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The role of myocardial viability assessment in identifying patients with ischemic cardiomyopathy who will benefit from surgical revascularization is controversial. This study assessed myocardial viability and its relationship to long-term outcomes in 601 patients with ischemic cardiomyopathy who were assigned to surgical revascularization plus medical therapy or medical therapy alone.

Key Points Quality-of-life (QOL) measurement grew out of work by social scientists and health-services researchers in the 1960s and 1970s to define the value of health-care spending Measuring QOL has some similarity with other forms of clinical testing but, because the objects of measurement are subjective experiences, psychometric tools and theory are used to guide the process The goal of measurement is to use the patterns of responses from patients on QOL scales to marshal evidence that the (unobservable) QOL construct is present at some quantitative level The choice of which instrument to use in a particular area of research or clinical indication is primarily a matter of expert judgment QOL and other patient-reported outcomes are still not measured in most clinical trials of cardiovascular disease A typical approach to QOL measurement is to combine a disease-specific measure that is sensitive to the intervention under study with one or more generic instruments providing normative data In this Review, Daniel Mark examines the use of health-related quality of life (QOL) as an outcome measure in clinical cardiovascular research. The main concepts, assumptions, tools, and methods used to assess QOL are discussed. Applied research into QOL outcomes in coronary artery disease, heart failure, and atrial fibrillation are also summarized, with an emphasis on experience from large, randomized clinical trials. The field of quality-of-life (QOL) measurement grew out of attempts in the 1960s and 1970s to connect the ever-increasing levels of public expenditure on technology-based health care for chronic diseases with evidence of the benefits and harms to patients. Most of the concepts, methods, and standards for measuring QOL were derived from psychometrics, but the degree to which current tools adhere to these methods varies greatly. Despite the importance of QOL, patient-reported outcomes are not measured in most cardiovascular clinical trials. Lack of familiarity with QOL measures and their interpretation, and unrealistic expectations about the information these measures can provide, are obstacles to their use. Large clinical trials of revascularization therapy for coronary artery disease and medical treatments for heart failure show small-to-moderate QOL effects, primarily detected with disease-specific instruments. Larger treatment effects, seen in trials of device therapy for heart failure and ablation therapy for atrial fibrillation, have been detected with both generic and disease-specific instruments. A large gap remains between the parameters currently being measured in clinical research and the data needed to incorporate the 'patient's voice' into therapeutic decision-making.

Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed.

We aimed to determine the association of MR severity and type with all-cause death in a large, real-world, clinical setting. We reviewed full echocardiography studies at Duke Echocardiography Laboratory (01/01/1995–12/31/2010), classifying MR based on valve morphology, presence of coronary artery disease, and left ventricular size and function. Survival was compared among patients stratified by MR type and baseline severity. Of 93,007 qualifying patients, 32,137 (34.6%) had ≥mild MR. A total of 8094 (8.7%) had moderate/severe MR, which was primary myxomatous (14.1%), primary non-myxomatous (6.2%), secondary non-ischemic (17.0%), and secondary ischemic (49.4%). At 10 years, patients with primary myxomatous MR or MR due to indeterminate cause had survival rates of >60%; primary non-myxomatous, secondary ischemic, and non-ischemic MR had survival rates <50%. While mild (HR 1.06, 95% CI 1.03–1.09), moderate (HR 1.31, 95% CI 1.27–1.37), and severe (HR 1.55, 95% CI 1.46–1.65) MR were independently associated with all-cause death, the relationship of increasing MR severity with mortality varied across MR types (P ≤ .001 for interaction); the highest risk associated with worsening severity was seen in primary myxomatous MR followed by secondary ischemic MR and primary non-myxomatous MR. Although MR severity is independently associated with increased all-cause death risk for most forms of MR, the absolute mortality rates associated with worse MR severity are much higher for primary myxomatous, non-myxomatous, and secondary ischemic MR. The findings from this study support carefully defining MR by type and severity.

The outcomes in patients by visual assessment and quantitative coronary angiography (QCA) for obstructive coronary artery disease (CAD) are not known. Our objectives were to compare visual and QCA estimates of obstructive CAD and to assess their relationship to outcomes in stable patients with symptoms of CAD. The PROMISE trial randomized 10,003 patients with CAD symptoms to anatomical or functional testing. Site reports of invasive angiography detailing visual stenosis and independent, blinded QCA were performed for obstructive CAD (≥50% stenosis). Disagreement between methods was determined and compared with outcomes (death, myocardial infarction, unstable angina hospitalization, or major procedural complications). Of 929 patients (9.3% of PROMISE cohort) with angiograms assessed by sites and QCA, 593 (64%) had obstructive CAD per site reports, whereas 428 (46%) had stenosis ≥50% per QCA. Results differed in 177 patients (disagreement rate 19.1%, κ=0.63), of whom 171 had CAD per sites but not per QCA. One-year unadjusted Kaplan-Meier event rates were highest (5.1%) when QCA and visual assessment agreed for CAD, lowest (0.9%) when the 2 agreed for no obstructive CAD, and intermediate (3.1%) for patients who had CAD per visual assessment but not per QCA. Visual estimation of angiograms results in more frequent diagnosis of obstructive CAD as compared with QCA. Concordance of results for presence or absence of obstructive CAD was associated with high and low event rates, respectively. Disagreement was associated with intermediate event rates, suggesting that cardiologists integrated clinical information into routine visual assessment of angiograms.

A multicenter trial evaluated patients with previous anterior-wall myocardial infarction who were not candidates for an implantable cardioverter–defibrillator. Patients were randomly assigned either to have an automated external defibrillator (AED) at home for management of cardiac arrest or to receive standard treatment. At a median follow-up of 3 years, there was no significant difference between the two groups in mortality from any cause. Patients with previous anterior-wall myocardial infarction were randomly assigned either to have an automated external defibrillator (AED) at home for management of cardiac arrest or to receive standard treatment. At a median follow-up of 3 years, there was no significant difference between the two groups in mortality from any cause. Sudden cardiac arrest remains an unsolved public health problem, with approximately 166,200 out-of-hospital cardiac arrests occurring annually in the United States. 1 The use of automated external defibrillators (AEDs) by trained lay responders in community-based public-access defibrillation programs has been shown to increase survival after sudden cardiac arrest. However, what effect the use of the device has on overall mortality for the community at risk is unknown. 2 – 5 Particularly impressive results have been reported when sudden cardiac arrest is witnessed and an AED is immediately available, as on airplanes and in casinos and airports. 6 – 8 However, the effect of such programs . . .

Primary prevention implantable cardioverter defibrillator (ICD) reduce all-cause mortality by reducing sudden cardiac death. There are conflicting data regarding whether patients with more advanced heart failure derive ICD benefit owing to the competing risk of nonsudden death. We performed a patient-level meta-analysis of New York Heart Association (NYHA) class II/III heart failure patients (left ventricular ejection fraction ≤35%) from 4 primary prevention ICD trials (MADIT-I, MADIT-II, DEFINITE, SCD-HeFT). Bayesian-Weibull survival regression models were used to assess the impact of NYHA class on the relationship between ICD use and mortality. Of the 2,763 patients who met study criteria, 68% (n=1,867) were NYHA II and 52% (n=1,435) were randomized to an ICD. In a multivariable model including all study patients, the ICD reduced mortality (hazard ratio [HR] 0.65, 95% posterior credibility interval [PCI]) 0.40-0.99). The interaction between NYHA class and the ICD on mortality was significant (posterior probability of no interaction=.036). In models including an interaction term for the NYHA class and ICD, the ICD reduced mortality among NYHA class II patients (HR 0.55, PCI 0.35-0.85), and the point estimate suggested reduced mortality in NYHA class III patients (HR 0.76, PCI 0.48-1.24), although this was not statistically significant. Primary prevention ICDs reduce mortality in NYHA class II patients and trend toward reducing mortality in the heterogeneous group of NYHA class III patients. Improved risk stratification tools are required to guide patient selection and shared decision making among NYHA class III primary prevention ICD candidates.

The gentamicin–collagen sponge is used outside the U.S. to prevent surgical-site infection. In this trial of patients undergoing colorectal surgery, patients who had such sponges inserted above the fascia had higher, not lower, rates of infection. Postoperative surgical-site infection continues to be a significant problem after general surgical procedures, especially colorectal surgery. Reported incidences of surgical-site infection among patients who undergo colorectal surgery range from 8.2% 1 to 26%, 2 with an incidence of approximately 18 to 20% in most series. 3 – 7 Postoperative surgical-site infection is associated with a significant rate of complications and cost. 8 – 10 Thus, prevention of these frequent infections has been the focus of numerous strategies. 2 – 7 , 11 The gentamicin–collagen sponge was developed to prevent and treat wound infections by providing high gentamicin concentrations locally, avoiding the high systemic concentrations associated with nephrotoxicity. The sponge's . . .

Studies that have shown clinical depression to be a risk factor for cardiac events after coronary artery bypass graft (CABG) surgery have had small sample sizes, short follow-up, and have not had adequate power to assess mortality. We sought to assess whether depression is associated with an increased risk of mortality. We assessed 817 patients undergoing CABG at Duke University Medical Center between May, 1989, and May, 2001. Patients completed the Center for Epidemiological Studies-Depression (CES-D) scale before surgery, 6 months after CABG, and were followed-up for up to 12 years. In 817 patients there were 122 deaths (15%) in a mean follow-up of 5·2 years. 310 patients (38%) met the criterion for depression (CES-D ⩾16): 213 (26%) for mild depression (CES-D 16–26) and 97 (12%) for moderate to severe depression (CES-D ⩾27). Survival analyses, controlling for age, sex, number of grafts, diabetes, smoking, left ventricular ejection fraction, and previous myocardial infarction, showed that patients with moderate to severe depression at baseline (adjusted hazard ratio [HR] 2·4, [95% CI 1·4–4·0]; p=0·001) and mild or moderate to severe depression that persisted from baseline to 6 months (adjusted HR 2·2, [1·2–4·2]; p=0·015) had higher rates of death than did those with no depression. Despite advances in surgical and medical management of patients after CABG, depression is an important independent predictor of death after CABG and should be carefully monitored and treated if necessary.

Cognitive decline has increasingly been recognized as a complication after cardiac surgery. Although important advances in techniques for perioperative anesthesia, surgery, and the protection of organs have resulted in substantial reductions in age-adjusted and risk-adjusted mortality, 1 the incidence of cognitive decline has changed little over the past 15 years. Elderly patients with multiple health problems, who are at higher risk than other groups of patients for neurologic and neurocognitive problems, are now able to undergo surgical procedures relatively late in life without serious concern about loss of life. However, they are at substantially increased risk for central nervous system dysfunction . . .