Variability in reporting of key outcome predictors in acute myocardial infarction cardiogenic shock trials.

BACKGROUND: Among acute myocardial infarction patients with cardiogenic shock (AMICS), a number of key variables predict mortality, including cardiac arrest (CA) and shock classification as proposed by Society for Cardiovascular Angiography and Intervention (SCAI). Given this prognostic importance, we examined the frequency of reporting of high risk variables in published randomized controlled trials (RCTs) of AMICS patients. METHODS: We identified 15 RCTs enrolling 2,500 AMICS patients and then reviewed rates of CA, baseline neurologic status, right heart catheterization data, lactate levels, inotrope and vasopressor requirement, hypothermia, mechanical ventilation, left ventricular ejection fraction (LVEF), mechanical circulatory support, and specific cause of death based on the primary manuscript and Data in S1. RESULTS: A total of 2,500 AMICS patients have been enrolled in 15 clinical trials over 21 years with only four trials enrolling >80 patients. The reporting frequency and range for key prognostic factors was: neurologic status (0% reported), hypothermia (28% reported, prevalence 33-75%), specific cause of death (33% reported), cardiac index and wedge pressure (47% reported, range 1.6-2.3 L min-1  m-2 and 15-24 mmHg), lactate (60% reported, range 4-7.7 mmol/L), LVEF (73% reported, range 25-45%), CA (80% reported, prevalence 0-92%), MCS (80% reported, prevalence 13-100%), and mechanical ventilation (93% reported, prevalence 35-100%). This variability was reflected in the 30-day mortality which ranged from 20-73%. CONCLUSIONS: In a comprehensive review of seminal RCTs in AMICS, important predictors of outcome were frequently not reported. Future efforts to standardize CS trial data collection and reporting may allow for better assessment of novel therapies for AMICS.

Intraaortic balloon pump in myocardial infarction: Always, Never, or for the Right Patient?

SEMPER FI was a 100-patient pilot study that randomized acute myocardial infarction (AMI) patients with persistent ischemia following percutaneous coronary intervention (PCI) to intraaortic balloon pump (IABP) versus control. AMI patients with persistent ischemia receiving short-term IABP post-PCI had a greater resolution of persistent ST segment elevation and a trend for decreased clinical events. These results support a larger adequately powered trial of IABP versus control in AMI patients with persistent ischemia following primary PCI.

Mitral annular peak systolic and diastolic velocities are characteristic of healthy hearts: A Doppler tissue imaging study.

INTRODUCTION: Although systolic and diastolic dysfunction must coexist, they are most often considered in isolation. Therefore, a simple and reproducible quantitative measurement that integrates systolic and diastolic function is desirable. We hypothesize that the absolute sum of lateral mitral annular systolic and early diastolic peak velocities is predictive of overall cardiac function. METHODS: In this study, lateral mitral annular systolic (S') and early diastolic (E') peak velocities were measured in healthy subjects and compared against subjects with progressive degrees of systolic and diastolic dysfunction. RESULTS: A total of 149 subjects (56% male, mean age 48 years) were enrolled and stratified according to global left ventricular function: 76 normal, 40 mild-moderate dysfunction, and 33 moderate-severe dysfunction. Adjusting for baseline differences including age, univariate analysis showed mean S' + E' values were significantly different between subjects with normal, mild-moderate, and moderate-severe global left ventricular function (27, 17, 13 cm/s; P < 0.001 for all comparisons). The absolute sum of S' + E' ≥ 20 cm/s identified normal global left ventricular function with a sensitivity of 95%, specificity of 85%, and ROC area under the curve of 0.924. CONCLUSIONS: In a cohort of subjects with varying levels of combined systolic and diastolic function, the easily obtainable composite score of S' + E' ≥ 20 cm/s is strongly predictive of normal global left ventricular function with a high degree of sensitivity and specificity. Additional studies should be considered to expand this concept to additional populations.

Clinical Characteristics and Outcomes of STEMI Patients With Cardiogenic Shock and Cardiac Arrest.

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.

The safety of sacubitril-valsartan for the treatment of chronic heart failure.

INTRODUCTION: Sacubitril-valsartan is a combination drug that contains the neprilysin inhibitor sacubitril and angiotensin II receptor blocker valsartan. In 2015, the US Food and Drug Administration approved sacubitril-valsartan for treatment of heart failure patients with reduced ejection fraction and New York Heart Association class II-IV symptoms following a large, Phase III clinical trial (PARADIGM-HF) that demonstrated a 20% reduction in the combined primary end-point of death from cardiovascular cause or hospitalization for heart failure compared to enalapril. Areas covered: This review discusses the clinical efficacy and safety of angiotensin receptor neprilysin inhibitor sacubitril-valsartan in heart failure with reduced ejection fraction. Expert opinion: Based on the PARADIGM-HF trial, sacubitril-valsartan offers compelling reductions in meaningful clinical endpoints, independent of age or severity of disease. The rate of adverse events was comparable between the enalapril and sacubitril-valsartan groups, although the absolute rates are likely underestimated due to the entry criteria and run-in period. Future trials and post-market surveillance are critical to better understand the risk of angioedema in high risk populations, particularly African-Americans, as well as long-term theoretical risks including the potential for increased cerebral amyloid plaque deposition with possible development of neurocognitive disease. Current trials are underway to evaluate potential benefit in patients with heart failure with preserved ejection fraction.

Why we need intravenous antiplatelet agents.

Oral ADP-receptor antagonists combined with aspirin are the standard for dual antiplatelet therapy (DAPT) during percutaneous coronary intervention (PCI). However, the oral route of administration of ADP-receptor antagonists leaves them vulnerable to unpredictable and often inadequate platelet inhibition at the time of PCI, while their prolonged effects often lead to the decision not to load them prior to PCI. Intravenous antiplatelet agents, including glycoprotein IIb/IIIa inhibitors (GPI) and cangrelor, a reversible P2Y12 inhibitor, address these shortcomings. In June 2015, the US FDA approved cangrelor for the prevention of thrombotic events associated with coronary stenting. This review examines the current state of peri-PCI DAPT and demonstrates that the selective use of GPIs and intravenous ADP-antagonist agents reduces the risk of periprocedural thrombosis.