Abstract Patient-reported outcomes (PRO) are defined as reports coming directly from patients about how they feel or function in relation to a health condition and its therapy. Although there are ...numerous compelling reasons why PRO could be an important help in clinical care, they have not evolved into clinical tools integrated into care. The purpose of this review is to assess existing PRO instruments for heart failure with respect to their psychometric properties and potential for use in clinical care. We performed a systematic search of articles published between July 2008 and January 2015 within the MEDLINE, PROMIS, PROQOLID, and Cochrane Library databases. Included instruments had to be developed and tested for heart failure and have had their development processes and psychometric properties described. A total of 31 instruments were identified, 9 of which met all inclusion criteria. After evaluating each remaining instrument in terms of psychometric and clinical criteria and symptom coverage, only 2 instruments—Minnesota Living with Heart Failure and Kansas City Cardiomyopathy questionnaire—met all evaluation criteria. Although clinically useful PRO instruments exist, increasing education to providers on the value and interpretability of PRO instruments, as well as a more streamlined approach to their implementation in the clinical setting is necessary. A clinical trial comparing the routine use of disease-specific PRO with clinical care could further support their incorporation into practice.
Background Seasonal variation with winter preponderance of myocardial infarction incidence has been described decades ago, but only a few small studies have classified myocardial infarction based on ...ST-segment elevation. It is unclear whether seasonal and circadian variations are equally present in warmer and colder regions. We investigated whether seasonal and circadian variations in acute myocardial infarction (AMI) are more prominent in colder northern states compared with warmer southern states. We also investigated the peak time of admission to better understand the circadian rhythm. Methods Data from the GWTG-CAD database were used. We analyzed 82,971 consecutive acute myocardial infarction (AMI) patients treated at 276 US centers from 2003 to 2008. The country was geographically divided into warmer southern and colder northern states using latitude 35 degrees for this purpose. Results Overall, acute myocardial infarction (AMI) admissions varied across seasons ( P < .01), and were higher in winter (winter vs. spring n = 21,483 vs. 20,291, respectively). When stratified based on type of AMI, non–ST-segment elevation myocardial infarction (NSTEMI) admissions varied across seasons ( P < .01) and were highest in winter and lowest in spring. Seasonal variation was not significant in STEMI admissions ( P = .30). Seasonal variation with winter predominance was noted in AMI patients in warmer southern states ( P < .01), but not in colder states. The distributions of length of stay for AMI patients and door to balloon times for STEMI patients were minimally different across all four seasons ( P < .01) with longest occurring in winter. Most patients with AMI presented during daytime with a peak close to 11 am and a nadir at approximately 4 am. Conclusions Seasonal variation with winter predominance exists in AMI admissions and was significant in NSTEMI admissions but not in STEMI admissions. Seasonal variation was only significant in warmer southern states.
Abstract We propose that stage D advanced heart failure be defined as the presence of progressive and/or persistent severe signs and symptoms of heart failure despite optimized medical, surgical, and ...device therapy. Importantly, the progressive decline should be primarily driven by the heart failure syndrome. Formally defining advanced heart failure and specifying when medical and device therapies have failed is challenging, but signs and symptoms, hemodynamics, exercise testing, biomarkers, and risk prediction models are useful in this process. Identification of patients in stage D is a clinically important task because treatments are inherently limited, morbidity is typically progressive, and survival is often short. Age, frailty, and psychosocial issues affect both outcomes and selection of therapy for stage D patients. Heart transplant and mechanical circulatory support devices are potential treatment options in select patients. In addition to considering indications, contraindications, clinical status, and comorbidities, treatment selection for stage D patients involves incorporating the patient's wishes for survival versus quality of life, and palliative and hospice care should be integrated into care plans. More research is needed to determine optimal strategies for patient selection and medical decision making, with the ultimate goal of improving clinical and patient centered outcomes in patients with stage D heart failure.
Objectives To evaluate the use of intraoperative guidance by means of C-arm cone-beam computed tomography (CT) (cone-beam computed tomography CBCT) and the use of postoperative CBCT to assess for ...successful aneurysm exclusion in fenestrated branched endovascular aneurysm repair (FEVAR). Methods Patients with FEVAR who underwent CBCT were retrospectively evaluated and categorized into one of two groups. The CBCT-fusion group was comprised of patients who underwent preprocedural CBCT to guide FEVAR using fusion imaging with multidetector computed tomography (MDCT). The postprocedure CBCT group consisted of patients undergoing CBCT following deployment of the endograft. Outcomes from the CBCT-fusion group were compared with historical controls. These controls were patients who underwent FEVAR for similar groups of abdominal and thoracoabdominal aortic aneurysms in the 12 months preceding the initiation of a CBCT program. The findings on postprocedural CBCT were compared with those on predischarge MDCT. Results are expressed as mean ±standard error of the mean, or as median and interquartile range. Results Forty patients were included in the “CBCT-fusion” group and compared with the historical cohort. The use of perioperative guidance of FEVAR by means of CBCT resulted in a significantly lower contrast dose (94 cc 72-131 vs 136 cc 96-199; P = .001). While there was a trend toward lower operative (330 minutes 273-522 vs 387 minutes 290-477; P = .651) and fluoroscopy times (81 min 54-118 vs 90 minutes (46-128), P = .932); this difference did not reach statistical significance. Nineteen patients were included in the “postprocedural CBCT” group and compared with predischarge MDCT. Postoperative CBCT identified eight endoleaks. Type I and III (n = 6) endoleaks were identified and treated during the primary procedure. When CBCT did not show an endoleak, this was confirmed by MDCT. The use of CBCT required significantly less contrast compared to MDCT (50 cc set amount vs 100 cc 80-125; P < .0001). Mean skin dose was 0.27 (0.011) Gy for preoperative CBCT and 0.552 (0.036) Gy for postoperative CBCT. Conclusions CBCT is a valuable addition to complicated aortic interventions such as FEVAR. Intraoperative use utilizing fusion imaging limits contrast dosage and postdeployment CBCT is of sufficient quality to evaluate successful aneurysm exclusion and for detection of early complications after FEVAR. With the information we are able to obtain from the CBCT at the completion of the FEVAR, we can intervene on problems earlier and potentially decrease the subsequent need for reintervention.
Background Studies on outcomes among patients with heart failure (HF) with preserved left ventricular ejection fraction (HF p EF), borderline left ventricular ejection fraction (HF b EF), and reduced ...left ventricular ejection fraction (HF r EF) remain limited. We sought to characterize mortality and readmission in patients with HF in the contemporary era. Methods Get With The Guidelines–HF was linked to Medicare data for longitudinal follow-up. Patients were grouped into HF p EF (left ventricular ejection fraction EF ≥50%), HF b EF (40% ≤ EF < 50%), and HF r EF (EF <40%). Multivariable models were constructed to examine the relationship between EF and outcomes at 30 days and 1 year and to study trends over time. Results A total of 40,239 patients from 220 hospitals between 2005 and 2011 were included in the study: 18,897 (47%) had HF p EF, 5,626 (14%) had HF b EF, and 15,716 (39%) had HF r EF. In crude survival analysis, patients with HF r EF had slightly increased mortality compared with HF b EF and HF p EF. After risk adjustment, mortality at 1 year was not significantly different for HF r EF, HF b EF, and HF p EF (HF r EF vs HF p EF, hazard ratio HR 1.040 95% CI 0.998-1.084, and HF b EF vs HF p EF, HR 0.967 95% CI 0.917-1.020). Patients with HF p EF had increased risk of all-cause readmission compared with HF r EF. Conversely, risk of cardiovascular and HF readmissions were higher in HF r EF and HF b EF compared with HF p EF. Conclusions Among patients hospitalized with HF, patients with HF p EF and HF b EF had slightly lower mortality and higher all-cause readmission risk than patients with HF r EF, although the mortality differences did not persist after risk adjustment. Irrespective of EF, these patients experience substantial mortality and readmission highlighting the need for new therapeutic strategies.
Background Guidelines recommend noninvasive tests (NITs) to risk stratify and identify patients with higher likelihood of coronary artery disease (CAD) prior to elective coronary angiography. ...However, a high percentage of patients are found to have nonobstructive CAD. We aimed to understand the relationship between patient characteristics, NIT findings, and the likelihood of nonobstructive CAD. Methods Patients undergoing elective catheterization without history of CAD were identified from 1,128 hospitals in National Cardiovascular Data Registry's CathPCI Registry between July 2009 and December 2011. Noninvasive tests included stress electrocardiogram, stress echocardiogram, stress radionuclide, stress cardiac magnetic resonance, and computed tomographic angiography. Patient demographics, risk factors, symptoms, and NIT results were correlated with the presence of nonobstructive CAD , defined as all native coronary stenoses <50%. Results Of 661,063 patients undergoing elective angiography, 386,003 (58.4%) had nonobstructive CAD. Preprocedure NIT was performed in 64% of patients; 51.9% were reported to be abnormal, but only 9% had high-risk findings. Independent factors associated with nonobstructive CAD were younger age, female sex, atypical chest pain, and a low-risk NIT. Patients with high-risk findings on NIT were more likely to have obstructive CAD (adjusted odds ratio 3.03 2.86-3.22). Noninvasive test findings had minimal incremental value beyond clinical factors for predicting obstructive disease ( C index = 0.75 for clinical factors vs 0.74 for NIT findings). Conclusion In current practice, about two-thirds of patients undergo NIT prior to elective cardiac catheterization, yet most patients have nonobstructive CAD. The weak correlation between most NIT results and the likelihood of obstructive CAD provides further impetus for improving preangiography assessment of likelihood of disease.
The need for consistent and current data describing the true incidence of sudden cardiac arrest (SCA) and/or sudden cardiac death (SCD) was highlighted during the most recent Sudden Cardiac Arrest ...Thought Leadership Alliance's (SCATLA) Think Tank meeting of national experts with broad representation of key stakeholders, including thought leaders and representatives from the American College of Cardiology, American Heart Association, and the Heart Rhythm Society. As such, to evaluate the true magnitude of this public health problem, we performed a systematic literature search in MEDLINE using the MeSH headings, “death, sudden” OR the terms “sudden cardiac death” OR “sudden cardiac arrest” OR “cardiac arrest” OR “cardiac death” OR “sudden death” OR “arrhythmic death.” Study selection criteria included peer-reviewed publications of primary data used to estimate SCD incidence in the U.S. We used Web of Science's Cited Reference Search to evaluate the impact of each primary estimate on the medical literature by determining the number of times each “primary source” has been cited. The estimated U.S. annual incidence of SCD varied widely from 180,000 to >450,000 among 6 included studies. These different estimates were in part due to different data sources (with data age ranging from 1980 to 2007), definitions of SCD, case ascertainment criteria, methods of estimation/extrapolation, and sources of case ascertainment. The true incidence of SCA and/or SCD in the U.S. remains unclear, with a wide range in the available estimates that are badly dated. As reliable estimates of SCD incidence are important for improving risk stratification and prevention, future efforts are clearly needed to establish uniform definitions of SCA and SCD and then to prospectively and precisely capture cases of SCA and SCD in the overall U.S. population.
Background Lipid levels among contemporary patients hospitalized with coronary artery disease (CAD) have not been well studied. This study aimed to analyze admission lipid levels in a broad ...contemporary population of patients hospitalized with CAD. Methods The Get With The Guidelines database was analyzed for CAD hospitalizations from 2000 to 2006 with documented lipid levels in the first 24 hours of admission. Patients were divided into low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), and triglyceride categories. Factors associated with LDL and HDL levels were assessed along with temporal trends. Results Of 231,986 hospitalizations from 541 hospitals, admission lipid levels were documented in 136,905 (59.0%). Mean lipid levels were LDL 104.9 ± 39.8, HDL 39.7 ± 13.2, and triglyceride 161 ± 128 mg/dL. Low-density lipoprotein cholesterol <70 mg/dL was observed in 17.6% and ideal levels (LDL <70 with HDL ≥60 mg/dL) in only 1.4%. High-density lipoprotein cholesterol was <40 mg/dL in 54.6% of patients. Before admission, only 28,944 (21.1%) patients were receiving lipid-lowering medications. Predictors for higher LDL included female gender, no diabetes, history of hyperlipidemia, no prior lipid-lowering medications, and presenting with acute coronary syndrome. Both LDL and HDL levels declined over time ( P < .0001). Conclusions In a large cohort of patients hospitalized with CAD, almost half have admission LDL levels <100 mg/dL. More than half the patients have admission HDL levels <40 mg/dL, whereas <10% have HDL ≥60 mg/dL. These findings may provide further support for recent guideline revisions with even lower LDL goals and for developing effective treatments to raise HDL.
Abstract Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these ...advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements. This review will examine the current landscape of cardiovascular clinical trials in the United States, highlight recently conducted registry-based clinical trials, and discuss the potential attributes of the recently launched pragmatic clinical trial by the Patient-Centered Outcomes Research Institute’s National Patient-Centered Clinical Research Network, called the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing the Benefits and Long-term Effectiveness) trial.
Elevated interleukin (IL)-6 levels have been linked to adverse outcomes in patients with and without baseline cardiovascular disease (CVD).
The purpose of this study was to examine the association ...between circulating IL-6 levels and CVD events without baseline CVD across racial and ethnic groups.
We conducted an observational analysis utilizing the MESA (Multi-Ethnic Study of Atherosclerosis), a multicenter, prospective community-based study of CVD at baseline from four racial and ethnic groups. IL-6 levels were measured at the time of enrollment (visit 1) and were divided into 3 terciles. Patient baseline characteristics and outcomes, including all-cause mortality, CV mortality, heart failure, and non-CV mortality, were included. Cox proportional hazard regression models were used to assess associations between IL-6 levels and study outcomes with IL-6 tercile 1 as reference.
Of 6,622 individuals, over half were women (53%) with a median age of 62 (IQR: 53-70) years. Racial and ethnic composition was non-Hispanic White (39%) followed by African American (27%), Hispanic (22%), and Chinese American (12%). Compared to tercile 1, participants with IL-6 tercile 3 had a higher adjusted risk of and all-cause mortality (HR: 1.98 95% CI: 1.67-2.36), CV mortality (HR: 1.55 95% CI: 1.05-2.30), non-CV mortality (HR: 2.05 95% CI: 1.65-2.56), and heart failure (HR: 1.48 95% CI: 0.99-2.19). When tested as a continuous variable, higher levels of IL-6 were associated with an increased risk of all individual outcomes. Compared to non-Hispanic White participants, the unadjusted and adjusted risk of all outcomes across all races and ethnicities was similar across all IL-6 terciles.
High levels of circulating IL-6 are associated with worse CV outcomes and increased all-cause mortality consistently across all racial and ethnic groups.
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