Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012.

BACKGROUND: We assessed trends in the performance of transcatheter aortic valve implantation in the United Kingdom from the first case in 2007 to the end of 2012. We analyzed changes in case mix, complications, outcomes to 6 years, and predictors of mortality. METHODS AND RESULTS: Annual cohorts were examined. Mortality outcomes were analyzed in the 92% of patients from England and Wales for whom independent mortality tracking was available. A total of 3980 transcatheter aortic valve implantation procedures were performed. In successive years, there was an increase in frequency of impaired left ventricular function, but there was no change in Logistic EuroSCORE. Overall 30-day mortality was 6.3%; it was highest in the first cohort (2007-2008), after which there were no further significant changes. One-year survival was 81.7%, falling to 37.3% at 6 years. Discharge by day 5 rose from 16.7% in 2007 and 2008 to 28% in 2012. The only multivariate preprocedural predictor of 30-day mortality was Logistic EuroSCORE ≥40. During long-term follow-up, multivariate predictors of mortality were preprocedural atrial fibrillation, chronic obstructive pulmonary disease, creatinine >200 µmol/L, diabetes mellitus, and coronary artery disease. The strongest independent procedural predictor of long-term mortality was periprocedural stroke (hazard ratio=3.00; P<0.0001). Nonfemoral access and postprocedural aortic regurgitation were also significant predictors of adverse outcome. CONCLUSIONS: We analyzed transcatheter aortic valve implantation in an entire country, with follow-up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer-term outcomes improved, and patients were discharged earlier. Periprocedural stroke, nonfemoral access, and postprocedural aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors.

Predictors of inhospital mortality following out-of-hospital cardiac arrest: Insights from a single-centre consecutive case series.

PURPOSE OF THE STUDY: Out-of-hospital cardiac arrest (OHCA) has a poor prognosis despite bystander resuscitation and rapid transfer to hospital. Optimal management of patients after arrival to hospital continues to be contentious, especially the timing of emergency coronary angiography±revascularisation. Robust predictors of inhospital outcome would be of clinical value for initial decision-making. STUDY DESIGN: A retrospective analysis of consecutive patients who presented to a university hospital following OHCA over a 70-month period (2008-2013). Patients were identified from the emergency department electronic patient registration and coding system. For those patients who underwent emergency percutaneous coronary intervention, details were crosschecked with national databases. RESULTS: We identified 350 consecutive patients who were brought to our hospital following OHCA. Return of spontaneous circulation (ROSC) for >20 min was achieved either before arrival or inhospital in 196 individuals. From the 350 subjects, 114 (32.6%) survived to hospital discharge. When sustained ROSC was achieved, either before or inhospital, survival to discharge was 58.2% (114 of 196). Non-shockable rhythm, absence of bystander cardiopulmonary resuscitation, 'downtime' >15 min and initial pH ≤7.11 were predictors of inhospital death. 12% patients who underwent angiography in the presence of ST elevation had no acute coronary occlusion. 21% patients with acute coronary occlusion at angiography did not have ST elevation. CONCLUSIONS: In our cohort of patients with OHCA, those who achieve ROSC had a survival-to-discharge rate of 58.2%. We identified four predictors of inhospital death, which are readily available at the time of patient presentation. Reliance on ST elevation to decide about coronary angiography and revascularisation may be flawed. More data are required.

The acute management of ST-segment-elevation myocardial infarction.

Acute ST-segment-elevation myocardial infarction (STEMI) results from complete obstruction to coronary artery blood flow accompanied by the appearance of ST-segment-elevation on the electrocardiogram. Emergency treatment is required to restore coronary perfusion, thereby limiting the extent of damage to the myocardium and the likelihood of early death or future heart failure. This concise guideline summarises key recommendations from the National Institute for Health and Care Excellence clinical guideline on acute management of STEMI (CG167), of relevance to all healthcare professionals involved. Guidance is presented on choice of reperfusion strategies, procedural aspects, use of additional drugs before and alongside reperfusion therapies, and treatment of patients who are unconscious or in cardiogenic shock.

Development of delivery indicators and delivery enablers for cardiovascular disease in the UK: a modified Delphi study.

INTRODUCTION: Standards to define and measure quality in healthcare for cardiovascular disease risk reduction and secondary prevention are available, but there is a paucity of indicators that could serve as facilitators of structural change at a system level. This research study aimed to develop a range of delivery indicators to help cardiac clinical networks assess delivery of and progress towards cardiovascular disease objectives. METHODS: This study used an adapted version of the European Society of Cardiology's four-step process for the development of quality indicators. The four steps in this study were as follows: identify critical factors of enablement, construct a list of candidate indicators, select a final set of indicators and assess availability of national data for each indicator. In this iterative process, a core project group of six members was supported by a wider review group of 21 people from the National Health Service (NHS) clinical and management personnel database. RESULTS: The core project group identified six relevant cardiovascular disease priorities in the NHS Long Term Plan and used an iterative process to identify 21 critical factors that impact on their implementation. A total of 57 potential indicators that could be measures of implementation were developed. The core project group agreed on a set of 38 candidate indicators that were circulated to the review group for rating. Based on these scores, the core project group excluded 5 indicators to arrive at a final set of 33 delivery indicators. National datasets were available for 22 of the final indicators, which were designated as delivery indicators. The remaining 11, for which national datasets were not available but locally available datasets could be used, were designated as delivery enablers. CONCLUSION: The suite of delivery indicators and delivery enablers for cardiovascular disease could allow a more focused evaluation of factors that impact on delivery of healthcare for cardiovascular disease.

Uncovering the treatable burden of severe aortic stenosis in the UK.

OBJECTIVE: To estimate the population prevalence and treatable burden of severe aortic stenosis (AS) in the UK. METHODS: We adapted a contemporary model of the population profile of symptomatic and asymptomatic severe AS in Europe and North America to estimate the number of people aged ≥55 years in the UK who might benefit from surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). RESULTS: With a point prevalence of 1.48%, we estimate that 291 448 men and women aged ≥55 years in the UK had severe AS in 2019. Of these, 68.3% (199 059, 95% CI 1 77 201 to 221 355 people) would have been symptomatic and, therefore, more readily treated according to their surgical risk profile; the remaining 31.7% of cases (92 389, 95% CI 70 093 to 144 247) being asymptomatic. Based on historical patterns of intervention, 58.4% (116 251, 95% CI 106 895 to 1 25 606) of the 199 059 symptomatic cases would qualify for SAVR, with 7208 (95% CI 7091 to 7234) being assessed as being in a high, preoperative surgical risk category. Among the remaining 41.6% (82 809, 95% CI 73 453 to 92 164) of cases potentially unsuitable for SAVR, an estimated 61.7% (51 093, 95% CI 34 780 to 67 655) might be suitable for TAVI. We estimate that 172 859 out of 291 448 prevalent cases of severe AS (59.3%) will subsequently die within 5 years without proactive management. CONCLUSIONS: These data suggest a high burden of severe AS in the UK requiring surgical or transcatheter intervention that challenges the ongoing capacity of the National Health Service to meet the needs of those affected.

Lifetime cardiovascular management of patients with previous Kawasaki disease.

Kawasaki disease (KD) is an inflammatory disorder of young children, associated with vasculitis of the coronary arteries with subsequent aneurysm formation in up to one-third of untreated patients. Those who develop aneurysms are at life-long risk of coronary thrombosis or the development of stenotic lesions, which may lead to myocardial ischaemia, infarction or death. The incidence of KD is increasing worldwide, and in more economically developed countries, KD is now the most common cause of acquired heart disease in children. However, many clinicians in the UK are unaware of the disorder and its long-term cardiac complications, potentially leading to late diagnosis, delayed treatment and poorer outcomes. Increasing numbers of patients who suffered KD in childhood are transitioning to the care of adult services where there is significantly less awareness and experience of the condition than in paediatric services. The aim of this document is to provide guidance on the long-term management of patients who have vascular complications of KD and guidance on the emergency management of acute coronary complications. Guidance on the management of acute KD is published elsewhere.

Temporal Trends in Identification, Management, and Clinical Outcomes After Out-of-Hospital Cardiac Arrest: Insights From the Myocardial Ischaemia National Audit Project Database.

BACKGROUND: There is wide variation in survival rates from out-of-hospital cardiac arrest (OHCA) and overall survival remains poor. There is an expert consensus that early reperfusion therapy in ST-elevation reduces mortality. The management of patients without ST-elevation, however, is controversial. METHODS AND RESULTS: The Myocardial Ischaemia National Audit Project database is a national registry of all hospital admissions in England and Wales treated as an acute coronary syndrome (ACS). We examined temporal trends, over a 5-year period, of OHCAs identified by Myocardial Ischaemia National Audit Project, admitted to hospital and treated as ACS, the interventional management of these patients and clinical outcomes. Four hundred ten thousand four hundred sixty-two patients were admitted to hospital in England and Wales with ACS. Of these, 9421 presented with OHCA (2.30%). There was an increase in OHCA cases as a proportion of ACS between 2009 and 2013 (1.79% in 2009 versus 2.74% in 2013; Ptrend<0.001). The rate of coronary angiography+percutaneous coronary intervention increased in ACS patients presenting with OHCA (54.9% in 2009 [876/1595] versus 66.3% in 2013 [884/1334]; Ptrend<0.001). Cox proportional hazards model with time-varying exposure to coronary angiography demonstrated a significant reduction in mortality in both the ST-elevation (hazard ratio, 0.30; 95% confidence interval, 0.28-0.32; P<0.05) and non-ST-elevation cohort (hazard ratio, 0.44; 95% confidence interval, 0.42-0.46; P<0.001). Predictors of favorable outcome were synonymous with the selection criteria for patients undergoing coronary angiography±percutaneous coronary intervention. CONCLUSIONS: This observational study showed that selection for coronary angiography±percutaneous coronary intervention was associated with reduced mortality in OHCA patients diagnosed with ACS. These data support the need for a randomized controlled trial.

Impact of call-to-balloon time on 30-day mortality in contemporary practice.

OBJECTIVE: Studies reporting an association between treatment delay and outcome for patients with ST segment elevation myocardial infarction (STEMI) have generally not included patients treated by a primary percutaneous coronary intervention (PPCI) service that systematically delivers reperfusion therapy to all eligible patients. We set out to determine the association of call-to-balloon (CTB) time with 30-day mortality after PPCI in a contemporary series of patients treated within a national reperfusion service. METHODS: We analysed data on 16 907 consecutive patients with STEMI treated by PPCI in England and Wales in 2011 with CTB time of ≤6 hours. RESULTS: The median CTB and door-to-balloon times were 111 and 41 min, respectively, with 80.9% of patients treated within 150 min of the call for help. An out-of-hours call time (58.2% of patients) was associated with a 10 min increase in CTB time, whereas inter-hospital transfer for PPCI (18.5% of patients) was associated with a 49 min increase in CTB time. CTB time was independently associated with 30-day mortality (p<0.0001) with a HR of 1.95 (95% CI 1.54 to 2.47) for a CTB time of >180-240 min compared with ≤90 min. The relationship between CTB time and 30-day mortality was influenced by patient risk profile with a greater absolute impact of increasing CTB time on mortality in high-risk patients. CONCLUSION: CTB time is a useful metric to assess the overall performance of a PPCI service. Delays to reperfusion remain important even in the era of organised national PPCI services with rapid treatment times and efforts should continue to minimise treatment delays.

Describing Activity in Primary Percutaneous Coronary Intervention: An Exploration of Denominators. From the HEAT Trial - A Systematic Evaluation of PPCI Activations in Liverpool, Explaining Denominators (HEAT-SEALED).

BACKGROUND: The provision of primary percutaneous coronary intervention (PPCI) in the emergency management of ST-elevation myocardial infarction (STEMI) is expensive and resource intensive. Accurate data collection is essential not only for outcomes analysis but also to characterize activity and performance for regions, centers, and operators. Inconsistency in the use of denominators currently creates problems in data interpretation. OBJECTIVE: To establish a system of denominator groupings, seeking to better describe the range of clinical activity resulting from an unselected series of PPCI activations. METHODS: The HEAT-SEALED pathway designates a key denominator group (n1-n9) to each phase of PPCI activity and identifies a final "destination category" for each patient leaving the pathway. HEAT-PPCI (How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention) is a true "all-comers" trial and provides an ideal platform to collect data for prospective validation of the pathway. We report data from all PPCI activation events for the HEAT-PPCI trial. RESULTS: Our findings demonstrate important differences between the sizes of key PPCI denominator groups and hence the potential for variation in reported outcomes depending on the denominator category selected. The main figures are: all activations (n1 = 2490); all suspected MI cases (n4 = 1940; 77.91%); patients in whom angiography was performed (n5 = 1904; 76.46%); cases in which diagnosis was confirmed with a probable culprit lesion (n6 = 1657; 66.54%), and cases with complete PCI success (n9 = 1441; 57.87%). CONCLUSION: The HEAT-SEALED pathway offers a practical and comprehensive solution to the problem of describing denominators in STEMI and PPCI. Routine application would facilitate a more consistent and precise description of activity and outcome.

Public access defibrillation remains out of reach for most victims of out-of-hospital sudden cardiac arrest.

INTRODUCTION: Public access defibrillation (PAD) prior to ambulance arrival is a key determinant of survival from out-of-hospital (OOH) cardiac arrest. Implementation of PAD has been underway in the UK for the past 12 years, and its importance in strengthening the chain of survival has been recognised in the government's recent 'Cardiovascular Disease Outcomes Strategy'. The extent of use of PAD in OOH cardiac arrests in the UK is unknown. We surveyed all OOH cardiac arrests in Hampshire over a 12-month period to ascertain the availability and effective use of PAD. METHODS: A retrospective review of all patients with OOH cardiac arrest attended by South Central Ambulance Service (SCAS) in Hampshire during a 1-year period (1 September 2011 to 31 August 2012) was undertaken. Emergency calls were reviewed to establish the known presence of a PAD. Additionally, a review of all known PAD locations in Hampshire was undertaken, together with a survey of public areas where a PAD may be expected to be located. RESULTS: The current population of Hampshire is estimated to be 1.76 million. During the study period, 673 known PADs were located in 278 Hampshire locations. Of all calls confirmed as cardiac arrest (n=1035), the caller reported access to an automated external defibrillator (AED) on 44 occasions (4.25%), successfully retrieving and using the AED before arrival of the ambulance on only 18 occasions (1.74%). CONCLUSIONS: Despite several campaigns to raise public awareness and make PADs more available, many public areas have no recorded AED available, and in those where an AED was available it was only used in a minority of cases by members of the public before arrival of the ambulance. Overall, a PAD was only deployed successfully in 1.74% OOH cardiac arrests. This weak link in the chain of survival contributes to the poor survival rate from OOH cardiac arrest and needs strengthening.

Key recommendations and evidence from the NICE guideline for the acute management of ST-segment-elevation myocardial infarction.

The acute management of ST-segment-elevation myocardial infarction (STEMI) has seen significant changes in the past decade. Although the incidence has been declining in the UK, STEMI still gives rise to around 600 hospitalised episodes per million people each year, with many additional cases resulting in death before hospital admission. In-hospital mortality following acute coronary syndromes has fallen over the past 30 years from around 20% to nearer 5%, and this improved outcome has been attributed to various factors, including timely access to an expanding range of effective interventional and pharmacological treatments. A formal review of the acute management of STEMI is therefore appropriate. The recently published NICE clinical guideline (CG167: The acute management of myocardial infarction with ST-segment elevation) provides evidence-based guidance on the acute management of STEMI, including the choice of reperfusion strategies, procedural aspects of the recommended interventions, the use of additional drugs before and longside reperfusion therapies, and the treatment of patients who are unconscious or in cardiogenic shock. The guideline development methods and detailed reviews of the evidence considered by the Guideline Development Group (GDG) can be found in the full version of the guideline (http://www.nice.org.uk/CG167), and the priority recommendations are summarised in box 1. Other related NICE clinical guidelines deal with the diagnosis of recent-onset chest pain of suspected cardiac origin http://www.nice.org.uk/CG95), the early management of unstable angina and non-STEMI (http://www.nice.org.uk/CG94), and secondary prevention after myocardial infarction (http://www.nice.org.uk/CG48, currently being updated with publication expected end of 2013).

The national infarct angioplasty project: UK experience and subsequent developments.

The UK had previously established a comprehensive strategy for in-hospital nurse-led thrombolysis for patients with ST-elevation myocardial infarction, with a growing use of pre-hospital thrombolysis by paramedical staff in the ambulance services. The National Infarct Angioplasty Project was sponsored by the government and examined the introduction of primary percutaneous coronary angioplasty (PPCI) in a variety of urban, rural and mixed communities. The project found that PPCI could be delivered within acceptable timelines, would be cost-effective, and could be delivered to the majority of the population. A project was therefore undertaken in England to transform services. There has been a rapid change and by 2012/13 over 95% of eligible patients received PPCI. Survival of patients with STEMI has improved over time and length of stay in hospital halved. However, nearly a quarter of STEMI patients do not receive reperfusion therapy (often because of late presentation) and additional work is needed to minimise delays to treatment. There are unexplained differences between regions in numbers of PPCI procedures per million population, and there is also variance between centres in the proportion of patients who are in shock or on a ventilator. Additional research is needed to ensure a consistent approach for these sick patients, who might have the most to gain from early treatment. The national audit programmes have been instrumental in measuring the changes in strategies, monitoring performance and highlighting the associated improvements in outcomes. A new risk model is being developed to allow a more comprehensive comparison of outcomes in different hospitals.

The importance of audit to monitor applications of procedures and improve primary angioplasty results.

Although clinical trials have demonstrated that primary percutaneous coronary intervention (PPCI) provides better outcomes than thrombolysis for STEMI, it cannot be assumed that similar results can be obtained in day-to-day practice. To determine whether standards are being met, continuous audit of PPCI programmes is necessary, with appropriate feedback to participating centres and operators. Both the MINAP and BCIS national audit projects allow central electronic collection of data on consecutive patients presenting to every hospital involved in the acute management of these patients. Regular programmed feedback is provided to centres performing primary PCI that attempts to take account of statistical variation and differences in case mix between units by making use of funnel plots, statistical process control graphs and risk adjustment models. This reporting of "process" and "outcome" data, both confidentially and within the public domain, has been used to drive up clinical performance and has been associated with steady improvements and reduced inequalities of care.