Prevalence and Impact of Concomitant Atrial Fibrillation in Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial Infarction.

Background: Concomitant atrial fibrillation (AF) is associated with an adverse prognosis in patients with acute myocardial infarction (MI). However, it remains unclear whether this is due to a causal effect of AF or whether AF acts as a surrogate marker for comorbidities in this population. Furthermore, there are limited data on whether coronary artery disease distribution impacts the risk of developing AF. Methods: Consecutive patients admitted with acute MI and treated using percutaneous coronary intervention (PCI) at a single centre were retrospectively identified. Associations between AF and major adverse cardiac and cerebrovascular events (MACCEs) over a median of five years of follow-up were assessed using Cox regression, with adjustment for confounding factors performed using both multivariable modelling and a propensity-score-matched analysis. Results: AF was identified in N = 65/1000 (6.5%) of cases; these patients were significantly older (mean: 73 vs. 65 years, p < 0.001), with lower creatinine clearance (p < 0.001), and were more likely to have a history of cerebrovascular disease (p = 0.011) than those without AF. In addition, patients with AF had a greater propensity for left main stem (p = 0.001) or left circumflex artery (p = 0.004) involvement. Long-term MACCE rates were significantly higher in the AF group than in the non-AF group (50.8% vs. 34.2% at five years), yielding an unadjusted hazard ratio (HR) of 1.86 (95% CI: 1.32-2.64, p < 0.001). However, after adjustment for confounding factors, AF was no longer independently associated with MACCEs, either on multivariable (adjusted HR: 1.25, 95% CI: 0.81-1.92, p = 0.319) or propensity-score-matched (HR: 1.04, 95% CI: 0.59-1.82, p = 0.886) analyses. Conclusions: AF is observed in 6.5% of patients admitted with acute MI, and those with AF are more likely to have significant diseases involving left main or circumflex arteries. Although unadjusted MACCE rates were significantly higher in patients with AF, this effect was not found to remain significant after adjustment for comorbidities. As such, this study provided no evidence to suggest that AF is independently associated with MACCEs.

Complex High-Risk Percutaneous Coronary Intervention Types, Trends, and Outcomes in Nonsurgical Centres.

BACKGROUND: Limited data are available on complex high-risk percutaneous coronary intervention (CHiP) trends and outcomes in nonsurgical centres (NSCs), particularly in health care systems where most centres are NSCs. METHODS: Using data from a national registry, we studied the characteristics and outcomes of CHiP procedures performed for stable angina from 2006 to 2017 according to the presence or absence of on-site surgical cover. Multivariate regression analyses and propensity score matching were used to determine risks for in-hospital death, major bleeding, and major cardiovascular or cerebral events (MACCE). RESULTS: Out of 134,730 CHiP procedures, 42,433 (31.5%) were performed in NSCs, increasing from 12.5% in 2006 to 42% in 2017. Compared with surgical centres (SCs), patients who had a CHiP procedure undertaken in NSCs were, on average, 2.4 years older and had a greater prevalence of cardiovascular risks. Common CHiP procedures performed in NSCs included poor left ventricular function (41.6%), chronic renal failure (38.8%), and chronic total occlusion percutaneous coronary intervention (31.1%). NSC-based CHiP is associated with lower odds of mortality (adjusted odds ratio [aOR] 0.7, 95% confidence interval [CI] 0.5-0.8) and major bleeding (aOR 0.7, 95% CI 0.6-0.8). In both groups, MACCE odds were similar (aOR 1.0, 95% CI 0.9-1.1). CONCLUSIONS: CHiP numbers have steadily increased in NSCs. NSC patients were older and had a higher prevalence of cardiovascular risks than SC patients. Mortality and major bleeding odds were significantly lower in those cases undertaken in NSCs, although MACCE odds were not different between the groups.

Diabetes mellitus and presentation, care and outcomes of patients with NSTEMI: the Association for Acute Cardiovascular Care-European Association of Percutaneous Cardiovascular Interventions EURObservational Research Programme NSTEMI Registry of the European Society of Cardiology.

AIM: Diabetes mellitus (diabetes) is common amongst patients with NSTEMI. We describe presentation, care and outcomes of patients admitted with NSTEMI by diabetes status. METHODS: Prospective cohort study including 2928 patients (1104 with prior diabetes, 1824 without) admitted to hospital with NSTEMI from 287 centres in 59 countries. Quality of care was evaluated based on 12 guideline-recommended care interventions. Outcomes included in-hospital acute heart failure, cardiogenic shock, repeat myocardial infarction, stroke/transient ischaemic attack (TIA), BARC Type ≥ 3 bleeding and death, as well as 30-day mortality. RESULTS: Patients with diabetes had higher comorbidity burden and more frequently presented with Killip Class II-IV heart failure (10.2% vs 3.7%, P < 0.001), haemodynamic instability (7.1% vs 3.7%, P < 0.001) and ongoing chest pain (43.1% vs 37.0%, P < 0.001), than those without diabetes. Overall, care quality received was similar by diabetes status (60.0% vs 60.5% received ≥ 80% of eligible care interventions, P = 0.786), but patients with diabetes experienced higher rates of in-hospital acute heart failure (15.3% vs 6.8% P < 0.001), cardiogenic shock (4.5% vs 2.5%, P = 0.002), stroke/TIA (2.0% vs 0.8%, P = 0.006) and death (2.5% vs 1.4%, P = 0.022), and higher 30-day mortality (3.3% vs 2.0%, P = 0.025). Of NSTEMI with diabetes, only 1.9% and 9.0% received prescription for GLP-1 RAs and SGLT2 inhibitors, respectively, on discharge, and only 45.9% were referred for cardiac rehabilitation. CONCLUSION: NSTEMI patients with diabetes, compared to those without, present more clinically unwell and have worse outcomes despite receiving equal quality of care. Prescription of cardiovascular-protective glycaemic agents is an actionable target to reduce risk of further events.

European Society of Cardiology Quality indicators for the care and outcomes of adults undergoing transcatheter aortic valve implantation.

BACKGROUND AND AIMS: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing transcatheter aortic valve intervention (TAVI). METHODS: We followed the European Society of Cardiology (ESC) methodology for the development of QIs. Key domains were identified by constructing a conceptual framework for the delivery of TAVI care. A list of candidate QIs were developed by conducting a systematic review of the literature. A modified Delphi method was then used to select the final set of QIs. Finally, we mapped the QIs to the EuroHeart Data Standards for TAVI to ascertain the extent to which the EuroHeart TAVI registry captures information to calculate the QIs. RESULTS: We formed an international group of experts in quality improvement and TAVI, including representatives from the European Association of Percutaneous Cardiovascular Interventions, the European Association of Cardiovascular Imaging and the Association of Cardiovascular Nursing & Allied Professions. In total, 27 QIs were selected across eight domains of TAVI care, comprising 22 main (81%) and five secondary (19%) QIs. Of these, 19/27 (70%) are now being utilised in the EuroHeart TAVI registry. CONCLUSION: We present the 2023 ESC QIs for TAVI, developed using a standard methodology and in collaboration with ESC Associations. The EuroHeart TAVI registry allows calculation of the majority of the QIs, which may be used for benchmarking care and quality improvement initiatives.

Sex-specific presentation, care, and clinical events in individuals admitted with NSTEMI: the ACVC-EAPCI EORP NSTEMI registry of the European Society of Cardiology.

AIMS: Women have historically been disadvantaged in terms of care and outcomes for non-ST-segment elevation myocardial infarction (NSTEMI). We describe patterns of presentation, care, and outcomes for NSTEMI by sex in a contemporary and geographically diverse cohort. METHODS AND RESULTS: Prospective cohort study including 2947 patients (907 women, 2040 men) with Type I NSTEMI from 287 centres in 59 countries, stratified by sex. Quality of care was evaluated based on 12 guideline-recommended care interventions. The all-or-none scoring composite performance measure was used to define receipt of optimal care. Outcomes included acute heart failure, cardiogenic shock, repeat myocardial infarction, stroke/transient ischaemic attack, BARC Type ≥3 bleeding, or death in-hospital, as well as 30-day mortality. Women admitted with NSTEMI were older, more comorbid, and more frequently categorized as at higher ischaemic (GRACE >140, 54.0% vs. 41.7%, P < 0.001) and bleeding (CRUSADE >40, 51.7% vs. 17.6%, P < 0.001) risk than men. Women less frequently received invasive coronary angiography (ICA; 83.0% vs. 89.5%, P < 0.001), smoking cessation advice (46.4% vs. 69.5%, P < 0.001), and P2Y12 inhibitor prescription at discharge (81.9% vs. 90.0%, P < 0.001). Non-receipt of ICA was more often due to frailty for women than men (16.7% vs. 7.8%, P = 0.010). At ICA, more women than men had non-obstructive coronary artery disease or angiographically normal arteries (15.8% vs. 6.3%, P < 0.001). Rates of in-hospital adverse outcomes and 30-day mortality were low and did not differ by sex. CONCLUSION: In contemporary practice, women presenting with NSTEMI, compared with men, less frequently receive antiplatelet prescription, smoking cessation advice, or are considered eligible for ICA.

Sex-Specific Differences in Potent P2Y12 Inhibitor Use in British Cardiovascular Intervention Society Registry STEMI Patients.

BACKGROUND: Sex-based outcome differences for women with ST-segment-elevation myocardial infarction (STEMI) have not been adequately addressed, and the role played by differences in prescription of potent P2Y12 inhibitors (P-P2Y12) is not well defined. This study explores the hypothesis that disparities in P-P2Y12 (prasugrel or ticagrelor) use may play a role in outcome disparities for women with STEMI. METHODS: Data from British Cardiovascular Intervention Society national percutaneous coronary intervention database were analyzed, and 168 818 STEMI patients treated with primary percutaneous coronary intervention from 2010 to 2020 were included. RESULTS: Among the included women (43 131; 25.54%) and men (125 687; 74.45%), P-P2Y12 inhibitors were prescribed less often to women (51.71%) than men (55.18%; P<0.001). Women were more likely to die in hospital than men (adjusted odds ratio, 1.213 [95% CI, 1.141-1.290]). Unadjusted mortality was higher among women treated with clopidogrel (7.57%), than P-P2Y12-treated women (5.39%), men treated with clopidogrel (4.60%), and P-P2Y12-treated men (3.61%; P<0.001). The strongest independent predictor of P-P2Y12 prescription was radial access (adjusted odds ratio, 2.368 [95% CI, 2.312-2.425]), used in 67.93% of women and 74.38% of men (P<0.001). Two risk adjustment models were used. Women were less likely to receive a P-P2Y12 (adjusted odds ratio, 0.957 [95% CI, 0.935-0.979]) with risk adjustment for baseline characteristics alone, when procedural factors including radial access were included in the model differences were not significant (adjusted odds ratio, 1.015 [95% CI, 0.991-1.039]). CONCLUSIONS: Women were less likely to be prescribed prasugrel or ticagrelor, were less likely to have radial access, and had a higher mortality when being treated for STEMI. Improving rates of P-P2Y12 use and radial access may decrease outcome disparities for women with STEMI.

Intraprocedural versus next day transthoracic echocardiography following minimalist transfemoral TAVI.

BACKGROUND: Routine pre-discharge echocardiography (ECHO) is recommended post transcatheter aortic valve implantation (TAVI) as a baseline for future comparison. However, there is no clear guidance on the optimal timing of this study. AIM: The purpose of this retrospective study was to investigate the safety and work-force efficiency of intraprocedural same-day ECHO versus next-day ECHO, following transfemoral TAVI. METHODS AND RESULTS: In this retrospective study 100 consecutive patients who underwent intraprocedural ECHO only were compared with 100 consecutive patients undergoing both intraprocedural and routine next-day ECHO following elective transfemoral TAVI. All patients received the Sapien 3/Ultra transcatheter heart valve and were treated with a minimalist procedure with conscious sedation. The composite of in-hospital mortality, urgent ECHO and new tamponade after leaving the cath lab and before discharge was not different between the two groups (4 vs. 4%, P = 1). There was no paravalvular leak more than mild in any of the cases. Length of stay was similar (1 day). CONCLUSIONS: Intraprocedural post-TAVI ECHO appears as safe as next day pre-discharge ECHO and obviates the need for a routine next day study, thereby reducing burden on echocardiography services and allows better utilisation of resources.

Isoprenaline induced myocardial infarction in a patient with high-grade atrioventricular block: a case report.

Background: Isoprenaline is widely used in the treatment of symptomatic bradycardia. Myocardial infarction precipitated by the therapeutic use of isoprenaline has not been reported in the literature. Case summary: We describe the case of a 67-year-old male patient who presented to our institution with symptomatic Mobitz type II 2:1 atrioventricular block. He had a several-month history of unexplained syncope. He had several cardiovascular risk factors but did not have a diagnosis of coronary artery disease. On admission, he was symptomatic with dizziness but had no chest pain. High-sensitivity troponin I was normal. After initiation of an isoprenaline infusion, he developed cardiac-sounding chest pain and an ischaemic electrocardiogram. Emergency coronary angiography was performed that demonstrated a severe mid-vessel stenosis in his right coronary artery that was treated with percutaneous coronary intervention and the deployment of one drug-eluting stent. He remained in Mobitz type II 2:1 atrioventricular block 48 hours after the procedure, and a dual-chamber permanent pacemaker was implanted. He was discharged in a stable condition with no further chest pain or bradyarrhythmia. Discussion: To our knowledge, this is the first reported case of myocardial infarction precipitated by the therapeutic use of isoprenaline. Our hypothesis is that isoprenaline increased myocardial oxygen demand and induced a type 2 myocardial infarction in this patient with occult coronary artery disease. Isoprenaline should be used with caution in patients with confirmed or suspected coronary artery disease.

Characteristics and Outcomes of Patients Who Underwent Coronary Atherectomy in Centers With and Without On-Site Cardiac Surgery.

We aimed to describe the clinical characteristics and outcomes of patients who underwent atherectomy at the time of percutaneous coronary intervention in centers with on-site surgical centers (SCs) versus nonsurgical centers (NSCs). Patients treated with coronary atherectomy between January 1, 2006, to December 31, 2019, from the British Cardiovascular Society Intervention (BCIS) registry were included. Primary outcomes were in-hospital all-cause mortality and major adverse cardiovascular and cerebrovascular events. A total of 20,833 patients were treated with coronary atherectomy, of which 7,983 (38%) were performed at NSC. The proportion of coronary atherectomies performed in NSC increased from 12.5% in 2006 to 42% in 2019. Compared with patients treated at SC, patients treated in NSC were older (mean age 75.1 ± SD years vs 74.2 ± SD, p <0.001), but had comparable prevalence of hypertension (NSC 73.9% vs SC 72.8%, p = 0.085), diabetes mellitus (NSC 32.2% vs SC 31.6%, p = 0.43) and renal disease (NSC 6.0% vs SC 6.0%, p = 0.99). Intracoronary imaging was used more often in NSC than SC (22.3% vs 19.4%, p <0.001). After adjustment, the odds of in-hospital mortality (odds ratios [OR] 0.76, 95% confidence intervals [CI] 0.50 to 1.16), major adverse cardiovascular and cerebrovascular events (OR 0.80, 95% CI 0.53 to 1.21), emergency coronary artery bypass graft (OR 0.49, 95% CI 0.15 to 1.57), major bleeding (OR 0.67, 95% CI 0.36 to 1.24) and coronary perforation (OR 1.07, 95% CI 0.97 to 1.43) in NSC were comparable with SC. In conclusion, coronary atherectomy in hospitals with off-site surgical cover has become more frequent, with no association with poorer outcomes, compared with hospitals with on-site surgical cover.

Improved prognosis after cardiac resynchronization therapy over a decade.

AIMS: The past decade has seen an increased delivery of cardiac resynchronization therapy (CRT) for patients with heart failure (HF). We explored whether clinical outcomes after CRT have changed from the perspective of an entire public healthcare system. METHODS AND RESULTS: A national database covering the population of England (56.3 million in 2019) was used to explore clinical outcomes after CRT from 2010 to 2019. A total of 64 698 consecutive patients (age 71.4 ± 11.7 years; 74.8% male) underwent CRT-defibrillation [n = 32 313 (49.7%)] or CRT-pacing [n = 32 655 (50.3%)] implantation. From 2010-2011 to 2018-2019, there was a 76% increase in CRT implantations. During the same period, the proportion of patients with hypertension (59.6-73.4%), diabetes (26.5-30.8%), and chronic kidney disease (8.62-22.5%) increased, as did the Charlson comorbidity index (CCI ≥ 3 from 20.0% to 25.1%) (all P < 0.001). Total mortality decreased at 30 days (1.43-1.09%) and 1 year (9.51-8.13%) after implantation (both P < 0.001). At 2 years, total mortality [hazard ratio (HR): 0.72; 95% confidence interval (CI) 0.69-0.76] and total mortality or HF hospitalization (HR: 0.59; 95% CI 0.57-0.62) decreased from 2010-2011 to 2018-2019, after correction for age, race, sex, device type (CRT-defibrillation or pacing), comorbidities (hypertension, diabetes, chronic kidney disease, and myocardial infarction), or the CCI (HR: 0.81; 95% CI 0.77-0.85). CONCLUSIONS: From the perspective of an entire public health system, survival has improved and HF hospitalizations have decreased after CRT implantation over the past decade. This prognostic improvement has occurred despite an increasing comorbidity burden.

Intracoronary imaging in PCI for acute coronary syndrome: Insights from British Cardiovascular Intervention Society registry.

BACKGROUND: While previous studies have demonstrated the superiority of ICI-guided PCI over an angiography-based approach, there are limited data on all-comer ACS patients. This study aimed to identify the characteristics and in-hospital outcomes of patients undergoing intracoronary imaging (ICI) guided percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). METHODS: All patient undergoing PCI for ACS in England and Wales between 2006 and 2019 were retrospectively analyzed and stratified according to ICI utilization. The outcomes assessed were in-hospital all-cause mortality and major adverse cardiovascular and cerebrovascular events (MACCE) using multivariable logistic regression models. RESULTS: 598,921 patients underwent PCI for ACS, of which 41,716 (7.0 %) had ICI which was predominantly driven by IVUS use (5.6 %). ICI use steadily increased from 1.4 % in 2006 to 13.5 % in 2019. Adjusted odds of mortality (OR 0.69, 95%CI 0.58-0.83) and MACCE (OR 0.77, 95%CI 0.73-0.83) were significantly lower in the ICI group. The association between ICI and improved outcomes varied according to vessel treated with both left main stem (LMS) and LMS/left anterior descending (LAD) PCI associated with significantly lower odds of mortality (OR 0.34, 95%CI 0.27-0.44, OR 0.51 95%CI 0.45-0.56) and MACCE (OR 0.44 95%CI 0.35-0.54, OR 0.67 95%CI 0.62-0.72) respectively. CONCLUSIONS: Although ICI use has steadily increased, less than one in seven patients underwent ICI-guided PCI. The association between ICI use and improved in-hospital outcomes was mainly observed in PCI procedures involving LMS and LAD.

Timing of cardiac resynchronization therapy implantation.

AIMS: The optimum timing of cardiac resynchronization therapy (CRT) implantation is unknown. We explored long-term outcomes after CRT in relation to the time interval from a first heart failure hospitalization (HFH) to device implantation. METHODS AND RESULTS: A database covering the population of England (56.3 million in 2019) was used to quantify clinical outcomes after CRT implantation in relation to first HFHs. From 2010 to 2019, 64 968 patients [age: 71.4 ± 11.7 years; 48 606 (74.8%) male] underwent CRT implantation, 57% in the absence of a previous HFH, 12.9% during the first HFH, and 30.1% after ≥1 HFH. Over 4.54 (2.80-6.71) years [median (interquartile range); 272 989 person-years], the time in years from the first HFH to CRT implantation was associated with a higher risk of total mortality [hazard ratio (HR); 95% confidence intervals (95% CI)] (1.15; 95% CI 1.14-1.16, HFH (HR: 1.26; 95% CI 1.24-1.28), and the combined endpoint of total mortality or HFH (HR: 1.19; 95% CI 1.27-1.20) than CRT in patients with no previous HFHs, after co-variate adjustment. Total mortality (HR: 1.67), HFH (HR: 2.63), and total mortality or HFH (HR: 1.92) (all P < 0.001) were highest in patients undergoing CRT ≥2 years after the first HFH. CONCLUSION: In this study of a healthcare system covering an entire nation, delays from a first HFH to CRT implantation were associated with progressively worse long-term clinical outcomes. The best clinical outcomes were observed in patients with no previous HFH and in those undergoing CRT implantation during the first HFH. CONDENSED ABSTRACT: The optimum timing of CRT implantation is unknown. In this study of 64 968 consecutive patients, delays from a first heart failure hospitalization (HFH) to CRT implantation were associated with progressively worse long-term clinical outcomes. Each year from a first HFH to CRT implantation was associated with a 21% higher risk of total mortality and a 34% higher risk of HFH. The best outcomes after CRT were observed in patients with no previous HFHs and in those undergoing implantation during their first HFH.

Presentation, care, and outcomes of patients with NSTEMI according to World Bank country income classification: the ACVC-EAPCI EORP NSTEMI Registry of the European Society of Cardiology.

BACKGROUND: The majority of NSTEMI burden resides outside high-income countries (HICs). We describe presentation, care, and outcomes of NSTEMI by country income classification. METHODS AND RESULTS: Prospective cohort study including 2947 patients with NSTEMI from 287 centres in 59 countries, stratified by World Bank country income classification. Quality of care was evaluated based on 12 guideline-recommended care interventions. The all-or-none scoring composite performance measure was used to define receipt of optimal care. Outcomes included in-hospital acute heart failure, stroke/transient ischaemic attack, and death, and 30-day mortality. Patients admitted with NSTEMI in low to lower-middle-income countries (LLMICs), compared with patients in HICs, were younger, more commonly diabetic, and current smokers, but with a lower burden of other comorbidities, and 76.7% met very high risk criteria for an immediate invasive strategy. Invasive coronary angiography use increased with ascending income classification (LLMICs, 79.2%; upper middle income countries [UMICs], 83.7%; HICs, 91.0%), but overall care quality did not (≥80% of eligible interventions achieved: LLMICS, 64.8%; UMICs 69.6%; HICs 55.1%). Rates of acute heart failure (LLMICS, 21.3%; UMICs, 12.1%; HICs, 6.8%; P < 0.001), stroke/transient ischaemic attack (LLMICS: 2.5%; UMICs: 1.5%; HICs: 0.9%; P = 0.04), in-hospital mortality (LLMICS, 3.6%; UMICs: 2.8%; HICs: 1.0%; P < 0.001) and 30-day mortality (LLMICs, 4.9%; UMICs, 3.9%; HICs, 1.5%; P < 0.001) exhibited an inverse economic gradient. CONCLUSION: Patients with NSTEMI in LLMICs present with fewer comorbidities but a more advanced stage of acute disease, and have worse outcomes compared with HICs. A cardiovascular health narrative is needed to address this inequity across economic boundaries.

Temporal Trends in In-Hospital Outcomes Following Unprotected Left-Main Percutaneous Coronary Intervention: An Analysis of 14 522 Cases From British Cardiovascular Intervention Society Database 2009 to 2017.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used as a treatment option for unprotected left main stem artery (unprotected left main stem percutaneous intervention) disease. However, whether patient outcomes have improved over time is uncertain. METHODS: Using the United Kingdom national PCI database, we studied all patients undergoing unprotected left main stem percutaneous intervention between 2009 and 2017. We excluded patients who presented with ST-segment-elevation, cardiogenic shock, and with an emergency indication for PCI. RESULTS: Between 2009 and 2017, in the study-indicated population, 14 522 unprotected left main stem percutaneous intervention procedures were performed. Significant temporal changes in baseline demographics were observed with increasing patient age and comorbid burden. Procedural complexity increased over time, with the number of vessels treated, bifurcation PCI, number of stents used, and use of intravascular imaging and rotational atherectomy increased significantly through the study period. After adjustment for baseline differences, there were significant temporal reductions in the occurrence of peri-procedural myocardial infarction (P<0.001 for trend), in-hospital major adverse cardiac or cerebrovascular events (P<0.001 for trend), and acute procedural complications (P<0.001 for trend). In multivariable analysis examining the associates of in-hospital major adverse cardiac or cerebrovascular events, while age per year (odds ratio, 1.02 [95% CIs, 1.01-1.03]), female sex (odds ratio, 1.47 [1.19-1.82]), 3 or more stents (odds ratio, 1.67 [05% [1.02-2.67]), and patient comorbidity were associated with higher rates of in-hospital major adverse cardiac or cerebrovascular events, by contrast use of intravascular imaging (odds ratio, 0.56 [0.45-0.70]), and year of PCI (odds ratio, 0.63 [0.46-0.87]) were associated with lower rates of in-hospital major adverse cardiac or cerebrovascular events. CONCLUSIONS: Despite trends for increased patient and procedural complexity, in-hospital patient outcomes have improved after unprotected left main stem percutaneous intervention over time.

Outlier identification and monitoring of institutional or clinician performance: an overview of statistical methods and application to national audit data.

BACKGROUND: Institutions or clinicians (units) are often compared according to a performance indicator such as in-hospital mortality. Several approaches have been proposed for the detection of outlying units, whose performance deviates from the overall performance. METHODS: We provide an overview of three approaches commonly used to monitor institutional performances for outlier detection. These are the common-mean model, the 'Normal-Poisson' random effects model and the 'Logistic' random effects model. For the latter we also propose a visualisation technique. The common-mean model assumes that the underlying true performance of all units is equal and that any observed variation between units is due to chance. Even after applying case-mix adjustment, this assumption is often violated due to overdispersion and a post-hoc correction may need to be applied. The random effects models relax this assumption and explicitly allow the true performance to differ between units, thus offering a more flexible approach. We discuss the strengths and weaknesses of each approach and illustrate their application using audit data from England and Wales on Adult Cardiac Surgery (ACS) and Percutaneous Coronary Intervention (PCI). RESULTS: In general, the overdispersion-corrected common-mean model and the random effects approaches produced similar p-values for the detection of outliers. For the ACS dataset (41 hospitals) three outliers were identified in total but only one was identified by all methods above. For the PCI dataset (88 hospitals), seven outliers were identified in total but only two were identified by all methods. The common-mean model uncorrected for overdispersion produced several more outliers. The reason for observing similar p-values for all three approaches could be attributed to the fact that the between-hospital variance was relatively small in both datasets, resulting only in a mild violation of the common-mean assumption; in this situation, the overdispersion correction worked well. CONCLUSION: If the common-mean assumption is likely to hold, all three methods are appropriate to use for outlier detection and their results should be similar. Random effect methods may be the preferred approach when the common-mean assumption is likely to be violated.

Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial.

Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis. Cerebral embolic protection (CEP) devices may impact periprocedural stroke by capturing debris destined for the brain. However, there is a lack of high-quality randomised trial evidence supporting the use of CEP during TAVI. The British Heart Foundation (BHF) PROTECT-TAVI trial will address whether the routine use of CEP reduces the incidence of stroke in patients undergoing TAVI. BHF PROTECT-TAVI is a prospective, open-label, outcome-adjudicated, multicentre randomised controlled trial. The trial is open to all adult patients scheduled for TAVI at participating specialist cardiac centres across the United Kingdom who are able to receive the CEP device. The trial will recruit 7,730 participants. Participants will be randomised in a 1:1 ratio to undergo TAVI with CEP or TAVI without CEP (standard of care). The primary outcome is the incidence of stroke at 72 hours post-TAVI. Key secondary outcomes include the incidence of stroke and all-cause mortality up to 12 months post-TAVI, disability and cognitive outcomes, stroke severity, access site complications and a health economics analysis. The sample size of 7,730 participants has 80% power to detect a 33% relative risk reduction from a 3% incidence of the primary outcome in the controls. Trial recruitment commenced in October 2020. As of October 2022, 3,068 patients have been enrolled. BHF PROTECT-TAVI is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine CEP with the SENTINEL device to reduce stroke in TAVI.

Sex Differences in Clinical Profile and Outcome After Percutaneous Coronary Intervention for Chronic Total Occlusion.

BACKGROUND: There are limited data around sex differences in the risk profile, treatments and outcomes of percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) lesions in contemporary interventional practice. We investigated the impact of sex on clinical and procedural characteristics, complications and clinical outcomes in a national cohort. METHODS & RESULTS: We created a longitudinal cohort (2006-2018, n = 30,605) of patients with stable angina who underwent CTO PCI in the British Cardiovascular Intervention Society (BCIS) database. Clinical, demographic, procedural and outcome data were analysed in two groups stratified by sex: male (n = 24,651), female (n = 5954). Female patients were older (68 vs 64 years, P < 0.001), had higher prevalence of diabetes mellitus (DM), hypertension (HTN) and prior stroke. Utilization of intravascular ultrasound (IVUS), drug eluting stents (DES), radial or dual access and enabling strategies during CTO PCI were higher in male compared to female patients. Following multivariable analysis, there was no significant difference in in-patient mortality (adjusted odds ratio (OR):1.40, 95 % CI: 0.75-2.61, P = 0.29) and major cardiovascular and cerebrovascular events (MACCE) (adjusted OR: 1.01, 95 % CI: 0.78-1.29, P = 0.96). The crude and adjusted rates of procedural complications (adjusted OR: 1.37, 95 % CI: 1.23-1.52, P < 0.001), coronary artery perforation (adjusted OR: 1.60, 95 % CI: 1.26-2.04, P < 0.001) and major bleeding (adjusted OR: 2.06, 95 % CI: 1.62-2.61, P < 0.001) were higher in women compared with men. CONCLUSION: Female patients treated by CTO PCI were older, underwent lesser complex procedures, but had higher adjusted risk of procedural complications with a similar adjusted risk of mortality and MACCE compared with male patients.

Care of patients with ST-elevation myocardial infarction: an international analysis of quality indicators in the acute coronary syndrome STEMI Registry of the EURObservational Research Programme and ACVC and EAPCI Associations of the European Society of Cardiology in 11 462 patients.

AIMS: To use quality indicators to study the management of ST-segment elevation myocardial infarction (STEMI) in different regions. METHODS AND RESULTS: Prospective cohort study of STEMI within 24 h of symptom onset (11 462 patients, 196 centres, 26 European Society of Cardiology members, and 3 affiliated countries). The median delay between arrival at a percutaneous cardiovascular intervention (PCI) centre and primary PCI was 40 min (interquartile range 20-74) with 65.8% receiving PCI within guideline recommendation of 60 min. A third of patients (33.2%) required transfer from their initial hospital to one that could perform emergency PCI for whom only 27.2% were treated within the quality indicator recommendation of 120 min. Radial access was used in 56.6% of all primary PCI, but with large geographic variation, from 76.4 to 9.1%. Statins were prescribed at discharge to 98.7% of patients, with little geographic variation. Of patients with a history of heart failure or a documented left ventricular ejection fraction ≤40%, 84.0% were discharged on an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and 88.7% were discharged on beta-blockers. CONCLUSION: Care for STEMI shows wide geographic variation in the receipt of timely primary PCI, and is in contrast with the more uniform delivery of guideline-recommended pharmacotherapies at time of hospital discharge.

Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart).

AIMS: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform. CONCLUSION: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies. ONE-SENTENCE SUMMARY: The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI.

Cohort profile: the ESC EURObservational Research Programme Non-ST-segment elevation myocardial infraction (NSTEMI) Registry.

AIMS: The European Society of Cardiology (ESC) EURObservational Research Programme (EORP) Non-ST-segment elevation myocardial infarction (NSTEMI) Registry aims to identify international patterns in NSTEMI management in clinical practice and outcomes against the 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without ST-segment-elevation. METHODS AND RESULTS: Consecutively hospitalised adult NSTEMI patients (n = 3620) were enrolled between 11 March 2019 and 6 March 2021, and individual patient data prospectively collected at 287 centres in 59 participating countries during a two-week enrolment period per centre. The registry collected data relating to baseline characteristics, major outcomes (in-hospital death, acute heart failure, cardiogenic shock, bleeding, stroke/transient ischaemic attack, and 30-day mortality) and guideline-recommended NSTEMI care interventions: electrocardiogram pre- or in-hospital, pre-hospitalization receipt of aspirin, echocardiography, coronary angiography, referral to cardiac rehabilitation, smoking cessation advice, dietary advice, and prescription on discharge of aspirin, P2Y12 inhibition, angiotensin converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB), beta-blocker, and statin. CONCLUSION: The EORP NSTEMI Registry is an international, prospective registry of care and outcomes of patients treated for NSTEMI, which will provide unique insights into the contemporary management of hospitalised NSTEMI patients, compliance with ESC 2015 NSTEMI Guidelines, and identify potential barriers to optimal management of this common clinical presentation associated with significant morbidity and mortality.