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In this double-blind, placebo-controlled trial involving 2854 patients with Chagas' cardiomyopathy, no clinical benefit was found with 2 to 3 months of benznidazole therapy during 5 years of followup. Chagas’ disease is the third most common parasitic disease globally, after malaria and schistosomiasis. 1 Chagas’ cardiomyopathy is the most common form of nonischemic cardiomyopathy and one of the leading causes of complications and death in Latin America. 2 An estimated 6 million to 7 million persons are infected, and 36,800 new cases occur each year. Chagas’ cardiomyopathy develops in approximately 25% of patients infected with Trypanosoma cruzi . 3 – 5 Chagas’ disease has two phases: acute and chronic. Acute infection is usually a self-limited febrile illness. 6 In the chronic phase, cardiac or digestive complications develop in approximately one third of patients two . . .

In a single-group trial, 352 patients with acute major bleeding while taking a factor Xa inhibitor were treated with andexanet. Andexanet markedly reduced anti–factor Xa activity, and 82% of the patients had excellent or good hemostatic efficacy at 12 hours.

Patients with ST-segment elevation MI and multivessel coronary disease who had undergone successful culprit-lesion PCI were assigned to a strategy of either PCI of all other suitable stenoses or no further revascularization. At 3 years, the risk of cardiovascular death or new MI was lower with complete revascularization.

Andexanet alfa, a catalytically inactive decoy of factor Xa, successfully reversed the factor Xa inhibitory effects of rivaroxaban and apixaban in a small study involving patients with acute major bleeding. In randomized clinical trials, factor Xa inhibitors have been shown to be safe and effective for the treatment and prevention of venous thromboembolism and for stroke prevention in patients with atrial fibrillation. 1 – 4 However, factor Xa inhibitors have been associated with major and even fatal bleeding events. 1 – 4 Such episodes of acute major bleeding may be difficult to treat because there is no reversal agent. Andexanet alfa (andexanet) has been designed and developed specifically to reverse the effects of both direct and indirect factor Xa inhibitors. It is a recombinant, modified human factor Xa decoy protein that binds factor Xa . . .

Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3·1 years (SD 1·0). The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients (90 [7% per year]) in the no-testing group than patients who did receive it (104 [8% per year]; HR 0·86, 95% CI 0·65–1·14; pnon-inferiority <0·0001). The first safety composite outcome occurred in 69 (5·6%) of 1236 patients with no-testing and in 81 (6·5%) of 1242 patients with defibrillation testing, p=0·33. The second, pre-specified safety composite outcome, which included only events most likely to be directly caused by testing, occurred in 3·2% of patients with no-testing and in 4·5% with defibrillation testing, p=0·08. Heart failure needing intravenous treatment with inotropes or diuretics was the most common adverse event (in 20 [2%] of 1236 patients in the no-testing group vs 28 [2%] of 1242 patients in the testing group, p=0·25). Routine defibrillation testing at the time of ICD implantation is generally well tolerated, but does not improve shock efficacy or reduce arrhythmic death. Boston Scientific and the Heart and Stroke Foundation (Ontario Provincial office).

A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy. The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI. This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients. The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.

Patients with STEMI were assigned to primary PCI with or without thrombectomy. At 180 days, there was no significant between-group difference in the primary outcome of death or cardiovascular events. Patients in the thrombectomy group had a higher rate of stroke at 30 days. Primary percutaneous coronary intervention (PCI), when available, is the most effective method of achieving reperfusion in patients with ST-segment elevation myocardial infarction (STEMI). 1 However, a major limitation of primary PCI is the possibility of distal embolization of thrombus and failure to restore flow at the microvascular level. Measures of microvascular tissue reperfusion, such as the degree of ST-segment resolution or angiographic myocardial blush grade, have been shown to predict the rate of death after primary PCI. 2 , 3 Removal of the thrombus by manual thrombectomy before stent deployment has the potential of reducing distal embolization and improving microvascular perfusion. Small, randomized . . .

Purpose Blood sampling for diagnostic testing causes blood loss. Small-volume tubes have the same cost, dimensions, and blood-draw techniques as standard-volume tubes, and are compatible with laboratory equipment; however, they are not commonly used. We sought to assess the feasibility of a stepped-wedge cluster trial to determine whether small-volume tubes reduce transfusion compared with standard-volume tubes in intensive care unit (ICU) patients. Methods We conducted a prospective mixed-methods pilot study (before-after design) in one ICU with a six-week control period (standard-volume tubes) and a six-week intervention period (small-volume tubes). All patients admitted to the ICU were included. Feasibility was assessed as successful switch to small-volume tubes; adherence to tube size; sufficient volume for testing; user acceptance; barriers and facilitators to implementation; and 95% transfusion collection. We explored end-user acceptability using focus groups. Results One hundred and sixty-five patients were included in the standard-volume and 204 in the small-volume periods. Transition to small-volume tubes was successful. Random audits showed 100% compliance. The proportion of samples with inadequate volume for testing was the same for both groups (both, 0.2%). Based on ten focus groups, small-volume tubes were acceptable with no barriers identified. Transfusion data collection was 100%. Median [interquartile range] estimated blood loss due to laboratory testing per patient per day in ICU was 11 [8–17] mL with standard-volume and 6 [4–8] mL with small-volume tubes. Conclusion Small-volume tubes can be implemented with acceptability to end-users and without barriers. They did not result in an increased frequency of inadequate samples. These results inform a trial to determine whether small-volume tubes reduce transfusion. Study registration ClinicalTrials.gov (NCT03284944); registered 15 September 2017.

A significant proportion of patients with ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Following successful culprit lesion percutaneous coronary intervention (PCI) for STEMI, the question of whether to routinely revascularize non-culprit lesions or manage them conservatively with optimal medical therapy (OMT) alone is a common dilemma facing clinicians. COMPLETE is a prospective, randomized, international, multicenter, parallel group, open-label trial with blinded evaluation of outcomes. Following successful PCI (contemporary drug eluting stents recommended) of the culprit lesion for STEMI, a total of 4041 patients from 140 centers in 31 countries were randomized to receive either complete revascularization, consisting of staged PCI of all suitable non-culprit lesions plus optimal medical therapy (OMT), or to culprit lesion-only PCI, consisting of OMT alone. OMT comprises evidence-based therapy for STEMI, including and dual antiplatelet therapy with ticagrelor, HTN and lipid management. All coronary angiograms in the trial are being evaluated in a central angiographic core lab to assess quality and completeness of revascularization. The co-primary outcomes are (1): the composite of CV death or new non-fatal MI and (2 the composite of CV death, new non-fatal MI or ischemia-driven revascularization at a median follow-up of 3 years. The COMPLETE trial is an international multicenter randomized trial that will help determine whether complete revascularization involving staged PCI of non-culprit lesions improves outcomes in patients with STEMI and multivessel CAD. (clinicaltrials.govNCT01740479).

The Zookeeper's Sleepers is about a zookeeper who is just dozing off when one of her animals comes and says, \"I am awake. I cannot sleep.\" She hands him a book and tells him to read. The scene repeats with different animals and a different number of animals, each one in turn saying they can't sleep and the zookeeper hands each one a book to read. In the end, all the animals come saying they can't read and so the zookeeper reads to them and then to her surprise, finds that she is awake and cannot sleep.