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Hereditary transthyretin amyloidosis (ATTRv) is associated with polyneuropathy, cardiomyopathy, or both. The effects of eplontersen on cardiac structure and function were assessed. NEURO-TTRansform was an open-label trial involving 144 adults with ATTRv polyneuropathy (49 patients [34%] with cardiomyopathy) receiving eplontersen throughout and compared with a historical placebo group (n = 60; 30 patients [50%] with cardiomyopathy) from the NEURO-TTR trial at week 65. Treatment effect (eplontersen vs placebo), presented as mean difference (95% confidence interval) was analyzed after adjusting for age, sex, region, baseline value, ATTRv disease stage, previous ATTRv treatment, and V30M transthyretin variant. There were notable differences at baseline between the eplontersen group and historical placebo. In the cardiomyopathy subgroup, 65 weeks of eplontersen treatment was associated with improvement from baseline relative to placebo in left ventricular ejection fraction of 4.3% (95% confidence interval 1.40–21.01; P =.049) and stroke volume 10.64 mL (95% confidence interval 3.99–17.29; P =.002) while the remainder of echocardiographic parameters remained stable. Eplontersen was associated with stable or improved measures of cardiac structure and function vs historical placebo in patients with ATTRv polyneuropathy and cardiomyopathy. Further investigation into eplontersen's effect on transthyretin amyloid cardiomyopathy is being conducted in the CARDIO-TTRansform trial. vATTR, variant transthyretin; LV, left ventricle; E/e′, ratio of early diastolic mitral inflow velocity to early diastolic mitral annulus velocity; NT-proBNP, N-terminal prohormone of brain natriuretic peptide. [Display omitted] [ABSTRACT FROM AUTHOR]

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2005.03.009 Byline: Tobias T. Lee, Jersey Chen, David J. Cohen, Lana Tsao Abstract: The association between low blood pressure and prognosis in the general population has been controversial, with some reports suggesting an increased mortality for patients with the lowest blood pressures. Whereas many standard heart failure therapies decrease blood pressure, the relationship between mortality and blood pressure in patients with heart failure has not been previously evaluated. Author Affiliation: Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA Article History: Received 6 October 2004; Accepted 1 March 2005

Objectives: This study sought to analyze recent trends over time in heart failure (HF) hospital stay rates, length of stay (LOS), and in-hospital mortality by age groups with a large national dataset of U.S. hospital discharges. Background: Heart failure hospital stay rates, LOS, and mortality have fallen over the past decade for older Medicare beneficiaries, but whether this holds true for younger adults is unknown. Methods: From the National Inpatient Sample, we calculated HF hospital stay rates, LOS, and in-hospital mortality from 2001 to 2009 with survey data analysis techniques. Results: Hospital stays (n = 1,686,089) with a primary discharge diagnosis of HF were identified from National Inpatient Sample data between 2001 and 2009. The overall national hospital stay rate decreased from 633 to 463 hospital stays/100,000 persons, (−26.9%, p-for-trend <0.001). However, statistically significant declines (p < 0.001) were only observed for patients 55 to 64 years of age (−36.5%) 65 to 74 years (−37.4%), and ≥75 years (−28.3%) but not for patients 18 to 44 years of age (−12.8%, p = 0.57) or 45 to 55 years (−16.2%, p = 0.04). Statistically significant declines in LOS were only observed for patients 65 years of age and older. Overall in-hospital mortality fell from 4.5% to 3.3%, a relative decline of −27.4%, (p-for-trend <0.001), but patients 18 to 44 years of age did not exhibit a significant decline (−8.1%, p-for-trend = 0.18). In secondary analyses significant declines in HF hospital stay rate over time were observed for white men, white women, and black women but not for black men (−9.5%, p-for-trend = 0.43). Conclusions: Younger patients have not experienced comparable declines in HF hospital stay, LOS, and in-hospital mortality as older patients. Black men remain a vulnerable population for HF hospital stay. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to estimate heart failure (HF) and cardiomyopathy (CM) rates after adjuvant trastuzumab therapy and chemotherapy in a population of older women with early-stage breast cancer. Background: Newer biologic therapies for breast cancer such as trastuzumab have been reported to increase HF and CM in clinical trials, especially in combination with anthracycline chemotherapy. Elderly patients, however, typically have a higher prevalence of cardiovascular risk factors and have been underrepresented in trastuzumab clinical trials. Methods: Using Surveillance, Epidemiology, and End Results-Medicare data from 2000 through 2007, we identified women 67 to 94 years of age with early-stage breast cancer. We calculated 3-year incidence rates of HF or CM for the following mutually exclusive treatment groups: trastuzumab (with or without nonanthracycline chemotherapy), anthracycline plus trastuzumab, anthracycline (without trastuzumab and with or without nonanthracycline chemotherapy), other nonanthracycline chemotherapy, or no adjuvant chemotherapy or trastuzumab therapy. HF or CM events were ascertained from administrative Medicare claims. Poisson regression was used to quantify risk of HF or CM, adjusting for sociodemographic factors, cancer characteristics, and cardiovascular conditions. Results: We identified 45,537 older women (mean age: 76.2 years, standard deviation: 6.2 years) with early-stage breast cancer. Adjusted 3-year HF or CM incidence rates were higher for patients receiving trastuzumab (32.1 per 100 patients) and anthracycline plus trastuzumab (41.9 per 100 patients) compared with no adjuvant therapy (18.1 per 100 patients, p < 0.001). Adding trastuzumab to anthracycline therapy added 12.1, 17.9, and 21.7 HF or CM events per 100 patients over 1, 2, and 3 years of follow-up, respectively. Conclusions: HF or CM are common complications after trastuzumab therapy for older women, with higher rates than those reported from clinical trials. [Copyright &y& Elsevier]

Objectives: The goal of this study was to compare patterns of downstream testing and procedures after stress testing with imaging performed at physician offices versus at hospital-outpatient facilities Background: Stress testing with imaging has grown dramatically in recent years, but whether the location of where the test is performed correlates with different patterns for subsequent cardiac testing and procedures is unknown Methods: We identified 82,178 adults with private health insurance from 2005 to 2007 who underwent ambulatory myocardial perfusion imaging (MPI) or stress echocardiography (SE). Subsequent MPI, SE, cardiac catheterization or revascularization within 6 months was compared between physician office and hospital outpatient settings. Results: Overall, 85.1% of MPI and 84.9% of SE were performed in physician offices. The proportion of patients who underwent subsequent MPI, SE, or cardiac catheterization was not statistically different between physician office and hospital outpatient settings for MPI (14.2% vs. 13.9%, p = 0.44) or SE (7.9% vs. 8.6%, p = 0.21). However, patients with physician office imaging had slightly higher rates of repeat MPI within 6 months compared with hospital-outpatient imaging for both index MPI (3.5% vs. 2.0%, p < 0.001) and SE (3.4% vs. 2.1%, p < 0.001), and slightly lower rates of cardiac catheterization after index MPI (11.4% vs. 12.2%, p = 0.04) and SE (4.5% vs. 7.0%, p < 0.001). Differences in 6-month utilization were observed across the 5 healthcare markets after index MPI but not after index SE Conclusions: Physician office imaging is associated with slightly higher repeat MPI and fewer cardiac catheterizations than hospital outpatient imaging, but no overall difference in the proportion of patients undergoing additional further testing or procedures. Although regional variation exists, especially for MPI, the relationship between physician office location of stress testing with imaging and greater downstream resource utilization appears modest. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to describe radiation exposure from cardiac imaging procedures over time in a general population. Background: Cardiac imaging procedures frequently expose patients to ionizing radiation, but their contribution to effective doses of radiation in the general population is unknown. Methods: We used administrative claims to identify cardiac imaging procedures performed from 2005 to 2007 in 952,420 nonelderly insured adults in 5 U.S. health care markets. We estimated 3-year cumulative effective doses of radiation in millisieverts from these procedures We then calculated population-based annual rates of radiation exposure to effective doses ≤3 mSv/year (background level of radiation from natural sources), >3 to 20 mSv/year, or >20 mSv/year (upper annual limit for occupational exposure averaged over 5 years). Results: A total of 90,121 (9.5%) individuals underwent at least 1 cardiac imaging procedure using radiation. Among patients who underwent ≥1 cardiac imaging procedures, the mean cumulative effective dose over 3 years was 23.1 mSv (range 1.5 to 543.7 mSv). Myocardial perfusion imaging accounted for 74% of the cumulative effective dose. Overall, 47.8% of cardiac imaging procedures were performed in physician offices; this proportion was higher for myocardial perfusion imaging (74.8%) and cardiac computed tomography studies (76.5%). The annual population-based rate of receiving an effective dose of >3 to 20 mSv/year was 89.0 per 1,000; and 3.3 per 1,000 for cumulative doses >20 mSv/year. Annual effective doses increased with age and were generally higher among men. Conclusions: Cardiac imaging procedures lead to substantial radiation exposure and effective doses for many patients in the U.S. [ABSTRACT FROM AUTHOR]

Objective: To determine the incremental cost-effectiveness of clopidogrel plus aspirin (C + A) compared with aspirin (A) alone during the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) trial from a US payer perspective. Background: Although the CHARISMA trial did not find a benefit of adding clopidogrel to aspirin in its overall study cohort, a benefit was suggested in a prespecified subgroup of patients with established cardiovascular (CV) disease. The cost-effectiveness of dual antiplatelet therapy in this population is unknown. Methods: Medical resource utilization was assessed prospectively, and costs for hospitalizations, physician services, outpatient care, and medications were assigned using 2007 US dollars. Life expectancy was estimated contingent on fatal and nonfatal CV events using statistical models of long-term survival from the Saskatchewan Health database. Results: C + A was associated with a 12.5% relative reduction in CV death, myocardial infarction, or stroke compared with A alone (6.9% vs. 7.9%, P = 0.048) over a median 28 months of follow-up. Severe or moderate bleeding events were higher in patients receiving C + A versus A alone (3.6% vs. 2.5%, P < 0.001). Mean cost/patient was $2607 higher for C + A, while projected life expectancy increased by an average of 0.072 years due to fewer in-trial events. The resulting incremental cost-effectiveness ratio (ICER) for C + A was $36,343/year of life gained. Findings were insensitive to discount rate, life expectancy projections, post-event costs, and indirect costs from lost productivity; the ICER was most sensitive to the cost of clopidogrel. Bootstrap analysis demonstrated that the ICER for C + A remained <$50,000/life-year gained in 70.6% of bootstrap replicates and <$100,000/life-year gained in 87.4%. Conclusions: Among patients with established CV disease, adding clopidogrel to aspirin appears to increase life expectancy modestly at a cost generally considered acceptable within the US health-care system. [ABSTRACT FROM AUTHOR]

Despite rapid technologic advances and sustained growth, less attention has been focused on quality in imaging than in other areas of cardiovascular medicine. To address this deficit, representatives from cardiovascular imaging societies, private payers, government agencies, the medical imaging industry, and experts in quality measurement met in the second Quality in Cardiovascular Imaging Think Tank. The participants endorsed the previous consensus definition of quality in imaging and proposed quality measures. Additional areas of needed effort included data standardization and structured reporting, appropriateness criteria, imaging registries, laboratory accreditation, partnership development, and imaging research. The second American College of Cardiology–Duke University Think Tank continued the process of the development, dissemination, and adoption of quality improvement initiatives for all cardiovascular imaging modalities. [Copyright &y& Elsevier]

Ticagrelor reduced major adverse cardiovascular events (MACE) and increased bleeding in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease. Limb events including revascularization, acute limb ischemia (ALI), and amputation are major morbidities in patients with T2DM and atherosclerosis. This study sought to determine the effect of ticagrelor on limb events. Patients were randomized to ticagrelor or placebo on top of aspirin and followed for a median of 3 years. MACE (cardiovascular death, myocardial infarction, or stroke), limb events (ALI, amputation, revascularization), and bleeding were adjudicated by an independent and blinded clinical events committee. The presence of peripheral artery disease (PAD) was reported at baseline. Of 19,220 patients randomized, 1,687 (8.8%) had PAD at baseline. In patients receiving placebo, PAD was associated with higher MACE (10.7% vs 7.3%; HR: 1.48; P < 0.001) and limb (9.5% vs 0.8%; HR: 10.67; P < 0.001) risk. Ticagrelor reduced limb events (1.6% vs 1.3%; HR: 0.77; 95% CI: 0.61-0.96; P = 0.022) with significant reductions for revascularization (HR: 0.79; 95% CI: 0.62-0.99; P = 0.044) and ALI (HR: 0.24; 95% CI: 0.08-0.70; P = 0.009). The benefit was consistent with or without PAD (HR: 0.80; 95% CI: 0.58-1.11; and HR: 0.76; 95% CI: 0.55-1.05, respectively; P interaction = 0.81). There was no effect modification of ticagrelor vs placebo based on PAD for MACE (P interaction = 0.40) or TIMI major bleeding (P interaction = 0.3239). Patients with T2DM and atherosclerosis are at high risk of limb events. Ticagrelor decreased this risk, but increased bleeding. Future trials evaluating the combination of ticagrelor and aspirin would further elucidate the benefit/risk of such therapy in patients with PAD, including those without coronary artery disease. (A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus [THEMIS]: NCT01991795) [Display omitted] [ABSTRACT FROM AUTHOR]

Background Stroke is a common and important adverse event after acute myocardial infarction (AMI) in the elderly. It is unclear whether the risk of stroke after AMI has changed with improvements in treatments and outcomes for AMI in the last decade. Methods To assess trends in risk of stroke after AMI, we used a national sample of Medicare data to identify Fee-for-Service patients (n = 2,305,441) aged ≥65 years who were discharged alive after hospitalization for AMI from 1999 to 2010. Results We identified 57,848 subsequent hospitalizations for ischemic stroke and 4,412 hospitalizations for hemorrhagic stroke within 1 year after AMI. The 1-year rate of ischemic stroke decreased from 3.4% (95% CI 3.3%-3.4%) to 2.6% (2.5%-2.7%; P < .001). The risk-adjusted annual decline was 3% (hazard ratio, 0.97; [0.97-0.98]) and was similar across all age and sex-race groups. The rate of hemorrhagic stroke remained stable at 0.2% and did not differ by subgroups. The 30-day mortality for patients admitted with ischemic stroke after AMI decreased from 19.9% (18.8%-20.9%) to 18.3% (17.1%-19.6%) and from 48.3% (43.0%-53.6%) to 45.7% (40.3%-51.2%) for those admitted with hemorrhagic stroke. We observed a decrease in 1-year mortality from 37.8% (36.5%-39.1%) to 35.3% (33.8%-36.8%) for ischemic stroke and from 66.6% (61.4%-71.5%) to 60.6% (55.1%-65.9%) for hemorrhagic stroke. Conclusions From 1999 to 2010, the 1-year risk for ischemic stroke after AMI declined, whereas the risk of hemorrhagic stroke remained unchanged. However, 30-day and 1-year mortality continued to be high. [ABSTRACT FROM AUTHOR]

Rates of acute myocardial infarction (AMI) hospitalizations for elderly Medicare patients decreased during the previous decade. However, trends in population rates of AMI hospitalizations for all adults by subgroups have not been described. Using data from a large all-payer administrative database of hospitalizations, we calculated annual AMI hospitalization rates from 2001 through 2007. Trend analysis was performed across age, gender, and ethnicity categories using survey regression. Overall rate decreased from 314 to 222 AMI hospitalizations per 100,000 patients from 2001 through 2007, representing a 29.2% decrease. Significant decreases were observed in AMI hospitalization rate for each group by age categories (p <0.001) and by gender (p <0.001). When stratified by ethnicity and gender, age-adjusted AMI hospitalization rates in white men and women decreased by 30.8% and 31.4%, whereas black men and women had significantly slower rates of decrease of 13.6% and 12.6%, respectively. In conclusion, although the overall rate of AMI hospitalizations decreased from 2001 through 2007, the observed decrease was smaller for black patients compared to white patients across all age groups studied. [Copyright &y& Elsevier]

Objective: To determine whether age-related macular degeneration (AMD) is a risk indicator for coronary heart disease (CHD) and cardiovascular disease (CVD) events independent of other known risk factors in a multi-ethnic cohort. Design: Population-based prospective cohort study. Participants: A diverse population sample of 6233 men and women aged 45 to 84 years without known CVD from the Multi-Ethnic Study of Atherosclerosis (MESA). Methods: Participants in the MESA had retinal photographs taken between 2002 and 2003. Photographs were evaluated for AMD. Incident CHD and CVD events were ascertained during clinical follow-up visits for up to 8 years after the retinal images were taken. Main Outcome Measures: Incident CHD and CVD events. Results: Of the 6814 persons at risk of CHD, there were 893 participants with early AMD (13.1%) and 27 patients (0.5%) at baseline. Over a mean follow-up period of 5.4 years, there was no statistically significant difference in incident CHD or CVD between the AMD and non-AMD groups (5.0% vs. 3.9%, P = 0.13 for CHD and 6.6% vs. 5.5%, P = 0.19 for CVD). In Cox regression models adjusting for CVD risk factors, there was no significant relationship between presence of any AMD and any CHD/CVD events (hazard ratio 0.99; 95% confidence interval, 0.74–1.33; P = 0.97). No significant association was found between subgroups of early AMD or late AMD and incident CHD/CVD events. Conclusions: In persons without a history of CVD, AMD was not associated with an increased risk of CHD or CVD. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to report on the all-cause readmission and repeat revascularization rates after percutaneous coronary intervention (PCI). Background: Although PCIs are frequently performed, 30-day rates of readmission and repeat revascularization after PCI are not known. Methods: Retrospective analysis of a cohort of Medicare fee-for-service admissions associated with a PCI in 2005. Primary outcomes were 30-day all-cause readmission rates and 30-day readmission rates associated with a revascularization procedure. Results: A total of 315,241 PCI procedures performed at 1,108 hospitals were included in the analysis. The all-cause 30-day readmission rate was 14.6%, and the all-cause 30-day mortality rate was 1.0%. All-cause 30-day mortality among readmitted patients was higher than patients who were not readmitted (3.6% vs. 0.6%; p < 0.001). The 30-day readmission rate of acute myocardial infarction (AMI) patients was significantly higher than that of non-AMI patients (AMI 17.5%, non-AMI 13.6%, p < 0.001). Among all patients readmitted within 30 days after the index PCI, 27.5% had an associated revascularization procedure (PCI 25.8%, coronary artery bypass grafting 1.7%). The median readmission rates varied across hospitals, from 8.9% in the lowest decile to 22.0% in the highest decile. Conclusions: A substantial proportion of PCI patients are readmitted within 30 days of discharge, and readmission rates vary widely across hospitals. Readmissions within 30 days of an index PCI procedure were associated with a significantly higher 30-day mortality rate, and more than one-quarter of such readmissions resulted in a repeat revascularization procedure. These findings warrant further attention to determine whether these readmissions are preventable. [Copyright &y& Elsevier]