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In the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) study, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) improved outcome compared with angiography-guided PCI for up to 2 years of follow-up. The aim in this study was to investigate whether the favourable clinical outcome with the FFR-guided PCI in the FAME study persisted over a 5-year follow-up. The FAME study was a multicentre trial done in Belgium, Denmark, Germany, the Netherlands, Sweden, the UK, and the USA. Patients (aged ≥18 years) with multivessel coronary artery disease were randomly assigned to undergo angiography-guided PCI or FFR-guided PCI. Before randomisation, stenoses requiring PCI were identified on the angiogram. Patients allocated to angiography-guided PCI had revascularisation of all identified stenoses. Patients allocated to FFR-guided PCI had FFR measurements of all stenotic arteries and PCI was done only if FFR was 0·80 or less. No one was masked to treatment assignment. The primary endpoint was major adverse cardiac events at 1 year, and the data for the 5-year follow-up are reported here. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00267774. After 5 years, major adverse cardiac events occurred in 31% of patients (154 of 496) in the angiography-guided group versus 28% (143 of 509 patients) in the FFR-guided group (relative risk 0·91, 95% CI 0·75–1·10; p=0·31). The number of stents placed per patient was significantly higher in the angiography-guided group than in the FFR-guided group (mean 2·7 [SD 1·2] vs 1·9 [1·3], p<0·0001). The results confirm the long-term safety of FFR-guided PCI in patients with multivessel disease. A strategy of FFR-guided PCI resulted in a significant decrease of major adverse cardiac events for up to 2 years after the index procedure. From 2 years to 5 years, the risks for both groups developed similarly. This clinical outcome in the FFR-guided group was achieved with a lower number of stented arteries and less resource use. These results indicate that FFR guidance of multivessel PCI should be the standard of care in most patients. St Jude Medical, Friends of the Heart Foundation, and Medtronic.

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.

Fractional flow reserve (FFR) is a measure of the functional significance of a coronary stenosis. In this study, the use of FFR, as compared with angiography alone, in guiding the placement of coronary stents resulted in the use of fewer stents and better clinical outcomes. The use of fractional flow reserve, as compared with coronary angiography alone, in guiding the placement of coronary stents resulted in the use of fewer stents and better clinical outcomes. The presence of myocardial ischemia is an important risk factor for an adverse clinical outcome. 1 – 3 Revascularization of stenotic coronary lesions that induce ischemia can improve a patient's functional status and outcome. 3 – 5 For stenotic lesions that do not induce ischemia, however, the benefit of revascularization is less clear, and medical therapy alone is likely to be equally effective. 6 , 7 With the introduction of drug-eluting stents, the percentage of patients with multivessel coronary artery disease in whom percutaneous coronary intervention (PCI) is performed has increased. 8 , 9 Because drug-eluting stents are expensive and are associated with potential late complications, their appropriate . . .

Background: Lower socioeconomic status (SES) has been associated with increased mortality from coronary heart disease. This excess risk, relative to affluent patients, may be due to a combination of more adverse cardiovascular-risk factors, inequalities in access to cardiac investigations, longer waiting times for cardiac revascularisation and lower use of secondary prevention drugs. We sought to investigate whether socio-economic status influenced long-term all-cause mortality after PCI in a large metropolitan city (London), which serves a population of 11 million people with a mixed social background over a 10-year period. Methods: We conducted an observational cohort study of 123,780 consecutive PCI procedures from the Pan-London (United Kingdom) PCI registry. This data set is collected prospectively and includes all patients treated between January 2005 and December 2015. The database includes PCI performed for stable angina and ACS (ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina). Patient socio-economic status was defined by the English Index of Multiple Deprivation (IMD) score, according to residential postcode. Patients were analysed by quintile of IMD score (Q1, least deprived; Q5, most deprived). Median follow-up was 3.7 (IQR: 2.0–5.1) years and the primary outcome was all-cause mortality. Results: The mean age of the patients was 64.3 ± 12.1 years and 25.2% were female. A total of 22.4% of patients were diabetic and 27.3% had a history of previous myocardial infarction. The rates of long-term all-cause mortality increased progressively across quintiles of IMD score, with patients in Q5 showing significantly higher long-term mortality rates compared with patients in Q1 (p = 0.0044). This persisted following the inclusion of a propensity score in the proportional hazard model as a covariate (HR for Q5 compared to Q1: 1.15 [95% CI: 1.10–1.42]). Conclusions: This study has demonstrated that low SES is an independent predictor of adverse clinical outcomes following PCI in the large, diverse metropolitan city of London. There clearly are inequalities in cardio-vascular risk factors, time to access to medical treatment/PCI, access to complex imaging and devices during PCI, access to secondary prevention after PCI, and even race differences. Hence, attention to reducing the burden of cardiovascular risk factors and improving primary prevention, particularly in patients with lower SES, is required.

ST2 is a circulating biomarker that is well established for predicting outcome in heart failure (HF). This is the first study to look at ST2 concentrations in optimally treated patients with stable but significant left ventricular systolic dysfunction (LVSD) compared to patients with severe aortic stenosis (AS). Two cohorts were retrospectively studied: 94 patients undergoing transcatheter aortic valve implantation for severe AS (63 with normal ejection fraction [EF] and 31 with reduced EF), and 50 patients with severe LVSD from non-valvular causes. ST2 pre-procedural samples were taken, and repeated again at 3 and 6 months. Patients were followed-up for 2 years. Data was analyzed using SPSS software. Baseline concentrations of soluble ST2 did not differ significantly between the HF group and AS group with normal EF (EF ≥ 50%). However, in the AS group with a low EF (EF < 50%) ST2 concentrations were significantly higher that the HF group (p = 0.009). New York Heart Association class IV HF, baseline N-terminal pro-B-type natriuretic peptide and gender were all independent predictors of soluble ST2 (sST2) baseline concentrations. Raised ST2 concentrations in the context of severe AS may be a marker for subclinical or clinical left ventricular dysfunction. More research is required to assess its use for assessment of prognosis and response to treatment.

ObjectiveTo define the incidence and risk factors for infective endocarditis (IE) following surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI).MethodsAll patients who underwent first SAVR or TAVI in England between 2007 and 2016 were identified from the NICOR databases. Hospital admissions with a primary diagnosis of IE were identified by linkage with the NHS Hospital Episode Statistics database. Approval was obtained from the NHS Research Ethics Committee.Results2057 of 91 962 patients undergoing SAVR developed IE over a median follow-up of 53.9 months—an overall incidence of 4.81 [95% CI 4.61 to 5.03] per 1000 person-years. Correspondingly, 140 of 14 195 patients undergoing TAVI developed IE over a median follow-up of 24.5 months—an overall incidence of 3.57 [95% CI 3.00 to 4.21] per 1000 person-years. The cumulative incidence of IE at 60 months was higher after SAVR than after TAVI (2.4% [95% CI 2.3 to 2.5] vs 1.5% [95% CI 1.3 to 1.8], HR 1.60, p<0.001). Across the entire cohort, SAVR remained an independent predictor of IE after multivariable adjustment. Risk factors for IE included younger age, male sex, atrial fibrillation, and dialysis.ConclusionsIE is a rare complication of SAVR and TAVI. In our population, the incidence of IE was higher after SAVR than after TAVI.

BackgroundCurrent risk scores inadequately predict long-term mortality after transcatheter aortic valve replacement (TAVR), limiting their ability to guide decisions around procedural futility. We aimed to develop and externally validate a machine learning (ML) model using only preprocedural variables to predict 1-year all-cause mortality.MethodsAn ML model was trained on a retrospective cohort of 1025 TAVR patients using 52 clinical and echocardiographic variables. Feature selection and model tuning were performed via a multiobjective evolutionary algorithm to optimise predictive performance and model simplicity. The final model used 13 preprocedural variables and was externally validated in an independent cohort of 270 patients. Performance was compared with European System for Cardiac Operative Risk Evaluation II (EuroSCORE II), FRANCE-2 and TAVI2-SCORE using the area under the curve (AUC), calibration and net reclassification improvement (NRI).ResultsThe ML model demonstrated excellent discrimination, with AUCs of 0.81 in the discovery cohort and 0.84 in the external validation cohort. This exceeded the performance of EuroSCORE II (AUC: 0.61 and 0.70), FRANCE-2 (0.52 and 0.58) and TAVI2-SCORE (0.56 and 0.64). Calibration plots showed strong agreement between predicted and observed risks. NRI in the test set compared with FRANCE-2 was 0.62 (95% CI: 0.49 to 0.75); compared with TAVI2-SCORE, it was 0.36 (95% CI: 0.14 to 0.61). The final model incorporated age, atrial fibrillation, creatinine, haemoglobin, pulmonary function, frailty markers (Katz Index, poor mobility) and tricuspid regurgitation. Misclassification analysis revealed that most errors were clustered near the decision threshold, with no evidence of systematic bias. Performance was consistent across subgroups and robust to temporal and institutional variation.ConclusionThis externally validated ML model, using 13 routinely available variables, significantly outperforms existing risk scores in predicting 1-year mortality post-TAVR. Its simplicity and generalisability support its potential use in real-world clinical decision-making to identify patients at high risk of procedural futility.

ObjectivePerforming transfemoral transcatheter aortic valve implantation (TAVI) without general anaesthesia (GA) has been increasingly adopted. We sought to study the impact of GA and non-GA approaches on procedural outcome and 30-day and 1-year mortality in transfemoral TAVI.MethodsThe UK TAVI registry holds information for every TAVI procedure in the UK. We analysed the data for patients implanted during 2013–2014 using either an Edwards Sapien or a Medtronic CoreValve prosthesis. Propensity score-matching analysis was performed to adjust for confounding factors.Results2243 patients were studied (aged 81.4±7.5 years, 1195 males). 1816 (81%) underwent TAVI with GA and 427 (19%) without GA. Transoesophageal echocardiography (TOE) was used in 92.3% of GA and 12.4% of non-GA cases (p<0.001). There was no significant difference in the rate of successful valve deployment (GA 97.2% vs non-GA 95.7%, p=0.104) and in the incidence of more than mild aortic regurgitation (AR) at the end of the procedure (GA 5.6% vs non-GA 7.0%, p=0.295). However, procedure time was longer (131±60 vs 121±60mins, p=0.002) and length of stay was greater (8.0±13.5 vs 5.7±5.5 days, p<0.001) for GA cases. 30-day and 1-year mortality rates did not differ between the GA and non-GA cases. After propensity matching, these results remained unchanged. A second propensity analysis (adjusted for mode of anaesthesia) did not show an association between use of TOE and rate of successful valve deployment or frequency of significant AR. Neither was TOE associated with a longer procedural time or greater length of stay.ConclusionProcedure outcome, and 30-day and 1-year mortality are not influenced by mode of anaesthesia. However, GA is associated with longer procedure duration and greater length of stay.

ObjectiveDespite improvements in its management, infective endocarditis (IE) is associated with poor survival. The aim of this study was to evaluate the impact of a multidisciplinary endocarditis team (ET), including a cardiologist, microbiologist and a cardiac surgeon, on the outcome of patients with acute IE according to medical or surgical treatment strategies.MethodsWe conducted an observational before-and-after study of 196 consecutive patients with definite IE, who were treated at a tertiary reference centre between 2009 and 2015. The study was divided into two periods: period 1, before the formation of the ET (n=101), and period 2, after the formation of the ET (n=95). The role of the ET included regular multidisciplinary team meetings to confirm diagnosis, inform the type and duration of antibiotic therapy and recommend early surgery, when indicated, according to European guidelines.ResultsThe patient demographics and predisposing conditions for IE were comparable between the two study periods. In the time period following the introduction of the ET, there was a reduction in both the time to commencement of IE-specific antibiotic therapy (4.0±4.0 days vs 2.5±3.2 days; P=0.004) and the time from suspected IE to surgery (7.8±7.3 days vs 5.3±4.2 days; P=0.004). A 12-month Kaplan-Meier survival for patients managed medically was 42.9% in the pre-ET period and 66.7% in the post-ET period (P=0.03). The involvement of the ET was a significant independent predictor of 1-year survival in patients managed medically (HR 0.24, 95% CI 0.07 to 0.87; P=0.03).ConclusionsA standardised multidisciplinary team approach may lead to earlier diagnosis of IE, more appropriate individualised management strategies, expedited surgery, where indicated, and improved survival in those patients chosen for medical management, supporting the recent change in guidelines to recommend the use of a multidisciplinary team in the care of patients with IE.

During the current SARS-CoV-2 pandemic the restructure of healthcare services to meet the huge increase in demand for hospital resource and capacity has led to the proposal that where necessary ST elevation myocardial infarction (STEMI) could be managed by intravenous thrombolysis in the first instance as a means of reducing the workforce requirements of a primary angioplasty service run at a heart attack centre. Our modelling, based on data from the UK, shows that contrary to reducing demand, the effect on both mortality and bed occupancy would be negative with 158 additional deaths per year for each 10% reduction in primary angioplasty and at a cost of ~8,000 additional bed days per year for the same reduction. Our analysis demonstrates that specialist services such as heart attack pathways should be protected during the COVID crisis to maximise the appropriate use of resource and prevent unnecessary mortality.