Ischemic heart disease (IHD) is the most common cause of heart failure (HF); however, the role of revascularization in these patients is still unclear. Consensus on proper use of cardiac imaging to help determine which candidates should be considered for revascularization has been hindered by the absence of clinical studies that objectively and prospectively compare the prognostic information of each test obtained using both standard and advanced imaging.
This paper describes the design and methods to be used in the Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) multi-center trial. The primary objective is to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, myocardial infarction (MI), cardiac arrest and re-hospitalization for cardiac causes.In AIMI-HF, patients with HF of ischemic etiology (n = 1,261) will follow HF imaging strategy algorithms according to the question(s) asked by the physicians (for example, Is there ischemia and/or viability?), in agreement with local practices. Patients will be randomized to either standard (SPECT, Single photon emission computed tomography) imaging modalities for ischemia and/or viability or advanced imaging modalities: cardiac magnetic resonance imaging (CMR) or positron emission tomography (PET). In addition, eligible and consenting patients who could not be randomized, but were allocated to standard or advanced imaging based on clinical decisions, will be included in a registry.
AIMI-HF will be the largest randomized trial evaluating the role of standard and advanced imaging modalities in the management of ischemic cardiomyopathy and heart failure. This trial will complement the results of the Surgical Treatment for Ischemic Heart Failure (STICH) viability substudy and the PET and Recovery Following Revascularization (PARR-2) trial. The results will provide policy makers with data to support (or not) further investment in and wider dissemination of alternative 'advanced' imaging technologies.
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Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada; Department of Epidemiology and Community Medicine, University of Ottawa, ON, Canada. Electronic address: firstname.lastname@example.org.
Bystander CPR rates are lowest at home, where 85% of out-of-hospital cardiac arrests occur. We sought to identify barriers and facilitators to CPR training and performing CPR among older individuals most likely to witness cardiac arrest.
We selected independent-living Canadians aged =55 using random-digit-dial telephone calls. Respondents were randomly assigned to answer 1 of 2 surveys eliciting barriers and facilitators potentially influencing either CPR training or performance. We developed survey instruments using the Theory of Planned Behavior, measuring salient attitudes, social influences, and control beliefs.
Demographics for the 412 respondents (76.4% national response rate): Mean age 66, 58.7% female, 54.9% married, 58.0% CPR trained (half >10 years ago). Mean intentions to take CPR training in the next 6 months or to perform CPR on a victim were relatively high (3.6 and 4.1 out of 5). Attitudinal beliefs were most predictive of respondents' intentions to receive training or perform CPR (Adjusted OR; 95%CI were 1.81; 1.41-2.32 and 1.63; 1.26-2.04 respectively). Respondents who believed CPR could save a life, were employed, and had seen CPR advertised had the highest intention to receive CPR training. Those who believed CPR should be initiated before EMS arrival, were proactive in a group, and felt confident in their CPR skills had the highest intention to perform CPR.
Attitudinal beliefs were most predictive of respondents' intention to complete CPR training or perform CPR on a real victim. Behavioral change techniques targeting these specific beliefs are most likely to make an impact.
There is little clear evidence as to the optimal energy levels for initial and subsequent shocks in biphasic waveform defibrillation. The present study compared fixed lower- and escalating higher-energy regimens for out-of-hospital cardiac arrest.
The Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation (BIPHASIC Trial) was a multicenter, randomized controlled trial of 221 out-of-hospital cardiac arrest patients who received > or = 1 shock given by biphasic automated external defibrillator devices that were randomly programmed to provide, blindly, fixed lower-energy (150-150-150 J) or escalating higher-energy (200-300-360 J) regimens. Patient mean age was 66.0 years; 79.6% were male. The cardiac arrest was witnessed in 63.8%; a bystander performed cardiopulmonary resuscitation in 23.5%; and initial rhythm was ventricular fibrillation/ventricular tachycardia in 92.3%. The fixed lower- and escalating higher-energy regimen cases were similar for the 106 multishock patients and for all 221 patients. In the primary analysis in multishock patients, conversion rates differed significantly (fixed lower, 24.7%, versus escalating higher, 36.6%; P=0.035; absolute difference, 11.9%; 95% CI, 1.2 to 24.4). Ventricular fibrillation termination rates also were significantly different between groups (71.2% versus 82.5%; P=0.027; absolute difference, 11.3%; 95% CI, 1.6 to 20.9). For the secondary analysis of first shock success, conversion rates were similar between the fixed lower and escalating higher study groups (38.4% versus 36.7%; P=0.92), as were ventricular fibrillation termination rates (86.8% versus 88.8%; P=0.81). There were no distinguishable differences between regimens for survival outcomes or adverse effects.
This is the first randomized trial to compare fixed lower and escalating higher biphasic energy regimens in out-of-hospital cardiac arrest, and it demonstrated higher rates of ventricular fibrillation conversion and termination with an escalating higher-energy regimen for patients requiring multiple shocks. These results suggest that patients in ventricular fibrillation benefit from higher biphasic energy levels if multiple defibrillation shocks are required.
Comment In: Evid Based Med. 2007 Oct;12(5):14217909233
Comment In: Circulation. 2007 Nov 6;116(19):e522; author reply e52317984386
We compare the predictive accuracy of emergency physicians' unstructured clinical judgment to the Canadian C-Spine rule.
This prospective multicenter cohort study was conducted at 10 Canadian urban academic emergency departments. Included in the study were alert, stable, adult patients with a Glasgow Coma Scale score of 15 and trauma to the head or neck. This was a substudy of the Canadian C-Spine and CT Head Study. Eligible patients were prospectively evaluated before radiography. Physicians estimated the probability of unstable cervical spine injury from 0% to 100% according to clinical judgment alone and filled out a data form. Interobserver assessments were done when feasible. Patients underwent cervical spine radiography or follow-up to determine clinically important cervical spine injuries. Analyses included comparison of areas under the receiver operating characteristic (ROC) curve with 95% confidence intervals (CIs) and the kappa coefficient.
During 18 months, 6265 patients were enrolled. The mean age was 36.6 years (range 16 to 97 years), and 50.1% were men. Sixty-four (1%) patients had a clinically important injury. The physicians' kappa for a 0% predicted probability of injury was 0.46 (95% CI 0.28 to 0.65). The respective areas under the ROC curve for predicting cervical spine injury were 0.85 (95% CI 0.80 to 0.89) for physician judgment and 0.91 (95% CI 0.89 to 0.92) for the Canadian C-Spine rule (P
Comment In: Ann Emerg Med. 2004 Jun;43(6):789-90; author reply 790-115259167
Comment In: Ann Emerg Med. 2003 Sep;42(3):403-412944894
Comment In: Ann Emerg Med. 2004 Jun;43(6):78815259165
Comment In: Ann Emerg Med. 2004 Jun;43(6):788-915259166
The Canadian C-Spine (cervical-spine) Rule (CCR) and the National Emergency X-Radiography Utilization Study (NEXUS) Low-Risk Criteria (NLC) are decision rules to guide the use of cervical-spine radiography in patients with trauma. It is unclear how the two decision rules compare in terms of clinical performance.
We conducted a prospective cohort study in nine Canadian emergency departments comparing the CCR and NLC as applied to alert patients with trauma who were in stable condition. The CCR and NLC were interpreted by 394 physicians for patients before radiography.
Among the 8283 patients, 169 (2.0 percent) had clinically important cervical-spine injuries. In 845 (10.2 percent) of the patients, physicians did not evaluate range of motion as required by the CCR algorithm. In analyses that excluded these indeterminate cases, the CCR was more sensitive than the NLC (99.4 percent vs. 90.7 percent, P
Cardiac resynchronization (CRT) prolongs survival in patients with systolic heart failure and QRS prolongation. However, most trials excluded patients with permanent atrial fibrillation.
The Resynchronization for Ambulatory Heart Failure Trial (RAFT) randomized patients to an implantable cardioverter defibrillator (ICD) or ICD+CRT, stratified by the presence of permanent atrial fibrillation. Patients with permanent atrial fibrillation were randomized to CRT-ICD (n=114) or ICD (n=115). Patients receiving a CRT-ICD were similar to those receiving an ICD: age (71.6±7.3 versus 70.4±7.7 years), left ventricular ejection fraction (22.9±5.3% versus 22.3±5.1%), and QRS duration (151.0±23.6 versus 153.4±24.7 ms). There was no difference in the primary outcome of death or heart failure hospitalization between those assigned to CRT-ICD versus ICD (hazard ratio, 0.96; 95% CI, 0.65-1.41; P=0.82). Cardiovascular death was similar between treatment arms (hazard ratio, 0.97; 95% CI, 0.55-1.71; P=0.91); however, there was a trend for fewer heart failure hospitalizations with CRT-ICD (hazard ratio, 0.58; 95% CI, 0.38-1.01; P=0.052). The change in 6-minute hall walk duration between baseline and 12 months was not different between treatment arms (CRT-ICD: 19±84 m versus ICD: 16±76 m; P=0.88). Patients treated with CRT-ICD showed a trend for a greater improvement in Minnesota Living with Heart Failure score between baseline and 6 months (CRT-ICD: 41±21 to 31±21; ICD: 33±20 to 28±20; P=0.057).
Patients with permanent atrial fibrillation who are otherwise CRT candidates appear to gain minimal benefit from CRT-ICD compared with a standard ICD.
To assist physicians with difficult decisions about hospital admission for patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) presenting in the emergency department, we sought to identify clinical characteristics associated with serious adverse events.
We conducted this prospective cohort study in 6 large Canadian academic emergency departments. Patients were assessed for standardized clinical variables and then followed for serious adverse events, defined as death, intubation, admission to a monitored unit or new visit to the emergency department requiring admission.
We enrolled 945 patients, of whom 354 (37.5%) were admitted to hospital. Of 74 (7.8%) patients with a subsequent serious adverse event, 36 (49%) had not been admitted after the initial emergency visit. Multivariable modelling identified 5 variables that were independently associated with adverse events: prior intubation, initial heart rate = 110/minute, being too ill to do a walk test, hemoglobin
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A number of countries have implemented a policy of universal leukoreduction of their blood supply, but the potential role of leukoreduction in decreasing postoperative mortality and infection is unclear.
To evaluate clinical outcomes following adoption of a national universal prestorage leukoreduction program for blood transfusions.
Retrospective before-and-after cohort study conducted from August 1998 to August 2000 in 23 academic and community hospitals throughout Canada, enrolling 14 786 patients who received red blood cell transfusions following cardiac surgery or repair of hip fracture, or who required intensive care following a surgical intervention or multiple trauma.
Universal prestorage leukoreduction program introduced by 2 Canadian blood agencies. A total of 6982 patients were enrolled during the control period and 7804 patients were enrolled following prestorage leukoreduction.
All-cause in-hospital mortality and serious nosocomial infections (pneumonia, bacteremia, septic shock, all surgical site infections) occurring after first transfusion and at least 2 days after index procedure or intensive care unit admission. Secondary outcomes included rates of posttransfusion fever and antibiotic use.
Unadjusted in-hospital mortality rates were significantly lower following the introduction of leukoreduction compared with the control period (6.19% vs 7.03%, respectively; P =.04). Compared with the control period, the adjusted odds of death following leukoreduction were reduced (odds ratio [OR], 0.87; 95% confidence interval [CI], 0.75-0.99), but serious nosocomial infections did not decrease (adjusted OR, 0.97; 95% CI, 0.87-1.09). The frequency of posttransfusion fevers decreased significantly following leukoreduction (adjusted OR, 0.86; 95% CI, 0.79-0.94), as did antibiotic use (adjusted OR, 0.90; 95% CI, 0.82-0.99).
A national universal leukoreduction program is potentially associated with decreased mortality as well as decreased fever episodes and antibiotic use after red blood cell transfusion in high-risk patients.
Current use of cranial computed tomography (CT) for minor head injury is increasing rapidly, highly variable, and inefficient. The Canadian CT Head Rule (CCHR) and New Orleans Criteria (NOC) are previously developed clinical decision rules to guide CT use for patients with minor head injury and with Glasgow Coma Scale (GCS) scores of 13 to 15 for the CCHR and a score of 15 for the NOC. However, uncertainty about the clinical performance of these rules exists.
To compare the clinical performance of these 2 decision rules for detecting the need for neurosurgical intervention and clinically important brain injury.
In a prospective cohort study (June 2000-December 2002) that included 9 emergency departments in large Canadian community and university hospitals, the CCHR was evaluated in a convenience sample of 2707 adults who presented to the emergency department with blunt head trauma resulting in witnessed loss of consciousness, disorientation, or definite amnesia and a GCS score of 13 to 15. The CCHR and NOC were compared in a subgroup of 1822 adults with minor head injury and GCS score of 15.
Neurosurgical intervention and clinically important brain injury evaluated by CT and a structured follow-up telephone interview.
Among 1822 patients with GCS score of 15, 8 (0.4%) required neurosurgical intervention and 97 (5.3%) had clinically important brain injury. The NOC and the CCHR both had 100% sensitivity but the CCHR was more specific (76.3% vs 12.1%, P
Canadian Emergency Medical Services annually transport 1.3 million patients with potential neck injuries to local emergency departments. Less than 1% of those patients have a c-spine fracture and even less (0.5%) have a spinal cord injury. Most injuries occur before the arrival of paramedics, not during transport to the hospital, yet most patients are transported in ambulances immobilized. They stay fully immobilized until a bed is available, or until physician assessment and/or X-rays are complete. The prolonged immobilization is often unnecessary and adds to the burden of already overtaxed emergency medical services systems and crowded emergency departments.
The goal of this study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients using a validated clinical decision rule, the Canadian C-Spine Rule, in order to determine the need for immobilization during transport to the emergency department.This cohort study will be conducted in Ottawa, Canada with one emergency medical service. Paramedics with this service participated in an earlier validation study of the Canadian C-Spine Rule. Three thousand consecutive, alert, stable adult trauma patients with a potential c-spine injury will be enrolled in the study and evaluated using the Canadian C-Spine Rule to determine the need for immobilization. The outcomes that will be assessed include measures of safety (numbers of missed fractures and serious adverse outcomes), measures of clinical impact (proportion of patients transported without immobilization, key time intervals) and performance of the Rule.
Approximately 40% of all very low-risk trauma patients could be transported safely, without c-spine immobilization, if paramedics were empowered to make clinical decisions using the Canadian C-Spine Rule. This safety study is an essential step before allowing all paramedics across Canada to selectively immobilize trauma victims before transport. Once safety and potential impact are established, we intend to implement a multi-centre study to study actual impact.
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