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Aims Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health—with a psychological intervention if needed—psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. Methods and results This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0–100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [ B = −2.67, 95% confidence interval (CI) (−5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [ B = −0.49, 95% CI (−1.19; 0.21), P = 0.17] or anxiety symptoms [ B = −0.39, 95% CI (−0.96; 0.18), P = 0.18]. Conclusion The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients. [ABSTRACT FROM AUTHOR]

Conventional randomized controlled trials (RCTs) can be expensive, time intensive, and complex to conduct. Trial recruitment, participation, and data collection can burden participants and research personnel. In the past two decades, there have been rapid technological advances and an exponential growth in digitized healthcare data. Embedding RCTs, including cardiovascular outcome trials, into electronic health record systems or registries may streamline screening, consent, randomization, follow-up visits, and outcome adjudication. Moreover, wearable sensors (i.e. health and fitness trackers) provide an opportunity to collect data on cardiovascular health and risk factors in unprecedented detail and scale, while growing internet connectivity supports the collection of patient-reported outcomes. There is a pressing need to develop robust mechanisms that facilitate data capture from diverse databases and guidance to standardize data definitions. Importantly, the data collection infrastructure should be reusable to support multiple cardiovascular RCTs over time. Systems, processes, and policies will need to have sufficient flexibility to allow interoperability between different sources of data acquisition. Clinical research guidelines, ethics oversight, and regulatory requirements also need to evolve. This review highlights recent progress towards the use of routinely generated data to conduct RCTs and discusses potential solutions for ongoing barriers. There is a particular focus on methods to utilize routinely generated data for trials while complying with regional data protection laws. The discussion is supported with examples of cardiovascular outcome trials that have successfully leveraged the electronic health record, web-enabled devices or administrative databases to conduct randomized trials. [ABSTRACT FROM AUTHOR]

Aims  While myocardial ischaemia plays a major role in the pathogenesis of heart failure (HF), the indications for coronary angiography during acute HF are not established. We determined the association of early coronary angiography during acute HF hospitalization with 2-year mortality, cardiovascular death, HF readmissions, and coronary revascularization. Methods and results  In a two-stage sampling process, we identified acute HF patients who presented to 70 emergency departments in Ontario (April 2010 to March 2013) and determined whether they underwent early coronary angiography within 14 days after presentation using administrative databases. After clinical record review, we defined a cohort with acute ischaemic HF as patients with at least one factor suggesting underlying ischaemic heart disease, including previous myocardial infarction, troponin elevation, or angina on presentation. We oversampled patients undergoing angiography. We used inverse-probability-of-treatment weighting (IPTW) to adjust for baseline differences. Of 7239 patients with acute HF, 2994 met inclusion criteria [median age 75 (interquartile range 65–83) years; 40.9% women]. Early angiography was performed in 1567 patients (52.3%) and was associated with lower all-cause mortality [hazard ratio (HR) 0.74, 95% confidence interval (CI) 0.61–0.90, P  = 0.002], cardiovascular death (HR 0.72, 95% CI 0.56–0.93, P  = 0.012), and HF readmissions (HR 0.84, 95% CI 0.71–0.99, P  = 0.042) after IPTW. Those undergoing early angiography experienced higher rates of percutaneous coronary intervention (HR 2.58, 95% CI 1.73–3.86, P  < 0.001) and coronary artery bypass grafting (HR 2.94, 95% CI 1.75–4.93, P  < 0.001) within 2 years. Conclusions  Early coronary angiography was associated with lower all-cause mortality, cardiovascular death, HF readmissions, and higher rates of coronary revascularization in acute HF patients with possible ischaemia. [ABSTRACT FROM AUTHOR]

The document is a comment on the European Medicines Agency's evaluation of mavacamten for symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The author expresses concern about the EMA's interpretation of the benefits of mavacamten on patients' health status. They argue that the clinical trials reviewed by the EMA used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure health status, and that a 5-point change in the KCCQ score is considered small but clinically important. The author believes that a larger proportion of patients experienced clinically important improvements in symptoms, function, and quality of life when treated with mavacamten. [Extracted from the article]

Aims To examine whether test utilization and prevalence of ischemia with positron emission tomography (PET) myocardial perfusion imaging (MPI) follow the previously described trends with single photon computed tomography (SPECT). Methods and results MPI studies performed between January 2003 and December 2017 were identified. Number of PET and SPECT MPI studies performed per year was determined. Trends in the proportion of studies showing any ischaemia (>0%) with both modalities were compared before and after adjusting for baseline differences in patient characteristics using propensity scores. Interaction between imaging modality and year of testing was examined using modified Poisson regression. A total of 156 244 MPI studies were performed (30% PET and 70% SPECT). Between 2003 and 2017, the number of PET studies increased from 18 to 61 studies/1000 patient encounters, while SPECT volumes declined from 169 to 34/1000 patient encounters (P  < 0.001 for within-group comparisons). The prevalence of any ischaemia in SPECT-tested patients declined from 53.9% to 28.3% between 2003 and 2017, whereas ischaemia prevalence in PET-tested patients declined from 57.2% to 38.2% (P  < 0.001 for within-modality comparisons), with more PET studies showing ischaemia compared to SPECT [relative risk (RR) 1.44, 95% confidence interval (CI) 1.42–1.47; P  < 0.001]. After propensity score matching of 26 066 patients tested with SPECT with 26 066 patients tested with PET, the between-modality difference in ischaemia prevalence was significantly attenuated, with a slightly higher overall likelihood of detecting ischaemia with PET compared to SPECT (RR 1.08, 95% CI 1.05–1.11; P  < 0.001). Conclusions Utilization of PET MPI at a large-volume referral centre increased significantly between 2003 and 2017. Despite a significant decrease in the prevalence of ischaemia with SPECT and PET during the same period, the decline was less with PET, perhaps related to baseline risk of tested patients. [ABSTRACT FROM AUTHOR]

Aims: Incorporating patient-reported outcomes (PROs) into routine care of atrial fibrillation (AF) enables direct integration of symptoms, function, and health-related quality of life (HRQoL) into practice. We report our initial experience with a system-wide PRO initiative among AF patients.Methods and Results: All patients with AF in our practice undergo PRO assessment with the Toronto AF Severity Scale (AFSS), and generic PROs, prior to electrophysiology clinic visits. We describe the implementation, feasibility, and results of clinic-based, electronic AF PRO collection, and compare AF-specific and generic HRQoL assessments. From October 2016 to February 2019, 1586 unique AF patients initiated 2379 PRO assessments, 2145 of which had all PRO measures completed (90%). The median completion time for all PRO measures per visit was 7.3 min (1st, 3rd quartiles: 6, 10). Overall, 38% of patients were female (n = 589), mean age was 68 (SD 12) years, and mean CHA2DS2-VASc score was 3.8 (SD 2.0). The mean AFSS symptom score was 8.6 (SD 6.6, 1st, 3rd quartiles: 3, 13), and the full range of values was observed (0, 35). Generic PROs of physical function, general health, and depression were impacted at the most severe quartiles of AF symptom score (P < 0.0001 for each vs. AFSS quartile).Conclusion: Routine clinic-based, PRO collection for AF is feasible in clinical practice and patient time investment was acceptable. Disease-specific AF PROs add value to generic HRQoL instruments. Further research into the relationship between PROs, heart rhythm, and AF burden, as well as PRO-guided management, is necessary to optimize PRO utilization. [ABSTRACT FROM AUTHOR]

Aims The prognosis of patients with MINOCA (myocardial infarction with non-obstructive coronary arteries) is poorly understood. We examined major adverse cardiac events (MACE) defined as all-cause mortality, re-hospitalization for acute myocardial infarction (AMI), heart failure (HF), or stroke 12-months post-AMI in patients with MINOCA versus AMI patients with obstructive coronary artery disease (MICAD). Methods and results Multicentre, observational cohort study of patients with AMI (≥65 years) from the National Cardiovascular Data Registry CathPCI Registry (July 2009–December 2013) who underwent coronary angiography with linkage to the Centers for Medicare and Medicaid (CMS) claims data. Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis. The primary endpoint was MACE at 12 months, and secondary endpoints included the components of MACE over 12 months. Among 286 780 AMI admissions (276 522 unique patients), 16 849 (5.9%) had MINOCA. The 12-month rates of MACE (18.7% vs. 27.6%), mortality (12.3% vs. 16.7%), and re-hospitalization for AMI (1.3% vs. 6.1%) and HF (5.9% vs. 9.3%) were significantly lower for MINOCA vs. MICAD patients (P < 0.001), but was similar between MINOCA and MICAD patients for re-hospitalization for stroke (1.6% vs. 1.4%, P  = 0.128). Following risk-adjustment, MINOCA patients had a 43% lower risk of MACE over 12 months (hazard ratio = 0.57, 95% confidence interval 0.55–0.59), in comparison to MICAD patients. This pattern was similar for adjusted risks of the MACE components. Conclusion This study confirms an unfavourable prognosis in elderly patients with MINOCA undergoing coronary angiography, with one in five patients with MINOCA suffering a major adverse event over 12 months. Open in new tab Download slide Open in new tab Download slide [ABSTRACT FROM AUTHOR]

Aims  Positron emission tomography (PET) myocardial perfusion imaging (MPI) can non-invasively measure myocardial blood flow reserve (MBFR). We aimed to examine whether MBFR identifies patients with a survival benefit after revascularization, helping to guide post-test management. Methods and results  We examined all-cause mortality in 12 594 consecutive patients undergoing Rb82 rest/stress PET MPI from January 2010 to December 2016, after excluding those with cardiomyopathy, prior coronary artery bypass surgery (CABG), and missing MBFR. Myocardial blood flow reserve was calculated as the ratio of stress to rest absolute myocardial blood flow. A Cox model adjusted for patient and test characteristics, early revascularization (percutaneous coronary intervention or CABG ≤90 days of MPI), and the interaction between MBFR and early revascularization was developed to identify predictors of all-cause mortality. After a median follow-up of 3.2 years, 897 patients (7.1%) underwent early revascularization and 1699 patients (13.5%) died. Ischaemia was present in 4051 (32.3%) patients, with 1413 (11.2%) having ≥10% ischaemia. Mean MBFR was 2.0 ± 1.3, with MBFR <1.8 in 4836 (38.5%). After multivariable adjustment, every 0.1 unit decrease in MBFR was associated with 9% greater hazard of all-cause death (hazard ratio 1.09, 95% confidence interval 1.08–1.10; P  < 0.001). There was a significant interaction between MBFR and early revascularization (P  < 0.001); such that patients with MBFR ≤1.8 had a survival benefit with early revascularization, regardless of type of revascularization or level of ischaemia. Conclusion  Myocardial blood flow reserve on PET MPI is associated with all-cause mortality and can identify patients who receive a survival benefit with early revascularization compared to medical therapy. This may be used to guide revascularization, and prospective validation is needed. [ABSTRACT FROM AUTHOR]

An editorial is presented on Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction. Topics include providing the complete understanding of the health status benefits of empagliflozin on patients' health status; and diminishing the mean population-level benefits of empagliflozin by improving the health status of patients being minimally symptomatic.

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patientrelated outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices. [ABSTRACT FROM AUTHOR]

Background: Angina and depression are common in ischemic heart disease (IHD), but their association remains understudied. Purpose: This study was conducted in order to evaluate the association of 1 year change in depression with change in patient-reported outcomes of stable angina. Methods: Five hundred sixty-nine stable angina patients completed the Seattle Angina Questionnaire and Patient Health Questionnaire (PHQ) at baseline and 1 year. Participants were divided into four groups: not depressed, new onset of depression at 1 year, remitted at 1 year, and persistently depressed. Associations between depression and angina symptoms were evaluated using regression models. Results: Compared to those not depressed, newly depressed participants reported more angina ( β = −11.7, p < 0.001) and physical limitations ( β = −11.8, p < 0.001) and lower treatment satisfaction ( β = −15.03, p < 0.001) and quality of life ( β = −15.4, p < 0.001). Persistently depressed participants reported physical limitations ( β = −7.4, p < 0.05), lower treatment satisfaction ( β = −10.1, p < 0.001), and poorer quality of life ( β = −10.03, p < 0.001). Conclusions: Changes in depression scores and angina outcomes were significantly associated. [ABSTRACT FROM AUTHOR]

Aims High-density lipoprotein (HDL) is highly heterogeneous and the link of its subclasses to prognosis remains controversial. We aimed to rigorously examine the associations of HDL subclasses with prognosis in secondary prevention. Methods and results We collaboratively analysed data from two, complementary prospective cohorts: the TRIUMPH study of 2465 acute myocardial infarction patients, and the IHCS study of 2414 patients who underwent coronary angiography. All patients had baseline HDL subclassification by vertical-spin density gradient ultracentrifugation. Given non-linearity, we stratified by tertiles of HDL-C and its two major subclasses (HDL2-C, HDL3-C), then compared multivariable-adjusted hazard ratios for mortality and mortality/myocardial infarction. Patients were middle-aged to elderly (TRIUMPH: 58.2 ± 12.2 years; IHCS: 62.6 ± 12.6 years), and the majority were men (TRIUMPH: 68.0%; IHCS: 65.5%). IHCS had lower mean HDL-C levels (34.6 ± 10.1 mg/dL) compared with TRIUMPH (40 ± 10.6 mg/dL). HDL3-C accounted for >3/4 of HDL-C (mean HDL3-C/HDL-C 0.78 ± 0.05 in both cohorts). During 2 years of follow-up in TRIUMPH, 226 (9.2%) deaths occurred, while death/myocardial infarction occurred in 401 (16.6%) IHCS patients over 5 years. No independent associations with outcomes were observed for HDL-C or HDL2-C. In contrast, the lowest tertile of HDL3-C was independently associated with >50% higher risk in each cohort (TRIUMPH: with middle tertile as reference, fully adjusted HR for mortality of HDL3-C, 1.57; 95% CI, 1.13–2.18; IHCS: fully adjusted HR for mortality/myocardial infarction, 1.55; 95% CI, 1.20–2.00). Conclusion In secondary prevention, increased risk for long-term hard clinical events is associated with low HDL3-C, but not HDL2-C or HDL-C, highlighting the potential value of subclassifying HDL-C. [ABSTRACT FROM PUBLISHER]

Background: Emotional support and depression may influence adherence to risk factor management instructions after acute myocardial infarction (AMI), but their role requires further investigation. Purpose: To examine the longitudinal association between perceived emotional support and risk factor management adherence and assess depressive symptoms as a moderator of this association. Methods: Among 2,202 AMI patients, we assessed adherence to risk factor management instructions over the first recovery year. Modified Poisson mixed-effects regression evaluated associations, with adjustment for demographic and clinical factors. Results: Patients with low baseline support had greater risk of poor adherence over the first year than patients with high baseline support (relative risk [RR] = 1.20, 95% confidence interval [CI] = 1.02-1.43). In stratified analyses, low support remained a significant predictor of poor adherence for non-depressed (RR = 1.41, 95% CI = 1.23-1.61) but not depressed (RR = 1.01, 95% CI = 0.78-1.30) patients ( p for interaction < 0.001). Conclusions: Low emotional support is associated with poor risk factor management adherence after AMI. This relationship is moderated by depression, with a significant relationship observed only among non-depressed patients. [ABSTRACT FROM AUTHOR]

Abstract: Background: Premature stopping of anti-platelet therapy has potentially fatal consequences for myocardial infarction (MI) patients who have received a drug-eluting stent (DES). Exploring multiple perspectives to identify contributing factors to the problem is essential. Aim: We gained patient and clinician perspectives as to why MI patients prematurely stop anti-platelet therapy (clopidogrel) after DES implantation. Methods: This qualitative, descriptive study of DES-treated MI patients (n =22) and of clinicians (physicians and nurse practitioners; n =17) from multiple U.S. cities used content analysis of interview data. Findings across patients and clinicians were then compared to examine congruent and contrasting reasons for premature clopidogrel discontinuance. Findings: Patients frequently identified communication and education (e.g. unaware they should be taking clopidogrel, unaware of intended duration of therapy) as the primary reasons for having stopped. Patients rarely cited cost, while clinicians most commonly cited cost as a reason for premature stopping. Conclusions: The discrepancy in perceptions of patients and clinicians as to the primary reason for early discontinuance suggests an important opportunity for improving persistence. Rather than focusing on the high costs of medications, something outside of their control, physicians should consider communicating more effectively the importance and intended duration of clopidogrel to their patients. [ABSTRACT FROM AUTHOR]

A reprint of the report "AACVPR/ACCF/AHA 2010 Update: Performance Measures on Cardiac Rehabilitation for Referral to Cardiac Rehabilitation /Secondary Prevention Services," by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) Task Force on Performance Measures, is presented. It focuses on the leadership role taken by these associations in developing measures of the quality of care for cardiovascular disease (CVD).

Abstract: Background: Valid assessments of health-related Quality of Life (HRQL) are increasingly important in chronic, incurable conditions, such as chronic heart failure (CHF). Aims: To evaluate the psychometric properties of a Swedish version of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in hospitalized patients with decompensated CHF. Method and results: The KCCQ and SF-36 were administered to patients (n =118) with CHF at baseline and then 1 (n =51) and 4 months (n =83) after admission. The Swedish version of the KCCQ appears to have acceptable convergent and discriminant validity for all suggested health domains. Cronbach''s alpha and test–retest reliability met for most of the scales the minimum of 0.70. Known-groups comparison indicated that the KCCQ discriminated between patients differing in the New York Heart Association (NYHA) classification (criterion validity). The KCCQ was also more responsive to changes in the NYHA classification as compared with the SF-36. However, KCCQ has some weakness in the response distributions for two questions and the convergent validity in one question. Conclusion: Overall, the KCCQ is a valid and reliable instrument in a Swedish CHF population. It yields reliable and valid scores and is quite responsive to clinical change. [Copyright &y& Elsevier]

Aims: The aim of this study was to investigate the impact on 10-year survival of patient-reported anginal status at 1 year following percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in patients with left main coronary artery disease (LMCAD) and/or three-vessel CAD (3VD). Methods and results: In this post hoc analysis of the randomized SYNTAX Extended Survival study, patients were classified as having residual angina (RA) if their self-reported Seattle Angina Questionnaire angina frequency (SAQ-AF) scale was =90 at the 1-year follow-up post-revascularization with PCI or CABG. The primary endpoint of all-cause death at 10 years was compared between the RA and no-RA groups. A sensitivity analysis was performed using a 6-month SAQ-AF. At 1 year, 373 (26.1%) out of 1428 patients reported RA. Whilst RA at 1 year was an independent correlate of repeat revascularization at 5 years [18.3 vs. 11.5%; adjusted hazard ratio (HR): 1.54; 95% confidence interval (CI): 1.10-2.15], it was not associated with all-cause death at 10 years (22.1 vs. 21.6%; adjusted HR: 1.11; 95% CI: 0.83-1.47). These results were consistent when stratified by the modality of revascularization (PCI or CABG) or by anginal frequency. The sensitivity analysis replicating the analyses based on 6-month angina status resulted in similar findings. Conclusion: Among patients with LMCAD and/or 3VD, patient-reported RA at 1 year post-revascularization was independently associated with repeat revascularization at 5 years; however, it did not significantly increase 10-year mortality, irrespective of the primary modality of revascularization or severity of RA. [ABSTRACT FROM AUTHOR]

Background: While smoking is a major modifiable risk factor for secondary prevention of myocardial infarction (MI), active smoking is common among patients hospitalized with acute MI. Recent studies suggest that nicotinic receptor variants, and specifically the high-risk CHRNA5 rs16969968 A allele, are associated with cessation failure among noncardiac patients. This study investigates the association between CHRNA5 rs16969968 and smoking cessation in patients hospitalized with acute MI. Methods: Using data from the TRIUMPH study, we ascertained smoking status at the time of index hospitalization for acute MI and 1 year after hospitalization. After adjusting for age and sex, we used logistic regression to model the association between smoking cessation and CHRNA5 rs16969968. Results: At index admission, 752 (Caucasian) subjects were active smokers and 699 were former smokers. Among these ever smokers, the A allele was associated with significantly decreased abstinence (45.0% abstinence for A allele carriers vs. 51.7% for GG homozygotes; OR = 0.70, 95% CI = 0.56–0.88, p = .0027). The A allele was also significantly associated with decreased abstinence at 1 year (69.1% abstinence for A allele carriers vs. 76.0% for GG homozygotes; OR = 0.70, 95% CI = 0.53–0.94, p = .0185). Conclusions: Among patients who have smoked and who are hospitalized with acute MI, the high-risk CHRNA5 allele was associated with lower likelihood of quitting before hospitalization and significantly less abstinence 1 year after hospitalization with MI. CHRNA5 rs16969968 genotype may therefore identify patients who would benefit from aggressive, personalized smoking cessation intervention. [ABSTRACT FROM PUBLISHER]