Impact of Inpatient Percutaneous Coronary Intervention Volume on 30-Day Readmissions After Acute Myocardial Infarction-Cardiogenic Shock.

BACKGROUND: There are limited data on volume-outcome relationships in acute myocardial infarction (AMI) with cardiogenic shock (CS). OBJECTIVES: In this study, the authors sought to evaluate the association between hospital percutaneous coronary intervention (PCI) volume and readmission after AMI-CS. METHODS: Adult AMI-CS patients were identified from the Nationwide Readmissions Database for 2016-2019 and were categorized into hospital quartiles (Q1 lowest volume to Q4 highest) based on annual inpatient PCI volume. Outcomes of interest included 30-day all-cause, cardiac, noncardiac, and heart-failure (HF) readmissions. RESULTS: There were 49,558 AMI-CS admissions at 3,954 PCI-performing hospitals. Median annual PCI volume was 174 (Q1-Q3: 70-316). Patients treated at Q1 hospitals were on average older, female, and with higher comorbidity burden. Patients at Q4 hospitals had higher rates of noncardiac organ dysfunction, complications, and use of cardiac support therapies. Overall, 30-day readmission rate was 18.5% (n = 9,179), of which cardiac, noncardiac, and HF readmissions constituted 56.2%, 43.8%, and 25.8%, respectively. From Q1 to Q4, there were no differences in 30-day all-cause (17.6%, 18.4%, 18.2%, 18.7%; P = 0.55), cardiac (10.9%, 11.0%, 10.6%, 10.2%; P = 0.29), and HF (5.0%, 4.8%, 4.8%, 4.8%; P = 0.99) readmissions. Noncardiac readmissions were noted more commonly in higher quartiles (6.7%, 7.4%, 7.7%, 8.5%; P = 0.001) but was not significant after multivariable adjustment. No relationship was noted between hospital PCI volume as a continuous variable and readmissions. CONCLUSIONS: In AMI-CS, there was no association between hospital annual PCI volume and 30-day readmissions despite higher acuity in the higher volume PCI centers suggestive of better care pathways for CS at higher volume centers.

Risk of Suicide, Hair Loss, and Aspiration with GLP1-Receptor Agonists and Other Diabetic Agents: A Real-World Pharmacovigilance Study.

PURPOSE: With the increasing popularity of glucagon-like peptide 1 receptor agonists (GLP1-RAs), numerous safety concerns arose pertaining to suicide, hair loss, and aspiration risks. We attempted to validate these concerns. METHODS: We queried four pharmacovigilance databases to compare GLP1-RAs to sodium-glucose transporter 2 inhibitors (SGLT2is) with respect to these adverse events (AE): the FDA Adverse Event Reporting System (FAERS), the Australian Database of Adverse Event Notifications (DAEN), the European Medicines Agency's (EudraVigilance), and the World Health Organization-Vigibase. OpenVigil 2.1 was utilized to perform a disproportionality analysis for GLP1-RAs, SGLT2is, dipeptidyl peptidase 4 inhibitors (DPP4is), sulfonylureas, metformin, and insulin. The following indices were extracted from the FAERS database from Q4/2003 until Q3/2023: relative reporting ratio (RRR), proportional reporting ratio (PRR), reporting odds ratio (ROR), and chi-squared (χ2). A positive signal was detected if PRR > 2 and χ2 > 4 for any drug-event pair. RESULTS: No positive signals were observed between GLP1-RAs and either suicide, hair loss, or aspiration risks. Semaglutide [ROR = 0.60 (0.51-0.71)] and liraglutide [ROR = 0.28 (0.23-0.35)] had higher suicidal events than DPP4is and SGLT2is. GLP1-RAs were the most reported class with hair loss [ROR = 0.61 (0.60-0.64)], and semaglutide, liraglutide, and dulaglutide were the three leading medications. GLP1-RAs ranked lower with aspiration events, which were led by sitagliptin and DPP4is as a group. CONCLUSION: GLP1-RAs exhibit higher reporting of suicide, hair loss, and aspiration events when compared to several other antidiabetic medications despite not meeting the criteria for positive signals yet. This warrants intensive monitoring and reporting.

A Real­World Pharmacovigilance Study of FDA Adverse Event Reporting System (FAERS) for Mavacamten.

BACKGROUND: Mavacamten is a first-in-class cardiac myosin inhibitor approved by the US Food and Drug Administration (FDA) for symptomatic obstructive hypertrophic cardiomyopathy (HCM). This pharmacovigilance study aimed to assess mavacamten-related adverse drug reactions (ADRs) in the real world as reported in the FDA Adverse Event Reporting System (FAERS). METHODS: We conducted disproportionality analyses with four signal detection algorithms-reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and the multi-item gamma Poisson shrinker to identify mavacamten-related ADRs. RESULTS: Out of 4,500,131 reports from the FAERS database, 1004 mavacamten-related ADRs were identified from 1 January 2022 to 30 September 2023. A total of 26 significant disproportionality preferred terms (PTs) conforming to the four signal detection algorithms were noted. Some of the statistically significant cardiac ADRs at PT level include decreased ejection fraction (EF) [ROR 33.60 (95% confidence interval, CI 21.79-51.82), PRR 32.86 (χ2 615.96), information component (IC) 5.03, IC025 4.61, empirical Bayesian geometric mean (EBGM) 32.77, EBGM05 21.25], cardiac failure [ROR 9.39 (95% CI 6.49-13.60), PRR 9.13 (χ2 202.42), IC 3.19, IC025 2.83, EBGM 9.12, EBGM05 6.30], and atrial fibrillation [ROR 16.63 (95% CI 12.72-21.75), PRR 15.66 (χ2 769.93), IC 3.97, IC025 3.71, EBGM 15.64, EBGM05 11.96]. CONCLUSIONS: The results of our study were consistent with the safety data of clinical trials, including reduced ejection fraction, atrial fibrillation, dyspnea, and syncope. We also found potential new and unexpected ADR signals, such as urinary tract infection, gout, and peripheral edema.

Echocardiographic predictors and associated outcomes of multiple vegetations in infective endocarditis: A pilot study.

BACKGROUND: Infective endocarditis (IE) is a life-threatening infection with an annual mortality of 40%. Embolic events reported in up to 80% of patients. Vegetations of > 10 mm size are associated with increased embolic events and poor prognosis. There is a paucity of literature on the association of multiple vegetations with outcome. AIM: To study the echocardiographic (ECHO) features and outcomes associated with the presence of multiple vegetations. METHODS: In this retrospective, single-center, cohort study patients diagnosed with IE were recruited from June 2017 to June 2019. A total of 84 patients were diagnosed to have IE, of whom 67 with vegetation were identified. Baseline demographic, clinical, laboratory, and ECHO parameters were reviewed. Outcomes that were studied included recurrent admission, embolic phenomenon, and mortality. RESULTS: Twenty-three (34%) patients were noted to have multiple vegetations, 13 (56.5%) were male and 10 (43.5%) were female. The mean age of these patients was 50. Eight (35%) had a prior episode of IE. ECHO features of moderate to severe valvular regurgitation [odds ratio (OR) = 4], presence of pacemaker lead (OR = 4.8), impaired left ventricle (LV) relaxation (OR = 4), and elevated pulmonary artery systolic pressure (PASP) (OR = 2.2) are associated with higher odds of multiple vegetations. Of these moderate to severe valvular regurgitation (P = 0.028), pacemaker lead (P = 0.039) and impaired relaxation (P = 0.028) were statistically significant. These patients were noted to have an increased association of recurrent admissions (OR = 3.6), recurrent bacteremia (OR = 2.4), embolic phenomenon (OR = 2.5), intensive care unit stay (OR = 2.8), hypotension (OR = 2.1), surgical intervention (OR = 2.8) and device removal (OR = 4.8). Of this device removal (P = 0.039) and recurrent admissions (P = 0.017) were statistically significant. CONCLUSION: This study highlights the associations of ECHO predictors and outcomes in patients with IE having multiple vegetations. ECHO features of moderate to severe regurgitation, presence of pacemaker lead, impaired LV relaxation, and elevated PASP and outcomes including recurrent admissions and device removal were found to be associated with multiple vegetations.

Stroke Risk After Mitral Valve Interventions: A Systematic Review and Network Meta-Analysis.

Previous research indicates varying stroke rates after mitral valve (MV) interventions. This study aimed to compare postprocedural stroke risks after transcatheter and surgical MV interventions. Electronic databases were searched from inception to February 2024 for studies comparing stroke rates after mitral transcatheter edge-to-edge repair (mTEER), surgical MV repair/replacement, or guideline-directed medical therapy (GDMT). Primary end points were all-time and early (<30 days) stroke. Secondary outcomes included new-onset atrial fibrillation and 1-year all-cause mortality. A frequentist network meta-analysis was employed to compare outcomes. The network meta-analysis included 18 studies (3 randomized controlled trials and 15 observational), with 51,703 patients. mTEER was associated with a decreased risk of all-time (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.41 to 0.89) and early stroke (OR 0.41, 95% CI 0.33 to 0.51) compared with surgery, and a similar risk of all-time (OR 1.54, 95% CI 0.76 to 3.12) and early stroke (OR 2.12, 95% CI 0.53 to 8.47) compared with GDMT. Conversely, surgery was associated with an increased risk of all-time (OR 2.55, 95% CI 1.17 to 5.57) and early stroke (OR 5.15, 95% CI 1.27 to 20.84) compared with GDMT. There were no statistically significant differences in the risk of new-onset atrial fibrillation (OR 0.38, 95% CI 0.11 to 1.31) and 1-year all-cause mortality (OR 1.43, 95% CI 0.91 to 2.24) between mTEER versus surgery. In conclusion, mTEER was associated with a lower risk of stroke and similar risks of new-onset atrial fibrillation and 1-year mortality compared with surgical MV interventions. Further studies are needed to understand the mechanisms of stroke and to determine strategies to reduce stroke risk after MV interventions.

Medicare Coverage and Patient Out-of-Pocket Costs for Cardiovascular-Kidney-Metabolic Medications.

This cross-sectional study evaluates the association between Medicare coverage and patient out-of-pocket costs for cardiovascular-kidney-metabolic medications.

Contemporary American and European Guidelines for Heart Failure Management: JACC: Heart Failure Guideline Comparison.

This review serves to compare contemporary clinical practice recommendations for the management of heart failure (HF), as codified in the 2021 European Society of Cardiology (ESC) guideline, the 2022 American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) guideline, and the 2023 focused update of the 2021 ESC document. Overall, these guidelines aim to solidify significant advances throughout the HF continuum since the publication of previous full guideline iterations (2013 and 2016 for the ACC/AHA and ESC, respectively). All guidelines provide new recommendations for an increasingly complex landscape of HF care, with focus on primary HF prevention, HF stages, rapid initiation and optimization of evidence-based pharmacotherapies, overlapping cardiac and noncardiac comorbidities, device-based therapies, and management pathways for special groups of patients, including those with cardiac amyloidosis. Importantly, the ACC/AHA/HFSA document features special emphasis on HF risk prediction and screening, cost/value, social determinants of health, and health care disparities. The review discusses major similarities and differences between these recent guidelines and guideline updates, as well as their potential downstream implications for clinical care.

Association Between Polyvascular Disease and Transcatheter Aortic Valve Replacement Outcomes: Insights From the STS/ACC TVT Registry.

BACKGROUND: Atherosclerotic cardiovascular disease is highly prevalent in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Polyvascular disease (PVD), defined as involvement of ≥2 vascular beds (VBs), that is, coronary, cerebrovascular, or peripheral, portends a poor prognosis in patients with atherosclerotic cardiovascular disease; however, data on the association of PVD with outcomes of patients undergoing TAVR are limited. METHODS: The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy Registry was analyzed to identify patients who underwent TAVR from November 2011 to March 2022. The exposure of interest was PVD. The primary outcome was all-cause mortality. Secondary outcomes included major vascular complications, major/life-threatening bleeding, myocardial infarction, transient ischemic attack/stroke, and valve- and non-valve-related readmissions. Outcomes were assessed at 30 days and 1 year. RESULTS: Of 443 790 patients who underwent TAVR, PVD was present in 150 823 (34.0%; 111 425 [25.1%] with 2VB-PVD and 39 398 [8.9%] with 3VB-PVD). On multivariable analysis, PVD was associated with increased all-cause mortality at 1 year (hazard ratio, 1.17 [95% CI, 1.14-1.20]). There was an incremental increase in 1-year mortality with an increasing number of VBs involved (no PVD [reference]; 2VB-PVD: hazard ratio, 1.12 [95% CI, 1.09-1.15]: and 3VB-PVD: hazard ratio, 1.31 [95% CI, 1.26-1.36]). Patients with versus without PVD had higher rates of major vascular complications, major/life-threatening bleeding, transient ischemic attack/stroke, and non-valve-related readmissions at 30 days and 1 year. CONCLUSIONS: PVD is associated with worse outcomes after TAVR, and the risk is highest in patients with 3VB-PVD.

Predictors and Outcomes of Sudden Cardiac Arrest in Heart Failure With Preserved Ejection Fraction: A Nationwide Inpatient Sample Analysis.

Sudden cardiac arrest (SCA) is the leading cause of cardiovascular mortality in heart failure with preserved ejection fraction (HFpEF), contributing to around 25% of deaths observed in pivotal HFpEF trials. However, predictors and outcomes of in-hospital SCA in HFpEF have not been well characterized. We queried the Nationwide Inpatient Sample (2016 to 2017) to identify adult hospitalizations with a diagnosis of HFpEF. Patients with acute or chronic conditions associated with SCA (e.g., acute myocardial infarction, acute pulmonary embolism, sarcoidosis) were excluded. We ascertained whether SCA occurred during these hospitalizations, identified predictors of SCA using multivariate logistic regression, and determined outcomes of SCA in HFpEF. Of 2,909,134 hospitalizations, SCA occurred in 1.48% (43,105). The mean age of the SCA group was 72.3 ± 12.4 years, 55.8% were women, and 66.4% were White. Presence of third-degree atrioventricular block (odds ratio [OR] 5.95, 95% confidence interval [CI] 5.31 to 6.67), left bundle branch block (OR 1.96, 95% CI 1.72 to 2.25), and liver disease (OR 1.87, 95% CI 1.73 to 2.02) were the leading predictors of SCA in HFpEF. After excluding patients with do-not-resuscitate status, the SCA group versus those without SCA had higher mortality (25.9% vs 1.6%), major bleeding complications (4.1% vs 1.7%), increased use of percutaneous coronary intervention (2.5% vs 0.7%), and mechanical circulatory assist device (1.2% vs 0.1%). These observational inpatient data suggest identifiable risk factors for SCA in HFpEF including cardiac arrhythmias. Further research is warranted to identify the best tools to risk-stratify patients with HFpEF to implement targeted SCA prevention strategies.

Association Between Hospital Volume and 30-Day Readmissions After Transcatheter Mitral Valve Edge-to-Edge Repair.

Data on the association between hospital procedural volume and 30-day readmissions after mitral valve transcatheter edge-to-edge repair (mTEER) are limited. We used the 2019 Nationwide Readmissions Database to identify hospitals that performed at least 5 mTEERs. Hospitals were categorized based on tertiles of annual mTEER volume as low-volume (5 to 13), medium-volume (14 to 28), and high-volume (29 to 171). Multivariable hierarchical logistic regression models and restricted cubic spline analyses were used to examine the association between hospital mTEER volume and 30-day readmissions. Median (interquartile range) annual hospital mTEER volume was 20 (11.5 to 34). Of 234 hospitals included in the study, 77 (32.9%), 77 (32.9%), and 80 (34.2%) were categorized as low-volume, medium-volume, and high-volume. Of 5,574 index mTEER procedures included in this study, 634 (11.4%), 1,353 (24.3%), and 3,587 (64.3%) were performed at low-volume, medium-volume, and high-volume centers, respectively. In the overall study cohort, rates of 30-day all-cause readmissions after mTEER were 13.2%. In multivariable analyses, there was no significant association between hospital mTEER volume (as a categorical variable) and 30-day all-cause or cause-specific (cardiac, non-cardiac, heart failure) readmissions. Similarly, no significant relation was observed between hospital mTEER volume as a continuous variable and 30-day all-cause or cause-specific readmissions in restricted cubic spline analysis. In conclusion, in a nationally representative sample of 234 hospitals with >5,500 mTEER procedures, we found no association between annual hospital mTEER volume and 30-day all-cause or cause-specific readmissions.

Association Between Psychosocial Risk Factors and Readmissions After Acute Myocardial Infarction: Role of COVID-19 Pandemic.

Psychosocial risk factors (PSRFs) are known to be associated with worse cardiovascular (CV) outcomes. However, there are limited data on the impact of PSRFs on readmissions after acute myocardial infarction (AMI) before and during the COVID-19 (Coronavirus Disease 2019) pandemic. Therefore, we aimed to examine this association and whether the effects of PSRFs were amplified during the COVID-19 pandemic. We queried the 2019 and 2020 Nationwide Readmissions Database for adult (age ≥18 years) index admissions with AMI as the primary diagnosis. They were then divided into 2 cohorts based on the presence or absence of ≥1 PSRF and compared across non-COVID-19 (2019) and COVID-19 (2020) time periods. The primary outcome was 30-day all-cause readmissions. Secondary outcomes included cause-specific readmissions (cardiac, noncardiac, AMI, heart failure). Multivariable hierarchical logistic regression was conducted to evaluate differences in outcomes. The study included 380,820 patients with index AMI, of which 214,384 (56%) had ≥1 PSRFs. Patients with PSRFs were younger, more likely to be female, and had a higher prevalence of CV risk factors. Of 30-day all-cause readmissions were higher in patients with PSRFs in both eras. Moreover, noncardiac and heart failure readmissions were also higher in patients with PSRFs admitted with AMI in 2019 and 2020. This study of a nationally representative population magnifies the association of PSRF with more unplanned readmissions after AMI in both pre-COVID-19 and COVID-19 times.

Association of Psychosocial Risk Factors and Outcomes in Heart Failure: Does COVID-19 Affect Outcomes?

Psychosocial risk factors (PSRFs) have emerged as crucial nontraditional risk factors affecting outcomes in patients with heart failure (HF). There is a paucity of data studying these risk factors in HF nationally. Additionally, whether the COVID-19 pandemic impacted outcomes remains unexplored, given the increased psychosocial risk during these times. Our objective is to assess the impact of PSRFs on the outcomes of HF and their comparison across non-COVID-19 and COVID-19 eras. Patients with a diagnosis of HF were selected using the 2019-2020 Nationwide Readmissions Database. Two cohorts were created based on the presence or absence of PSRFs and compared across non-COVID-19 and COVID-19 eras. We examined the association using hierarchical multivariable logistic regression models. A total of 305,955 patients were included, of which 175,348 (57%) had PSRFs. Patients with PSRFs were younger, less likely to be female, and had a higher prevalence of cardiovascular risk factors. All-cause readmissions were higher in patients with PSRFs in both the eras. All-cause mortality [odds ratio, OR 1.15 (1.04-1.27), P = 0.005] and composite of MACE [OR 1.11 (1.06-1.16), P < 0.001] were higher in patients in the non-COVID-19 era. Compared to 2019, patients with PSRFs and HF in 2020 had significantly higher all-cause mortality [OR 1.13 (1.03-1.24), P = 0.009]; however, the composite of MACE was comparable [OR 1.04 (1.00-1.09), P = 0.03]. In conclusion, the presence of PSRFs in patients with HF is associated with a significant increase in all-cause readmissions in COVID-19 and non-COVID-19 eras. The worse outcomes evident in the COVID-19 era highlights the importance of multidisciplinary care in this vulnerable population.

Influence of non-alcoholic fatty liver disease on non-variceal upper gastrointestinal bleeding: A nationwide analysis.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is the leading cause of liver disease globally with an estimated prevalence of 25%, with the clinical and economic burden expected to continue to increase. In the United States, non-variceal upper gastrointestinal bleeding (NVUGIB) has an estimated incidence of 61-78 cases per 100000 people with a mortality rate of 2%-15% based on co-morbidity burden. AIM: To identify the outcomes of NVUGIB in NAFLD hospitalizations in the United States. METHODS: We utilized the National Inpatient Sample from 2016-2019 to identify all NVUGIB hospitalizations in the United States. This population was divided based on the presence and absence of NAFLD. Hospitalization characteristics, outcomes and complications were compared. RESULTS: The total number of hospitalizations for NVUGIB was 799785, of which 6% were found to have NAFLD. NAFLD and GIB was, on average, more common in younger patients, females, and Hispanics than GIB without NAFLD. Interestingly, GIB was less common amongst blacks with NAFLD. Multivariate logistic regression analysis was conducted, controlling for the multiple covariates. The primary outcome of interest, mortality, was found to be significantly higher in patients with NAFLD and GIB [adjusted odds ratio (aOR) = 1.018 (1.013-1.022)]. Secondary outcomes of interest, shock [aOR = 1.015 (1.008-1.022)], acute respiratory failure [aOR = 1.01 (1.005-1.015)] and acute liver failure [aOR = 1.016 (1.013-1.019)] were all more likely to occur in this cohort. Patients with NAFLD were also more likely to incur higher total hospital charges (THC) [$2148 ($1677-$2618)]; however, were less likely to have a longer length of stay [0.27 d (0.17-0.38)]. Interestingly, in our study, the patients with NAFLD were less likely to suffer from acute myocardial infarction [aOR = 0.992 (0.989-0.995)]. Patients with NAFLD were not more likely to suffer acute kidney injury, sepsis, blood transfusion, intubation, or dialysis. CONCLUSION: NVUGIB in NAFLD hospitalizations had higher inpatient mortality, THC, and complications such as shock, acute respiratory failure, and acute liver failure compared to those without NAFLD.

Risk Factors and Subtyping of Ischemic Stroke in Young Adults in the Indian Population.

OBJECTIVE: To evaluate the risk factors and etiological subtyping of ischemic stroke in young adults in the Indian population. METHODS: This is a retrospective study of 160 patients, in the age group of 18 to 45 years with ischemic stroke, registered at a tertiary care hospital in Delhi, India between March 2014 and January 2018. Hypertension, diabetes mellitus, dyslipidemia, smoking, alcohol consumption, previous history of stroke, valvular heart disease, coronary artery disease (CAD), atrial fibrillation, family history, and migraine were considered as the identifiable risk factors. Stroke subtyping was done according to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. RESULTS: The mean age of the patients was 36.2 years with 74% being males. Headache, vomiting, difficulty in speech, and hemiparesis were the common complaints at presentation. Common risk factors identified were hypertension (50%), prior stroke or transient ischemic attack (TIA; 32%), dyslipidemia (25%), family history of stroke (18%), and smoking (15%). The most common TOAST subtype was undetermined (64%), followed by other determined cause (ODC; 20%), and cardioembolism (15%). CONCLUSION: There is a certain dissimilarity in the risk factors for ischemic stroke in young adults living in developing countries compared to those belonging to developed nations. Primary and secondary prevention targeted at the modifiable risk factors of ischemic stroke is necessary. Cerebral artery dissection, being a prevalent cause of ischemic stroke in young adults, should be carefully evaluated. A more appropriate stroke classification system specifically tailored for younger patients is needed.