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Transcatheter aortic valve replacement (TAVR) is an effective treatment for severe symptomatic aortic stenosis (AS) in patients who are inoperable or at high risk for surgery. However, the intermediate to long-term mortality is high, emphasizing the importance of patient selection. We therefore sought to evaluate the prognostic value of frailty among older TAVR recipients, hypothesizing that frail patients would experience a higher mortality rate and a higher likelihood of poor outcome 1 year after TAVR. This substudy of the PARTNER (Placement of AoRtic TraNscathetER Valves) Trial was conducted at 3 high-enrolling sites where frailty was assessed systematically prior to TAVR. In total, 244 patients received TAVR at the participating sites. Frailty was assessed using a composite of four markers (serum albumin, dominant hand grip strength, gait speed, and Katz activity of daily living (ADLs) survey), which were combined into a frailty score. The cohort was dichotomized at median frailty score. Outcomes measures were the time to death from any cause over 1 year of follow up and poor outcome at one year. Poor outcome was defined as: (1) death, (2) Kansas City Cardiomyopathy Questionnaire – Overall Summary score (KCCQ-OS) <60, or (3) decrease of ≥10 points in the KCCQ-OS score from baseline to 1 year. At 1 year, the Kaplan-Meier estimated all-cause mortality rate was 32.7% in the frail group and 15.9% in the non-frail group (log-rank p=0.004). At 1 year, poor outcome occurred in 50.0% of the frail group and 31.5% of the non-frail group (p=0.02). In conclusion, Frailty was associated with increased mortality and a higher rate of poor outcome 1 year after TAVR. Clinical Trial Registration: ClinicalTrials.gov, Unique Identifier # NCT00530894

Background Black patients with myocardial infarction (MI) have worse outcomes than white patients, including higher mortality, more angina, and worse quality of life. The TRIUMPH study was designed to examine whether racial differences in socioeconomic, clinical, genetic, metabolic, biomarker or treatment characteristics mediate observed disparities in outcomes. Methods and Results Between June 1, 2005 and December 31, 2008, 31567 patients with MI were prospectively screened, 6152 had an eligible MI, and 4340 (71%) were enrolled from 24 US centers. Consenting patients had detailed chart abstractions of their medical history and processes of inpatient care, supplemented with a detailed baseline interview. Detailed genetic and metabolic data were obtained at hospital discharge in 2979 (69%) and 3013 patients (69%), respectively. In a subset of patients, blood and urine samples were obtained at 1-month (obtained in 27% of survivors) and blood samples at 6-months (obtained in 19% of survivors). Centralized follow-up interviews sought to quantify patients’ post-discharge care and outcomes, with a focus on their health status (symptoms, function, and quality of life). At 1, 6 and 12 months, 23%, 27% and 24% were lost to follow-up. Vital status was available for 99% of patients at 12-months. Conclusions TRIUMPH is a novel MI registry with detailed information on patients’ socio-demographic, clinical, treatment, health status, metabolic, and genetic characteristics. The wealth of patient data collected in TRIUMPH will provide unique opportunities to examine factors that may mediate racial differences in mortality and health status after MI and the complex interactions between genetic and environmental determinants of post-MI outcomes.

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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.

Importance While there is increasing emphasis on incorporating patient-reported outcome measures (PROMs) in routine care for heart failure (HF) patients, how best to interpret longitudinally collected PROMs is unknown. Objective To examine the strength of association between a prior, a current or change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores with death and hospitalization in patients with preserved (HFpEF) and reduced (HFrEF) ejection fractions. Design, Setting, and Participants Secondary analyses of the TOPCAT trial of 1,372 patients with HFpEF and the HF-ACTION trial that included 1,669 patients with HFrEF. Exposure Prior, current and change in KCCQ Overall Summary scores (KCCQ-os) in 5-points increments (higher scores = better health status) Main Outcomes and Measures Time to cardiovascular death/first HF hospitalization (primary outcome) and all-cause death (secondary outcome). Results Each 5-point difference in prior or current KCCQ-os scores were associated with a 6%-9% and 6%-8% lower risk for subsequent cardiovascular death/first HF hospitalization in patients with HFpEF and HFrEF in unadjusted analyses (all P<0.001). Results were similar for change in KCCQ-os. In models with the prior and current KCCQ-os, only the current KCCQ-os was significantly associated with 10% and 7% lower risk/5 points for subsequent cardiovascular death/first HF hospitalization in patients with HFpEF and HFrEF, respectively (all P<0.001). Similar results were observed when the current and Δ KCCQ-os were considered together, when adjusted for important patient and treatment characteristics, when including 3 sequential KCCQ-os scores and when examining all-cause death as the outcome. Conclusions and Relevance In serial health status evaluations of HF patients, the most recent score was most strongly associated with subsequent death and cardiovascular hospitalization in HFpEF and HFrEF. Measuring serial PROMs in the clinical care of patients with HF can provide an updated assessment of prognosis. Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: TOPCAT (NCT00094302) and HF-ACTION (NCT00047437)

Background-Improving functional status and quality of life are important goals of treatment for patients with severe aortic stenosis. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure health status measure and has been used in studies of patients with aortic stenosis. However, its psychometric properties have not yet been evaluated in these patients. Methods and Results-We analyzed data from 955 patients, enrolled in the PARTNER trial of transcatheter aortic valve replacement, to evaluate the reliability, responsiveness, validity, and prognostic importance of the KCCQ in patients with severe aortic stenosis. The KCCQ was administered at baseline and at 1, 6, and 12 months after randomization to medical therapy, transcatheter aortic valve replacement, or surgical valve replacement. Among clinically stable patients, there were only small changes in the KCCQ domain scores over time (mean differences 0.1-4.2 points), and the intraclass correlation coefficients showed good agreement between paired assessments (0.65-0.76). However, the domain scores of patients who underwent transcatheter aortic valve replacement showed large changes after treatment (mean differences 13-30 points). Construct validity was demonstrated by comparing each domain against a relevant reference measure (Spearman correlations 0.46-0.69). Finally, among 157 patients randomized to medical management, lower KCCQ overall summary scores at baseline were strongly associated with an increased risk of mortality during the following 12 months. Conclusions-The KCCQ is a highly reliable, responsive, and valid measure of symptoms, functional status, and quality of life in patients with severe, symptomatic aortic stenosis. (Circ Heart Fail. 2013;6:61-67.)

BACKGROUND A series of models have been developed to identify patients at high risk for poor outcomes after transcatheter aortic valve replacement (TAVR) to help guide treatment choices, offer patients realistic expectations of long-term outcomes, and support decision making. OBJECTIVES We examined the performance of the previously developed TAVR Poor Outcome risk models in an external dataset and explored the incremental contribution of geriatric domains to model performance. METHODS Poor outcome after TAVR was defined as death, poor quality of life (QOL), or decline in QOL, as assessed using the Kansas City Cardiomyopathy Questionnaire. We tested 4 TAVR Poor Outcome risk models: 6-month and 1-year full and clinical (reduced) models. We examined each model’s discrimination and calibration in the CoreValve trial dataset, then tested the incremental contribution of frailty and disability markers to the model’s discrimination using the incremental discrimination index (IDI). RESULTS Among 2,830 patients who underwent TAVR in the CoreValve US Pivotal Extreme and High Risk trials and associated continued access registries, 31.2% experienced a poor outcome at 6 months following TAVR (death: 17.6%; very poor QOL: 11.6%; QOL decline: 2.0%) and 50.8% experienced a poor outcome at 1 year (death: 30.2%; poor QOL: 19.6%; QOL: decline 1.0%). The models demonstrated similar discrimination as in the Placement of Aortic Transcatheter Valves Trial cohorts (c-indexes: 0.637 to 0.665) and excellent calibration. Adding frailty as a syndrome increased the c-indexes by 0.000 to 0.004 (IDI p < 0.01 for all except the 1-year clinical model), with the most important individual components being disability and unintentional weight loss. CONCLUSIONS Although discrimination of the TAVR Poor Outcome risk models was generally moderate, calibration was excellent among patients with different risk profiles and treated with a different TAVR device. These findings demonstrated the value of these models for individualizing outcome predictions in high-risk patients undergoing TAVR.