27.7% to 18.1%, p=0.05) and (26.4% to 20.8%, p=0.05) respectively (Figure). Notably the 90-day heart failure-hospitalization rate significantly decreased after PBMV (16.9% to 12.0% [relative reduction 28.9%], p=0.01). Conclusions: Patients who received PBMV for rheumatic and non-rheumatic MS had similar in-hospital mortality and 30-day all-cause readmission rates. There was no change in the 90-day all cause hospitalization rate before and after PBMV however the 90-day heart failure-hospitalizations were significantly reduced. Future studies are needed to examine the role of PBMV in patients without rheumatic MS.

Clinical and Anamnestic Characteristics, Cardiovascular Pharmacotherapy and Long-term Outcomes in Multimorbid Patients after COVID-19

Aim. To study the clinical and anamnestic characteristics, pharmacotherapy of cardiovascular diseases (CVD) and long-term outcomes in post-COVID-19 patients with cardiovascular multimorbidity (CVMM), enrolled in the prospective hospital registry.Material and methods. In patients with confirmed COVID-19 included in the TARGET-VIP registry, the CVMM criterion was the presence of two or more CVDs: arterial hypertension (AH), coronary heart disease (CHD), chronic heart failure (CHF), atrial fibrillation (AF). There were 163 patients in the CVMM group and 382 – in the group without CVD. The information was obtained initially from hospital history sheet, and afterwards – from a telephone survey of patients after 30-60 days, 6 and 12 months, from electronic databases. The follow-up period was 13.0±1.5 months.Results. The age of post-COVID patients with CVMM was 73.7±9.6 years, without CVD – 49.4±12.4 years (p&lt;0.001), the proportion of men was 53.9% and 58.4% (p=0.34). In the group with CVMM the majority of patients had AH (92.3-93.3%), CHD (90.4-91.4%), and minority – CHF (42.7-46.0%) and AF (42.9-43.4%). The combination of 3-4 CVDs prevailed (58.9-60.3%). The proportion of cases of chronic non-cardiac pathologies was higher in the CVMM group (80.9%) compared to the group without CVD (36.7%; p&lt;0.001). The frequency of proper cardiovascular pharmacotherapy during the follow-up period decreased from 56.8% to 51.3% (p for trend = 0.18). The frequency of anticoagulant therapy in AF decreased significantly: from 89.1% at the discharge from the hospital to 56.4% after 30-60 days (p=0.001), 57.1% and 53.6% after 6 and 12 months of monitoring (p for a trend &lt;0.001). There were no other significant changes in the frequency of other kinds of the proper cardiovascular pharmacotherapy (p&gt;0.05). There were higher rate of all-cause mortality among patients with CMMM (12.9% vs 2.9%, p&lt;0.001) as well as rates of hospitalization (34.7% and 9.9%, p&lt;0.001) and non-fatal myocardial infarction (MI) – 2.5% vs 0.5% (p=0.048). The proportion of new cases of CVD in the groups with CVMM and without CVD was 5.5% and 3.7% (p=0.33). The incidence of acute respiratory viral infection (ARVI)/influenza was higher in the group without CVD – 28.3% vs 19.0% (p=0.02). The proportion of cases of recurrent COVID-19 in groups with CVMM and without CVD was 3.7 % and 1.8% (p=0.19).Conclusion. Post COVID-19 patients with CVMM were older and had the bigger number of chronic non-cardiac diseases than patients without CVD. The quality of cardiovascular pharmacotherapy in patients with CVMM was insufficient at the discharge from the hospital with following non-significant decrease during 12 months of follow-up. The frequency of anticoagulant therapy in AF decreased by 1.6 times after 30-60 days and by 1.7 times during the year of follow-up. The proportion of new cases of CVD was 5.5% and 3.7% with no significant differences between compared groups. The rate of all-cause mortality, hospitalizations and non-fatal MI was significantly higher in patients with CVMM, but the frequency of ARVI/influenza was significantly higher in patients without CVD. Recurrent COVID-19 was registered in 3.7% and 1.8% of cases, there were no significant differences between compared groups.

Hospitalizations and Mortality in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial

BackgroundThe impact of transcatheter edge-to-edge repair (TEER) on the rate and prognostic impact of hospitalizations in patients with heart failure (HF) and severe secondary mitral regurgitation is unknown. ObjectivesThis study sought to evaluate the effect of the MitraClip percutaneous edge-to edge repair system on fatal and nonfatal hospitalizations and their relationship with mortality in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. MethodsPatients with HF (n = 614) with severe secondary mitral regurgitation were randomized to TEER plus guideline-directed medical therapy (GDMT) versus GDMT alone. Hospitalizations were classified as fatal if death occurred during that hospitalization or nonfatal if the patient was discharged alive. ResultsAt 2 years, TEER treatment, compared with GDMT alone, resulted in lower time-to-first-event rates of any heart failure hospitalization (HFH) (34.8% vs 56.4%; HR: 0.51; 95% CI: 0.39-0.66) and fatal HFH (6.5% vs 12.6%; HR: 0.47; 95% CI: 0.26-0.85). TEER also resulted in lower rates of all-cause nonfatal and fatal hospitalizations. During the 2-year follow-up period, patients who underwent TEER spent an average of 2 more months alive and out of the hospital than did patients treated with GDMT alone (581 ± 27 days vs 519 ± 26 days; P = 0.002). All HFHs (adjusted HR: 6.37; 95% CI: 4.63-8.78) and nonfatal HFHs (adjusted HR: 1.78; 95% CI: 1.27-2.49) were consistently independently associated with increased 2-year mortality in both the TEER and GDMT groups (Pinteraction = 0.34 and 0.39, respectively). ConclusionsIn the COAPT trial, compared with GDMT alone, patients with HF and severe secondary mitral regurgitation undergoing TEER with the percutaneous edge-to edge repair system had lower 2-year rates of fatal and nonfatal all-cause hospitalizations and HFH and spent more time alive and out of the hospital. HFHs were strongly associated with mortality, irrespective of treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT]; NCT01626079)