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1.
Circulation ; 2024 Sep 12.
Article in English | MEDLINE | ID: mdl-39263752

ABSTRACT

Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams show great promise to improve management and outcomes of acute pulmonary embolism (PE). However, the absence of randomized evidence and lack of consensus leads to tremendous variations in treatment and compromises the wide implementation of new innovations. Moreover, the changing landscape of health care, where quality, cost, and accountability are increasingly relevant, dictates that a broad spectrum of outcomes of care must be routinely monitored to fully capture the impact of modern PE treatment. We set out to standardize data collection in patients with PE undergoing evaluation and treatment, and thus establish the foundation for an expanding evidence base that will address gaps in evidence and inform future care for acute PE. To do so, >100 international PE thought leaders convened in Washington, DC, in April 2022 to form the Pulmonary Embolism Research Collaborative. Participants included physician experts, key members of the US Food and Drug Administration, patient representatives, and industry leaders. Recognizing the multidisciplinary nature of PE care, the Pulmonary Embolism Research Collaborative was created with representative experts from stakeholder medical subspecialties, including cardiology, pulmonology, vascular medicine, critical care, hematology, cardiac surgery, emergency medicine, hospital medicine, and pharmacology. A list of critical evidence gaps was composed with a matching comprehensive set of standardized data elements; these data points will provide a foundation for productive research, knowledge enhancement, and advancement of clinical care within the field of acute PE, and contribute to answering urgent unmet needs in PE management. Evidence produced through the Pulmonary Embolism Research Collaborative, as it is applied to data collection, promises to provide crucial knowledge that will ultimately produce a robust evidence base that will lead to standardization and harmonization of PE management and improved outcomes.

2.
JACC Adv ; 3(9): 101199, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39238851

ABSTRACT

Background: Acute myocardial infarction (AMI) remains a common reason for admission to the intensive care unit (ICU). However, there is limited data comparing outcomes for patients with AMI admitted to specific ICUs. Objectives: The purpose of this study was to assess clinical outcomes between patients with AMI requiring invasive mechanical ventilation admitted to the medical ICU (MICU) compared to cardiac (CICU). Methods: We utilized the Vizient Clinical Data Base to identify patients with a primary diagnosis of AMI between October 2015 and December 2019 and requiring invasive mechanical ventilation. Using multivariable logistic regression, we compared clinical outcomes for patients admitted to the MICU vs CICU. Results: We identified 12,639 patients, 25.2% (n = 3,185) of which were admitted to a MICU and 74.8% (n = 9,454) to a CICU. Patients admitted to a CICU were more likely to present with STEMI (57.0% vs 42.8%), cardiogenic shock (46.0% vs 37.4%), and require mechanical circulatory support and vasoactive medications (all, P < 0.001). Median ventilator days were 4 days in both ICUs and not statistically different after multivariable adjustment (P = 0.81). In-hospital mortality was 42.7% compared to 41.3% for MICU vs CICU admissions, respectively (P = 0.15). After multivariable adjustment, CICU admission was associated with lower in-hospital mortality (OR: 0.85, 95% CI: 0.78-0.93, P = 0.001), which persisted when stratified by cardiogenic shock, cardiac arrest, STEMI, largest hospital size (>750 beds), and teaching hospitals (all, P < 0.05). Conclusions: Admission to the CICU, as compared to MICU, was associated with lower in-hospital mortality for patients with AMI. These findings may support optimal triage of critically ill patients with AMI.

3.
Article in English | MEDLINE | ID: mdl-39208447

ABSTRACT

BACKGROUND: The Shock Academic Research Consortium (SHARC) recently proposed pragmatic consensus definitions to standardize classification of cardiogenic shock (CS) in registries and clinical trials. We aimed to describe contemporary CS epidemiology using the SHARC definitions in a cardiac intensive care unit (CICU) population. METHODS: The Critical Care Cardiology Trials Network (CCCTN) is a multinational research network of advanced CICUs coordinated by the TIMI Study Group (Boston, MA). CS was defined as a cardiac disorder resulting in SBP<90mmHg for ≥30 minutes (or the need for vasopressors, inotropes, or mechanical circulatory support [MCS] to maintain SBP ≥90mmHg) with evidence of hypoperfusion. Primary etiologic categories included acute myocardial infarction-related CS (AMI-CS), heart failure-related CS (HF-CS), and non-myocardial (secondary) CS. Post-cardiotomy CS was not included. HF-CS was further subcategorized as de novo vs. acute-on-chronic HF-CS. Patients with both cardiogenic and non-cardiogenic components of shock were classified separately as mixed CS. RESULTS: Of 8,974 patients meeting shock criteria (2017-2023), 65% had isolated CS and 17% had mixed shock. Among patients with CS (n=5,869), 27% had AMI-CS (65% STEMI), 59% HF-CS (72% acute-on-chronic, 28% de novo), and 14% secondary CS. Patients with AMI-CS and de novo HF-CS were most likely to have had concomitant cardiac arrest (p<0.001). Patients with AMI-CS and mixed CS were most likely to present in more severe shock stages (SCAI D or E; p<0.001). Temporary MCS use was highest in AMI-CS (59%). In-hospital mortality was highest in mixed CS (48%), followed by AMI-CS (41%), similar in de novo HF-CS (31%) and secondary CS (31%), and lowest in acute-on-chronic HF-CS (25%; p<0.001). CONCLUSIONS: SHARC consensus definitions for CS classification can be pragmatically applied in contemporary registries and reveal discrete subpopulations of CS with distinct phenotypes and outcomes that may be relevant to clinical practice and future research.

4.
JACC Heart Fail ; 12(9): 1625-1635, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39093257

ABSTRACT

BACKGROUND: The prognostic implications of phenotypes along the preshock to cardiogenic shock (CS) continuum remain uncertain. OBJECTIVES: This study sought to better characterize pre- or early shock and normotensive CS phenotypes and examine outcomes compared to those with conventional CS. METHODS: The CCCTN (Critical Care Cardiology Trials Network) is a registry of contemporary cardiac intensive care units. Consecutive admissions (N = 28,703 across 47 sites) meeting specific criteria based on hemodynamic variables, perfusion parameters, and investigator-reported CS were classified into 1 of 4 groups or none: isolated low cardiac output (CO), heart failure with isolated hypotension, normotensive CS, or SCAI (Society of Cardiovascular Angiography and Intervention) stage C CS. Outcomes of interest were in-hospital mortality and incidence of subsequent hypoperfusion among pre- and early shock states. RESULTS: A total of 2,498 admissions were assigned to the 4 groups with the following distribution: 4.8% isolated low CO, 4.4% isolated hypotension, 12.1% normotensive CS, and 78.7% SCAI stage C CS. Overall in-hospital mortality was 21.3% (95% CI: 19.7%-23.0%), with a gradient across phenotypes (isolated low CO 3.6% [95% CI: 1.0%-9.0%]; isolated hypotension 11.0% [95% CI: 6.9%-16.6%]; normotensive CS 17.0% [95% CI 13.0%-21.8%]; SCAI stage C CS 24.0% [95% CI: 22.1%-26.0%]; global P < 0.001). Among those with an isolated low CO and isolated hypotension on admission, 47 (42.3%) and 56 (30.9%) subsequently developed hypoperfusion. CONCLUSIONS: In a large contemporary registry of cardiac critical illness, there exists a gradient of mortality for phenotypes along the preshock to CS continuum with risk for subsequent worsening of preshock states. These data may inform refinement of CS definitions and severity staging.


Subject(s)
Hospital Mortality , Registries , Shock, Cardiogenic , Humans , Shock, Cardiogenic/therapy , Shock, Cardiogenic/mortality , Male , Female , Aged , Middle Aged , Critical Care , Heart Failure/physiopathology , Heart Failure/therapy , Prognosis , Phenotype , Hypotension/epidemiology , Coronary Care Units/statistics & numerical data
5.
Curr Cardiol Rep ; 26(8): 815-820, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38913233

ABSTRACT

PURPOSE OF REVIEW: The endotracheal intubation of patients with pulmonary arterial hypertension (PAH) in respiratory distress is a highly morbid procedure that can precipitate hemodynamic collapse. Here we review our strategy for confronting this difficult clinical situation. RECENT FINDINGS: There are no clinical trials that explore best practices in the management of patients with PAH and respiratory failure. Here we provide a practical approach to respiratory support, inopressor and pulmonary vasodilator selection, hemodynamic considerations, point-of-care ultrasound monitoring, and endotracheal intubation in patients with PAH in respiratory failure.


Subject(s)
Intubation, Intratracheal , Respiratory Insufficiency , Humans , Respiratory Insufficiency/therapy , Respiratory Insufficiency/etiology , Pulmonary Arterial Hypertension/physiopathology , Pulmonary Arterial Hypertension/therapy , Hypertension, Pulmonary/physiopathology , Hypertension, Pulmonary/therapy , Hemodynamics , Vasodilator Agents/therapeutic use
6.
J Am Heart Assoc ; 13(6): e031979, 2024 Mar 19.
Article in English | MEDLINE | ID: mdl-38456417

ABSTRACT

Cardiogenic shock continues to carry a high mortality rate despite contemporary care, with no breakthrough therapies shown to improve survival over the past few decades. It is a time-sensitive condition that commonly results in cardiovascular complications and multisystem organ failure, necessitating multidisciplinary expertise. Managing patients with cardiogenic shock remains challenging even in well-resourced settings, and an important subgroup of patients may require cardiac replacement therapy. As a result, the idea of leveraging the collective cognitive and procedural proficiencies of multiple providers in a collaborative, team-based approach to care (the "shock team") has been advocated by professional societies and implemented at select high-volume clinical centers. A slowly maturing evidence base has suggested that cardiogenic shock teams may improve patient outcomes. Although several registries exist that are beginning to inform care, particularly around therapeutic strategies of pharmacologic and mechanical circulatory support, none of these are currently focused on the shock team approach, multispecialty partnership, education, or process improvement. We propose the creation of a Cardiogenic Shock Team Collaborative-akin to the successful Pulmonary Embolism Response Team Consortium-with a goal to promote sharing of care protocols, education of stakeholders, and discovery of how process and performance may influence patient outcomes, quality, resource consumption, and costs of care.


Subject(s)
Shock, Cardiogenic , Humans , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/therapy , Shock, Cardiogenic/etiology
7.
Circulation ; 149(14): e1051-e1065, 2024 04 02.
Article in English | MEDLINE | ID: mdl-38406869

ABSTRACT

Cardiogenic shock continues to portend poor outcomes, conferring short-term mortality rates of 30% to 50% despite recent scientific advances. Age is a nonmodifiable risk factor for mortality in patients with cardiogenic shock and is often considered in the decision-making process for eligibility for various therapies. Older adults have been largely excluded from analyses of therapeutic options in patients with cardiogenic shock. As a result, despite the association of advanced age with worse outcomes, focused strategies in the assessment and management of cardiogenic shock in this high-risk and growing population are lacking. Individual programs oftentimes develop upper age limits for various interventional strategies for their patients, including heart transplantation and durable left ventricular assist devices. However, age as a lone parameter should not be used to guide individual patient management decisions in cardiogenic shock. In the assessment of risk in older adults with cardiogenic shock, a comprehensive, interdisciplinary approach is central to developing best practices. In this American Heart Association scientific statement, we aim to summarize our contemporary understanding of the epidemiology, risk assessment, and in-hospital approach to management of cardiogenic shock, with a unique focus on older adults.


Subject(s)
Heart Transplantation , Heart-Assist Devices , Humans , Aged , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/epidemiology , Shock, Cardiogenic/therapy , American Heart Association , Treatment Outcome
8.
JACC Adv ; 3(3)2024 Mar.
Article in English | MEDLINE | ID: mdl-38352139

ABSTRACT

Background: Over the past decade there has been increasing interest in critical care medicine (CCM) training for cardiovascular medicine (CV) physicians either in isolation (separate programs in either order [CV/CCM], integrated critical care cardiology [CCC] training) or hybrid training with interventional cardiology (IC)/heart failure/transplant (HF) with targeted CCC training. Objective: To review the contemporary landscape of CV/CCM, CCC, and hybrid training. Methods: We reviewed the literature from 2000-2022 for publications discussing training in any combination of internal medicine CV/CCM, CCC, and hybrid training. Information regarding training paradigms, scope of practice and training, duration, sequence, and milestones was collected. Results: Of the 2,236 unique citations, 20 articles were included. A majority were opinion/editorial articles whereas two were surveys. The training pathways were classified into - (i) specialty training in both CV (3 years) and CCM (1-2 years) leading to dual American Board of Internal Medicine (ABIM) board certification, or (ii) base specialty training in CV with competencies in IC, HF or CCC leading to a non-ABIM certificate. Total fellowship duration varied between 4-7 years after a three-year internal medicine residency. While multiple articles commented on the ability to integrate the fellowship training pathways into a holistic and seamless training curriculum, few have highlighted how this may be achieved to meet competencies and standards. Conclusions: In 20 articles describing CV/CCM, CCC, and hybrid training, there remains significant heterogeneity on the standardized training paradigms to meet training competencies and board certifications, highlighting an unmet need to define CCC competencies.

9.
Circ Cardiovasc Qual Outcomes ; 17(1): e010092, 2024 01.
Article in English | MEDLINE | ID: mdl-38179787

ABSTRACT

BACKGROUND: Wide interhospital variations exist in cardiovascular intensive care unit (CICU) admission practices and the use of critical care restricted therapies (CCRx), but little is known about the differences in patient acuity, CCRx utilization, and the associated outcomes within tertiary centers. METHODS: The Critical Care Cardiology Trials Network is a multicenter registry of tertiary and academic CICUs in the United States and Canada that captured consecutive admissions in 2-month periods between 2017 and 2022. This analysis included 17 843 admissions across 34 sites and compared interhospital tertiles of CCRx (eg, mechanical ventilation, mechanical circulatory support, continuous renal replacement therapy) utilization and its adjusted association with in-hospital survival using logistic regression. The Pratt index was used to quantify patient-related and institutional factors associated with CCRx variability. RESULTS: The median age of the study population was 66 (56-77) years and 37% were female. CCRx was provided to 62.2% (interhospital range of 21.3%-87.1%) of CICU patients. Admissions to CICUs with the highest tertile of CCRx utilization had a greater burden of comorbidities, had more diagnoses of ST-elevation myocardial infarction, cardiac arrest, or cardiogenic shock, and had higher Sequential Organ Failure Assessment scores. The unadjusted in-hospital mortality (median, 12.7%) was 9.6%, 11.1%, and 18.7% in low, intermediate, and high CCRx tertiles, respectively. No clinically meaningful differences in adjusted mortality were observed across tertiles when admissions were stratified by the provision of CCRx. Baseline patient-level variables and institutional differences accounted for 80% and 5.3% of the observed CCRx variability, respectively. CONCLUSIONS: In a large registry of tertiary and academic CICUs, there was a >4-fold interhospital variation in the provision of CCRx that was primarily driven by differences in patient acuity compared with institutional differences. No differences were observed in adjusted mortality between low, intermediate, and high CCRx utilization sites.


Subject(s)
Cardiology , Hemodynamic Monitoring , Aged , Female , Humans , Male , Coronary Care Units , Critical Care , Hospital Mortality , Intensive Care Units , Registries , United States/epidemiology , Middle Aged , Multicenter Studies as Topic , Clinical Trials as Topic
10.
Eur Heart J Acute Cardiovasc Care ; 12(10): 651-660, 2023 Oct 25.
Article in English | MEDLINE | ID: mdl-37640029

ABSTRACT

AIMS: Invasive haemodynamic assessment with a pulmonary artery catheter is often used to guide the management of patients with cardiogenic shock (CS) and may provide important prognostic information. We aimed to assess prognostic associations and relationships to end-organ dysfunction of presenting haemodynamic parameters in CS. METHODS AND RESULTS: The Critical Care Cardiology Trials Network is an investigator-initiated multicenter registry of cardiac intensive care units (CICUs) in North America coordinated by the TIMI Study Group. Patients with CS (2018-2022) who underwent invasive haemodynamic assessment within 24 h of CICU admission were included. Associations of haemodynamic parameters with in-hospital mortality were assessed using logistic regression, and associations with presenting serum lactate were assessed using least squares means regression. Sensitivity analyses were performed excluding patients on temporary mechanical circulatory support and adjusted for vasoactive-inotropic score. Among the 3603 admissions with CS, 1473 had haemodynamic data collected within 24 h of CICU admission. The median cardiac index was 1.9 (25th-75th percentile, 1.6-2.4) L/min/m2 and mean arterial pressure (MAP) was 74 (66-86) mmHg. Parameters associated with mortality included low MAP, low systolic blood pressure, low systemic vascular resistance, elevated right atrial pressure (RAP), elevated RAP/pulmonary capillary wedge pressure ratio, and low pulmonary artery pulsatility index. These associations were generally consistent when controlling for the intensity of background pharmacologic and mechanical haemodynamic support. These parameters were also associated with higher presenting serum lactate. CONCLUSION: In a contemporary CS population, presenting haemodynamic parameters reflecting decreased systemic arterial tone and right ventricular dysfunction are associated with adverse outcomes and systemic hypoperfusion.


Subject(s)
Hemodynamics , Shock, Cardiogenic , Humans , Prognosis , Vascular Resistance , Lactates
11.
JACC Heart Fail ; 11(8 Pt 1): 903-914, 2023 08.
Article in English | MEDLINE | ID: mdl-37318422

ABSTRACT

BACKGROUND: The appropriate use of pulmonary artery catheters (PACs) in critically ill cardiac patients remains debated. OBJECTIVES: The authors aimed to characterize the current use of PACs in cardiac intensive care units (CICUs) with attention to patient-level and institutional factors influencing their application and explore the association with in-hospital mortality. METHODS: The Critical Care Cardiology Trials Network is a multicenter network of CICUs in North America. Between 2017 and 2021, participating centers contributed annual 2-month snapshots of consecutive CICU admissions. Admission diagnoses, clinical and demographic data, use of PACs, and in-hospital mortality were captured. RESULTS: Among 13,618 admissions at 34 sites, 3,827 were diagnosed with shock, with 2,583 of cardiogenic etiology. The use of mechanical circulatory support and heart failure were the patient-level factors most strongly associated with a greater likelihood of the use of a PAC (OR: 5.99 [95% CI: 5.15-6.98]; P < 0.001 and OR: 3.33 [95% CI: 2.91-3.81]; P < 0.001, respectively). The proportion of shock admissions with a PAC varied significantly by study center ranging from 8% to 73%. In analyses adjusted for factors associated with their placement, PAC use was associated with lower mortality in all shock patients admitted to a CICU (OR: 0.79 [95% CI: 0.66-0.96]; P = 0.017). CONCLUSIONS: There is wide variation in the use of PACs that is not fully explained by patient level-factors and appears driven in part by institutional tendency. PAC use was associated with higher survival in cardiac patients with shock presenting to CICUs. Randomized trials are needed to guide the appropriate use of PACs in cardiac critical care.


Subject(s)
Heart Failure , Pulmonary Artery , Humans , Heart Failure/therapy , Intensive Care Units , Hospitalization , Hospital Mortality , Catheters
12.
Can J Cardiol ; 39(4): 406-419, 2023 04.
Article in English | MEDLINE | ID: mdl-36731605

ABSTRACT

Cardiogenic shock is an extreme manifestation of acute decompensated heart failure. Cardiogenic shock is often caused by-and has traditionally been studied in the setting of-acute myocardial infarction (AMI CS); however, there is increasing incidence and recognition of cardiogenic shock not associated with acute myocardial infarction (non-AMI CS) as a distinct entity. Despite decades of study and technologic advancements, cardiogenic shock mortality remains as high as 50%, regardless of etiology. New approaches to shock phenotyping and classification have emerged, with a focus on appropriately matching patient physiology to a growing list of available interventions. Further study is needed to determine whether these efforts will lead to more nuanced use of mechanical circulatory support and improved patient outcomes, especially in non-AMI CS. In the meantime, models of care incorporating multidisciplinary decision making, such as shock teams, may improve patient selection and outcomes.


Subject(s)
Heart Failure , Myocardial Infarction , Humans , Shock, Cardiogenic/therapy , Shock, Cardiogenic/complications , Myocardial Infarction/complications , Myocardial Infarction/therapy , Heart Failure/complications , Treatment Outcome
13.
Circ Heart Fail ; 16(1): e009714, 2023 01.
Article in English | MEDLINE | ID: mdl-36458542

ABSTRACT

BACKGROUND: Algorithmic application of the 2019 Society of Cardiovascular Angiography and Intervention (SCAI) shock stages effectively stratifies mortality risk for patients with cardiogenic shock. However, clinician assessment of SCAI staging may differ. Moreover, the implications of the 2022 SCAI criteria update remain incompletely defined. METHODS: The Critical Care Cardiology Trials Network is a multicenter registry of cardiac intensive care units (CICUs). Between 2019 and 2021, participating centers (n=32) contributed at least a 2-month snapshot of consecutive medical CICU admissions. In-hospital mortality was assessed across 3 separate staging methods: clinician assessment, Critical Care Cardiology Trials Network algorithmic application of the 2019 SCAI criteria, and a revision of the Critical Care Cardiology Trials Network application using the 2022 SCAI criteria. RESULTS: Of 9612 admissions, 1340 (13.9%) presented with cardiogenic shock with in-hospital mortality of 35.2%. Both clinician and algorithm-based staging using the 2019 SCAI criteria identified a stepwise gradient of mortality risk (stage C-E: 19.0% to 83.7% and 14.6% to 52.2%, respectively; Ptrend<0.001 for each). Clinician assignment of SCAI stages identified higher risk patients compared with algorithm-based assignment (stage D: 49.9% versus 29.3%; stage E: 83.7% versus 52.2%). Algorithmic application of the 2022 SCAI criteria, with incorporation of the vasoactive-inotropic score, more closely approximated clinician staging (mortality for stage C-E: 21.9% to 70.5%; Ptrend<0.001). CONCLUSIONS: Both clinician and algorithm-based application of the 2019 SCAI stages identify a stepwise gradient of mortality risk, although clinician-staging may better allocate higher risk patients into advanced SCAI stages. Updated algorithmic staging using the 2022 SCAI criteria and vasoactive-inotropic score further refines risk stratification.


Subject(s)
Cardiology , Heart Failure , Humans , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/therapy , Critical Care , Angiography , Registries , Hospital Mortality
15.
Eur Heart J Qual Care Clin Outcomes ; 8(7): 703-708, 2022 10 26.
Article in English | MEDLINE | ID: mdl-36029517

ABSTRACT

AIMS: The aims of the Critical Care Cardiology Trials Network (CCCTN) are to develop a registry to investigate the epidemiology of cardiac critical illness and to establish a multicentre research network to conduct randomised clinical trials (RCTs) in patients with cardiac critical illness. METHODS AND RESULTS: The CCCTN was founded in 2017 with 16 centres and has grown to a research network of over 40 academic and clinical centres in the United States and Canada. Each centre enters data for consecutive cardiac intensive care unit (CICU) admissions for at least 2 months of each calendar year. More than 20 000 unique CICU admissions are now included in the CCCTN Registry. To date, scientific observations from the CCCTN Registry include description of variations in care, the epidemiology and outcomes of all CICU patients, as well as subsets of patients with specific disease states, such as shock, heart failure, renal dysfunction, and respiratory failure. The CCCTN has also characterised utilization patterns, including use of mechanical circulatory support in response to changes in the heart transplantation allocation system, and the use and impact of multidisciplinary shock teams. Over years of multicentre collaboration, the CCCTN has established a robust research network to facilitate multicentre registry-based randomised trials in patients with cardiac critical illness. CONCLUSION: The CCCTN is a large, prospective registry dedicated to describing processes-of-care and expanding clinical knowledge in cardiac critical illness. The CCCTN will serve as an investigational platform from which to conduct randomised controlled trials in this important patient population.


Subject(s)
Cardiology , Critical Illness , Humans , United States/epidemiology , Critical Illness/epidemiology , Coronary Care Units , Critical Care/methods , Registries
16.
Circulation ; 146(18): 1344-1356, 2022 11.
Article in English | MEDLINE | ID: mdl-36036760

ABSTRACT

BACKGROUND: The efficacy and safety of prophylactic full-dose anticoagulation and antiplatelet therapy in critically ill COVID-19 patients remain uncertain. METHODS: COVID-PACT (Prevention of Arteriovenous Thrombotic Events in Critically-ill COVID-19 Patients Trial) was a multicenter, 2×2 factorial, open-label, randomized-controlled trial with blinded end point adjudication in intensive care unit-level patients with COVID-19. Patients were randomly assigned to a strategy of full-dose anticoagulation or standard-dose prophylactic anticoagulation. Absent an indication for antiplatelet therapy, patients were additionally randomly assigned to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death attributable to venous or arterial thrombosis, pulmonary embolism, clinically evident deep venous thrombosis, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent deep venous thrombosis, through hospital discharge or 28 days. The primary efficacy analyses included an unmatched win ratio and time-to-first event analysis while patients were on treatment. The primary safety outcome was fatal or life-threatening bleeding. The secondary safety outcome was moderate to severe bleeding. Recruitment was stopped early in March 2022 (≈50% planned recruitment) because of waning intensive care unit-level COVID-19 rates. RESULTS: At 34 centers in the United States, 390 patients were randomly assigned between anticoagulation strategies and 292 between antiplatelet strategies (382 and 290 in the on-treatment analyses). At randomization, 99% of patients required advanced respiratory therapy, including 15% requiring invasive mechanical ventilation; 40% required invasive ventilation during hospitalization. Comparing anticoagulation strategies, a greater proportion of wins occurred with full-dose anticoagulation (12.3%) versus standard-dose prophylactic anticoagulation (6.4%; win ratio, 1.95 [95% CI, 1.08-3.55]; P=0.028). Results were consistent in time-to-event analysis for the primary efficacy end point (full-dose versus standard-dose incidence 19/191 [9.9%] versus 29/191 [15.2%]; hazard ratio, 0.56 [95% CI, 0.32-0.99]; P=0.046). The primary safety end point occurred in 4 (2.1%) on full dose and in 1 (0.5%) on standard dose (P=0.19); the secondary safety end point occurred in 15 (7.9%) versus 1 (0.5%; P=0.002). There was no difference in all-cause mortality (hazard ratio, 0.91 [95% CI, 0.56-1.48]; P=0.70). There were no differences in the primary efficacy or safety end points with clopidogrel versus no antiplatelet therapy. CONCLUSIONS: In critically ill patients with COVID-19, full-dose anticoagulation, but not clopidogrel, reduced thrombotic complications with an increase in bleeding, driven primarily by transfusions in hemodynamically stable patients, and no apparent excess in mortality. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04409834.


Subject(s)
COVID-19 , Thrombosis , Venous Thrombosis , Humans , Critical Illness , Thrombosis/drug therapy , Clopidogrel/therapeutic use , Hemorrhage/chemically induced , Anticoagulants/adverse effects , Venous Thrombosis/drug therapy , Venous Thrombosis/epidemiology , Venous Thrombosis/prevention & control , Platelet Aggregation Inhibitors/adverse effects , Treatment Outcome
17.
Curr Opin Cardiol ; 37(3): 241-249, 2022 05 01.
Article in English | MEDLINE | ID: mdl-35612936

ABSTRACT

PURPOSE OF REVIEW: Cardiogenic shock (CS) is a highly morbid condition with mortality remaining greater than 30% despite improved pathophysiologic understanding and access to mechanical circulatory support (MCS). In response, shock teams modeled on successful multidisciplinary care structures for other diseases are being implemented nationwide. RECENT FINDINGS: Primary data supporting a benefit of shock team implementation on patient outcomes are relatively limited and entirely observational. Four single-center before-and-after studies and one multicenter registry study have demonstrated improved outcomes in patients with CS, potentially driven by increased pulmonary artery catheter (PAC) utilization and earlier (and more appropriate) initiation of MCS. Shock teams are also supported by a growing body of literature recognizing the independent benefit of the interventions they seek to implement, including patient phenotyping with PAC use and an algorithmic approach to CS care. Though debated, MCS is also highly likely to improve CS outcomes when applied appropriately, which further supports a multidisciplinary shock team approach to patient and device selection. SUMMARY: Shock teams likely improve patient outcomes by facilitating early patient phenotyping and appropriate intervention. Institutions should strongly consider adopting a multidisciplinary shock team approach to CS care, though additional data supporting these interventions are needed.


Subject(s)
Heart-Assist Devices , Shock, Cardiogenic , Humans , Multicenter Studies as Topic , Registries , Shock, Cardiogenic/therapy
18.
ASAIO J ; 68(6): 753-758, 2022 06 01.
Article in English | MEDLINE | ID: mdl-35184086

ABSTRACT

The Impella mechanical circulatory support (MCS) system is a catheter-based continuous flow cardiac assist device that is widely used in the treatment of cardiogenic shock in medical and surgical cardiac intensive care units. As with all forms of MCS, device-related complications remain a major concern, the incidence of which can be mitigated by adhering to a few fundamental concepts in device management. The purpose of this review is to comprehensively describe our strategy for managing, repositioning, and weaning the Impella catheter.


Subject(s)
Heart-Assist Devices , Catheters/adverse effects , Heart-Assist Devices/adverse effects , Humans , Intensive Care Units , Retrospective Studies , Shock, Cardiogenic/surgery , Treatment Outcome
20.
J Card Fail ; 28(4): 675-681, 2022 04.
Article in English | MEDLINE | ID: mdl-35051622

ABSTRACT

BACKGROUND: Acute heart failure (HF) is an important complication of coronavirus disease 2019 (COVID-19) and has been hypothesized to relate to inflammatory activation. METHODS: We evaluated consecutive intensive care unit (ICU) admissions for COVID-19 across 6 centers in the Critical Care Cardiology Trials Network, identifying patients with vs without acute HF. Acute HF was subclassified as de novo vs acute-on-chronic, based on the absence or presence of prior HF. Clinical features, biomarker profiles and outcomes were compared. RESULTS: Of 901 admissions to an ICU due to COVID-19, 80 (8.9%) had acute HF, including 18 (2.0%) with classic cardiogenic shock (CS) and 37 (4.1%) with vasodilatory CS. The majority (n = 45) were de novo HF presentations. Compared to patients without acute HF, those with acute HF had higher cardiac troponin and natriuretic peptide levels and similar inflammatory biomarkers; patients with de novo HF had the highest cardiac troponin levels. Notably, among patients critically ill with COVID-19, illness severity (median Sequential Organ Failure Assessment, 8 [IQR, 5-10] vs 6 [4-9]; P = 0.025) and mortality rates (43.8% vs 32.4%; P = 0.040) were modestly higher in patients with vs those without acute HF. CONCLUSIONS: Among patients critically ill with COVID-19, acute HF is distinguished more by biomarkers of myocardial injury and hemodynamic stress than by biomarkers of inflammation.


Subject(s)
COVID-19 , Cardiology , Heart Failure , Biomarkers , COVID-19/epidemiology , Critical Care , Critical Illness/epidemiology , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/therapy , Hospital Mortality , Humans , Intensive Care Units , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/epidemiology , Shock, Cardiogenic/therapy , Troponin
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