Impella versus VA-ECMO for the treatment of patients with cardiogenic shock: the Impella Network Project - observational study protocol for cost-effectiveness and budget impact analyses.

INTRODUCTION: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.

Percutaneous Microaxial Ventricular Assist Device Versus Intra-Aortic Balloon Pump for Nonacute Myocardial Infarction Cardiogenic Shock.

BACKGROUND: Evidence on the comparative outcomes following percutaneous microaxial ventricular assist devices (pVAD) versus intra-aortic balloon pump for nonacute myocardial infarction cardiogenic shock is limited. METHODS AND RESULTS: We included 704 and 2140 Medicare fee-for-service beneficiaries aged 65 to 99 years treated with pVAD and intra-aortic balloon pump, respectively, for nonacute myocardial infarction cardiogenic shock from 2016 to 2020. Patients treated using pVAD compared with those treated using intra-aortic balloon pump were more likely to be concurrently treated with mechanical ventilation, renal replacement therapy, and blood transfusions. We computed propensity scores for undergoing pVAD using patient- and hospital-level factors and performed a matching weight analysis. The use of pVAD was associated with higher 30-day mortality (adjusted odds ratio, 1.92 [95% CI, 1.59-2.33]) but not associated with in-hospital bleeding (adjusted odds ratio, 1.00 [95% CI, 0.81-1.24]), stroke (adjusted odds ratio, 0.91 [95% CI, 0.56-1.47]), sepsis (OR, 0.91 [95% CI, 0.64-1.28]), and length of hospital stay (adjusted mean difference, +0.4 days [95% CI, -1.4 to +2.3]). A quasi-experimental instrumental variable analysis using the cross-sectional institutional practice preferences showed similar patterns, though not statistically significant (adjusted odds ratio, 1.38; 95% CI, 0.28-6.89). CONCLUSIONS: Our investigation using the national sample of Medicare beneficiaries showed that the use of pVAD compared with intra-aortic balloon pump was associated with higher mortality in patients with nonacute myocardial infarction cardiogenic shock. Providers should be cautious about the use of pVAD for nonacute myocardial infarction cardiogenic shock, while adequately powered high-quality randomized controlled trials are warranted to determine the clinical effects of pVAD.

Early Serial Assessment of Aggregate Vasoactive Support and Mortality in Cardiogenic Shock: Insights From the Critical Care Cardiology Trials Network Registry.

BACKGROUND: Associations of early changes in vasoactive support with cardiogenic shock (CS) mortality remain incompletely defined. METHODS: The Critical Care Cardiology Trials Network is a multicenter registry of cardiac intensive care units. Patients admitted with CS (2018-2023) had vasoactive dosing assessed at 4 and 24 hours from cardiac intensive care unit admission and quantified by the vasoactive-inotropic score (VIS). Prognostic associations of VIS at both time points, as well as change in VIS from 4 to 24 hours, were examined. Interaction testing was performed based on mechanical circulatory support status. RESULTS: Among 3665 patients, 82% had a change in VIS <10, with 7% and 11% having a ≥10-point increase and decrease from 4 to 24 hours, respectively. The 4 and 24-hour VIS were each associated with cardiac intensive care unit mortality (13%-45% and 11%-73% for VIS <10 to ≥40, respectively; Ptrend <0.0001 for each). Stratifying by the 4-hour VIS, changes in VIS from 4 to 24 hours had a graded association with mortality, ranging from a 2- to >4-fold difference in mortality comparing those with a ≥10-point increase to ≥10-point decrease in VIS (Ptrend <0.0001). The change in VIS alone provided good discrimination of cardiac intensive care unit mortality (C-statistic, 0.72 [95% CI, 0.70-0.75]) and improved discrimination of the 24-hour Sequential Organ Failure Assessment score (0.72 [95% CI, 0.69-0.74] to 0.76 [95% CI, 0.74-0.78]) and the clinician-assessed Society for Cardiovascular Angiography and Interventions shock stage (0.72 [95% CI, 0.70-0.74] to 0.77 [95% CI, 0.75-0.79]). Although present in both groups, the mortality risk associated with VIS was attenuated in patients managed with versus without mechanical circulatory support (odds ratio per 10-point higher 24-hour VIS, 1.36 [95% CI, 1.23-1.49] versus 1.84 [95% CI, 1.69-2.01]; Pinteraction <0.0001). CONCLUSIONS: Early changes in the magnitude of vasoactive support in CS are associated with a gradient of risk for mortality. These data suggest that early VIS trajectory may improve CS prognostication, with the potential to be leveraged for clinical decision-making and research applications in CS.

Capillary refill time assessment after fluid challenge in patients on venoarterial extracorporeal membrane oxygenation: A retrospective study.

BACKGROUND: Monitoring fluid therapy is challenging in patients assisted with Veno-arterial ECMO. The aim of our study was to evaluate the usefulness of capillary refill time to assess the response to fluid challenge in patients assisted with VA-ECMO. METHODS: Retrospective monocentric study in a cardiac surgery ICU. We assess fluid responsiveness after a fluid challenge in patients on VA-ECMO. We recorded capillary refill time before and after fluid challenge and the evolution of global hemodynamic parameters. RESULTS: A total of 27 patients were included. The main indications for VA-ECMO were post-cardiotomy cardiogenic shock (44%). Thirteen patients (42%) were responders and 14 non-responders (58%). In the responder group, the index CRT decreased significantly (1.7 [1.5; 2.1] vs. 1.2 [1; 1.3] s; p = 0.01), whereas it remained stable in the non-responder group (1.4 [1.1; 2.5] vs. 1.6 [0.9; 1.9] s; p = 0.22). Diagnosis performance of CRT variation to assess response after fluid challenge shows an AUC of 0.68 (p = 0.10) with a sensitivity of 79% [95% CI, 52-92] and a specificity of 69% [95% CI, 42-87], with a threshold at 23%. CONCLUSION: In patients treated with VA-ECMO index capillary refill time is a reliable tool to assesses fluid responsiveness. SPECIALTY: Critical care, Cardiac surgery, ECMO.

Ventricular fibrillation/ventricular tachycardia within 72 h of VA-ECMO: incidence, outcomes, risk factors, and management.

AIMS: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is an important technique for the treatment of refractory cardiogenic shock and cardiac arrest; however, the early management of ventricular fibrillation/ventricular tachycardia (VF/VT), within 72 h of VA-ECMO, and its effects on patient prognosis remain unclear. METHODS AND RESULTS: We retrospectively analysed patients at the First Affiliated Hospital of Nanjing Medical University who underwent VA-ECMO between January 2017 and March 2022. The patients were divided into two groups, VF/VT and nVF/VT, based on whether or not VF/VT occurred within 72 h after the initiation of VA-ECMO. We utilized logistic regression analysis to evaluate the independent risk factors for VF/VT in patients undergoing VA-ECMO and to ascertain whether the onset of VF/VT affected 28 day survival rate, length of intensive care unit stay, and/or other clinical prognostic factors. Subgroup analysis was performed for the VF/VT group to determine whether defibrillation affected prognosis. In the present study, 126 patients were included, 65.87% of whom were males (83/126), with a mean age of 46.89 ± 16.23, a 28 day survival rate of 57.14% (72/126), an incidence rate of VF/VT within 72 h of VA-ECMO initiation of 27.78% (35/126), and 80% of whom (28/35) received extracorporeal cardiopulmonary resuscitation. The incidence of VF/VT resulting from cardiac arrest at an early stage was significantly higher than that of refractory cardiogenic shock (80% vs. 20%; P = 0.022). The restricted cubic spline model revealed a U-shaped relationship between VF/VT incidence and initial heart rate (iHR), and multivariate logistic regression analysis showed that an iHR > 120 b.p.m. [odds ratio (OR) 6.117; 95% confidence interval (CI) 1.672-22.376; P = 0.006] and hyperlactataemia (OR 1.125; 95% CI 1.016-1.246; P = 0.023) within 1 h of VA-ECMO initiation were independent risk factors for the occurrence of VF/VT. VF/VT was not found to be associated with the 28 day survival of patients undergoing VA-ECMO support, nor did it affect other secondary endpoints. Defibrillation did not alter the overall prognosis in patients with VF/VT during VA-ECMO. CONCLUSIONS: An iHR > 120 b.p.m. and hyperlactataemia were independent risk factors for the occurrence of VF/VT within 72 h of VA-ECMO initiation. The occurrence of VF/VT does not affect, nor does defibrillation in these patients improve the overall patient prognosis. TRIAL REGISTRATION: ChiCTR1900026105.

[Temporary circulatory assistance by Impella™ in interventional cardiology: Observational study and medico-economic assessment after four years of use]. / Assistance circulatoire temporaire par Impella™ en cardiologie interventionnelle : étude observationnelle et bilan médicoéconomique après quatre ans d'utilisation.

OBJECTIVES: During life-threatening emergencies or risky cardiologic interventions, pharmacology can be limited and the use of appropriate medical devices is then necessary. The Impella™ catheter, CP and 2.5, has been referenced for the exclusive use of the interventional cardiology technical platform at Hôpital Nord (AP-HM) in the absence of rapid access to the Extracorporeal Circulation unit. It is a temporary mechanical circulatory support device mainly indicated in refractory cardiogenic shock and coronary angioplasty at high risk of hemodynamic instability. The objective of this study, observational and retrospective, is to carry out a clinical and economic assessment linked to the use of this device over a period of four years (2017-2020). METHODS: The criteria relating to the 71 patients (51 Impella™ CP and 20 Impella™ 2.5) and their clinical evolution as well as the costs and valuation of the stays were determined. RESULTS: In particular, the Impella™ CP enabled myocardial recovery in 18 out of 51 patients and it was an intermediary in the context of heavier care for 11 patients. The balance between expenditure and valuation shows a deficit of -819,937 euros over the study period, with however a probable margin for improvement. CONCLUSIONS: The Impella™ is of clinical interest under very specific conditions. Its high cost and the absence of inclusion on the list of reimbursements in addition to Homogeneous Groups of Stays represent a significant financial burden for health care establishments. Thus, optimizing the rating of future stays is a necessity.

Association of socioeconomic status in the incidence, quality-of-care metrics, and outcomes for patients with cardiogenic shock in a pre-hospital setting.

AIMS: The relationship between lower socioeconomic status (SES) and poor cardiovascular outcomes is well described; however, there exists a paucity of data exploring this association in cardiogenic shock (CS). This study aimed to investigate whether any disparities exist between SES and the incidence, quality of care or outcomes of CS patients attended by emergency medical services (EMS). METHODS AND RESULTS: This population-based cohort study included consecutive patients transported by EMS with CS between 1 January 2015 and 30 June 2019 in Victoria, Australia. Data were collected from individually linked ambulance, hospital, and mortality datasets. Patients were stratified into SES quintiles using national census data produced by the Australian Bureau of Statistics.A total of 2628 patients were attended by EMS for CS. The age-standardized incidence of CS amongst all patients was 11.8 [95% confidence interval (95% CI), 11.4-12.3] per 100 000 person-years, with a stepwise increase from the highest to lowest SES quintile (lowest quintile 17.0 vs. highest quintile 9.7 per 100 000 person-years, P-trend < 0.001). Patients in lower SES quintiles were less likely to attend metropolitan hospitals and more likely to be received by inner regional and remote centres without revascularization capabilities. A greater proportion of the lower SES groups presented with CS due to non-ST elevation myocardial infarction (NSTEMI) or unstable angina pectoris (UAP), and overall were less likely to undergo coronary angiography. Multivariable analysis demonstrated an increased 30-day all-cause mortality rate in the lowest three SES quintiles when compared with the highest quintile. CONCLUSION: This population-based study demonstrated discrepancies between SES status in the incidence, care metrics, and mortality rates of patients presenting to EMS with CS. These findings outline the challenges in equitable healthcare delivery within this cohort.

Serial Assessment of Shock Severity in Cardiac Intensive Care Unit Patients.

BACKGROUND: One-time assessment of the Society for Cardiovascular Angiography and Interventions (SCAI) shock classification robustly predicts mortality in the cardiac intensive care unit (CICU). We sought to determine whether serial SCAI shock classification could improve risk stratification. METHODS AND RESULTS: Unique admissions to a single academic level 1 CICU from 2015 to 2018 were included in this retrospective cohort study. Electronic health record data were used to assign the SCAI shock stage during 4-hour blocks of the first 24 hours of CICU admission. Shock was defined as hypoperfusion (SCAI shock stage C, D, or E). In-hospital death was evaluated using logistic regression. Among 2918 unique CICU patients, 1537 (52.7%) met criteria for shock during ≥1 block, and 266 (9.1%) died in the hospital. The SCAI shock stage on admission was: A, 37.6%; B, 31.5%; C, 25.9%; D, 1.8%; and E, 3.3%. Patients who met SCAI criteria for shock on admission (first 4 hours) and those with worsening SCAI shock stage after admission were at higher risk for in-hospital death. Each higher admission (adjusted odds ratio, 1.36 [95% CI, 1.18-1.56]; area under the receiver operating characteristic curve, 0.70), maximum (adjusted odds ratio, 1.59 [95% CI, 1.37-1.85]; area under the receiver operating characteristic curve, 0.73) and mean (adjusted odds ratio, 2.42 [95% CI, 1.99-2.95]; area under the receiver operating characteristic curve, 0.78) SCAI shock stage was incrementally associated with a higher in-hospital mortality rate. Discrimination was highest for the mean SCAI shock stage (P<0.05). Each additional 4-hour block meeting SCAI criteria for shock predicted a higher mortality rate (adjusted odds ratio, 1.15 [95% CI, 1.07-1.24]). CONCLUSIONS: Dynamic assessment of shock using serial SCAI shock classification assignment can improve mortality risk stratification in CICU patients by quantifying the magnitude and duration of shock.

Use and Implications of Echocardiography in the Hemodynamic Assessment of Cardiogenic Shock.

Cardiogenic shock (CS) is a complex multisystem syndrome due to pump failure, associated with high mortality and morbidity. Its hemodynamic characterization is key to the diagnostic algorithm and management. Pulmonary artery catheterization is the gold standard for the left and right hemodynamic evaluation, but some concerns exist for invasivity and untoward mechanical and infective complications. Transthoracic echocardiography is a robust noninvasive diagnostic tool for hemodynamic multiparametric assessment that well applies to the management of CS. Its applications expand from etiology definition to the choice of therapeutic intervention and their monitoring. The present review aims at detailing the role of ultrasounds in CS emphasizing the clinical implications of combining cardiac and non-cardiac ultrasounds examinations that may correlate with prognosis.

The changing face of cardiogenic shock: definitions, epidemiology, and severity assessment.

PURPOSE OF REVIEW: Cardiogenic shock (CS) has been recognized for >50 years, most commonly in the setting of myocardial infarction. This review covers recent advances in the definitions, epidemiology and severity assessment of cardiogenic shock. RECENT FINDINGS: In this review, the authors discuss the evolving definitions of cardiogenic shock, detailing the early approaches as well as more contemporary ideas. The epidemiology of CS is reviewed and then granular detail on the assessment of shock severity is provided including the role of lactate measurement and invasive hemodynamic assessment. The development of the Society for Cardiac Angiography and Intervention (SCAI) consensus statement on Classification of Cardiogenic Shock is reviewed by the principal authors. The revised SCAI Shock document is reviewed as well and the future directions for assessment of shock along with clinical applications are reviewed. SUMMARY: Cardiogenic shock mortality has not changed in a significant way in many years. Recent advances such as more granular assessment of shock severity have the potential to improve outcomes by allowing research to separate the patient groups which may respond differently to various therapies.

Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock.

Importance: Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS). Objective: To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data. Design, Setting, and Participants: This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022. Interventions: Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump). Main Outcomes and Measures: Thirty-day all-cause mortality and readmissions. Results: Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations. Conclusions: In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.

Simulation-based assessment of care for an infant with cardiogenic shock in the emergency department.

BACKGROUND: Congenital heart disease (CHD) is the leading cause of infant deaths associated with birth defects. Neonates with undiagnosed CHD often present to general emergency departments (GEDs) for initial resuscitation that are less prepared than paediatric centres, resulting in disparities in the quality of care. Neonates with undiagnosed CHD represent a challenge; thus, it is necessary for GEDs to be prepared for this population. AIM: To evaluate the process of resuscitative care provided to a neonate in cardiogenic shock due to CHD in the GEDs in a simulated setting and to describe the impact of teams and GED variables on the process of care. METHODS: This is a prospective simulation-based assessment of the process of care provided to a neonate with coarctation of the aorta in cardiogenic shock. Simulation sessions were conducted at participating GEDs utilizing each GED's interdisciplinary team and resources. The primary outcome was adherence to best practice, as measured by a 15-item overall composite adherence score (CAS). In addition, we stratified the overall CAS into CHD-critical items and the general resuscitation items CAS. The secondary outcome was the impact of the team's and GED's characteristics on the scores. RESULTS: This study enrolled 32 teams from 12 GEDs. Among 161 participants, 103 (63.97%) were registered nurses, 33 (20.50%) were physicians, 17 (10.56%) were respiratory therapists, and 8 (4.97%) were other medical professionals. The overall median CAS was 84, with the CHD-critical items having a median CAS of 34.5. The most underperformed tasks are checking pulses on the upper and lower extremities (44%), obtaining blood pressure in the upper and lower extremities (25%), and administering prostaglandin E1 (22%). CONCLUSIONS: Using in situ simulation in a set of GEDs, we revealed gaps in the resuscitation care of neonates with CHD in cardiogenic shock. RELEVANCE TO CLINICAL PRACTICE: These findings highlight the importance of targeted improvement programs for high-stakes illnesses in GED.

Epidemiology, monitoring, and treatment strategy in cardiogenic shock. A multinational cross-sectional survey of ESC-acute cardiovascular care association research section.

AIMS: Cardiogenic shock (CS) is a life-threatening condition burdened by mortality in up to 50% of cases. Few recommendations exist with intermediate-low level of evidence on CS management and no data on adherence across centres exist. We performed a survey to frame CS management at multinational level. METHODS AND RESULTS: An international cross-sectional survey was created and approved by European Society of Cardiology-Acute Cardiovascular Care Association board. A total of 337 responses from 60 countries were obtained. Data were assessed by the hospital level of care of the participants. The most common cause of CS was AMI (AMI-CS-79.9%) with significant difference according to hospital levels (P = 0.001), followed by acutely decompensated heart failure (HF) (13.4%), myocarditis (3.5%), and de novo HF (1.75%). In 37.8%, percutaneous coronary intervention (PCI) is performed to all CS-patients as a standard approach, whereas 42.1% used PCI if electrocardiogram suggestive of ischaemia and 20.1% only if Universal definition of myocardial infarction criteria are fulfilled. Management (catecholamine titration and mechanical circulatory support escalation) is driven by mean arterial pressure (87.1%), echocardiography (84.4%), and lactate levels (83.4%). Combination of vasopressor and inotrope is chosen with the same frequency (37.7%) than inotrope alone as first-line pharmacological therapy (differences amongst hospital levels; P > 0.5). Noradrenaline is first-line vasopressor (89.9%) followed by dopamine (8.5%), whereas dobutamine is confirmed as the first-line inotrope (65.9%). CONCLUSION: Cardiogenic shock management is heterogenous and often not adherent to current recommendations. Quality improvement on an international level with evidence-based quality indicators should be developed to standardize diagnostic and therapeutic pathways.

Clinical Outcomes and Cost Associated With an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump in Patients Presenting With Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Importance: Intravascular microaxial left ventricular assist device (LVAD) compared with intra-aortic balloon pump (IABP) has been associated with increased risk of mortality and bleeding among patients with acute myocardial infarction (AMI) and cardiogenic shock (CS) undergoing percutaneous coronary intervention (PCI). However, evidence on the association of device therapy with a broader array of clinical outcomes, including data on long-term outcomes and cost, is limited. Objective: To examine the association between intravascular LVAD or IABP use and clinical outcomes and cost in patients with AMI complicated by CS. Design, Setting, and Participants: This retrospective propensity-matched cohort study used administrative claims data for commercially insured patients from 14 states across the US. Patients included in the analysis underwent PCI for AMI complicated by CS from January 1, 2015, to April 30, 2020. Data analysis was performed from April to November 2021. Exposures: Use of either an intravascular LVAD or IABP. Main Outcomes and Measures: The primary outcomes were mortality, stroke, severe bleeding, repeat revascularization, kidney replacement therapy (KRT), and total health care costs during the index admission. Clinical outcomes and cost were also assessed at 30 days and 1 year. Results: Among 3077 patients undergoing PCI for AMI complicated by CS, the mean (SD) age was 65.2 (12.5) years, and 986 (32.0%) had cardiac arrest. Among 817 propensity-matched pairs, intravascular LVAD use was associated with significantly higher in-hospital (36.2% vs 25.8%; odds ratio [OR], 1.63; 95% CI, 1.32-2.02), 30-day (40.1% vs 28.3%; OR, 1.71; 95% CI, 1.37-2.13), and 1-year mortality (58.9% vs 45.0%; hazard ratio [HR], 1.44; 95% CI, 1.21-1.71) compared with IABP. At 30 days, intravascular LVAD use was associated with significantly higher bleeding (19.1% vs 14.5%; OR, 1.35; 95% CI, 1.04-1.76), KRT (12.2% vs 7.0%; OR, 1.88; 95% CI, 1.30-2.73), and mean cost (+$51 680; 95% CI, $31 488-$75 178). At 1 year, the association of intravascular LVAD use with bleeding (29.7% vs 24.3%; HR, 1.36; 95% CI, 1.05-1.75), KRT (18.1% vs 10.9%; HR, 1.95; 95% CI, 1.35-2.83), and mean cost (+$46 609; 95% CI, $22 126-$75 461) persisted. Conclusions and Relevance: In this propensity-matched analysis of patients undergoing PCI for AMI complicated by CS, intravascular LVAD use was associated with increased short-term and 1-year risk of mortality, bleeding, KRT, and cost compared with IABP. There is an urgent need for additional evidence surrounding the optimal management of patients with AMI complicated by CS.

Epidemiology and management of right ventricular-predominant heart failure and shock in the cardiac intensive care unit.

Cardiogenic shock from left ventricular failure is a common presentation in the intensive care unit. In contrast, right ventricular (RV)-predominant heart failure (HF) causing shock is less well recognized. We review the epidemiology and mechanisms of RV-predominant HF and discuss pharmacologic and device-based approaches for the management of this challenging clinical problem.

Gender Differences in the Outcomes of Cardiogenic Shock Requiring Percutaneous Mechanical Circulatory Support.

There is evidence for the lower use of percutaneous mechanical circulatory support (pMCS) in women. We aimed to determine (1) whether gender differences exist regarding in-hospital mortality, hospital course, and procedures; (2) whether socio-demographic and treatment-related factors were associated with these differences. Using the National Inpatient Sample, we collected the International Classification of Diseases, Ninth Revision, Clinical Modification codes for cardiogenic shock (CS) because of acute myocardial infarction AMI or acutely decompensated advanced heart failure and included intra-aortic balloon pump, Impella or Tandem Heart percutaneous ventricular assist devices (pVADs), extracorporeal membrane oxygenation. Demographics, co-morbidities, in-hospital course and procedures were recorded, and the Charlson Co-morbidity Index was calculated. Multivariable hierarchical logistic regression analysis and additional sensitivity analyses were performed. We identified 376,116 cases of CS because of acute myocardial infarction or acutely decompensated advanced heart failure, of which 113,305 required pMCS. Women were more likely to be older, non-White, insured by Medicare, and have a higher burden of co-morbidities and higher Charlson Co-morbidity Index. pMCS devices were inserted in 35,516 women (24.9%) and 77,789 men (33.3%). Women were less likely to receive pVAD or pulmonary artery (PA) catheters. Blood transfusions and acute respiratory failure were more common in women than men. Women had 15% higher in-hospital mortality and in a multivariate analysis, women, older age, having no insurance, diabetes mellitus, chronic kidney disease, cerebrovascular disease, peripheral arterial disease, longer time to pMCS insertion, receiving PA catheter, pVAD or extracorporeal membrane oxygenation and having cardiac arrest were associated with higher in-hospital mortality. In conclusion, women requiring pMCS support had a higher co-morbidity load, in-hospital mortality, acute respiratory failure, blood transfusions, and lower PA catheter use. Studies addressing early gender-specific interventions in CS are needed to reduce these differences.

Age stratified sex-related differences in incidence, management, and outcomes of cardiogenic shock.

BACKGROUND: There is a lack of data on age-stratified sex differences in the incidence, treatment, and outcomes of cardiogenic shock (CS). We sought to study these differences from a contemporary database. METHODS: Patients admitted with CS (2004-2018) were identified from the United States National Inpatient Sample. We compared CS (acute myocardial infarction-related cardiogenic shock [AMI-CS] and non-acute myocardial infarction-related cardiogenic shock [Non-AMI-CS]) incidence, management, and outcomes in males and females, stratified into four age groups (20-44, 45-64, 65-84, and ≥85 years of age). Propensity score matching (PSM) was used for adjustment. RESULTS: A total of 1,506,281 weighted hospitalizations for CS were included (AMI-CS, 39%; Non-AMI-CS, 61%). Across all age groups, females had a lower incidence of CS compared with males. After PSM and among the AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 45-64 (28.5% vs. 26.3%) and 65-84 years (39.3% vs. 37.9%) (p < 0.01, for all). Among the Non-AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 20-44 (33.5% vs. 30.5%), 45-64 (35.1% vs. 31.9%), and 65-84 years (41.7% vs. 40.3%) (p < 0.01, for all). Similar age-dependent differences in the management of CS were also observed between females and males. CONCLUSIONS: Females have a lower incidence of CS regardless of age. Significant disparities in the management and outcomes of CS were observed based on sex. However, these disparities varied by age and etiology of CS (AMI-CS vs. Non-AMI-CS) with pronounced disparity among females in the age range of 45-84 years.

Outcomes Associated With Peripheral Artery Disease in Myocardial Infarction With Cardiogenic Shock.

BACKGROUND: Mortality rates for patients presenting with acute myocardial infarction (AMI) and cardiogenic shock (CS) remain high despite advances in revascularization strategies and mechanical circulatory support (MCS) devices. OBJECTIVES: This study sought to elucidate the association between comorbid lower extremity peripheral artery disease (PAD) and outcomes in CS and AMI. METHODS: PAD status was defined in Medicare beneficiaries hospitalized with CS and AMI from October 1, 2015 to June 30, 2018. Primary outcomes ascertained through December 31, 2018 included in- and out-of-hospital mortality. Secondary outcomes included bleeding, amputation, stroke, and lower extremity revascularization. Multivariable regression models with adjustment for confounders were used to estimate risk. Subgroup analyses included patients treated with MCS and those who underwent coronary revascularization. RESULTS: Among 71,690 patients, 5.9% (N = 4,259) had PAD. Mean age was 77.8 ± 7.9 years, 58.7% were male, and 84.3% were White. Cumulative in-hospital mortality was 47.2%, with greater risk among those with PAD (56.3% vs 46.6% without PAD; adjusted OR: 1.50; 95% CI: 1.40-1.59). PAD patients also had greater risk of in-hospital amputation (1.6% vs 0.2%; adjusted OR: 7.0; 95% CI: 5.26-9.37) and out-of-hospital mortality (67.9% vs 40.7%; adjusted HR: 1.78; 95% CI: 1.67-1.90). MCS was less frequently utilized in PAD patients (21.5% vs 38.6% without PAD; P < 0.001) and was associated with higher mortality, need for lower extremity revascularization, and amputation risk. Findings were consistent in patients who underwent coronary revascularization. CONCLUSIONS: Among patients presenting with AMI and CS, PAD was associated with worse limb outcomes and survival. In addition to lower MCS utilization rates, those with PAD who received MCS had increased mortality, lower extremity revascularization, and amputation rates.

Management and Outcomes of Acute Myocardial Infarction-Cardiogenic Shock in Uninsured Compared With Privately Insured Individuals.

BACKGROUND: There are limited data on uninsured patients presenting with acute myocardial infarction-cardiogenic shock (AMI-CS). This study sought to compare the management and outcomes of AMI-CS between uninsured and privately insured individuals. METHODS: Using the National Inpatient Sample (2000-2016), a retrospective cohort of adult (≥18 years) uninsured admissions (primary payer-self-pay or no charge) were compared with privately insured individuals. Interhospital transfers were excluded. Outcomes of interest included in-hospital mortality, temporal trends in admissions, use of cardiac procedures, do-not-resuscitate status, palliative care referrals, and resource utilization. RESULTS: Of 402 182 AMI-CS admissions, 21 966 (5.4%) and 93 814 (23.3%) were uninsured and privately insured. Compared with private insured individuals, uninsured admissions were younger, male, from a lower socioeconomic status, had lower comorbidity, higher rates of acute organ failure, ST-segment elevation AMI-CS (77.3% versus 76.4%), and concomitant cardiac arrest (33.8% versus 31.9%; all P<0.001). Compared with 2000, in 2016, there were more uninsured (adjusted odds ratio, 1.15 [95% CI, 1.13-1.17]; P<0.001) and less privately insured admissions (adjusted odds ratio, 0.85 [95% CI, 0.83-0.87]; P<0.001). Uninsured individuals received less frequent coronary angiography (79.5% versus 81.0%), percutaneous coronary intervention (60.8% versus 62.2%), mechanical circulatory support (54% versus 55.5%), and had higher palliative care (3.8% versus 3.2%) and do-not-resuscitate status use (4.4% versus 3.2%; all P<0.001). Uninsured admissions had higher in-hospital mortality (adjusted odds ratio, 1.62 [95% CI, 1.55-1.68]; P<0.001) and resource utilization. CONCLUSIONS: Uninsured individuals have higher in-hospital mortality and lower use of guideline-directed therapies in AMI-CS compared with privately insured individuals.