Despite a high rate of early revascularization and use of intra-aortic balloon pump counterpulsation therapy, the prognosis of patients with cardiogenic shock has remained poor. In the hopes of ...improving outcomes, clinicians are increasingly turning to percutaneous left and right mechanical circulatory support devices. Until recently, the evidence base for these devices had consisted only of observational data, meta-analyses, and small feasibility trials. In this article, we describe the contemporary outcomes of patients with cardiogenic shock, the hemodynamics of cardiogenic shock, and hemodynamic effects of percutaneous mechanical circulatory support devices. We then use this discussion to provide clinicians with a useful framework for understanding when selecting between or while managing patients with a percutaneous mechanical circulatory support devices. We critically review the recently published data for and against the use of commercially available devices-the intra-aortic balloon pump counterpulsation, the Impella system, the TandemHeart, and venous-arterial extracorporeal membrane oxygenation-and highlight gaps in our understanding. Given such gaps, a consensus multidisciplinary approach that combines expertise from interventional cardiologists, heart failure specialists, cardiac surgeons, and cardiac anesthesiologists may help pair the right patient with the right device at the right time.
Acute myocardial infarction–related cardiogenic shock (AMI-CS) is characterized by systemic hypoperfusion due to cardiomyocyte necrosis and ventricular dysfunction.
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Cardiogenic shock affects 5 to ...10% of patients presenting with acute myocardial infarction, and more than half the patients with AMI-CS die during the index hospitalization.
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Prompt reperfusion of the infarct-related artery has been the only treatment that prolongs survival,
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but mortality from AMI-CS has remained high despite the availability of primary percutaneous coronary intervention. The universal clinical sign of AMI-CS is a lack of perfusion to vital organs that cannot be reversed with just restoration of flow to the ischemic myocardium. . . .
Abstract
Identification and management of patients at high bleeding risk undergoing percutaneous
coronary intervention are of major importance, but a lack of standardization in defining
this ...population limits trial design, data interpretation, and clinical decision-making.
The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among
leading research organizations, regulatory authorities, and physician-scientists from the
United States, Asia, and Europe focusing on percutaneous coronary intervention–related
bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April
2018 and in Paris, France, in October 2018. These meetings were organized by the
Cardiovascular European Research Center on behalf of the ARC-HBR group and included
representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals
and Medical Devices Agency, as well as observers from the pharmaceutical and medical
device industries. A consensus definition of patients at high bleeding risk was developed
that was based on review of the available evidence. The definition is intended to provide
consistency in defining this population for clinical trials and to complement clinical
decision-making and regulatory review. The proposed ARC-HBR consensus document represents
the first pragmatic approach to a consistent definition of high bleeding risk in clinical
trials evaluating the safety and effectiveness of devices and drug regimens for patients
undergoing percutaneous coronary intervention.
Randomized clinical trials provide the foundation of clinical evidence to guide physicians in their selection of treatment options. Importantly, randomization is the only reliable method to control ...for confounding factors when comparing treatment groups. However, randomized trials have limitations, including the increasingly prohibitive costs of conducting adequately powered studies. Local and national regulatory requirements, delays in approval, and unnecessary trial processes have led to increased costs and decreased efficiency. Another limitation is that clinical trials involve selected patients who are treated according to protocols that might not represent real-world practice. A possible solution is registry-based randomized clinical trials. By including a randomization module in a large inclusive clinical registry with unselected consecutive enrolment, the advantages of a prospective randomized trial can be combined with the strengths of a large-scale all-comers clinical registry. We believe that prospective registry-based randomized clinical trials are a powerful tool for conducting studies efficiently and cost-effectively.
BACKGROUND:Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in ...Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump).
METHODS:From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levelstime period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs).
RESULTS:Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008–2016) versus the pre-Impella era (years 2004–2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with deathodds ratio, 1.24 (95% CI, 1.13–1.36); bleedingodds ratio, 1.10 (95% CI, 1.00–1.21); and strokeodds ratio, 1.34 (95% CI, 1.18–1.53), although a similar, nonsignificant result was observed for acute kidney injuryodds ratio, 1.08 (95% CI, 1.00–1.17).
CONCLUSIONS:Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.
Abstract Background Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. ...Operator volume patterns and associated outcomes since this change are unknown. Objectives The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample. Methods Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality. Results The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding. Conclusions Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses.
Cardiogenic shock (CS) remains the most common cause of mortality in patients with acute myocardial infarction. The SHOCK trial (Should We Emergently Revascularize Occluded Coronaries for Cardiogenic ...Shock) demonstrated a survival benefit with early revascularization in patients with CS complicating acute myocardial infarction (AMICS) 20 years ago. After an initial improvement in mortality related to revascularization, mortality rates have plateaued. A recent Society of Coronary Angiography and Interventions classification scheme was developed to address the wide range of CS presentations. In addition, a recent scientific statement from the American Heart Association recommended the development of CS centers using standardized protocols for diagnosis and management of CS, including mechanical circulatory support devices (MCS). A number of CS programs have implemented various protocols for treating patients with AMICS, including the use of MCS, and have published promising results using such protocols. Despite this, practice patterns in the cardiac catheterization laboratory vary across health systems, and there are inconsistencies in the use or timing of MCS for AMICS. Furthermore, mortality benefit from MCS devices in AMICS has yet to be established in randomized clinical trials. In this article, we outline the best practices for the contemporary interventional management of AMICS, including coronary revascularization, the use of MCS, and special considerations such as the treatment of patients with AMICS with cardiac arrest.
IMPORTANCE: Cardiogenic shock affects between 40 000 and 50 000 people in the US per year and is the leading cause of in-hospital mortality following acute myocardial infarction. OBSERVATIONS: ...Thirty-day mortality for patients with cardiogenic shock due to myocardial infarction is approximately 40%, and 1-year mortality approaches 50%. Immediate revascularization of the infarct-related coronary artery remains the only treatment for cardiogenic shock associated with acute myocardial infarction supported by randomized clinical trials. The Percutaneous Coronary Intervention Strategies with Acute Myocardial Infarction and Cardiogenic Shock (CULPRIT-SHOCK) clinical trial demonstrated a reduction in the primary outcome of 30-day death or kidney replacement therapy; 158 of 344 patients (45.9%) in the culprit lesion revascularization–only group compared with 189 of 341 patients (55.4%) in the multivessel percutaneous coronary intervention group (relative risk, 0.83 95% CI, 0.71-0.96; P = .01). Despite a lack of randomized trials demonstrating benefit, percutaneous mechanical circulatory support devices are frequently used to manage cardiogenic shock following acute myocardial infarction. CONCLUSIONS AND RELEVANCE: Cardiogenic shock occurs in up to 10% of patients immediately following acute myocardial infarction and is associated with mortality rates of nearly 40% at 30 days and 50% at 1 year. Current evidence and clinical practice guidelines support immediate revascularization of the infarct-related coronary artery as the primary therapy for cardiogenic shock following acute myocardial infarction.
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