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Objectives This study sought to determine if percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease would produce noninferior clinical results when compared with no PCI (control arm). Background PCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice. Methods Patients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population. Results At 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021). Conclusions Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding. (Assessing the Effects of Stenting in Significant Coronary Artery Disease Prior to Transcatheter Aortic Valve Implantation; ISRCTN75836930 )

BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Aims Non-valvular atrial fibrillation (AF) greatly increases the risk of ischaemic stroke. For people with contraindications to oral anticoagulation, left atrial appendage occlusion (LAAO) provides a non-pharmacological management alternative. The aim of this study was to measure the procedural safety and longer-term effectiveness of LAAO for AF in a UK setting. Methods and results This was a prospective, single-armed registry of patients with AF for whom anticoagulation was unsuitable. Registry data were collected between October 2014 and April 2018 and linked to routine data sources for follow-up. Data from 583 LAAO procedures were entered into the registry, of which 537 (from 525 patients) were eligible for inclusion (median CHA2DS2-VASc score 4). A closure device was successfully implanted in 93.4% of cases, with a procedural success rate (device implanted without major complication) of 88.9%. Five patients (1.0%) died in hospital. During follow-up [median 729 (Q1:Q3, 523:913) days] 45 patients experienced neurological events; 33 of which were ischaemic. The ischaemic neurological event rate was 3.3 (1.6–5.0)% at 1 year (n = 387) and 7.0 (4.3–9.6)% at 2 years (n = 196). There were significant improvements in overall patient health (via Visual Analogue Scale) measured at 6 weeks and 6 months, but no significant improvements observed in patient utility over time. Conclusion The findings of our study suggest that LAAO is not without procedural risk, but that this risk may be justified in high-risk patients with AF who cannot take an anticoagulant. Moreover, the data do not provide support for more widespread use of LAAO as the complication rate was relatively high and would be difficult to justify in many patients with AF who tolerate anticoagulation.

Background: Whether an initial invasive strategy in patients with stable ischemic heart disease and at least moderate ischemia improves outcomes in the setting of a history of heart failure (HF) or left ventricular dysfunction (LVD) when ejection fraction is ≥35% but Methods: Among 5179 participants randomized into ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), all of whom had left ventricular ejection fraction (LVEF) ≥35%, we compared cardiovascular outcomes by treatment strategy in participants with a history of HF/LVD at baseline versus those without HF/LVD. Median follow-up was 3.2 years. Results: There were 398 (7.7%) participants with HF/LVD at baseline, of whom 177 had HF/LVEF >45%, 28 HF/LVEF 35% to 45%, and 193 LVEF 35% to 45% but no history of HF. HF/LVD was associated with more comorbidities at baseline, particularly previous myocardial infarction, stroke, and hypertension. Compared with patients without HF/LVD, participants with HF/LVD were more likely to experience a primary outcome composite of cardiovascular death, nonfatal myocardial infarction, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest (4-year cumulative incidence rate, 22.7% versus 13.8%; cardiovascular death or myocardial infarction, 19.7% versus 12.3%; and all-cause death or HF, 15.0% versus 6.9%). Participants with HF/LVD randomized to the invasive versus conservative strategy had a lower rate of the primary outcome (17.2% versus 29.3%; difference in 4-year event rate, −12.1% [95% CI, −22.6 to −1.6%]), whereas those without HF/LVD did not (13.0% versus 14.6%; difference in 4-year event rate, −1.6% [95% CI, −3.8% to 0.7%]; P interaction = 0.055). A similar differential effect was seen for the primary outcome, all-cause mortality, and cardiovascular mortality when invasive versus conservative strategy–associated outcomes were analyzed with LVEF as a continuous variable for patients with and without previous HF. Conclusions: ISCHEMIA participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD were at increased risk for the primary outcome. In the small, high-risk subgroup with HF and LVEF 35% to 45%, an initial invasive approach was associated with better event-free survival. This result should be considered hypothesis-generating. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01471522.

Objectives The authors used the British Cardiovascular Intervention Society (BCIS) national percutaneous coronary intervention (PCI) database to explore temporal changes in the use of intravascular imaging for unprotected left main stem PCI (uLMS PCI), defined the associates of imaging use, and correlate clinical outcomes including survival with imaging use. Background Limited registry data support the use of intravascular imaging during uLMS PCI to improve outcomes. Methods Data were analyzed from 11,264 uLMS PCI procedures performed in England and Wales between 2007 and 2014. Multivariate logistic regression was used to identify associates of imaging use. Propensity matching created 5,056 pairs of subjects with and without imaging and logistic regression was performed to quantify the association between imaging and outcomes. Multivariate logistic regression to identify the independent predictors of 12-month mortality was performed. Results Imaging use increased from 30.2% in 2007 to 50.2% in 2014 (p for trend Conclusions The observed lower mortality with use of intravascular imaging to guide uLMS PCI justifies the undertaking of a large-scale randomized trial.

BACKGROUND: Patients with underlying cardiovascular disease and coronavirus disease 2019 (COVID‐19) infection are at increased risk of morbidity and mortality. OBJECTIVES: This study was designed to characterize the presenting profile and outcomes of patients hospitalized with acute coronary syndrome (ACS) and COVID‐19 infection. METHODS: This observational cohort study was conducted using multisource data from all acute NHS hospitals in England. All consecutive patients hospitalized with diagnosis of ACS with or without COVID‐19 infection between 1 March and 31 May 2020 were included. The primary outcome was in‐hospital and 30‐day mortality. RESULTS: A total of 12 958 patients were hospitalized with ACS during the study period, of which 517 (4.0%) were COVID‐19‐positive and were more likely to present with non‐ST‐elevation acute myocardial infarction. The COVID‐19 ACS group were generally older, Black Asian and Minority ethnicity, more comorbid and had unfavourable presenting clinical characteristics such as elevated cardiac troponin, pulmonary oedema, cardiogenic shock and poor left ventricular systolic function compared with the non‐COVID‐19 ACS group. They were less likely to receive an invasive coronary angiography (67.7% vs 81.0%), percutaneous coronary intervention (PCI) (30.2% vs 53.9%) and dual antiplatelet medication (76.3% vs 88.0%). After adjusting for all the baseline differences, patients with COVID‐19 ACS had higher in‐hospital (adjusted odds ratio (aOR): 3.27; 95% confidence interval (CI): 2.41–4.42) and 30‐day mortality (aOR: 6.53; 95% CI: 5.1–8.36) compared to patients with the non‐COVID‐19 ACS. CONCLUSION: COVID‐19 infection was present in 4% of patients hospitalized with an ACS in England and is associated with lower rates of guideline‐recommended treatment and significant mortality hazard.

Objectives The aim of this study was to evaluate national temporal trends in same-day discharge (SDD) and compare clinical outcomes with those among patients admitted for overnight stay undergoing elective percutaneous coronary intervention (PCI) for stable angina. Background Overnight observation has been the standard of care following PCI, with no previous national analyses around changes in practice or clinical outcomes from health care systems in which SDD is the predominant practice for elective PCI. Methods Data from 169,623 patients undergoing elective PCI between 2007 and 2014 were obtained from the British Cardiovascular Intervention Society registry. Multiple logistic regressions and the British Cardiovascular Intervention Society risk model were used to study the association between SDD and 30-day mortality. Results The rate of SDD increased from 23.5% in 2007 to 57.2% in 2014, with center SDD median prevalence varying from 17% (interquartile range: 6% to 39%) in 2007 to 66% (interquartile range: 45% to 77%) in 2014. The largest independent association with SDD was observed for radial access (odds ratio: 1.69; 95% confidence interval: 1.65 to 1.74; p Conclusions SDD has become the predominant model of care among elective PCI cases in the United Kingdom, in increasingly complex patients. SDD appears to be safe, with 30-day mortality rates in line with those calculated using the national risk prediction score used for public reporting. Changes toward SDD practice have important economic implications for health care systems worldwide.

Objectives\ud This study aims to examine in-hospital gastrointestinal (GI) bleeding, its predictors and clinical outcomes, including long-term outcomes, in a national cohort of patients undergoing percutaneous coronary intervention (PCI) in England and Wales.\ud \ud Background\ud GI bleeding remains associated with significant morbidity, mortality and socioeconomic burden.\ud \ud Methods\ud We examined the temporal changes in in-hospital GI bleeding in a national cohort of patients undergoing PCI between 2007-2014 in England and Wales, its predictors and prognostic consequences. Multivariate analysis was performed to identify independent risk factors between GI bleeding and 30-day mortality. Survival analysis was performed comparing patients with, and without, GI bleeding. \ud \ud Results\ud There were 480 in-hospital GI bleeds in 549,298 patients (0.09%). Overall, rates of GI bleeding remained stable over time but a significant decline was observed for patients with ST segment elevation myocardial infarction (STEMI). The strongest predictors of bleeding events were STEMI - odds ratio (OR) 7.28 (95% confidence interval (95% CI) 4.82-11.00), glycoprotein IIb/IIIa inhibitor use OR 3.42 (95% CI 2.76-4.24) and use of circulatory support OR 2.65 (95% CI 1.90-3.71). Anti-platelets/coagulants (clopidogrel, prasugrel and warfarin) were not independently associated with GI bleeding. GI bleeding was independently associated with a significant increase in all-cause 30-day mortality (OR 2.08 (1.52-2.83)). Patients with in-hospital GI bleed who survived to 30-days had increased all-cause mortality risk at 1 year compared to non-bleeders (HR 1.49 (1.07-2.09)).\ud \ud Conclusions\ud In-hospital GI bleeding following PCI is rare but is a clinically important event associated with increased 30-day and long-term mortality.

Objectives Using the British Cardiovascular Intervention Society percutaneous coronary intervention (PCI) database, temporal trends, predictors, and outcomes of radial access (RA) versus femoral access (FA) for unprotected left main stem percutaneous coronary intervention (LMS-PCI) were studied. Background Data on arterial access site for LMS-PCI are poorly defined. Methods Data were analyzed from 19,482 LMS-PCI procedures performed in England and Wales between 2007 and 2014. Multivariate logistic regression was used to identify predictors of access site choice and its association with outcomes. Results The frequency of FA use fell from 77.7% in 2007 to 31.7% in 2014 (p Conclusions In contemporary practice, the radial artery is the predominant access site for unprotected LMS-PCI, and its use is associated with shorter length of stay, less vascular complications, and less major bleeding than femoral access.

Supplemental Digital Content is available in the text., Background: Aortic stenosis requires timely treatment with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). This study aimed to investigate the indirect impact of coronavirus disease 2019 (COVID-19) on national SAVR and TAVR activity and outcomes. Methods: The UK TAVR Registry and the National Adult Cardiac Surgery Audit were used to identify all TAVR and SAVR procedures in England, between January 2017 and November 2020. The number of isolated aortic valve replacement (AVR), AVR+coronary artery bypass graft surgery, AVR+other surgery, and TAVR procedures per month was calculated. Separate negative binomial regression models were fit to monthly procedural counts, with functions of time as covariates, to estimate the expected change in activity during COVID-19. Results: We included 15 142 TAVR cases, 13 357 isolated AVR cases, 8550 AVR+coronary artery bypass graft cases, and 6773 AVR+other cases. Before March 2020 (UK lockdown), monthly TAVR activity was rising, with a slight decrease in the SAVR activity during 2019. We observed a rapid and significant drop in TAVR and SAVR activity during the COVID-19 pandemic, especially for elective cases. Cumulatively, over the period March to November 2020, we estimated an expected 4989 (95% CI, 4020–5959) cases of aortic stenosis who have not received treatment. Conclusions: This study has demonstrated a significant decrease in TAVR and SAVR activity in England following the COVID-19 outbreak. This situation should be monitored closely, to ensure that monthly activity rapidly returns to expected levels. There is potential for significant backlog in the near-to-medium term and potential for increased mortality in this population.

Background There are limited data on the impact of the COVID‐19 pandemic on left main (LM) coronary revascularisation activity, choice of revascularisation strategy, and post‐procedural outcomes. Methods All patients with LM disease (≥50% stenosis) undergoing coronary revascularisation in England between January 1, 2017 and August 19, 2020 were included (n = 22,235), stratified by time‐period (pre‐COVID: 01/01/2017–29/2/2020; COVID: 1/3/2020–19/8/2020) and revascularisation strategy (percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG). Logistic regression models were performed to examine odds ratio (OR) of 1) receipt of CABG (vs. PCI) and 2) in‐hospital and 30‐day postprocedural mortality, in the COVID‐19 period (vs. pre‐COVID). Results There was a decline of 1,354 LM revascularisation procedures between March 1, 2020 and July 31, 2020 compared with previous years' (2017–2019) averages (−48.8%). An increased utilization of PCI over CABG was observed in the COVID period (receipt of CABG vs. PCI: OR 0.46 [0.39, 0.53] compared with 2017), consistent across all age groups. No difference in adjusted in‐hospital or 30‐day mortality was observed between pre‐COVID and COVID periods for both PCI (odds ratio (OR): 0.72 [0.51. 1.02] and 0.83 [0.62, 1.11], respectively) and CABG (OR 0.98 [0.45, 2.14] and 1.51 [0.77, 2.98], respectively) groups. Conclusion LM revascularisation activity has significantly declined during the COVID period, with a shift towards PCI as the preferred strategy. Postprocedural mortality within each revascularisation group was similar in the pre‐COVID and COVID periods, reflecting maintenance in quality of outcomes during the pandemic. Future measures are required to safely restore LM revascularisation activity to pre‐COVID levels.

Background and objectiveThe impact of the COVID-19 pandemic on the quality of care for patients with acute myocardial infarction (AMI) is uncertain. We aimed to compare quality of AMI care in England and Wales during and before the COVID-19 pandemic using the 2020 European Society of Cardiology Association for Acute Cardiovascular Care quality indicators (QIs) for AMI.MethodsCohort study of linked data from the AMI and the percutaneous coronary intervention registries in England and Wales between 1 January 2017 and 27 May 2020 (representing 236 743 patients from 186 hospitals). At the patient level, the likelihood of attainment for each QI compared with pre COVID-19 was calculated using logistic regression. The date of the first national lockdown in England and Wales (23 March 2020) was chosen for time series comparisons.ResultsThere were 10 749 admissions with AMI after 23 March 2020. Compared with before the lockdown, patients admitted with AMI during the first wave had similar age (mean 68.0 vs 69.0 years), with no major differences in baseline characteristics (history of diabetes (25% vs 26%), renal failure (6.4% vs 6.9%), heart failure (5.8% vs 6.4%) and previous myocardial infarction (22.9% vs 23.7%)), and less frequently had high Global Registry of Acute Coronary Events risk scores (43.6% vs 48.6%). There was an improvement in attainment for 10 (62.5%) of the 16 measured QIs including a composite QI (43.8% to 45.2%, OR 1.06, 95% CI 1.02 to 1.10) during, compared with before, the lockdown.ConclusionDuring the first wave of the COVID-19 pandemic in England and Wales, quality of care for AMI as measured against international standards did not worsen, but improved modestly.

Background The objective of the study was to identify any changes in primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) in England by analysing procedural numbers, clinical characteristics and patient outcomes during the COVID-19 pandemic.\ud \ud Methods We conducted a retrospective cohort study of patients who underwent PCI in England between January 2017 and April 2020 in the British Cardiovascular Intervention Society-National Institute of Cardiovascular Outcomes Research database. Analysis was restricted to 44 hospitals that reported contemporaneous activity on PCI. Only patients with primary PCI for STEMI were included in the analysis.\ud \ud Results A total of 34 127 patients with STEMI (primary PCI 33 938, facilitated PCI 108, rescue PCI 81) were included in the study. There was a decline in the number of procedures by 43% (n=497) in April 2020 compared with the average monthly procedures between 2017 and 2019 (n=865). For all patients, the median time from symptom to hospital showed increased after the lockdown (150 (99–270) vs 135 (89–250) min, p=0.004) and a longer door-to-balloon time after the lockdown (48 (21–112) vs 37 (16–94) min, p

Background: The objective of the study was to evaluate changes in percutaneous coronary intervention (PCI) practice in England by analyzing procedural numbers, changes in the clinical presentation, and characteristics of patients and their clinical outcomes during the coronavirus disease 2019 (COVID-19) pandemic. Methods: We conducted a retrospective cohort study of all patients who underwent PCI in England between January 2017 and April 2020 in the British Cardiovascular Intervention Society database. Results: Forty-four hospitals reported PCI procedures for 126 491 patients. There were ≈700 procedures performed each week before the lockdown. After the March 23, 2020 lockdown (11th/12th week in 2020), there was a 49% fall in the number of PCI procedures after the 12th week in 2020. The decrease was greatest in PCI procedures performed for stable angina (66%), followed by non–ST-segment–elevation myocardial infarction (45%), and ST-segment–elevation myocardial infarction (33%). Patients after the lockdown were younger (64.5 versus 65.5 years, P P P =0.001), previous myocardial infarction (23.5% versus 26.7%, P =0.008), previous PCI (24.3% versus 28.3%, P =0.001), or previous coronary artery bypass graft (4.6% versus 7.2%, P Conclusions: The lockdown in England has resulted in a significant decline in PCI procedures. Fewer patients underwent PCI for stable angina. This enabled greater capacity for urgent and emergency cases, and a reduced length of stay was seen for such patients. Significant changes in the characteristics of patients towards a lower risk phenotype were observed, particularly for non–ST-segment–elevation myocardial infarction, reflecting a more conservative approach to this cohort.

Summary Background Several countries affected by the COVID-19 pandemic have reported a substantial drop in the number of patients attending the emergency department with acute coronary syndromes and a reduced number of cardiac procedures. We aimed to understand the scale, nature, and duration of changes to admissions for different types of acute coronary syndrome in England and to evaluate whether in-hospital management of patients has been affected as a result of the COVID-19 pandemic. Methods We analysed data on hospital admissions in England for types of acute coronary syndrome from Jan 1, 2019, to May 24, 2020, that were recorded in the Secondary Uses Service Admitted Patient Care database. Admissions were classified as ST-elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), myocardial infarction of unknown type, or other acute coronary syndromes (including unstable angina). We identified revascularisation procedures undertaken during these admissions (ie, coronary angiography without percutaneous coronary intervention [PCI], PCI, and coronary artery bypass graft surgery). We calculated the numbers of weekly admissions and procedures undertaken; percentage reductions in weekly admissions and across subgroups were also calculated, with 95% CIs. Findings Hospital admissions for acute coronary syndrome declined from mid-February, 2020, falling from a 2019 baseline rate of 3017 admissions per week to 1813 per week by the end of March, 2020, a reduction of 40% (95% CI 37–43). This decline was partly reversed during April and May, 2020, such that by the last week of May, 2020, there were 2522 admissions, representing a 16% (95% CI 13–20) reduction from baseline. During the period of declining admissions, there were reductions in the numbers of admissions for all types of acute coronary syndrome, including both STEMI and NSTEMI, but relative and absolute reductions were larger for NSTEMI, with 1267 admissions per week in 2019 and 733 per week by the end of March, 2020, a percent reduction of 42% (95% CI 38–46). In parallel, reductions were recorded in the number of PCI procedures for patients with both STEMI (438 PCI procedures per week in 2019 vs 346 by the end of March, 2020; percent reduction 21%, 95% CI 12–29) and NSTEMI (383 PCI procedures per week in 2019 vs 240 by the end of March, 2020; percent reduction 37%, 29–45). The median length of stay among patients with acute coronary syndrome fell from 4 days (IQR 2–9) in 2019 to 3 days (1–5) by the end of March, 2020. Interpretation Compared with the weekly average in 2019, there was a substantial reduction in the weekly numbers of patients with acute coronary syndrome who were admitted to hospital in England by the end of March, 2020, which had been partly reversed by the end of May, 2020. The reduced number of admissions during this period is likely to have resulted in increases in out-of-hospital deaths and long-term complications of myocardial infarction and missed opportunities to offer secondary prevention treatment for patients with coronary heart disease. The full extent of the effect of COVID-19 on the management of patients with acute coronary syndrome will continue to be assessed by updating these analyses. Funding UK Medical Research Council, British Heart Foundation, Public Health England, Health Data Research UK, and the National Institute for Health Research Oxford Biomedical Research Centre.

BackgroundAortic stenosis requires timely treatment with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). This study aimed to investigate the indirect impact of COVID-19 on national SAVR and TAVR activity and outcomes.MethodsThe UK TAVR Registry and the National Adult Cardiac Surgery Audit were used to identify all TAVR and SAVR procedures in England, between January 2017 and June 2020. The number of isolated AVR, AVR+coronary artery bypass graft (CABG) surgery, AVR+other surgery and TAVR procedures per month was calculated. Separate negative binomial regression models were fit to monthly procedural counts, with functions of time as covariates, to estimate the expected change in activity during COVID-19.ResultsWe included 13376 TAVR cases, 12328 isolated AVR cases, 7829 AVR+CABG cases, and 6014 AVR+Other cases. Prior to March 2020 (UK lockdown), monthly TAVR activity was rising, with a slight decrease in SAVR activity during 2019. We observed a rapid and significant drop in TAVR and SAVR activity during the COVID-19 pandemic, especially for elective cases. Cumulatively, over the period March to June 2020, we estimated an expected 2294 (95% CI 1872, 2716) cases of severe aortic stenosis who have not received treatment.ConclusionThis study has demonstrated a significant decrease in TAVR and SAVR activity in England following the COVID-19 outbreak. This situation should be monitored closely, to ensure that monthly activity rapidly returns to expected levels. There is potential for significant backlog in the near-to-medium term, and potential for increased mortality in this population.

Aims COVID-19 might have affected the care and outcomes of hospitalized acute myocardial infarction (AMI). We aimed to determine whether the COVID-19 pandemic changed patient response, hospital treatment, and mortality from AMI. Methods and results Admission was classified as non-ST-elevation myocardial infarction (NSTEMI) or STEMI at 99 hospitals in England through live feeding from the Myocardial Ischaemia National Audit Project between 1 January 2019 and 22 May 2020. Time series plots were estimated using a 7-day simple moving average, adjusted for seasonality. From 23 March 2020 (UK lockdown), median daily hospitalizations decreased more for NSTEMI [69 to 35; incidence risk ratios (IRR) 0.51, 95% confidence interval (CI) 0.47–0.54] than STEMI (35 to 25; IRR 0.74, 95% CI 0.69–0.80) to a nadir on 19 April 2020. During lockdown, patients were younger (mean age 68.7 vs. 66.9 years), less frequently diabetic (24.6% vs. 28.1%), or had cerebrovascular disease (7.0% vs. 8.6%). ST-elevation myocardial infarction more frequently received primary percutaneous coronary intervention (81.8% vs. 78.8%), thrombolysis was negligible (0.5% vs. 0.3%), median admission-to-coronary angiography duration for NSTEMI decreased (26.2 vs. 64.0 h), median duration of hospitalization decreased (4 to 2 days), secondary prevention pharmacotherapy prescription remained unchanged (each > 94.7%). Mortality at 30 days increased for NSTEMI [from 5.4% to 7.5%; odds ratio (OR) 1.41, 95% CI 1.08–1.80], but decreased for STEMI (from 10.2% to 7.7%; OR 0.73, 95% CI 0.54–0.97). Conclusion During COVID-19, there was a substantial decline in admissions with AMI. Those who presented to hospital were younger, less comorbid and, for NSTEMI, had higher 30-day mortality.

There is limited national data regarding emergency cardiac surgery for complications sustained after percutaneous coronary intervention (PCI). This study aimed to examine emergency cardiac surgery after PCI in England and Wales and postsurgical patient outcomes. We analyzed patients in the British Cardiovascular Intervention Society database who underwent PCI between 2007 and 2014 and compared characteristics and outcomes for patients with and without emergency cardiac surgery. A total of 549,303 patients were included in the analysis and 362 (0.07%) underwent emergency cardiac surgery. There was a modest decline in the annual rate of emergency cardiac surgery from 0.09% to 0.06% between 2007 and 2014. Variables associated with emergency cardiac surgery included receipt of circulatory support (Odds ratio (OR) 39.20 95% confidence interval (CI) 27.75 to 55.36), aortic dissection (OR 28.39 95%CI 14.59 to 55.26), coronary dissection (OR 18.50 95%CI 13.60 to 25.18), coronary perforation (OR 7.86 95%CI 4.27 to 14.46), cardiac tamponade (OR 6.77 95%CI 3.13 to 14.66), and on-site surgical cover (OR 2.15 95%CI 1.56 to 2.97). After adjustments, patients with emergency cardiac surgery were at increased odds of 30-day mortality (OR 4.41 95%CI 2.94 to 6.62) and in-hospital major adverse cardiac and cerebrovascular events (OR 1.63 95%CI 1.07 to 2.48). On site surgical cover was independently associated with increased odds of mortality (OR 1.26 95%CI 1.20 to 1.33) following emergency cardiac surgery. In conclusion, emergency cardiac surgery after PCI is a rarely required procedure and in England and Wales there appears to be a decline in recent years. Patients who underwent emergency cardiac surgery have higher risk of adverse outcomes and longer length of hospital stay.

Background: Financial pressures for reducing hospitalization costs have driven to a move toward same day discharge (SDD) following uncomplicated percutaneous coronary intervention. The UK healthcare system has transitioned to predominantly SDD for elective percutaneous coronary intervention. This study aimed to examine patient’s clinical, procedural, and institutional characteristics that are associated with the increased adoption of SDD adoption over time in the United Kingdom and determine whether these vary by region. Methods: The data were derived from the British Cardiovascular Intervention Society including all the elective percutaneous coronary intervention from 2007 to 2014 in the United Kingdom. We structured 8 meaningful groups of variables, and their relative importance was obtained by decomposing the R 2 in each study year. Results: The relative importance of Strategic Health Authorities was substantially higher than all other factors every year, with some reduction over time, from 49.2% (95% CI, 45.4%–52.4%) in 2007 to 43.4% (95% CI, 39.9%–46.6%) in 2014. Center volume followed with 8.95% (95% CI, 7.0%–10.9%) to 19.8% (95% CI, 16.7%–22.4%). Between patients’ clinical and procedural characteristics, pharmacology and access site had the highest relative importance values, from 14.3% (95% CI, 12.1%–16.4%) to 7.1% (95% CI, 5.5%–8.8%) and from 3.6% (95% CI, 2.3%–5.1%) to 11.8% (95% CI, 9.4%–14.3%), respectively. Relative importance of different groups varied differently across Strategic Health Authorities. Conclusions: Growth of SDD was mainly associated with regional characteristics, while subcontributors varied substantially between different regions. Standardized guidelines would provide more homogenous adoption of SDD nationally. This analysis might be of wider interest in healthcare systems slower in SDD adoption.

Aims This study aims to examine the temporal trends and outcomes in patients who undergo percutaneous coronary intervention (PCI) with a previous or current diagnosis of cancer, according to cancer type and the presence of metastases. Methods and results Individuals undergoing PCI between 2004 and 2014 in the Nationwide Inpatient Sample were included in the study. Multivariable analyses were used to determine the association between cancer diagnosis and in-hospital mortality and complications. 6 571 034 PCI procedures were included and current and previous cancer rates were 1.8% and 5.8%, respectively. Both rates increased over time and the four most common cancers were prostate, breast, colon, and lung cancer. Patients with a current lung cancer had greater in-hospital mortality (odds ratio (OR) 2.81, 95% confidence interval (95% CI) 2.37–3.34) and any in-hospital complication (OR 1.21, 95% CI 1.10–1.36), while current colon cancer was associated with any complication (OR 2.17, 95% CI 1.90–2.48) and bleeding (OR 3.65, 95% CI 3.07–4.35) but not mortality (OR 1.39, 95% CI 0.99–1.95). A current diagnosis of breast was not significantly associated with either in-hospital mortality or any of the complications studied and prostate cancer was only associated with increased risk of bleeding (OR 1.41, 95% CI 1.20–1.65). A historical diagnosis of lung cancer was independently associated with an increased OR of in-hospital mortality (OR 1.65, 95% CI 1.32–2.05). Conclusions Cancer among patients receiving PCI is common and the prognostic impact of cancer is specific both for the type of cancer, presence of metastases and whether the diagnosis is historical or current. Treatment of patients with a cancer diagnosis should be individualized and involve a close collaboration between cardiologists and oncologists.

BACKGROUND The PRAMI and CvLPRIT trials support preventive percutaneous coronary intervention (PCI) for multivessel coronary disease found during ST-segment elevation myocardial infarction (STEMI). We assess our real-world experience of the management of multivessel disease identified during primary PCI (PPCI) in a large UK regional centre. PATIENTS AND METHODS All STEMI patients who underwent culprit-only PPCI during the study period (August 2011 to August 2013) were retrospectively assessed for eligibility to each trial. The two resulting groups were designated as the 'observational' cohorts. Primary outcomes were then determined and compared with the culprit-only revascularisation cohorts from the respective published randomized controlled trials (RCTs). RESULTS A total of 1143 consecutive cases were presented during the study period. Of these, 343 would have been suitable for inclusion to PRAMI and were included in the 'observational PRAMI' cohort; 196 patients were included in the 'observational CvLPRIT' cohort.The 'observational PRAMI' cohort experienced fewer primary outcome events (13.1 vs. 22.9%), cardiac deaths (0.6 vs. 4.3%) and nonfatal myocardial infarctions (3.5 vs. 8.7%) than the culprit-only PCI PRAMI cohort (n=231); there were significantly more diabetics (P=0.022) and anterior STEMI initial presentations in the culprit-only PCI PRAMI cohort. Primary outcomes were comparable to those of the preventive PCI PRAMI cohort.The 'observational CvLPRIT' cohort showed no significant difference in primary outcomes over 12 months (16.8 vs. 21.2%), but significantly lower all-cause mortality (2 vs. 6.9%) than the culprit-only PCI CvPLRIT cohort (n=146). The 30-day event rates were similar to the preventive PCI arm; the 12-month events were better than the nonpreventive, but not as good as the preventive RCT cohorts. CONCLUSION Outcomes from culprit-only primary PCI for multivessel disease in patients selected by the RCT criteria from an all-comers population representing real-life experience are better than those published in the two main RCTs. The RCTs may have selected a high-risk population for study exaggerating the benefits of preventive PCI.

Objectives Evaluate whether PCI in combination with optimal medical therapy (OMT) will reduce all-cause death and hospitalization for HF compared to a strategy of OMT alone. Background Ischemic cardiomyopathy (ICM) is the most common cause of heart failure (HF) and is associated with significant mortality and morbidity. Surgical revascularization has been shown to improve long-term outcomes in some patients, but surgery itself carries a major early hazard. Percutaneous coronary intervention (PCI) may allow a better balance between risk and benefit. Methods REVIVED-BCIS2 is a prospective, multi-center, open-label, randomized controlled trial, funded by the National Institute for Health Research in the United Kingdom. Follow-up will be for at least 2 years from randomization. Secondary outcomes include left ventricular ejection fraction (LVEF), quality of life scores, appropriate implantable cardioverter defibrillator therapy and acute myocardial infarction. Patients with LVEF ≤35%, extensive coronary disease and demonstrable myocardial viability are eligible for inclusion and those with a myocardial infarction within 4 weeks, decompensated HF or sustained ventricular arrhythmias within 72 h are excluded. A trial of 700 patients has more than 85% power to detect a 30% relative reduction in hazard. Results A total of 400 patients have been enrolled to date. Conclusions International guidelines do not provide firm recommendations on the role of PCI in managing severe ICM, because of a lack of robust evidence. REVIVED-BCIS2 will provide the first randomized data on the efficacy and safety of PCI in ICM and has the potential to inform guidelines pertaining to both revascularization and HF. (Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure [REVIVED-BCIS2]; NCT01920048) (REVascularisation for Ischaemic VEntricular Dysfunction; ISRCTN45979711)

Objectives The authors sought to determine the relationships between left radial access (LRA) or right radial access (RRA) and clinical outcomes using the British Cardiovascular Intervention Society (BCIS) database. Background LRA has been shown to offer procedural advantages over RRA in percutaneous coronary intervention (PCI) although few data exist from a national perspective around its use and association with clinical outcomes. Methods The authors investigated the relationship between use of LRA or RRA and clinical outcomes of in-hospital or 30-day mortality, major adverse cardiovascular events (MACE), in-hospital stroke, and major bleeding complications in patients undergoing PCI between 2007 and 2014. Results Of 342,806 cases identified, 328,495 (96%) were RRA and 14,311 (4%) were LRA. Use of LRA increased from 3.2% to 4.6% from 2007 to 2014. In patients undergoing a repeat PCI procedure, the use of RRA dropped to 72% at the second procedure and was even lower in females (65%) and patients >75 years of age (70%). Use of LRA (compared with RRA) was not associated with significant differences in in-hospital mortality (odds ratio [OR]: 1.19, 95% confidence interval [CI]: 0.90 to 1.57; p = 0.20), 30-day mortality (OR: 1.17, 95% CI: 0.93 to 1.74; p = 0.16), MACE (OR: 1.06, 95% CI: 0.86 to 1.32; p = 0.56), or major bleeding (OR: 1.22, 95% CI: 0.87 to 1.77; p = 0.24). In propensity match analysis, LRA was associated with a significant decrease in in-hospital stroke (OR: 0.52, 95% CI: 0.37 to 0.82; p = 0.005). Conclusions In this large PCI database, use of LRA is limited compared with RRA but conveys no increased risk of adverse outcomes, but may be associated with a reduction in PCI-related stroke complications.

Objectives Using the British Cardiovascular Intervention Society percutaneous coronary intervention (PCI) database, access site choice and outcomes of patients undergoing PCI with previous coronary artery bypass grafting (CABG) were studied. Background Given the influence of access site on outcomes, use of radial access in PCI-CABG warrants further investigation. Methods Data were analyzed from 58,870 PCI-CABG procedures performed between 2005 and 2014. Multivariate logistic regression was used to identify predictors of access site choice and its association with outcomes. Results The number of PCI-CABG cases and the percentage of total PCI increased significantly during the study period. Femoral artery (FA) utilization fell from 90.8% in 2005 to 57.6% in 2014 (p Conclusions In contemporary practice, FA access remains predominant during PCI-CABG with case complexity associated with it use. FA use was associated with longer length of stay, and higher rates of vascular complications, major bleeding, and transfusion.

Objectives This study sought to examine the relationship between access site practice and clinical outcomes in patients requiring percutaneous coronary intervention (PCI) following thrombolysis for ST-segment elevation myocardial infarction (STEMI). Background Transradial access (TRA) is associated with better outcomes in patients requiring PCI for STEMI. A significant proportion of STEMI patients may receive thrombolysis before undergoing PCI in many countries across the world. There are limited data around access site practice and its associated outcomes in this cohort of patients. Methods The author used the British Cardiovascular Intervention Society dataset to investigate the outcomes of patients undergoing PCI following thrombolysis between 2007 and 2014. Patients were divided into TRA and transfemoral access groups depending on the access site used. Multiple logistic regression and propensity score matching were used to study the association of access site with in-hospital and long-term mortality, major bleeding, and access site–related complications. Results A total of 10,209 patients received thrombolysis and PCI during the study time. TRA was used in 48% (n = 4,959) of patients; 3.3% (n = 336) patients died in hospital, 1.6% (n = 165) of patients experienced major bleeding, 4.2% (n = 437) experienced major adverse cardiac events (MACE), and 4.6% (n = 468) experienced 30-day mortality. After multivariate adjustment, TRA was associated with significantly reduced odds of in-hospital mortality (odds ratio [OR]: 0.59; 95% confidence interval [CI]: 0.42 to 0.83; p = 0.002), major bleeding (OR: 0.45; 95% CI: 0.31 to 0.66; p Conclusions TRA is associated with decreased odds of bleeding complications, mortality, and MACE in patients undergoing PCI following thrombolysis and should be preferred access site choice in this cohort of patients.

Objectives The study sought to determine the risk factors for post-transcatheter aortic valve replacement (TAVR) dialysis and to determine the impact of pre-TAVR or post-TAVR dialysis on mortality. Background TAVR is now established as an alternative treatment to surgical aortic valve replacement. Data examining the impact of dialysis on outcomes after TAVR are lacking. Methods The UK TAVI (Transcatheter Aortic Valve Implantation) Registry was established to report outcomes on all TAVR procedures performed within the United Kingdom (2007 to 2014). Data were collected prospectively on 6,464 patients with a median follow-up of 625 days. Results The proportion of patients on dialysis before TAVR has remained constant at 1.8%. After TAVR, the proportion of patients newly needing dialysis after TAVR has fallen from 6.1% (2007 to 2008) to 2.3% (2013 to 2014). The risk of new dialysis requirement after TAVR was independently associated with lower baseline renal function, year of procedure, impaired left ventricular function, diabetes, use of an Edwards valve, a nontransfemoral approach, need for open surgery, and moderate-to-severe aortic regurgitation after the procedure. Requirement for new dialysis after TAVR was associated with higher mortality at 30 days (hazard ratio: 6.44; 95% confidence interval: 4.87 to 8.53) and at 4 years (hazard ratio: 3.54; 95% confidence interval: 2.99 to 4.19; p Conclusions The proportion of patients needing dialysis after TAVR has decreased over time. Post-TAVR dialysis is associated with increased mortality. Factors identified with dialysis requirement after TAVR require further investigation.

In the United Kingdom, a clinical data set is completed for every patient undergoing coronary intervention and certain structural interventions, and sent to central servers in the National Institute for Cardiovascular Outcomes Research (NICOR) on behalf of the British Cardiovascular Intervention Society (BCIS). These data are linked to the national mortality register. In addition, data are obtained about the structure of healthcare provision using an annual survey. Analyses of these data are provided for different audiences in several formats. Public reports of individual consultant operator activity and risk-adjusted outcomes from percutaneous coronary intervention (PCI) have also been produced annually since 2012. Transcatheter aortic valve implantation (TAVI) has been performed since 2007. Over 2,000 cases were performed in 2015, giving a rate of 30 per million population. Complications to discharge have fallen as case mix has changed and technologies improved. While the mean age has remained about 81 years, the logistic EuroSCORE of patients treated by TAVI has fallen from about 22 in 2010 to 18 in 2015. Tracked 30-day mortality was 3.7% in 2014. Left atrial appendage occlusion and patent foramen ovale (PFO) closure for stroke, and the use of the MitraClip® system (Abbott Vascular, Santa Clara, CA, USA) for mitral regurgitation have been funded through a process called "commissioning through evaluation".

Objectives\ud The aim of this study was to assess, using a national percutaneous coronary intervention (PCI) database, access-site choice and outcomes after chronic total occlusion (CTO) PCI.\ud \ud Background\ud Given the influence of access site on outcomes, the use of radial access in CTO PCI warrants further investigation.\ud \ud Methods\ud Data were analyzed from the British Cardiovascular Intervention Society dataset of 26,807 elective CTO PCI procedures performed in England and Wales between 2006 and 2013. Multivariate logistic regression was used to identify predictors of access-site choice and its association with outcomes.\ud \ud Results\ud There was a significant decrease in femoral artery (FA) access from 84.6% in 2006 to 57.9% in 2013. Procedural factors associated with FA access included dual access (odds ratio [OR]: 3.89; 95% confidence interval [CI]: 3.45 to 4.32), CrossBoss/Stingray (OR: 1.87; 95% CI: 1.43 to 2.12), intravascular ultrasound (OR: 1.32; 95% CI: 1.21 to 1.53), and microcatheter use (OR: 1.18; 95% CI: 1.03 to 1.39). There was an association between FA access and the number of CTO devices used (p = 0.001 for trend). Access-site complications (1.5% vs. 0.5%; p < 0.001), periprocedural myocardial infarction (0.5% vs. 0.2%; p = 0.037), major bleeding (0.8% vs. 0.2%, p < 0.001), transfusion (0.4% vs. 0%; p < 0.001), and 30-day death (0.6% vs. 0.1%; p = 0.002) were more frequent in patients undergoing CTO PCI using FA access. An access-site complication during CTO PCI was associated with significant increases in transfusion (8.0% vs. 0.1%; p < 0.001), procedural coronary complication (17.3% vs. 5.8%; p < 0.0001), major bleeding (8.4% vs. 0.3%; p < 0.001), and mortality at all time points.\ud \ud Conclusions\ud FA access remains predominant during CTO PCI, with case complexity and device size associated with its use. Access-site complications were more frequent with FA use and strongly correlated with adverse outcomes.

Complex high-risk and indicated revascularization using percutaneous coronary intervention (CHIP-PCI) is an emerging concept that is poorly studied.To define temporal changes in CHIP-PCI volumes, and the relationship between operator CHIP-PCI volume and patient outcomes.Data were analyzed on all CHIP-PCI procedures undertaken for stable angina in England and Wales between 2007 and 2014. Operator volume data was available for 2012-14. CHIP-PCI was defined by patient characteristics (age ≥80years, left ventricular (LV) ejection fraction30%, previous CABG, or chronic renal failure) and/or by procedural characteristics (left main PCI, chronic total occlusion PCI, LV support, use of rotational atherectomy or laser atherectomy). CHIP-PCI as a percentage of total PCI increased from 28.1% in 2007 to 36.2% in 2014 (P.001). Between 2012 and 2014, a total of 30,268 CHIP-PCI cases were performed. Total operator volume varied from 1 to 580 cases with median total operator volume of 29 cases. Higher operator volumes were associated with a greater degree of patient comorbidity and increasing procedural complexity. After adjustment for baseline difference, in-hospital major bleeding (P.001 for trend), access site complications (P.001) and coronary perforation (P = .002) were associated with increasing operator CHIP-PCI volumes. However, the frequency of in-hospital death (P = .394) and 12-month mortality (P = .638) were similar across the volume quartiles. Higher volumes quartiles were associated with a greater likelihood of same day discharge (P.001).CHIP-PCI cases are an increasingly large population in contemporary PCI practice. Higher operator volumes were not associated with improved 12-month survival.Data were analyzed on all complex high-risk and indicated revascularization using percutaneous coronary intervention (CHIP-PCI) procedures in England and Wales between 2007 and 2014. CHIP-PCI as a percentage of total PCI increased from 28.1% in 2007 to 36.2% in 2014 (P.001). Median total operator volume was 29 cases with higher volumes associated with more patient comorbidity and increasing procedural complexity. In-hospital major bleeding (P.001 for trend), access site complications (P.001) and coronary perforation (P = .002) all associated with increasing operator CHIP-PCI volumes. However, trends for in-hospital death (P = .394), and 12-month mortality (P = .638) were similar across the volume quartiles.

Background:High survival rates are commonly reported following primary percutaneous coronary intervention for ST-elevation myocardial infarction, with most contemporary studies reporting overall survival.Aims:The aim of this study was to describe survival following primary percutaneous coronary intervention for ST-elevation myocardial infarction corrected for non-cardiovascular deaths by reporting relative survival and investigate clinically significant factors associated with poor long-term outcomes.Methods and Results:Using the prospective UK Percutaneous Coronary Intervention registry, primary percutaneous coronary intervention cases ( n=88,188; 2005–2013) were matched to mortality data for the UK populace. Crude five-year relative survival was 87.1% for the patients undergoing primary percutaneous coronary intervention and 94.7% for patients 75 years: 4.69, 4.27–5.16). After four years, there was no excess mortality for ages 56–65 years (excess mortality rate ratio 1.27, 0.95–1.70), but persisting excess mortality for older groups (66–75 years: excess mortality rate ratio 1.72, 1.30–2.27; >75 years: 1.66, 1.15–2.41). Excess mortality was associated with cardiogenic shock (excess mortality rate ratio 6.10, 5.72–6.50), renal failure (2.52, 2.27–2.81), left main stem stenosis (1.67, 1.54–1.81), diabetes (1.58, 1.47–1.69), previous myocardial infarction (1.52, 1.40–1.65) and female sex (1.33, 1.26–1.41); whereas stent deployment (0.46, 0.42–0.50) especially drug eluting stents (0.27, 0.45–0.55), radial access (0.70, 0.63–0.71) and previous percutaneous coronary intervention (0.67, 0.60–0.75) were protective.Conclusions:Following primary percutaneous coronary intervention for ST-elevation myocardial infarction, long-term cardiovascular survival is excellent. Failure to account for non-cardiovascular death may result in an underestimation of the efficacy of primary percutaneous coronary intervention.

There are limited data on aspirin (ASA) desensitization for patients with coronary disease. We present our experience with a rapid nurse-led oral desensitization regimen in patients with aspirin sensitivity undergoing coronary angiography.This single-center retrospective observational study includes patients with a history of ASA sensitivity undergoing coronary angiography with intent to perform percutaneous coronary intervention (PCI).Between January 2012 and January 2017, 24 patients undergoing coronary angiography for stable coronary disease (7 cases) or acute coronary syndromes (non-ST-segment myocardial infarction [NSTEMI; 8 cases], STEMI [9 cases]) underwent aspirin desensitization having reported previous reactions to aspirin. At initial presentation, previous sensitivity reactions were reported as: mucocutaneous reactions in 17 patients (urticaria in 3 [13%], nonurticarial rash in 6 [25%], angio-oedema in 8 [33%]), respiratory sensitivity in 4 (17%), and systemic anaphylactoid reactions in 3 (13%). Seventeen (71%) patients underwent PCI. Desensitization was acutely successful in 22 (92%) patients and unsuccessful in 2 (8%) patients who both had a single short-lived episode of acute bronchospasm treated successfully with nebulized salbutamol. Fifteen successfully desensitized patients completed 12 months of aspirin; no patient had recurrent hypersensitivity reaction. Aspirin was stopped prior to 12 months in 7 patients (replaced by warfarin [1 case], no antiplatelet or single antiplatelet clinically indicated and clopidogrel chosen [4 cases], patient choice without evidence of recurrent hypersensitivity [1 case], and death due to cardiogenic shock following STEMI [1 case]).A rapid aspirin desensitization protocol is safe and effective across a broad spectrum of hypersensitivity reactions and clinical presentations.

Background There are limited data on outcomes of patients with previous coronary artery bypass graft (CABG) presenting with non–ST-segment–elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). We compare clinical characteristics and outcomes in non–ST-segment–elevation myocardial infarction patients undergoing PCI with or without prior CABG surgery in a national cohort. Methods and Results We identified 205 039 patients with non–ST-segment–elevation myocardial infarction who underwent PCI between 2007 and 2014 in the British Cardiovascular Intervention Society database. Clinical, demographic, procedural, and outcome data were analyzed by dividing into 3 groups: group 1, PCI in native coronary arteries and no prior CABG (n=186 670); group 2, PCI in native arteries with prior CABG (n=8825); group 3, PCI in grafts (n=9544). Patients in group 2 and 3 were older and had more comorbidities and higher mortality at 30 days (group 2, 2.6% and group 3, 1.9%) and 1 year (group 2, 8.29% and group 3, 7.08%) as compared with group 1 (1.7% and 4.87%). After multivariable analysis, no significant difference in outcomes was observed in 30-days mortality (odds ratio; group 2=0.87 [CI, 0.69–1.80; P =0.20], group 3=0.91 [CI, 0.71–1.17; P =0.46]), in-hospital major adverse cardiovascular event (odds ratio: group 2=1.08 [CI, 0.88–1.34; P =0.45], group 3=0.97 [CI=0.77–1.23; P =0.82]), and in-hospital stroke (odds ratio: group 2=1.37 [CI, 0.71–2.69; P =0.35], group 3=1.13 [CI, 0.55–2.34; P =0.73]; group 1=reference). Conclusions Patients with prior CABG are presenting with non–ST-segment–elevation myocardial infarction and treated with PCI had more comorbid illnesses, but once these differences were adjusted for, prior CABG did not independently confer additional risk of mortality and major adverse cardiovascular event.

Aims Percutaneous mitral valve leaflet repair is a treatment option for some people with severe mitral valve regurgitation for whom conventional mitral valve surgery is clinically inappropriate. This study aimed to determine the safety, efficacy, and costs of percutaneous mitral valve leaflet repair, using the MitraClip device in a UK setting. Methods and results This was a prospective, single-armed registry with a follow-up of 2 years that reported a range of procedural, clinical and patient-orientated outcomes. Registry data were linked to routine data sources to allow for more comprehensive follow up concerning mortality and healthcare resource use. The registry received data for 199 mainly elective patients with mixed mitral regurgitation aetiology. A MitraClip device was implanted in 187 patients (94%), with a procedural success rate of 86%, with 8% of patients having a serious in-hospital adverse event (including 5% mortality). Percutaneous mitral valve leaflet repair reduced mitral regurgitation from 100% MR grade ≥ 3+ to 7% at discharge. There were corresponding improvements in New York Heart Association functional class, reducing from 92% (class ≥ 3) at baseline to 18% at 6 weeks. There were significant improvements in generic and disease specific quality of life indicators up to 2 years. The all-cause mortality rate was estimated to be 12.7% (95% CI 7.5 to 17.7%) at 1 year. Percutaneous mitral valve leaflet repair was associated with reduced hospital readmissions and potential cost-savings in post-procedural care. Conclusion This study shows that percutaneous mitral valve leaflet repair using MitraClip is a relatively safe and effective treatment in patients unable to tolerate surgery and has the potential to reduce ongoing healthcare costs in the UK.

Objectives To evaluate the feasibility and safety of direct transcatheter aortic valve implantation (TAVI) by the transfemoral approach without balloon pre-dilatation using the Edwards SapienXT valve. Background TAVI is established in selected high-risk patients with severe aortic stenosis. Balloon aortic valvuloplasty (BAV) is recommended prior to valve implantation, but may contribute to procedural risk. It is unknown whether this is necessary for successful passage and deployment of the device. Methods 81 patients (mean age 84 [95%CI:82–85.8], 62% male, median EuroScore 22.8% [95%CI:20.5–27]) undergoing transfemoral TAVI (35 by direct implantation [direct group]; 46 with balloon pre-dilatation [balloon group]) between 2010 and 2013 were analyzed for efficacy and safety endpoints. Results Procedural success was 100%. Pre and post-procedural peak gradients in the direct group were 66mmHg (95%CI:59–72.8) and 14mmHg (95%CI:12–17.8)(P

Background— The transradial access (TRA) site has become the default access site for percutaneous coronary intervention in the United Kingdom, with randomized trials and national registry data showing reductions in mortality associated with TRA use. This study evaluates regional changes in access site practice in England and Wales over time, examines whether changes in access site practice have been uniform nationally and across different patient subgroups, and provides national estimates for the potential number of lives saved or lost associated with regional differences in access site practice. Methods and Results— Using the British Cardiovascular Intervention Society database, we investigated outcomes for growth of TRA in different regions in England and Wales in 448 853 patients who underwent percutaneous coronary intervention from 2005 to 2012. Multiple logistic regression was used to quantify the effect of TRA on 30-day mortality and quantify lives saved and lost by differences in TRA adoption. TRA use increased from 14.0% to 58.6% in 417 038 PCI patients with large variations in different parts of the country. TRA was independently associated with a decreased risk of 30-day mortality (odds ratio=0.70; 95% confidence interval=0.66–0.74), with significant but small differences observed across different regions. The number of estimated lives saved was 450 (95% confidence interval=275–650), and we estimate that an additional 264 (95% confidence interval=153–399) lives would have been saved if TRA adoption were uniform nationally. Conclusions— TRA has become the dominant percutaneous coronary intervention approach in the United Kingdom, with a wide variation in different parts of the country. Changes in practice have contributed to mortality reductions, and inequalities have resulted in missed opportunities for further improvements.

The impact of operator and centre volume on clinical outcomes and quality of care has been of considerable debate in recent years in a number of surgical- and procedural-based specialities. A relationship between higher volumes at both the institutional and operator levels and better clinical outcomes would at first appear intuitive, based on the premise that performing a procedure very infrequently would be likely to lead to unfamiliarity, complications, and poorer outcomes. In the current review, we study the relationship between operator volume and outcomes in the setting of percutaneous coronary intervention (PCI), and examine the evidence for current clinical competency guidelines that advocate that a minimum number of PCI procedures be undertaken annually. Whilst both high institutional and operator volumes have been shown to be associated with better outcomes by reducing death and in-hospital mortality, these data are often derived from the pre-stent era, or when high-volume operators undertook far smaller numbers of procedures than is currently recommended to maintain clinical competency. The emphasis of specific volume requirements for optimal outcomes needs to be interpreted with caution, as volume is not a surrogate for quality and merely one of the variables associated with outcome. Healthcare providers should focus on other measures of quality such as robust clinical care pathways, evidence-based treatments, periodic case review, using validated risk assessment scores, and ascertainment of outcome to improve care and reduce adverse events.

OBJECTIVE: This study aims to evaluate outcomes associated with different P2Y12 agents in Saphenous Vein graft (SVG) percutaneous coronary intervention (PCI).BACKGROUND: SVG PCI is associated with greater risks of ischemic complications, compared with native coronary PCI. Outcomes associated with the use of potent P2Y12 blocking drugs, Prasugrel and Ticagrelor, in SVG PCI are unknown.METHODS: Patients included in the study underwent SVG PCI in the United Kingdom between 2007 and 2014 for acute coronary syndrome and were grouped by P2Y12 antiplatelet use. In-hospital major adverse cardiac events, major bleeding and 30-day and 1-year mortality were examined. Multiple imputations with chained equations to impute missing data were used. Adjustment for baseline imbalances was performed using (1) multiple logistic regression (MLR) and (separately) (2) propensity score matching (PSM).RESULTS: Data weres analyzed from 8,119 patients and most cases were treated with Clopidogrel (n = 7,401), followed by Ticagrelor (n = 497) and Prasugrel (n = 221). In both MLR and PSM models, there was no significant evidence to suggest that either Prasugrel or Ticagrelor was associated with significantly lower 30-day mortality compared with Clopidogrel. The odds ratios reported from the multivariable analysis were 1.22 (95% CI: 0.60-2.51) for Prasugrel vs. Clopidogrel and 0.48 (95% CI: 0.20-1.16) for Ticagrelor vs. Clopidogrel. No significant differences were seen for in-hospital ischemic or bleeding events.CONCLUSIONS: Our real world national study provides no clear evidence to indicate that use of potent P2Y12 blockers in SVG PCI is associated with improved clinical outcomes.

Background: Enabling strategies (ESs) are increasingly used during percutaneous coronary intervention for chronic total occlusive disease (CTO-PCI), enhancing procedural success. Using the British Cardiovascular Society dataset, we examined changes in the use of ESs and procedural/clinical outcomes for CTO-PCI. Methods and Results: ESs were defined as intravascular ultrasound, rotational/laser atherectomy, dual arterial access, use of microcatheters, penetration catheters or CrossBoss, and procedures categorized by number of ESs used. Data were analysed on all elective CTO-PCI procedures performed in England and Wales between 2006 and 2014. Multivariable logistic regression was used to identify predictors of procedural success. During 28 050 CTO-PCIs, there were significant temporal increases in ES use. There was a stepwise increase in CTO success with increased ES use, with 83.8% of cases successful where ≥3 ESs were used. Overall, CTO-PCI success rate for the whole cohort increased from 55.4% in 2006 to 66.9% in 2014 ( P P Conclusions: ES use during CTO-PCI was associated with significant improvements in CTO-PCI success. ES use was associated with increased procedural complications and in-hospital major adverse cardiovascular events, but not with 30-day mortality.

Background Major bleeding is a recognised complication after PCI. This study aims to evaluate the incidence, trends over time, predictors and prognostic significance of intracranial, gastrointestinal and retroperitoneal bleeding after PCI. Methods We analysed patients who underwent PCI in England and Wales between 2007 and 2014 in the British Cardiovascular Intervention Society Database. In-hospital intracranial, gastrointestinal and retroperitoneal bleeding events were recorded in addition to patient demographics, procedural characteristics and the outcomes in-hospital major adverse cardiovascular events and 30 day mortality. Overall and rates of events over the years of study were examined and multivariable logistic regression were used to identify independent predictors of bleeding and adverse outcomes associated with bleeding. Results A total of 107 (0.03%, n=426,046) intracranial bleeds, 480 (0.09%, n=549,298) gastrointestinal bleeds and 291 (0.06%, n=511,106) retroperitoneal bleeds were captured in the dataset. We observed in decline over all in intracranial and retroperitoneal bleeds over time and a decline in gastrointestinal bleeding among the STEMI subgroup. Age, diagnosis of NSTEMI, diagnosis of STEMI, valvular heart disease, warfarin use, glycoprotein IIb/IIIa inhibitor use and thrombolysis were predictors of bleeding events. The adjusted odds of 30 day mortality and in-hospital MACE were OR 10.14 95% CI 5.34–19.25 and OR 9.49 95% CI 4.93–18.27, respectively for patients who developed intracranial bleeds, OR 2.13 95% CI 1.59–2.85 and OR 3.73 95% CI 2.81–4.96, respectively for patients who developed gastrointestinal bleeding and OR 3.59 95% CI 2.19–5.90 and OR 5.76 95% CI 3.71–8.95, respectively for patients who developed retroperitoneal bleeding. Conclusions Major bleeding is rare occurring in less than 1% of patients who undergo PCI but when it occurs it is associated with adverse outcomes. Observed declines in bleeding may be related to decline in use of antithrombotic medications.

There are limited data on aspirin desensitisation for patients with coronary disease.1 This study aimed to evaluate our single-centre experience with a rapid oral desensitisation regime in patients with aspirin sensitivity undergoing coronary angiography. Methods This single-centre retrospective observational study includes patients with self-reported hypersensitivity reactions to aspirin confirmed by clinical history who were planned to undergo coronary angiography with intent to perform percutaneous coronary intervention between Jan 2012 and Jan 2017. The aspirin desensitisation protocol is shown in table 1. All patients had blood pressure, oxygen saturation and peak flow measurements every 30 min during the dug administration and for 3 three hours after the final dose. Continuous ECG monitoring was not routinely performed unless clinically indicated. No patients received pre-treatment with steroids, antihistamines or antileukotrienes. The primary outcome was cessation of aspirin due to recurrent hypersensitivity reaction within 12 months. Results Twenty-four patients were included in the study including patients with both stable coronary disease (7 cases) and acute coronary syndromes (NSTEMI (8 cases), STEMI (9 cases)). Previous reactions reported were mucocutaneous reactions in 17 patients (urticaria in 3 (13%), non-urticarial rash in 6 (25%), angio-oedema in 8 (33%)), respiratory sensitivity in 4 patients (17%) and systemic anaphylactoid reactions in 3 patients (13%). Percutaneous coronary intervention (PCI) was performed in 17 patients (71%) and coronary artery bypass grafting in 1 patient (4.2%). Desensitisation was acutely successful in 22 patients (92%). Two cases were unsuccessful, both following primary PCI (previous true anaphylactoid reaction experienced bronchospasm requiring nebulised salbutamol (1 case), previous angio-oedema experienced an exacerbation of her poorly controlled asthma (but no angio-oedema) treated with nebulised salbutamol (1 case)). Both patients were discharged on single antiplatelet therapy (clopidogrel and prasugrel respectively). Fifteen successfully desensitised patients completed 12 months of aspirin; no patients suffered a recurrent hypersensitivity reaction. Aspirin was stopped prior to 12 months in seven patients (replaced by formal anticoagulation (1 case), no antiplatelet or only single antiplatelet clinically indicated and clopidogrel chosen (4 cases), patient choice without evidence of recurrent hypersensitivity (1 case), death due to cardiogenic shock following STEMI (1 case)). Conclusion Our rapid desensitisation protocol is significantly faster than the ADAPTED registry protocol (120 vs 330 min) and appears as effective across a wide range of clinical presentations and hypersensitivity reactions. Reference . Rossini R, et al. Results of the Multicenter ADAPTED Registry (Aspirin Desensitization in Patients with Coronary Artery Disease). Circ Cardiovasc Interv. 2017;10:e004368.

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; P trend P trend P P 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.

OBJECTIVES: To study the relationship between diabetes mellitus (DM) and left ventricular (LV) function on outcomes following percutaneous coronary intervention (PCI).BACKGROUND: DM is a growing public health challenge worldwide and a significant risk factor for cardiovascular disease and heart failure.METHODS: All PCI procedures performed between 2006 and 2013 with LV function and diabetic status recorded in the BCIS-NICOR database were included. Demographic, procedural, and clinical outcomes data were collected. Multivariable logistic regression was used to provide adjusted estimates of clinical outcome by LV function and DM, including DM sub-type.RESULTS: Of 260,726 patients, DM was present in 52,160 (20%); moderate LV systolic dysfunction (LVSD) was present in 51,266 (20%), and severe LVSD in 18,148 (7%). Worsening LVSD in diabetic patients was associated with poorer prognosis following PCI; moderate LVSD odds ratio (OR) 2.03 (95% CI 1.72-2.38) and severe LVSD OR 4.17 (95% CI 3.52-4.93). There was a higher crude and adjusted mortality rate for patients with DM across all grades of LVSD. However, the relative effect of DM appeared attenuated in the severe LVSD group compared with moderate or good LV function, particularly evident in patients with insulin requiring DM (good LV OR 2.09 [95% CI 1.66-2.65]; moderate LVSD OR 1.56 [95% CI 1.26-1.93], poor LV OR 1.40 [95% CI 1.13-1.74]).CONCLUSIONS: DM was associated with increased 30-day mortality for all grades of LV function. The prognostic impact of DM was strongest in patients with normal LV function and less evident in patients with severe LV systolic dysfunction.

Background: Transradial access (TRA) for percutaneous coronary intervention (PCI) is associated with a reduced risk of mortality compared with transfemoral access, access site–related bleeding complications, and shorter length of stay. The budget impact from a healthcare system that has largely transitioned to TRA for PCI has not been previously published. Methods and Results: Data from 323 656 patients undergoing PCI between 2010 and 2014 were obtained from the British Cardiovascular Intervention Society database. Costs for TRA and transfemoral access PCI were estimated based on procedure cost, length of stay, and differences in the rates of complications (major bleeding and vascular complications). In the base case, a propensity-matched data set between transfemoral access and TRA was used to directly compare the cost per PCI, whereas in the real-world analysis, the full data set was used. Across all indications and all years, TRA offered an average cost saving of £250.59 per procedure (22% reduction) versus transfemoral access with the majority of cost saving derived from reduced length of stay (£190.43) rather than direct costs of complications (£3.71). In the real-world analysis, adoption of TRA was estimated to have provided cost savings of £13.31 million across England between 2010 and 2014; however, if operators in all regions had adopted TRA at the rate of the region with the highest utilization, cost savings of £33.40 million could have been achieved. Conclusions: The transition to TRA in England has been associated with significant cost savings across the national healthcare system, in addition to the well-established clinical benefits.

Background— Retroperitoneal hemorrhage (RH) is a rare bleeding complication of percutaneous coronary intervention, which can result as a consequence of femoral access or can occur spontaneously. This study aims to evaluate temporal changes in RH, its predictors, and clinical outcomes in a national cohort of patients undergoing percutaneous coronary intervention in the United Kingdom. Methods and Results— We analyzed RH events in patients who underwent percutaneous coronary intervention between 2007 and 2014. Multiple logistic regression models were used to identify factors associated with RH and to quantify the association between RH and 30-day mortality and major adverse cardiovascular events. A total of 511 106 participants were included, and 291 in hospital RH events were recorded (0.06%). Overall, rates of RH declined from 0.09% to 0.03% between 2007 and 2014. The strongest independent predictors of RH events were femoral access (odds ratio [OR], 19.66; 95% confidence interval [CI], 11.22–34.43), glycoprotein IIb/IIIa inhibitor (OR, 2.63; 95% CI, 1.99–3.47), and warfarin use (OR, 2.53; 95% CI, 1.07–5.99). RH was associated with a significant increase in 30-day mortality (OR, 3.59; 95% CI, 2.19–5.90) and in-hospital major adverse cardiovascular events (OR, 5.76; 95% CI, 3.71–8.95). A legacy effect was not observed; patients with RH who survived 30 days did not have higher 1-year mortality compared with those without this complication (hazard ratio, 0.97; 95% CI, 0.49–1.91). Conclusions— Our results suggest that RH is a rare event that is declining in the United Kingdom, related to transition to transradial access site utilization, but remains a clinically important event associated with increased 30-day mortality but no long-term legacy effect.

Co-morbidities have typically been considered as prevalent cardiovascular risk factors and cardiovascular diseases rather than systematic measures of general co-morbidity burden in patients who underwent percutaneous coronary intervention (PCI). Charlson co-morbidity index (CCI) is a measure of co-morbidity burden providing a means of quantifying the prognostic impact of 22 co-morbid conditions on the basis of their number and prognostic impact. The study evaluated the impact of the CCI on cardiac mortality and major adverse cardiovascular events (MACE) after PCI through analysis of the Nobori-2 study. The prognostic impact of CCI was studied in 3,067 patients who underwent PCI in 4,479 lesions across 125 centers worldwide on 30-day and 1- and 5-year cardiac mortality and MACE. Data were adjusted for potential confounders using stepwise logistic regression; 2,280 of 3,067 patients (74.4%) had ≥1 co-morbid conditions. CCI (per unit increase) was independently associated with an increase in both cardiac death (odds ratio [OR] 1.47 95% confidence interval [CI] 1.20 to 1.80, p = 0.0002) and MACE (OR 1.29 95% CI 1.14 to 1.47, p ≤0.0011) at 30 days, with similar observations recorded at 1 and 5 years. CCI score ≥2 was independently associated with increased 30-day cardiac death (OR 4.25, 95% CI 1.24 to 14.56, p = 0.02) at 1 month, and this increased risk was also observed at 1 and 5 years. In conclusion, co-morbid burden, as measured using CCI, is an independent predictor of adverse outcomes in the short, medium, and long term. Co-morbidity should be considered in the decision-making process when counseling patients regarding the periprocedural risks associated with PCI, in conjunction with traditional risk factors.

Aims This study aims to evaluate temporal changes in stroke complications and their association with mortality and MACE outcomes in a national cohort of patients undergoing percutaneous coronary interventions (PCIs) in England and Wales. Methods and results A total of 426 046 patients who underwent PCI in England and Wales between 2007 and 2012 in the British Cardiovascular Intervention Society (BCIS) database were analysed. Statistical analyses were performed evaluating the rates of stroke complications according to the year of PCI and multiple logistic regressions were used to evaluate the odds of 30-day mortality and in-hospital major adverse cardiovascular events (MACE; a composite of in-hospital mortality, myocardial infarction or re-infarction, and revascularization) with stroke complications. Four hundred and thirty-six patients (0.1%) sustained an ischaemic stroke/TIA complication and 107 patients (0.03%) sustained a haemorrhagic stroke complication. Ischaemic stroke/TIA complications increased non-linearly from 0.67 (95% CI 0.47–0.87) to 1.14 (0.94–1.34) per 1000 patients between 2007 and 2012 ( P = 0.006), whilst haemorrhagic stroke rates decreased non-linearly from 0.29 (0.19–0.39) to 0.15 (0.05–0.25) per 1000 patients in 2012 ( P = 0.009). Following adjustment for baseline clinical and procedural demographics, ischaemic stroke was independently associated with both 30-day mortality (OR 4.92, 3.06–7.92) and in-hospital MACE (OR 3.11, 1.83–5.27). An even greater impact on prognosis was observed with haemorrhagic complications (30-day mortality: OR 13.87, 6.37–30.21), in-hospital MACE (OR 13.50, 6.30–28.92). Conclusions Incident ischaemic stroke complications have increased over time, whilst haemorrhagic stroke complications have decreased, driven through changes in clinical, procedural, drug-treatment, and demographic factors. Both ischaemic and haemorrhagic strokes are rare but devastating complications with high 30-day mortality and in-hospital MACE rates.

We investigate adoption of the TRA in different age groups and study the relationship between age and access site related outcomes in a national cohort of patients undergoing PCI in the UK. Previous studies have reported conflicting data on radial access site adoption between different age groups, with age an independent predictor of failure of procedures undertaken through the radial approach. Age and access site related outcomes (based on transradial (TRA) and transfemoral (TFA) access) were studied in 469,983 PCI procedures undertaken in the UK from 2006 to 2012 in the age groups