The American journal of cardiology
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Multicenter Study Clinical Trial
Analysis of different device-based intrathoracic impedance vectors for detection of heart failure events (from the Detect Fluid Early from Intrathoracic Impedance Monitoring study).
Detect Fluid Early from Intrathoracic Impedance Monitoring (DEFEAT-PE) is a prospective, multicenter study of multiple intrathoracic impedance vectors to detect pulmonary congestion (PC) events. Changes in intrathoracic impedance between the right ventricular (RV) coil and device can (RVcoil→Can) of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs (CRT-Ds) are used clinically for the detection of PC events, but other impedance vectors and algorithms have not been studied prospectively. An initial 75-patient study was used to derive optimal impedance vectors to detect PC events, with 2 vector combinations selected for prospective analysis in DEFEAT-PE (ICD vectors: RVring→Can + RVcoil→Can, detection threshold 13 days; CRT-D vectors: left ventricular ring→Can + RVcoil→Can, detection threshold 14 days). ⋯ An alternative algorithm, ultimately approved by the US Food and Drug Administration (RVring→Can + RVcoil→Can, detection threshold 14 days), resulted in (for all patients) sensitivity of 21.6% and a false-positive rate of 0.9 per patient-year. The CRT-D thoracic impedance vector algorithm selected in the derivation study was not superior to the ICD algorithm RVring→Can + RVcoil→Can when studied prospectively. In conclusion, to achieve an acceptably low false-positive rate, the intrathoracic impedance algorithms studied in DEFEAT-PE resulted in low sensitivity for the prediction of heart failure events.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of the efficacy of pharmacoinvasive management for ST-segment elevation myocardial infarction in smokers versus non-smokers (from the Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction).
Compared with non-smokers, cigarette smokers with ST-segment elevation myocardial infarctions derive greater benefit from fibrinolytic therapy. However, it is not known whether the optimal treatment strategy after fibrinolysis differs on the basis of smoking status. The Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) randomized patients with ST-segment elevation myocardial infarctions to a routine early invasive (pharmacoinvasive) versus a standard (early transfer only for rescue percutaneous coronary intervention or delayed angiography) strategy after fibrinolysis. ⋯ Smoking status did not modify treatment effect on any measured outcomes (p>0.10 for all). In conclusion, compared with non-smokers, current smokers receiving either standard or early invasive management of ST-segment elevation myocardial infarction after fibrinolysis have more favorable outcomes, which is likely attributable to their better baseline risk profile. The beneficial treatment effect of a pharmacoinvasive strategy is consistent in smokers and non-smokers.
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Randomized Controlled Trial Multicenter Study Comparative Study
Treatment and outcomes of ST segment elevation myocardial infarction and out-of-hospital cardiac arrest in a regionalized system of care based on presence or absence of initial shockable cardiac arrest rhythm.
The aim of this study was to evaluate the treatment and outcomes of patients with ST-segment elevation myocardial infarctions complicated by out-of-hospital cardiac arrest in a regional system of care. In this retrospective study, the effect of the absence of an initial shockable arrest rhythm was analyzed. The primary end point of survival with good neurologic outcome in patients with and without an initial shockable arrest rhythm was adjusted for age, witnessed arrest, bystander cardiopulmonary resuscitation, and treatment with therapeutic hypothermia and percutaneous coronary intervention. ⋯ In patients who underwent percutaneous coronary intervention, the likelihood of survival with good neurologic outcome was higher (risk ratio 2.7, 95% CI 1.1 to 6.8) in those with a shockable rhythm. In conclusion, the absence of an initial shockable rhythm in patients with ST-segment elevation myocardial infarctions plus out-of-hospital cardiac arrest is associated with significantly worse survival and neurologic outcome. These differences persist despite application of therapies including therapeutic hypothermia and percutaneous coronary intervention within a regionalized system of care.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of five-year outcomes of coronary artery bypass grafting versus percutaneous coronary intervention in patients with left ventricular ejection fractions≤50% versus >50% (from the CREDO-Kyoto PCI/CABG Registry Cohort-2).
Coronary heart disease is a major risk factor for left ventricular (LV) systolic dysfunction. However, limited data are available regarding long-term benefits of percutaneous coronary intervention (PCI) in the era of drug-eluting stent or coronary artery bypass grafting (CABG) in patients with LV systolic dysfunction with severe coronary artery disease. We identified 3,584 patients with 3-vessel and/or left main disease of 15,939 patients undergoing first myocardial revascularization enrolled in the CREDO-Kyoto PCI/CABG Registry Cohort-2. ⋯ Similarly, the risk of all-cause death tended to be greater after PCI than after CABG in both patients with moderate and severe LV systolic dysfunction without significant interaction (hazard ratio 1.57, 95% confidence interval 0.96 to 2.56, p=0.07 and hazard ratio 1.42, 95% confidence interval 0.71 to 2.82, p=0.32; interaction p=0.91). CABG was associated with better 5-year survival outcomes than PCI in patients with impaired LV systolic function (LVEF≤50%) with complex coronary disease in the era of drug-eluting stents. In both patients with moderate (35%
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Randomized Controlled Trial Multicenter Study
Impact of pre-procedural cardiopulmonary instability in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction Trial).
Rapid reperfusion with primary percutaneous coronary intervention improves survival in patients with ST-segment elevation myocardial infarction. Preprocedural cardiopulmonary instability and adverse events (IAE) may delay reperfusion time and worsen prognosis. The aim of this study was to evaluate the relation between preprocedural cardiopulmonary IAE, door-to-balloon time (DBT), and outcomes in the Harmonizing Outcomes With Revascularization and Stents in AMI (HORIZONS-AMI) trial. ⋯ Mortality at 3 years was significantly higher in patients with versus those without IAE (17.0% vs 6.3%, p<0.0001), and IAE was an independent predictor of mortality, whereas DBT was not. However, a significant interaction was present such that 3-year mortality was reduced in patients with DBT<99 minutes (the median) versus ≥99 minutes to a greater extent in patients with IAE (9.9% vs 20.7%, hazard ratio 0.43, 95% confidence interval 0.16 to 1.16) compared with those without IAE (5.0% vs 7.2%, hazard ratio 0.69, 95% confidence interval 0.50 to 0.95) (p for interaction=0.004). In conclusion, IAE before PCI is an independent predictor of death and identifies a high-risk group in whom faster reperfusion may be particularly important to improve survival.