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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".

Background: The performance of emerging transcatheter aortic valve implantation (TAVI) clinical prediction models (CPMs) in national TAVI cohorts distinct from those where they have been derived is unknown. This study aimed to investigate the performance of the German Aortic Valve, FRANCE-2, OBSERVANT and American College of Cardiology (ACC) TAVI CPMs compared with the performance of historic cardiac CPMs such as the EuroSCORE and STS-PROM, in a large national TAVI registry., Methods: The calibration and discrimination of each CPM were analyzed in 6676 patients from the UK TAVI registry, as a whole cohort and across several subgroups. Strata included gender, diabetes status, access route, and valve type. Furthermore, the amount of agreement in risk classification between each of the considered CPMs was analyzed at an individual patient level., Results: The observed 30-day mortality rate was 5.4%. In the whole cohort, the majority of CPMs over-estimated the risk of 30-day mortality, although the mean ACC score (5.2%) approximately matched the observed mortality rate. The areas under ROC curve were between 0.57 for OBSERVANT and 0.64 for ACC. Risk classification agreement was low across all models, with Fleiss's kappa values between 0.17 and 0.50., Conclusions: Although the FRANCE-2 and ACC models outperformed all other CPMs, the performance of current TAVI-CPMs was low when applied to an independent cohort of TAVI patients. Hence, TAVI specific CPMs need to be derived outside populations previously used for model derivation, either by adapting existing CPMs or developing new risk scores in large national registries., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

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

Background and Purpose: Stroke after percutaneous coronary intervention (PCI) is a serious complication, but its determinants and outcomes after PCI in different clinical settings are poorly documented., Methods: The British Cardiovascular Intervention Society (BCIS) database was used to study 560 439 patients who underwent PCI in England and Wales between 2006 and 2013. We examined procedural-type specific determinants of ischemic and hemorrhagic stroke and the likelihood of subsequent 30-day mortality and in-hospital major adverse cardiovascular events (a composite of in-hospital mortality, myocardial infarction or reinfarction, and repeat revascularization)., Results: A total of 705 stroke cases were recorded (80% ischemic). Stroke after an elective PCI or PCI for acute coronary syndrome indications was associated with a higher risk of adverse outcomes compared with those without stroke; 30-day mortality and major adverse cardiovascular events outcomes in fully adjusted model were odds ratios 37.90 (21.43-67.05) and 21.05 (13.25-33.44) for elective and 5.00 (3.96-6.31) and 6.25 (5.03-7.77) for acute coronary syndrome, respectively. Comparison of odds of these outcomes between these 2 settings showed no differences; corresponding odds ratios were 1.24 (0.64-2.43) and 0.63 (0.35-1.15), respectively., Conclusions: Hemorrhagic and ischemic stroke complications are uncommon, but serious complications can occur after PCI and are independently associated with worse mortality and major adverse cardiovascular events outcomes in both the elective and acute coronary syndrome setting irrespective of stroke type. Our study provides a better understanding of the risk factors and prognosis of stroke after PCI by procedure type, allowing physicians to provide more informed advice around stroke risk after PCI and counsel patients and their families around outcomes if such neurological complications occur., (© 2016 American Heart Association, Inc.)

Background: The current risk model for percutaneous coronary intervention (PCI) in the UK is based on outcomes of patients treated in a different era of interventional cardiology. This study aimed to create a new model, based on a contemporary cohort of PCI treated patients, which would: predict 30 day mortality; provide good discrimination; and be well calibrated across a broad risk-spectrum., Methods and Results: The model was derived from a training dataset of 336,433 PCI cases carried out between 2007 and 2011 in England and Wales, with 30 day mortality provided by record linkage. Candidate variables were selected on the basis of clinical consensus and data quality. Procedures in 2012 were used to perform temporal validation of the model. The strongest predictors of 30-day mortality were: cardiogenic shock; dialysis; and the indication for PCI and the degree of urgency with which it was performed. The model had an area under the receiver operator characteristic curve of 0.85 on the training data and 0.86 on validation. Calibration plots indicated a good model fit on development which was maintained on validation., Conclusion: We have created a contemporary model for PCI that encompasses a range of clinical risk, from stable elective PCI to emergency primary PCI and cardiogenic shock. The model is easy to apply and based on data reported in national registries. It has a high degree of discrimination and is well calibrated across the risk spectrum. The examination of key outcomes in PCI audit can be improved with this risk-adjusted model., (Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

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; <60, 60-<70, 70-<80, and ≥80 in the British Cardiovascular Intervention Society database. We studied access site practice in 469,983 patients who underwent PCI procedures in the United Kingdom. TRA utilization increased from 17.5% to 65.6% in the age group <60, and 16.6% to 54.5% in the age group ≥80 between 2006 and 2012. TRA was independently associated with decreased 30-day mortality in all age groups (<60: OR 0.64; 95% CI 0.54-0.74, P < 0.0001; 60-<70: OR 0.65; 95% CI 0.57-75, P < 0.0001, 70-<80: OR 0.58 (0.52-0.65, P < 0.0001 and ≥80: OR 0.65 (0.57-0.73, P < 0.0001). Adoption of the TRA for PCI has occurred least in older patients in the UK despite similar associations between TRA use and decreased 30-day mortality observed in all age groups., (© 2015 Wiley Periodicals, Inc.)

Many patients have iliofemoral vessel anatomy unsuitable for conventional transfemoral (TF) transcatheter aortic valve implantation (TAVI). Safe and practical alternatives to the TF approach are, therefore, needed. This study compared outcomes of alternative nonfemoral routes, transapical (TA), direct aortic (DA), and subclavian (SC), with standard femoral access. In this retrospective study, data from 3,962 patients in the UK TAVI registry were analyzed. All patients who received TAVI through a femoral, subclavian, TA, or DA approach were eligible for inclusion. The primary outcome measure was survival up to 2 years. Median Logistic EuroSCORE was similar for SC, DA, and TA but significantly lower in the TF cohort (22.1% vs 20.3% vs 21.2% vs 17.0%, respectively, p <0.0001). Estimated 1-year survival rate was similar for TF (84.6 ± 0.7%) and SC (80.5 ± 3%, p = 0.27) but significantly worse for TA (74.7 ± 1.6%, p <0.001) and DA (75.2 ± 3.3%, p <0.001). A Cox proportional hazard model was used to analyze survival up to 2 years. Survival in the SC group was not significantly different from the TF group (hazard ratio [HR] 1.22, 95% confidence interval [CI] 0.88 to 1.70, p = 0.24). In contrast, survival in the TA (HR 1.74, 95% CI 1.43 to 2.11; p <0.001) and DA (HR 1.55, 95% CI 1.13 to 2.14; p <0.01) cohorts was significantly reduced compared with TF. In conclusion, TA and DA TAVI were associated with similar survival, both significantly worse than with the TF route. In contrast, subclavian access was not significantly different from TF and may represent the safest nonfemoral access route for TAVI., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Background: Gender is a strong predictor of periprocedural major bleeding complications after percutaneous coronary intervention (PCI). The access site represents an important site of such bleeding complications, which has driven adoption of the transradial access (TRA) use during PCI, although female gender is an independent predictor of transradial PCI failure. This study sought to define gender differences in access site practice and study associations between access site choice and clinical outcomes for PCI over a 6-year period, through the analysis of the British Cardiovascular Intervention Society observational database., Methods and Results: In-hospital major adverse cardiovascular events (a composite of in-hospital mortality and in-hospital myocardial reinfarction and target vessel revascularization), in-hospital bleeding complications, and 30-day mortality were studied based on gender and access site choice (transfemoral access, TRA) in 412,122 patients who underwent PCI between 2007 and 2012 in the United Kingdom. Use of TRA increased in both genders over time, although this lagged behind in women (21% in 2007 to 58% in 2012) compared with men (24% in 2007 to 64% in 2012). In both men and women, TRA was independently associated with a lower in-hospital major adverse cardiovascular event (odds ratio [OR] 0.82, 95% CI 0.76-0.90; OR 0.75, 95% CI 0.66-0.84), in-hospital major bleeding (OR 0.54, 95% CI 0.44-0.66; OR 0.26, 95% CI 0.20-0.33), and 30-day mortality (OR 0.80, 95% CI 0.73-0.89; OR 0.82, 95% CI 0.71-0.94), respectively., Conclusions: Where possible, TRA should be considered as the preferred access site choice for PCI, particularly in women in whom the greatest reductions bleeding end points were observed across all indications., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Aims: The Impella is a percutaneous ventricular assist device. The majority of published data describes the 2.5L and 5.0L devices, and little data is available for the newer 3.8L device. We examined the indications and outcomes from our single-centre "real-world" registry at The Queen Elizabeth Hospital, Birmingham, UK, using all three pump sizes., Methods and Results: Records from all patients who underwent attempted Impella-assisted procedures at our centre were examined retrospectively. Impella implantation was attempted in 49 patients (mean age 72 ± 13 years; 80% male) and was successful in 48 (98%). 45 patients underwent high-risk percutaneous coronary intervention (PCI), one patient underwent balloon aortic valvuloplasty and 3 patients had Impella as a bridge to cardiac transplantation. The 2.5L and 3.8L devices were used in 36 (75%) and 11 (23%) patients, respectively, while one patient (2%) had the 5L device. Vascular complications occurred in only one patient (2%) and stroke and peri-procedural myocardial infarction occurred in one patient (2%), while in-hospital mortality was 20% (10/49)., Conclusions: In this large real-world registry, we have demonstrated the safety and feasibility of the Impella device for a wide range of indications. This includes the first series of the 3.8L device which provides superior support with no increase in vascular complications.

Background: Around one third of patients undergoing percutaneous coronary intervention (PCI) have left ventricular (LV) dysfunction. Whilst the prevalence of LV dysfunction is known to increase with age, the prevalence of LV dysfunction in different age groups in the PCI setting is not known and the effect of age on the prognostic value of LV function in the PCI setting has not been examined., Methods: The relationship between LV function and 30-day mortality in patients undergoing PCI in different age groups (<60 years, 60 to <70 years, 70 to <80 years and ≥80 years) was studied in 246,840 patients in the UK between 2006 and 2011., Results: Prevalent LV dysfunction in patients undergoing PCI increased with age; 25,106/83,161 (30.2%: <60 years), 24,114/76,895 (31.4%: 60 to <70 years), 23,580/64,711 36.4% (70 to <80 years) and 9,851/22,073 (44.6%) in patients aged 80 or over (P < 0.0001). Poor LV function was independently associated with increased risk of 30-day mortality outcomes in all age groups (OR 5.65:95% CI 4.21-7.58, age <60 years; OR 5.07: 95% CI 3.91-6.57, age 60 to <70 years; OR 4.50: 95% CI 3.64-5.57, 70 to <80 years and OR 4.83:95% CI 3.79-6.15, age ≥80 years)., Conclusions: Our analysis suggests that worsening LV function is an important independent predictor of worse 30-day mortality outcomes across all age groups and underscores the need for a measure of LV function in all patients for accurate risk stratification prior to PCI., (© 2014 Wiley Periodicals, Inc.)

Objective: Assessment of the feasibility and outcomes of the 2.5 L and 3.8 L Impella cardiac pump in patients with severe aortic stenosis (AS) and left ventricular impairment undergoing percutaneous revascularization (PCI) with or without balloon aortic valvuloplasty (BAV)., Methods: We reviewed the clinical and procedural findings from a consecutive series of unselected patients with severe AS who underwent PCI during Impella support. In addition, we describe novel "balloon-assist" techniques that allowed implantation of Impella into the left ventricle (LV) when initial unassisted attempts failed., Results: Five patients with severe AS were identified (four males, age 78.2 years, aortic valve area (AVA) 0.6 cm(2) , left ventricular ejection fraction (LVEF) 24 ± 5%, mean Society of Thoracic Surgeons (STS) mortality 11% (range 3-17%)). The Impella catheter traversed the aortic valve (AV) unassisted in only one patient, with four cases requiring balloon-assist techniques. All patients underwent planned revascularisation; mean procedure time 177 min (range 135-252 min), mean number of stents 3.4 (range 1-8), with three patients requiring rotational atherectomy. All procedures were well tolerated, with absence of arrhythmia, hypotension, pulmonary edema, stroke, or myocardial infarction. One patient died 48 hr post-PCI of multi-organ failure. The four remaining patients were well at 30 days., Conclusion: Implantation of the 2.5 and 3.8 L Impella appears feasible in patients with severe AS and left ventricle (LV) impairment. A balloon-assist technique may be used to facilitate device implantation when initial unassisted attempts fail. Improved hemodynamic stability may enhance the tolerability of lengthy and complex procedures., (© 2014 Wiley Periodicals, Inc.)

Gender differences exist in outcomes after percutaneous coronary intervention and coronary artery bypass graft surgery but have yet to be fully explored after transcatheter aortic valve implantation. We aimed to investigate gender differences after transcatheter aortic valve implantation in the UK National Institute for Cardiovascular Outcomes Research registry. A retrospective analysis was performed of Medtronic CoreValve and Edwards SAPIEN implantation in 1,627 patients (756 women) from January 2007 to December 2010. Men had more risk factors: poor left ventricular systolic function (11.9% vs 5.5%, p <0.001), 3-vessel disease (19.4% vs 9.2%, p <0.001), previous myocardial infarction (29.5% vs 13.0%, p <0.001), peripheral vascular disease (32.4% vs 23.3%, p <0.001), and higher logistic EuroSCORE (21.8 ± 14.2% vs 21.0 ± 13.4%, p = 0.046). Thirty-day mortality was 6.3% (confidence interval 4.3% to 7.9%) in women and 7.4% (5.6% to 9.2%) in men and at 1 year, 21.9% (18.7% to 25.1%) and 22.4% (19.4% to 25.4%), respectively. There was no mortality difference: p = 0.331 by log-rank test; hazard ratio for women 0.91 (0.75 to 1.10). Procedural success (96.6% in women vs 96.4% in men, p = 0.889) and 30-day cerebrovascular event rates (3.8% vs 3.7%, p = 0.962) did not differ. Women had more major vascular complications (7.5% vs 4.2%, p = 0.004) and less moderate or severe postprocedural aortic regurgitation (7.5% vs 12.5%, p = 0.001). In conclusion, despite a higher risk profile in men, there was no gender-related mortality difference; however, women had more major vascular complications and less postprocedural moderate or severe aortic regurgitation., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the influence of access site utilization on mortality, major adverse cardiac and cardiovascular events (MACCE), bleeding, and vascular complications in a large number of patients treated by primary percutaneous coronary intervention (PPCI) in the United Kingdom over a 5-year period, through analysis of the British Cardiovascular Intervention Society database., Background: Despite advances in antithrombotic and antiplatelet therapy, bleeding complications remain an important cause of morbidity and mortality in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. A significant proportion of such bleeding complications are related to the access site, and adoption of radial access may reduce these complications. These benefits have not previously been studied in a large unselected national population of PPCI patients., Methods: Mortality (30-day), MACCE (a composite of 30-day mortality and in-hospital myocardial re-infarction, target vessel revascularization, and cerebrovascular events), and bleeding and access site complications were studied based on transfemoral access (TFA) and transradial access (TRA) site utilization in PPCI STEMI patients. The influence of access site selection was studied in 46,128 PPCI patients; TFA was used in 28,091 patients and TRA in 18,037. Data were adjusted for potential confounders using Cox regression that accounted for the propensity to undergo radial or femoral approach., Results: TRA was independently associated with a lower 30-day mortality (hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.52 to 0.97; p < 0.05), in-hospital MACCE (HR: 0.73, 95% CI: 0.57 to 0.93; p < 0.05), major bleeding (HR: 0.37, 95% CI: 0.18 to 0.74; p < 0.01), and access site complications (HR: 0.38, 95% CI: 0.19 to 0.75; p < 0.01)., Conclusions: This analysis of a large number of PPCI procedures demonstrates that utilization of TRA is independently associated with major reductions in mortality, MACCE, major bleeding, and vascular complication rates., (Copyright © 2013. Published by Elsevier Inc.)

ST-segment elevation in the inferior leads has been previously described following transseptal puncture for balloon mitral valvuloplasty. The mechanism, however, is obscure, and immediate left and right coronary angiography has not suggested that embolism or vascular spasm is the cause. We hypothesized that a neurally-mediated mechanism was responsible and have since treated 3 further patients with inferior ST-segment elevation following transseptal puncture for balloon valvuloplasty with intravenous atropine, with rapid resolution of ST-segment elevation in each case.