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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 . . .

The aim of this study was to define the incidence of left ventricular thrombus (LVT) and its predictors in the contemporary era of primary percutaneous intervention (pPCI) and contrast echocardiography. We retrospectively analyzed 1,059 patients presenting with ST-elevation myocardial infarction (STEMI) to our tertiary cardiac center and treated with pPCI. Preprocedural pharmacology and procedural technique (including access route, the use of drug-eluting stents, and thrombectomy) were at the operators' discretion. Transthoracic echocardiography was performed before discharge; echo contrast agent was used when appropriate. LVT was detected in 42 subjects (4%). There were no significant differences in baseline demographics or pre-PCI clinical features between the 2 groups. Post-treatment, mean ejection fraction (EF) in patients with LVT was 35 ± 8.4% and in those without LVT was 47 ± 10%, p <0.001. Thirty-seven patients (88%) in the LVT group presented with an anterior STEMI versus 471 patients (42%) in the without LVT group (p <0.001). Apical akinesis was noted in all patients with LVT irrespective of the principal location of the MI. Multivariate analysis predictors of LVT were reduced EF, anterior site of MI, and the use of platelet glycoprotein IIb/IIIa inhibitors. After diagnosis of LVT, patients were treated with warfarin for 3 to 6 months. No significant difference in mortality was detectable at discharge between the 2 groups. In conclusion, in the contemporary era of pPCI, the incidence of LVT in patients with STEMI is significantly lower than that of the previous (thrombolysis) literature. The early presence of LVT is more likely in patients with anterior STEMI (involving the apex) and reduced EF.

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.

No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions. Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months. The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group. A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.

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.

Transcatheter aortic valve implantation (TAVI) is a proven treatment for life-threatening aortic valve disease, predominantly severe aortic stenosis. However, even among developed nations, access to TAVI is not uniform. The Valve for Life initiative was launched by the European Association of Percutaneous Cardiovascular Interventions in 2015 with the objective of improving access to transcatheter valve interventions across Europe. The UK has been identified as a country with low penetration of these procedures and has been selected as the fourth nation to be included in the initiative. Specifically, the number of TAVI procedures carried out in the UK is significantly lower than almost all other European nations. Furthermore, there is substantial geographical inequity in access to TAVI within the UK. As a consequence of this underprovision, waiting times for TAVI are long, and mortality among those waiting intervention is significant. This article reviews these issues, reports new data on access to TAVI in the UK and presents the proposals of the UK Valve for Life team to address the current problems in association with the British Cardiovascular Intervention Society.