There is a growing demand to collect patients' experiences of their health status (their symptoms, function, and quality of life) in clinical trials, quality assessment initiatives, and in routine ...clinical care. In heart failure, the 23-item, disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) has been shown to be valid, reliable, sensitive to clinical change, and prognostic of both clinical events and costs. However, its use has been limited, in part, by its length. We sought to develop a shortened version of the instrument that maintains the psychometric properties of the full KCCQ.
Using data from 3 clinical studies incorporating 4168 patients, we derived and validated a 12-item KCCQ, the KCCQ-12, to capture symptom frequency, physical and social limitations, and quality of life impairment as a result of heart failure, as well as an overall summary score. The KCCQ-12 scores had high correlations with the original scales (>0.93 for all scales in all clinical settings), high test–retest reliability (>0.76 for all domains), high responsiveness (16–31 point improvements after discharge from hospitalization; standardized response mean =0.61–1.12), and comparable prognostic significance and interpretation of clinically important differences as compared with the full KCCQ.
The KCCQ-12 is a shorter version of the original 23-item instrument that should be more feasible to implement while preserving the psychometric properties of the full instrument.
The current acute kidney injury (AKI) risk prediction model for patients undergoing percutaneous coronary intervention (PCI) from the American College of Cardiology (ACC) National Cardiovascular Data ...Registry (NCDR) employed regression techniques. This study aimed to evaluate whether models using machine learning techniques could significantly improve AKI risk prediction after PCI.
We used the same cohort and candidate variables used to develop the current NCDR CathPCI Registry AKI model, including 947,091 patients who underwent PCI procedures between June 1, 2009, and June 30, 2011. The mean age of these patients was 64.8 years, and 32.8% were women, with a total of 69,826 (7.4%) AKI events. We replicated the current AKI model as the baseline model and compared it with a series of new models. Temporal validation was performed using data from 970,869 patients undergoing PCIs between July 1, 2016, and March 31, 2017, with a mean age of 65.7 years; 31.9% were women, and 72,954 (7.5%) had AKI events. Each model was derived by implementing one of two strategies for preprocessing candidate variables (preselecting and transforming candidate variables or using all candidate variables in their original forms), one of three variable-selection methods (stepwise backward selection, lasso regularization, or permutation-based selection), and one of two methods to model the relationship between variables and outcome (logistic regression or gradient descent boosting). The cohort was divided into different training (70%) and test (30%) sets using 100 different random splits, and the performance of the models was evaluated internally in the test sets. The best model, according to the internal evaluation, was derived by using all available candidate variables in their original form, permutation-based variable selection, and gradient descent boosting. Compared with the baseline model that uses 11 variables, the best model used 13 variables and achieved a significantly better area under the receiver operating characteristic curve (AUC) of 0.752 (95% confidence interval CI 0.749-0.754) versus 0.711 (95% CI 0.708-0.714), a significantly better Brier score of 0.0617 (95% CI 0.0615-0.0618) versus 0.0636 (95% CI 0.0634-0.0638), and a better calibration slope of observed versus predicted rate of 1.008 (95% CI 0.988-1.028) versus 1.036 (95% CI 1.015-1.056). The best model also had a significantly wider predictive range (25.3% versus 21.6%, p < 0.001) and was more accurate in stratifying AKI risk for patients. Evaluated on a more contemporary CathPCI cohort (July 1, 2015-March 31, 2017), the best model consistently achieved significantly better performance than the baseline model in AUC (0.785 versus 0.753), Brier score (0.0610 versus 0.0627), calibration slope (1.003 versus 1.062), and predictive range (29.4% versus 26.2%). The current study does not address implementation for risk calculation at the point of care, and potential challenges include the availability and accessibility of the predictors.
Machine learning techniques and data-driven approaches resulted in improved prediction of AKI risk after PCI. The results support the potential of these techniques for improving risk prediction models and identification of patients who may benefit from risk-mitigation strategies.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Summary Background Despite the importance of ST-segment elevation myocardial infarction (STEMI) in China, no nationally representative studies have characterised the clinical profiles, management, ...and outcomes of this cardiac event during the past decade. We aimed to assess trends in characteristics, treatment, and outcomes for patients with STEMI in China between 2001 and 2011. Methods In a retrospective analysis of hospital records, we used a two-stage random sampling design to create a nationally representative sample of patients in China admitted to hospital for STEMI in 3 years (2001, 2006, and 2011). In the first stage, we used a simple random-sampling procedure stratified by economic–geographical region to generate a list of participating hospitals. In the second stage we obtained case data for rates of STEMI, treatments, and baseline characteristics from patients attending each sampled hospital with a systematic sampling approach. We weighted our findings to estimate nationally representative rates and assess changes from 2001 to 2011. This study is registered with ClinicalTrials.gov , number NCT01624883. Findings We sampled 175 hospitals (162 participated in the study) and 18 631 acute myocardial infarction admissions, of which 13 815 were STEMI admissions. 12 264 patients were included in analysis of treatments, procedures, and tests, and 11 986 were included in analysis of in-hospital outcomes. Between 2001 and 2011, estimated national rates of hospital admission for STEMI per 100 000 people increased (from 3·5 in 2001, to 7·9 in 2006, to 15·4 in 2011; ptrend <0·0001) and the prevalence of risk factors—including smoking, hypertension, diabetes, and dyslipidaemia—increased. We noted significant increases in use of aspirin within 24 h (79·7% 95% CI 77·9–81·5 in 2001 vs 91·2% 90·5–91·8 in 2011, ptrend <0·0001) and clopidogrel (1·5% 95% CI 1·0–2·1 in 2001 vs 82·1% 81·1–83·0 in 2011, ptrend <0·0001) in patients without documented contraindications. Despite an increase in the use of primary percutaneous coronary intervention (10·6% 95% CI 8·6–12·6 in 2001 vs 28·1% 26·6–29·7 in 2011, ptrend <0·0001), the proportion of patients who did not receive reperfusion did not significantly change (45·3% 95% CI 42·1–48·5 in 2001 vs 44·8% 43·1–46·5 in 2011, ptrend =0·69). The median length of hospital stay decreased from 12 days (IQR 7–18) in 2001 to 10 days (6–14) in 2011 (ptrend <0·0001). Adjusted in-hospital mortality did not significantly change between 2001 and 2011 (odds ratio 0·82, 95% CI 0·62–1·10, ptrend =0·07). Interpretation During the past decade in China, hospital admissions for STEMI have risen; in these patients, comorbidities and the intensity of testing and treatment have increased. Quality of care has improved for some treatments, but important gaps persist and in-hospital mortality has not decreased. National efforts are needed to improve the care and outcomes for patients with STEMI in China. Funding National Health and Family Planning Commission of China.
Abstract Background Various national campaigns launched in recent years have focused on young women with acute myocardial infarctions (AMIs). Contemporary longitudinal data about sex differences in ...clinical characteristics, hospitalization rates, length of stay (LOS), and mortality have not been examined. Objectives This study sought to determine sex differences in clinical characteristics, hospitalization rates, LOS, and in-hospital mortality by age group and race among young patients with AMIs using a large national dataset of U.S. hospital discharges. Methods Using the National Inpatient Sample, clinical characteristics, AMI hospitalization rates, LOS, and in-hospital mortality were compared for patients with AMI across ages 30 to 54 years, dividing them into 5-year subgroups from 2001 to 2010, using survey data analysis techniques. Results A total of 230,684 hospitalizations were identified with principal discharge diagnoses of AMI in 30- to 54-year-old patients from Nationwide Inpatient Sample data, representing an estimated 1,129,949 hospitalizations in the United States from 2001 to 2010. No statistically significant declines in AMI hospitalization rates were observed in the age groups <55 years or stratified by sex. Prevalence of comorbidities was higher in women and increased among both sexes through the study period. Women had longer LOS and higher in-hospital mortality than men across all age groups. However, observed in-hospital mortality declined significantly for women from 2001 to 2010 (from 3.3% to 2.3%, relative change 30.5%; p for trend < 0.0001) but not for men (from 2% to 1.8%, relative change 8.6%; p for trend = 0.60). Conclusions AMI hospitalization rates for young people have not declined over the past decade. Young women with AMIs have more comorbidity, longer LOS, and higher in-hospital mortality than young men, although their mortality rates are decreasing.
Hypertension is common in China and its prevalence is rising, yet it remains inadequately controlled. Few studies have the capacity to characterise the epidemiology and management of hypertension ...across many heterogeneous subgroups. We did a study of the prevalence, awareness, treatment, and control of hypertension in China and assessed their variations across many subpopulations.
We made use of data generated in the China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Million Persons Project from Sept 15, 2014, to June 20, 2017, a population-based screening project that enrolled around 1·7 million community-dwelling adults aged 35–75 years from all 31 provinces in mainland China. In this population, we defined hypertension as systolic blood pressure of at least 140 mm Hg, or diastolic blood pressure of at least 90 mm Hg, or self-reported antihypertensive medication use in the previous 2 weeks. Hypertension awareness, treatment, and control were defined, respectively, among hypertensive adults as a self-reported diagnosis of hypertension, current use of antihypertensive medication, and blood pressure of less than 140/90 mm Hg. We assessed awareness, treatment, and control in 264 475 population subgroups—defined a priori by all possible combinations of 11 demographic and clinical factors (age 35–44, 45–54, 55–64, and 65–75 years, sex men and women, geographical region western, central, and eastern China, urbanity urban vs rural, ethnic origin Han and non-Han, occupation farmer and non-farmer, annual household income < ¥10 000, ¥10 000–50 000, and ≥¥50 000, education primary school and below, middle school, high school, and college and above, previous cardiovascular events yes or no, current smoker yes or no, and diabetes yes or no), and their associations with individual and primary health-care site characteristics, using mixed models.
The sample contained 1 738 886 participants with a mean age of 55·6 years (SD 9·7), 59·5% of whom were women. 44·7% (95% CI 44·6–44·8) of the sample had hypertension, of whom 44·7% (44·6–44·8) were aware of their diagnosis, 30·1% (30·0–30·2) were taking prescribed antihypertensive medications, and 7·2% (7·1–7·2) had achieved control. The age-standardised and sex-standardised rates of hypertension prevalence, awareness, treatment, and control were 37·2% (37·1–37·3), 36·0% (35·8–36·2), 22·9% (22·7–23·0), and 5·7% (5·6–5·7), respectively. The most commonly used medication class was calcium-channel blockers (55·2%, 55·0–55·4). Among individuals whose hypertension was treated but not controlled, 81·5% (81·3–81·6) were using only one medication. The proportion of participants who were aware of their hypertension and were receiving treatment varied significantly across subpopulations; lower likelihoods of awareness and treatment were associated with male sex, younger age, lower income, and an absence of previous cardiovascular events, diabetes, obesity, or alcohol use (all p<0·01). By contrast, control rate was universally low across all subgroups (<30·0%).
Among Chinese adults aged 35–75 years, nearly half have hypertension, fewer than a third are being treated, and fewer than one in twelve are in control of their blood pressure. The low number of people in control is ubiquitous in all subgroups of the Chinese population and warrants broad-based, global strategy, such as greater efforts in prevention, as well as better screening and more effective and affordable treatment.
Ministry of Finance and National Health and Family Planning Commission, China.
To improve the patient-centeredness of care, patient-reported outcomes have been increasingly used to quantify patients' symptoms, function, and quality of life. In heart failure, the Kansas City ...Cardiomyopathy Questionnaire (KCCQ) has been qualified by the U.S. Food and Drug Administration as a Clinical Outcome Assessment and recommended as a performance measure for quantifying the quality of care. By systematically asking the same questions reproducibly over time, the KCCQ can validly and sensitively capture the impact of heart failure on patients' lives and is strongly associated with clinical events over time. This review describes how to interpret the KCCQ, how it should be analyzed in clinical trials to maximize the interpretability of results, and how it can be used in clinical practice and population health. By providing a deeper understanding of the KCCQ, it is hoped that its use can further improve the patient-centeredness of heart failure care.
Adoption of the results of large-scale randomized controlled trials in percutaneous coronary intervention (PCI) may differ internationally, yet few studies have described the potential variations in ...PCI practice patterns.
Using representative national registries, we compared temporal trends in procedural volume, patient characteristics, pre-procedural testing, procedural characteristics, and quality metrics in the United States and Japan.
The National Cardiovascular Data Registry CathPCI was used to describe care in the United States, and the J-PCI was used to assess practice patterns in Japan (numbers of participating hospitals: 1,752 in the United States and 1,108 in Japan). Both registries were summarized between 2013 and 2017.
PCI volume increased by 15.8% in the United States from 550,872 in 2013 to 637,650 in 2017, primarily because of an increase in nonelective PCIs (p for trend <0.001). In Japan, the volume of PCIs increased by 36%, from 181,750 in 2013 to 247,274 in 2017, primarily because of an increase in elective PCIs (p for trend <0.001). The proportion of PCI cases for elective conditions was >2-fold greater in Japan (72.7%) than in the United States (33.8%; p < 0.001). Overall, the ratio of nonelective PCI (vs. elective PCI; 27.3% vs. 66.2%; p < 0.001) and the performance of noninvasive stress testing in patients with stable disease (15.2% vs. 55.3%; p < 0.001) was lower in Japan than in the United States. Computed tomography angiography was more commonly used in Japan (22.3% vs. 2.0%; p < 0.001).
Elective PCI is more than twice as common in Japan as in the United States in contemporary practice. Computed tomography angiography is much more frequently used pre-procedurally in Japan than in the United States.
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BACKGROUND:Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in ...Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump).
METHODS:From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levelstime period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs).
RESULTS:Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008–2016) versus the pre-Impella era (years 2004–2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with deathodds ratio, 1.24 (95% CI, 1.13–1.36); bleedingodds ratio, 1.10 (95% CI, 1.00–1.21); and strokeodds ratio, 1.34 (95% CI, 1.18–1.53), although a similar, nonsignificant result was observed for acute kidney injuryodds ratio, 1.08 (95% CI, 1.00–1.17).
CONCLUSIONS:Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.
BACKGROUND:In patients with transthyretin amyloid cardiomyopathy, tafamidis reduces all-cause mortality and cardiovascular hospitalizations and slows decline in quality of life compared with placebo. ...In May 2019, tafamidis received expedited approval from the US Food and Drug Administration as a breakthrough drug for a rare disease. However, at $225 000 per year, it is the most expensive cardiovascular drug ever launched in the United States, and its long-term cost-effectiveness and budget impact are uncertain. We therefore aimed to estimate the cost-effectiveness of tafamidis and its potential effect on US health care spending.
METHODS:We developed a Markov model of patients with wild-type or variant transthyretin amyloid cardiomyopathy and heart failure (mean age, 74.5 years) using inputs from the ATTR-ACT trial (Transthyretin Amyloidosis Cardiomyopathy Clinical Trial), published literature, US Food and Drug Administration review documents, healthcare claims, and national survey data. We compared no disease–specific treatment (“usual care”) with tafamidis therapy. The model reproduced 30-month survival, quality of life, and cardiovascular hospitalization rates observed in ATTR-ACT; future projections used a parametric survival model in the control arm, with constant hazards reduction in the tafamidis arm. We discounted future costs and quality-adjusted life-years by 3% annually and examined key parameter uncertainty using deterministic and probabilistic sensitivity analyses. The main outcomes were lifetime incremental cost-effectiveness ratio and annual budget impact, assessed from the US healthcare sector perspective. This study was independent of the ATTR-ACT trial sponsor.
RESULTS:Compared with usual care, tafamidis was projected to add 1.29 (95% uncertainty interval, 0.47–1.75) quality-adjusted life-years at an incremental cost of $1 135 000 (872 000–1 377 000), resulting in an incremental cost-effectiveness ratio of $880 000 (697 000–1 564 000) per quality-adjusted life-year gained. Assuming a threshold of $100 000 per quality-adjusted life-year gained and current drug price, tafamidis was cost-effective in 0% of 10 000 probabilistic simulations. A 92.6% price reduction from $225 000 to $16 563 would be necessary to make tafamidis cost-effective at $100 000/quality-adjusted life-year. Results were sensitive to assumptions related to long-term effectiveness of tafamidis. Treating all eligible patients with transthyretin amyloid cardiomyopathy in the United States with tafamidis (n=120 000) was estimated to increase annual healthcare spending by $32.3 billion.
CONCLUSIONS:Treatment with tafamidis is projected to produce substantial clinical benefit but would greatly exceed conventional cost-effectiveness thresholds at the current US list price. On the basis of recent US experience with high-cost cardiovascular medications, access to and uptake of this effective therapy may be limited unless there is a large reduction in drug costs.