Percutaneous coronary intervention with Impella support with and without intra-aortic balloon in cardiogenic shock patients.

To assess the clinical characteristics and in-hospital bleeding complications and major adverse cardiac and cerebrovascular events (MACCE) associated with the use of Impella alone or the combination of an intra-aortic balloon pump (IABP) with Impella in cardiogenic shock (CS) patients undergoing percutaneous coronary intervention (PCI). All CS patients who underwent PCI and were treated with an Impella mechanical circulatory support (MCS) device were identified. Patients were divided into two groups: having MCS support with Impella alone or with both, IABP and Impella simultaneously (dual MCS group). Bleeding complications were classified by a modified Bleeding Academic Research Consortium (BARC) classification. Major bleeding was defined as BARC≥3 bleeding. MACCE was the composite of in-hospital death, myocardial infarction, cerebrovascular events and major bleeding complications. Between 2010 and 2018 a total of 101 patients were treated at six tertiary care New York hospitals with either Impella (n = 61) or dual MCS with Impella and IABP (n = 40). Clinical characteristics were similar for both groups. Dual MCS patients presented more often with a STEMI (77.5 % vs. 45.9 %, p = 0.002) and had left main coronary artery intervention (20.3 % vs. 8.6 %, p = 0.03). Major bleeding complications (69.4 % vs. 74.1 %, p = 0.62) and MACCE rates (80.6 % vs. 79.3 %, p = 0.88) were very high but similar in both groups, however access site bleeding complications were lower in patients treated with dual MCS. In-hospital mortality was 29.5 % for the Impella group and 25.0 % for the dual MCS group (p = 062). Access site bleeding complications were lower in in patients treated with dual MCS (5.0 % vs. 24.6 %, p = 0.01). In CS patients undergoing PCI with either the Impella device alone or with Impella and IABP, major bleeding complications and MACCE rates were high but not significantly different between the two groups. In hospital mortality was relatively low in both MCS groups despite the high-risk characteristics of these patients. Future studies should assess the risks and benefits of the simultaneous use of these two MCS in CS patients undergoing PCI.

Bhuiyan R ，Bimal T ，Fishbein J ，Gandotra P ，Selim S ，Ong L ，Gruberg L ... -  《-》

Mechanical circulatory support versus vasopressors alone in patients with acute myocardial infarction and cardiogenic shock undergoing percutaneous coronary intervention.

Previous studies have compared Impella use to intra-aortic balloon pump (IABP) use in patients with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI). Our objective was to compare clinical outcomes in patients with AMI-CS undergoing PCI who received Impella (percutaneous left ventricular assist device) without vasopressors, IABP without vasopressors, and vasopressors without mechanical circulatory support (MCS). We queried the National Inpatient Sample (NIS) using ICD-10 codes (2015-2018) to identify patients with AMI-CS undergoing PCI. We created three propensity-matched cohorts to examine clinical outcomes in patients receiving Impella versus IABP, Impella versus vasopressors without MCS, and IABP versus vasopressors without MCS. Among 17,762 patients, Impella use was associated with significantly higher in-hospital major bleeding (31.4% vs. 13.6%; p < 0.001) and hospital charges (p < 0.001) compared to IABP use, with no benefit in mortality (34.1% vs. 26.9%; p = 0.06). Impella use was associated with significantly higher mortality (42.3% vs. 35.7%; p = 0.02), major bleeding (33.9% vs. 22.7%; p = 0.001), and hospital charges (p < 0.001), when compared to the use of vasopressors without MCS. There were no significant differences in clinical outcomes between IABP use and the use of vasopressor without MCS. In this analysis of retrospective data of patients with AMI-CS undergoing PCI, Impella use was associated with higher mortality, major bleeding, and in-hospital charges when compared to vasopressor therapy without MCS. When compared to IABP use, Impella was associated with no mortality benefit, along with higher major bleeding events and in-hospital charges. A vasopressor-only strategy suggested no difference in clinical outcomes when compared to IABP. This study uses the NIS for the first time to highlight outcomes in AMI-CS patients undergoing PCI when treated with vasopressor support without MCS, compared to Impella and IABP use.

Javaid AI ，Michalek JE ，Gruslova AB ，Hoskins SA ，Ahsan CH ，Feldman MD ... -  《-》

Safety and efficacy of mechanical circulatory support with Impella or intra-aortic balloon pump for high-risk percutaneous coronary intervention and/or cardiogenic shock: Insights from a network meta-analysis of randomized trials.

Mechanical circulatory support (MCS) with Impella or intra-aortic balloon pump (IABP) is used for high-risk percutaneous coronary intervention (PCI) and/or for cardiogenic shock (CS) due to acute myocardial infarction. We aimed to investigate the efficacy and safety of Impella or IABP when compared with no MCS using a network meta-analysis of randomized controlled trials (RCTs). EMBASE and MEDLINE were searched through February 2020 for RCT evaluating efficacy of Impella vs. IABP vs. no MCS in patients undergoing high-risk PCI or CS. The primary efficacy outcome was 30 day or in-hospital all-cause mortality whereas the primary safety outcomes were major bleeding and vascular complications. Our search identified nine RCTs enrolling a total of 1,996 patients with high-risk PCI and/or CS. There was no significant difference with Impella or IABP on all-cause mortality when compared with no MCS (Impella vs. no MCS; OR:0.82 [0.35-1.90], p = .65, IABP vs. no MCS; OR:0.77 [0.47-1.28], p = .31, I2 = 18.1%). Impella significantly increased major bleeding compared with no MCS (Impella vs. no MCS; OR:7.01 [1.11-44.4], p = .038, I2 = 19.2%). IABP did not increase the risk of major bleeding compared with no MCS (OR:1.27 [0.75-2.16], p = .38, I2 = 19.2%) but increased vascular complication compared with no MCS (OR:1.92 [1.01-3.64], p = .045, I2 = 1.5%). Neither Impella nor IABP decreased all-cause short-term mortality when compared with no MCS for high-risk PCI and/or CS. Moreover, Impella increased major bleeding compared with no MCS.

Kuno T ，Takagi H ，Ando T ，Kodaira M ，Numasawa Y ，Fox J ，Bangalore S ... -  《-》

Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Dhruva SS ，Ross JS ，Mortazavi BJ ，Hurley NC ，Krumholz HM ，Curtis JP ，Berkowitz A ，Masoudi FA ，Messenger JC ，Parzynski CS ，Ngufor C ，Girotra S ，Amin AP ，Shah ND ，Desai NR ... -  《-》

A Comparison of In-Hospital Outcomes Between the Use of Impella and IABP in Acute Myocardial Infarction Cardiogenic Shock Undergoing Percutaneous Coronary Intervention.

Jin C ，Yandrapalli S ，Yang Y ，Liu B ，Aronow WS ，Naidu SS ... -  《-》