Search

Background: The outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS) and the efficacy and safety of extracorporeal life support (ECLS) may be affected by the timing of hospital admission., Objectives: The present ECLS-SHOCK substudy sought to investigate the prognostic impact of on-hours vs off-hours admission and the efficacy of ELCS according to the timing of hospital admission time in AMI-CS., Methods: Patients with AMI-CS enrolled in the multicenter, randomized ECLS-SHOCK trial from 2019 to 2022 were included. The prognosis of patients admitted during regular hours (ie, on-hours) was compared to patients admitted during off-hours. Thereafter, the prognostic impact of ECLS was investigated stratified by the timing of hospital admission. The primary endpoint was 30-day all-cause mortality. Statistical analyses included Kaplan-Meier, univariable, and multivariable logistic regression analyses., Results: Of 417 patients enrolled in the ECLS-SHOCK trial, 48.4% (n = 202) were admitted during off-hours. Patients admitted during off-hours were younger (median age = 62 years [Q1-Q3: 55-69 years] vs 63 years [Q1-Q3: 58-71 years]; P = 0.036) and more commonly treated using initial femoral access for coronary angiography (79.0% [n = 158/200] vs 67.9% [n = 146/215]; P = 0.011). However, off-hours admission was not associated with an increased risk of 30-day all-cause mortality (off-hours vs on-hours: 46.0% [n = 93/202] vs 50.7% [n = 109/215]; OR: 0.83; 95% CI: 0.56-1.22). Furthermore, ECLS had no prognostic impact on 30-day all-cause mortality in patients with AMI-CS admitted during on-hours (50.5% [n = 52/103] vs 50.9% [n = 57/112]; P = 0.95; OR: 0.98; 95% CI: 0.58-1.68) or in patients admitted during off-hours (45.3% [n = 48/106] vs 46.9% [n = 45/96]; P = 0.82; OR: 0.94; 95% CI: 0.54-1.63). Finally, ECLS was associated with an increased risk of bleeding events, especially in patients admitted during on-hours., Conclusions: The prognosis in AMI-CS was not affected by admission time with a similar effect of ECLS during on- and off-hours., Competing Interests: Funding Support and Author Disclosure Supported by the Else Kröner Fresenius Foundation, the German Heart Research Foundation, and the Helios Health Institute (formerly Leipzig Heart Institute). Dr Rassaf has received honoraria, lecture fees, and grant support from Edwards Lifesciences, AstraZeneca, Bayer, Novartis, Berlin Chemie, Daiicho-Sankyo, Boehringer Ingelheim, Novo Nordisk, Cardiac Dimensions, and Pfizer, all unrelated to this work; and is a cofounder of Bimyo GmbH, a company that develops cardioprotective peptides. Dr Clemmensen has previously or currently been involved in research contracts, consulting, and Speakers Bureau for Abbott, Abiomed, AstraZeneca, Aventis, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CeleCor, CytoSorbent, Daiichi-Sankyo, Eli-Lilly, Evolva, Ferrer, Fibrex, Idorsia, Janssen, Merck, Myogen, Medtronic, Mitsubishi Pharma, The Medicines Company, Nycomed, Organon, Pfizer, Pharmacia, Philips, Regado, Sanofi, Searle, Servier, and ViFor Pharma; and has received research and/or educational grants from Abbott, Abiomed, AstraZeneca, Aventis, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CeleCor, CytoSorbent, Daiichi-Sankyo, Eli-Lilly, Evolva, Ferrer, Fibrex, Idorsia, Janssen, Merck, Myogen, Medtronic, Mitsubishi Pharma, The Medicines Company, Nycomed, Organon, Pfizer, Pharmacia, Philips, Regado, Sanofi, Searle, Servier, and ViFor Pharma. Dr Linke has received grants from Novartis and Edwards Lifesciences; has received personal fees from Abbott, Abiomed, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Edwards Lifesciences, Medtronic, Meril, Novartis, Sanofi Genzyme, and Pfizer; and has received other fees from Picardia, Filterlex, and Transverse Medical outside the submitted work. Dr Pöss has received research grants (institutional) from German Cardiac Society, German Heart Research Foundation, Dr Rolf M. Schwiete Foundation, and Maquet Cardiopulmonary GmbH. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Contemporary data comparing the outcomes of transradial access (TRA) vs transfemoral access (TFA) among patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI) are limited., Objectives: This study examines in-hospital outcomes and institutional variation among patients with AMI-CS undergoing TRA-PCI vs TFA-PCI., Methods: Patients admitted with AMI-CS from the NCDR CathPCI registry between April 2018 and June 2021 were included. Multivariable logistic regression and inverse probability weighting models were used to assess the association between access site and in-hospital outcomes. A falsification analysis using non-access site-related bleeding was performed., Results: Among 35,944 patients with AMI-CS undergoing PCI, 25.6% were performed with TRA. The proportion of TRA-PCI increased over the study period (22.0% in the second quarter of 2018 vs 29.1% in the second quarter of 2021; P-trend <0.001). Significant institutional-level variability in the use of TRA-PCI was also observed: 20.9% of all sites using TRA in <2% of PCIs (low utilization) vs 1.9% of all sites using TRA in >80% of PCIs (high utilization). Patients undergoing TRA-PCI had a significantly lower adjusted incidence of major bleeding (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.67-0.76), mortality (OR: 0.73; 95% CI: 0.69-0.78), vascular complications (OR: 0.67; 95% CI: 0.54-0.84), and new dialysis (OR: 0.86; 95% CI: 0.77-0.97). There was no difference in non-access site related bleeding (OR: 0.93; 95% CI: 0.84-1.03). Sensitivity analyses revealed similar benefit with TRA-PCI among patients without arterial cross-over. There were no significant interactions observed between TRA-PCI with mechanical circulatory support and in-hospital outcomes., Conclusions: In this large nationwide contemporary analysis of patients with AMI-CS, about quarter of PCIs were performed via TRA with wide variability across US institutions. TRA-PCI was associated with significantly lower incidence of in-hospital major bleeding, mortality, vascular complications, and new dialysis. This benefit was observed irrespective of mechanical circulatory support use., Competing Interests: Funding Support and Author Disclosures The American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) supported this research. Dr Virani has received grant support from the Department of Veterans Affairs, National Institutes of Health, and Tahir and Jooma Family; and has received an honorarium from the American College of Cardiology. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Patients with acute pulmonary embolism (PE) and hypotension (high-risk PE) have high mortality. Cardiogenic shock can also occur in nonhypotensive or normotensive patients (intermediate-risk PE) but is less well characterized., Objectives: The authors sought to evaluate the prevalence and predictors of normotensive shock in intermediate-risk PE., Methods: Intermediate-risk PE patients in the FLASH (FlowTriever All-Comer Registry for Patient Safety and Hemodynamics) registry undergoing mechanical thrombectomy with the FlowTriever System (Inari Medical) were included. The prevalence of normotensive shock (systolic blood pressure ≥90 mm Hg but cardiac index ≤2.2 L/min/m 2 ) was assessed. A composite shock score consisting of markers of right ventricular function and ischemia (elevated troponin, elevated B-type natriuretic peptide, moderately/severely reduced right ventricular function), central thrombus burden (saddle PE), potential additional embolization (concomitant deep vein thrombosis), and cardiovascular compensation (tachycardia) was prespecified and assessed for its ability to identify normotensive shock patients., Results: Over one-third of intermediate-risk PE patients in FLASH (131/384, 34.1%) were in normotensive shock. The normotensive shock prevalence was 0% in patients with a composite shock score of 0 and 58.3% in those with a score of 6 (highest score). A score of 6 was a significant predictor of normotensive shock (odds ratio: 5.84; 95% CI: 2.00-17.04). Patients showed significant on-table improvements in hemodynamics post-thrombectomy, including normalization of the cardiac index in 30.5% of normotensive shock patients. Right ventricular size, function, dyspnea, and quality of life significantly improved at the 30-day follow-up., Conclusions: Although hemodynamically stable, over one-third of intermediate-risk FLASH patients were in normotensive shock with a depressed cardiac index. A composite shock score effectively further risk stratified these patients. Mechanical thrombectomy improved hemodynamics and functional outcomes at the 30-day follow-up., Competing Interests: Funding Support and Author Disclosures Inari Medical sponsored the FLASH registry. Dr Bangalore is a consultant for Abbott Vascular, Boston Scientific, Biotronik, Amgen, Pfizer, Merck, Reata, and Inari Medical. Dr Jaber is a consultant for Inari Medical and Medtronic. Dr Toma is a consultant for Medtronic and Philips. Dr Weinberg is a consultant for Boston Scientific, Magneto Thrombectomy Solutions, and Medtronic. Dr Mina is a consultant for Inari Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

In the United States, the frequency of using percutaneous mechanical circulatory support devices for acute myocardial infarction complicated by cardiogenic shock is increasing. These devices require large-bore vascular access to provide left, right, or biventricular cardiac support, frequently under urgent/emergent circumstances. Significant technical and logistical variability exists in device insertion, care, and removal in the cardiac catheterization laboratory and in the cardiac intensive care unit. This variability in practice may contribute to adverse outcomes observed in centers that receive patients with cardiogenic shock, who are at higher risk for circulatory insufficiency, venous stasis, bleeding, and arterial hypoperfusion. In this position statement, we aim to: 1) describe the public health impact of bleeding and vascular complications in cardiogenic shock; 2) highlight knowledge gaps for vascular safety and provide a roadmap for a regulatory perspective necessary for advancing the field; 3) propose a minimum core set of process elements, or "vascular safety bundle"; and 4) develop a possible study design for a pragmatic trial platform to evaluate which structured approach to vascular access drives most benefit and prevents vascular and bleeding complications in practice., Competing Interests: Funding Support and Author Disclosures Dr Damluji was supported by research funding from the Pepper Scholars Program of the Johns Hopkins University Claude D. Pepper Older Americans Independence Center funded by the National Institute on Aging (P30-AG021334) and mentored patient-oriented research career development award from the National Heart, Lung, and Blood Institute (NHLBI) (K23-HL153771-01). Dr Samsky received salary support from a National Institutes of Health T32 Training Grant (HL069749). Dr Smilowitz was supported, in part, by the NHLBI (Award Number K23HL150315); and has served on the advisory board for Abbott Vascular. Dr Tehrani has served as a consultant for Medtronic; and on the advisory board for Abbott Medical and Retriever Medical. Dr West is an employee of Abbott Vascular. Dr Moazami has served on an independent provider quality panel for Medtronic related to safety evaluation of mechanical support devices. Dr Truesdell has served as a consultant and a speaker for Abiomed. Dr Dangas has received research grant support from Mt. Sinai Hospital, Abbott Vascular, Boston Scientific, Medtronic, and Biotronik. Dr Amin has received research grant support from Terumo. Dr Rao has received institutional research funding from Bayer, the NHLBI, and the American College of Cardiology. Dr Krucoff has received consulting and research grants support from Edwards, Medtronic, Abbott Vascular, Abiomed, Cardiovascular Systems, Inc, Boston Scientific, Bard, Cook Medical, and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The content and opinions expressed in this manuscript do not necessarily reflect guidance or policies of the U.S. Food and Drug Administration., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the association between cardiac surgery availability and percutaneous coronary intervention (PCI) volume with clinical outcomes of cardiogenic shock (CS) complicating acute coronary syndrome (ACS)., Background: CS remains a grave complication of ACS with high mortality rates despite timely reperfusion and improved heart failure therapies., Methods: The study analyzed data from consecutive patients with CS complicating ACS who underwent PCI and were prospectively enrolled in the VCOR (Victorian Cardiac Outcomes Registry) from 26 hospitals in Victoria. We compared patients treated at cardiac surgical centers (CSCs) versus non-CSCs as well as the annual CS PCI volume (stratified into tiers of <10, 10-25, and >25 cases) for in-hospital major adverse cardiac and cerebrovascular events (MACCE) and long-term mortality., Results: Of 1,179 patients with CS, the mean age of patients was 65 years; males comprised 74%, and 22% had diabetes mellitus. Cardiac arrest occurred in 38% of patients, while 90% presented with ST-segment elevation myocardial infarction and 26% received intra-aortic balloon pump support. Overall, in-hospital and long-term mortality were 42% and 51%, respectively. There was no difference among patients treated non-CSCs compared with a CSCs for in-hospital MACCE and mortality (both P > 0.05). Similarly, there was no association between tiers of annual CS PCI volume with in-hospital MACCE and mortality (both P > 0.05)., Conclusions: Comparable short- and long-term mortality rates among patients with ACS complicated by CS treated by PCI irrespective of cardiac surgery availability and CS PCI volume support the emergent treatment of these gravely ill patients at their presenting PCI-capable hospital., Competing Interests: Funding Support and Author Disclosures The Victorian Cardiac Outcomes Registry was originally co-funded by the Victorian Department of Health in 2011 and by a one-off grant from Medibank Private. It is currently funded by the Department of Health and Human Services, Victoria, with in-kind funding from Monash University. Dr Noaman is supported by the Australian National Health Foundation (Health Professional Scholarship Award ID 102336) and the National Health and Medical Research Council Centre of Research Excellence in Cardiovascular Outcome Improvement (CRECOI Scholarship). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Waksman has served on advisory boards for Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; has been a consultant for Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd, and Transmural Systems Inc; has received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; has served on a Speakers Bureau for AstraZeneca; and is an investor in MedAlliance and Transmural Systems Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objectives: The aim of this study was to examine the sex differences in the risk profile, management, and outcomes among patients presenting with acute myocardial infarction cardiogenic shock (AMI-CS)., Background: Contemporary clinical data regarding sex differences in the management and outcomes of AMI patients presenting with CS are scarce., Methods: Patients admitted with AMI-CS from the National Cardiovascular Data Registry Chest Pain-MI registry between October 2008 to December 2017 were included. Sex differences in baseline characteristics, in-hospital management, and outcomes were compared. Patients ≥65 years of age with available linkage data to Medicare claims were included in the analysis of 1-year outcomes. Multivariable logistic regression and Cox proportional hazards models adjusting for patient and hospital-related covariates were used to estimate sex-specific differences in in-hospital and 1-year outcomes, respectively., Results: Among 17,195 patients presenting with AMI-CS, 37.3% were women. Women were older, had a higher prevalence of comorbidities, and had worse renal function at presentation. Women were less likely to receive guideline-directed medical therapies within 24 hours and at discharge, undergo diagnostic angiography (85.0% vs 91.1%), or receive mechanical circulatory support (25.4% vs 33.8%). Women had higher risks of in-hospital mortality (adjusted OR: 1.10; 95% CI: 1.02-1.19) and major bleeding (adjusted OR: 1.23; 95% CI: 1.12-1.34). For patients ≥65 years of age, women did not have a higher risk of all-cause mortality (adjusted HR: 0.98; 95% CI: 0.88-1.09) and mortality or heart failure hospitalization (adjusted HR: 1.01; 95% CI: 0.91-1.12) at 1 year compared with men., Conclusions: In this large nationwide analysis of patients with AMI-CS, women were less likely to receive guideline recommended care, including revascularization, and had worse in-hospital outcomes than men. At 1 year, there were no sex differences in the risk of mortality. Efforts are needed to address sex disparities in the initial care of AMI-CS patients., Competing Interests: Funding Support and Author Disclosures The American College of Cardiology Foundation’s National Cardiovascular Data Registry supported this research. Dr Elgendy has received research grants from Caladrius Biosciences, Inc., unrelated to this manuscript content. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. All rights reserved.)

Objectives: This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients., Background: Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients., Methods: We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries., Results: We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P < 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P < 0.001), dyslipidemia (36.4% vs 53.6%, P < 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P < 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P < 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P < 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P < 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P < 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P < 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P < 0.001) and 30-day mortality (39.9% vs 45.9%, P < 0.001) were lower in RCT patients., Conclusions: RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality., Competing Interests: Funding Support and Author Disclosures Dr Basir is a consultant/speaker for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll. Dr Alaswad has received honoraria for consulting/speaking from Boston Scientific, Cardiovascular Systems Inc, LivaNova, and Teleflex. Dr Brilakis has received honoraria for consulting/speaking from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, Cardiovascular Systems Inc, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; has received research support from Regeneron and Siemens; and is a shareholder of MHI Ventures. Dr Napp has received honoraria for lecturing/consulting and has received research support from Cytosorbents; has received honoraria for lecturing from Abbott and Maquet; and has received honoraria for lecturing/proctoring/consulting and research funding from Abiomed. Dr O’Neill is a consultant/speaker for Abbott Vascular, Abiomed, Boston Scientific, Edwards, and Zoll. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to quantify and understand the unloading effect of percutaneous balloon atrial septostomy (BAS) in acute cardiogenic shock (CS) treated with venoarterial (VA) extracorporeal membranous oxygenation (ECMO)., Background: In CS treated with VA ECMO, increased left ventricular (LV) afterload is observed that commonly interferes with myocardial recovery or even promotes further LV deterioration. Several techniques for LV unloading exist, but the optimal strategy and the actual extent of such procedures have not been fully disclosed., Methods: In a porcine model (n = 11; weight 56 kg [53-58 kg]), CS was induced by coronary artery balloon occlusion (57 minutes [53-64 minutes]). Then, a step-up VA ECMO protocol (40-80 mL/kg/min) was run before and after percutaneous BAS was performed. LV pressure-volume loops and multiple hemoglobin saturation data were evaluated. The Wilcoxon rank sum test was used to assess individual variable differences., Results: Immediately after BAS while on VA ECMO support, LV work decreased significantly: pressure-volume area, end-diastolic pressure, and stroke volume to ∼78% and end-systolic pressure to ∼86%, while superior vena cava and tissue oximetry did not change. During elevating VA ECMO support (40-80 mL/kg/min) with BAS vs without BAS, we observed 1) significantly less mechanical work increase (122% vs 172%); 2) no end-diastolic volume increase (100% vs 111%); and 3) a considerable increase in end-systolic pressure (134% vs 144%)., Conclusions: In acute CS supported by VA ECMO, atrial septostomy is an effective LV unloading tool. LV pressure is a key component of LV work load, so whenever LV work reduction is a priority, arterial pressure should carefully be titrated low while maintaining organ perfusion., Competing Interests: Funding Support and Author Disclosures This work was supported by a Euro ELSO research grant; by the Department for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation, Mediterranean Institute for Transplantation and Advanced Specialized Therapies; by the Cardio-Thoracic Surgery Department, Maastricht University Medical Centre; and by the Technology Agency of the Czech Republic (project FW01010679). Dr Lorusso is principal investigator of the PERSIST-AVR study (sponsored by LivaNova); is a consultant to LivaNova, Getinge, and Medtronic; and is an advisory board member for Eurosets. Dr Belohlavek is a consultant to Abiomed, Medtronic, Eurosets, and Getinge. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objectives: The aim of this study was to compare in-hospital outcomes and long-term mortality of multivessel versus culprit vessel-only percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation myocardial infarction (NSTEMI), multivessel disease (MVD) and cardiogenic shock., Background: The clinical benefits of complete revascularization in patients with NSTEMI, MVD, and cardiogenic shock remain uncertain., Methods: Among 25,324 patients included in the National Cardiovascular Data Registry CathPCI Registry from July 2009 to March 2018, the rates of in-hospital procedural outcomes were compared between those undergoing multivessel PCI and those undergoing culprit vessel-only PCI after 1:1 propensity score matching. Among patients aged ≥65 years matched to the Centers for Medicare and Medicaid Services database, long-term mortality was compared using proportional hazards analysis., Results: Multivessel PCI was performed in 9,791 patients (38.7%), which increased from 32.2% in 2010 to 44.2% in 2017 (p for trend <0.001). After 1:1 propensity matching (n = 7,864 in each group), those undergoing multivessel PCI had a 3.5% (95% confidence interval [CI]: 2.0% to 5.0%) lower absolute rate of in-hospital mortality (30.9% vs. 34.4%; p < 0.001; odds ratio [OR]: 0.85; 95% CI: 0.80 to 0.91), but a higher risk for bleeding (13.2% vs. 10.8%; p < 0.001; OR: 1.26; 95% CI: 1.15 to 1.40) and new requirement for dialysis (5.7% vs. 4.6%; p = 0.001; OR: 1.26; 95% CI: 1.10 to 1.46). Among those surviving to discharge, all-cause mortality was similar through 7 years (conditional hazard ratio: 0.95; 95% CI: 0.87 to 1.03; p = 0.20)., Conclusions: Nearly 40% of patients with NSTEMI with MVD and cardiogenic shock underwent multivessel PCI, which was associated with lower in-hospital mortality but greater peri-procedural complications. Among those surviving to discharge, multivessel PCI did not confer additional long-term mortality benefit., Competing Interests: Funding Support and Author Disclosures Dr. Brilkais has received consulting and speaker honoraria from Abbott Vascular, the American Heart Association (associate editor, Circulation), Amgen, Biotronik, Boston Scientific, the Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; has received research support from Regeneron and Siemens; is an owner of Hippocrates; and is a shareholder in MHI Ventures. Dr. Chan is supported by a grant from the National Heart, Lung, and Blood Institute (1R01HL123980). Dr. Spertus has received grant funding from the National Institutes of Health, the Patient-Centered Outcomes Research Institute, Abbott Vascular, and Bayer; has equity interest in Health Outcomes Sciences; has a copyright to the Seattle Angina Questionnaire; and has served as a consultant to Novartis, Bayer, United Healthcare, and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Ventricular septal rupture (VSR) represents a rare complication of acute myocardial infarction, often presenting with cardiogenic shock and associated with high in-hospital mortality despite prompt intervention. Although immediate surgery is recommended for patients who cannot be effectively stabilized, the ideal timing of intervention remains controversial. Mechanical circulatory support (MCS) may allow hemodynamic stabilization and delay definitive treatment even in critical patients. However, the interactions between MCS and VSR pathophysiology as well as potentially related adverse effects remain unclear. A systematic review was performed, from 2000 onward, to identify reports describing MCS types, effects, complications, and outcomes in the pre-operative VSR-related setting. One hundred eleven studies (2,440 patients) were included. Most patients had well-known negative predictors (e.g., cardiogenic shock, inferior infarction). Almost all patients had intra-aortic balloon pumps, with additional MCS adopted in 129 patients (77.5% being venoarterial extracorporeal membrane oxygenation). Mean MCS bridging time was 6 days (range: 0 to 23 days). In-hospital mortality was 50.4%, with the lowest mortality rate in the extracorporeal membrane oxygenation group (29.2%). MCS may enhance hemodynamic stabilization and delayed VSR treatment. However, the actual effects and interaction of the MCS-VSR association should be carefully assessed to avoid further complications or incorrect MCS-VSR coupling., Competing Interests: Funding Support and Author Disclosures Prof. Lorusso is a principal investigator of the PERSIST-AVR Study sponsored by LivaNova; and is consultant for Medtronic, LivaNova, and Eurosets (all honoraria paid to the University). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to investigate whether earlier extracorporeal membrane oxygenation (ECMO) support is associated with improved clinical outcomes in patients with refractory cardiogenic shock (CS)., Background: The prognosis of patients with refractory CS receiving ECMO remains poor. However, little is known about the association between the timing of ECMO implantation and clinical outcomes in these patients., Methods: From a multicenter registry, 362 patients with refractory CS who underwent ECMO between January 2014 and December 2018 were identified. Participants were classified into 3 groups according to tertiles of shock-to-ECMO time (early, intermediate, and late ECMO). Inverse probability of treatment weighting was conducted to adjust for baseline differences among the groups, followed by a weighted Cox proportional hazards regression analysis to calculate hazard ratios and 95% confidence intervals for 30-day mortality associated with each ECMO time group., Results: The overall 30-day mortality rate was 40.9%. The risk for 30-day mortality was lower in the early group than in the late group (hazard ratio: 0.53; 95% confidence interval: 0.28 to 0.99). Early ECMO support was also associated with lower risk for in-hospital mortality, ECMO weaning failure, composite of all-cause mortality or rehospitalization for heart failure at 1 year, all-cause mortality at 1 year, and poor neurological outcome at discharge. However, the incidence of adverse events, including stroke, limb ischemia, ECMO-site bleeding, and gastrointestinal bleeding, did not differ significantly among the groups., Conclusions: Earlier ECMO support was associated with improved clinical outcomes in patients with refractory CS., Competing Interests: Funding Support and Author Disclosures This work was supported by the Korea Health Technology Research & Development Project (grants HI17C0882, HI16C2211, and HI15C2782) through the Korea Health Industry Development Institute, funded by the Ministry of Health and Welfare, Republic of Korea; the Bio & Medical Technology Development Program of the National Research Foundation, funded by the Korean government (grant 2015M3A9C6031514); and the Cardiovascular Research Center (Seoul, Republic of Korea). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the combined impact of race, ethnicity, and sex on in-hospital outcomes using data from the National Inpatient Sample., Background: Cardiogenic shock (CS) is a major cause of mortality following ST-segment elevation myocardial infarction (STEMI). Early revascularization reduces mortality in such patients. Mechanical circulatory support (MCS) devices are increasingly used to hemodynamically support patients during revascularization. Little is known about racial, ethnic, and sex disparities in patients with STEMI and CS., Methods: The National Inpatient Sample was queried from January 2006 to September 2015 for hospitalizations with STEMI and CS. The associations between sex, race, ethnicity, and outcomes were examined using complex-samples multivariate logistic or generalized linear model regressions., Results: Of 159,339 patients with STEMI and CS, 57,839 (36.3%) were women. In-hospital mortality was higher for all women (range 40% to 45.4%) compared with men (range 30.4% to 34.7%). Women (adjusted odds ratio [aOR]: 1.11; 95% confidence interval [CI]: 1.06 to 1.16; p < 0.001) as well as Black (aOR: 1.18; 95% CI: 1.04 to 1.34; p = 0.011) and Hispanic (aOR: 1.19; 95% CI: 1.06 to 1.33; p = 0.003) men had higher odds of in-hospital mortality compared with White men, with Hispanic women having the highest odds of in-hospital mortality (aOR: 1.46; 95% CI: 1.26 to 1.70; p < 0.001). Women were older (age: 69.8 years vs. 63.2 years), had more comorbidities, and underwent fewer invasive cardiac procedures, including revascularization, right heart catheterization, and MCS., Conclusions: There are significant racial, ethnic, and sex differences in procedural utilization and clinical outcomes in patients with STEMI and CS. Women are less likely to undergo invasive cardiac procedures, including revascularization and MCS. Women as well as Black and Hispanic patients have a higher likelihood of death compared with White men., Competing Interests: FUNDING SUPPORT AND Author Disclosures Dr. Basir is a consultant for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll. Dr. O’Neill is a consultant for Abiomed, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This paper details trends and outcomes in U.S. patients undergoing transcatheter aortic valve replacement (TAVR) who present pre-procedurally with cardiogenic shock., Background: Demographic, procedural characteristics, and clinical outcomes in U.S. patients undergoing TAVR after presenting with cardiogenic shock are unknown., Methods: The STS/ACC TVT (Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy) registry linked with Centers for Medicare & Medicaid Services claims data was used to identify patients between 2014 and 2017 who presented with cardiogenic shock before TAVR in comparison to a high-risk cohort that did not present with cardiogenic shock. The primary outcome of interest was 30-day mortality. Secondary outcomes included 30-day procedural complications., Results: Presentations with cardiogenic shock currently represent 4.1% of the U.S. TAVR population. A total of 2,220 patients with acute cardiogenic shock undergoing TAVR (median STS 9.8) were compared with 12,851 high-risk patients (median STS 10.2). Cardiogenic shock was associated with higher 30-day mortality (19.1% vs. 4.9%) and higher rates of complications. The absence of 30-day major complications was not associated with a marked reduction in 30-day mortality, and overall procedural success rates were high. The risk of death from acute cardiogenic shock before TAVR was strongly related to the degree of shock pre-procedure., Conclusions: TAVR appears to be a viable treatment option for patients presenting with aortic stenosis and acute cardiogenic shock. Although procedural success is high, this population remains at an elevated risk of death, which appears to be mostly driven by the degree of pre-procedural shock., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare outcomes of patients enrolled in the NCSI (National Cardiogenic Shock Initiative) trial who were treated using a revascularization strategy of percutaneous coronary intervention (PCI) of multivessel PCI (MV-PCI) versus culprit-vessel PCI (CV-PCI)., Background: In patients with multivessel disease who present with acute myocardial infarction and cardiogenic shock (AMICS), intervening on the nonculprit vessel is controversial. There are conflicting published reports and lack of evidence, particularly in patients treated with early mechanical circulatory support (MCS)., Methods: From July 2016 to December 2019, patients who presented with AMICS to 57 participating hospitals were included in this analysis. All patients were treated using a standard shock protocol emphasizing early MCS, revascularization, and invasive hemodynamic monitoring. Patients with multivessel coronary artery disease (MVCAD) were analyzed according to whether CV-PCI or MV-PCI was undertaken during the index procedure., Results: Of 198 patients with MVCAD, 126 underwent MV-PCI (64%) and 72 underwent CV-PCI (36%). Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction. Patients who underwent MV-PCI had a trend toward more severe impairment of cardiac output and worse lactate clearance on presentation, and cardiac performance was significantly worse at 12 h. However, 24 h from PCI, the hemometabolic derangements were similar. Survival and rates of acute kidney injury were not significantly different between groups (69.8% MV-PCI vs. 65.3% CV-PCI; p = 0.51; and 29.9% vs. 34.2%; p = 0.64, respectively)., Conclusions: In patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions was associated with similar hospital survival and acute kidney injury when compared with culprit-only PCI. Selective nonculprit PCI can be safety performed in AMICS in patients supported with mechanical circulatory support., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine frequency, associated factors, and impact of bleeding in infarct-related cardiogenic shock., Background: Early revascularization is associated with improved survival in patients with acute myocardial infarction complicated by cardiogenic shock. On the downside, invasive treatment and accompanying antithrombotic therapies are associated with an increased bleeding risk. Prospective data assessing the incidence, severity, risk factors, and prognostic implication of bleeding in patients with cardiogenic shock are scarce., Methods: As a pre-defined subanalysis of the CULPRIT-SHOCK (PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock) randomized trial, we examined distribution of bleeding events in 684 patients with infarct-related cardiogenic shock and compared patients with any bleeding to those without., Results: A total of 21.5% patients experienced at least 1 bleeding event until 30 days after randomization. The vast majority of bleeding (57%) occurred within the first 2 days of hospitalization. Patients with bleeding had prolonged catecholamine treatment and mechanical ventilation and there was a significant association with sepsis, peripheral ischemic complications, new atrial fibrillation, and ventricular fibrillation. In multivariable analysis, bleeding was associated with a significantly higher mortality (hazard ratio: 2.11; 95% confidence interval: 1.63 to 2.75; p < 0.0001). Treatment with active mechanical support by extracorporeal membrane oxygenation or Impella emerged as the major risk factor for bleeding., Conclusions: Risk of bleeding in infarct-related cardiogenic shock is high and associated with increased mortality., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the prognostic value of the SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) scores in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS)., Background: The prognostic value of the SYNTAX score in this high-risk setting remains unclear., Methods: The CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock) trial was an international, open-label trial, where patients presenting with infarct-related CS and multivessel disease were randomized to a culprit-lesion-only or an immediate multivessel PCI strategy. Baseline SYNTAX score was assessed by a central core laboratory and categorized as low SYNTAX score (SS ≤22), intermediate SYNTAX score (2232). Adjudicated endpoints of interest were the 30-day risk of death or renal replacement therapy (RRT) and 1-year death. Associations between baseline SYNTAX score and outcomes were assessed using multivariate logistic regression., Results: Pre-PCI SYNTAX score was available in 624 patients, of whom 263 (42.1%), 207 (33.2%) and 154 (24.7%) presented with low, intermediate and high SYNTAX score, respectively. A stepwise increase in the incidence of adverse events was observed from low to intermediate and high SYNTAX score for the 30-day risk of death or RRT and the 1-year risk of death (p < 0.001, for all). After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death. There was no significant interaction between SYNTAX score and the coronary revascularization strategy for any outcomes., Conclusions: In patients presenting with multivessel disease and infarct-related CS, the SYNTAX score was strongly associated with 30-day death or RRT and 1-year mortality., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare the clinical characteristics and long-term outcomes of patients with ST-segment elevation myocardial infarction (STEMI) with and without cardiogenic shock (CS) or cardiac arrest (CA) before percutaneous coronary intervention (PCI)., Background: Patients with STEMI complicated by CS or CA are underrepresented in STEMI registries., Methods: Consecutive patients with STEMI or new left bundle branch block within 24 h of symptom onset were included in a regional STEMI program comprising a PCI center (Minneapolis Heart Institute at Abbott Northwestern Hospital), 11 hospitals <60 miles from PCI center (zone 1), and 19 hospitals 60 to 210 miles from PCI center (zone 2). No patients were excluded. Patients were stratified based on the presence (+) or absence (-) of CS or CA before PCI. Patients with CA were further classified based on initial rhythm. Primary outcomes were in-hospital and 5-year mortality., Results: Between March 2003 and December 2014, 4,511 STEMI patients were included in the regional program, including 398 (9%) with CS and 499 (11%) with CA. Hospital mortality was: CS+ and CA+, 44%; CS+ and CA-, 23%; CS- and CA+, 19%; and CS- and CA-, 2% (p < 0.001). The 5-year survival probability for CS+ and CA+ patients was 0.69 (95% confidence interval: 0.61 to 0.76) and 0.89 (95% confidence interval: 0.84 to 0.93), respectively (p < 0.01). Compared with patients with shockable rhythms, CA patients with nonshockable rhythms had significantly lower odds of survival at hospital discharge and at 5 years (both p < 0.001)., Conclusions: The combination of CS and CA significantly increases short-term mortality in patients with STEMI. After 5 years of follow-up, CS patients remained at high risk of fatal events, whereas the prognosis of CA patients was determined by initial rhythm at presentation., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine the most risk-adjustment model for 30-day all-cause mortality in order to report risk-adjusted outcomes. The study also explored whether the exclusion of extreme high-risk conditions of cardiogenic shock, intubated out-of-hospital cardiac arrest (OHCA), or the need for mechanical ventricular support affected the model's predictive accuracy., Background: Robust risk-adjustment models are a critical component of clinical quality registries, allowing outcomes to be reported in a fair and meaningful way. The Victorian Cardiac Outcomes Registry encompasses all 30 hospitals in the state of Victoria, Australia, that undertake percutaneous coronary intervention., Methods: Data were collected on 27,544 consecutive percutaneous coronary intervention procedures from 2014 to 2016. Twenty-eight patient risk factors and procedural variables were considered in the modeling process. The multivariable logistic regression analysis considered derivation and validation datasets, along with a temporal validation period., Results: The model included risk-adjustment for cardiogenic shock, intubated OHCA, estimated glomerular filtration rate, left ventricular ejection fraction, angina type, mechanical ventricular support, ≥80 years of age, lesion complexity, percutaneous access site, and peripheral vascular disease. The C-statistic for the derivation dataset was 0.921 (95% confidence interval: 0.905 to 0.936), with C-statistics of 0.931 and 0.934 for 2 validation datasets reflecting the 2014 to 2016 and 2017 periods. Subgroup modeling excluding cardiogenic shock and intubated OHCA provided similar risk-adjusted outcomes (p = 0.32)., Conclusions: Our study has developed a highly predictive risk-adjustment model for 30-day mortality that included high-risk presentations. Therefore, we do not need to exclude high-risk cases in our model when determining risk-adjusted outcomes., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine the impact of age on procedural and clinical outcomes in patients with cardiogenic shock (CS)., Background: The use of early revascularization therapy with percutaneous coronary intervention (PCI) has been shown to improve outcome in patients with acute myocardial infarction (AMI) complicated by CS., Methods: Data from consecutive patients with AMI and CS treated with PCI enrolled into the prospective ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry were centrally collected and analyzed. Patients were divided into 4 groups according to their age (<65, 65 to 74, 75 to 84, and >85 years). Patients' characteristics, procedural features, antithrombotic therapies, and in-hospital complications were compared among the 4 groups., Results: Between 2010 and 2015, a total of 2,323 consecutive patients with AMI and CS were treated by PCI in 51 hospitals. TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 patency after PCI decreased with increasing age from 84% to 78%, while in-hospital mortality increased from 32% to 56%. Bleeding rates were low (2.0% to 2.3%) and not different among age groups. In the multivariate analysis, higher age, TIMI flow grade <3 after PCI, 3-vessel disease, and left main PCI were independent predictors of mortality., Conclusions: PCI in patients with AMI and CS is associated with a high procedural success rate and a low bleeding rate, even in very elderly patients, while mortality increases with increasing age. Because mortality in elderly patients with CS without revascularization therapy is very high, it seems justified to perform PCI in selected patients to reduce mortality., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)