Patient-centered care in Coronary Heart Disease: what do you want to measure? A systematic review of reviews on patient-reported outcome measures.

BACKGROUND: The number of published articles on Patient-Reported Outcomes Measures (PROMs) in Coronary Heart Disease (CHD), a leading cause of disability-adjusted life years lost worldwide, has been growing in the last decades. The aim of this study was to identify all the disease-specific PROMs developed for or used in CHD and summarize their characteristics (regardless of the construct), to facilitate the selection of the most adequate one for each purpose. METHODS: A systematic review of reviews was conducted in MEDLINE, Scopus, and the Cochrane Database of Systematic Reviews. PROQOLID and BiblioPRO libraries were also checked. PROMs were classified by construct and information was extracted from different sources regarding their main characteristics such as aim, number of items, specific dimensions, original language, and metric properties that have been assessed. RESULTS: After title and abstract screening of 1224 articles, 114 publications were included for full text review. Finally, we identified 56 PROMs: 12 symptoms scales, 3 measuring functional status, 21 measuring Health-Related Quality of Life (HRQL), and 20 focused on other constructs. Three of the symptoms scales were specifically designed for a study (no metric properties evaluated), and only five have been included in a published study in the last decade. Regarding functional status, reliability and validity have been assessed for Duke Activity Index and Seattle Angina Questionnaire, which present multiple language versions. For HRQL, most of the PROMs included physical, emotional, and social domains. Responsiveness has only been evaluated for 10 out the 21 HRQL PROMs identified. Other constructs included psychological aspects, self-efficacy, attitudes, perceptions, threats and expectations about the treatment, knowledge, adjustment, or limitation for work, social support, or self-care. CONCLUSIONS: There is a wide variety of instruments to assess the patients' perspective in CHD, covering several constructs. This is the first systematic review of specific PROMs for CHD including all constructs. It has practical significance, as it summarizes relevant information that may help clinicians, researchers, and other healthcare stakeholders to choose the most adequate instrument for promoting shared decision making in a trend towards value-based healthcare.

Adaptation and psychometric validation of Diabetes Health Profile (DHP-18) in patients with type 2 diabetes in Quito, Ecuador: a cross-sectional study.

INTRODUCTION: The Diabetes Health Profile (DHP-18), structured in three dimensions (psychological distress (PD), barriers to activity (BA) and disinhibited eating (DE)), assesses the psychological and behavioural burden of living with type 2 diabetes. The objectives were to adapt the DHP-18 linguistically and culturally for use with patients with type 2 DM in Ecuador, and to evaluate its psychometric properties. METHODS: Participants were recruited using purposive sampling through patient clubs at primary health centres in Quito, Ecuador. The DHP-18 validation consisted in the linguistic validation made by two Ecuadorian doctors and eight patient interviews. And in the psychometric validation, where participants provided clinical and sociodemographic data and responded to the SF-12v2 health survey and the linguistically and culturally adapted version of the DHP-18. The original measurement model was evaluated with confirmatory factor analysis (CFA). Reliability was assessed through internal consistency using Cronbach's alpha and test-retest reproducibility by administering DHP-18 in a random subgroup of the participants two weeks after (n = 75) using intraclass correlation coefficient (ICC). Convergent validity was assessed by establishing previous hypotheses of the expected correlations with the SF12v2 using Spearman's coefficient. RESULTS: Firstly, the DHP-18 was linguistically and culturally adapted. Secondly, in the psychometric validation, we included 146 participants, 58.2% female, the mean age was 56.8 and 31% had diabetes complications. The CFA indicated a good fit to the original three factor model (χ2 (132) = 162.738, p < 0.001; CFI = 0.990; TLI = 0.989; SRMR = 0.086 and RMSEA = 0.040. The BA dimension showed the lowest standardized factorial loads (λ) (ranging from 0.21 to 0.77), while λ ranged from 0.57 to 0.89 and from 0.46 to 0.73, for the PD and DE dimensions respectively. Cronbach's alphas were 0.81, 0.63 and 0.74 and ICCs 0.70, 0.57 and 0.62 for PD, BA and DE, respectively. Regarding convergent validity, we observed weaker correlations than expected between DHP-18 dimensions and SF-12v2 dimensions (r > -0.40 in two of three hypotheses). CONCLUSIONS: The original three factor model showed good fit to the data. Although reliability parameters were adequate for PD and DE dimensions, the BA presented lower internal consistency and future analysis should verify the applicability and cultural equivalence of some of the items of this dimension to Ecuador.

Association of Socioeconomic Status With Ischemic Stroke Survival.

Background and Purpose- The aim of the study was to determine the impact of individuals' socioeconomic status and their Primary Care Service Area Socioeconomic Index on survival after ischemic stroke. Methods- We conducted a nationwide population-based cohort study in Catalonia, Spain. We included all patients with first ischemic stroke admitted to a public hospital between January 1, 2015, and December 31, 2016. We measured both individual socioeconomic status (categorized as exempts, <€18 000 [$US 20 468] income per year, and >€18 000 income per year) and Primary Care Service Area Socioeconomic Index (from 0 to 100 categorized in quartiles). We used mixed-effects logistic and survival models to estimate odds ratios and hazard ratios for the short- (30 days) and the long-term (3 years) all-cause case fatality rates by individuals' socioeconomic status groups. Results- The cohort consisted of 16 344 ischemic stroke patients with 24 638 person-years of follow-up. We did not find an association between the lowest socioeconomic individual status and short-term survival (odds ratio, 1.03; 95% CI, 0.76-1.40), although we found it in patients with <€18 000 income/year (odds ratio, 1.26; 95% CI, 1.10-1.45). At long-term, after adjustment, we observed a gradient in mortality risk with decreasing individual socioeconomic status (hazard ratio, 1.52; 95% CI, 1.30-1.77). The Primary Care Service Area Socioeconomic Index had only an influence on short-term survival (odds ratio, 1.19; 95% CI, 1.03-1.37). Conclusions- Individuals' socioeconomic status was associated with short- and long-term survival in patients with ischemic stroke. Conversely, Primary Care Service Area Socioeconomic Index measures had an influence only in short-term survival. A small fraction of this association is due to differences in comorbidity and cardiovascular risk factors. Interventions addressing both individuals' and primary care service socioeconomic aspects might eventually affect differently short- and long-term survival.

Outcomes After Direct Thrombectomy or Combined Intravenous and Endovascular Treatment Are Not Different.

BACKGROUND AND PURPOSE: Whether intravenous thrombolysis adds a further benefit when given before endovascular thrombectomy (EVT) is unknown. Furthermore, intravenous thrombolysis delays time to groin puncture, mainly among drip and ship patients. METHODS: Using region-wide registry data, we selected cases that received direct EVT or combined intravenous thrombolysis+EVT for anterior circulation strokes between January 2011 and October 2015. Treatment effect was estimated by stratification on a propensity score. The average odds ratios for the association of treatment with good outcome and death at 3 months and symptomatic bleedings at 24 hours were calculated with the Mantel-Haenszel test statistic. RESULTS: We included 599 direct EVT patients and 567 patients with combined treatment. Stratification through propensity score achieved balance of baseline characteristics across treatment groups. There was no association between treatment modality and good outcome (odds ratio, 0.97; 95% confidence interval, 0.74-1.27), death (odds ratio, 1.07; 95% confidence interval, 0.74-1.54), or symptomatic bleedings (odds ratio, 0.56; 95% confidence interval, 0.25-1.27). CONCLUSIONS: This observational study suggests that outcomes after direct EVT or combined intravenous thrombolysis+EVT are not different. If confirmed by a randomized controlled trial, it may have a significant impact on organization of stroke systems of care.

The Use of a Binary Composite Endpoint and Sample Size Requirement: Influence of Endpoints Overlap.

Although composite endpoints (CE) are common in clinical trials, the impact of the relationship between the components of a binary CE on the sample size requirement (SSR) has not been addressed. We performed a computational study considering 2 treatments and a CE with 2 components: the relevant endpoint (RE) and the additional endpoint (AE). We assessed the strength of the components' interrelation by the degree of relative overlap between them, which was stratified into 5 groups. Within each stratum, SSR was computed for multiple scenarios by varying the events proportion and the effect of the therapy. A lower SSR using CE was defined as the best scenario for using the CE. In 25 of 66 scenarios the degree of relative overlap determined the benefit of using CE instead of the RE. Adding an AE with greater effect than the RE leads to lower SSR using the CE regardless of the AE proportion and the relative overlap. The influence of overlapping decreases when the effect on RE increases. Adding an AE with lower effect than the RE constitutes the most uncertain situation. In summary, the interrelationship between CE components, assessed by the relative overlap, can help to define the SSR in specific situations and it should be considered for SSR computation.

Outcomes of a contemporary cohort of 536 consecutive patients with acute ischemic stroke treated with endovascular therapy.

BACKGROUND AND PURPOSE: We sought to assess outcomes after endovascular treatment/therapy of acute ischemic stroke, overall and by subgroups, and looked for predictors of outcome. METHODS: We used data from a mandatory, population-based registry that includes external monitoring of completeness, which assesses reperfusion therapies for consecutive patients with acute ischemic stroke since 2011. We described outcomes overall and by subgroups (age ≤ or >80 years; onset-to-groin puncture ≤ or >6 hours; anterior or posterior strokes; previous IV recombinant tissue-type plasminogen activator or isolated endovascular treatment/therapy; revascularization or no revascularization), and determined independent predictors of good outcome (modified Rankin Scale score ≤2) and mortality at 3 months by multivariate modeling. RESULTS: We analyzed 536 patients, of whom 285 received previous IV recombinant tissue-type plasminogen activator. Overall, revascularization (modified Thrombolysis In Cerebral Infarction scores, 2b and 3) occurred in 73.9%, 5.6% developed symptomatic intracerebral hemorrhages, 43.3% achieved good functional outcome, and 22.2% were dead at 90 days. Adjusted comparisons by subgroups systematically favored revascularization (lower proportion of symptomatic intracerebral hemorrhages and death rates and higher proportion of good outcome). Multivariate analyses confirmed the independent protective effect of revascularization. Additionally, age >80 years, stroke severity, hypertension (deleterious), atrial fibrillation, and onset-to-groin puncture ≤6 hours (protective) also predicted good outcome, whereas lack of previous disability and anterior circulation strokes (protective) as well as and hypertension (deleterious) independently predicted mortality. CONCLUSIONS: This study reinforces the role of revascularization and time to treatment to achieve enhanced functional outcomes and identifies other clinical features that independently predict good/fatal outcome after endovascular treatment/therapy.

Assessing health-related quality of life in patients with heart failure: a systematic, standardized comparison of available measures.

To systematically evaluate available health-related quality of life (HRQL) instruments for use in patients with heart failure (HF). Seven HF-specific HRQL questionnaires and associated studies of their metric properties were identified by systematic review: the Chronic Heart Failure Assessment Tool, the Cardiac Health Profile congestive heart failure, the Chronic Heart Failure Questionnaire (CHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Left Ventricular Disease Questionnaire (LVDQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Quality of Life in Severe Heart Failure Questionnaire. Each instrument was assessed by four experts using a standardized tool for evaluating patient-reported outcomes (EMPRO; scores from 0 to 100). Four questionnaires were given adequate scores (median >50) for the attribute "conceptual model." The LVDQ had the highest rated median for "reliability" (72.8). The CHFQ, the KCCQ, and the MLHFQ all got reasonable scores for "validity" (from 54.4 to 76.4). The reviewers rated the KCCQ the highest in terms of "sensitivity to change" (median 94.4). Only the CHFQ (50.0) and the KCCQ (72.2) received adequate scores for the "interpretability" attribute. The most highly rated instruments based on the overall EMPRO score were the KCCQ (64.4) and the MLHFQ (60.7), followed by the CHFQ (59.2). Based on the first systematic and reliable expert-based evaluation of available HF-specific HRQL questionnaires, the evidence seems to support the choice of the KCCQ, the MLHFQ, and the CHFQ over the others, which require further research on metric properties.

Functional outcome after primary endovascular therapy or IV thrombolysis alone for stroke. An observational, comparative effectiveness study.

BACKGROUND: Among the acute ischemic stroke patients with large vessel occlusions and contraindications for the use of IV thrombolysis, mainly on oral anticoagulation or presenting too late, primary endovascular therapy is often performed as an alternative to the standard therapy even though evidence supporting the use of endovascular reperfusion therapies is not yet established. Using different statistical approaches, we compared the functional independence rates at 3 months among patients undergoing primary endovascular therapy and patients treated only with IV thrombolysis. METHODS: We used data from a prospective, government-mandated and externally audited registry of reperfusion therapies for ischemic stroke (January 2011 to November 2012). Patients were selected if treated with either IV thrombolysis alone (n = 1,582) or primary endovascular thrombectomy (n = 250). A series of exclusions were made to homogenize the clinical characteristics among the two groups. We then carried out multivariate logistic regression and propensity score matching analyses on the final study sample (n = 1,179) to compare functional independence at 3 months, as measured by the modified Rankin scale scores 0-2, between the two groups. RESULTS: The unadjusted likelihood of good outcome was poorer among the endovascular group (OR: 0.69; 95% CI: 0.47-1.0). After adjustment, no differences by treatment modality were seen (OR: 1.51; 95% CI: 0.93-2.43 for primary endovascular therapy). Patients undergoing endovascular thrombectomy within 180-270 min (OR: 2.89; 95% CI: 1.17-7.15) and patients with severe strokes (OR: 1.84; 95% CI: 1.02-3.35) did better than their intravenous thrombolysis counterparts. The propensity score-matched analyses with and without adjustment by additional covariates showed that endovascular thrombectomy was as effective as intravenous thrombolysis alone in achieving functional independence (OR for unadjusted propensity score matched: 1.35; 95% CI: 0.9-2.02, OR for adjusted propensity score matched: 1.45; 95% CI: 0.91-2.32). CONCLUSION: This comparative effectiveness study shows that in ischemic stroke patients with contraindications for IV thrombolysis, primary endovascular treatment might be an alternative therapy at least as effective as IV thrombolysis alone. Randomized controlled trials are urgently needed.

Care-related quality of life of informal caregivers of stroke survivors: Cross-sectional analysis of a randomized clinical trial.

PURPOSE: We aimed to describe the intensity of care and its consequences on informal caregivers of stroke survivors according to the degree of care receivers' functional dependence for activities of daily living; and to identify the factors associated with caregivers' care-related quality of life. METHODS: Cross-sectional analysis of prospective data collected in a cost-utility study alongside the RACECAT trial in Catalonia (Spain). One-hundred and thirty-two care receiver-caregiver pairs were interviewed six months after stroke. Functional dependence for activities of daily living was measured with the Barthel index. We assessed caregivers care-related quality of life with the CarerQoL, which measures seven dimensions of subjective burden (CarerQoL-7D) and a happiness score (CarerQoL-VAS). We evaluated the association between characteristics of informal caregivers, characteristics of care receivers, and intensity of care, and the caregiver's care-related quality of life (subjective burden and happiness) in a hypothesized model using a structural equation model. RESULTS: Of the 132 caregivers, 74,2% were women with an average age of 59.4 ± 12.5 years. The 56.8% of them were spouses. The care intensity ranged from a mean of 24h/week for mild to 40h/week for severe dependence. Most caregivers (76.3%) were satisfied with their task, regardless of dependence, but showed increasing problems in caring for severely dependent persons. Being a woman (coeff. -0.23; 95%CI: -0.40, -0.07), spending more time in care tasks (coeff -0.37; -0.53, -0.21) and care receiver need of constant supervision (coeff 0.31; -0.47, -0.14) were associated with higher burden of care, irrespective of the degree of dependence. Caregiver burden (coeff 0.46; 0.30-0.61) and care receiver anxiety or depression (coeff -0.19; -0.34, -0.03) were associated with lower caregiver happiness. CONCLUSIONS: The findings suggest the importance of developing mainly two types of support interventions for caregivers: respite and psychosocial support. Especially for women with high caring burden and/or caring for persons with high levels of anxiety or depression.

Long-term outcome of aortic dissection with patent false lumen: predictive role of entry tear size and location.

BACKGROUND: Patent false lumen in aortic dissection has been associated with poor prognosis. We aimed to assess the natural evolution of this condition and predictive factors. METHODS AND RESULTS: One hundred eighty-four consecutive patients, 108 surgically treated type A and 76 medically treated type B, were discharged after an acute aortic dissection with patent false lumen. Transesophageal echocardiography was performed before discharge, and computed tomography was performed at 3 months and yearly thereafter. Median follow-up was 6.42 years (quartile 1 to quartile 3: 3.31-10.49). Forty-nine patients died during follow-up (22 type A, 27 type B), 31 suddenly. Surgical or endovascular treatment was indicated in 10 type A and 25 type B cases. Survival free from sudden death and surgical-endovascular treatment was 0.90, 0.81, and 0.46 (95% CI, 0.36-0.55) at 3, 5, and 10 years, respectively. Multivariate analysis identified baseline maximum descending aorta diameter (hazard ratio [HR]: 1.32 [1.10-1.59]; P=0.003), proximal location (HR: 1.84 [1.06-3.19]; P=0.03), and entry tear size (HR: 1.13 [1.08-1.2]; P<0.001) as predictors of dissection-related adverse events, whereas mortality was predicted by baseline maximum descending aorta diameter (HR: 1.36 [1.08-1.70]; P=0.008), entry tear size (HR: 1.1 [1.04-1.16]; P=0.001), and Marfan syndrome (HR: 3.66 [1.65-8.13]; P=0.001). CONCLUSIONS: Aortic dissection with persistent patent false lumen carries a high risk of complications. In addition to Marfan syndrome and aorta diameter, a large entry tear located in the proximal part of the dissection identifies a high-risk subgroup of patients who may benefit from earlier and more aggressive therapy.

Evidence on the global measurement model of the Minnesota Living with Heart Failure Questionnaire.

PURPOSE: The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is the most widely used health-related quality of life measure in both clinical and research settings. Nevertheless, its measurement model has never been confirmed. This study aims to fill that gap with a large international sample. METHODS: Data from eight studies (3,847 patients with heart failure) from 21 countries were merged and analysed. Common variables included MLHFQ scores, functional capacity, cardiovascular risk factors and the socio-demographic characteristics of the patient. The measurement model of the MLHFQ was assessed by means of exploratory and confirmatory factor analyses (EFA-CFA). The reliability of MLHFQ scores was evaluated using Cronbach's alpha coefficient and the MLHFQ's ability to differentiate among known groups was assessed through severity levels. RESULTS: Findings from the EFA and CFA suggest that the MLHFQ total and domain-specific scores fall within a bifactor model. The physical and emotional scores were supported within the sample, as was the original total score. Furthermore, a third factor was revealed regarding social environment. The reliability coefficient reached 0.9 for almost all physical and total scores. All the MLHFQ mean scores showed the ability to differentiate among functional capacity groups, with most of the effect size coefficients reaching 0.8. CONCLUSIONS: Beyond the suitable degree of reliability and validity displayed by the MLHFQ scores in the different country-specific versions, our results confirmed for the first time the unidimensionality of the most commonly used score in HF patients: the total MLHFQ score. Moreover, the social environment domain identified in this study can now be considered when assessing these patients' HRQL, especially as a relevant outcome with regard to disease management.

Comprehensive Geriatric Hospital at Home: Adaptation to Referral and Case-Mix Changes During the COVID-19 Pandemic.

OBJECTIVES: To describe the evolution of a Hospital at Home (HAH) based on comprehensive geriatric assessment (CGA), including its adaptability to changing case-mixes and pathways during the COVID-19 pandemic. DESIGN: Observational study of consecutive admissions to a combined step-up (admissions from home) and step-down (hospital discharge) HAH during 3 periods: prepandemic (2018‒February 2020) vs pandemic (March‒December 2020, and January‒December 2021). SETTING AND PARTICIPANTS: Participants were all consecutive patients admitted to a CGA-based HAH, located in Barcelona, Spain. Referrals followed acute events or exacerbation of chronic conditions, by either primary care (step-up) or after post-acute discharge (step-down). METHODS: HAH intervention based on CGA and incorporated geriatric rehabilitation. Patient case-mix, functional evolution (Barthel index), and mortality were compared across periods and between pathways. RESULTS: HAH capacity expanded 3 fold from 15 to 45 virtual beds and altogether managed 688 consecutive patients [mean age (SD) = 82.5 (9.6) years; 59% women]. Pandemic case-mix was slightly older (mean age = 83.5 vs 82 years, P = .012) than prepandemic, with greater mobility impairment. Across periods, step-up increased (26.1%, 40.9%, 48.2%, P < .01) because of medical events, skin ulcers, and post-acute stroke, whereas step-down decreased; multivariable models showed no differences in functional improvement or mortality. When comparing pathways, step-up featured older patients with higher comorbidity, worse functional status, and lower absolute functional gain than step-down (5.6 vs 13 points of Barthel index, P < .01), remaining statistically significant after adjusting for covariates (P = .003); no differences in mortality were observed. CONCLUSIONS AND IMPLICATIONS: A multipurpose, step-down and step-up CGA HAH expanded its activity and adapted to changing case-mixes and pathways throughout COVID-19 pandemic waves. Although further quantitative and qualitative studies are needed to assess the impact of this model, our results suggest that harnessing the adaptability of HAH may help advance a paradigm shift toward more person-centered, cost-effective models of clinical care aimed at older adults.

Strengths and limitations of patient registries in infective endocarditis.

BACKGROUND: Infective endocarditis (IE) is a serious albeit relatively infrequent disease. Given the paucity of cases, particularly in non-referral centres, patient registries have progressively gained relevance to inform about the epidemiology, clinical presentation, and natural history of IE in the last two decades. Although they have become key to advancing knowledge of IE, registries also have shortcomings that lead to relevant consequences that are often overlooked. OBJECTIVES: We aimed to discuss the strengths and limitations of registries in IE. SOURCES: We conducted a PubMed search of relevant articles published between January 2000 and June 2022. CONTENT: The backbone of the contemporary knowledge on IE has been built upon data collected in prospective registries, which has allowed us to collect data on relatively unknown aspects of the disease, identify knowledge gaps, and generate new hypotheses, serving as platforms for further research endeavours. Well-exploited registries can provide key information on how IE is distributed across populations and how it differentially impacts patients and subgroups. However, registries face several difficulties, such as the definition of IE, which includes subjective variables and changes over time. Other limitations include difficulty achieving a comprehensive collection of cases (which depends on both project funding and information systems), over-representation of the centres that created the registry, lack of inclusion of variables to assess endpoints that are relevant to patients in terms of quality of life and prognosis, and ethical issues. IMPLICATIONS: The review of the advantages and disadvantages of registries aims to improve the quality of the information collected, the viability of the registry itself, and the ability to answer questions that are relevant to both researchers and patients.

Development of a risk score for patients with ischaemic cardiomyopathy.

BACKGROUND: Ischaemic cardiomyopathy is a leading cause of heart failure and is associated with a poor prognosis. AIM: To evaluate predictors of major adverse cardiovascular events (MACE) and to develop a risk score for the disease. METHODS: All patients with ischaemic cardiomyopathy referred to a tertiary hospital between 2010 and 2018 for stress-rest gated single-photon emission computed tomography (SPECT) were included retrospectively (n=747). Clinical and gated SPECT-derived variables were analysed as predictors of MACE, a combined endpoint of cardiovascular mortality, heart failure hospitalization or myocardial infarction during follow-up. A multivariable Cox model using backwards stepwise regression with competing risks was used to select the best parsimonious model. RESULTS: After a median follow-up of 4.7 years, 313 patients had MACE (41.9%). Independent predictors of MACE were previous heart failure admission, worsening angina or dyspnoea, estimated glomerular filtration rate ≤60mL/min/1.73 m2, age>73 years, diabetes, atrial fibrillation, end-diastolic volume index>83mL/m2 and>12% of scarred myocardium. A risk score ranging from 0 to 12 classified patients as at intermediate risk (event rate of 4.0 MACE per 100 person-years), high risk (11.3 MACE per 100 person-years) or very high risk (27.8 MACE per 100 person-years). The internally validated area under the curve was 0.720 (95% confidence interval 0.660-0.740) and calibration was adequate (Hosmer-Lemeshow test P=0.28) for MACE. CONCLUSIONS: In patients with ischaemic cardiomyopathy, a simple risk score using dichotomic and readily available variables obtained from clinical assessment and gated SPECT accurately predicts the risk of MACE.

Noncompliance with certain quality indicators is associated with risk-adjusted mortality after stroke.

BACKGROUND AND PURPOSE: To investigate the 30-day and 12-month mortality risks among hospitalized stroke patients according to compliance with guideline-based process indicators. METHODS: We used data from the Second Stroke Audit and the Mortality Register of Catalonia (Spain). The audit retrospectively explored quality of stroke care based on compliance with indicators among patients discharged from all public hospitals in Catalonia in 2007; they were identified and selected through a pre-established sampling method. The magnitude of the independent association of each indicator with 30-day and 12-month mortality was assessed using logistic regression with generalized estimating equations to account for clustering of patients within hospitals. Generalized estimating equations modeling was initially restricted to patients alive >72 hours poststroke to control for confounding by severity. Analyses were also run in 3 other samples (all patients, patients alive >7 days, and patients alive >14 days). RESULTS: Of 1767 stroke admissions in the Second Stroke Audit, 1697 patients survived >72 hours poststroke. Within this sample, the adjusted 30-day mortality risk was negatively associated with nonadherence to different indicators, of which only antithrombotics at discharge (OR, 4.3; 95% CI, 1.72-10.78) remained significant in all data sets. At 12 months, the adjusted mortality risk was negatively associated with management of hypertension (OR, 1.87; 95% CI, 1.22-2.86) and antithrombotics at discharge (OR, 2.79; 95% CI, 1.41-5.54). Both remained unchanged across different samples. CONCLUSIONS: Assessing the impact of quality of stroke care on mortality is complex and is hampered by residual confounding, particularly in the short-term. Nevertheless, this study suggests that at least a few indicators should be used to monitor quality of stroke services.

Association of renin-angiotensin system blockers with COVID-19 diagnosis and prognosis in patients with hypertension: a population-based study.

BACKGROUND: The effect of renin-angiotensin system (RAS) blockade either by angiotensin-converting enzyme inhibitors (ACEis) or angiotensin-receptor blockers (ARBs) on coronavirus disease 2019 (COVID-19) susceptibility, mortality and severity is inadequately described. We examined the association between RAS blockade and COVID-19 diagnosis and prognosis in a large population-based cohort of patients with hypertension (HTN). METHODS: This is a cohort study using regional health records. We identified all individuals aged 18-95 years from 87 healthcare reference areas of the main health provider in Catalonia (Spain), with a history of HTN from primary care records. Data were linked to COVID-19 test results, hospital, pharmacy and mortality records from 1 March 2020 to 14 August 2020. We defined exposure to RAS blockers as the dispensation of ACEi/ARBs during the 3 months before COVID-19 diagnosis or 1 March 2020. Primary outcomes were: COVID-19 infection and severe progression in hospitalized patients with COVID-19 (the composite of need for invasive respiratory support or death). For both outcomes and for each exposure of interest (RAS blockade, ACEi or ARB) we estimated associations in age-, sex-, healthcare area- and propensity score-matched samples. RESULTS: From a cohort of 1 365 215 inhabitants we identified 305 972 patients with HTN history. Recent use of ACEi/ARBs in patients with HTN was associated with a lower 6-month cumulative incidence of COVID-19 diagnosis {3.78% [95% confidence interval (CI) 3.69-3.86%] versus 4.53% (95% CI 4.40-4.65%); P < 0.001}. In the 12 344 patients with COVID-19 infection, the use of ACEi/ARBs was not associated with a higher risk of hospitalization with need for invasive respiratory support or death [OR = 0.91 (0.71-1.15); P = 0.426]. CONCLUSIONS: RAS blockade in patients with HTN is not associated with higher risk of COVID-19 infection or with a worse progression of the disease.

Impact of revascularization guided by functional testing in ischaemic cardiomyopathy.

AIMS: The burden of ischaemia is a risk factor for adverse outcomes in ischaemic cardiomyopathy (ICM) but is not systematically tested when deciding on revascularization. Limited data exists in patients with ICM regarding the interaction between ischaemia and early coronary revascularization (ECR). This study sought to determine if the burden of ischaemia modifies the outcomes of ECR in ICM. METHODS AND RESULTS: Consecutive patients with ICM (left ventricular ejection fraction < 40%) with a stress-rest gated single-photon emission computed tomography (N = 747) were followed-up for ECR and major cardiovascular events (MACEs, cardiovascular death, myocardial infarction, or heart failure hospitalization). A 1:1 matched population was selected using a propensity score for ECR. The interaction between ischaemia and ECR was evaluated in the matched cohort. In the initial cohort, 131 patients underwent ECR. Of them, 109 were matched to non-ECR patients. After a median follow up of 4.1 years, 102 (46.8%) patients experienced a MACE. The effect of revascularization on MACE was dependent of the percent of ischaemia (P for the interaction at 10% ischaemia = 0.021), so that a trend towards a decreased risk of MACE was seen in patients with >10% of ischaemia [hazard ratio (HR) = 0.59 (0.30-1.18)], whereas a non-significant increase of MACE was observed in those with <10% ischaemia (HR = 1.67 [0.94-2.96]). CONCLUSIONS: In a contemporary cohort of patients with ICM, the beneficial effects of ECR may be mediated by the percent of ischaemia. This study supports stress testing in ICM and an ischaemia-guided approach for ECR.

Corrigendum: Dynamics of Emergency Cardiovascular Hospital Admissions and In-Hospital Mortality During the COVID-19 Pandemic: Time Series Analysis and Impact of Socioeconomic Factors.

[This corrects the article DOI: 10.3389/fcvm.2022.827212.].

Dynamics of Emergency Cardiovascular Hospital Admissions and In-Hospital Mortality During the COVID-19 Pandemic: Time Series Analysis and Impact of Socioeconomic Factors.

Aims: This study aimed to evaluate the decline in urgent cardiovascular hospital admissions and in-hospital mortality during the COVID pandemic in two successive waves, and to evaluate differences by sex, age, and deprivation index subgroups. Methods and Results: We obtained acute cardiovascular hospital episodes during the years 2019-2020 from region-wide data on public healthcare usage for the population of Catalonia (North-East Spain). We fitted time models to estimate the incidence rate ratios (IRRs) of the acute coronary syndrome (ACS) and acute heart failure (HF) admissions during the first pandemic wave, the between-waves period, and the second wave compared with the corresponding pre-COVID-19 periods and to test for the interaction with sex, age, and area-based socioeconomic level. We evaluated the effect of COVID-19 period on in-hospital mortality. ACS (n = 8,636) and HF (n = 27,566) episodes were defined using primary diagnostic ICD-10 codes. ACS and HF admissions decreased during the first wave (IRR = 0.66, 95%CI: 0.58-0.76 and IRR = 0.61, 95% CI: 0.55-0.68, respectively) and during the second wave (IRR = 0.80, 95%CI: 0.72-0.88 and IRR = 0.76, 95%CI: 0.69-0.84, respectively); acute HF admissions also decreased in the period between waves (IRR: 0.81, 95%CI: 0.74-0.89). The impact was similar in all sex and socioeconomic subgroups and was higher in older patients with ACS. In-hospital mortality was higher than expected only during the first wave. Conclusion: During the first wave of the COVID-19 pandemic, there was a marked decline in urgent cardiovascular hospital admissions that were attenuated during the second wave. Both the decline and the attenuation of the effect have been similar in all subgroups regardless of age, sex, or socioeconomic status. In-hospital mortality for ACS and HF episodes increased during the first wave, but not during the second wave.

Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death.

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain. METHODS: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital. RESULTS: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66-0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years. CONCLUSIONS: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY.