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The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial demonstrated no overall difference in the composite primary endpoint and the secondary endpoints of cardiovascular (CV) death/myocardial infarction or all-cause mortality between an initial invasive or conservative strategy among participants with chronic coronary disease and moderate or severe myocardial ischemia. Detailed cause-specific death analyses have not been reported.We compared overall and cause-specific death rates by treatment group using Cox models with adjustment for pre-specified baseline covariates. Cause of death was adjudicated by an independent Clinical Events Committee as CV, non-CV, and undetermined. We evaluated the association of risk factors and treatment strategy with cause of death.Four-year cumulative incidence rates for CV death were similar between invasive and conservative strategies (2.6% vs 3.0%; hazard ratio [HR] 0.98; 95% CI [0.70-1.38]), but non-CV death rates were higher in the invasive strategy (3.3% vs 2.1%; HR 1.45 [1.00-2.09]). Overall, 13% of deaths were attributed to undetermined causes (38/289). Fewer undetermined deaths (0.6% vs 1.3%; HR 0.48 [0.24-0.95]) and more malignancy deaths (2.0% vs 0.8%; HR 2.11 [1.23-3.60]) occurred in the invasive strategy than in the conservative strategy.In International Study of Comparative Health Effectiveness with Medical and Invasive Approaches, all-cause and CV death rates were similar between treatment strategies. The observation of fewer undetermined deaths and more malignancy deaths in the invasive strategy remains unexplained. These findings should be interpreted with caution in the context of prior studies and the overall trial results.

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 To assess the recording and accuracy of acute myocardial infarction (AMI) hospital admissions between two electronic health record databases within an English cancer population over time and understand the factors that affect case-ascertainment. Methods and results We identified 112 502 hospital admissions for AMI in England 2010–2017 from the Myocardial Ischaemia National Audit Project (MINAP) disease registry and hospital episode statistics (HES) for 95 509 patients with a previous cancer diagnosis up to 15 years prior to admission. Cancer diagnoses were identified from the National Cancer Registration Dataset (NCRD). We calculated the percentage of AMI admissions captured by each source and examined patient characteristics associated with source of ascertainment. Survival analysis assessed whether differences in survival between case-ascertainment sources could be explained by patient characteristics. A total of 57 265 (50.9%) AMI admissions in patients with a prior diagnosis of cancer were captured in both MINAP and HES. Patients captured in both sources were younger, more likely to have ST-segment elevation myocardial infarction and had better prognosis, with lower mortality rates up to 9 years after AMI admission compared with patients captured in only one source. The percentage of admissions captured in both data sources improved over time. Cancer characteristics (site, stage, and grade) had little effect on how AMI was captured. Conclusion MINAP and HES define different populations of patients with AMI. However, cancer characteristics do not substantially impact on case-ascertainment. These findings support a strategy of using multiple linked data sources for observational cardio-oncological research into AMI.

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.

BackgroundThe COVID-19 pandemic has resulted in a high death toll. We aimed to describe the place and cause of death during the COVID-19 pandemic.MethodsThis national death registry included all adult (aged ≥18 years) deaths in England and Wales between 1st January 2014 and 30th June 2020. Analyses were based upon ICD-10 codes corresponding to the underlying cause of death as stated on the Medical Certificate of Cause of Death. Daily deaths during COVID-19 pandemic were compared against the expected daily deaths estimated using Farrington surveillance algorithm for daily historical data between 2014 and 2020, by place and cause of death.FindingsBetween 2nd March and 30th June 2020, there was an excess mortality of 57,860 (a proportional increase of 35%) compared with the expected deaths, of which 50,603 (86.2%) were COVID-19 related. Almost half the excess deaths occurred in care homes (25,611 deaths) where deaths were 55% higher than expected. One fifth of the excess deaths occurred in hospital (15,938 deaths; a proportional increase of 21%) with the remainder occurring at home (16,190 deaths; a proportional increase of 39%). At home, only 14% of 16,190 excess deaths were related to COVID-19, with 5,963 deaths due to cancer and 2,485 deaths due to cardiac disease, very few of which involved COVID-19. In care homes or hospices, 61% of the 25,611 excess deaths were related to COVID-19, 5,539 of which were due to respiratory disease and most of these (4,315 deaths) involved COVID-19. In hospital, there were 16,174 fewer deaths than expected which did not involve COVID-19, and there were 4,088 fewer deaths due to cancer and 1,398 fewer deaths due to cardiac disease than expected.InterpretationThe COVID-19 pandemic has resulted in a substantial increase in the absolute numbers of deaths occurring at home and care homes. There was a huge burden of excess deaths occurring in care homes, which were poorly characterised, and were likely to be, at least in part, the result of undiagnosed COVID-19. There was a smaller but important and ongoing excess in deaths at home, particularly from cancer and cardiac disease, which suggests avoidance of hospital care for non-COVID-19 conditions.FundingThe study is unfunded.

Background: Patients with significant (≥50%) left main disease (LMD) have a high risk of cardiovascular events, and guidelines recommend revascularization to improve survival. However, the impact of intermediate LMD (stenosis, 25%–49%) on outcomes is unclear. Methods: Randomized ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) participants who underwent coronary computed tomography angiography at baseline were categorized into those with (25%–49%) and without ( Results: Among the 3699 participants who satisfied the inclusion criteria, 962 (26%) had intermediate LMD. Among invasive strategy participants with intermediate LMD on coronary computed tomography angiography, 49 (7.0%) had significant (≥50% stenosis) left main stenosis on invasive angiography. Patients with intermediate LMD had a higher risk of cardiovascular events in the unadjusted but not in the fully adjusted model compared with those without intermediate LMD. An invasive strategy increased procedural MI and decreased nonprocedural MI with no significant difference for other outcomes including the primary end point. There was no meaningful heterogeneity of treatment effect based on intermediate LMD status except for nonprocedural MI for which there was a greater absolute reduction with invasive management in the intermediate LMD group (−6.4% versus −2.0%; P interaction =0.049). The invasive strategy improved angina-related quality of life and the benefit was durable throughout follow-up without significant heterogeneity based on intermediate LMD status. Conclusions: In the ISCHEMIA trial, there was no meaningful heterogeneity of treatment benefit from an invasive strategy regardless of intermediate LMD status except for a greater absolute risk reduction in nonprocedural MI with invasive management in those with intermediate LMD. An invasive strategy increased procedural MI, reduced nonprocedural MI, and improved angina-related quality of life. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01471522.

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.

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.

Aims We hypothesized that a decline in admissions with heart failure during COVID-19 pandemic would lead to a reciprocal rise in mortality for patients with heart failure in the community. Methods and results We used National Heart Failure Audit data to identify 36 974 adults who had a hospital admission with a primary diagnosis of heart failure between February and May in either 2018, 2019, or 2020. Hospital admissions for heart failure in 2018/19 averaged 160/day but were much lower in 2020, reaching a nadir of 64/day on 27 March 2020 [incidence rate ratio (IRR): 0.40, 95% confidence interval (CI): 0.38–0.42]. The proportion discharged on guideline-recommended pharmacotherapies was similar in 2018/19 compared to the same period in 2020. Between 1 February–2020 and 31 May 2020, there was a 29% decrease in hospital deaths related to heart failure (IRR: 0.71, 95% CI: 0.67–0.75; estimated decline of 448 deaths), a 31% increase in heart failure deaths at home (IRR: 1.31, 95% CI: 1.24–1.39; estimated excess 539), and a 28% increase in heart failure deaths in care homes and hospices (IRR: 1.28, 95% CI: 1.18–1.40; estimated excess 189). All-cause, inpatient death was similar in the COVID-19 and pre-COVID-19 periods [odds ratio (OR): 1.02, 95% CI: 0.94–1.10]. After hospital discharge, 30-day mortality was higher in 2020 compared to 2018/19 (OR: 1.57, 95% CI: 1.38–1.78). Conclusion Compared with the rolling daily average in 2018/19, there was a substantial decline in admissions for heart failure but an increase in deaths from heart failure in the community. Despite similar rates of prescription of guideline-recommended therapy, mortality 30 days from discharge was higher during the COVID-19 pandemic period.

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.

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.

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.

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.

Objectives To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort. Background New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge. Methods We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively. Results Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation. Conclusions A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI.

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.

ObjectiveThere are concerns that healthcare and outcomes of black, Asian and minority ethnic (BAME) communities are disproportionately impacted by the COVID-19 pandemic. We investigated admission rates, treatment and mortality of BAME with acute myocardial infarction (AMI) during COVID-19.MethodsUsing multisource national healthcare records, patients hospitalised with AMI in England during 1 February–27 May 2020 were included in the COVID-19 group, whereas patients admitted during the same period in the previous three consecutive years were included in a pre-COVID-19 group. Multilevel hierarchical regression analyses were used to quantify the changes in-hospital and 7-day mortality in BAME compared with whites.ResultsOf 73 746 patients, higher proportions of BAME patients (16.7% vs 10.1%) were hospitalised with AMI during the COVID-19 period compared with pre-COVID-19. BAME patients admitted during the COVID-19 period were younger, male and likely to present with ST-elevation acute myocardial infarction. COVID-19 BAME group admitted with non-ST-elevation acute myocardial infarction less frequently received coronary angiography (86.1% vs 90.0%, pConclusionIn this multisource linked cohort study, compared with whites, BAME patients had proportionally higher hospitalisation rates with AMI, less frequently received guidelines indicated care and had higher early mortality during COVID-19 period compared with pre-COVID-19 period. There is a need to develop clinical pathways to achieve equity in the management of these vulnerable populations.

Background Evidence supports an excess of deaths during the COVID-19 pandemic. We report the incidence and mortality of thrombo-embolic events (TE) during the COVID-19 pandemic. Methods Multi-sourced nationwide cohort study of adults (age ≥18 years) admitted to hospital with TE and deaths from TE in England (hospital and community) between 1st February 2018 and 31st July 2020. Relative risks, adjusted for age, sex, atrial fibrillation, co-morbidities and time trend comparing before and during the COVID-19 pandemic were estimated using Poisson regression. Findings Of 272,423 patients admitted with TE to 195 hospitals, 86,577 (31.8%) were admitted after 2nd March 2020 (first COVID-19 death in the UK). The incidence of TE hospitalised increased during the COVID-19 pandemic from 1090 to 1590 per 100,000 (absolute risk change 45.9% [95% CI 45.1–46.6%], adjusted relative risk [ARR] 1.43 [95% CI 1.41–1.44]) driven particularly by pulmonary embolism; 1.49, 95% CI 1.46–1.52. TE were more frequent among those with COVID-19; 1.9% vs. 1.6%, absolute risk change 21.7%, 95% CI 21.0–22.4%, ARR 1.20, 95% CI 1.18–1.22. There was an increase in the overall mortality from TE during the pandemic (617, 6.7% proportional increase compared with the historical baseline), with more TE deaths occurring in the community compared with the historical rate (44% vs. 33%). Interpretation The COVID-19 pandemic has resulted in an increase in the incidence of hospitalised TE. There were more deaths from TE in the community highlighting a number of mechanisms including the hypercoagulable state associated with COVID-19 infection and potential impact of delays in seeking help. Research in context Evidence before this study We searched PubMed on 16 November 2020 for articles that documented the incidence and mortality of thrombo-embolic events (TE) during the COVID-19 pandemic using the search terms “COVID-19” OR “Coronavirus*” OR “2019-nCOV” OR “SARS-CoV” AND (“Thromboembolism” OR “Venous Thromboembolism” OR “thromboembol*”) with no language or time restrictions. The majority of data on TE in COVID-19 pertains to hospitalised patients from retrospective cohort studies. One study found that TE in hospitalised patients was associated with an increased mortality rate (adjusted hazard ratio 1.82; 95% CI 1.54–2.15). A systematic review and meta-analysis of 35 studies in 9249 hospitalised patients calculated an overall pooled incidence of TE of 17.8% (95% CI: 9.9–27.4%), rising to 22.9% (95% CI: 14.5–32.4%) in patients admitted to intensive care (ICU). The most contemporary data are from a cohort of 1114 patients (715 outpatient, 399 hospitalised, 170 admitted to ICU). With robust COVID-19-specific therapies and widespread thromboprophylaxis the prevalence of venous TE in ICU patients was reported as 7% (n = 12) when catheter-/device-related events were excluded, and among the outpatients there was no TE reported. No published studies have used nationwide data to investigate TE during the pandemic or the effect of the pandemic on outcomes of patients with TE but without Covid-19. Added value of this study This retrospective multi-sourced nationwide unlinked cohort study compares the overall incidence and mortality of TE prior to and during the COVID-19 pandemic. We found an increased incidence of TE despite only a small proportion having a diagnosis of COVID-19. This may highlight the lack of testing, particularly in the community during the initial phase of the pandemic, and the possibility of other factors contributing to TE risk, such as decreased daily activity mandated by home quarantine and alterations in medication concordance. Mortality from TE was higher in the community during the pandemic and this highlights that adverse societal effects of the pandemic, such as aversion to seeking medical assessment, may precipitate worse outcomes related to TE. Implications of all the available evidence Evidence suggests that COVID-19 produces a hypercoagulable state and thromboprophylaxis is recommended in hospitalised patients to prevent excess mortality from TE. Whether to anticoagulate non-hospitalised ambulatory patients with COVID-19 will be answered by ongoing trials. Clinicians should consider the risks posed by decreased daily activity and fear of medical contact, and provide appropriate advice to patients., Graphical abstract Unlabelled Image

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.

Background Studies have reported significant reduction in acute myocardial infarction–related hospitalizations during the coronavirus disease 2019 (COVID‐19) pandemic. However, whether these trends are associated with increased incidence of out‐of‐hospital cardiac arrest (OHCA) in this population is unknown. Methods and Results Acute myocardial infarction hospitalizations with OHCA during the COVID‐19 period (February 1–May 14, 2020) from the Myocardial Ischaemia National Audit Project and British Cardiovascular Intervention Society data sets were analyzed. Temporal trends were assessed using Poisson models with equivalent pre–COVID‐19 period (February 1–May 14, 2019) as reference. Acute myocardial infarction hospitalizations during COVID‐19 period were reduced by >50% (n=20 310 versus n=9325). OHCA was more prevalent during the COVID‐19 period compared with the pre–COVID‐19 period (5.6% versus 3.6%), with a 56% increase in the incidence of OHCA (incidence rate ratio, 1.56; 95% CI, 1.39–1.74). Patients experiencing OHCA during COVID‐19 period were likely to be older, likely to be women, likely to be of Asian ethnicity, and more likely to present with ST‐segment–elevation myocardial infarction. The overall rates of invasive coronary angiography (58.4% versus 71.6%; P P =0.05) in those with ST‐segment–elevation myocardial infarction. The adjusted in‐hospital mortality probability increased from 27.7% in February 2020 to 35.8% in May 2020 in the COVID‐19 group ( P Conclusions In this national cohort of hospitalized patients with acute myocardial infarction, we observed a significant increase in incidence of OHCA during COVID‐19 period paralleled with reduced access to guideline‐recommended care and increased in‐hospital mortality.

OBJECTIVE: To address the issue of limited national data on the prevalence and distribution of underlying conditions among COVID-19 deaths between sexes and across age groups.PATIENTS AND METHODS: All adult (≥18 years) deaths recorded in England and Wales (March 1, 2020, to May 12, 2020) were analyzed retrospectively. We compared the prevalence of underlying health conditions between COVID and non-COVID-related deaths during the COVID-19 pandemic and the age-standardized mortality rate (ASMR) of COVID-19 compared with other primary causes of death, stratified by sex and age group.RESULTS: Of 144,279 adult deaths recorded during the study period, 36,438 (25.3%) were confirmed COVID deaths. Women represented 43.2% (n=15,731) of COVID deaths compared with 51.9% (n=55,980) in non-COVID deaths. Overall, COVID deaths were younger than non-COVID deaths (82 vs 83 years). ASMR of COVID-19 was higher than all other common primary causes of death, across age groups and sexes, except for cancers in women between the ages of 30 and 79 years. A linear relationship was observed between ASMR and age among COVID-19 deaths, with persistently higher rates in men than women across all age groups. The most prevalent reported conditions were hypertension, dementia, chronic lung disease, and diabetes, and these were higher among COVID deaths. Pre-existing ischemic heart disease was similar in COVID (11.4%) and non-COVID (12%) deaths.CONCLUSION: In a nationwide analysis, COVID-19 infection was associated with higher age-standardized mortality than other primary causes of death, except cancer in women of select age groups. COVID-19 mortality was persistently higher in men and increased with advanced age.

Background\ud Risk factors for further bleeding and ischemic events after acute coronary syndrome (ACS) often overlap. Little is known about sex-based differences in the management and outcomes of ACS patients according to their combined bleeding-ischemic risk.\ud \ud Methods\ud All ACS hospitalizations in the United Kingdom (2010-2017) were retrospectively analyzed, stratified by sex and bleeding-ischemic risk combination (using CRUSADE and GRACE scores). Multivariable logistic regression was performed to examine association between risk-groups and 1) receipt of guideline-recommended management and 2) in-hospital outcomes.\ud \ud Results\ud Of 584,360 patients, a third of males (32.3%) and females (32.6%) were in the dual high-risk group (High CRUSADE- High GRACE). In comparison to the dual low-risk group (Low CRUSADE-Low GRACE), the dual high-risk patients of both sexes were 59-83% less likely to receive coronary angiography (CA) or percutaneous coronary intervention (PCI), 31-34% less likely to receive dual antiplatelet therapy (DAPT) on discharge, with a significant increase in odds of MACE (8-fold), all-cause and cardiac mortality (30 to 40-fold), and bleeding (40-43%). The greatest difference in management and clinical outcomes between sexes was found in the dual-high risk group where females were less likely to receive guideline-recommended therapy (PCI and DAPT), compared to males, and were more likely to experience MACE, all-cause and cardiac mortality.\ud \ud Conclusion\ud ACS patients with dual high-risk for bleeding and recurrent ischemia, especially females, are less likely to receive guideline-recommended therapy and experience significantly worse outcomes. Novel strategies are needed to effectively manage this highly prevalent, complex patient group and address the under-treatment of females.

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.

OBJECTIVES We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI). BACKGROUND Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined. METHODS We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke. RESULTS A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p

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 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.

Background\ud Aortic stenosis (AS) poses a perioperative management dilemma to physicians looking after patients who require non-cardiac surgery. The objective of this review is to investigate mortality and adverse cardiovascular events in patients with and without AS who underwent non-cardiac surgery.\ud \ud Methods\ud We searched MEDLINE and EMBASE for studies that evaluated mortality and adverse cardiovascular events in patients with and without AS who underwent non-cardiac surgery. Pooled risk ratios for mortality and adverse outcomes (myocardial infarction, stroke, heart failure, death) were calculated using the dichotomous analysis method and subgroup analysis was performed considering the effect of severity of AS and symptoms.\ud \ud Results\ud We identified 9 relevant studies with 29,327 participants. Among studies of severe AS, there was no significant difference in mortality (RR: 1.49, 95%CI:0.85–2.61; P = 0.16) associated with non-cardiac surgery, but there was a significant increase in the composite adverse outcome (RR: 2.30, 95%CI:1.33–3.97; P = 0.003). When the analysis involved any other degree of AS, eight studies were included and the pooled results showed a significant increase in composite adverse outcome (RR: 1.64, 95%CI:1.23–2.19; P < 0.001) and myocardial infarction (RR: 1.90, 95%CI:1.54–2.34; P < 0.001). When patients with asymptomatic AS were considered, the pooled results of four studies suggested an increased risk of composite adverse outcomes (RR: 1.59, 95%CI:1.19–2.12; P = 0.002) but not mortality, myocardial infarction, heart failure or stroke.\ud \ud Conclusions\ud Patients with AS undergoing non-cardiac surgery have not been shown to be at increased risk of mortality, but have significantly higher rates of adverse cardiovascular events compared to patients without AS.

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.

Improved and durable control of hypertension is a global priority for healthcare providers and policymakers. There are several lifestyle measures that are proven to result in improved blood pressure (BP) control. Moreover, there is incontrovertible evidence from large scale randomised controlled trials (RCTs) that antihypertensive drugs lower BP safely and effectively in the long-term resulting in substantial reduction in cardiovascular morbidity and mortality. Importantly, however, evidence is accumulating to suggest that patients neither sustain long-term healthy behaviours nor adhere to lifelong drug treatment regimens and thus alternative measures to control hypertension warrant further investigation. Endovascular renal denervation (RDN) appears to hold some promise as a non-pharmacological approach to lowering BP and achieves renal sympathectomy using either radiofrequency energy or ultrasound-based approaches. This treatment modality has been evaluated in clinical trials in humans since 2009 but initial studies were compromised by being non-randomised, without sham control and small in size. Subsequently, clinical trial design and rigour of execution has been greatly improved resulting in recent sham-controlled RCTs that demonstrate short-term reduction in ambulatory BP without any significant safety concerns in both medication-naïve and medication-treated hypertensive patients. Despite this, the joint UK societies still feel that further evaluation of this therapy is warranted and that RDN should not be offered to patients outside of the context of clinical trials. This document reviews the updated evidence since our last consensus statement from 2014 and provides a research agenda for future clinical studies.

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.

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— 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.

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.

Aims The aim of this registry was to monitor practice patterns and outcomes in patients treated with Absorb bioresorbable vascular scaffolds (BVS) during the early phase of usage in the UK. Methods and results A total of 1,005 patients with de novo coronary lesions were treated using careful implantation techniques at 24 centres. Follow-up at one year was obtained in 99%. An independent clinical events committee and angiographic core lab adjudicated all events. Patient age was 52 years and 46% presented with acute coronary syndromes. Lesion complexity was B2/C in 47.4%, with an average of 1.4±0.6 BVS implanted and a BVS length of 28±14.3 mm. A single BVS was implanted in 71.3%. High pressure post-dilatation was performed in 94.9%, with 50% using intravascular imaging. Device success was achieved in 98.7% and procedure success in 97.3% of patients. At one year, the device-oriented endpoint target lesion failure was 3.2%, and the patient-oriented endpoint major adverse cardiac events was 3.4%. Definite ST occurred in 1.4%. By multivariable analysis, scaffold size of 2.5 mm predicted ST at one year (OR 3.27, 95% CI: 1.28-8.37; p=0.014). Conclusions With careful patient selection and technique, TLF rates following BVS implantation in real-world practice are comparable with contemporary drug-eluting stents. ST rates remain high, with small vessel size identified as a contributory factor.

Background Transcatheter aortic valve implantation (TAVI) is indicated for patients with aortic stenosis who are intermediate‐high surgical risk. Although all‐cause mortality rates after TAVI are established, survival attributable to the procedure is unclear because of competing causes of mortality. The aim was to report relative survival (RS) after TAVI, which accounts for background mortality risks in a matched general population. Methods and Results National cohort data (n=6420) from the 2007 to 2014 UK TAVI registry were matched by age, sex, and year to mortality rates for England and Wales (population, 57.9 million). The Ederer II method related observed patient survival to that expected from the matched general population. We modelled RS using a flexible parametric approach that modelled the log cumulative hazard using restricted cubic splines. RS of the TAVI cohort was 95.4%, 90.2%, and 83.8% at 30 days, 1 year, and 3 years, respectively. By 1‐year follow‐up, mortality hazards in the >85 years age group were not significantly different from those of the matched general population; by 3 years, survival rates were comparable. The flexible parametric RS model indicated that increasing age was associated with significantly lower excess hazards after the procedure; for example, by 2 years, a 5‐year increase in age was associated with 20% lower excess mortality over the general population. Conclusions RS after TAVI was high, and survival rates in those aged >85 years approximated those of a matched general population within 3 years. High rates of RS indicate that patients selected for TAVI tolerate the risks of the procedure well.

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.

This study sought to determine the relationships among access site practice, clinical presentation, and procedural outcomes in a large patient population.Transradial access (TRA) has been associated with improved patient outcomes in selected populations in randomized trials. It is unclear whether these outcomes are achievable in clinical practice.Using the BCIS (British Cardiovascular Intervention Society) database, we investigated outcomes for percutaneous coronary intervention procedures undertaken between 2007 and 2012 according to access site practice. Patients were categorized as stable, non-ST-segment elevation acute coronary syndrome (NSTEACS) and ST-elevation acute coronary syndrome (STEACS). The impact of access site on 30-day mortality, major adverse cardiac events, bleeding, and arterial access site complications was studied.Data from 210,260 TRA and 229,687 transfemoral access procedures were analyzed. Following multivariate analysis, TRA was independently associated with a reduction in bleeding in all presenting syndromes (stable odds ratio [OR]: 0.24, p0.001; NSTEACS OR: 0.35, p0.001; STEACS OR: 0.47, p0.001) as well as access site complications (stable OR: 0.21, p0.001; NSTEACS OR: 0.19; STEACS OR: 0.16, p0.001). TRA was associated with reduced major adverse cardiac events only in patients with unstable syndromes (stable OR: 1.08, p = 0.25; NSTEACS OR: 0.72, p0.001; STEACS OR: 0.70, p0.001). TRA was associated with improved outcomes compared with a transfemoral access (TFA) with a vascular closure device in a propensity matched cohort.In this large study, TRA is associated with reduced percutaneous coronary intervention-related complications in all patient groups and may reduce major adverse cardiac events and mortality in ACS patients. TRA is superior to transfemoral access with closure devices. Use of TRA may lead to important patient benefits in routine practice. TRA should be considered the preferred access site for percutaneous coronary intervention.

Background Vascular complications from transfemoral (TF) secondary access during transcatheter aortic valve implantation (TAVI) are common. We compare our experience of transradial (TR) versus transfemoral secondary access during TAVI and describe techniques for performing iliofemoral arterial intervention from the transradial approach. Methods All TAVI procedures with a single secondary access were included. Demographics, procedural details and 30-day outcomes were recorded. VARC-2 criteria were used for procedural complications. Procedures with TF primary access were stratified by the site of secondary arterial access. Results Single secondary access was used in 199 cases, of which 20 were performed via non-TF access. Of the 179 TF primary access cases, 115 (64%) used TR secondary access and 64 (36%) used TF secondary access. In the TR cohort percutaneous vascular intervention was performed from the transradial approach in 19 cases (17%). Emergent TF secondary access was not required in any case. There were no differences in procedural time, radiation dose, contrast use, bleeding complications, stroke or mortality between the groups. There was one secondary access complication in the TF cohort and none in the TR cohort. Conclusions Transradial (TR) secondary access during TAVI is safe and feasible and may reduce the secondary access site vascular complication rate. With appropriate equipment, most peripheral vascular complications can be managed entirely via TR access avoiding unplanned femoral arterial access. TR secondary access should be considered the default approach for non-TF TAVI cases and can be considered for all TF cases as long as dedicated equipment is available.