Atrial fibrillation or flutter on initial electrocardiogram is associated with worse outcomes in patients admitted for worsening heart failure with reduced ejection fraction: findings from the EVEREST Trial.

BACKGROUND: Heart failure (HF) complicated by atrial fibrillation/flutter (AF/AFL) is associated with worse outcomes. However, the clinical profile and outcomes of patients following hospitalization for HF with AF/AFL on initial electrocardiogram (ECG) has not been well studied. METHODS: EVEREST was a randomized trial of vasopressin-2 receptor blockade, in addition to standard therapy, in 4133 patients hospitalized with HF with ejection fraction ≤40%. A post hoc analysis was performed comparing the clinical characteristics and outcomes [all-cause mortality and cardiovascular mortality/HF hospitalization] of patients with AF/AFL versus sinus rhythm (SR) on baseline ECG, which were centrally analyzed. Times to events were compared using log-rank tests and Cox regression models. RESULTS: Of the 4133 patients, 1195 (29%) were classified with AF/AFL and 2071(50%) with SR. The remaining patients (21%) were excluded because ECGs were unavailable (n = 106), rhythm was paced (n = 727), or junctional/other supraventricular (n = 34). AF/AFL patients were older, with increased weight, faster heart rate, higher blood urea nitrogen, and natriuretic peptide levels compared to SR patients. Anticoagulation was prescribed in 67% of AF/AFL patients on discharge. AF/AFL patients were less likely to receive ß-blockers or angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (all P < .05). After risk adjustment, AF/AFL was associated with increased mortality (hazard ratio 1.23; 95% CI, 1.04-1.46) and cardiovascular mortality/HF hospitalization (hazard ratio 1.26; 95% CI, 1.07-1.47). CONCLUSION: AF/AFL on initial ECG in patients hospitalized with HF with reduced ejection fraction is associated with lower use of evidence-based therapies and increased mortality and rehospitalization compared to patients in SR.

Valve-in-Ring Transcatheter Aortic Valve Replacement After Left Ventricular Assist Device Therapy.

Aortic regurgitation after left ventricular assist device (LVAD) implantation is a well-described problem that decreases the clinical effectiveness of LVAD therapy and may eventually prompt consideration of aortic valve replacement once the regurgitation becomes severe. Transcatheter aortic valve replacement is an attractive, less invasive option compared with surgical aortic valve replacement in these patients. We report a valve-in-ring transcatheter aortic valve replacement for a patient with severe aortic regurgitation associated with LVAD destination therapy. Our case demonstrates that this approach is feasible in humans and can yield excellent clinical results.

Development of a risk score to identify patients with type 2 diabetes mellitus and multivessel coronary artery disease who can defer bypass surgery.

BACKGROUND: Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines provide a class I recommendation for patients with type 2 diabetes mellitus and multivessel coronary artery disease (CAD) to be treated with coronary artery bypass graft surgery (CABG). However, these patients are heterogeneous in terms of the risks and benefits associated with CABG. We sought to develop a risk score to identify low-risk patients with diabetes and multivessel CAD in whom CABG can be safely deferred. METHODS: Patients in the CABG strata randomized to intensive medical therapy (IMT) in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial who experienced death, myocardial infarction (MI), or stroke were compared with those who did not. We developed a risk score for death, MI, or stroke using a Cox proportional hazards model that included the following variables: age, history of heart failure, history of hypercholesterolemia, history of stroke, transient ischemic attack, serum creatinine, insulin use, myocardial jeopardy index, and HbA1c. RESULTS: Among patients with a risk score less than the median, those randomized to IMT or prompt CABG experienced similar rates of event-free survival at 5 years (77.8% vs. 83.2%, logrank P = 0.24). Among patients with a risk score greater than the median, those randomized to IMT experienced worse rates of event-free survival at 5 years than those randomized to prompt CABG (60.3% vs 73.2%, logrank P = 0.01). CONCLUSIONS: A novel risk score identifies low-risk patients with diabetes and stable, symptomatic multivessel CAD in whom CABG can be safely deferred.

Effect of prompt revascularization on outcomes in diabetic patients with stable ischemic heart disease and previous myocardial infarction in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

BACKGROUND: Survivors of a myocardial infarction (MI) are at a considerable risk of developing further cardiovascular events, including recurrent MI, heart failure, stroke, and death. Patients with type 2 diabetes mellitus and stable ischemic heart disease (SIHD) have worse outcomes than their nondiabetic counterparts, and those with previous MI may be at particularly high risk. Yet, little is known about the effect of adding prompt revascularization to intensive medical therapy in this high-risk group. PATIENTS AND METHODS: We carried out a post-hoc analysis of the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial, which randomized patients with type 2 diabetes mellitus and SIHD to prompt revascularization with percutaneous coronary intervention or coronary artery bypass grafting in addition to intensive medical therapy or intensive medical therapy alone. Previous MI status was defined by a history of MI or pathologic Q-waves. The primary endpoints were death, nonfatal or fatal MI, nonfatal or fatal stroke, congestive heart failure, and a composite of death/MI/stroke. RESULTS: Of the 2280 patients with evaluable data, 936 had previous MI. In these patients, there were no differences in the 5-year event-free rates of all-cause death, MI, stroke, congestive heart failure, or death/MI/stroke between those who were randomized to prompt revascularization in addition to intensive medical therapy and those who were randomized to intensive medical therapy alone. CONCLUSION: In diabetic patients with SIHD and previous MI, adding prompt revascularization to intensive medical therapy yielded no benefit compared with intensive medical therapy alone. These findings underscore the importance of intensive medical therapy in mitigating further ischemic events.

Increased Hazard of Myocardial Infarction With Insulin-Provision Therapy in Actively Smoking Patients With Diabetes Mellitus and Stable Ischemic Heart Disease: The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) Trial.

BACKGROUND: In the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial, randomization of diabetic patients with stable ischemic heart disease to insulin provision (IP) therapy, as opposed to insulin sensitization (IS) therapy, resulted in biochemical evidence of impaired fibrinolysis but no increase in adverse clinical outcomes. We hypothesized that the prothrombotic effect of IP therapy in combination with the hypercoagulable state induced by active smoking would result in an increased risk of myocardial infarction (MI). METHODS AND RESULTS: We analyzed BARI 2D patients who were active smokers randomized to IP or IS therapy. The primary end point was fatal or nonfatal MI. PAI-1 (plasminogen activator inhibitor 1) activity was analyzed at 1, 3, and 5 years. Of 295 active smokers, MI occurred in 15.4% randomized to IP and in 6.8% randomized to IS over the 5.3 years (P=0.023). IP therapy was associated with a 3.2-fold increase in the hazard of MI compared with IS therapy (hazard ratio: 3.23; 95% confidence interval, 1.43-7.28; P=0.005). Baseline PAI-1 activity (19.0 versus 17.5 Au/mL, P=0.70) was similar in actively smoking patients randomized to IP or IS therapy. However, IP therapy resulted in significantly increased PAI-1 activity at 1 year (23.0 versus 16.0 Au/mL, P=0.001), 3 years (24.0 versus 18.0 Au/mL, P=0.049), and 5 years (29.0 versus 15.0 Au/mL, P=0.004) compared with IS therapy. CONCLUSIONS: Among diabetic patients with stable ischemic heart disease who were actively smoking, IP therapy was independently associated with a significantly increased hazard of MI. This finding may be explained by higher PAI-1 activity in active smokers treated with IP therapy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

The long-term risk of smoking in diabetic patients with stable ischemic heart disease treated with intensive medical therapy and lifestyle modification.

Introduction The long-term risk of smoking in diabetic patients with stable ischemic heart disease (SIHD) is unknown. We sought to analyze the impact of smoking on outcomes of diabetic patients with SIHD when other cardiovascular risk factors are being aggressively treated. Methods The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial randomized 2368 diabetics with SIHD to intensive medical therapy (IMT) with prompt revascularization or IMT alone. Smoking status was obtained at baseline, 6 months, and 1, 2, 3, 4 and 5 years. The primary endpoint of interest was all-cause mortality. Results Of 2360 patients, 33.1% of patients never smoked, 54.4% were former smokers, and 12.5% were current smokers. The rate of all-cause mortality was greater for current (2.5 deaths/100 patient-years) and former smokers (3.1 deaths/100 patient-years) than never smokers (2.1 deaths/100 patient-years) (P = 0.007). Cardiac death, cardiovascular death, fatal or nonfatal myocardial infarction, and fatal or nonfatal stroke were not increased in current or former smokers compared with never smokers. Compared with never smokers, current smokers experienced a 49% increased hazard of death (Hazard Ratio (HR) 1.49, 95% Confidence Interval (CI): 0.97-2.29, P = 0.07) whereas former smokers had a 37% increased hazard of death (HR 1.37, 95% CI: 1.04-2.79, P = 0.02) when considering smoking status as a time-dependent variable and adjusting for factors that differed by smoking status. Conclusions Current and former smoking are associated with increased all-cause mortality in diabetics with SIHD but not with increased cardiovascular morbidity or mortality.

Understanding operator stent choice in the catheterization laboratory using a pre-procedure survey: Opportunities for quality improvement.

OBJECTIVES: We sought to characterize how the perceived risk of early dual antiplatelet therapy (DAPT) discontinuation is incorporated into operator decision-making regarding stent choice, using a simple pre-procedure survey screening for clinical variables that may lead to early DAPT discontinuation. BACKGROUND: Understanding which factors influence operator decision-making regarding stent choice during percutaneous coronary intervention (PCI) could help identify areas for quality improvement. METHODS: We retrospectively identified 1202 patients who underwent PCI from July 2008 to January 2013 at the Durham Veterans Affairs Medical Center. We excluded patients without a complete pre-procedure survey within 14days of PCI, repeat procedures on the same patient and those who received both drug-eluting stents (DES) and bare-metal stents (BMS) or no stent during PCI, leaving 864 patients. The primary outcome was the independent association of "yes" responses to survey items with the odds of DES use during PCI. RESULTS: Of 864 patients, 661 received DES and 203 received BMS. A "yes" response to "planned major surgery or dental work in the next year" (OR 0.20, 95% CI 0.11-0.36, p<0.001), "recent bleeding event or bleeding diathesis" (OR 0.31, 95% CI 0.14-0.68, p=0.003) or "currently taking Coumadin" (OR 0.39, 95% CI 0.19-0.78, p=0.007) was independently associated with lower odds of DES use. CONCLUSIONS: Responses to 3 items on a simple pre-procedure survey screening for clinical variables that may lead to early DAPT discontinuation were independently associated with stent type used during PCI, suggesting the importance of these factors in an operator's stent choice.

Risk of bloodborne pathogen exposure among Zambian healthcare workers.

PURPOSE: Understanding the risks of bloodborne pathogen transmission is fundamental to prioritizing interventions when resources are limited. This study investigated the risks to healthcare workers in Zambia. DESIGN: A survey was completed anonymously by a convenience sample of workers in three hospitals and two clinics in Zambia. Respondents provided information regarding job category, injuries with contaminated sharps, hepatitis B vaccination status and the availability of HIV post-exposure prophylaxis (PEP). RESULTS: Nurses reported the largest number of injuries. The average annual sharps injury rate was 1.3 injuries per worker, and service workers (housekeepers, laundry, ward assistants) had the highest rate of these injuries, 1.9 per year. Injuries were often related to inadequate disposal methods. Syringe needles accounted for the largest proportion of injuries (60%), and 15% of these injuries were related to procedures with a higher-than-average risk for infection. Most workers (88%) reported the availability of PEP, and only 8% were fully vaccinated against hepatitis B. CONCLUSIONS: The injury risks identified among Zambian workers are serious and are exacerbated by the high prevalence of bloodborne pathogens in the population. This suggests that there is a high risk of occupationally acquired bloodborne pathogen infection. The findings also highlight the need for a hepatitis B vaccination program focused on healthcare workers. The risks associated with bloodborne pathogens threaten to further diminish an already scarce resource in Zambia - trained healthcare workers. To decrease these risks, we suggest the use of low-cost disposal alternatives, the implementation of cost-sensitive protective strategies and the re-allocation of some treatment resources to primary prevention.