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.

High thrombus burden despite thrombolytic therapy in ST-elevation myocardial infarction in a patient with COVID-19.

Consideration of thrombolysis as first-line reperfusion therapy in patients with COVID-19 and STEMI is recommended by ACC/SCAI guidelines. We describe a patient with COVID-19, who presented with ST-elevation myocardial infarction and was treated with thrombolysis and anticoagulation. He was later found to have a significant persistent thrombus burden requiring thrombectomy and stent placement. Invasive hemodynamics on multiple high-dose pressers revealed a high cardiac output state with low systemic vascular resistance, consistent with distributive rather than cardiogenic shock. Our case illustrates that thrombolytic therapy alone may not be adequate in patients with STEMI and COVID-19, as well as the importance of early invasive hemodynamics in management of shock in patient with STEMI and COVID-19 infection.

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.

Defining the common femoral artery: Insights from the femoral arterial access with ultrasound trial.

OBJECTIVE: We sought to establish the typical location of the common femoral artery (CFA) bifurcation, the origin and most inferior reflection of the inferior epigastric artery (IEA) relative to the femoral head (FH) and whether patient demographics predicted anatomical variations. BACKGROUND: In the absence of ultrasound guidance or prior imaging, the precise location of the CFA bifurcation and IEA can only be determined following access site angiography. Fluoroscopic landmarks are commonly used to estimate the location of the CFA bifurcation, but the position of the IEA is less well characterized. METHODS: Prospectively collected data on 989 patients with femoral angiography in the FAUST trial were analyzed. The level of CFA bifurcation and the origin and most inferior reflection of the IEA were classified by angiography. Logistic regression was used to explore whether baseline demographics were associated with anatomic variations. RESULTS: The CFA bifurcation occurs below the middle 1/3rd of the femoral head in 95% of patients, and no patient factors are predictive of a high bifurcation. The IEA origin has a more variable anatomically pattern, with high BSA, male gender, and white race associated with a low IEA origin. CONCLUSION: Operators should attempt to access the CFA at the level of the middle 1/3rd of the FH to maximize the chance of CFA cannulation. However, this location carries an 11% risk of being at or above the IEA origin. Baseline demographics were of limited utility for predicting anatomic variants of the CFA bifurcation and the course of the IEA. © 2016 Wiley Periodicals, Inc.

Usefulness of computed tomography to predict residual mitral regurgitation after transcatheter mitral valve edge-to-edge repair.

BACKGROUND: Multidetector computed tomography (MDCT) can provide valuable information for preprocedural planning of transcatheter mitral valve interventions. However, no data exist on MDCT parameters predicting residual mitral regurgitation (MR) post-MitraClip (Abbott Laboratories, Abbott Park, IL, USA). METHODS: We analyzed preprocedural MDCTs of 78 consecutive patients with secondary MR undergoing MitraClip implantation at our institution. Moderate-or-severe mitral leaflet calcification (MLC) was defined as calcification, with-or-without mitral annular calcification, extending beyond the mitral leaflet base. Residual MR was assessed by postprocedural transesophageal echocardiography, and clinical outcomes were assessed at 1-year. RESULTS: Fifteen patients (19 %) had residual MR ≥2+. Compared to patients with none-or-mild residual MR, MDCT-derived mitral valve orifice area (MVOA) to mitral annulus area (MAA) ratio was significantly lower (0.32 ±â€¯0.06 vs. 0.39 ±â€¯0.09; p = 0.003), and the prevalence of MLC was higher (40 % vs. 18 %; p = 0.057) in those with residual MR ≥2+. Furthermore, the MVOA/MAA ratio and MLC were independent predictors of residual MR ≥2+ post-MitraClip [adjusted odds ratio (ORadj): 0.88 (0.80-0.97) and 5.50 (1.16-26.23), respectively]. On receiver-operating-characteristic-curve analysis, MVOA/MAA ratio <0.31 had a sensitivity of 87 % and a specificity of 60 % for residual MR ≥2+. When patients were classified according to the presence of MLC and an MVOA/MAA ratio <0.31, those with both parameters had significantly higher rates of postprocedural residual MR ≥2+ and mitral reintervention at 1-year than those with only one, and those without both parameters. CONCLUSIONS: In patients with secondary MR undergoing the MitraClip procedure, preprocedural MDCT parameters, specifically MVOA/MAA ratio and MLC, are useful to predict postprocedural residual MR.

Computed tomography angiography-derived extracellular volume fraction predicts early recovery of left ventricular systolic function after transcatheter aortic valve replacement.

AIMS: Recovery of left ventricular ejection fraction (LVEF) after aortic valve replacement has prognostic importance in patients with aortic stenosis (AS). The mechanism by which myocardial fibrosis impacts LVEF recovery in AS is not well characterized. We sought to evaluate the predictive value of extracellular volume fraction (ECV) quantified by cardiac CT angiography (CTA) for LVEF recovery in patients with AS after transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: In 109 pre-TAVR patients with LVEF <50% at baseline echocardiography, CTA-derived ECV was calculated as the ratio of change in CT attenuation of the myocardium and the left ventricular (LV) blood pool before and after contrast administration. Early LVEF recovery was defined as an absolute increase of ≥10% in LVEF measured by post-TAVR follow-up echocardiography within 6 months of the procedure. Early LVEF recovery was observed in 39 (36%) patients. The absolute increase in LVEF was 17.6 ± 8.8% in the LVEF recovery group and 0.9 ± 5.9% in the no LVEF recovery group (P < 0.001). ECV was significantly lower in patients with LVEF recovery compared with those without LVEF recovery (29.4 ± 6.1% vs. 33.2 ± 7.7%, respectively, P = 0.009). In multivariable analysis, mean pressure gradient across the aortic valve [odds ratio (OR): 1.07, 95% confidence interval (CI): 1.03-1.11, P: 0.001], LV end-diastolic volume (OR: 0.99, 95% CI: 0.98-0.99, P: 0.035), and ECV (OR: 0.92, 95% CI: 0.86-0.99, P: 0.018) were independent predictors of early LVEF recovery. CONCLUSION: Increased myocardial ECV on CTA is associated with impaired LVEF recovery post-TAVR in severe AS patients with impaired LV systolic function.

Percutaneous mitral valve repair with MitraClip XTR for acute mitral regurgitation due to papillary muscle rupture.

Papillary muscle rupture is an infrequent and highly morbid mechanical complication of acute myocardial infarction. Surgical repair or replacement is traditionally considered first-line therapy. However, many of these patients present in extremis with prohibitively high surgical risk. Repair of mitral regurgitation with the MitraClip device (Abbot Vascular, Menlo Park, CA, USA) is an established therapy to treat degenerative and functional mitral regurgitation. We present a case of successful repair of severe mitral regurgitation due to papillary muscle rupture in the setting of acute myocardial infarction. A two-clip strategy resulted in mild residual mitral regurgitation with resolution of cardiogenic shock and refractory hypoxemia requiring veno-venous extracorporeal membrane oxygenation. Six-month follow-up echocardiogram identified durable results with mild mitral regurgitation and left ventricular ejection fraction of 63 %. Our case demonstrates that percutaneous mitral valve repair with MitraClip is a well-tolerated procedure that can provide acute and long-term benefit for patients with acute mitral regurgitation due to papillary muscle rupture who are at prohibitively high surgical risk. .

Prognostic Value of Computed Tomography-Derived Extracellular Volume in TAVR Patients With Low-Flow Low-Gradient Aortic Stenosis.

OBJECTIVES: The association between extracellular volume (ECV) measured by computed tomography angiography (CTA) and clinical outcomes was evaluated in low-flow low-gradient (LFLG) aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients with LFLG AS comprise a high-risk group with respect to clinical outcomes. Although ECV, a marker of myocardial fibrosis, is traditionally measured with cardiac magnetic resonance, it can also be measured using cardiac CTA. The authors hypothesized that in LFLG AS, increased ECV may be associated with adverse clinical outcomes. METHODS: In 150 LFLG patients with AS who underwent TAVR, ECV was quantified using pre-TAVR CTA. Echocardiographic and clinical information including all-cause death and heart failure rehospitalization (HFH) was obtained from electronic medical records. A Cox proportional hazards model was used to evaluate the association between ECV and death+HFH. RESULTS: During a median follow-up of 13.9 months (range 0.07 to 28.9 months), there were 31 death+HFH events (21%). Patients who experienced death+HFH had a greater median Society of Thoracic Surgery score (9.9 vs. 4.7; p < 0.01), lower left ventricular ejection fraction (42.3 ± 20.2% vs. 52.7 ± 17.2%; p < 0.01), lower mean transvalvular gradient (24.9 ± 8.9 mm Hg vs. 28.1 ± 7.3 mm Hg; p = 0.04) and increased mean ECV (35.5 ± 9.6% vs. 29.9 ± 8.2%; p < 0.01) compared with patients who did not experience death+HFH. In a multivariable Cox proportional hazards model, increase in ECV was associated with increase in death+HFH, (hazard ratio per 1% increase: 1.04, 95% confidence interval: 1.01 to 1.09; p < 0.01). CONCLUSIONS: In patients with LFLG AS, CTA measured increase in ECV is associated with increased risk of adverse clinical outcomes post-TAVR and may thus serve as a useful noninvasive marker for prognostication.

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.

Comparison of distributions of survivin among tissues from urinary bladders of dogs with cystitis, transitional cell carcinoma, or histologically normal urinary bladders.

OBJECTIVE: To compare distributions of survivin among tissues from urinary bladders of dogs with cystitis, transitional cell carcinoma (TCC), or histologically normal urinary bladders. SAMPLE POPULATION: 24 archived and 7 fresh-frozen specimens of urinary bladders from dogs with cystitis. PROCEDURES: Immunohistochemical analysis of archived tissue specimens was performed to identify survivin protein in the nucleus and cytoplasm of cells by use of polyclonal rabbit anti-survivin antibody. Tissues that contained > or = 5% immunoreactive cells were considered positive for survivin protein. Reverse-transcription PCR analysis was performed on fresh-frozen tissues to identify survivin mRNA. Data on tissues from dogs with TCC or histologically normal urinary bladders that were obtained during another study were used for statistical comparisons. RESULTS: Twelve of 24 (50%) cystitic tissues were positive for nuclear survivin, compared with 28 of 41 (68%) TCC tissues and 0 of 46 (0%) normal tissues. Two of 24 (8%) cystitic tissues were positive for cytoplasmic survivin, compared with 7 of 41 (17%) TCC tissues and 17 of 46 (37%) normal tissues. Proportions of specimens that contained nuclear or cytoplasmic survivin were significantly different between cystitic and normal tissues but not between cystitic and TCC tissues. Four of 7 cystitic tissues were positive for survivin mRNA, which was comparable with results for TCC and normal tissues. CONCLUSIONS AND CLINICAL RELEVANCE: Nuclear survivin was detected in TCC and cystitic tissues but not in normal urinary bladder tissues. Additional studies are needed to determine whether nuclear survivin contributes to the development or progression of TCC.

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.