Background Despite the growing epidemic of heart failure with preserved ejection fraction (HFpEF), no valid measure of patients’ health status (symptoms, function and quality of life) exists. We evaluated the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated measure of heart failure with reduced ejection fraction (HFrEF), in HFpEF patients. Methods and Results Using a prospective HF registry, we dichotomized patients into HFrEF (EF ≤ 40) and HFpEF (EF ≥ 50). The associations between NYHA class, a commonly used criterion standard, and KCCQ Overall Summary and Total Symptom domains were evaluated using Spearman correlations and two-way ANOVA with differences between HFrEF and HFpEF patients tested with interaction terms. Predictive validity of the KCCQ Overall Summary scores was assessed with Kaplan-Meier curves for death and all-cause hospitalization. Covariate adjustment was made using Cox proportional hazards models. Internal reliability was assessed with Cronbach’s α. Conclusions Among 849 patients, 200 (24%) had HFpEF. KCCQ summary scores were strongly associated with NYHA class in both HFpEF (r = −0.62, p < .001) and HFrEF patients (r = −0.55; p=0.27 for interaction). One-year event-free rates by KCCQ category among HFpEF patients were 0–25=13.8%, 26–50=59.1%, 51–75=73.8%, and 76–100=77.8%, (log rank p < .001), with no significant interaction by EF (p=0.37). The KCCQ domains demonstrated high internal consistency among HFpEF patients (Cronbach’s α = 0.96 for overall summary and ≥ 0.69 in all sub-domains). Conclusion Among patients with HFpEF, the KCCQ appears to be a valid and reliable measure of health status and offers excellent prognostic ability. Future studies should extend and replicate our findings, including the establishment of its responsiveness to clinical change.
Aims Heart failure (HF) patients with a mid-range LVEF (HFmrEF) are not well characterized. Accordingly, we examined the epidemiology, pathophysiology and clinical outcomes of HF patients with an LV EF of 40–50%. Methods and Results We identified patients with an LVEF between 40–50% at enrollment into a HF registry, and determined whether LVEF was improved, worsened, or the same compared to a prior LVEF. Three subgroups of HFmrEF patients were identified: HFmrEF improved (prior LVEF < 40%); HFmrEF deteriorated (prior LVEF > 50%); HFmrEF unchanged (prior LVEF 40–50%). The majority of patients (73%) were HFmrEF improved, 17% were HFmrEF deteriorated and 10% were HFmrEF unhanged. The demographics of the HFmrEF cohort were heterogeneous, with more CAD in the HFmrEF improved group and a more hypertension and diastolic dysfunction in the HFmrEF deteriorated group. HFmrEF improved patients had significantly (p < 0.001) better clinical outcomes relative to matched patients with HFrEF, and significantly (P < 0.01) improved clinical outcomes relative to HFmrEF deteriorated patients, whereas clinical outcomes of the HFmrEF deteriorated subgroup of patients were not significantly different from matched HFpEF patients. Conclusions Patients with a mid-range EF are heterogeneous. Obtaining historical information with regard to prior LVEF allows one to identify a distinct pathophysiological substrate and clinical course for HFmrEF patients. Viewed together, these results suggest that in the modern era of HF therapeutics, the use of LVEF to categorize the pathophysiology of HF may be misleading, and argue for establishing a new taxonomy for classifying HF patients.
Background: Compared to traditional risk factors, coronary artery calcium (CAC) scores improve prognostic accuracy for atherosclerotic cardiovascular disease (ASCVD) outcomes. However, the relative impact of statins on ASCVD outcomes stratified by CAC scores is unknown. Objectives: To determine if CAC can identify patients most likely to benefit from statin treatment. Methods: We identified consecutive subjects without pre-existing ASCVD or malignancy who underwent CAC scoring from 2002 to 2009 at Walter Reed. The primary outcome was first major adverse cardiovascular event (MACE), a composite of acute myocardial infarction, stroke, and cardiovascular death. The effect of statin therapy on outcomes was analyzed stratified by CAC presence and severity, after adjusting for baseline comorbidities with inverse probability of treatment weights based on propensity scores. Results: 13,644 patients (mean age 50 years; 71% men) were followed for a median of 9.4 years. Comparing patients with and without statin exposure, statin therapy was associated with reduced risk of MACE in patients with CAC (adjusted subhazard ratio [aSHR] 0.76, 95% CI 0.60–0.95, p=0.015) but not in patients without CAC (aSHR 1.00, 95% CI 0.79–1.27, p=0.99). The effect of statin use on MACE was significantly related to the severity of CAC (p <0.0001 for interaction), with the NNT to prevent one initial MACE outcome over 10 years ranging from 100 (CAC 1–100) to 12 (CAC >100). Conclusions: In a large-scale cohort without baseline ASCVD, the presence and severity of CAC identified patients most likely to benefit from statins for the primary prevention of cardiovascular diseases. Condensed Abstract: Prior studies have shown that coronary artery calcium (CAC) screening improves risk prediction of atherosclerotic cardiovascular disease (ASCVD), but the true impact of statins on ASCVD outcomes stratified by CAC scores is unknown. In this retrospective cohort of 13,644 patients without pre-existing atherosclerotic cardiovascular disease or malignancy who underwent CAC scoring at Walter Reed Army Medical Center, increasing severity of CAC was associated with increased benefit from statin treatment for the prevention of cardiovascular morbidity and mortality. CAC presence and severity may help stratify patients most likely to benefit from statins.
Objective The purpose of this study was to determine the incidence and clinical significance of postoperative delirium (PD) in patients with aortic stenosis undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Method Between 2010 and 2013, 427 patients underwent TAVR (n = 168) or SAVR (n = 259) and were screened for PD using the Confusion Assessment Method for the Intensive Care Unit. The incidence of PD in both treatment groups was determined and its association with morbidity and mortality was retrospectively compared. Results PD occurred in 135 patients (32%) with a similar incidence between SAVR (33% [86 out of 259]) and TAVR (29% [49 out of 168]) (P = .40). TAVR by transfemoral approach had the lowest incidence of PD compared with SAVR (18% vs 33%; P = .025) or TAVR when performed by alternative access techniques (18% vs 35%; P = .02). Delirium was associated with longer initial intensive care unit stay (70 vs 27 hours), intensive care unit readmission (10% [14 out of 135] vs 2% [6 out of 292]), and longer hospital stay (8 vs 6 days) (P < .001 for all). PD was associated with increased mortality at 30 days (7% vs 1%; P < .001) and 1 year (21% vs 8%; P < .001). After multivariable adjustment, PD remained associated with increased 1-year mortality (hazard ratio, 3.02; 95% confidence interval, 1.75–5.23; P < .001). There was no interaction between PD and aortic valve replacement approach with respect to 1-year mortality (P = .12). Among propensity-matched patients (n = 170), SAVR-treated patients had a higher incidence of PD than TAVR-treated patients (51% vs 29%; P = .004). Conclusions PD occurs commonly after SAVR and TAVR and is associated with increased morbidity and mortality. Given the high incidence of PD and its associated adverse outcomes, further studies are needed to minimize PD and potentially improve patient outcomes.
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