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Impact of anemia on outcomes and resource utilization in patients with myocardial infarction: A national database analysis

Jhand, Aravdeep S; Abusnina, Waiel; Tak, Hyo Jung; Ahmed, Arslan; Ismayl, Mahmoud; Altin, S Elissa; Sherwood, Matthew W; Alexander, John H; Rao, Sunil V; Abbott, J Dawn; Carson, Jeffrey L; Goldsweig, Andrew M
BACKGROUND:Although anemia is common in patients with myocardial infarction (MI), management remains controversial. We quantified the association of anemia with in-hospital outcomes and resource utilization in patients admitted with MI using a large national database. METHODS:All hospitalizations with a primary diagnosis code for acute MI in the National Inpatient Sample (NIS) between 2014 and 2018 were identified. Among these hospitalizations, patients with anemia were identified using a secondary diagnosis code. Data on demographic and clinical variables were collected. Outcomes of interest included in-hospital adverse events, length of stay (LOS), and total cost. Multivariable logistic regression and generalized linear models were used to evaluate the relationship between anemia and outcomes. RESULTS:Among 1,113,181 MI hospitalizations, 254,816 (22.8%) included concomitant anemia. Anemic patients were older and more likely to be women. After adjustment for demographics and comorbidities, anemia was associated with higher mortality (7.1 vs. 4.3%; odds ratio 1.09; 95% confidence interval [CI] 1.07-1.12, p < 0.001). Anemia was also associated with a mean of 2.71 days longer LOS (average marginal effects [AME] 2.71; 95% CI 2.68-2.73, p < 0.05), and $ 9703 mean higher total costs (AME $9703, 95% CI $9577-$9829, p < 0.05). Anemic patients who received blood transfusions had higher mortality as compared with those who did not (8.2% vs. 7.0, p < 0.001). CONCLUSION/CONCLUSIONS:In MI patients, anemia was associated with higher in-hospital mortality, adverse events, total cost, and length of stay. Transfusion was associated with increased mortality, and its role in MI requires further research.
PMID: 38697401
ISSN: 1874-1754
CID: 5658162

American Heart Association Cardiogenic Shock Registry: Design and Implementation

Morrow, David A; Jessup, Mariell; Abraham, William T; Acker, Michael; Aringo, Angeline; Batchelor, Wayne; Chikwe, Joanna; Costello, Shaina; Drakos, Stavros G; Farmer, Steven; Gelijns, Annetine; Gillette, Nicole; Hochman, Judith S; Isler, Maria; Kapur, Navin K; Kilic, Arman; Kormos, Robert; Lewis, Eldrin F; Lindenfeld, JoAnn; Lombardi, Pierluca; Mancini, Donna; Rao, Sunil V; Rutan, Christine; Samsky, Marc; Krucoff, Mitchell W
BACKGROUND/UNASSIGNED:Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique collaboration across clinical specialties, federal regulators, payors, and industry, the American Heart Association volunteers and staff have launched a quality improvement registry to better understand the clinical manifestations of shock phenotypes, and to benchmark the management patterns, and outcomes of patients presenting with cardiogenic shock to hospitals across the United States. METHODS/UNASSIGNED:Participating hospitals will enroll consecutive hospitalized patients with cardiogenic shock, regardless of etiology or severity. Data are collected through individual reviews of medical records of sequential adult patients with cardiogenic shock. The electronic case record form was collaboratively designed with a core minimum data structure and aligned with Shock Academic Research Consortium definitions. This registry will allow participating health systems to evaluate patient-level data including diagnostic approaches, therapeutics, use of advanced monitoring and circulatory support, processes of care, complications, and in-hospital survival. Participating sites can leverage these data for onsite monitoring of outcomes and benchmarking versus other institutions. The registry was concomitantly designed to provide a high-quality longitudinal research infrastructure for pragmatic randomized trials as well as translational, clinical, and implementation research. An aggregate deidentified data set will be made available to the research community on the American Heart Association's Precision Medicine Platform. On March 31, 2022, the American Heart Association Cardiogenic Shock Registry received its first clinical records. At the time of this submission, 100 centers are participating. CONCLUSIONS/UNASSIGNED:The American Heart Association Cardiogenic Shock Registry will serve as a resource using consistent data structure and definitions for the medical and research community to accelerate scientific advancement through shared learning and research resulting in improved quality of care and outcomes of shock patients.
PMID: 38887950
ISSN: 1941-7705
CID: 5671952

Association Between Frailty and Management and Outcomes of Acute Myocardial Infarction Complicated by Cardiogenic Shock

Jamil, Yasser; Park, Dae Yong; Rao, Sunil V.; Ahmad, Yousif; Sikand, Nikhil V.; Bosworth, Hayden B.; Coles, Theresa; Damluji, Abdulla A.; Nanna, Michael G.; Samsky, Marc D.
Background: Cardiogenic shock (CS) in the setting of acute myocardial infarction (AMI) is associated with high morbidity and mortality. Frailty is a common comorbidity in patients with cardiovascular disease and is also associated with adverse outcomes. The impact of preexisting frailty at the time of CS diagnosis following AMI has not been studied. Objectives: The purpose of this study was to examine the prevalence of frailty in patients admitted with AMI complicated by CS (AMI-CS) hospitalizations and its associations with in-hospital outcomes. Methods: We retrospectively analyzed the National Inpatient Sample from 2016 to 2020 and identified all hospitalizations for AMI-CS. We classified them into frail and nonfrail groups according to the hospital frailty risk score cut-off of 5 and compared in-hospital outcomes. Results: A total of 283,700 hospitalizations for AMI-CS were identified. Most (70.8%) occurred in the frail. Those with frailty had higher odds of in-hospital mortality (adjusted OR [aOR]: 2.17, 95% CI: 2.07 to 2.26, P < 0.001), do-not-resuscitate status, and discharge to a skilled nursing facility compared with those without frailty. They also had higher odds of in-hospital adverse events, including intracranial hemorrhage, gastrointestinal hemorrhage, acute kidney injury, and delirium. Importantly, AMI-CS hospitalizations in the frail had lower odds of coronary revascularization (aOR: 0.55, 95% CI: 0.53-0.58, P < 0.001) or mechanical circulatory support (aOR: 0.89, 95% CI: 0.85-0.93, P < 0.001). Lastly, hospitalizations for AMI-CS showed an overall increase from 53,210 in 2016 to 57,065 in 2020 (P trend <0.001), with this trend driven by a rise in the frail. Conclusions: A high proportion of hospitalizations for AMI-CS had concomitant frailty. Hospitalizations with AMI-CS and frailty had higher rates of in-hospital morbidity and mortality compared to those without frailty.
SCOPUS:85192747005
ISSN: 2772-963x
CID: 5659502

Case Volumes and Outcomes Among Early-Career Interventional Cardiologists in the United States

Rymer, Jennifer A; Narcisse, Dennis I; Chen, Angel; Wojdyla, Daniel; Ashley, Sarah; Damluji, Abdulla A; Shah, Binita; Nanna, Michael G; Swaminathan, Rajesh; Gutierrez, J Antonio; Uzendu, Anezi; Nelson, Adam J; Bethel, Garrett; Kearney, Katherine; Jones, W Schuyler; Rao, Sunil V; Doll, Jacob A
BACKGROUND:Little is known about the procedural characteristics, case volumes, and mortality rates for early- vs non-early-career interventional cardiologists in the United States. OBJECTIVES/OBJECTIVE:This study examined operator-level data for patients who underwent percutaneous coronary intervention (PCI) between April 2018 and June 2022. METHODS:Data were collected from the National Cardiovascular Data Registry CathPCI Registry, American Board of Internal Medicine certification database, and National Plan and Provider Enumeration System database. Early-career operators were within 5 years of the end of training. Annual case volume, expected mortality and bleeding risk, and observed/predicted mortality and bleeding outcomes were evaluated. RESULTS:A total of 1,451 operators were early career; 1,011 changed their career status during the study; and 6,251 were non-early career. Overall, 514,540 patients were treated by early-career and 2,296,576 patients by non-early-career operators. The median annual case volume per operator was 59 (Q1-Q3: 31-97) for early-career and 57 (Q1-Q3: 28-100) for non-early-career operators. Early-career operators were more likely to treat patients presenting with ST-segment elevation myocardial infarction and urgent indications for PCI (both P < 0.001). The median predicted mortality risk was 2.0% (Q1-Q3: 1.5%-2.7%) for early-career and 1.8% (Q1-Q3: 1.2%-2.4%) for non-early-career operators. The median predicted bleeding risk was 4.9% (Q1-Q3: 4.2%-5.7%) for early-career and 4.4% (Q1-Q3: 3.7%-5.3%) for non-early-career operators. After adjustment, an increased risk of mortality (OR: 1.08; 95% CI: 1.05-1.17; P < 0.0001) and bleeding (OR: 1.08; 95% CI: 1.05-1.12; P < 0.0001) were associated with early-career status. CONCLUSIONS:Early-career operators are caring for patients with more acute presentations and higher predicted risk of mortality and bleeding compared with more experienced colleagues, with modestly worse outcomes. These data should inform institutional practices to support the development of early-career proceduralists.
PMID: 38749617
ISSN: 1558-3597
CID: 5656192

Polyvascular Disease: A Narrative Review of Risk Factors, Clinical Outcomes and Treatment

Tannu, Manasi; Hess, Connie N; Gutierrez, J Antonio; Lopes, Renato; Swaminathan, Rajesh V; Altin, S Elissa; Rao, Sunil V
PURPOSE OF REVIEW/OBJECTIVE:Polyvascular disease has a significant global burden and is associated with increased risk of major adverse cardiac events with each additional vascular territory involved. The purpose of this review is to highlight the risk factors, associated outcomes, emerging genetic markers, and evidence for screening and treatment of polyvascular disease. RECENT FINDINGS/RESULTS:inhibitors and low-dose anticoagulation, but the optimal timing and dosage of these agents has not been established, and the ischemic benefit must be balanced against the increased risk of bleeding in the polyvascular population. Due to the high prevalence and risks associated with polyvascular disease, early identification and treatment intensification are crucial to reduce disease progression. Future research is needed to develop screening protocols and determine the optimal timing and dosing of therapy to prevent ischemic events.
PMID: 38743352
ISSN: 1534-3170
CID: 5658662

Burnout in cardiology: a narrative review

Alexandrou, Michaella; Simsek, Bahadir; Rempakos, Athanasios; Kostantinis, Spyridon; Karacsonyi, Judit; Rangan, Bavana V; Mastrodemos, Olga C; Allana, Salman S; Rao, Sunil V; Linzer, Mark; Egred, Mohaned; Milkas, Anastasios; Sandoval, Yader; Burke, M Nicholas; Brilakis, Emmanouil S
The frequency of burnout is rising among cardiologists, affecting not only their well-being but also the quality of patient care. Computerization of practice, bureaucracy, excessive workload, lack of control/autonomy, hostile and hectic work environments, insufficient income, and work life imbalance are the main categories listed as contributing factors to cardiologists' burnout. Organization- and physician-directed interventions can be impactful; however, the effectiveness and feasibility of these interventions have rarely been assessed in cardiology. This review summarizes recent publications on burnout in cardiology, discusses the contributing factors and implications of burnout on physicians' health and patient safety, and explores possible interventions.
PMID: 38422526
ISSN: 1557-2501
CID: 5655542

Evaluating registry-based trial economics: Results from the STRESS clinical trial

Eisenstein, Eric L.; Hill, Kevin D.; Wood, Nancy; Kirchner, Jerry L.; Anstrom, Kevin J.; Granger, Christopher B.; Rao, Sunil V.; Baldwin, H. Scott; Jacobs, Jeffrey P.; Jacobs, Marshall L.; Kannankeril, Prince J.; Graham, Eric M.; O'Brien, Sean M.; Li, Jennifer S.
Background: Registry-based trials have the potential to reduce randomized clinical trial (RCT) costs. However, observed cost differences also may be achieved through pragmatic trial designs. A systematic comparison of trial costs across different designs has not been previously performed. Methods: We conducted a study to compare the current Steroids to Reduce Systemic inflammation after infant heart surgery (STRESS) registry-based RCT vs. two established designs: pragmatic RCT and explanatory RCT. The primary outcome was total RCT design costs. Secondary outcomes included: RCT duration and personnel hours. Costs were estimated using the Duke Clinical Research Institute's pricing model. Results: The Registry-Based RCT estimated duration was 31.9 weeks greater than the other designs (259.5 vs. 227.6 weeks). This delay was caused by the Registry-Based design's periodic data harvesting that delayed site closing and statistical reporting. Total personnel hours were greatest for the Explanatory design followed by the Pragmatic design and the Registry-Based design (52,488 vs 29,763 vs. 24,480 h, respectively). Total costs were greatest for the Explanatory design followed by the Pragmatic design and the Registry-Based design ($10,140,263 vs. $4,164,863 vs. $3,268,504, respectively). Thus, Registry-Based total costs were 32 % of the Explanatory and 78 % of the Pragmatic design. Conclusion: Total costs for the STRESS RCT with a registry-based design were less than those for a pragmatic design and much less than an explanatory design. Cost savings reflect design elements and leveraging of registry resources to improve cost efficiency, but delays to trial completion should be considered.
SCOPUS:85182579373
ISSN: 2451-8654
CID: 5628942

Evaluating registry-based trial economics: Results from the STRESS clinical trial

Eisenstein, Eric L; Hill, Kevin D; Wood, Nancy; Kirchner, Jerry L; Anstrom, Kevin J; Granger, Christopher B; Rao, Sunil V; Baldwin, H Scott; Jacobs, Jeffrey P; Jacobs, Marshall L; Kannankeril, Prince J; Graham, Eric M; O'Brien, Sean M; Li, Jennifer S
BACKGROUND/UNASSIGNED:Registry-based trials have the potential to reduce randomized clinical trial (RCT) costs. However, observed cost differences also may be achieved through pragmatic trial designs. A systematic comparison of trial costs across different designs has not been previously performed. METHODS/UNASSIGNED:We conducted a study to compare the current Steroids to Reduce Systemic inflammation after infant heart surgery (STRESS) registry-based RCT vs. two established designs: pragmatic RCT and explanatory RCT. The primary outcome was total RCT design costs. Secondary outcomes included: RCT duration and personnel hours. Costs were estimated using the Duke Clinical Research Institute's pricing model. RESULTS/UNASSIGNED:The Registry-Based RCT estimated duration was 31.9 weeks greater than the other designs (259.5 vs. 227.6 weeks). This delay was caused by the Registry-Based design's periodic data harvesting that delayed site closing and statistical reporting. Total personnel hours were greatest for the Explanatory design followed by the Pragmatic design and the Registry-Based design (52,488 vs 29,763 vs. 24,480 h, respectively). Total costs were greatest for the Explanatory design followed by the Pragmatic design and the Registry-Based design ($10,140,263 vs. $4,164,863 vs. $3,268,504, respectively). Thus, Registry-Based total costs were 32 % of the Explanatory and 78 % of the Pragmatic design. CONCLUSION/UNASSIGNED:Total costs for the STRESS RCT with a registry-based design were less than those for a pragmatic design and much less than an explanatory design. Cost savings reflect design elements and leveraging of registry resources to improve cost efficiency, but delays to trial completion should be considered.
PMCID:10826145
PMID: 38298917
ISSN: 2451-8654
CID: 5627232

Implementation of a Multidimensional Strategy to Reduce Post-PCI Bleeding Risk

Price, Andrea L; Amin, Amit P; Rogers, Susan; Messenger, John C; Moussa, Issam D; Miller, Julie M; Jennings, Jonathan; Masoudi, Frederick A; Abbott, J Dawn; Young, Rebecca; Wojdyla, Daniel M; Rao, Sunil V
BACKGROUND/UNASSIGNED:The American College of Cardiology Reduce the Risk: PCI Bleed Campaign was a hospital-based quality improvement campaign designed to reduce post-percutaneous coronary intervention (PCI) bleeding events. The aim of the campaign was to provide actionable evidence-based tools for participants to review, adapt, and adopt, depending upon hospital resources and engagement. METHODS/UNASSIGNED:We used data from 8 757 737 procedures in the National Cardiovascular Data Registry between 2015 and 2021 to compare patient and hospital characteristics and bleeding outcomes among campaign participants (n=195 hospitals) and noncampaign participants (n=1384). Post-PCI bleeding risk was compared before and after campaign participation. Multivariable hierarchical logistic regression was used to determine the adjusted association between campaign participation and post-PCI bleeding events. Prespecified subgroups were examined. RESULTS/UNASSIGNED:Campaign hospitals were more often higher volume teaching facilities located in urban or suburban locations. After adjustment, campaign participation was associated with a significant reduction in the rate of bleeding (bleeding: adjusted odds ratio, 0.61 [95% CI, 0.53-0.71]). Campaign hospitals had a greater decrease in bleeding events than noncampaign hospitals. In a subgroup analysis, the reduction in bleeding was noted in non-ST-segment-elevation acute coronary syndrome and ST-segment-elevation myocardial infarction patients, but no significant reduction was seen in patients without acute coronary syndrome. CONCLUSIONS/UNASSIGNED:Participation in the American College of Cardiology Reduce the Risk: PCI Bleed Campaign was associated with a significant reduction in post-PCI bleeding. Our results underscore that national quality improvement efforts can be associated with a significant impact on PCI outcomes.
PMCID:10942247
PMID: 38410946
ISSN: 1941-7632
CID: 5639762

Bleeding Outcomes in Patients Treated With Asundexian in Phase II Trials

Eikelboom, John W; Mundl, Hardi; Alexander, John H; Caso, Valeria; Connolly, Stuart J; Coppolecchia, Rosa; Gebel, Martin; Hart, Robert G; Holberg, Gerlind; Keller, Lars; Patel, Manesh R; Piccini, Jonathan P; Rao, Sunil V; Shoamanesh, Ashkan; Tamm, Miriam; Viethen, Thomas; Yassen, Ashraf; Bonaca, Marc P
BACKGROUND:Phase II trials of asundexian were underpowered to detect important differences in bleeding. OBJECTIVES/OBJECTIVE:The goal of this study was to obtain best estimates of effects of asundexian vs active control/placebo on major and clinically relevant nonmajor (CRNM) and all bleeding, describe most common sites of bleeding, and explore association between asundexian exposure and bleeding. METHODS:We performed a pooled analysis of 3 phase II trials of asundexian in patients with atrial fibrillation (AF), recent acute myocardial infarction (AMI), or stroke. Bleeding was defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria. RESULTS:In patients with AF (n = 755), both asundexian 20 mg and 50 mg once daily vs apixaban had fewer major/CRNM events (3 of 249; incidence rate [IR] per 100 patient-years 5.47 vs 1 of 254 [IR: not calculable] vs 6 of 250 [IR: 11.10]) and all bleeding (12 of 249 [IR: 22.26] vs 10 of 254 [IR: 18.21] vs 26 of 250 [IR: 50.56]). In patients with recent AMI or stroke (n = 3,409), asundexian 10 mg, 20 mg, and 50 mg once daily compared with placebo had similar rates of major/CRNM events (44 of 840 [IR: 7.55] vs 42 of 843 [IR: 7.04] vs 56 of 845 [IR: 9.63] vs 41 of 851 [IR: 6.99]) and all bleeding (107 of 840 [IR: 19.57] vs 123 of 843 [IR: 22.45] vs 130 of 845 [IR: 24.19] vs 129 of 851 [IR: 23.84]). Most common sites of major/CRNM bleeding with asundexian were gastrointestinal, respiratory, urogenital, and skin. There was no significant association between asundexian exposure and major/CRNM bleeding. CONCLUSIONS:Analyses of phase II trials involving >500 bleeds highlight the potential for improved safety of asundexian compared with apixaban and similar safety compared with placebo. Further evidence on the efficacy of asundexian awaits the results of ongoing phase III trials.
PMID: 38325992
ISSN: 1558-3597
CID: 5632262