Background—

Coronary computed tomographic angiography (cCTA) allows rapid, noninvasive exclusion of obstructive coronary artery disease (CAD). However, concern exists whether implementation of cCTA in the assessment of patients presenting to the emergency department with acute chest pain will lead to increased downstream testing and costs compared with alternative strategies. Our aim was to compare observed actual costs of usual care (UC) with projected costs of a strategy including early cCTA in the evaluation of patients with acute chest pain in the Rule Out Myocardial Infarction Using Computer Assisted Tomography I (ROMICAT I) study.

Methods and Results—

We compared cost and hospital length of stay of UC observed among 368 patients enrolled in the ROMICAT I study with projected costs of management based on cCTA. Costs of UC were determined by an electronic cost accounting system. Notably, UC was not influenced by cCTA results because patients and caregivers were blinded to the cCTA results. Costs after early implementation of cCTA were estimated assuming changes in management based on cCTA findings of the presence and severity of CAD. Sensitivity analysis was used to test the influence of key variables on both outcomes and costs. We determined that in comparison with UC, cCTA-guided triage, whereby patients with no CAD are discharged, could reduce total hospital costs by 23% (P<0.001). However, when the prevalence of obstructive CAD increases, index hospitalization cost increases such that when the prevalence of ≥50% stenosis is >28% to 33%, the use of cCTA becomes more costly than UC.

Conclusions—

cCTA may be a cost-saving tool in acute chest pain populations that have a prevalence of potentially obstructive CAD <30%. However, increased cost would be anticipated in populations with higher prevalence of disease.

Clinical Trial Registration—

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00990262.

Background—

Clinical guidelines recommend digoxin for patients with symptomatic systolic heart failure (HF) receiving optimal medical therapy, but this recommendation is based on limited, older trial data. We evaluated the effectiveness and safety of digoxin in a contemporary cohort of patients with incident systolic HF.

Methods and Results—

We identified adults with incident systolic HF between 2006 and 2008 within Kaiser Permanente Northern California who had no prior digoxin use. We used multivariable extended Cox regression to examine the association between new digoxin use and risks of death and HF hospitalization, controlling for medical history, laboratory results, medications, HF disease severity, and the propensity for digoxin use. We also conducted analyses stratified by sex and concurrent β-blocker use. Among 2891 newly diagnosed patients with systolic HF, 529 (18%) received digoxin. During a median 2.5 years of follow-up, incident digoxin use was associated with higher rates of death (14.2 versus 11.3 per 100 person-years) and HF hospitalization (28.2 versus 24.4 per 100 person-years). In multivariable analysis, incident digoxin use was associated with higher mortality (hazard ratio, 1.72; 95% confidence interval, 1.25–2.36) but no significant difference in the risk of HF hospitalization (hazard ratio, 1.05; 95% confidence interval, 0.82–1.34). Results were similar in analyses stratified by sex and β-blocker use.

Conclusions—

Digoxin use in patients with incident systolic HF was independently associated with a higher risk of death but no difference in HF hospitalization.

Background—

Translation of evidence-based heart failure (HF) therapies to clinical practice is incomplete and may vary internationally. We examined common measures of quality of care in patients enrolled in the international Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure trial.

Methods and Results—

Patients were admitted to 398 hospitals for acute HF in 5 regions (North America, n=3149; Latin America, n=658; Asia Pacific, n=1744; Central Europe, n=966; and Western Europe, n=490). Predefined quality indicators assessed at hospital discharge included the following: medications (angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers, aldosterone antagonists, hydralazine/nitrates, statin therapy, and warfarin), use (or planned use) of implantable intracardiac devices, and blood pressure control (<140/90 mm Hg). We determined regional variations in quality indicators as well as the temporal variation of these indicators during the course of the trial. There was significant variation in conformity among different quality indicators, ranging from 0% to 89%. Of all potential performance opportunities, 19 076 of 32 268 (59%) were met, with Central Europe highest at 64%, followed by North America (63%), Western Europe (61%), Latin America (56%), and Asia Pacific (51%; P<0.0001). North America, Central Europe, and Asia Pacific regions demonstrated a modest increase in quality indicator conformity over time, although there was no significant change in other regions.

Conclusions—

Quality of care for patients hospitalized with acute HF varies and remains suboptimal even within a randomized clinical trial, which included quality improvement interventions. Specific measures designed to improve performance measures should be implemented even within multicenter clinical trials.

Clinical Trial Registration—

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.

Background—

Substantial efforts over the past decade have increased rates of intravenous tissue plasminogen activator (tPA) use in the United States. We sought to determine changes in patient characteristics and rates of tPA use over time among hospitalized acute ischemic stroke (AIS) patients.

Methods and Results—

We analyzed all AIS patients (n=1 093 895) and those arriving ≤2 hours and treated with tPA ≤3 hours after onset (n=50 798) from 2003 to 2011 in the American Heart Association’s Get with the Guideline–Stroke (GWTG–Stroke). Categorical data were analyzed by Pearson χ² and continuous data by Wilcoxon test. Intravenous tPA use ≤3 hours after onset increased from 4.0% to 7.0% in all AIS admissions and 42.6% to 77.0% in AIS patients arriving ≤2 hours and fully eligible for tPA (P<0.001). In univariate analysis, tPA use increased over time, especially in those aged >85 years, nonwhite, and with milder strokes (National Institutes of Health Stroke Scale 0–4). Door-to-image time (median 24 versus 20 minutes) and door-to-tPA time (median 81 versus 72 minutes) also improved, with ≈65% of tPA-treated patients getting brain imaging ≤25 minutes after arrival. Multivariable analysis showed that with each additional calendar year, the odds that an eligible patient would receive tPA increased by 1.37-fold, adjusting for other covariates.

Conclusions—

The frequency of IV tPA use among all AIS patients, regardless of contraindications, nearly doubled from 2003 to 2011. Treatment with tPA has expanded to include more patients with mild deficits, nonwhite race/ethnicity, and oldest old age.

Background—

Residents who live in neighborhoods that are primarily black, Latino, or poor are more likely to have an out-of-hospital cardiac arrest, less likely to receive cardiopulmonary resuscitation (CPR), and less likely to survive. No prior studies have been conducted to understand the contributing factors that may decrease the likelihood of residents learning and performing CPR in these neighborhoods. The goal of this study was to identify barriers and facilitators to learning and performing CPR in 3 low-income, high-risk, and predominantly black neighborhoods in Columbus, OH.

Methods and Results—

Community-Based Participatory Research approaches were used to develop and conduct 6 focus groups in conjunction with community partners in 3 target high-risk neighborhoods in Columbus, OH, in January to February 2011. Snowball and purposeful sampling, done by community liaisons, was used to recruit participants. Three reviewers analyzed the data in an iterative process to identify recurrent and unifying themes. Three major barriers to learning CPR were identified and included financial, informational, and motivational factors. Four major barriers were identified for performing CPR and included fear of legal consequences, emotional issues, knowledge, and situational concerns. Participants suggested that family/self-preservation, emotional, and economic factors may serve as potential facilitators in increasing the provision of bystander CPR.

Conclusions—

The financial cost of CPR training, lack of information, and the fear of risking one’s own life must be addressed when designing a community-based CPR educational program. Using data from the community can facilitate improved design and implementation of CPR programs.

Background—

Positive affect has been associated with better prognosis in patients with ischemic heart disease, but the underlying mechanisms remain unclear. We examined whether positive affect predicted time to first cardiac-related hospitalization and all-cause mortality, and whether exercise mediated this relationship in patients with established ischemic heart disease.

Methods and Results—

The sample comprised 607 patients with ischemic heart disease from Holbæk Hospital, Denmark. In 2005, patients completed the Global Mood Scale (GMS) to assess positive affect and a purpose-designed question on exercise. Data on mortality and hospitalization were collected from Danish national registers for the period 2006–2010. Adjusted Cox and logistic regression were used to analyze the mediation model. Because no significant association between positive affect and cardiac-related hospitalization was found, we constructed no mediation model for hospitalization. Importantly, patients with high positive affect had a significantly reduced risk of all-cause mortality (hazard ratio, 0.58; 95% confidence interval, 0.37–0.92; unadjusted analysis) and were more likely to exercise (odds ratio, 1.99; 95% confidence interval, 1.44–2.76; unadjusted analysis; odds ratio, 1.48; 95% confidence interval, 1.03–2.13; adjusted analysis). When controlling for positive affect and other relevant variables, patients engaged in exercise were less likely to die during follow-up (hazard ratio, 0.50; 95% confidence interval, 0.31–0.80; P=0.004). Importantly, exercise acted as a mediator in the relationship between positive affect and mortality.

Conclusions—

Patients with higher levels of positive affect were more likely to exercise and had a lower risk of dying during 5-year follow-up, with exercise mediating the relationship between positive affect and mortality. Interventions aimed at increasing both positive affect and exercise may have better results with respect to patients’ prognosis and psychological well-being than interventions focusing on 1 of these factors alone.

Background—

Oral anticoagulation therapy is the primary tool in reducing stroke risk in patients with nonvalvular atrial fibrillation but is underused. Patients nonpersistent with therapy contribute to this underuse. The objective of this study was to compare persistence rates in newly diagnosed nonvalvular atrial fibrillation patients treated with warfarin versus dabigatran as their oral anticoagulation.

Methods and Results—

US Department of Defense administrative claims were used to identify patients receiving warfarin or dabigatran between October 28, 2010, and June 30, 2012. Patient records were examined for a minimum of 12 months before index date to restrict the analyses to those newly diagnosed with nonvalvular atrial fibrillation and naive-to-treatment, identifying 1775 on warfarin and 3370 on dabigatran. Propensity score matching was used to identify 1745 matched pairs. Persistence was defined as time on therapy to discontinuation. Kaplan–Meier curves were used to depict persistence over time. Cox proportional hazards model was used to determine the factors significantly associated with persistence. Using a 60-day permissible medication gap, the persistence rates were higher for dabigatran than for warfarin at both 6 months (72% versus 53%) and 1 year (63% versus 39%). Patients on dabigatran with a low-to-moderate risk of stroke (CHADS₂<2) or with a higher bleed risk (HEMORR₂HAGES>3) had a higher likelihood of nonpersistence (hazard ratios, 1.37; 95% confidence interval, 1.17–1.60; P<0.001; and hazard ratios, 1.24; 95% confidence interval, 1.04–1.47; P=0.016).

Conclusions—

Patients who initiated dabigatran treatment were more persistent than patients who began warfarin treatment. Within each cohort, patients with lower stroke risk were more likely to discontinue therapy.

Background—

Endovascular aortic aneurysm repair (EVAR) is often offered to patients with abdominal aortic aneurysms (AAAs) considered preoperatively to be unfit for open AAA repair (oAAA). This study describes the short- and long-term outcomes of patients undergoing EVAR with AAAs <6.5 cm who are considered unfit for oAAA.

Methods and Results—

We analyzed elective EVARs for AAAs <6.5 cm diameter in the Vascular Study Group of New England (2003–2011). Patients were designated as fit or unfit for oAAA by the treating surgeon. End points included in-hospital major adverse events and long-term mortality. We identified patient characteristics associated with being unfit for open repair and predictors of survival using multivariable analyses. Of 1653 EVARs, 309 (18.7%) patients were deemed unfit for oAAA. These patients were more likely to have advanced age, cardiac disease, chronic obstructive pulmonary disease, and larger aneurysms at the time of repair (54 versus 56 mm, P=0.001). Patients unfit for oAAA had higher rates of cardiac (7.8% versus 3.1%, P<0.01) and pulmonary (3.6 versus 1.6, P<0.01) complications and worse survival rates at 5 years (61% versus 80%; log rank P<0.01) compared with those deemed fit for oAAA. Finally, patients designated as unfit for oAAA had worse survival, even adjusting for patient characteristics and aneurysm size (hazard ratio, 1.6; 95% confidence interval, 1.2–2.2; P<0.01).

Conclusions—

In patients with AAAs <6.5 cm, designation by the operating surgeon as unfit for oAAA provides insight into both short- and long-term efficacy of EVAR. Patients unable to tolerate oAAA may not benefit from EVAR unless their risk of AAA rupture is very high.

Background—

Cardiac perforation is a feared complication of implantable cardioverter-defibrillator (ICD) lead implantation because of the potential for significant morbidity and mortality. Predictors of perforation and the severity of associated adverse events have not been well studied. We sought to identify predictors of cardiac perforation from ICD lead implantation and subsequent outcomes.

Methods and Results—

We studied 440 251 first-time ICD recipients in the ICD Registry implanted between January 2006 and September 2011. Using hierarchical multivariable logistic regression adjusting for patient, implanting physician, and hospital characteristics, we examined the predictors of perforation and the association of perforation with other major complications, length of stay, and in-hospital mortality. Cardiac perforation occurred in 625 patients (0.14%). After multivariable adjustment, older age, female sex, left bundle branch block, worsened heart failure class, higher left ventricular ejection fraction, and non–single-chamber ICD implant were associated with a greater odds of perforation. Conversely, atrial fibrillation, diabetes mellitus, previous cardiac bypass surgery, and higher implanter procedural volume were associated with a lower odds of perforation (all P<0.05). After adjustment, ICD recipients with perforation had greater odds of other associated major complications (odds ratio, 27.5; 95% confidence interval, 19.9–38.0; P<0.0001), postprocedural hospital stays >3 days (odds ratio, 16.3; 95% confidence interval, 13.7–19.4; P<0.0001), and in-hospital death (odds ratio, 17.7; 95% confidence interval, 12.2–25.6; P<0.0001).

Conclusions—

In a large population of ICD recipients, specific patient and implanter characteristics predicted cardiac perforation risk. Cardiac perforation was associated with a substantially increased risk of other major complications, prolonged hospital stays, and death.

Background—

Transcatheter aortic valve replacement (TAVR) has emerged as a less invasive option for valve replacement of patients with severe aortic stenosis. Although it has been recommended that TAVR should not be offered to patients who will not improve functionally or derive meaningful survival benefit from the procedure, no guidance exists on how best to identify such patients. The first step in this process is to define a poor outcome that can then be used as a foundation for subsequent case identification. We sought to evaluate potential definitions of a poor outcome after TAVR that combine both mortality and quality of life components.

Methods and Results—

Using data from 463 patients who underwent TAVR as part of the Placement of AoRTic TraNscathetER Valve (PARTNER) trial, we evaluated 6-month mortality and quality of life outcomes using the Kansas City Cardiomyopathy Questionnaire to explore potential definitions of a poor outcome. We then compared the strengths and weaknesses of each potential definition by examining the relationship between baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores for each patient. Based on these analyses, we argue that the most appropriate definition of a poor outcome after TAVR is (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary score <45, or (3) Kansas City Cardiomyopathy Questionnaire decrease of ≥10 points, which best reflects a failure to achieve the therapeutic goals of TAVR.

Conclusions—

Using empirical data on a large number of patients enrolled in the PARTNER trial, we propose a definition for poor outcome after TAVR that combines both mortality and quality of life measures into a single composite end point. Use of this end point (or other similar end points) in future studies can facilitate development of predictive models that may be useful to identify patients who are poor candidates for TAVR and to provide such patients and their families with appropriate expectations of functional recovery after TAVR.