Project description:BackgroundMechanical circulatory support (MCS) with the Impella device (Abiomed, Danvers, MA) has been associated with higher in-hospital mortality than intra-aortic balloon pump (IABP) in the Premier Healthcare Database and National Cardiovascular Data Registry.MethodsThe objective of this retrospective cohort study was to describe trends and outcomes of Impella usage in acute myocardial infarction complicated by cardiogenic shock (AMICS) treated with MCS (Impella or IABP) using real-world observational data from the National Inpatient Sample (NIS) including hospitalizations for AMICS managed with MCS between January 2012 to December 2017. The primary outcomes included in-hospital mortality, transfusion, acute kidney injury, stroke, total costs, and length of stay. Propensity score matching was performed with hierarchical models using risk factor and Elixhauser comorbidity variables.Results and conclusionWe identified 54,480 hospitalizations for AMICS managed with MCS including 5750 (10.5%) utilizing Impella. Throughout the study period, Impella usage increased yearly to 19.9% of AMICS cases in 2017. After propensity score matching, Impella was associated with higher in-hospital mortality (odds ratio [OR] 1.74, 95% confidence interval [CI] 1.41-2.13) and transfusions (OR 1.97, 95% CI 1.40-2.78) than IABP, without association with acute kidney injury or stroke. Impella use was associated with higher hospital costs (mean difference $22,416.80 [95% CI $17,029-27,804]). Impella usage for AMICS increased significantly from 2012 to 2017 and was associated with increased in-hospital mortality and costs. Randomized controlled trials are urgently needed to assess the safety and efficacy of Impella.
Project description:BackgroundAcute myocardial infarction (AMI) complicated by cardiogenic shock has a high mortality rate. Mechanical circulatory support (MCS) has been increasingly used; however, the optimal timing for MCS insertion remains uncertain. This study aimed to evaluate outcomes of pre-percutaneous coronary intervention (PCI) vs post-PCI MCS insertion in AMI patients with cardiogenic shock.MethodsA systematic search using 4 databases, including PubMed, Embase, Web of Science, and Cochrane CENTRAL, was conducted from inception to October 25, 2024. Studies comparing outcomes of MCS insertion pre-PCI vs post-PCI in this setting were included.ResultsThere were 36 studies with a total of 6218 participants were included in this meta-analysis, using a random-effects model. Most of the included studies were non-randomized and retrospective. Early MCS insertion (prior to PCI) was associated with a lower risk of in-hospital mortality compared to late insertion (post-PCI), with an odds ratio (OR) of 0.46 (95%CI 0.36 to 0.57), p < 0.01. Subgroup analysis by MCS type (IABP, Impella, and ECMO) demonstrated that early insertion prior to PCI significantly reduced in-hospital mortality, regardless of the MCS type. Early MCS insertion prior to PCI was also associated with lower 30-day mortality (OR 0.62, (95%CI 0.43 to 0.89), p = 0.01) and 6-month mortality (OR 0.53, (95%CI 0.34 to 0.83), p = 0.01) compared to late insertion. There was no difference in 1-year mortality or in MCS-related complications.ConclusionsEarly MCS insertion prior to PCI is potentially associated with reduced in-hospital, 30-day, and 6-month mortality compared to post-PCI insertion in AMI patients with cardiogenic shock.
Project description:BackgroundAcute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with significant morbidity and mortality. Mechanical circulatory support (MCS) devices increase systemic blood pressure and end organ perfusion while reducing cardiac filling pressures.Methods and resultsThe National Cardiogenic Shock Initiative (NCT03677180) is a single-arm, multicenter study. The purpose of this study was to assess the feasibility and effectiveness of utilizing early MCS with Impella in patients presenting with AMI-CS. The primary end point was in-hospital mortality. A total of 406 patients were enrolled at 80 sites between 2016 and 2020. Average age was 64±12 years, 24% were female, 17% had a witnessed out-of-hospital cardiac arrest, 27% had in-hospital cardiac arrest, and 9% were under active cardiopulmonary resuscitation during MCS implantation. Patients presented with a mean systolic blood pressure of 77.2±19.2 mm Hg, 85% of patients were on vasopressors or inotropes, mean lactate was 4.8±3.9 mmol/L and cardiac power output was 0.67±0.29 watts. At 24 hours, mean systolic blood pressure improved to 103.9±17.8 mm Hg, lactate to 2.7±2.8 mmol/L, and cardiac power output to 1.0±1.3 watts. Procedural survival, survival to discharge, survival to 30 days, and survival to 1 year were 99%, 71%, 68%, and 53%, respectively.ConclusionsEarly use of MCS in AMI-CS is feasible across varying health care settings and resulted in improvements to early hemodynamics and perfusion. Survival rates to hospital discharge were high. Given the encouraging results from our analysis, randomized clinical trials are warranted to assess the role of utilizing early MCS, using a standardized, multidisciplinary approach.
Project description:ImportanceMechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit.ObjectiveTo examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use.Design, setting, and participantsThis cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020.ExposuresTherapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only.Main outcomes and measuresUse of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use.ResultsAmong the 28 304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P < .001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P < .001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only.Conclusions and relevanceThis study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.
Project description:Despite advanced therapies, the mortality of patients with myocardial infarction (MI) complicated by cardiogenic shock (CS) remains around 50%. Mechanical complications of MI are rare nowadays but associated with high mortality in patients who present with CS. Different treatment strategies and mechanical circulatory support (MCS) devices have been increasingly used to improve the grim prognosis of refractory CS. This article discusses current evidence regarding the use of MCS in MI complicated by CS, ventricular septal rupture, free wall rupture and acute mitral regurgitation. Device selection should be tailored according to the cause and severity of CS. Early MCS initiation and multidisciplinary team cooperation is mandatory for good results. MCS associated bleeding remains a major complication and an obstacle to better outcomes. Ongoing prospective randomized trials will improve current knowledge regarding MCS indications, timing, and patient selection in the coming years.
Project description:BackgroundAs health care markets in the United States have become increasingly consolidated, the role of market concentration on physician treatment behavior remains unclear. In cardiology, specifically, there has been evolving treatment of acute myocardial infarction complicated by cardiogenic shock (AMI-CS) with increasing use of mechanical circulatory support (MCS). However, there remains wide variation in it use. The role of market concentration in the utilization of MCS in AMI-CS is unknown. We examined the use of MCS in AMI-CS and its effect on outcomes between competitive and concentrated markets.Methods and resultsWe used the National Inpatient Sample to query patients admitted with AMI-CS between 2003 and 2009. The primary study outcome was the use of mechanical circulatory support. The primary study exposure was market concentration, measured using the Herfindahl-Hirschman Index, which was used to classify markets as unconcentrated (competitive), moderately concentrated, and highly concentrated. Baseline characteristics, procedures, and outcomes were compared for patients in differently concentrated markets. Multivariable logistic regression was used to examine the association between HHI and use of MCS.ResultsThere were 32,406 hospitalizations for patients admitted with AMI-CS. Patients in unconcentrated markets were more likely to receive MCS than in highly concentrated markets (unconcentrated 46.8% [5087/10,873], moderately concentrated 44.9% [2933/6526], and high concentrated 44.5% [6676/15,007], p < 0.01). Multivariable regression showed that patients in more concentrated markets had decreased use of MCS in patients in later years of the study period (2009, OR 0.64, 95% CI 0.44-0.94, p = 0.02), with no effect in earlier years. There was no significant difference in in-hospital mortality.ConclusionMultivariable analysis did not show an association with market concentration and use of MCS in AMI-CS. However, subgroup analysis did show that competitive hospital markets were associated with more frequent use of MCS in AMI-CS as frequency of utilization increased over time. Further studies are needed to evaluate the effect of hospital market consolidation on the use of MCS and outcomes in AMI-CS.
Project description:BackgroundLimited knowledge exists on inter-hospital variation in the utilization of short-term, nondurable mechanical circulatory support (MCS) for myocardial infarction (MI) complicated by cardiogenic shock (CS).Methods and resultsHospitalizations for MI with CS in 2014 in a nationally representative all-payer database were included. The proportion of hospitalizations for MI with CS using MCS (MCS ratio) and in-hospital mortality were evaluated. Hospital characteristics and outcomes were compared across quartiles of MCS usage. Of 1813 hospitals evaluated, 1440 (79.4%) performed ≥10 percutaneous coronary interventions annually. Of these, 1064 (73.9%) had at least one code for MCS. Forty-one percent of hospitals did not use MCS. The median (interquartile range) proportion of MCS use among admissions for MI with CS was 33.3% (0.0%-50.0%). High MCS utilizing hospitals were larger ( P<0.001). Eighty-five percent (2808/3301) of MCS use was intra-aortic balloon pump. There was significant variation in receipt of MCS at different hospitals (median odds ratio of receiving MCS at 2 random hospitals: 1.58; 95% CI, 1.45-1.70). Adjusted in-hospital mortality was not different across quartiles of MCS use (Q4 versus Q1; odds ratio, 0.95; 95% CI, 0.77-1.16; P=0.58).ConclusionsWide variation exists in hospital use of MCS for MI with CS, unexplained by patient characteristics. The predominant form of MCS use is intra-aortic balloon pump. Risk-adjusted mortality rates were not different between higher and lower MCS-utilizing hospitals.
Project description:BackgroundThere are limited sex-specific data on patients receiving temporary mechanical circulatory support (MCS) for acute myocardial infarction-cardiogenic shock (AMI-CS).MethodsAll admissions with AMI-CS with MCS use were identified using the National Inpatient Sample from 2005 to 2016. Outcomes of interest included in-hospital mortality, discharge disposition, use of palliative care and do-not-resuscitate (DNR) status, and receipt of durable left ventricular assist device (LVAD) and cardiac transplantation.ResultsIn AMI-CS admissions during this 12-year period, MCS was used more frequently in men-50.4% vs 39.5%; P < 0.001. Of the 173,473 who received MCS (32% women), intra-aortic balloon pumps, percutaneous LVAD, extracorporeal membrane oxygenation, and ≥ 2 MCS devices were used in 92%, 4%, 1%, and 3%, respectively. Women were on average older (69 ± 12 vs 64 ± 13 years), of black race (10% vs 6%), and had more comorbidity (mean Charlson comorbidity index 5.0 ± 2.0 vs 4.5 ± 2.1). Women had higher in-hospital mortality than men (34% vs 29%, adjusted odds ratio [OR]: 1.19, 95% confidence interval [CI]: 1.16-1.23; P < 0.001) overall, in intra-aortic balloon pumps users (OR: 1.20 [95% CI: 1.16-1.23]; P < 0.001), and percutaneous LVAD users (OR: 1.75 [95% CI: 1.49-2.06]; P < 0.001), but not in extracorporeal membrane oxygenation or ≥ 2 MCS device users (P > 0.05). Women had higher use of palliative care, DNR status, and discharges to skilled nursing facilities.ConclusionsThere are persistent sex disparities in the outcomes of AMI-CS admissions receiving MCS support. Women have higher in-hospital mortality, palliative care consultation, and use of DNR status.
Project description:In the setting of ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, three primary treatment objectives include providing circulatory support, ventricular unloading, and restoring myocardial perfusion. In addition to primary percutaneous coronary intervention, each of these three objectives can be achieved with appropriate use of an acute mechanical circulatory support (AMCS) pump. Over the past decade, utilization of percutaneously-delivered AMCS devices including the Impella axial-flow catheter, TandemHeart left atrial-to-femoral artery bypass system, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has grown exponentially. In this review, we will discuss the hemodynamic impact of each AMCS device and clinical data surrounding their use in the setting of STEMI complicated by cardiogenic shock.