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BackgroundIn response to an increased need for patient information in congenital heart disease, we previously developed an online, evidence-based information portal for patients with congenital aortic and pulmonary valve disease. To assess its effectiveness, a stepped-wedge cluster randomised trial was conducted.MethodsAdult patients and caregivers of paediatric patients with congenital aortic and/or pulmonary valve disease and/or tetralogy of Fallot who visited the outpatient clinic at any of the four participating centres in the Netherlands between 1 March 2016–1 July 2017 were prospectively included. The intervention (information portal) was introduced in the outpatient clinic according to a stepped-wedge randomised design. One month after outpatient clinic visit, each participant completed a questionnaire on disease-specific knowledge, anxiety, depression, mental quality of life, involvement and opinion/attitude concerning patient information and involvement.Results343 participants were included (221 control, 122 intervention). Cardiac diagnosis (p=0.873), educational level (p=0.153) and sex (p=0.603) were comparable between the two groups. All outcomes were comparable between groups in the intention-to-treat analyses. However, only 51.6% of subjects in the intervention group (n=63) reported actually visiting the portal. Among these subjects (as-treated), disease-specific knowledge (p=0.041) and mental health (p=0.039) were significantly better than in control subjects, while other baseline and outcome variables were comparable.ConclusionEven after being invited by their cardiologists, only half of the participants actually visited the information portal. Only in those participants that actually visited the portal, knowledge of disease and mental health were significantly better. This underlines the importance of effective implementation of online evidence-based patient information portals in clinical practice.

ObjectivesReport predictors and the natural course of paravalvular leak (PVL) following implantation of the ACURATE neo transcatheter heart valve (THV).BackgroundUnderstanding the mechanisms of PVL may help to improve patient selection, patient outcomes and the design of next-generation THVs.MethodsA total of 30 patients (mean age 81±5 years, 47% women) undergoing transcatheter aortic valve replacement with the ACURATE neo were enrolled in the PREDICT PVL study. The effective regurgitant orifice area (EROA, in mm2) of PVL was assessed by transthoracic and transoesophageal echocardiography before discharge and at 6 months follow-up.ResultsPVL was none/trace in 10 (33%), mild in 18 (60%) and moderate in 2 (7%) patients and occurred in distinct locations with largest EROAs in the area of the left coronary cusp and its adjacent commissures. Independent predictors for EROA were implantation depth (r coefficient −1.9 mm2 per mm implantation depth, p=0.01), leaflet calcification (6.2 mm2 per calcification grade, p=0.03) and THV size L (7.6 mm2 more than size S or M, p=0.01). At 6 months follow-up, EROA decreased by 29% from 13.7±9.7 mm2 to 9.5±7.9 mm2 (pConclusionsPVL occurred predominantly in the region of the left coronary cusp and decreased by 29% during 6 months of follow-up. Our results underscore the importance of adequate patient selection and optimal implantation depth.

ObjectiveTo understand human factors (HF) contributing to disturbances during invasive cardiac procedures, including frequency and nature of distractions, and assessment of operator workload.MethodsSingle centre prospective observational evaluation of 194 cardiac procedures in three adult cardiac catheterisation laboratories over 6 weeks. A proforma including frequency, nature, magnitude and level of procedural risk at the time of each distraction/interruption was completed for each case. The primary operator completed a National Aeronautical and Space Administration (NASA) task load questionnaire rating mental/physical effort, level of frustration, time-urgency, and overall effort and performance.Results264 distractions occurred in 106 (55%) out of 194 procedures observed; 80% were not relevant to the case being undertaken; 14% were urgent including discussions of potential ST-elevation myocardial infarction requiring emergency angioplasty. In procedures where distractions were observed, frequency per case ranged from 1 to 16 (mean 2.5, SD ±2.2); 43 were documented during high-risk stages of the procedure. Operator rating of NASA task load parameters demonstrated higher levels of mental and physical workload and effort during cases in which distractions occurred.ConclusionsIn this first description of HF in adult cardiac catheter laboratories, we found that fewer than half of all procedures were completed without interruption/distraction. The majority were unnecessary and without relation to the case or list. We propose the introduction of a ‘sterile cockpit’ environment within catheter laboratories, as adapted from aviation and used in surgical operating theatres, to minimise non-emergent interruptions and disturbances, to improve operator conditions and overall patient safety.

ObjectiveTo determine the impact of ivabradine on outcomes important to patients with angina pectoris caused by coronary artery disease.MethodsWe conducted a systematic review. We included randomised clinical trials comparing ivabradine versus placebo or no intervention for patients with angina pectoris due to coronary artery disease published prior to June 2020. We used Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Cochrane methodology, Trial Sequential Analysis, Grading of Recommendations Assessment, Development, and Evaluation, and our eight-step procedure. Primary outcomes were all-cause mortality, serious adverse events and quality of life.ResultsWe included 47 randomised clinical trials enrolling 35 797 participants. All trials and outcomes were at high risk of bias. Ivabradine compared with control did not have effects when assessing all-cause mortality (risk ratio [RR] 1.04; 95% CI 0.96 to 1.13), quality of life (standardised mean differences −0.05; 95% CI −0.11 to 0.01), cardiovascular mortality (RR 1.07; 95% CI 0.97 to 1.18) and myocardial infarction (RR 1.03; 95% CI 0.91 to 1.16). Ivabradine seemed to increase the risk of serious adverse events after removal of outliers (RR 1.07; 95% CI 1.03 to 1.11) as well as the following adverse events classified as serious: bradycardia, prolonged QT interval, photopsia, atrial fibrillation and hypertension. Ivabradine also increased the risk of non-serious adverse events (RR 1.13; 95% CI 1.11 to 1.16). Ivabradine might have a statistically significant effect when assessing angina frequency (mean difference (MD) 2.06; 95% CI 0.82 to 3.30) and stability (MD 1.48; 95% CI 0.07 to 2.89), but the effect sizes seemed minimal and possibly without any relevance to patients, and we identified several methodological limitations, questioning the validity of these results.ConclusionOur findings do not support that ivabradine offers significant benefits on patient important outcomes, but rather seems to increase the risk of serious adverse events such as atrial fibrillation and non-serious adverse events. Based on current evidence, guidelines need reassessment and the use of ivabradine for angina pectoris should be reconsidered.PROSPERO registration numberCRD42018112082.

Background and purposeReal-world data about treatment convenience and satisfaction in Asian non-valvular atrial fibrillation (NVAF) patients after switching from vitamin K antagonists (VKAs) to non-VKA oral anticoagulants were evaluated.MethodsIn this non-interventional study involving 49 sites across five countries in Southeast Asia and South Korea, 379 stable NVAF patients who switched from VKA therapy to dabigatran during routine clinical practice were recruited and followed up for 6 months. Treatment convenience and satisfaction were evaluated using Perception on Anticoagulant Treatment Questionnaire-2 (PACT-Q2). Through post hoc analysis, factors associated with improved treatment convenience scores at visit 2 were described.ResultsTreatment convenience and satisfaction significantly improved after switching from VKAs to dabigatran at visit 2 and visit 3 (convenience: p80th percentile) response on treatment convenience were female sex, younger age (ConclusionDabigatran was associated with a significant improvement in treatment convenience and satisfaction after switching from VKAs when used for stroke prevention in NVAF patients from Southeast Asia and South Korea.

BackgroundThe aim of this study was to assess by a census supported by the Italian Society of Cardiology (Società Italiana di Cardiologia, SIC) the present implementation of telemedicine in the field of cardiovascular disease in Italy.MethodsA dedicated questionnaire was sent by email to all the members of the SIC: data on telemedicine providers, service provided, reimbursement, funding and organisational solutions were collected and analysed.ResultsReported telemedicine activities were mostly stable and public hospital based, focused on acute cardiovascular disease and prehospital triage of suspected acute myocardial infarction (prehospital ECG, always interpreted by a cardiologist and not automatically reported by computerised algorithms). Private companies delivering telemedicine services in cardiology (ECGs, ambulatory ECG monitoring) were also present. In 16% of cases, ECGs were also delivered through pharmacies or general practitioners. ICD/CRT-D remote control was performed in 42% of cases, heart failure patient remote monitoring in 37% (21% vital parameters monitoring, 32% nurse telephone monitoring). Telemedicine service was public in 74% of cases, paid by the patient in 26%. About half of telemedicine service received no funding, 17% received State and/or European Union funding.ConclusionsSeveral telemedicine activities have been reported for the management of acute and chronic cardiovascular disease in Italy. The whole continuum of cardiovascular disease is covered by telemedicine solutions. A periodic census may be useful to assess the implementation of guidelines recommendations on telemedicine.

BackgroundBalloon aortic valvuloplasty (BAV) has seen renewed interest since the advent of transcatheter aortic valve implantation (TAVI). The study aimed to characterise a contemporary BAV cohort and determinants of clinical outcomes.MethodsPatients undergoing BAV at a single tertiary centre were retrospectively reviewed over a 10-year period, and functional and mortality outcomes were reported with up to a 2-year follow-up.Results224 patients (aged 82.5±8.3 years; 48% female) underwent BAV over the study period. Indications were either destination treatment (39%) or bridge-to-valve replacement (61%)—including bridge-to-decision (29%), symptom relief while on the waitlist (27%), and temporary contraindications to TAVI/aortic valve replacement (AVR) (5%). The mean reduction of aortic mean pressure gradient was 38%. Procedural mortality occurred in 0.5%, stroke in 1.3%, and major bleeding in 0.9%. Twelve-month mortality was 36% overall, and 26% and 50% in the bridging and destination groups, respectively. New York HeartAssociation (NYHA) class improved by ≥1 at 30 days in 50%. Among the bridge-to-TAVI/AVR group, 40% proceeded to TAVI/AVR within 12 months following BAV. In multivariate analysis, active malignancy at baseline (OR: 4.4, 95% CI: 1.3 to 15.1, p=0.02), smoking history (OR: 3.3, 95% CI: 1.3 to 7.9, pConclusionsBAV remains a useful procedure with relatively low rates of complications, however, 1-year mortality rates are high. Contemporary indications for BAV include a bridge to definitive valve replacement or destination treatment.

ObjectiveTo determine research priorities in advanced heart failure (HF) for patients, carers and healthcare professionals.MethodsPriority setting partnership using the systematic James Lind Alliance method for ranking and setting research priorities. An initial open survey of patients, carers and healthcare professionals identified respondents’ questions, which were categorised to produce a list of summary research questions; questions already answered in existing literature were removed. In a second survey of patients, carers and healthcare professionals, respondents ranked the summary research questions in order of priority. The top 25 unanswered research priorities were then considered at a face-to-face workshop using nominal group technique to agree on a ‘top 10’.Results192 respondents submitted 489 responses each containing one or more research uncertainty. Out-of-scope questions (35) were removed, and collating the responses produced 80 summary questions. Questions already answered in the literature (15) were removed. In the second survey, 65 questions were ranked by 128 respondents. The top 10 priorities were developed at a consensus meeting of stakeholders and included a focus on quality of life, psychological support, the impact on carers, role of the charity sector and managing prognostic uncertainty. Ranked priorities by physicians and patients were remarkably divergent.ConclusionsEngaging stakeholders in setting research priorities led to a novel set of research questions that might not have otherwise been considered. These priorities can be used by researchers and funders to direct future research towards the areas which matter most to people living with advanced HF.

Background Huge variability in quality of service delivery of cardiac rehabilitation (CR) in the UK. This study aimed to ascertain whether the variation in quality of CR delivery is associated with participants’ characteristics. Methods Individual patient data from 1 April 2013 to 31 March 2014 were collected electronically from the UK’s National Audit of Cardiac Rehabilitation database. Quality of CR delivery is categorised as low, middle, and high based on six service-level criteria. The study included a range of patient variables: patient demographics, cardiovascular risk factors, comorbidities, physical and psychosocial health measures, and index of multiple deprivation. Results The chance that a CR patient with more comorbidities attended a high-quality programme was 2.13 and 1.85 times higher than the chance that the same patient attended a low- or middle-quality programme, respectively. Patients who participated in high-quality CR programmes tended to be at high risk (e.g. increased waist size and high blood pressure); high BMI, low physical activity levels and high Hospital Anxiety and Depression Scale scores; and were more likely to be smokers, and be in more socially deprived groups than patients in low-quality programmes. Conclusions These findings show that the quality of CR delivery can be improved and meet national standards by serving a more multi-morbid population which is important for patients, health providers and commissioners of healthcare. In order for low-quality programmes to meet clinical standards, CR services need to be more inclusive in respect of patients’ characteristics identified in the study. Evaluation and dissemination of information about the populations served by CR programmes may help low-quality programmes to be more inclusive.

BackgroundElderly, frail patients are often excluded from clinical trials so there is lack of data regarding optimal management when they present with symptomatic coronary artery disease (CAD).ObjectiveThe aim of this observational study was to evaluate an unselected elderly population with CAD for the occurrence of frailty, and its association with quality of life (QoL) and clinical outcomes.MethodsConsecutive patients aged ≥80 years presenting with CAD were prospectively assessed for frailty (Fried frailty phenotype (FFP), Edmonton frailty scale (EFS)), QoL (Short form survey (SF-12)) and comorbidity (Charlson Comorbidity Index (CCI)). Patients were re-assessed at 4 months to determine any change in frailty and QoL status as well as the clinical outcome.ResultsOne hundred fifty consecutive patients with symptomatic CAD were recruited in the study. The mean age was 83.7±3.2 years, 99 (66.0%) were men. The clinical presentation was stable angina in 68 (45.3%), the remainder admitted with an acute coronary syndrome including 21 (14.0%) with ST-elevation myocardial infarction. Frailty was present in 28% and 26% by FFP and EFS, respectively, and was associated with a significantly higher CCI (7.5±2.4 in frail, 6.2±2.2 in prefrail, 5.9±1.6 in those without frailty, p=0.005). FFP was significantly related to the physical composite score for QoL, while EFS was significantly related to the mental composite score for QoL (p=0.003). Treatment was determined by the cardiologist: percutaneous coronary intervention in 51 (34%), coronary artery bypass graft surgery in 15 (10%) and medical therapy in 84 (56%). At 4 months, 14 (9.3%) had died. Frail participants had the lowest survival. Cardiovascular symptom status and the mental composite score of QoL significantly improved (52.7±11.5 at baseline vs 55.1±10.6 at follow-up, p=0.04). However, overall frailty status did not significantly change, nor the physical health composite score of QoL (37.2±11.0 at baseline vs 38.5±11.3 at follow-up, p=0.27).ConclusionsIn patients referred to hospital with CAD, frailty is associated with impaired QoL and a high coexistence of comorbidities. Following cardiac treatment, patients had improvement in cardiovascular symptoms and mental component of QoL.

ObjectiveWe evaluated atrial fibrillation (AF) patients’ perceptions of anticoagulation treatment with dabigatran or a vitamin K antagonist (VKA) for stroke prevention, according to accepted indications.MethodsThe RE-SONANCE observational, prospective, multicentre, international study used the validated Perception on Anticoagulant Treatment Questionnaire (PACT-Q) to assess patients with AF already taking a VKA who were switched to dabigatran (cohort A), and newly diagnosed patients initiated on either dabigatran or a VKA (cohort B). Visit 1 (V1) was at baseline, and visit 2 (V2) and visit 3 (V3) were at 30–45 and 150–210 days after baseline, respectively. Primary outcomes were treatment satisfaction and convenience in cohort A at V2 and V3 versus baseline, and in cohort B for dabigatran and a VKA at V2 and V3.ResultsThe main analysis set comprised 4100 patients in cohort A and 5365 in cohort B (dabigatran: 3179; VKA: 2186). In cohort A, PACT-Q2 improved significantly (pConclusionsSwitching to dabigatran from long-term VKA therapy or newly initiated dabigatran is associated with improved patient treatment convenience and satisfaction compared with VKA therapy.

Next to anticoagulation, pulmonary vein isolation (PVI) is the most important interventional procedure in the treatment of atrial fibrillation (AF). Despite widespread clinical application of this therapy, patients often require multiple procedures to reach clinical success. In contrast to conventional imaging modalities, MRI allows direct visualisation of the ablation lesion. Therefore, the use of real-time MRI to guide cardiac electrophysiology procedures may increase clinical effectiveness. An essential aspect, from a decision-making point of view, is the effect on costs and the potential cost-effectiveness of new technologies. Generally, health technology assessment (HTA) studies are performed when innovations are close to clinical application. However, early stage HTA can inform users, researchers and funders about the ultimate clinical and economic potential of a future innovation. Ultimately, this can guide funding allocation. In this study, we performed an early HTA evaluate MRI-guided PVIs.MethodsWe performed an economic evaluation using a decision tree with a time-horizon of 1 year. We calculated the clinical effectiveness (defined as the proportion of patients that is long-term free of AF after a single procedure) required for MRI-guided PVI to be cost-effective compared with conventional treatment.ResultsDepending on the cost-effectiveness threshold (willingness to pay for one additional quality-of-life adjusted life year (QALY), interventional MRI (iMRI) guidance for PVI can be cost-effective if clinical effectiveness is 69.8% (at €80 000/QALY) and 77.1% (at €20 000/QALY), compared with 64% for fluoroscopy-guided procedures.ConclusionUsing an early HTA, we established a clinical effectiveness threshold for interventional MRI-guided PVIs that can inform a clinical implementation strategy. If crucial technologies are developed, it seems plausible that iMRI-guided PVIs will be able to reach this threshold.

Introduction Use of the prehospital 12-lead ECG (PHECG) is recommended in patients presenting to emergency medical services (EMS) with suspected acute coronary syndrome (ACS). Prior research found that although PHECG use was associated with improved 30-day survival, a third of patients (typically women, the elderly and those with comorbidities) under EMS care did not receive a PHECG. The overall aim of the PHECG2 study is to update evidence on care and outcomes for patients eligible for PHECG, specifically addressing the following research questions: (1) Is there a difference in 30-day mortality, and in reperfusion rate, between those who do and those who do not receive PHECG? (2) Has the proportion of eligible patients who receive PHECG changed since the introduction of primary percutaneous coronary intervention networks? (3) Are patients that receive PHECG different from those that do not in terms of social and demographic factors, or prehospital clinical presentation? (4) What factors influence EMS clinicians’ decisions to perform PHECG? Methods and analysis This is an explanatory, mixed-method study comprising four work packages (WPs). WP1 is a population-based, linked-data analysis of a national ACS registry (Myocardial Ischaemia National Audit Project). WP2 is a retrospective chart review of patient records from three large regional EMS. WP3 comprises focus groups of EMS personnel. WP4 will synthesise findings from WP1–3 to inform the development of an intervention to increase PHECG uptake. Ethics and dissemination The study has been approved by the London-Hampstead Research Ethics Committee (ref: 18LO1679). Findings will be disseminated through feedback to participating EMS, conference presentations and publication in peer-reviewed journals. Trial registration number NCT03699137

Background Patients with severe aortic stenosis (AS) and concomitant active cancer (AC) are considered high-risk patients and usually are not allowed to undergo surgical valve replacement. Transcatheter aortic valve replacement (TAVR) may be an attractive option for them; however, little is known about the outcomes of TAVR in this subset of complex patients. Methods and results In this meta-analysis, Medline, Cochrane Library and Scopus databases were searched (anytime up to April 2019) for studies evaluating the outcomes of TAVR in patients with or without AC. We assessed pooled estimates (with their 95% confidence intervals [CIs]) of the risk ratio (RR) for the all-cause mortality at the 30-day and 1-year follow-ups, a 4-point safety outcome (any bleeding, stroke, need for a pacemaker and acute kidney injury) and a 2-point efficacy outcome (device success and residual mean gradient [mean difference]). Three studies (5162 patients) were included. Of those patients, a total of 368 patients (7.1%) had AC. Apart from a significantly higher need for a postprocedural pacemaker (RR 1.29, 95% CI: 1.06–1.58, P=0.01), TAVR in AC patients resulted in similar outcomes for safety and efficacy at the 30-day follow-up compared to those without AC. Patients with AC experienced similar rates of the all-cause mortality at the 30-day follow-up compared to those without (RR 0.92, 95% CI: 0.53 to 1.59, P=0.76); however, the all-cause mortality was significantly higher in patients with AC at the 1-year follow-up (RR 1.71, 95% CI: 1.26 to 2.33, P=0.0006). This mortality difference was independent of cancer stage (advanced or limited) at the 30-day follow-up but not at the 1-year follow-up; only patients with limited cancer stages showed similar all-cause mortality rates compared to those without cancer at the 1-year follow-up (RR 1.22, 95% CI: 0.79 to 1.91, P=0.37). Conclusion TAVR in patients with AC is associated with similar 30-day and potentially worse 1-year outcomes compared to those in patients without AC. The 1-year all-cause mortality appears to be dependent on the cancer stage. Involving a specialized oncologist who usually considers cancer stage in the decision-making process and applying additional preoperative scores such as frailty indices might refine the risk assessment process among these patients. All-cause mortality (cancer vs no) Funding Acknowledgement Type of funding source: None

It is established that neurodevelopmental disability (NDD) is common in neonates undergoing complex surgery for congenital heart disease (CHD); however, the trajectory of disability over the lifetime of individuals with CHD is unknown. Several ‘big issues’ remain undetermined and further research is needed in order to optimise patient care and service delivery, to assess the efficacy of intervention strategies and to promote best outcomes in individuals of all ages with CHD. This review article discusses ‘gaps’ in our knowledge of NDD in CHD and proposes future directions.

IntroductionDespite the availability of diverse evidence-based diagnostic and treatment options, many patients with acute coronary syndrome (ACS) still fail to receive effective, safe and timely diagnoses and therapies. The Association of Acute CardioVascular Care of the European Society of Cardiology has proposed and retrospectively validated a set of ACS-specific quality indicators. Combining these indicators with the principles of clinical governance—a holistic, patient-centred approach intended to promote continuous quality improvement—we designed the clinical governance programme in patients with ACS.Methods and analysisThis is a multicentre quality improvement initiative exploring multiple dimensions of care, including diagnosis, therapy, patient satisfaction, centre organisation and efficiency in all comers patients with ACS.The study will enrol ≈ 5000 patients prospectively (ie, at the time of the first objective qualifying ACS criterion) with a 1-year follow-up. Consecutive inclusion will be promoted by a simplified informed consent process and quantified by the concordance with corresponding hospital administrative records using diagnosis-related group codes of ACS.Coprimary outcome measures are (1) timely reperfusion in patients with ST-elevation ACS and (2) optimal medical therapy at discharge in patients with confirmed acute myocardial infarction. Secondary outcomes broadly include multiple indicators of the process of care. Clinical endpoints (ie, death, myocardial infarction, stroke and bleeding) will be adjudicated by a clinical event committee according to predefined criteria.Ethics and disseminationThe study has been approved by local ethics committee of all study sites. As a quality improvement initiative and to promote consecutive inclusion of the population of interest, a written informed consent will be requested only to patients who are discharged alive. Dissemination will be actively promoted by (1) the registration site (ClinicalTrials.Gov ID NCT04255537), (2) collaborations with investigators through open data access and sharing.

ObjectiveTo understand the experiences of patients with dual antiplatelet therapy (DAPT) and nuisance bleeding, and their perspectives of the impact of nuisance bleeding on medication adherence and information seeking.MethodsWe conducted focus groups with patients who had undergone percutaneous coronary intervention, coronary artery bypass graft and conservatively managed acute coronary syndrome patients. Two focus groups were with patients at the early stages of treatment (0–3 months), and two with patients coming to the end of treatment (9–12 months). Group discussions were audio recorded, and recordings were transcribed verbatim, anonymised and analysed using framework analysis.FindingsNine patients taking DAPT for up to 3 months, and 12 taking DAPT between 9 and 12 months participated in the focus groups. We found that: (1) participants adhered to treatment when they believed DAPT was important to health outcomes; (2) those who experienced nuisance bleeding reported symptoms to be mild and manageable; (3) participants’ and their family’s understanding of DAPT risks and benefits, and their ability to manage symptoms, influenced perspectives of and experiences with adherence. Factors influencing DAPT knowledge included access to medication counselling, engaging with information communicated during medication counselling, and access to timely, relevant and expert information and advice after discharge from hospital.ConclusionsPositive attitudes towards adherence were facilitated by knowledge and understanding of DAPT and confidence in dealing with symptoms caused by DAPT, but hindered by lack of opportunities to access relevant, timely and appropriate medication counselling. Education interventions should aim to support medication literacy through family-centred approaches and involve patients and families at all stages of intervention design and evaluation.

Hypertension is a global public health issue and a major cause of morbidity and mortality. Its prevalence is increasing in many Asian countries, with a number of countries with blood pressure above the global average. Although the average systolic blood pressure is decreasing worldwide since the 1980s at the rate of about 1 mm Hg systolic blood pressure per decade, it is increasing in low-income and middle-income countries, especially in the East and South Asian population. Of note, the much larger base Asian population results in a considerably larger absolute number of individuals affected. When compared with Western countries, hypertension among Asian populations has unique features in terms of its onset, clustering of associated cardiovascular risk factors, complications and outcomes. Moreover, only a minority of hypertensive individuals are receiving treatment and achieving control. Projected number of deaths related to hypertension dramatically increased in the last 25 years in some Asian regions with a disproportionately high mortality and morbidity from stroke compared with Western countries. The relation between blood pressure and the risk of stroke is stronger in Asia than in Western regions. Although new Guidelines for hypertension diagnosis and management have been recently released from Europe and North America, the unique features of Asian hypertensive patients raise concerns on the clinical applicability of Western Guidelines to Asian populations. To this purpose, we critically reviewed key elements from the most updated Guidelines. We also discussed their core concepts to verify the impact on hypertension prevention and management in Asian countries.

BackgroundA systematic review of low-risk death has been shown successful in identifying system weaknesses. The aim was to analyse early mortality in low-risk patients undergoing cardiac surgery and to determine the cause of death, classify if they were unavoidable or potentially preventable as a result of technical or system errors.MethodsWe included all low-risk patients who underwent cardiac surgery at our institution from 1 September 2009 to 31 August 2019. In patients operated between 2009 and 2011, we defined low risk as an additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) I less than or equal to 3, and from 2012 and onwards as a EuroSCORE II less than or equal to 1.5. The medical records for the patients who died within 30 days of surgery were thoroughly examined and the cause of death was classified as cardiac or non-cardiac. Furthermore, deaths were categorised as not preventable, preventable (technical error) or preventable (system error).ResultsDuring the study period 3103 low-risk patients underwent surgery, and 11 patients died within 30 days of the operation (0.35%). Six of these (55%) were classified as preventable and five non-preventable. Four of the preventable deaths were classified as technical errors and two were due to system errors.ConclusionsA repeated systematic review of deaths in patients with a low preoperative risk showed that a majority of deaths were preventable, and therefore potentially avoidable. Similar to the previous assessment at our unit, mortality was very low and failure to communicate remains a modifiable factor that should be addressed.

ObjectiveTo measure medium-term outcomes and determine the predictors of mortality in patients with coronary artery disease (CAD) both during and after hospitalisation in a resource-limited South-East Asian setting.MethodsFrom February 2013 to December 2014, we conducted a prospective observational cohort study of 477 patients admitted to Makassar Cardiac Center, Indonesia, with acute coronary syndrome and stable CAD. We actively obtained data on clinical outcomes and after-discharge management until April 2017. Multivariable Cox proportional hazard analysis was performed to examine predictors for our primary outcome, all-cause mortality.ResultsFrom hospital admission, patients were followed over a median of 18 (IQR 6–36) months; in total 154 (32.3%) patients died. More patients with acute myocardial infarction died in the hospital compared with patients with unstable and stable angina (p=0.002). Over the total follow-up, there was a difference in mortality between non-ST-segment elevation myocardial infarction (n=41, 48.2%), ST-segment elevation myocardial infarction (n=65, 30.8%), unstable angina (n=18, 26.5%) and stable coronary artery disease (n=30, 26.5%) groups (p=0.007). The independent predictors of all-cause mortality were hyperglycaemia on admission (HR 1.55 (95% CI 1.12 to 2.14), p=0.008), heart failure/Killip class ≥2 (HR 2.50 (95% CI 1.76 to 3.56), pConclusionsPatients with CAD in a poor South-East Asian setting experience high in-hospital and medium-term mortality. The initial severity of the disease, lack of access to guidelines-recommended therapy and poor adherence to after-discharge medications are the main drivers for excess mortality. Improved access to early and late hospital care and patient education should be prioritised for better survival.

ObjectiveWe aimed to determine the relationship between the prevalence of in-hospital complications and annual institutional patient volume in a population of patients undergoing percutaneous coronary intervention (PCI).MethodsClinical data of patients receiving PCI between January 2010 and June 2015 were collected from 14 academic institutions in the Tokyo area and subsequently used for analysis. We employed multivariate hierarchical logistic regression models to determine the effect of institutional volume on several in-hospital outcomes, including in-hospital mortality and procedure-related complications.ResultsA total of 14 437 PCI cases were included and categorised as receiving intervention from either lower-volume (ConclusionsIn conclusion, we observed no significant association between annual institutional volume and in-hospital outcomes within the contemporary PCI multicentre registry.Trial registration numberUMIN R000005598.

Objective In the era of limited healthcare budgets, healthcare costs of heart valve implantations need to be considered to inform cost-effectiveness analyses. We aimed to provide age group-specific costs estimates of heart valve implantations, related complications and other healthcare utilisation following the intervention. Methods We performed retrospective analyses of healthcare costs of patients who had undergone heart valve implantations in 2010–2013 and controls using claims data from Dutch health insurers. Heart valve implantations included surgical valve replacement and transcatheter valve implantation in all heart valve positions. Patients were divided in four age groups. Control groups were created by taking random samples of the Dutch population stratified by age, gender, socioeconomic status and comorbidities. We applied non-parametric bootstrapping to address uncertainty of the cost estimates. The association of patient and intervention characteristics with costs was determined by (multilevel) generalised linear models. Results The baseline characteristics of 18 903 patients and 188 925 controls were comparable. The annual healthcare costs were substantially higher for surgical heart valve replacement patients than for controls, especially in the year of heart valve implantation. Factors associated with increased annual healthcare costs for patients were older age, female gender, comorbidities, low socioeconomic status and complications. Conclusions We provided a comprehensive overview of age group-specific incidence of heart valve implantations, subsequent survival and complications as well as associated healthcare costs of all patients in the Netherlands. Our results provide real-world costs estimates that can be used as a benchmark for costs of future innovative heart valve implantations.

Background Transcatheter aortic valve implantation (TAVI) is a minimally invasive treatment for aortic valve patients who are inoperable or have a prohibitively high surgical risk for surgical aortic valve replacement (SAVR). Most studies compare the efficacy of TAVI and SAVR, yet the assessment of TAVI for this group of patients requires more study. Methods This quasiexperimental study compares TAVI cases (ages of 75–90 years, n=187) ex-post with a control group without implantation (n=728, 4:1 ratio intended). The control group was drawn randomly on the condition that it matches the TAVI cases based on age at aortic valve disease incidence, gender and comorbidity index. The mortality risk is analysed from incident diagnosis. Data were taken from three random samples of health claims data in Germany’s largest public health insurance (Allgemeine Ortskrankenkassen) and cover the years 2004–2013 (n=750 000). Results Compared with the medically treated control group with 6+ comorbidities, medically treated patients with fewer comorbidities have half the mortality risk (HR 0.48, 95% CI 0.34 to 0.69, p

Objective To determine the agreement of measures of care in different settings—hospitals, nursing homes (NHs), and home health agencies (HHAs)—and identify communities with high-quality care in all settings. Data Sources/Study Setting Publicly available quality measures for hospitals, NHs, and HHAs, linked to hospital service areas (HSAs). Study Design We constructed composite quality measures for hospitals, HHAs, and nursing homes. We used these measures to identify HSAs with exceptionally high- or low-quality of care across all settings, or only high hospital quality, and compared these with respect to sociodemographic and health system factors. Principal Findings We identified three dimensions of hospital quality, four HHA dimensions, and two NH dimensions; these were poorly correlated across the three care settings. HSAs that ranked high on all dimensions had more general practitioners per capita, and fewer specialists per capita, than HSAs that ranked highly on only the hospital measures. Conclusion Higher quality hospital, HHA, and NH care are not correlated at the regional level; regions where all dimensions of care are high differ systematically from regions which score well on only hospital measures and from those which score well on none.

Background The impact of cardiac troponin (cTn) testing on the downstream use of cardiovascular services is not well understood. We conducted this large-scale single centre cohort study to investigate the patterns of testing that result from the use of cTn. Methods We conducted this investigation using data collected between 1 January 2013 and 18 December 2015 from an academically affiliated tertiary care centre. Data from all hospitalised patients evaluated with cTn (Roche Elecsys cTn-T) assay were collected from our integrated data repository and divided into two cohorts: all cTn assays negative (

Objective Adults with congenital heart disease (CHD) are at increased risk of infective endocarditis (IE). Women with CHD have a lower IE risk, potentially due to gender-related differences in dental care. We aimed to assess self-reported dental hygiene measures in adults with CHD, and to identify factors associated with good oral hygiene. Methods and results Descriptive study includes 187 adults with CHD at increased risk of IE. The patients’ IE knowledge was assessed using an adapted version of the Leuven Knowledge Questionnaire for CHD. Their mean age was 34.9±14.9 years, 73 of them (39%) were women, 91 (49%) were at high risk for IE, including 66 (35%) with a prosthetic valve, 14 (7%) with a history of IE and 11 (6%) with cyanotic CHD or residual shunts/valvular regurgitation in the proximity of prosthetic material. The self-defined IE knowledge score did not differ between men and women (21.6±10.0 vs 23.4±10.0; p=0.225). 126 patients (67%) reported to have a good oral hygiene. Female gender (OR 2.4, 95% CI 1.1 to 4.4), and a higher IE knowledge score (OR 1.2, 95% CI 1.1 to 1.5, per 5 points) were the variables independently associated with good oral hygiene. Conclusions In adults with CHD, patients with a higher IE knowledge score and women are more likely to practise dental care as recommended. Gender differences in oral hygiene practise may explain the observed lower female IE incidence rate. Efforts to improve patients’ knowledge on IE are encouraged.

Objective In patients with mild to moderate operative risk, surgical aortic valve replacement (SAVR) is still the preferred treatment for patients with severe symptomatic aortic stenosis (AS). Aiming to broaden the knowledge of postsurgical outcomes, this study reports a broad set of morbidity outcomes following surgical intervention. Methods Our cohort comprised 442 patients referred for severe AS; 351 had undergone SAVR, with the remainder (91) not operated on. All patients were evaluated using the 6-minute walk test (6MWT), were assigned a New York Heart Association class (NYHA) and Canadian Cardiovascular Society class (CCS), with additional scores for health-related quality of life (HRQoL), cognitive function (Mini-Mental State Examination (MMSE)) and myocardial remodelling (at inclusion and at 1-year follow-up). Adverse events and mortality were recorded. Results Three-year survival after SAVR was 90.0%. SAVR was associated with an improved NYHA class, CCS score and HRQoL, and provoked reverse ventricular remodelling. The 6MWT decreased, while the risks of major adverse cardiovascular events (death, non-fatal stroke/transient ischaemic attack or myocardial infarction) and all-cause hospitalisation (incidence rate per 100 patient-years) were 13.5 and 62.4, respectively. The proportion of cognitive disability measured by MMSE increased after SAVR from 3.2% to 8.8% (p=0.005). Proportion of patients living independently at home, having attained NYHA class I, was met by 49.1% at 1 year. Unoperated individuals had a poor prognosis in terms of any outcome. Conclusion This study provides knowledge of outcomes beyond what is known about the mortality benefit after SAVR to provide insight into the morbidity burden of modern-day SAVR.

Background Lack of evidence-based data on the spectrum of cardiovascular disease (CVD) in pregnancy or in the postpartum period, as well as on maternal and fetal outcome, provides challenges for treating physicians, particularly in areas of low resources. The objectives of this study were to investigate the spectrum of disease, mode of presentation and maternal and fetal outcome of patients referred to a dedicated Cardiac Disease and Maternity Clinic (CDM). Methods The prospective cohort study was conducted at a single tertiary care centre in South Africa. Two hundred and twenty-five women presenting with CVD in pregnancy, or within 6 months postpartum, were studied over a period of 2 years. Clinical assessment, echocardiography and laboratory tests were performed at baseline and follow-up visits. Prepartum, peripartum and postpartum complications were grouped into cardiac, neonatal and obstetric events. Results Ethnicity was black African (45%), mixed ethnicity (32%), white (15%), Indian/others (8%) and 12% were HIV positive. Of the 225 consecutive women (mean age 28.8+/-6.4), 196 (86.7%) presented prepartum and 73 in modified WHO class I. The 152 women presenting in a higher risk group (modified WHO class II-IV) were offered close follow-up at the CDM clinic and were diagnosed with congenital heart disease (32%, 15 operated previously), valvular heart disease (26%, 15 operated previously), cardiomyopathy (27%) and other (15%). Women presenting with symptoms of CVD or heart failure postpartum (n=30) presented in a higher New York Heart Association, had higher heart rates (p42 days postpartum. Perinatal death occurred in 1/152 (0.7%)-translating to a perinatal mortality rate of 7/1000 live births. Conclusions Disease patterns were markedly different to that seen in the developed world. However, joint obstetric-cardiac care in the low-resource cohort was associated with excellent survival outcome rates of pregnant mothers (even with complex diseases) and their offspring and was similar to that seen in the western world. Mortality typically occurred in the postpartum period, beyond the standard date of recording maternal death.

IntroductionThe Intermountain Risk Score (IMRS) was developed and validated to predict short-term and long-term mortality in hospitalised patients using demographics and commonly available laboratory data. In this study, we sought to determine whether the IMRS also predicts all-cause mortality in patients hospitalised with heart failure with preserved ejection fraction (HFpEF) and whether it is complementary to the Get with the Guidelines Heart Failure (GWTG-HF) risk score or N-terminal pro-B-type natriuretic peptide (NT-proBNP).Methods and resultsWe used the Stanford Translational Research Integrated Database Environment to identify 3847 adult patients with a diagnosis of HFpEF between January 1998 and December 2016. Of these, 580 were hospitalised with a primary diagnosis of acute HFpEF. Mean age was 76±16 years, the majority being female (58%), with a high prevalence of diabetes mellitus (36%) and a history of coronary artery disease (60%). Over a median follow-up of 2.0 years, 140 (24%) patients died. On multivariable analysis, the IMRS and GWTG-HF risk score were independently associated with all-cause mortality (standardised HRs IMRS (1.55 (95% CI 1.27 to 1.93)); GWTG-HF (1.60 (95% CI 1.27 to 2.01))). Combining the two scores, improved the net reclassification over GWTG-HF alone by 36.2%. In patients with available NT-proBNP (n=341), NT-proBNP improved the net reclassification of each score by 46.2% (IMRS) and 36.3% (GWTG-HF).ConclusionIMRS and GWTG-HF risk scores, along with NT-proBNP, play a complementary role in predicting outcome in patients hospitalised with HFpEF.

Over the past decade, a shortage of registered nurses (RNs) has been one of the most critical concerns for health care institutions, particularly hospitals (Spetz and Given 2003; Buerhaus, Auerbach, and Staiger 2009). The Bureau of Health Professions of the Health Resources and Services Administration estimated that the RN shortage would grow from 6 percent in 2002 to 20 percent by 2020 (DHHS 2002). Researchers proposed that high turnover and intent of RNs to leave the profession would further worsen the future shortage (Aiken et al. 2001; HSM Group 2002). Since 2007, however, when the U.S. economy slipped into a severe recession, immediate concern over the RN shortage abated. During the recession, RN employment and retention sharply increased compared with other professions, virtually ending the decade-long shortage of hospital RNs (Staiger, Auerbach, and Buerhaus 2012). Nevertheless, workforce researchers expect that the absence of an RN shortage may be short-lived and that increases in RN turnover and a shortage will reemerge once the economy has recovered (Buerhaus, Auerbach, and Staiger 2009; Staiger, Auerbach, and Buerhaus 2012). Thus, policy makers, administrators, and researchers must closely monitor RN turnover because it affects stability in the nursing workforce and threatens the consistency and quality of patient care. Past studies have identified an array of complex and multifaceted factors associated with nurse turnover; however, most of them have focused on the determinants of nurse turnover such as organizational factors, management style, workload, burnout, and pay/benefits (O'Brien-Pallas et al. 2006; Hayes et al. 2012). Few studies have examined the consequences of nurse turnover, particularly its effect on the quality of hospital patient care. Many researchers assume that nurse turnover will negatively affect the quality of patient care that is provided by nurses (Shortell et al. 1994; Tai, Bame, and Robinson 1998; O'Brien-Pallas et al. 2006). However, this assumption has been supported by only a few empirical studies that examined the relationship between nurse turnover and patient outcomes (Leiter, Harvie, and Frizzell 1998; O'Brien-Pallas et al. 2010; VHA 2002). Moreover, their findings could be challenged because the studies were based mostly on small sample sizes, used data from a narrow set of unit types or a limited number of hospital settings, analyzed facility-level data that might not account for differences in turnover rates among unit types, used a cross-sectional design that might make it difficult to account for changes in nurse turnover and outcomes over time, or considered turnover intention as a proxy for actual turnover instead of testing the direct effect of actual turnover on patient outcomes (Hayes et al. 2012). To address these concerns, therefore, we longitudinally examined the association between turnover of nurses, specifically RNs, and the patient outcome of pressure ulcers at the unit level.

To determine whether quality measures based on computer-extracted EHR data can reproduce findings based on data manually extracted by reviewers.We studied 12 measures of care indicated for adolescent well-care visits for 597 patients in three pediatric health systems.Observational study.Manual reviewers collected quality data from the EHR. Site personnel programmed their EHR systems to extract the same data from structured fields in the EHR according to national health IT standards.Overall performance measured via computer-extracted data was 21.9 percent, compared with 53.2 percent for manual data. Agreement measures were high for immunizations. Otherwise, agreement between computer extraction and manual review was modest (Kappa = 0.36) because computer-extracted data frequently missed care events (sensitivity = 39.5 percent). Measure validity varied by health care domain and setting. A limitation of our findings is that we studied only three domains and three sites.The accuracy of computer-extracted EHR quality reporting depends on the use of structured data fields, with the highest agreement found for measures and in the setting that had the greatest concentration of structured fields. We need to improve documentation of care, data extraction, and adaptation of EHR systems to practice workflow.

Atrial fibrillation (AF) is a global problem with a significant impact on health outcomes, affecting up to 1% to 2% of the global adult population, and is projected to increase in both developed and developing countries over the coming decades.[1][1] AF is associated with higher mortality and

OBJECTIVES: To ascertain the characteristics associated with delayed cardiac rehabilitation (CR) and determine if an association between CR timing and fitness outcomes exists in patients receiving routine care. METHODS: The study used data from the UK National Audit of Cardiac Rehabilitation, a data set which captures information on routine CR practice and patient outcomes. Data from 1 January 2012 to 8 September 2015 were included. Logistic regression models were used to explore the relationship between timing of CR and fitness-related outcomes as measured by patient-reported exercise level (150 min/week: yes/no), Dartmouth quality of life physical fitness scale and the incremental shuttle-walk test. RESULTS: Based on UK data current CR practice shows that programmes do not always adhere to recommendations on the start of prompt CR, that is, start CR within 28 days of referral (42 days for coronary artery bypass graft (CABG)). Wait time exceeded recommendations in postmyocardial infarction (post-MI), elective percutaneous coronary intervention (PCI), MI-PCI and post-CABG surgery patients. This was particularly pronounced in the medically managed post-MI group, median wait time 40 days. Furthermore, statistical analysis revealed that delayed CR significantly impacts fitness outcomes. For every 1-day increase in CR wait time, patients were 1% less likely to improve across all fitness-related measures (p