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To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2007.10.022 Byline: Judith E. Mitchell (a), Anne S. Hellkamp (d), Daniel B. Mark (d), Jill Anderson (b), Jeanne E. Poole (c), Kerry L. Lee (d), Gust H. Bardy (b)(c) Abstract: The SCD-HeFT demonstrated that implantable cardioverter/defibrillator (ICD) therapy significantly improved survival compared to medical therapy alone in stable moderately symptomatic heart failure patients with an ejection fraction [less than or equal to]35%. The purpose of this report is to describe the outcomes in African Americans (AAs) and other minorities. Author Affiliation: (a) State University of New York Downstate Medical Center, Brooklyn, NY (b) Seattle Institute for Cardiac Research, Seattle, WA (c) The University of Washington, Seattle, WA (d) Duke Clinical Research Institute, Duke University Medical Center, Durham, NC Article History: Received 30 June 2007; Accepted 14 October 2007

Background: The comparative effectiveness of differing dosages of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) on clinical and patient-reported outcomes in clinical practice in the United States is unknown. This study sought to characterize associations between the dosing of GDMT and outcomes for patients with HFrEF in U.S. clinical practice.Methods: This analysis included 4832 outpatients who had chronic HFrEF across 150 practices in the U.S. in the Change the Management of Patients with Heart Failure (CHAMP-HF) registry with no contraindication and available dosing data for at least 1 GDMT at baseline. Baseline dosing of angiotensin-converting enzyme (ACEI)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), beta-blocker, and mineralocorticoid receptor antagonist (MRA) therapies were examined. For each medication class, multivariable models assessed associations between medication dosing and clinical outcomes over 24 months (all-cause mortality, HF hospitalization) and patient-reported outcomes at 12 months (change in the Kansas City Cardiomyopathy Questionnaire Overall Summary score [KCCQ-OS]).Results: After adjustment, compared with target dosing, lower dosing was associated with higher all-cause mortality for ACEIs/ARBs/ARNIs (50% to < 100% target dosage, HR 1.16 [95% CI 0.87-1.55]; < 50% target dosage, HR 1.37 [95% CI 1.05-1.79]; none, HR 1.75 [95% CI 1.32-2.34; overall P< 0.001) and beta-blockers (50% to < 100% target dosage, HR 1.30 [95% CI 1.00-1.69]; < 50% target dosage, HR 1.41 [95% CI 1.11-1.79; none, HR 1.24 [95% CI 0.92-1.67]; overall P= 0.042). Lower dosing of ACEIs/ARBs/ARNIs was independently associated with higher risk of HF hospitalization (50% to < 100% target dosage, HR 1.08 [95% CI 0.90-1.30]; < 50% target dosage, HR 1.23 [1.04-1.47]; none, HR 1.29 [1.04-1.60]; overall P= 0.046), but beta-blocker dosing was not (overall P= 0.085). Target dosing of MRAs was not associated with risk of mortality or HF hospitalization. For each GDMT, compared with target dosing, lower dosing was not associated with change in the KCCQ-OS at 12 months, with the potential exception of worsening KCCQ-OS scores with lower dosing of ACEIs/ARBs/ARNIs.Conclusions: In this contemporary U.S. outpatient HFrEF registry, target dosing of ACEI/ARB/ARNI and beta-blocker therapy was associated with reduced mortality and was variably associated with HF hospitalization and patient-reported outcomes. MRA dosing was not associated with outcomes. The totality of these findings support the benefits of target dosing of GDMT in routine practice, as tolerated, with unmeasured differences among patients receiving differing dosages potentially explaining the differing results seen here compared with randomized clinical trials. [ABSTRACT FROM AUTHOR]

Background: ROCKET AF demonstrated the efficacy and safety of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism (SE) in patients with atrial fibrillation (AF). We examined baseline characteristics and outcomes in patients enrolled in Latin America compared with the rest of the world (ROW).Methods: ROCKET AF enrolled 14,264 patients from 45 countries. Of these, 1,878 (13.2%) were from 7 Latin American countries. The clinical characteristics and outcomes (adjusted by baseline characteristics) of these patients were compared with 12,293 patients from the ROW. Treatment outcomes of rivaroxaban compared with warfarin were also stratified by region.Results: The annual rate of stroke/SE was similar in those from Latin American and ROW (P= .63), but all-cause and vascular death were significantly higher than in ROW (HR 1.40, 95% CI 1.20-1.64; HR 1.38, 95% CI 1.14-1.68; P< .001). Rates of major or nonmajor clinically relevant bleeding tended to be lower in Latin America (HR 0.89, 95% CI 0.80-1.0; P= .05). Rates of stroke and/or SE were similar with rivaroxaban and warfarin in patients from Latin America and ROW (HR 0.83, 95% CI 0.54-1.29 vs HR 0.89, 95% CI 0.75-1.07; interaction P= .77).Conclusions: Patients with AF in Latin America had similar rates of stroke and/or SE, higher rates of vascular death, and lower rates of bleeding compared with patients in the ROW. The effect of rivaroxaban compared with warfarin in Latin America was similar to the ROW. Further studies analyzing patient- and country-specific determinants of these regional differences in Latin America are warranted. [ABSTRACT FROM AUTHOR]

Energy flexibility plays a crucial role in the current energy transition, as it can contribute to a stabilization of the grid. The integration of electricity from renewable energy sources leads to large fluctuations in power supply, compromising the reliability of supply and the grid stability. Employing surplus of variable renewable energy (VRE) to cover the industrial demand can on one hand reduce the need for grid upgrade on a long term. On the other hand, integrating VRE can contribute to fulfill decarbonisation targets in the industrial sector. As a consequence, the share of renewable energy in the total energy consumption can be increased. This paper aims at assessing the role of VRE integration in the process industry as a mean to leverage energy flexibility. The assessment consists of a scenario-based evaluation, complemented by a simulation model, able to quantify the reduction of specific CO 2 emissions. The developed approach is demonstrated within a case study in the paper industry. [ABSTRACT FROM AUTHOR]

Background: Nonadherence to optimal medical therapy following myocardial infarction (MI) is associated with adverse clinical outcomes such as stent thrombosis, recurrent cardiovascular events, and death. Whether adherence to medications prior to MI predicts post-MI medication adherence is unknown.Methods: We assessed adherence to P2Y12 inhibitors and statins before and after admission for MI among 8,147 MI patients who had Medicare insurance with Part D prescription coverage. Adherence was defined as a proportion of days covered with medication fills ≥80%. Multivariable logistic regression was used to assess the association between pre- and post-MI P2Y12 inhibitor adherence. As few patients were on P2Y12 inhibitors pre-MI, we also examined the association of pre-MI statin adherence with post-MI P2Y12 inhibitor and statin adherence.Results: Pre-MI medication nonadherence was observed in 427 of 2,633 (16%) patients on preadmission P2Y12 inhibitors and 1,233 of 6,934 (18%) patients on preadmission statins. Nonadherent patients were more likely to be of nonwhite race and have multiple prior hospital admissions. Patients who were nonadherent to P2Y12 inhibitors pre-MI were substantially less likely to adhere to P2Y12 inhibitors at 90 days (adjusted odds ratio [OR] 0.33, 95% CI 0.25-0.43) and 1 year post-MI (adjusted OR 0.29, 95% CI 0.21-0.39) compared with patients who were adherent pre-MI. Pre-MI statin nonadherence was also associated with lower post-MI adherence to P2Y12 inhibitors at 90 days (adjusted OR 0.65, 95% CI 0.53-0.79) and 1 year (adjusted OR 0.37, 95% CI 0.29-0.54).Conclusions: Prior medication adherence predicts post-MI adherence to P2Y12 inhibitors. Increasing accessibility of medication adherence data in the medical record may be an important tool to identify patients at higher risk for post-MI medication nonadherence and target efforts to improve adherence. [ABSTRACT FROM AUTHOR]

Importance: The extent to which levels of high-sensitivity C-reactive protein (hs-CRP), a known marker of increased cardiovascular risk, are elevated and are associated with standard cardiovascular risk factors in patients with a history of myocardial infarction (MI) is unknown.Objectives: To determine the pattern and determinants of the distribution of hs-CRP in those with a prior MI in the United States using a nationally representative sample.Design and Participants: Adults with hs-CRP data in the National Health and Nutrition Examination Surveys from 1999-2010.Results: Among 1296 individuals in our cohort, the median age was 65 years and the median hs-CRP level was 2.69 mg/L, measured an average of 7.1 years after the MI. Among these patients, 22% had hs-CRP levels of <1 mg/L, 61% had ≥2 mg/L, and 48% had ≥3 mg/L. Increasing hs-CRP was associated in a multivariable model with increasing body mass index (partial R2 [pR2] 0.113, P < .001), increasing non-high-density lipoprotein [HDL] (pR2 0.030, P < .001), increasing age (pR2 0.008, P = .017), and decreasing HDL (pR2 0.005, P = .046). Adjusted mean hs-CRP was also higher in women (3.6 vs 2.7 mg/L; P < .001), in people with hypertension (3.5 vs. 2.8, P = .030), and among smokers (4.2 vs 2.3 mg/L; P < .001), and lower in people with hyperlipidemia (2.8 vs. 3.5, P = .007). Standard cardiovascular risk factors accounted for only 22% of the variability in hs-CRP levels.Conclusions and Relevance: Among patients with prior MI, elevated hs-CRP is prevalent several years after the MI, and standard cardiovascular risk factors explain only a small proportion of hs-CRP variability. In light of emerging evidence on the importance of inflammation in the pathogenesis of cardiovascular disease, the high prevalence of elevated hs-CRP in patients with prior MI in the United States may have public health implications. [ABSTRACT FROM AUTHOR]

Background: We investigated the impact of polyvascular disease in patients enrolled in ROCKET AF.Methods: Cox regression models were used to assess clinical outcomes and treatment effects of rivaroxaban compared with warfarin in patients with atrial fibrillation and coronary, peripheral, or carotid artery disease, or any combination of the 3.Results: A total of 655 (4.6%) patients had polyvascular disease (≥2 disease locations), and 3,391 (23.8%) had single-arterial bed disease. Patients with polyvascular disease had similar rates of stroke/systemic embolism but higher rates of cardiovascular and bleeding events when compared with those without vascular disease. Use of rivaroxaban compared with warfarin was associated with higher rates of stroke in patients with polyvascular disease (hazard ratio [HR] 2.41, 95% CI 1.05-5.54); however, this was not seen in patients with single-bed (HR 0.90, 95% CI 0.64-1.28) or no vascular disease (HR 0.85, 95% CI 0.69-1.04; interaction P = .058). There was a significant interaction for major or nonmajor clinically relevant bleeding in patients with polyvascular (HR 1.23, 95% CI 0.91-1.65) and single-bed vascular disease (HR 1.30, 95% CI 1.13-1.49) treated with rivaroxaban compared with warfarin when compared with those without vascular disease (HR 0.95, 95% CI 0.87-1.04; interaction P = .0006). Additional antiplatelet therapy in this population did not improve stroke or cardiovascular outcomes.Conclusion: The use of rivaroxaban compared with warfarin was associated with a higher risk of stroke and bleeding in patients with polyvascular disease enrolled in ROCKET AF. Further studies are needed to understand the optimal management of this high-risk population. [ABSTRACT FROM AUTHOR]

Background: Heart failure with preserved ejection fraction may be associated with chronotropic incompetence, but little is known about the incidence and prevalence of permanent pacemaker use in this population or factors associated with its use.Methods: We analyzed patients with heart failure with preserved ejection fraction (ie, left ventricular ejection fraction greater than 40%) from the ADHERE registry (2001-2006) linked with Medicare claims. We described the use of both prevalent and incident permanent pacemakers in heart failure with preserved ejection fraction and determined factors associated with pacemaker use with logistic regression models.Results: Among 13,881 patients with heart failure with preserved ejection fraction, 3136 (22.6%) had a permanent pacemaker, and of these patients, 636 had a permanent pacemaker implanted during hospitalization. Permanent pacemaker use was more common among older patients (81 vs 79 years; P < .001), men (38% vs 34%; P < .001), patients with atrial fibrillation (58% vs 36%; P < .001), and patients with wider QRS duration (140 ms vs 94 ms; P < .001). Rates of digoxin, aldosterone antagonist, and loop diuretic use were slightly higher in patients with a permanent pacemaker compared with patients with no permanent pacemaker. Factors associated with both prevalent and incident pacemaker use included age, fast or slow heart rate, atrial fibrillation, and lower body mass index.Conclusions: Use of permanent pacemakers is relatively common among patients with heart failure with preserved ejection fraction. [ABSTRACT FROM AUTHOR]

Background: Assessing hospital-related network-level primary percutaneous coronary intervention (PCI) performance for ST-segment elevation myocardial infarction (STEMI) is challenging due to differential time-to-treatment metrics based on location of diagnostic electrocardiogram (ECG) for STEMI.Methods: STEMI patients undergoing primary PCI at 588 PCI-capable hospitals in AHA Mission: Lifeline (2008-2013) were categorized by initial STEMI identification location: PCI-capable hospitals (Group 1); pre-hospital setting (Group 2); and non-PCI-capable hospitals (Group 3). Patient-specific time-to-treatment categories were converted to minutes ahead of or behind their group-specific mean; average time-to-treatment difference for all patients at a given hospital was termed comprehensive ECG-to-device time. Hospitals were then stratified into tertiles based on their comprehensive ECG-to-device times with negative values below the mean representing shorter (faster) time intervals.Results: Of 117,857 patients, the proportion in Groups 1, 2, and 3 were 42%, 33%, and 25%, respectively. Lower rates of heart failure and cardiac arrest at presentation are noted within patients presenting to high-performing hospitals. Median comprehensive ECG-to-device time was shortest at -9 minutes (25th, 75th percentiles: -13, -6) for the high-performing hospital tertile, 1 minute (-1, 3) for middle-performing, and 11 minutes (7, 16) for low-performing. Unadjusted rates of in-hospital mortality were 2.3%, 2.6%, and 2.7%, respectively, but the adjusted risk of in-hospital mortality was similar across tertiles.Conclusions: Comprehensive ECG-to-device time provides an integrated hospital-related network-level assessment of reperfusion timing metrics for primary PCI, regardless of the location for STEMI identification; further validation will delineate how this metric can be used to facilitate STEMI care improvements. [ABSTRACT FROM AUTHOR]

Objectives: We examined trends in CRT utilization overall and by sex and race and to assess whether CRT use is associated with a reduction in HF hospitalization and mortality.Background: It is unknown whether underutilization and race/sex-based differences in cardiac resynchronization therapy (CRT) use have persisted. The association between CRT and heart failure (HF) hospitalization and mortality in real-world practice remains unclear.Methods: We linked 72,008 HF patients from 388 hospitals participating in Get With The Guidelines HF eligible for CRT with Centers for Medicare & Medicaid Services data to assess CRT utilization trends, HF hospitalization rates, and all-cause mortality.Results: From 2005-2014, 18,935 (26.3%) eligible patients had CRT in place, implanted, or prescribed. The majority were male (60.0%) and white (61.9%). CRT utilization increased during the study period (P = .0002) especially in the early period. Women were less likely to receive CRT, and this difference increased over time (interaction P = .0037) despite greater mortality risk reduction (interaction P = .0043). Black patients were less likely than white patients to have CRT throughout the study period (adjusted hazard ratio (HR) 0.79; 95% CI 0.74-0.85). Patients with CRT implanted during the index hospitalization had lower mortality (adjusted HR 0.65; 95% CI 0.59-0.71) and were less likely to be readmitted for HF than patients without CRT (adjusted HR 0.64; 95% CI 0.58-0.71).Conclusions/relevance: CRT use has increased in all populations, but it remains underutilized. CRT remains more common among white than black HF patients, and women were less likely than men to receive CRT despite deriving greater benefit. [ABSTRACT FROM AUTHOR]

Background: We aimed to investigate the relationship between aspirin use and clinical outcomes in patients enrolled in Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), in particular, those with known coronary artery disease (CAD).Methods: Patients in ROCKET AF, comparing rivaroxaban and warfarin, were analyzed. Aspirin use was assessed at baseline. Stroke and systemic embolism, myocardial infarction, death, and major or nonmajor clinically relevant (NMCR) bleeding were compared between groups. Multivariable modeling was done adjusting for baseline risk factors.Results: A total of 5,205 (36.5%) patients were receiving aspirin at baseline (mean dose 99.2mg); 30.6% of those had known CAD. Patients receiving aspirin were more likely to have prior myocardial infarction (22% vs 14%; P<.001) and heart failure (68% vs 59%; P<.001). Relative efficacy of rivaroxaban versus warfarin was similar with and without aspirin use for both stroke/systemic embolism (P=.95 for interaction), and major or NMCR bleeding (P=.76 for interaction). After adjustment, aspirin use was associated with similar rates of stroke/systemic embolism (hazard ratio [HR] 1.16, 95% CI 0.98-1.37; P=.094) but higher rates of all-cause death (HR 1.27, 95% CI 1.13-1.42; P<.0001) and major or NMCR bleeding (HR 1.32, 95% CI 1.21-1.43; P<.0001). There was a significant interaction between no CAD at baseline and aspirin for all-cause death (P=.009).Conclusions: Aspirin use at baseline was associated with an increased risk for bleeding and all-cause death in ROCKET AF, a risk most pronounced in patients without known CAD. Although these findings may reflect unmeasured clinical factors, further investigation is warranted to determine optimal aspirin use in patients with AF. [ABSTRACT FROM AUTHOR]

Background: We conducted a retrospective analysis examining the association between systolic blood pressure (SBP) or hypertension bracket and stroke risk in patients with atrial fibrillation (AF).Methods: The study included 14,256 anticoagulated patients in the ROCKET AF trial. Cox proportional hazards models were used to compare the risk of adverse outcomes by European Society of Cardiology hypertension bracket and screening SBP.Results: In total, 90.5% of patients had hypertension (55.8% controlled, 34.6% uncontrolled). The adjusted risk of stroke or systemic embolism (SE) increased significantly for every 10-mm Hg increase in screening SBP (hazard ratio [HR] 1.07, 95% CI 1.02-1.13). There was a trend toward an increased adjusted risk of stroke or SE in patients with controlled (HR 1.22, 95% CI 0.89-1.66) and uncontrolled hypertension (HR 1.42, 95% CI 1.03-1.95) (P = .06). In contrast, the adjusted risk of major bleeding was similar between hypertensive brackets and did not vary significantly by screening SBP. The benefit of rivaroxaban versus warfarin in preventing stroke or SE was consistent among patients regardless of SBP (P interaction = .69).Conclusions: In a trial of anticoagulated patients with AF, increasing screening SBP was independently associated with stroke and SE, and one-third of patients had uncontrolled hypertension. The relative effectiveness and safety of rivaroxaban versus warfarin were consistent across all levels of screening SBP. A single SBP may be an important factor in reducing the overall risk of stroke and SE in anticoagulated patients with AF. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to compare outcomes of ST-segment elevation myocardial infarction (STEMI) patients with a history of coronary artery bypass graft surgery (CABG), previous percutaneous coronary intervention (PCI), or no previous revascularization undergoing primary PCI. Background Limited data exist regarding door-to-balloon times and clinical outcomes of STEMI patients with a history of CABG or PCI undergoing primary PCI. Methods We examined 15,628 STEMI patients who underwent primary PCI at 297 sites in the United States. We used multivariable logistic regression analyses to compare door-to-balloon time delays >90 min and in-hospital major adverse cardiovascular or cerebrovascular events (MACCE). Results Patients with previous CABG were significantly older and more likely to have multiple comorbidities (p < 0.0001). Previous CABG was associated with a lower likelihood of a door-to-balloon time ≤90 min compared with patients with no previous revascularization. However, no significant differences in door-to-balloon times were noted between patients with previous PCI and those without previous revascularization. The unadjusted MACCE risk was significantly higher in patients with a history of CABG compared with patients without previous revascularization (odds ratio: 1.68, 95% confidence interval: 1.23 to 2.31). However, after multivariable risk adjustment, there were no significant differences in MACCE risk between the 2 groups. No significant differences in in-hospital outcomes were seen in patients with a previous PCI and those without previous revascularization. Conclusions In a large cohort of STEMI patients undergoing primary PCI, patients with previous CABG were more likely to have reperfusion delays, yet risk-adjusted, in-hospital outcomes were similar to those without previous revascularization. No significant differences in reperfusion timeliness and in-hospital outcomes were seen in patients with a history of PCI compared with patients without previous revascularization. [ABSTRACT FROM AUTHOR]

Background: Guidelines recommend cardiac rehabilitation after acute myocardial infarction, yet little is known about the impact of cardiac rehabilitation on medication adherence and clinical outcomes among contemporary older adults. The optimal number of cardiac rehabilitation sessions is not clear.Methods: We linked patients 65years or older enrolled in the Acute Coronary Treatment Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) from January 2007 to December 2010 to Medicare longitudinal claims data to obtain 1 year follow-up.Results: A total of 11,862 patients participated in cardiac rehabilitation after acute myocardial infarction, attending a median number of 26 sessions. Patients attending ≥26 sessions were more likely to be male, had lesser prevalence of comorbid conditions and prior revascularization, and were more likely to present with ST-segment elevation myocardial infarction, compared with patients attending 1 to 25 sessions. Among patients with Medicare Part D prescription coverage, increasing number of cardiac rehabilitation sessions was associated with improvement in adherence to secondary prevention medications such as P2Y12 inhibitors and β-blockers. Each 5-session increase in participation was associated with lower mortality (adjusted hazard ratio [HR] 0.87, 95% CI 0.83-0.92) and lower overall risk of major adverse cardiac event (adjusted HR 0.69, 95% CI 0.65-0.73) and death/readmission (adjusted HR 0.79, 95% CI 0.76-0.83).Conclusions: In this older patient population, number of cardiac rehabilitation sessions attended was associated with improved medication adherence and lower downstream cardiovascular risk in a dose-response relationship. This provides support for the continued use of cardiac rehabilitation for older adults and encourages efforts to maximize attendance. [ABSTRACT FROM AUTHOR]

Background We sought to determine if outcomes with exercise training in heart failure (HF) vary according to ventricular pacing type. Methods and Results Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized 2,331 outpatients with HF and left ventricular ejection fraction ≤35% to usual care plus exercise training or usual care alone. We examined the relationship between outcomes and randomized treatment according to ventricular pacing status with the use of Cox proportional hazards modeling. In HF-ACTION 1,118 patients (48%) had an implanted cardiac rhythm device: 683 with right ventricular (RV) and 435 with biventricular (BiV) pacemakers. Patients with pacing devices were older, more frequently white, and had lower peak VO 2 ( P < .001 for all). Peak VO 2 improved similarly with training in groups with and without pacing devices. The primary composite end point—all-cause death or hospitalization—was reduced only in patients randomized to exercise training without a device (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.67–0.93 [ P = .004]; RV lead: HR 1.04, 95% CI 0.84–1.28 [ P = .74]; BiV pacing: HR 1.05, 95% CI 0.82–1.34 [ P = .72]; interaction P = .058). Conclusions Exercise training may improve exercise capacity in patients with implanted cardiac devices. However, the apparent beneficial effects of exercise on hospitalization or death may be attenuated in patients with implanted cardiac devices and requires further study. [ABSTRACT FROM AUTHOR]

Thrombolytic therapy or intense anticoagulation during percutaneous transluminal coronary revascularization (PTCR) increases the risk of vascular access site complications. This study evaluated the association of abciximab, a glycoprotein IIb/IIIa receptor blocker, with vascular access site complications after PTCR. Of 2,058 patients who underwent PTCR in the Evaluation of c7E3 for the Prevention of Ischemic Complications (EPIC) trial, major vascular access site bleeding (a drop in hematocrit > 15%), minor vascular access site bleeding (> 10% drop), or surgical repair of the access site occurred in 5%, 12%, and 1.4% of all patients, respectively. Minor and/or major bleeding or surgery occurred in 21.8% of abciximab patients, compared with 9.1% of placebo patients (p <0.001). Logistic regression analysis identified these predictors of minor and/or major bleeding and/or surgical repair, in descending order of importance: abciximab therapy, acute myocardial infarction at enrollment, high baseline hematocrit, time in catheterization laboratory, heavier weight, female gender, maximum in catherization laboratory activated clotting time, sheath size, and age (all p <0.05). Vascular access site complications increased median post-PTCR length of stay from 2 days (no bleeding) to 3 days (minor bleeding) and 6 days (major bleeding). Site-to-site variation in vascular access site complications varied sixfold. Analyses of subsequent studies of PTCR with abciximab will determine whether discontinuing heparin and removing sheaths early after PTCR reduces the risk of vascular access site complications. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to determine whether circadian patterns in ventricular arrhythmias (VAs) occur in a current primary prevention defibrillator (implantable cardioverter-defibrillator [ICD]) population. Background: Cardiovascular events, including VAs, demonstrate biorhythmic periodicity. Methods: We tested for deviation from the previously described occurrences of a morning peak, early morning nadir, and peak on Mondays in ICD therapies using generalized estimating equations and Student t tests. All hypothesis tests were performed in the entire cohort of patients with VAs as well as pre-specified subgroups. Results: Of 811 patients with an ICD, 186 subjects experienced 714 ICD therapy episodes for life-threatening VA. There was no morning (6 am to 12 pm) peak in therapies for the entire cohort or any subgroups. The overall cohort and several subgroups had a typical early morning (12 am to 6 am) nadir in therapies, with significantly less than 25% of therapies occurring during this 6-h block (all p < 0.05). A significant peak in therapies on Mondays occurred only in patients not on beta-blocker therapy (22% of events for the week, p = 0.029). Conclusions: In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) population, the distribution of life-threatening VA failed to show a typical early morning peak or increased VA events on Mondays. A typical early morning nadir was seen in the entire cohort. An increased rate of events on Mondays was found in the subgroup of subjects not on beta-blocker therapy. These findings may indicate suppression of the neurohormonal triggers for VA by current heart failure therapy, particularly the use of beta-blockers in heart failure. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to determine if 6-min walk test data assists in treatment decisions for patients with heart failure. Background: In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), a pre-specified subgroup analysis showed that patients with New York Heart Association functional class III symptoms did not benefit from implantable cardioverter-defibrillator (ICD) therapy and appeared to be harmed by amiodarone, whereas New York Heart Association functional class II patients obtained significant survival benefit from ICD. We postulated that a more objective measure of functional capacity, such as 6-min walk (6MW) distance, might provide a better tool for selecting these preventive therapies. Methods: A 6MW test was performed before randomization in 2,397 patients. Median follow-up was 45.5 months. All-cause mortality was the primary endpoint, with cause-specific mortality (heart failure, arrhythmic) examined in secondary analyses. Results: The hazard ratios (HRs) for ICD therapy compared to placebo were estimated within tertiles of baseline 6MW distance: HR: 0.42 (95% confidence interval [CI]: 0.26 to 0.66) for 6MW distance >386 m (top tertile); HR: 0.57 (95% CI: 0.39 to 0.83) for 6MW distance 288 to 386 m (middle tertile); and HR: 1.02 (95% CI: 0.75 to 1.39) for 6MW distance <288 m (bottom tertile). The corresponding HRs for amiodarone compared to placebo were 0.68 (95% CI: 0.46 to 1.02) for the top, 0.86 (95% CI: 0.61 to 1.21) for the middle, and 1.56 (95% CI: 1.17 to 2.09) for the bottom tertile. The 6MW distance was inversely related to heart failure–related mortality but not to arrhythmic mortality. ICD therapy reduced arrhythmic mortality in the top 2 tertiles of 6MW, but had no effect on heart failure mortality. Conclusions: A baseline 6MW distance <288 m identified a subgroup of SCD-HeFT patients who were harmed by amiodarone therapy and did not benefit from ICD. (Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]; NCT00000609) [Copyright &y& Elsevier]

Background: Antiarrhythmic drugs (AADs) and anticoagulation are mainstays of atrial fibrillation (AF) treatment. Objective: To study the use and outcomes of AAD therapy in anticoagulated patients with AF. Methods: Patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation trial (N = 14,264) were stratified by AAD use at baseline: amiodarone, other AAD, or no AAD. Multivariable adjustment was performed to compare stroke, bleeding, and death across AAD groups as well as across treatment assignment (rivaroxaban or warfarin). Results: Of 14,264 patients randomized, 1681 (11.8%) were treated with an AAD (1144 [8%] with amiodarone and 537 [3.8%] with other AADs). Amiodarone-treated patients were less often female (38% vs 48%), had more persistent AF (64% vs 40%), and more concomitant heart failure (71% vs 41%) than were patients receiving other AADs. Patients receiving no AAD more closely resembled amiodarone-treated patients. Time in therapeutic range was significantly lower in warfarin-treated patients receiving amiodarone than in those receiving no AAD (50% vs 58%; P < .0001). Compared with no AAD, neither amiodarone (adjusted hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.74–1.31; P = .9) nor other AADs (adjusted HR 0.66; 95% CI 0.37–1.17; P = .15) were associated with increased mortality. Similar results were observed for embolic and bleeding outcomes. Treatment effects of rivaroxaban vs warfarin in patients receiving no AAD were consistent with results from the overall trial (primary end point: adjusted HR 0.82; 95% CI 0.68–0.98; P interaction = .06; safety end point: adjusted HR 1.12; 95% CI 0.90–1.24; P interaction = .33). Conclusion: Treatment with AADs was not associated with increased morbidity or mortality in anticoagulated patients with AF. The effect of amiodarone on outcomes in patients receiving rivaroxaban requires further investigation. [Copyright &y& Elsevier]

Background: Biventricular (BV) electrical wavefront fusion can induce improvement in left ventricular (LV) size and function during cardiac resynchronization therapy (CRT). Changes in BV wave propagation sequence and duration register in the QRS complex on the standard electrocardiogram. We developed a wave interference method for the characterization of BV fusion to predict LV reverse remodeling. Objective: To develop a simple electrocardiographic method for predicting reverse remodeling during CRT. Methods: QRS complexes during left bundle branch block (LBBB) and CRT were analyzed in 375 patients with ejection fraction ≤35% and New York Heart Association class III-IV (Leiden study: n = 226) as well as in patients with ejection fraction ≤40% and New York Heart Association class I-II (REVERSE trial: n = 149) for predictors of ≥10% reduction in left ventricular end-systolic volume at 6 months. CRT-induced changes in ventricular activation (QRS fusion contour), electrical asynchrony (QRS difference = BV-paced QRS – LBBB QRS, in milliseconds), and LBBB substrate (LV activation time and QRS score for LV scar) were quantified. Results: Multivariable predictors of reverse remodeling were as follows: (1) either of 2 BV fusion patterns: QRS normalization in leads V1 and V2 (n = 66 [18%]; odds ratio [OR] 3.71; 95% confidence interval [CI] 1.26–10.94) or a new or an increased R wave in leads V1-V2 (n = 267 [71%]; OR 1.55; 95% CI 0.65–3.65); (2) QRS difference ≤ −25 ms (OR 2.35; 95% CI 1.12–4.91); and (3) good substrate (low to moderate QRS score and LV activation time ≥110 ms; OR 2.94; 95% CI 1.68–5.14). Remodeling rates were 40% for poor substrate and persistent LBBB QRS complex (absent BV fusion; QRS type 3: n = 42 [11%]) and 97% for the best BV QRS fusion pattern and greater reduction in electrical asynchrony (larger QRS difference). Conclusion: Easily determined QRS complex attributes before and after CRT predict LV reverse remodeling. [Copyright &y& Elsevier]

Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolus (PE), represents a serious complication in hospitalized ischemic stroke patients. This study examines the incidence of VTE and the patterns of VTE prophylaxis in acute ischemic stroke patients deemed appropriate for VTE prophylaxis (nonambulatory) in the Get With The Guidelines–Stroke (GWTG-S) study. Methods: We analyzed data from 149,916 patients who were admitted with acute ischemic stroke and enrolled in GWTG-S from 1259 U.S. hospitals. Patient variables and site characteristics were analyzed in relation to reported administration of VTE prophylaxis. Results: The overall rate of VTE prophylaxis in the analysis cohort was 93% (139,476/149,916). The median site prophylaxis rate was 95%, and prophylaxis rates ranged from 17% (1 site) to 100% (101 sites). Factors associated with increased likelihood of VTE prophylaxis in the multivariable model included history of atrial fibrillation/flutter, receipt of intravenous or intra-arterial tissue plasminogen activator, and admission to an academic hospital. Increasing age, black race, and a history of peripheral vascular disease, diabetes, or stroke were associated with lower likelihood of prophylaxis. Patients receiving care in the Midwest were less likely to receive prophylaxis compared to other regions. Conclusions: Despite a high overall rate of VTE prophylaxis, VTE was found to occur in approximately 3% of GWTG-S patients. Reported rates of VTE prophylaxis differed among hospitals by region and hospital type, and among patients by age, race, and medical comorbidities. [Copyright &y& Elsevier]

There are limited data on the use of angiotensin receptor-neprilysin inhibitors (ARNI) in minority demographic populations with heart failure with reduced ejection fraction (HFrEF). We used data from CHAMP-HF to describe ARNI use and associated health status and clinical outcomes across different races and ethnicities. CHAMP-HF was a prospective, observational cohort registry of outpatients in the United States with chronic HFrEF. We compared patients starting ARNI therapy to those not starting ARNI using a propensity-matched analysis. Patients were grouped as Hispanic or Non-Hispanic Black, Non-Hispanic White, or Non-Hispanic Other. Health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ), calculated from pre-match KCCQ score and post-match KCCQ score at least two weeks after the match. Outcomes were analyzed with multivariable models that included race/ethnicity group, ARNI use, and an interaction term between race/ethnicity and ARNI use. Cox proportional hazards models were used for death and HF hospitalization and multiple regression was used for change in KCCQ score. 1,516 patients from the CHAMP-HF registry were included, with 758 patients in each group (ARNI and no-ARNI). Changes in KCCQ score before and after ARNI initiation were similar among all race/ethnicity groups studied, including Hispanic and non-Hispanic Black patients. There was no significant interaction between race/ethnicity and ARNI use for change in KCCQ score (Table). In addition, there was no statistically significant interaction between race/ethnicity and ARNI use for HF hospitalization (P=0.82) or all-cause mortality (P=0.92). In a large registry of outpatients with HFrEF, the association between ARNI initiation and outcomes, including changes in health status, did not differ by race and ethnicity. These data support the use of ARNI therapy for chronic HFrEF irrespective of race and ethnicity. [ABSTRACT FROM AUTHOR]

Background: Dual coil implantable cardioverter-defibrillator (ICD) leads with a superior vena cava (SVC) electrode have been considered standard of care despite sparse data suggesting improved ICD defibrillation efficacy. SVC coils increase lead complexity, cost, risk of lead failure, and lead removal. Objective: To compare all-cause mortality, sudden cardiac death, implant defibrillation threshold (DFT) test energies, appropriate shock rates, and first shock efficacy for ventricular tachyarrhythmias for dual coil vs single coil leads in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Methods: In SCD-HeFT, 811 patients with heart failure received a single lead transvenous ICD (Medtronic model 7223) and underwent protocol-driven DFT testing. The selection of a dual vs single coil right ventricular (RV) lead was at the physician’s discretion. DFT data were available in 717 patients. Results: Dual coil leads were used in 563 and single coil in 246 patients. After 45.5-month follow-up, overall mortality was similar (19.4% for dual coil vs 21.5% for single coil; adjusted hazard ratio 0.95; 95% confidence interval 0.68–1.34; P = .78). Sudden cardiac death was also similar (3.6% for dual coil vs 3.7% for single coil; P = .96). First shock efficacy was 82.2% vs 91.9% (dual coil vs single coil; unadjusted odds ratio 0.41; 95% confidence interval 0.15–1.13; P = .085). Mean DFT was 12.1 ± 4.7 J vs 12.8 ± 4.8 J (dual coil vs single coil; P = .087). Conclusions: In the SCD-HeFT, the addition of an SVC coil for left-sided implants was not associated with improved outcome measures. We advocate returning to single coil RV ICD leads as the standard of care to decrease chronic lead complications. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to understand the possible risk of discontinuation in the context of clinical care. Background: Rivaroxaban is noninferior to warfarin for preventing stroke in atrial fibrillation patients. Concerns exist regarding possible increased risk of stroke and non–central nervous system (CNS) thromboembolic events early after discontinuation of rivaroxaban. Methods: We undertook a post-hoc analysis of data from the ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation, n = 14,624) for stroke or non-CNS embolism within 30 days after temporary interruptions of 3 days or more, early permanent study drug discontinuation, and end-of-study transition to open-label therapy. Results: Stroke and non-CNS embolism occurred at similar rates after temporary interruptions (rivaroxaban: n = 9, warfarin: n = 8, 6.20 vs. 5.05/100 patient-years, hazard ratio [HR]: 1.28, 95% confidence interval [CI]: 0.49 to 3.31, p = 0.62) and after early permanent discontinuation (rivaroxaban: n = 42, warfarin: n = 36, 25.60 vs. 23.28/100 patient-years, HR: 1.10, 95% CI: 0.71 to 1.72, p = 0.66). Patients transitioning to open-label therapy at the end of the study had more strokes with rivaroxaban (n = 22) versus warfarin (n = 6, 6.42 vs. 1.73/100 patient-years, HR: 3.72, 95% CI: 1.51 to 9.16, p = 0.0044) and took longer to reach a therapeutic international normalized ratio with rivaroxaban versus warfarin. All thrombotic events within 30 days of any study drug cessation (including stroke, non-CNS embolism, myocardial infarction, and vascular death) were similar between groups (HR: 1.02, 95% CI: 0.83 to 1.26, p = 0.85). Conclusions: In atrial fibrillation patients who temporarily or permanently discontinued anticoagulation, the risk of stroke or non-CNS embolism was similar with rivaroxaban or warfarin. An increased risk of stroke and non-CNS embolism was observed in rivaroxaban-treated patients compared with warfarin-treated patients after the end of the study, underscoring the importance of therapeutic anticoagulation coverage during such a transition. [Copyright &y& Elsevier]

BACKGROUND: Heart failure disease management (HFDM) may be beneficial in heart failure (HF) patients at risk for readmission or post-discharge mortality. However, characteristics of hospitalized HF patients referred to HFDM are not known. METHODS AND RESULTS: Get With the Guidelines (GWTG) program data was used to analyze 57,969 patients hospitalized with HF from January 2005 through January 2010 from 235 sites. Factors associated with referral to HFDM and rates of HF quality measures by referral status were studied. Mean age of patients was 69.7 ± 14.5 years, 52% were men, and 65% were white. HFDM referral occurred in 11,150 (19.2%) patients. The median rate of HFDM referral among all hospitals was 3.5% (25th-75th percentiles 0%-16.7%) and 8.7% (2.8%-27.7%) among hospitals with at least one previous HFDM referral. Quality and performance measures were higher in patients referred to HFDM. HFDM referral was associated with atrial fibrillation, implanted cardiac device, depression, and treatment at larger hospitals. Patients at higher 90-day mortality risk were paradoxically less likely to receive HFDM referral. CONCLUSIONS: HFDM referral occurred in less than one-fifth of hospitalized HF patients and was more frequently recommended to lower-risk patients. Increasing use and optimizing selection of patients for HFDM referral is a potential target for quality improvement. [ABSTRACT FROM AUTHOR]

Background: The implantable cardioverter-defibrillator (ICD) is an effective therapy for preventing sudden cardiac death (SCD) in patients with prior myocardial infarction (MI) and reduced left ventricular function; however, the optimal timing of ICD implantation after MI remains unknown. Objective: The purpose of this study was to determine whether the benefit of single-lead conservatively programmed ICD therapy varies as a function of time from MI to ICD implantation. Methods: We compared time to all-cause death and SCD between the ICD and placebo arms in the Sudden Cardiac Death in Heart Failure Trial. Rates of appropriate shocks in the ICD arm were also assessed as a function of time after MI. Results: Among the 712 patients with a history of MI, 274 died (38.5%), and 68 of these deaths were SCD (24.8%). Appropriate shocks were more common with increasing time after MI (adjusted hazard ratio [HR] per year after MI 1.04 [1.00–1.08]). Despite these differences, there was no evidence of differential mortality benefit with ICD implantation as a function of time after MI: continuous variable adjusted HR 1.00 [0.98,1.03] and shortest versus longest tertile adjusted HR 0.95 [0.66–1.34]. Sensitivity analyses also failed to show differential mortality benefit by quartile or with the use of an 18-month cutoff: <18 versus ≥18 months adjusted HR 1.08 [0.77, 1.51]. Conclusion: There is no evidence that ICD benefit varied with time from MI to implantation/randomization in this primary prevention population. Single-lead ICD benefit is not restricted to patients with a remote MI (>18 months). [ABSTRACT FROM AUTHOR]

Background: Ejection fraction (EF) is an important method of mortality prediction among cardiac patients, and has been used to identify the highest risk patients for enrollment in the defibrillator primary prevention trials. Evidence suggests that measures of EF by different imaging modalities may not be equivalent. In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), the type of imaging modality for EF assessment was not mandated.Methods: Baseline assessment of EF was performed using either echocardiography, radionuclide angiography (RNA), or contrast angiography. Multivariable analysis using a Cox proportional hazards model was used to examine whether the modality of assessing EF affected the likelihood of survival.Results: Among the 2,521 patients enrolled in SCD-HeFT, EF was measured by RNA in 616 (24%), echocardiography in 1,469 (58%), and contrast angiography in 436 (17%). Mean EF as measured by RNA was 25.1% +/- 6.9%; by echocardiography, 23.8 +/- 6.9%; and by angiography, 21.9 +/- 6.9%. These measures were significantly different (P < .001), and each pairwise comparison differed significantly (P < .001 for each). Multivariable analysis showed no significant difference in survival between patients enrolled based on RNA versus echocardiography (HR 1.06, 95% CI 0.88-1.28), RNA versus angiography (HR 1.25, 95% CI 0.97-1.62), or echocardiography versus angiography (HR 1.18, 95% CI 0.94-1.48).Conclusions: Among patients enrolled in SCD-HeFT, the distribution of ejection fractions measured by radionuclide angiography differed from those measured by echocardiography or contrast angiograms. Survival did not differ according to modality of EF assessment. [ABSTRACT FROM AUTHOR]

Objectives: This study was designed to analyze how patient preferences for survival versus quality-of-life change after hospitalization with advanced heart failure (HF). Background: Although patient-centered care is a priority, little is known about preferences to trade length of life for quality among hospitalized patients with advanced HF, and it is not known how those preferences change after hospitalization. Methods: The time trade-off utility, symptom scores, and 6-min walk distance were measured in 287 patients in the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheter Effectiveness) trial at hospitalization and again during 6 months after therapy to relieve congestion. Results: Willingness to trade was bimodal. At baseline, the median trade for better quality was 3 months'' survival time, with a modest relation to symptom severity. Preference for survival time was stable for most patients, but increase after discharge occurred in 98 of 145 (68%) patients initially willing to trade survival time, and was more common with symptom improvement and after therapy guided by pulmonary artery catheters (p = 0.034). Adjusting days alive after hospital discharge for patients'' survival preference reduced overall days by 24%, with the largest reduction among patients dying early after discharge (p = 0.0015). Conclusions: Preferences remain in favor of survival for many patients despite advanced HF symptoms, but increase further after hospitalization. The bimodal distribution and the stability of patient preference limit utility as a trial end point, but support its relevance in design of care for an individual patient. [Copyright &y& Elsevier]

Background: Common locations of death in patients with congestive heart failure (CHF) are unknown. In the SCD-HeFT, mortality of patients with CHF was assessed after randomization to an implantable cardioverter/defibrillator (ICD), amiodarone, or placebo. The aim of this study was to evaluate the location of deaths in SCD-HeFT. Methods: Among SCD-HeFT patients whose location of death was identified, we used logistic regression to assess the relationship of randomized treatment arm and other baseline predictors with the location of death. Cause of death was adjudicated by a therapy-blinded events committee. Results: In SCD-HeFT, 666 (26%) of 2521 patients died. Of the 604 (91%) for whom location of death was known, 58% died in hospital and 29% died at home. Patients randomized to receive an ICD were less likely to die at home than patients randomized to placebo (P = .002). Fewer patients randomized to ICDs died; even fewer randomized to ICDs died at home. Age, sex, etiology of heart failure, left ventricular ejection fraction, and New York Heart Association functional class were not associated with location of death. Sudden cardiac death represented 52% of all out-of-hospital deaths but in hospital deaths exceeded out-of-hospital deaths. Conclusion: Deaths in SCD-HeFT, a well-treated CHF population, were most often in hospital. ICDs were associated with lower total and sudden death rates at home and in hospital. Development of methods to identify which patients will not respond to optimal treatment, including an ICD, remain a challenge. [Copyright &y& Elsevier]

Background: Amiodarone's role as a cause of toxic optic neuropathy is based on case reports. Annual frequency estimates of 0.36% to 2.0%, which have been made without reference to the dose or duration of treatment, are 12 to 200 times higher than those for idiopathic nonarteritic anterior ischemic neuropathy. The object of this study was to determine the incidence, dose, and time until onset of bilateral vision loss from amiodarone as a secondary end point in an investigation of amiodarone's role in preventing sudden death.Methods: Randomized subjects received body weight-determined doses of closed-label amiodarone (n = 837) or placebo (n = 832) in a prospective double-masked manner. Closed-label amiodarone subjects were followed, unless death occurred, for a minimum of 27 months. Median follow-up in survivors was 45.5 months. The end point was removal from the study because of bilateral vision loss.Results: No subject was removed from the study because of bilateral vision loss. Subjects receiving continuous amiodarone for 4 to >60 months at daily doses of >2.0 mg/kg (n = 696), >3.0 mg/kg (n = 559), or >4.0 mg/kg (n = 219) had maximum possible (95% confidence) annual incidences of bilateral toxic vision loss of 0.23%, 0.29%, or 0.74%, respectively. The maximum possible annual incidence rate of bilateral vision loss from amiodarone in all 837 subjects (median age 60 years) receiving a mean daily dose of 3.7 mg/kg (300 mg) was 0.13%.Conclusions: At the doses commonly used clinically, bilateral vision loss from amiodarone toxic optic neuropathy occurs infrequently, if at all. [ABSTRACT FROM AUTHOR]

Background: Recent observations suggest statin treatment may be associated with lower mortality in heart failure (HF). The SCD-HeFT was a study of 2521 functional class II and III HF patients with left ventricular ejection fractions ≤35% and ischemic and nonischemic cardiomyopathy followed up for a median of 45.5 months. The study length, size, and degree of background HF, including the use of implantable defibrillator therapy, provide a unique opportunity to evaluate the impact of statin use in HF with mechanistic insights from subgroup analyses. Methods and Results: Statin use was reported in 965 (38%) of 2521 patients at baseline and 1187 (47%) at last follow-up. The relationships between statin use, randomization arm, disease category, and functional class and all cause mortality were assessed. Statin use was studied as a time-dependent covariate in a multivariable Cox proportional hazards model, adjusted for imbalances between statin and no-statin groups. Mortality risk was significantly lower in those taking a statin (HR [95% CI], 0.70 [0.58-0.83]). Mortality risk was lower with statin use in all prespecified subgroups: ischemic cardiomyopathy (0.69 [0.56-0.86]), nonischemic cardiomyopathy (0.67 [0.47-0.96]), implantable cardioverter defibrillator (ICD) (0.66 [0.46-0.95], non-ICD (0.71 [0.57-0.87]), New York Heart Association II (0.62 [0.48-0.79]), and New York Heart Association III (0.79 [0.61-1.03]). Conclusions: Statin use is associated with reduced all-cause mortality in HF patients. Statins appear to benefit patients with nonischemic and ischemic cardiomyopathy similarly. Statin benefits are similar in ICD and non-ICD patients. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to determine whether a prolonged paced QRS duration increases the risk of cardiac dysfunction.Background: Right ventricular apical pacing mimics left bundle branch block, results in a prolonged QRS duration of variable duration, and causes ventricular desynchronization.Methods: In the Mode Selection Trial (MOST), QRS duration was measured in patients who had at least one paced ventricular complex recorded on 12-lead ECG within 3 months of enrollment (early) and after 9 months (late). Clinical endpoints including heart failure hospitalization, mortality, and atrial fibrillation were analyzed. A total of 1,026 patients were included in the analysis. Median age was 75 years (25th, 75th percentiles = 69, 80) and median ejection fraction prior to implant was 55% (45, 60). The cumulative percent ventricular pacing (DDDR and VVIR) was 81% over a median follow-up of 33 months. During period, 123 patients had heart failure hospitalization, 197 died, and 261 patients had atrial fibrillation.Results: Cox proportional hazards models demonstrated that paced QRS duration was a strong predictor of heart failure hospitalization (hazard ratio 1.15; 95% confidence interval 1.07,1.23) for each 10-ms increase in paced QRS duration (P = .001). The increased risk was unaffected by adjustment for other known predictors of heart failure hospitalization in the study. Paced QRS duration was not significant for mortality (P = .41) or atrial fibrillation (P = .20) when baseline QRS duration and other predictors were included.Conclusions: Paced QRS duration is a significant, independent predictor of heart failure hospitalization in patients with sinus node dysfunction. A very long paced QRS duration is associated with increased heart failure hospitalization. [ABSTRACT FROM AUTHOR]

Background: Limited real-world data are available on outcomes following non-cardioembolic minor ischemic stroke (IS) or high-risk transient ischemic attack (TIA), particularly in the United States (US). We examined outcomes and Medicare payments following any severity IS or TIA as well as the subgroup with minor IS or high-risk TIA.Methods: Medicare beneficiaries >65 years were identified using US nationwide Get with the Guidelines (GWTG)-Stroke Registry linked to Medicare claims data. The cohort consisted of patients enrolled in Medicare fee-for-service plan, hospitalized with non-cardioembolic IS or TIA between 2011 and 2014, segmenting a subgroup with minor IS (National Institute of Health Stroke Scale [NIHSS] ≤5) or high-risk TIA (ABCD2-score ≥6) compatible with the THALES clinical trial population. Outcomes included functional status at discharge, clinical outcomes (all-cause mortality, ischemic stroke, and hemorrhagic stroke, individually and as a composite), hospitalizations, and population average inpatient Medicare payments following non-cardioembolic IS or TIA.Results: The THALES-compatible cohort included 62,518 patients from 1471 hospitals. At discharge, 37.0% were unable to ambulate without assistance, and 96.2% were prescribed antiplatelet therapy. Cumulative incidences at 30 days, 90 days, and 1 year for the composite outcome were 3.7%, 7.6%, and 17.2% and 2.4%, 4.0%, and 7.3% for subsequent stroke. The mean Medicare payment for the index hospitalization was $7951. The cumulative all-cause inpatient Medicare spending per patient (with or without any subsequent admission) at 30 days and 1 year from discharge was $1451 and $8105, respectively.Conclusions: The burden of illness for minor IS/high-risk TIA patients indicates an important unmet need. Improved therapeutic options may offer a significant impact on both patient outcomes and Medicare spending. [ABSTRACT FROM AUTHOR]

Background: Patients with sudden cardiac arrest occurring in the acute phase of myocardial infarction (MI-SCA) are believed to be at similar risk of death after revascularization compared with MI patients without SCA (MI-no SCA). Among patients with anterior MI, we examined whether those with MI-SCA were at greater risk of all-cause mortality or sudden cardiac death (SCD) than MI-no SCA patients.Methods: The Home Automated External Defibrillator Trial enrolled patients with anterior MI who had not received or were candidates for an implantable cardioverter defibrillator (ICD). Our cohort included patients with a reported SCA event, in the acute phase of an MI, prior to HAT trial enrollment. Cox proportional hazards models examined the adjusted association between MI-SCA versus MI-no SCA patients and all-cause mortality and sudden cardiac death (SCD). We also determined whether the relationship between prior SCA and outcomes changed with subsequent events (syncope, revascularization, and recurrent MI) during follow-up.Results: Of 6849 patients, 650 (9.5%) had MI-SCA before trial enrollment. Approximately 48% of patients had the MI-SCA event ≤1 year prior to enrollment; 71% of SCA events were in-hospital. MI-SCA patients were younger, more frequently white, and had higher rates of prior PCI versus MI-no SCA patients. There were no differences in adjusted all-cause mortality (hazard ratio [HR 0.95; 95% CI 0.65-1.38]) or SCD (HR 1.12; 95% CI 0.68-1.83) for MI-SCA vs. MI-no SCA. After ICD implantation, MI-SCA patients experienced higher all-cause mortality risk (HR 5.01, 95% CI 1.05-23.79) versus MI-no SCA patients; there was no mortality difference between MI-SCA and MI-no SCA patients without ICD implantation (HR 0.89, 95% CI 0.60-1.31), [interaction p = 0.035].Conclusions: Patients with MI-SCA had similar adjusted risk of all-cause mortality and SCD compared with MI-no SCA. After ICD implantation, MI-SCA patients had higher mortality compared with MI-no SCA patients. [ABSTRACT FROM AUTHOR]

The purpose of this study was to characterize the incidence, time course, frequency, and spectrum of acute and chronic complications arising from dual-chamber pacemaker implantation. This information may serve as a benchmark when comparing complication rates for dual-chamber pacemaker implantation with those for biventricular pacemaker implantation. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is common in patients with end-stage renal disease (ESRD). The impact of oral anticoagulation (OAC) in ESRD patients is uncertain.Objectives: The purpose of this study was to describe patterns of OAC use in ESRD patients with AF and their associations with cardiovascular outcomes.Methods: Using Medicare fee-for-service 5% claims data from 2007 to 2013, we analyzed treatment and outcomes in a cohort of patients with ESRD and AF. Prescription drug benefit information was used to determine the timing of OAC therapy. Cox proportional hazards modeling was used to compare outcomes including death, all-cause stroke, ischemic stroke, hemorrhagic stroke, and bleeding hospitalizations in ESRD patients treated with or without OAC.Results: The cohort included 8,410 patients with AF and ESRD. A total of 3,043 (36.2%) patients were treated with OAC at some time during the study period. Propensity scores used to match 1,519 patients with AF and ESRD on OAC with 3,018 ESRD patients without OAC. Treatment with OAC was not associated with hospitalization for stroke (hazard ratio [HR]: 1.00; 95% confidence interval [CI]: 0.23 to 1.35; p = 0.97) or death (HR: 1.02; 95% CI: 0.94 to 1.10; p = 0.62). OAC was associated with an increased risk of hospitalization for bleeding (HR: 1.26; 95% CI: 1.09 to 1.46; p = 0.0017) and intracranial hemorrhage (HR: 1.30; 95% CI: 1.07 to 1.59; p = 0.0094).Conclusions: OAC utilization was low in patients with AF and ESRD. We found no association between OAC use and reduced risk of stroke or death. OAC use was associated with increased risks of hospitalization for bleeding or intracranial hemorrhage. Alternative stroke prevention strategies are needed in patients with ESRD and AF. [ABSTRACT FROM AUTHOR]

Abstract The possibility to create dye-sensitized solar cells (DSSCs) using nontoxic and inexpensive materials under usual lab or industrial conditions, i.e. without a cleanroom, has aroused large interest in this technology during the last decades. DSSCs are known to function well in low light or diffuse light conditions. Therefore, they could be interesting for indoor use, where the ambient light may have different spectra. In DSSCs, the visible light is absorbed by a dye molecule. The efficiency is affected by the overlapping grade of the maxima in the dye absorption spectrum and in the illumination spectrum, i.e. through an appropriate choice of dye, the efficiency can be maximized for each illumination condition. In this study the effect of the illumination spectra on the energy-conversion efficiency was investigated. DSSCs built using anthocyanin dyes were illuminated by a halogen lamp and an LED lamp with color temperatures of 3000 K and 5000 K, respectively, in combination with color filters or without them. Depending on the illumination spectra, the efficiency of the cell was found to vary between 0.06% and 0.33%, pointing out the importance of tailoring the DSSCs for the planned application. [ABSTRACT FROM AUTHOR]