Early Utilization of Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: The National Cardiogenic Shock Initiative.

BACKGROUND: Acute 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 RESULTS: The 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. CONCLUSIONS: Early 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.

Clinical and economic outcomes of embolic complications and strategies for distal embolic protection during percutaneous coronary intervention in saphenous vein grafts.

BACKGROUND: Although distal embolic protection (DEP) is increasingly utilized in saphenous vein graft percutaneous coronary intervention (SVG PCI), the clinical and economic outcomes of different DEP strategies are unknown. METHODS: We compared 3 DEP strategies (no DEP, routine DEP, selective DEP in high-risk cases) in 126 consecutive cases of SVG PCI performed without DEP in a single catheterization laboratory over a 4-year period. No SVG PCI was excluded. High risk was defined using 2 multivariate predictors of embolic complication previously validated by NCDR (graft age greater than or equal to 8 years and or friable appearance with thrombus). Costs were determined by a ratio of cost-to-charges methodology and average cost of the two FDA-approved DEP devices ($1,350) with similar efficacy. RESULTS: Without DEP, the incidence of embolic complications was 17% (22/126), resulting in major adverse coronary events (MACE) in 3.2% (4/126) of all cases: 2 deaths, 1 myocardial infarction, and 1 emergency coronary artery bypass. Embolic complications significantly increased both procedure costs by $2,725 (p < .001) and total hospital costs approximately $2,800 (p < 0.05). Risk adjustment for selective DEP use correctly predicted 86% (19/22) of embolic complications, including all MACE, at an incremental cost of $684 per patient for selective DEP versus $1,150 per patient for routine DEP. Selective DEP would cost $43,127 per death prevented versus $72,461 using routine DEP during the index hospitalization. CONCLUSIONS: Embolic complications increase cost in excess of the cost of a DEP device. This risk adjustment model correctly predicted the majority of cases of embolic complication and all MACE, suggesting that selective DEP use may help reduce utilization of DEP by an almost 50% cost reduction compared to routine use.