Association of Hemometabolic Trajectory and Mortality: Insights From the Cardiogenic Shock Working Group Registry.

Cardiogenic shock (CS) is a hemodynamic syndrome that can progress to systemic metabolic derangements and end-organ dysfunction. Prior studies have reported hemodynamic parameters at the time of admission to be associated with mortality but hemodynamic trajectories in CS have not been well described. We studied the association between hemodynamic profiles and their trajectories and in-hospital mortality in patients with CS due to heart failure (HF-CS) and acute myocardial infarction (MI-CS). Using data from the large multicenter Cardiogenic Shock Working Group (CSWG) registry, we analyzed hemodynamic data obtained at the time of pulmonary artery catheter (PAC) insertion (dataset at baseline) and at PAC removal or death (dataset at final time point). Univariable regression analyses for prediction of in-hospital mortality were conducted for baseline and final hemodynamic values, as well as the interval change (delta-P). Data was further analyzed based on CS etiology and survival status. A total of 2260 patients with PAC data were included (70% male, age 61 ± 14 years, 61% HF-CS, 27% MI-CS). In-hospital mortality was higher in the MI-CS group (40.1%) compared with HF-CS (22.4%, P < .01). In the HF-CS cohort, survivors exhibited lower right atrial pressure (RAP), pulmonary artery pressure (PAP), cardiac output/index (CO/CI), lactate, and higher blood pressure (BP) than nonsurvivors at baseline. In this cohort, during hospitalization, improvement in metabolic (aspartate transaminase, lactate), BP, hemodynamic (RAP, pulmonary artery pulsatility index [PAPi], pulmonary artery compliance for right-sided profile and CO/CI for left-sided profile), had association with survival. In the MI-CS cohort, a lower systolic BP and higher PAP at baseline were associated with odds of death. Improvement in metabolic (lactate), BP, hemodynamic (RAP, PAPi for right-sided profile and CO/CI for left-sided profile) were associated with survival. In a large contemporary CS registry, hemodynamic trajectories had a strong association with short-term outcomes in both cohorts. These findings suggest the clinical importance of timing and monitoring hemodynamic trajectories to tailor management in patients with CS.

The Price We Pay for Progression in Shock Care: Economic Burden, Accessibility, and Adoption of Shock-Teams and Mechanical Circulatory Support Devices.

PURPOSE OF REVIEW: Cardiogenic shock (CS) is associated with high in-hospital and long-term mortality and morbidity that results in significant socio-economic impact. Due to the high costs associated with CS care, it is important to define the short- and long-term burden of this disease state on resources and review strategies to mitigate these. RECENT FINDINGS: In recent times, the focus on CS continues to be on improving short-term outcomes, but there has been increasing emphasis on the long-term morbidity. In this review we discuss the long-term outcomes of CS and the role of hospital-level and system-level disparities in perpetuating this. We discuss mitigation strategies including developing evidence-based protocols and systems of care, improvement in risk stratification and evaluation of futility of care, all of which address the economic burden of CS. CS continues to remain the pre-eminent challenge in acute cardiovascular care, and a combination of multi-pronged strategies are needed to improve outcomes in this population.

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.

Serial Shock Severity Assessment Within 72 Hours After Diagnosis: A Cardiogenic Shock Working Group Report.

BACKGROUND: The Cardiogenic Shock Working Group-modified Society for Cardiovascular Angiography and Interventions (CSWG-SCAI) staging was developed to risk stratify cardiogenic shock (CS) severity. Data showing progressive changes in SCAI stages and outcomes are limited. OBJECTIVES: We investigated serial changes in CSWG-SCAI stages and outcomes of patients presenting with cardiogenic shock complicating acute myocardial infarction (MI-CS) and heart failure-related CS (HF-CS). METHODS: The multicenter CSWG registry was queried. CSWG-SCAI stages were computed at CS diagnosis and 24, 48, and 72 hours. RESULTS: A total of 3,268 patients (57% HF-CS; 27% MI-CS) were included. At CS diagnosis, CSWG-SCAI stage breakdown was 593 (18.1%) stage B, 528 (16.2%) stage C, 1,659 (50.8%) stage D, and 488 (14.9%) noncardiac arrest stage E. At 24 hours, >50% of stages B and C patients worsened, but 86% of stage D patients stayed at stage D. Among stage E patients, 54% improved to stage D and 36% stayed at stage E by 24 hours. Minimal SCAI stage changes occurred beyond 24 hours. SCAI stage trajectories were similar between MI-CS and HF-CS groups. Within 24 hours, unadjusted mortality rates of patients with any SCAI stage worsening or improving were 44.6% and 34.2%, respectively. Patients who presented in or progressed to stage E by 24 hours had the worst prognosis. Survivors had lower lactate than nonsurvivors. CONCLUSIONS: Most patients with CS changed SCAI stages within 24 hours from CS diagnosis. Stage B patients were at high risk of worsening shock severity by 24 hours, associated with excess mortality. Early CS recognition and serial assessment may improve risk stratification.

Management of Myocardial Infarction: Emerging Paradigms for the Future.

Despite significant advancements in managing acute ST-segment elevation myocardial infarctions, the prevalence of heart failure has not decreased. Emerging paradigms with a focus on reducing infarct size show promising evidence in the improvement of the incidence of heart failure after experiencing acute coronary syndromes. Limiting infarct size has been the focus of multiple clinical trials over the past decades and has led to left ventricular (LV) unloading as a potential mechanism. Contemporary use of microaxial flow devices for LV unloading has suggested improvement in mortality in acute myocardial infarction complicated by cardiogenic shock. This review focuses on clinical data demonstrating evidence of infarct size reduction and highlights ongoing clinical trials that provide a new therapeutic approach to the management of acute myocardial infarction.

Racial, Ethnic, Socioeconomic, and Geographic Inequities in Access to Mechanical Circulatory Support.

Background: Hospital admissions for cardiogenic shock have increased in the United States. Temporary mechanical circulatory support (tMCS) can be used to acutely stabilize patients. We sought to evaluate the presence of racial, ethnic, and socioeconomic inequities in access to MCS in the United States among patients with cardiogenic shock. Methods: Medicare data were used to identify patients with cardiogenic shock admitted to hospitals with advanced tMCS (microaxial left ventricular assist device [mLVAD] or extracorporeal membranous oxygenation [ECMO]) capabilities within the 25 largest core-based statistical areas, all major metropolitan areas. We modeled the association between patient race, ethnicity, and socioeconomic status and use of mLVAD or ECMO. Results: After adjusting for age and clinical comorbidities, dual eligibility for Medicaid was associated with a 19.9% (95% CI, 11.5%-27.4%) decrease in odds of receiving mLVAD in a patient with cardiogenic shock (P < .001). After adjusting for age, clinical comorbidities, and dual eligibility for Medicaid, Black race was associated with 36.7% (95% CI, 28.4%-44.2%) lower odds of receiving mLVAD in a patient with cardiogenic shock. Dual eligibility for Medicaid was associated with a 62.0% (95% CI, 60.8%-63.1%) decrease in odds of receiving ECMO in a patient with cardiogenic shock (P < .001). Black race was associated with 36.0% (95% CI, 16.6%-50.9%) lower odds of receiving ECMO in a patient with cardiogenic shock, after adjusting for Medicaid eligibility. Conclusions: We identified large and significant racial, ethnic, and socioeconomic inequities in access to mLVAD and ECMO among patients presenting with cardiogenic shock to metropolitan hospitals with active advanced tMCS programs. These findings highlight systematic inequities in access to potentially lifesaving therapies.

Clinical outcomes of the post-closure technique for arteriotomy closure with the Impella cardiac power percutaneous left ventricular assist device.

With the increasing utilization of endovascular mechanical circulatory support devices, such as the Impella CP (Abiomed), there is a need for standardized guidelines for its safe removal. Development of the Perclose post-closure technique was facilitated by the introduction of a new Impella repositioning sheath in 2019, which enabled re-access to the sidearm and stylet, rewiring of the access artery, and Impella sheath removal. Our retrospective single-center study included all patients undergoing Perclose post-closure technique for vascular access closure after Impella removal between 2018 and 2024. Forty-six patients, with a mean age of 63.8 years, predominantly male (82.6%), were included in the analysis. Indications for Impella placement included complex percutaneous coronary intervention (34.8%) and cardiogenic shock (CS) (heart failure-CS: 32.6%, myocardial infarction-CS: 21.7%). Clinically relevant complications were encountered in less than 5% of cases. No instances of covered stent placement, fasciotomy, amputation, or access site infections were reported. Our study underscores the safety of the Perclose post-closure technique following Impella removal in a diverse cohort of patients, with an overall clinically significant complication rate of less than 5%. The Perclose post-closure technique is a reliable and well-tolerated method for vascular access closure in patients undergoing Impella support.

Increased Spironolactone Dosing in Acute Heart Failure Alters Potassium Homeostasis but Does not Enhance Decongestion.

BACKGROUND: The ATHENA-HF (Aldosterone Targeted Neurohormonal Combined with Natriuresis Therapy in Heart Failure) clinical trial found no improvements in natriuretic peptide levels or clinical congestion when spironolactone 100 mg/day for 96 hours was used in addition to usual treatment for acute heart failure. METHODS: We performed a post hoc analysis of ATHENA-HF to determine whether spironolactone treatment induced any detectable pharmacodynamic effects and whether patients with potentially greater aldosterone activity experienced additional decongestion. Trial subjects previously treated with spironolactone were excluded. We first examined for changes in renal potassium handling. Using the baseline serum potassium level as a surrogate marker of spironolactone activity, we then divided each treatment arm into tertiles of baseline serum potassium and explored for differences in laboratory and clinical congestion outcomes. RESULTS: Among spironolactone-naïve patients, the change in serum potassium did not differ after 24 hours or 48 hours but was significantly greater with spironolactone treatment compared to placebo at 72 hours (0.23 ± 0.55 vs 0.03 ± 0.60 mEq/L; P = 0.042) and 96 hours (0.32 ± 0.51 vs 0.13 ± 0.72 mEq/L; P = 0.046). Potassium supplementation was similar at treatment start and at 24 hours, but spironolactone-treated patients required substantially less potassium replacement at 48 hours (24% vs 36%; P = 0.048), 72 hours (21% vs 37%; P = 0.013), and 96 hours (11% vs 38%; P < 0.001). When the treatment arms were divided into tertiles of baseline serum potassium, there were no differences in the 96-hour log N-terminal pro-B-type natriuretic peptide levels, net fluid loss, urine output, or dyspnea relief in any of the potassium groups, with no effect modification by treatment exposure. CONCLUSIONS: Spironolactone 100 mg/day for 96 hours in patients receiving intravenous loop diuresis for acute heart failure has no clear added decongestive ability but does meaningfully limit potassium wasting.

Pragmatic approach to temporary mechanical circulatory support in acute right ventricular failure.

Acute right ventricular failure (RVF) is prevalent in multiple disease states and is associated with poor clinical outcomes. Right-sided temporary mechanical circulatory support (tMCS) devices are used to unload RV congestion and increase cardiac output in cardiogenic shock (CS) with hemodynamically significant RVF. Several RV-tMCS device platforms are available; however consensus is lacking on patient selection, timing of escalation to RV-tMCS, device management, and device weaning. The purposes of this review are to 1) describe the current state of tMCS device therapies for acute RVF with CS, 2) discuss principles of escalation to RV-tMCS device therapy, 3) examine important aspects of clinical management for patients supported by RV-tMCS devices including volume management, anticoagulation, and positive pressure ventilation, and 4) provide a framework for RV-tMCS weaning.

Mechanical Preload Reduction: Harnessing a Cornerstone of Heart Failure Management to Improve Clinical Outcomes.

Decongestion is a cornerstone therapeutic goal for those presenting with decompensated heart failure. Current approaches to clinical decongestion include reducing cardiac preload, which is typically limited to diuretics and hemofiltration. Several new technologies designed to mechanically reduce cardiac preload are in development. In this review, we discuss the pathophysiology of decompensated heart failure; the central role of targeting cardiac preload; emerging mechanical preload reduction technologies; and potential application of these devices.

Clinical outcomes among cardiogenic shock patients supported with high-capacity Impella axial flow pumps: A report from the Cardiogenic Shock Working Group.

BACKGROUND: The Impella 5.0 and 5.5 pumps (Abiomed, Danvers, MA) are large-bore transvalvular micro-axial assist devices used in cardiogenic shock (CS) for patients requiring high-capacity flow. Despite their increasing use, real-world data regarding indications, rates of utilization and clinical outcomes with this therapy are limited. The objective of our study was to examine clinical profiles and outcomes of patients in a contemporary, real-world CS registry of patients who received an Impella 5.0/5.5 alone or in combination with other temporary mechanical circulatory support (tMCS) devices. METHODS: The CS Working Group (CSWG) Registry includes patients from 34 US hospitals. For this analysis, data from patients who received an Impella 5.0/5.5 between 2020-2023 were analyzed. Use of Impella 5.0/5.5 with or without additional tMCS therapies, duration of support, adverse events and outcomes at hospital discharge were studied. Adverse events including stroke, limb ischemia, bleeding and hemolysis were not standardized by the registry but reported per individual CSWG Primary Investigator discretion. For those who survived, rates of native heart recovery (NHR) or heart replacement therapy (HRT) including heart transplant (HT), or durable ventricular assist device (VAD) were recorded. We also assessed outcomes based on shock etiology (acute myocardial infarction or MI-CS vs. heart failure-related CS or HF-CS). RESULTS: Among 6,205 patients, 754 received an Impella 5.0/5.5 (12.1%), including 210 MI-CS (27.8%) and 484 HF-CS (64.1%) patients. Impella 5.0/5.5 was used as the sole tMCS device in 32% of patients, while 68% of patients received a combination of tMCS devices. Impella cannulation sites were available for 524/754 (69.4%) of patients, with 93.5% axillary configuration. Survival to hospital discharge for those supported with an Impella 5.0/5.5 was 67%, with 20.4% NHR and 45.5% HRT. Compared to HF-CS, patients with MI-CS supported on Impella 5.0/5.5 had higher in-hospital mortality (45.2% vs 26.2%, p < 0.001) and were less likely to receive HRT (22.4% vs 56.6%, p < 0.001. For patients receiving a combination of tMCS during hospitalization, this was associated with higher rates of limb ischemia (9% vs. 3%, p < 0.01), bleeding (52% vs 33%, p < 0.01), and mortality (38% vs 25%; p < 0.001) compared to Impella 5.0/5.5 alone. Among Impella 5.0/5.5 recipients, the median duration of pump support was 12.9 days (IQR: 6.8-22.9) and longer in patients bridged to HRT (14 days; IQR: 7.7-28.4). CONCLUSIONS: In this multi-center cohort of patients with CS, use of Impella 5.0/5.5 was associated with an overall survival of 67.1% and high rates of HRT. Lower adverse event rates were observed when Impella 5.0/5.5 was the sole support device used. Further study is required to determine whether a strategy of early Impella 5.0/5.5 use for CS improves survival. CONDENSED ABSTRACT: High capacity Impella heart pumps are capable of provide up to 5.5 liter/min of flow while upper body surgical placement allows for ambulation. Patients with advanced cardiogenic shock from acute myocardial infarction or heart failure requiring temporary mechanical circulatory support may benefit from upfront use of Impella 5.5 to improve overall survival, including native heart recovery or successful bridge to durable left ventricular assist device surgery or heart transplantation.

Pathophysiology, diagnosis and management of right ventricular failure: A state of the art review of mechanical support devices.

The function of the right ventricle (RV) is to drive the forward flow of blood to the pulmonary system for oxygenation before returning to the left ventricle. Due to the thin myocardium of the RV, its function is easily affected by decreased preload, contractile motion abnormalities, or increased afterload. While various etiologies can lead to changes in RV structure and function, sudden changes in RV afterload can cause acute RV failure which is associated with high mortality. Early detection and diagnosis of RV failure is imperative for guiding initial medical management. Echocardiographic findings of reduced tricuspid annular plane systolic excursion (<1.7) and RV wall motion (RV S' <10 cm/s) are quantitatively supportive of RV systolic dysfunction. Medical management commonly involves utilizing diuretics or fluids to optimize RV preload, while correcting the underlying insult to RV function. When medical management alone is insufficient, mechanical circulatory support (MCS) may be necessary. However, the utility of MCS for isolated RV failure remains poorly understood. This review outlines the differences in flow rates, effects on hemodynamics, and advantages/disadvantages of MCS devices such as intra-aortic balloon pump, Impella, centrifugal-flow right ventricular assist devices, extracorporeal membrane oxygenation, and includes a detailed review of the latest clinical trials and studies analyzing the effects of MCS devices in acute RV failure.

American Heart Association Cardiogenic Shock Registry: Design and Implementation.

BACKGROUND: 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: 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: 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.

Factors associated with acute limb ischemia in cardiogenic shock and downstream clinical outcomes: Insights from the Cardiogenic Shock Working Group.

BACKGROUND: There are limited data depicting the prevalence and ramifications of acute limb ischemia (ALI) among cardiogenic shock (CS) patients. METHODS: We employed data from the Cardiogenic Shock Working Group (CSWG), a consortium including 33 sites. We constructed a multi-variable logistic regression to examine the association between clinical factors and ALI, we generated another logistic regression model to ascertain the association of ALI with mortality. RESULTS: There were 7,070 patients with CS and 399 (5.6%) developed ALI. Patients with ALI were more likely to be female (40.4% vs 29.4%) and have peripheral arterial disease (13.8% vs 8.3%). Stratified by maximum society for cardiovascular angiography & intervention (SCAI) shock stage, the rates of ALI were stage B 0.0%, stage C 1.8%, stage D 4.1%, and stage E 10.3%. Factors associated with higher risk for ALI included: peripheral vascular disease OR 2.24 (95% CI: 1.53-3.23; p < 0.01) and ≥2 mechanical circulatory support (MCS) devices OR 1.66 (95% CI: 1.24-2.21, p < 0.01). ALI was highest for venous-arterial extracorporeal membrane oxygenation (VA-ECMO) patients (11.6%) or VA-ECMO+ intra-aortic balloon pump (IABP)/Impella CP (16.6%) yet use of distal perfusion catheters was less than 50%. Mortality was 38.0% for CS patients without ALI but 57.4% for CS patients with ALI. ALI was significantly associated with mortality, adjusted OR 1.40 (95% CI 1.01-1.95, p < 0.01). CONCLUSIONS: The rate of ALI was 6% among CS patients. Factors most associated with ALI include peripheral vascular disease and multiple MCS devices. The downstream ramifications of ALI were dire with a considerably higher risk of mortality.

Innovating to resolve the pressure-oxygenation-paradox created by VA-ECMO could improve outcomes for acute myocardial infarction and cardiogenic shock.

VA-ECMO use is growing exponentially. Recent data shows no clinical benefit with routine use of VA-ECMO in acute myocardial infarction and shock, however clinical experience with ECMO is growing. Two key variables that may impact outcomes with ECMO in acute myocardial infarction and shock include it's effect on systemic pressure and oxygenation. We define the pressure-oxygenaton paradox of ECMO as a potential new avenue for therapeutic discovery.

Reperfusion Injury in Patients With Acute Myocardial Infarction: JACC Scientific Statement.

Despite impressive improvements in the care of patients with ST-segment elevation myocardial infarction, mortality remains high. Reperfusion is necessary for myocardial salvage, but the abrupt return of flow sets off a cascade of injurious processes that can lead to further necrosis. This has been termed myocardial ischemia-reperfusion injury and is the subject of this review. The pathologic and molecular bases for myocardial ischemia-reperfusion injury are increasingly understood and include injury from reactive oxygen species, inflammation, calcium overload, endothelial dysfunction, and impaired microvascular flow. A variety of pharmacologic strategies have been developed that have worked well in preclinical models and some have shown promise in the clinical setting. In addition, there are newer mechanical approaches including mechanical unloading of the heart prior to reperfusion that are in current clinical trials.