Racial Differences in Quality of Life in Patients With Heart Failure Treated With Sodium-Glucose Cotransporter 2 Inhibitors: A Patient-Level Meta-Analysis of the CHIEF-HF, DEFINE-HF, and PRESERVED-HF Trials.

BACKGROUND: Health status outcomes, including symptoms, function, and quality of life, are worse for Black compared with White patients with heart failure. Sodium-glucose cotransporter 2 inhibitors (SGLT2is) reduce cardiovascular mortality and improve health status in patients with heart failure, but whether the health status benefit of SGLT2is is similar across races is not established. The objective of this study was to compare the treatment effect of SGLT2is (versus placebo) on health status for Black compared with White patients with heart failure. METHODS: We combined patient-level data from 3 randomized clinical trials of SGLT2is: DEFINE-HF (Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure; n=263), PRESERVED-HF (Dapagliflozin in Preserved Ejection Fraction Heart Failure; n=324), and CHIEF-HF (A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure; n=448). These 3 United States-based trials enrolled a substantial proportion of Black patients, and each used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure health status at baseline and after 12 weeks of treatment. Among 1035 total participants, selecting self-identified Black and White patients with complete information yielded a final analytic cohort of 935 patients. The primary endpoint was KCCQ Clinical Summary score. Twelve-week change in KCCQ with SGLT2is versus placebo was compared between Black and White patients by testing the interaction between race and treatment using multivariable linear regression models adjusted for trial, baseline KCCQ (as a restricted cubic spline), race, and treatment. The data that support the findings of this study are available from the corresponding author upon reasonable request. RESULTS: Among 935 participants, 236 (25%) self-identified as Black, and 469 (50.2%) were treated with an SGLT2i. Treatment with an SGLT2i, compared with placebo, resulted in KCCQ Clinical Summary score improvements at 12 weeks of +4.0 points (95% CI, 1.7-6.3; P=0.0007) in White patients and +4.7 points (95% CI, 0.7-8.7; P=0.02) in Black patients, with no significant interaction by race and treatment (P=0.76). Other KCCQ scales showed similar results. CONCLUSIONS: Treatment with an SGLT2i resulted in consistent and significant improvements in health status for both Black and White patients with heart failure.

The Psychometric Performance of the Kansas City Cardiomyopathy Questionnaire-12 in Symptomatic Obstructive Hypertrophic Cardiomyopathy.

BACKGROUND: A primary goal of treating patients with obstructive hypertrophic cardiomyopathy (oHCM) is to improve their symptoms, function, and quality of life. While the psychometric properties of the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) have been described in oHCM, they have not been assessed for the shorter 12-item version (KCCQ-12), which is increasingly used in clinical practice. METHODS AND RESULTS: Using data from the EXPLORER-HCM trial, the psychometric properties of the KCCQ-12 were evaluated. The KCCQ-12 domain and summary scores had moderate correlations with the most relevant clinical (New York Heart Association class, exercise duration, peak oxygen consumption) and patient-reported measures (EQ-5D-5L visual analog scale, Work Productivity and Activity Impairment [WPAI] questionnaire, and Hypertrophic Cardiomyopathy Symptom Questionnaire [HCMSQ]). KCCQ-12 domain scores had strong internal consistency and test-retest reliability, demonstrated significant and proportional changes with different magnitudes of clinical change (assessed with the patient global impression of change and patient impression of severity), and demonstrated close equivalence to the KCCQ-23 scores. CONCLUSIONS: The KCCQ-12 demonstrated good psychometric performance for patients with oHCM, comparable to that of the KCCQ-23, supporting its use in clinical practice to care for patients with oHCM.

The Kansas City Cardiomyopathy Questionnaire in Relation to New York Heart Association Class.

BACKGROUND: In order to identify candidacy and treatment response for patients with obstructive hypertrophic cardiomyopathy (oHCM), clinicians need an accurate means of assessing symptoms, function, and quality of life. While the New York Heart Association (NYHA) Classification is most often used, the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) is more accurate and sensitive to change, although less familiar to practicing clinicians. To support interpreting the KCCQ, we describe cross-sectional and changes in KCCQ scores in the context of the NYHA. METHODS: Participants from the EXPLORER-HCM trial (NCT03470545) completed the KCCQ-23 and clinicians assigned NYHA classes at study visits. Participants were included if they had baseline and week 30 data for cross-sectional and longitudinal changes. Median KCCQ-23 scores were compared by NYHA class at baseline and week 30 and by change in NYHA class from baseline to week 30. RESULTS: Cross-sectionally, the KCCQ-23 Overall Summary Scores (KCCQ-23 OSS) and Clinical Summary Scores (KCCQ-23 CSS) had an inverse relationship with NYHA at baseline and 30 weeks, with marked variations in KCCQ-23 scores among patients assigned to the same NYHA class. When improving from NYHA class II to I, the median changes in KCCQ-23 OSS and KCCQ-23 CSS were 10 (IQR 4, 22) and 8 (IQR 2, 20), respectively. The changes were larger when improving from NYHA class III to II and from NYHA class III to I. CONCLUSION: KCCQ-23 scores are inversely related to NYHA classes, with significant variability within classes. Changes in scores are not linear, suggest greater differences when patients move between NYHA Class II and III than Class I and II. These insights may help clinicians better understand cross-sectional and changes in KCCQ scores.

Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication.

BACKGROUND: As a key treatment goal for patients with symptomatic peripheral artery disease (PAD), improving health status has also become an important end point for clinical trials and performance-based care. An understanding of patient factors associated with 1-year PAD health status is lacking in patients with PAD. METHODS: The health status of 1073 consecutive patients with symptomatic PAD in the international multicenter PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry was measured at baseline and 1 year with the Peripheral Artery Questionnaire (PAQ). The association of 47 patient characteristics with 1-year PAQ scores was assessed using a random forest algorithm. Variables of clinical significance were retained and included in a hierarchical multivariable linear regression model predicting 1-year PAQ summary scores. RESULTS: The mean age of patients was 67.7 ± 9.3 years, and 37% were female. Variables with the highest importance ranking in predicting 1-year PAQ summary score were baseline PAQ summary score, Patient Health Questionnaire-8 depression score, Generalized Anxiety Disorder-2 anxiety score, new onset symptom presentation, insurance status, current or prior diagnosis of depression, low social support, initial invasive treatment, duration of symptoms, and race. The addition of 19 clinical variables in an extended model marginally improved the explained variance in 1-year health status (from R2 0.312 to 0.335). CONCLUSIONS: Patients' 1-year PAD-specific health status, as measured by the PAQ, can be predicted from 10 mostly psychosocial and socioeconomic patient characteristics including depression, anxiety, insurance status, social support, and symptoms. These characteristics should be validated and tested in other PAD cohorts so that this model can inform risk adjustment and prediction of PAD health status in comparative effectiveness research and performance-based care.

Optimal timing of staged percutaneous coronary intervention after subintimal tracking and re-entry: Rationale and design of the subintimal tracking and re-entry with deferred stenting study.

BACKGROUND: Ten to fifteen percent of chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) are unsuccessful in contemporary practice. Subintimal tracking and re-entry (STAR) (one form of "investment procedure") with staged reattempt and stenting may further increase the ultimate success and safety of CTO as a bailout strategy. The optimal timing for staged stenting after STAR is unknown. METHODS AND RESULTS: We designed a six-center, prospective randomized trial with a planned enrollment of 150 patients where STAR is utilized in case of impending failure. The primary aim is to evaluate the optimal timing of the staged PCI after STAR by randomizing the timing to earlier (5-7 weeks) versus later (12-14 weeks) staged PCI. The primary endpoint of the study is the technical success rate of the staged procedure. The secondary endpoints include: (1) the rate of thrombolysis in myocardial infarction 3 flow at the start of staged intervention, (2) rate of partial technical and procedural success of the staged procedure, (3) rate of in-hospital and 12-month major cardiac and cerebrovascular adverse events, and (4) change in patient-reported quality at 30 days, 6 months, and 12 months assessed by Seattle Angina Questionnaire. CONCLUSION: This study will ascertain the optimal timing of staged stenting after bail-out STAR approach in contemporary CTO PCI (ClinicalTrials.gov NCT05089864).

Association Between Change in Ambulatory Pulmonary Artery Pressures and Natriuretic Peptides in Patients with Heart Failure: Results From the EMBRACE-HF Trial.

BACKGROUND: Remote monitoring of pulmonary artery (PA) pressures and serial N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurements guide heart failure (HF) treatment, but their association has yet to be described. METHODS AND RESULTS: In the Empagliflozin Evaluation by Measuring the Impact on Hemodynamics in Patients with Heart Failure (EMBRACE-HF) trial, patients with HF and a remote PA pressure monitoring device were randomized to empagliflozin vs placebo. PA diastolic pressures (PADP) and NT-proBNP levels were obtained at baseline and 6 and 12 weeks. We used linear mixed models to examine the association between change in PADP and change in NT-proBNP, adjusting for baseline covariates. Of 62 patients, the mean patient age was 66.2 years, and 63% were male. The mean baseline PADP was 21.8 ± 6.4 mm Hg, and the mean NT-proBNP was 1844.6 ± 2767.7 pg/mL. The mean change between baseline and averaged 6- and 12-week PADP was -0.4 ± 3.1 mm Hg, and the mean change between baseline and averaged 6- and 12-week NT-proBNP was -81.5 ± 878.6 pg/mL. In adjusted analyses, every 2-mm Hg decrease in PADP was associated with an NT-proBNP reduction of 108.9 pg/mL (95% confidence interval -4.3 to 222.0, P = .06). CONCLUSIONS: We observed that short-term decreases in ambulatory PADP seem to be associated with decreases in NT-proBNP. This finding may provide additional clinical context when tailoring treatment for patients with HF.

Percutaneous ventricular assist device for higher-risk percutaneous coronary intervention in surgically ineligible patients: Indications and outcomes from the OPTIMUM study.

BACKGROUND: Indications and outcomes for percutaneous ventricular assist device (pVAD) use in surgically ineligible patients undergoing percutaneous coronary intervention (PCI) remain poorly characterized. AIMS: We sought to describe the use and timing of pVAD and outcome in surgically ineligible patients. METHODS: Among 726 patients enrolled in the prospective OPTIMUM study, clinical and health status outcomes were assessed in patients who underwent pVAD-assisted PCI and those without pVAD. RESULTS: Compared with patients not receiving pVAD (N = 579), those treated with pVAD (N = 142) more likely had heart failure, lower left ventricular ejection fraction (30.7 ± 13.6 vs. 45.9 ± 15.5, p < 0.01), and higher STS 30-day predicted mortality (4.2 [2.1-8.0] vs. 3.3 [1.7-6.6], p = 0.01) and SYNTAX scores (36.1 ± 12.2, vs. 31.5 ± 12.1, p < 0.01). While the pVAD group had higher in-hospital (5.6% vs. 2.2%, p = 0.046), 30-day (9.0% vs. 4.0%, p = 0.01) and 6-month (20.4% vs. 11.7%, p < 0.01) mortality compared to patients without pVAD, this difference appeared to be largely driven by significantly higher mortality among the 20 (14%) patients with unplanned pVAD use (30% in-hospital mortality with unplanned PVAD vs. 1.6% with planned, p < 0.01; 30-day mortality, 38.1% vs. 4.5%, p < 0.01). The degree of 6-month health status improvement among survivors was similar between groups. CONCLUSION: Surgically ineligible patients with pVAD-assisted PCI had more complex baseline characteristics compared with those without pVAD. Higher mortality in the pVAD group appeared to be driven by very poor outcomes by patients with unplanned, rescue pVAD.

Predictors of Revascularization in Lower-Extremity Peripheral Artery Disease: Insights From the PORTRAIT Study.

BACKGROUND: Peripheral artery disease (PAD) guidelines recommend revascularization only for patients with lifestyle-limiting claudication that is refractory to goal-directed medical therapy (class IIA, level of evidence A). However, real-world invasive treatment patterns and predictors of revascularization in patients with symptomatic lower-extremity PAD are still largely unknown. AIM: We aimed to examine rates, patient-level predictors, and site variability of early revascularization in patients with new or worsening PAD symptoms. METHODS: Among patients with new-onset or recent exacerbation of PAD in the 10-center Patient-centered Outcomes Related to TReatment practices in peripheral Arterial disease: Investigating Trajectories (PORTRAIT) study enrolled between June 2011 and September 2015, we classified early revascularization (endovascular or surgical) as procedures being performed within 3 months of presentation. Hierarchical logistic regression was used to identify patient characteristics associated with early revascularization. Variability across sites was estimated using the median odds ratio (OR). RESULTS: Among 797 participants, early revascularization procedures were performed in 224 (28.1%). Rutherford class 3 (vs Rutherford class 1; OR=1.86, 95% confidence interval [CI] 1.04-3.33) and having lesions in both iliofemoral and below-the-knee arterial segments (vs below the knee only; OR=1.75, 95% CI: 1.15-2.67) were associated with a higher odds of revascularization. Longer PAD duration >12 months (vs 1-6 months; OR=0.50, 95% CI: 0.32-0.77), higher ankle-brachial index scores (per 0.1 unit increase; OR=0.86, 95% CI: 0.78-0.96), and higher Peripheral Artery Questionnaire Summary scores (per 10 unit increase; OR=0.89, 95% CI: 0.80-0.99) were associated with a lower odds of revascularization. The raw rates for revascularization in different sites ranged from 6.25% to 66.28%, and the median OR was 1.88, 95% CI: 1.38-3.57. CONCLUSIONS: About 1 in 3 patients with symptomatic PAD received early revascularization. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD. There was significant site variability in revascularization patterns, and further studies will better understand the source of this variability and optimal selection criteria for early revascularization. CLINICAL IMPACT: Real world patterns and predictors of early revascularization in peripheral artery disease are not well understood. In this retrospective analysis of the POTRAIT study, about 1 out of 3 patients with PAD symptoms received early revascularization, with significant site variability. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD.

Development and validation of a prediction model for angiographic perforation during chronic total occlusion percutaneous coronary intervention: OPEN-CLEAN perforation score.

BACKGROUND: Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality. METHODS: Among 1,000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN CTO), all perforations were reviewed by the angiographic core-lab. Eighty-nine patients (8.9%) with angiographic perforation were compared to 911 patients without perforation. We sought to describe the clinical and angiographic predictors of angiographic perforation during CTO PCI and develop a risk prediction model. RESULTS: Among eight clinically important candidate variables, independent risk factors for perforation included prior CABG (OR 2.0 [95% CI, 1.2-3.3], p < .01), occlusion length (OR 1.2 per 10 mm increase [95% CI, 1.1-1.3], p < .01), ejection fraction (OR 1.2 per 10% decrease [95% CI, 1.1-1.5], p < .01), age (OR 1.3 per 5 year increase [95%CI, 1.1-1.5], p < .01), and heavy calcification (OR 1.7 [95% CI, 1.0-2.7], p = .04). Three other potential candidate variables, glomerular filtration rate, proximal cap ambiguity, and target vessel, were not independently associated with perforation. The model was internally validated using bootstrapping methods. From the full model, a simplified perforation prediction score (OPEN-CLEAN score: CABG, Length [occlusion], EF < 50%, Age, CalcificatioN) was developed, which discriminated the risk of angiographic perforation well (c-statistics = 0.75) and demonstrated good calibration. CONCLUSION: This simple 5-variable prediction score may help CTO operators to risk-stratify patients for angiographic perforation using variables available prior to CTO PCI procedures.

Use of oral anticoagulants in patients with valvular atrial fibrillation: findings from the NCDR PINNACLE Registry.

Recent data suggest direct oral anticoagulants are as safe and efficacious as warfarin among select patients with valvular heart disease and atrial fibrillation (AF). However, real-world treatment patterns of AF stroke prophylaxis in the setting of valvular AF are currently unknown. Accordingly, using the prospective, ambulatory National Cardiovascular Data Registry Practice Innovation and Clinical Excellence (PINNACLE) Registry, we sought to characterize overall use, temporal trends in use, and the extent of practice-level variation in the use of any direct oral anticoagulant and warfarin among patients with valvular AF from January 1, 2013, to March 31, 2019.

Impact of body mass index on outcome and health status after chronic total occlusion percutaneous coronary intervention: Insights from the OPEN-CTO study.

BACKGROUND: The effect of body mass index (BMI) on the procedural outcomes and health status (HS) change after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is largely unknown. METHODS: Thousand consecutive patients enrolled in a 12-center prospective CTO PCI study (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures [OPEN-CTO]) were categorized into three groups by baseline BMI (obese ≥30, overweight 25-30, and normal 18.5-25), after excluding seven patients with BMI <18.5. Baseline and follow-up HS at 1 year were quantified using the Seattle Angina Questionnaire, Rose Dyspnea Score, and Personal Health Questionnaire-8 (PHQ-8). Hierarchical, multivariable logistic, and repeated measures linear regression models were used to assess procedural success, major adverse cardiovascular and cerebrovascular events (MACCE), and HS outcomes, as appropriate. RESULTS: The obese and overweight were 47.6% and 37.4%, respectively. While procedure time and contrast dose were similar among the groups, total radiation dose (mGy) was higher with increased BMI (3,019 ± 2,027, 2,267 ± 1,714, 1,642 ± 1,223, p < .01). Procedural success rates, as well as MACCE rates, were similar among the three groups (obese 83.1%, overweight 79.8%, normal 81.9%, p = .47 and 5.1, 8.4, and 8.7%, p = .11). These rates remained similar after adjustment for baseline characteristics. The HS improvement from baseline to 12 months after adjustment was similar in obese and overweight patients compared to normal weight patients. CONCLUSIONS: CTO PCI in obese and overweight patients can be performed with similar success and complication rates. Obese and overweight patients derive similar HS benefit from CTO PCI compared to normal weight patients.

Initial report of safety and procedure duration of robotic-assisted chronic total occlusion coronary intervention.

BACKGROUND: No previous reports have examined the impact of robotic-assisted (RA) chronic total occlusion (CTO) PCI on procedural duration or safety compared to totally manual CTO PCI. METHODS: Among 95 patients who underwent successful PCI of a single CTO lesion at two centers, 49 (52%) were performed RA and were performed 46 (48%) totally manually. Cockpit time was the time the primary operator entered to robotic cockpit until the procedure was complete. "Theoretical" cockpit time in the control group was time the primary operator would have entered the cockpit after lesion crossing until the procedure was complete. Major adverse events (MAEs) were the composite of death, myocardial infarction, clinical perforation, significant vessel dissection, arrhythmia, acute thrombosis, and stroke. RESULTS: The lesion characteristics, procedural time, and contrast dose were similar. All procedures except for one (2%) selected for robotic completion after lesion crossing were completed successfully. The frequency of MAE was similar between groups and there were no in-hospital deaths. The cockpit time was 8 min longer in RA CTO PCI than the theoretical cockpit time in totally manual CTO PCI (40.6 ± 12.7 vs. 32.1 ± 17.8, p < .01). CONCLUSION: RA CTO PCI was not associated with excess adverse events compared with totally manual CTO PCI and resulted in an average 41 min cockpit time equaling to 48% of procedure time without radiation exposure or requirement for the primary operator to wear a lead apron. Understanding the relationship between cockpit time and reductions in radiation exposure and lead apron-related orthopedic complications for operators requires future study.

Ankle-brachial index in patients with intermittent claudication is a poor indicator of patient-centered and clinician-based evaluations of functional status.

BACKGROUND: The association between the severity of ankle-brachial index (ABI), a traditional measure of the severity of peripheral artery disease (PAD), and patients' perceptions of their health status is poorly characterized. In Patient-Centered Outcomes Related to Treatment Practices in Peripheral Artery Disease: Investigating Trajectories (PORTRAIT), a study of patients with intermittent claudication (IC), we studied the correlation of ABI values and Rutherford symptom classification with PAD-specific health status as measured by the Peripheral Artery Questionnaire (PAQ). METHODS: Among 1251 patients with new onset or exacerbation of IC enrolled at 16 sites in the United States, Netherlands, and Australia, ABI values were categorized as mild (>0.80), moderate (0.40-0.79), and severe (<0.40). Spearman rank correlation coefficients were calculated between raw ABI values and PAQ scores and between the Rutherford classification and PAQ scores. RESULTS: Mean ABI was 0.67 (standard deviation, 0.19); 24.3% had mild, 67.6% moderate, and 8.1% severe PAD. According to the Rutherford classification, 22.7% were stage 1 (mild claudication), 49.5% stage 2 (moderate claudication), and 27.8% stage 3 (severe claudication). Correlations (95% confidence interval) were found between ABI and the PAQ summary score (r = 0.09 [0.04-0.15]) and the PAQ physical limitations score (r = 0.14 [0.09-0.20]); no correlations were found between ABI and the PAQ quality of life score (r = 0.03 [-0.02 to 0.09]) and the PAQ symptoms score (r = 0.04 [-0.01 to 0.10]). With the correlations between ABI and PAQ scores, ABI explained only 0.1% to 2.1% of the variation in PAQ scores. Rutherford classification had stronger but still modest associations with PAQ scores (PAQ summary, r = -0.27 [-0.21 to -0.32]; PAQ quality of life, r = -0.21 [-0.16 to -0.27]; PAQ symptoms, r = -0.18 [-0.13 to -0.23]; PAQ physical limitations, r = -0.27 [-0.22 to -0.32]); Rutherford class explained 3.2% to 7.3% of the variation in PAQ scores. CONCLUSIONS: In a large, international cohort of patients with IC, patient-centered health status assessments are weakly associated with physicians' or hemodynamic assessments. To best measure the impact of PAD on patients' symptoms, functional capacity, and quality of life, direct assessment from patients is needed, rather than relying on physiologic or clinician-assigned assessments.

Impact of subintimal plaque modification procedures on health status after unsuccessful chronic total occlusion angioplasty.

OBJECTIVES: We sought to determine the impact of subintimal plaque modification (SPM) on early health status following unsuccessful chronic total occlusion (CTO) PCI. BACKGROUND: Intentionally dilating the subintimal space during unsuccessful CTO PCI to facilitate flow through dissection planes and improve success of repeat PCI attempts is a technique used by some hybrid operators, and may improve health status by restoring distal vessel flow despite unsuccessful CTO PCI. METHODS: We studied 138 patients who underwent unsuccessful CTO PCI in a 12-center CTO PCI registry. Safety was assessed by comparing in-hospital outcomes of patients undergoing unsuccessful CTO PCI with and without SPM. The association between SPM and health status was quantified using the Seattle Angina Questionnaire Summary Score (SAQ SS), and the association between SPM and SAQ SS was determined using multivariable regression. RESULTS: SPM was performed in 59 patients (42.8%). Complication rates were similar comparing those with and without SPM. At 1-month, patients treated with SPM had larger increases in SAQ SS compared to patients who were not (28.3 ± 21.7 vs. 16.8 ±20.2, P = 0.012), and SPM was associated with an adjusted mean 10.5 point (95% CI 1.4-19.7, P = 0.02) greater SAQ SS improvement through 30 days. CONCLUSION: SPM was performed in almost half of unsuccessful CTO PCIs and was not associated with increased procedural complications. SPM was independently associated with better patient-reported health status at 30 days. Further studies are needed to assess the necessity of subsequent PCI in patients with significant health status improvements after SPM.

Initiation of ß-blocker therapy and depression after acute myocardial infarction.

INTRODUCTION: Although ß-blockers reduce mortality after acute myocardial infarction (AMI), early reports linking ß-blocker use with subsequent depression have potentially limited their use in vulnerable patients. We sought to provide empirical evidence to support or refute this concern by examining the association between ß-blocker initiation and change in depressive symptoms in AMI patients. METHODS: Using data from 2 US multicenter, prospective registries of AMI patients, we examined 1-, 6-, and 12-month changes in depressive symptoms after the index hospitalization among patients who were ß-blocker-naïve on admission. Depressive symptoms were assessed using the validated 8-item Patient Health Questionnaire (PHQ-8), which rates depressive symptoms from 0 to 24, with higher scores indicating more depressive symptoms. A propensity-matched repeated-measures linear regression model was used to compare change in depressive symptoms among patients who were and were not initiated on a ß-blocker after AMI. RESULTS: Of 3,470 AMI patients who were ß-blocker-naïve on admission, 3,190 (91.9%) were initiated on a ß-blocker and 280 (8.1%) were not. Baseline PHQ-8 scores were higher in patients not initiated on a ß-blocker (mean 5.78 ± 5.45 vs 4.88 ± 5.11, P = .005). PHQ-8 scores were progressively lower at 1, 6, and 12 months in both the ß-blocker (mean decrease at 12 months 1.16, P < .0001) and no-ß-blocker groups (mean decrease 1.71, P < .0001). After propensity matching 201 untreated patients with 567 treated patients, initiation of ß-blocker therapy was not associated with a difference in mean change in PHQ-8 scores at 1, 6, or 12 months after AMI (absolute mean difference with ß-blocker initiation at 12 months of 0.08, 95% CI -0.81 to 0.96, P = .86). CONCLUSIONS: Initiation of ß-blocker therapy after AMI was not associated with an increase in depressive symptoms. Restricting ß-blocker use because of concerns about depression appears unwarranted and may lead to undertreatment of AMI patients.

Usual source of care and outcomes following acute myocardial infarction.

BACKGROUND: The quality of the relationship between a patient and their usual source of care may impact outcomes, especially after an acute clinical event requiring regular follow-up. OBJECTIVE: To examine the association between the presence and strength of a usual source of care with mortality and readmission after hospitalization for acute myocardial infarction (AMI). DESIGN: Prospective Registry Evaluating Myocardial Infarction: Event and Recovery (PREMIER), an observational, 19-center study. PATIENTS: AMI patients discharged between January 2003 and June 2004. MAIN MEASURES: The strength of the usual source of care was categorized as none, weak, or strong based upon the duration and familiarity of the relationship. Main outcome measures were readmissions and mortality at 6 months and 12 months post-AMI, examined in multivariable analysis adjusting for socio-demographic characteristics, access and barriers to care, financial status, baseline risk factors, and AMI severity. KEY RESULTS: Among 2,454 AMI patients, 441 (18.0 %) reported no usual source of care, whereas 247 (10.0 %) and 1,766 (72.0 %) reported weak and strong usual sources of care, respectively. When compared with a strong usual source of care, adults with no usual source of care had higher 6-month mortality rates [adjusted hazard ratio (aHR) = 3.15, 95 % CI, 1.79-5.52; p < 0.001] and 12-month mortality rates (aHR = 1.92, 95 % CI, 1.19-3.12; p = 0.01); adults with a weak usual source of care trended toward higher mortality at 6 months (aHR = 1.95, 95 % CI, 0.98-3.88; p = 0.06), but not 12 months (p = 0.23). We found no association between the usual source of care and readmissions. CONCLUSIONS: Adults with no or weak usual sources of care have an increased risk for mortality following AMI, but not for readmission.

Early Longitudinal Change in Heart Failure Health Status Following Initiation of Canagliflozin.

BACKGROUND: Sodium glucose co-transporter 2 inhibitor (SGLT2i) therapy improves health status in heart failure (HF). There is insufficient description regarding the timing, rate, and extent of the health status changes in heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) after initiation of SGLT2is. OBJECTIVES: The authors sought to model the association of canagliflozin treatment with rates of change in HF symptom status in HFpEF and HFrEF. METHODS: Study participants with HFrEF and HFpEF were treated with either canagliflozin 100 mg or placebo for 12 weeks. The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) was assessed at baseline and at 2, 4, 6, and 12 weeks. Longitudinal modeling assessed slope of KCCQ change across the study. RESULTS: Among 448 individuals with HF (181 with HFrEF and 267 with HFpEF), participants with HFpEF had lower baseline KCCQ-TSS scores than those with HFrEF (54 ± 21 vs 64 ± 20). Modeling demonstrated initial rapid improvement in KCCQ-TSS in both HF groups, with deceleration over the next 4 to 6 weeks. The rate of change was greater among HFpEF participants (0.7 points/day; 95% CI: 0.3-1.1 points/day) than HFrEF participants (ΔKCCQ-TSS/day = 0.5; 95% CI: 0.1-1.0 points/day) randomized to canagliflozin, but these differences were not statistically significant (0.2 points/day; 95% CI: -0.4 to 0.7 points/day; P = 056). CONCLUSIONS: After canagliflozin therapy, regardless of EF, modeling shows the KCCQ-TSS improves rapidly with the greatest improvements occurring within the first weeks of treatment. These results have implications for clinical use of SGLT2is and may be useful in the design of trials examining impact of these agents on health status in HF. (A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure [CHIEF-HF]; NCT04252287).

Initiation of statin therapy after acute myocardial infarction is not associated with worsening depressive symptoms: insights from the Prospective Registry Evaluating Outcomes After Myocardial Infarctions: Events and Recovery (PREMIER) and Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) registries.

BACKGROUND: Whereas statins are considered the cornerstone of prevention after acute myocardial infarction (AMI), concerns about worsening depression in association with their use have been raised. METHODS: Using data from 2 prospective AMI registries (PREMIER and TRIUMPH), we examined the change in depressive symptoms from baseline and at 1, 6 and 12 months among statin-naïve patients who were and were not discharged on a statin. Depressive symptoms were assessed with the 8-item Patient Health Questionnaire (PHQ-8). Within-group change in PHQ-8 scores from baseline to each follow-up period was assessed using paired t tests. A repeated-measures propensity-matched analysis examined whether changes in PHQ-8 scores from baseline were different between statin-treated and statin-untreated patients. RESULTS: Of 3,675 patients not previously treated with statins, 3,050 (83%) were discharged on a statin and 625 (17%) were not. Scores of PHQ-8 in the statin group decreased from baseline by a mean (± SD) of 0.9 (± 5.1), 1.2 (± 5), and 1.1 (± 5.1) at 1, 6, and 12 months, respectively. Corresponding changes in the nonstatin group were 0.9 (± 5.2), 1.3 (± 5.1), and 1.5 (± 5.8), respectively (P < .0001 for all comparisons). After propensity matching, 451 patients not discharged on statins with 1,240 patients discharged on statins, the mean change in PHQ-8 scores between baseline and the 3 follow-up time points was not significantly different between groups (mean between-group difference at 1 month: -0.13, 95% CI [-0.69 to 0.43], P = .65; at 6 months: -0.07, 95% CI [-0.66 to 0.52], P = .82; and at 12 months: -0.05, 95% CI [-0.67 to 0.58], P = .88). CONCLUSIONS: Initiation of statins after AMI was not associated with worsening depression.

Health Status Outcomes in Older Adults Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention.

Background Although chronic total occlusions (CTOs) are common in older adults, they are less likely to be offered CTO percutaneous coronary intervention for angina relief than younger adults. The health status impact of CTO percutaneous coronary intervention in adults aged ≥75 years has not been studied. We sought to compare technical success rates and angina-related health status outcomes at 12 months between adults aged ≥75 and <75 years in the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion) registry. Methods and Results Angina-related health status was assessed with the Seattle Angina Questionnaire (score range 0-100, higher scores denote less angina). Technical success rates were compared using hierarchical modified Poisson regression, and 12-month health status was compared using hierarchical multivariable linear regression between adults aged ≥75 and <75 years. Among 1000 participants, 19.8% were ≥75 years with a mean age of 79.5±4.1 years. Age ≥75 years was associated with a lower likelihood of technical success (adjusted risk ratio=0.92 [95% CI, 0.86-0.99; P=0.02]) and numerically higher rates of in-hospital major adverse cardiovascular events (9.1% versus 5.9%, P=0.10). There was no difference in Seattle Angina Questionnaire Summary Score at 12 months between adults aged ≥75 and <75 years (adjusted difference=0.9 [95% CI, -1.4 to 3.1; P=0.44]). Conclusions Despite modestly lower success rates and higher complication rates, adults aged ≥75 years experienced angina-related health status benefits after CTO-percutaneous coronary intervention that were similar in magnitude to adults aged <75 years. CTO percutaneous coronary intervention should not be withheld based on age alone in otherwise appropriate candidates.