Long-term durability of self-expanding and balloon-expandable transcatheter aortic valve prostheses: UK TAVI registry.

BACKGROUND: With expansion of transcatheter aortic valve implantation (TAVI) into younger patients, valve durability is critically important. AIMS: We aimed to evaluate long-term valve function and incidence of severe structural valve deterioration (SVD) among patients ≥ 10-years post-TAVI and with echocardiographic follow-up at least 5-years postprocedure. METHODS: Data on patients who underwent TAVI from 2007 to 2011 were obtained from the UK TAVI registry. Patients with paired echocardiograms postprocedure and ≥5-years post-TAVI were included. Severe SVD was determined according to European task force guidelines. RESULTS: 221 patients (79.4 ± 7.3 years; 53% male) were included with median echocardiographic follow-up 7.0 years (range 5-13 years). Follow-up exceeded 10 years in 43 patients (19.5%). Valve types were the supra-annular self-expanding CoreValve (SEV; n = 143, 67%), balloon-expandable SAPIEN/XT (BEV; n = 67, 31%), Portico (n = 4, 5%) and unknown (n = 7, 3%). There was no difference between postprocedure and follow-up peak gradient in the overall cohort (19.3 vs. 18.4 mmHg; p = NS) or in those with ≥10-years follow-up (21.1 vs. 21.1 mmHg; p = NS). Severe SVD occurred in 13 patients (5.9%; median 7.8-years post-TAVI). Three cases (23.1%) were due to regurgitation and 10 (76.9%) to stenosis. Valve-related reintervention/death occurred in 5 patients (2.3%). Severe SVD was more frequent with BEV than SEV (11.9% vs. 3.5%; p = 0.02), driven by a difference in patients treated with small valves (BEV 28.6% vs. SEV 3.0%; p < 0.01). CONCLUSIONS: Hemodynamic function of transcatheter heart valves remains stable up to more than 10 years post-TAVI. Severe SVD occurred in 5.9%, and valve-related death/reintervention in 2.3%. Severe SVD was more common with BEV than SEV.

Risk of infective endocarditis after surgical and transcatheter aortic valve replacement.

OBJECTIVE: To define the incidence and risk factors for infective endocarditis (IE) following surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). METHODS: All 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. RESULTS: 2057 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. CONCLUSIONS: IE is a rare complication of SAVR and TAVI. In our population, the incidence of IE was higher after SAVR than after TAVI.

The influence of biological age and sex on long-term outcome after percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: Outcome following ST-segment elevation myocardial infarction (STEMI) is thought to be worse in women than in age-matched men. We assessed whether such differences occur in the UK Pan-London dataset and if age, and particularly menopause, influences upon outcome. METHODS: We undertook an observational cohort study of 26,799 STEMI patients (20,633 men, 6,166 women) between 2005-2015 at 8 centres across London, UK. Patient details were recorded at the time of the procedure into local databases using the British Cardiac Intervention Society (BCIS) PCI dataset. Primary outcome was all-cause mortality at a median follow-up of 4.1 years (IQR: 2.2-5.8 years). RESULTS: Kaplan-Meier analysis demonstrated a higher mortality rate in women versus men (15.6% men vs. 25.3% women, P<0.0001). Univariate Cox analysis revealed that female sex was a predictor of all-cause mortality (HR: 1.69 95% CI: 1.59-1.82). However, after multivariate adjustment, this effect of female sex diminished (HR: 1.05 95% CI: 0.90-1.25). In a sub-group analysis, we compared the sexes separated by age into the ≤55 and the >55 year olds. Age-stratified Cox analysis revealed that female sex was a univariate predictor of all-cause mortality (HR: 1.60 95% CI: 1.25-2.05) in the ≤55 group and in the >55 group (HR: 1.38 95% CI: 1.28-1.47). However, after regression adjustment incorporating the propensity score into a proportional hazard model as a covariate, whilst female sex was not a significant predictor of all-cause mortality in the ≤55 group it was a predictor in the >55 group. Moreover, whilst age did not influence outcome in <55 group, this effect in the >55 group was correlated with age. CONCLUSIONS: Overall women have a worse all-cause mortality following primary PCI for STEMI compared to men. However, this effect was driven predominantly by women >55 years of age since after adjusting for co-morbidities the risk in younger women did not differ significantly from that in men. These observations support the view that as women advance past the menopausal years their risk of further events following revascularization increases substantially and we suggest that routine assessment of hormonal status may improve clinical decision-making and ultimately outcome for women post-PCI.

Impact of Early (≤24 h) Versus Delayed (>24 h) Intervention in Patients With Non-ST Segment Elevation Myocardial Infarction: An Observational Study of 20,882 Patients From the London Heart Attack Group.

INTRODUCTION: We aimed to investigate the optimal timing of invasive coronary angiography and subsequent intervention in non-ST-segment elevation acute myocardial infarction (NSTEMI) patients. METHODS: We examined the impact of early (≤24 h) versus delayed (>24 h) intervention in a large observational cohort of 20,882 consecutive NSTEMI patients treated with PCI between 2005 and 2015 at 8 tertiary cardiac centers in London (UK) using Cox-regression analysis and propensity matching. RESULTS: Mean age was 64.5 ± 12.7 years and 26.1% were females. A quarter (27.6%), were treated within 24 h. Patients treated within 24 h were slightly younger (62.8 ± 12.8 vs. 65.2 ± 12.6, p < 0.001), most commonly male (76% vs. 72.9%, p < 0.001) and were more frequently ventilated (2.3% vs. 1.4%, p < 0.001) and in cardiogenic shock (3.6% vs. 1.4%, p < 0.001) with dynamic changes on their ECG (84.5% vs. 76.1% p < 0.001). At a median follow up of 4.2 years (interquartile range 1.8 to 7) 17.7% of patients had died. Estimated 5-year survival in patients treated within 24 h was 84.6% vs. 81% for those treated >24 h following their presentation (p < 0.001). This survival benefit remained following adjustment for confounders; HR(delayed vs. early management) 1.11 (95%CI 1.003 to 1.23, p = 0.046). In the propensity matched cohort of 4356 patients in each group, there remained a trend for higher survival in the early intervention group (p = 0.061). CONCLUSIONS: Notwithstanding the limitations of the retrospective design, this real-world cohort of NSTEMI patients suggests that an early intervention (≤24 h) may improve mid-term survival.

ST2 in patients with severe aortic stenosis and heart failure.

BACKGROUND: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Predictive model of increased mortality and bed occupancy if thrombolysis becomes the initial treatment strategy for STEMI during the SARS-CoV-2 pandemic.

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.

Prior Coronary Artery Bypass Graft Surgery and Outcome After Percutaneous Coronary Intervention: An Observational Study From the Pan-London Percutaneous Coronary Intervention Registry.

Background Limited information exists regarding procedural success and clinical outcomes in patients with previous coronary artery bypass grafting (CABG) undergoing percutaneous coronary intervention (PCI). We sought to compare outcomes in patients undergoing PCI with or without CABG. Methods and Results This was an observational cohort study of 123 780 consecutive PCI procedures from the Pan-London (UK) PCI registry from 2005 to 2015. The primary end point was all-cause mortality at a median follow-up of 3.0 years (interquartile range, 1.2-4.6 years). A total of 12 641(10.2%) patients had a history of previous CABG, of whom 29.3% (n=3703) underwent PCI to native vessels and 70.7% (n=8938) to bypass grafts. There were significant differences in the demographic, clinical, and procedural characteristics of these groups. The risk of mortality during follow-up was significantly higher in patients with prior CABG (23.2%; P=0.0005) compared with patients with no prior CABG (12.1%) and was seen for patients who underwent either native vessel (20.1%) or bypass graft PCI (24.2%; P<0.0001). However, after adjustment for baseline characteristics, there was no significant difference in outcomes seen between the groups when PCI was performed in native vessels in patients with previous CABG (hazard ratio [HR],1.02; 95%CI, 0.77-1.34; P=0.89), but a significantly higher mortality was seen among patients with PCI to bypass grafts (HR,1.33; 95% CI, 1.03-1.71; P=0.026). This was seen after multivariate adjustment and propensity matching. Conclusions Patients with prior CABG were older with greater comorbidities and more complex procedural characteristics, but after adjustment for these differences, the clinical outcomes were similar to the patients undergoing PCI without prior CABG. In these patients, native-vessel PCI was associated with better outcomes compared with the treatment of vein grafts.

Outcome of inter-hospital transfer versus direct admission for primary percutaneous coronary intervention: An observational study of 25,315 patients with ST-elevation myocardial infarction from the London Heart Attack Group.

BACKGROUND AND AIMS: In patients with ST-segment elevation myocardial infarction (STEMI), mortality is directly related to time to reperfusion with guidelines recommending patients be delivered directly to centres for primary percutaneous coronary intervention (PCI). The aim of this study was to describe the impact of inter-hospital transfer on reperfusion time and to assess whether or not treatment delays influenced clinical outcomes in comparison with direct admission to a primary PCI centre in a large regional network. METHOD AND RESULTS: We undertook an observational cohort study of patients with STEMI treated with primary PCI between 2005 and 2015 in London, UK. Patient details were recorded at the time of the procedure in databases using the British Cardiovascular Intervention Society PCI dataset. The primary end-point was all-cause mortality at a median of 4.1 years (interquartile range: 2.2-5.8 years). Secondary outcomes were in-hospital major adverse cardiac events. Of 25,315 patients, 17,560 (69.4%) were admitted directly to a primary PCI centre and 7755 (31.6%) were transferred from a non-primary PCI centre. Patients in the direct admission group were older and more likely to have left ventricular impairment compared with the inter-hospital transfer group. Median time from call for help to reperfusion in transferred patients was 52 minutes longer compared with patients admitted directly (p <0.001). However, call to first hospital admission was similar. Kaplan-Meier analysis demonstrated significantly lower mortality rates in patients who were transferred directed to a primary PCI centre compared with patients who were transferred from a non-PCI centre (17.4% direct vs. 18.7% transfer, p=0.017). Furthermore, after propensity matching, direct admission for primary PCI was still a predictor of all-cause mortality (hazard ratio: 0.89, 95% confidence interval: 0.64-0.95). CONCLUSIONS: In this large registry of over 25,000 STEMI patients treated by primary PCI survival was better in patients admitted directly to a cardiac centre versus patients transferred for primary PCI, most likely due to longer call to balloon times in patient transferred from other hospitals.

Complete Versus Culprit only Revascularisation in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction: Incidence and Outcomes from the London Heart Attack Group.

BACKGROUND: Despite advances in technology, patients with Cardiogenic Shock (CS) presenting with ST-segment myocardial infarction (STEMI) still have a poor prognosis with high mortality rates. A large proportion of these patients have multi-vessel coronary artery disease, the treatment of which is still unclear. We aimed to assess the trends in management of CS patients with multi-vessel disease (MVD), particularly looking at the incidence and outcomes of complete revascularisation compared to culprit vessel only. METHODS AND RESULTS: We undertook an observational cohort study of 21,210 STEMI patients treated between 2005 and 2015 at the 8 Heart Attack Centres in London, UK. Patients' details were recorded prospectively into local databases using the British Cardiac Intervention Society (BCIS) PCI dataset. 1058 patients presented with CS and MVD. Primary outcome was all-cause mortality. Patients were followed-up for a median of 4.1 years (IQR range: 2.2-5.8 years). 497 (47.0%) patients underwent complete revascularisation during primary PCI for CS with stable rates seen over time. These patients were more likely to be male, hypertensive and more likely to have poor LV function compared to the culprit vessel intervention group. Although crude, in hospital major adverse cardiac events (MACE) rates were similar (40.8% vs. 36.0%, p = 0.558) between the two groups. Kaplan-Meier analysis demonstrated no significant differences in mortality rates between the two groups (53.8% complete revascularisation vs. 46.8% culprit vessel intervention, p = 0.252) during the follow-up period. After multivariate cox analysis (HR 0.69 95% CI (0.44-0.98)) and the use of propensity matching (HR: 0.81 95% CI: 0.62-0.97) complete revascularisation was associated with reduced mortality. A number of co-variates were included in the model, including age, gender, diabetes, hypertension, hypercholesterolaemia, previous PCI, previous MI, chronic renal failure, Anterior infarct, number of treated vessels, pre-procedure TIMI flow, procedural success and GP IIb/IIIA use. CONCLUSION: In a contemporary observational series of CS patients with MVD, complete revascularisation appears to be associated with better outcomes compared to culprit vessel only intervention. This supports on-going clinical trials in this area and provides further evidence of the association of complete revascularisation in STEMI with good outcomes.

The association between the public reporting of individual operator outcomes with patient profiles, procedural management, and mortality after percutaneous coronary intervention: an observational study from the Pan-London PCI (BCIS) Registry using an interrupted time series analysis.

AIMS: The public reporting of healthcare outcomes has a number of potential benefits; however, unintended consequences may limit its effectiveness as a quality improvement process. We aimed to assess whether the introduction of individual operator specific outcome reporting after percutaneous coronary intervention (PCI) in the UK was associated with a change in patient risk factor profiles, procedural management, or 30-day mortality outcomes in a large cohort of consecutive patients. METHODS AND RESULTS: This was an observational cohort study of 123 780 consecutive PCI procedures from the Pan-London (UK) PCI registry, from January 2005 to December 2015. Outcomes were compared pre- (2005-11) and post- (2011-15) public reporting including the use of an interrupted time series analysis. Patients treated after public reporting was introduced were older and had more complex medical problems. Despite this, reported in-hospital major adverse cardiovascular and cerebrovascular events rates were significantly lower after the introduction of public reporting (2.3 vs. 2.7%, P < 0.0001). Interrupted time series analysis demonstrated evidence of a reduction in 30-day mortality rates after the introduction of public reporting, which was over and above the existing trend in mortality before the introduction of public outcome reporting (35% decrease relative risk 0.64, 95% confidence interval 0.55-0.77; P < 0.0001). CONCLUSION: The introduction of public reporting has been associated with an improvement in outcomes after PCI in this data set, without evidence of risk-averse behaviour. However, the lower reported complication rates might suggest a change in operator behaviour and decision-making confirming the need for continued surveillance of the impact of public reporting on outcomes and operator behaviour.

Long-Term Durability of Transcatheter Aortic Valve Prostheses.

BACKGROUND: Very little is known about long-term valve durability after transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study sought to evaluate the incidence of structural valve degeneration (SVD) 5 to 10 years post-procedure. METHODS: Demographic, procedural, and in-hospital outcome data on patients who underwent TAVR from 2007 to 2011 were obtained from the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. Patients in whom echocardiographic data were available both at baseline and ≥5 years post-TAVR were included. Hemodynamic SVD was determined according to European task force committee guidelines. RESULTS: A total of 241 patients (79.3 ± 7.5 years of age; 46% female) with paired post-procedure and late echocardiographic follow-up (median 5.8 years, range 5 to 10 years) were included. A total of 149 patients (64%) were treated with a self-expandable valve and 80 (34.7%) with a balloon-expandable valve. Peak aortic valve gradient at follow-up was lower than post-procedure (17.1 vs. 19.1 mm Hg; p = 0.002). More patients had none/trivial aortic regurgitation (AR) (47.5% vs. 33%), and fewer had mild AR (42.5% vs. 57%) at follow-up (p = 0.02). There was 1 case (0.4%) of severe SVD 5.3 years after implantation (new severe AR). There were 21 cases (8.7%) of moderate SVD (mean 6.1 years post-implantation; range 4.9 to 8.6 years). Twelve of these (57%) were due to new AR and 9 (43%) to restenosis. CONCLUSIONS: Long-term transcatheter aortic valve function is excellent. In the authors' study, 91% of patients remained free of SVD between 5 and 10 years post-implantation. The incidence of severe SVD was <1%. Moderate SVD occurred in 1 in 12 patients.

Complete Versus Culprit-Only Lesion Intervention in Patients With Acute Coronary Syndromes.

BACKGROUND: A large proportion of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) present with multivessel disease (MVD). There is uncertainty in the role of complete coronary revascularization in this group of patients. OBJECTIVES: The aim of this study was to investigate the outcomes of complete revascularization compared with culprit vessel-only intervention in a large contemporary cohort of patients undergoing percutaneous coronary intervention (PCI) for NSTEMI. METHODS: The authors undertook an observational cohort study of 37,491 NSTEMI patients treated between 2005 and 2015 at the 8 heart attack centers in London. Clinical details were recorded at the time of the procedure into local databases using the British Cardiac Intervention Society (BCIS) PCI dataset. A total of 21,857 patients (58.3%) presented with NSTEMI and MVD. Primary outcome was all-cause mortality at a median follow-up of 4.1 years (interquartile range: 2.2 to 5.8 years). RESULTS: A total of 11,737 (53.7%) patients underwent single-stage complete revascularization during PCI for NSTEMI, rates that significantly increased during the study period (p = 0.006). Those patients undergoing complete revascularization were older and more likely to be male, diabetic, have renal disease and a history of previous myocardial infarction/revascularization compared with the culprit-only revascularization group. Although crude, in-hospital major adverse cardiac event rates were similar (5.2% vs. 4.8%; p = 0.462) between the 2 groups. Kaplan-Meier analysis demonstrated significant differences in mortality rates between the 2 groups (22.5% complete revascularization vs. 25.9% culprit vessel intervention; p = 0.0005) during the follow-up period. After multivariate Cox analysis (hazard ratio: 0.90; 95% confidence interval: 0.85 to 0.97) and the use of propensity matching (hazard ratio: 0.89; 95% confidence interval: 0.76 to 0.98) complete revascularization was associated with reduced mortality. CONCLUSIONS: In NSTEMI patients with MVD, despite higher initial (in-hospital) mortality rates, single-stage complete coronary revascularization appears to be superior to culprit-only vessel PCI in terms of long-term mortality rates. This supports the need for further randomized study to confirm these findings.

Angiography Alone Versus Angiography Plus Optical Coherence Tomography to Guide Percutaneous Coronary Intervention: Outcomes From the Pan-London PCI Cohort.

OBJECTIVES: This study aimed to determine the effect on long-term survival of using optical coherence tomography (OCT) during percutaneous coronary intervention (PCI). BACKGROUND: Angiographic guidance for PCI has substantial limitations. The superior spatial resolution of OCT could translate into meaningful clinical benefits, although limited data exist to date about their effect on clinical endpoints. METHODS: This was a cohort study based on the Pan-London (United Kingdom) PCI registry, which includes 123,764 patients who underwent PCI in National Health Service hospitals in London between 2005 and 2015. Patients undergoing primary PCI or pressure wire use were excluded leaving 87,166 patients in the study. The primary endpoint was all-cause mortality at a median of 4.8 years. RESULTS: OCT was used in 1,149 (1.3%) patients, intravascular ultrasound (IVUS) was used in 10,971 (12.6%) patients, and angiography alone in the remaining 75,046 patients. Overall OCT rates increased over time (p < 0.0001), with variation in rates between centers (p = 0.002). The mean stent length was shortest in the angiography-guided group, longer in the IVUS-guided group, and longest in the OCT-guided group. OCT-guided procedures were associated with greater procedural success rates and reduced in-hospital MACE rates. A significant difference in mortality was observed between patients who underwent OCT-guided PCI (7.7%) compared with patients who underwent either IVUS-guided (12.2%) or angiography-guided (15.7%; p < 0.0001) PCI, with differences seen for both elective (p < 0.0001) and acute coronary syndrome subgroups (p = 0.0024). Overall this difference persisted after multivariate Cox analysis (hazard ratio [HR]: 0.48; 95% confidence interval [CI]: 0.26 to 0.81; p = 0.001) and propensity matching (hazard ratio: 0.39; 95% CI: 0.21 to 0.77; p = 0.0008; OCT vs. angiography-alone cohort), with no difference in matched OCT and IVUS cohorts (HR: 0.88; 95% CI: 0.61 to 1.38; p = 0.43). CONCLUSIONS: In this large observational study, OCT-guided PCI was associated with improved procedural outcomes, in-hospital events, and long-term survival compared with standard angiography-guided PCI.

Outcomes after chronic total occlusion percutaneous coronary interventions: an observational study of 5496 patients from the Pan-London CTO Cohort.

BACKGROUND: Chronic total occlusions (CTO) are commonly encountered in patients undergoing coronary angiography; however, percutaneous coronary intervention (PCI) is infrequently performed owing to technical difficulty, the perceived risk of complications and a lack of randomized data. The aim of this study was to analyse the frequency and outcomes of CTO-PCI procedures in a large contemporary cohort of successive patients. PATIENTS AND METHODS: We undertook an observational cohort study of 48 234 patients with stable angina of which 5496 (11.4%) procedures were performed for CTOs between 2005 and 2015 at nine tertiary cardiac centres across London, UK. Outcome was assessed by in-hospital major adverse cardiac events and all-cause mortality at a median follow-up of 4.8 years (interquartile range: 2.2-6.4 years). RESULTS: Over time, there was an increase in the proportion of elective PCI procedures performed for CTOs, but no increase in the absolute number. Overall success rates increased over time (74.3% in 2005 to 81.5% in 2015; P=0.0003) despite an increase in case complexity (previous myocardial infarction, diabetes, renal failure, previous coronary artery bypass grafting, peripheral vascular disease and left ventricular impairment) that correlated with procedural advancements. Successful CTO PCI was associated with lower mortality [9.5%, 95% confidence interval (CI): 8.1-11.6 vs. 15.3%, 95% CI: 13.7-20.6, P<0.0001] that persisted after multivariate cox analysis (hazard ratio: 0.37, 95% CI: 0.25-0.62) and propensity matching (hazard ratio=0.36, 95% CI: 0.18-0.73, P=0.0005). CONCLUSION: Successful procedures were associated with lower mortality suggesting that the greater uptake of CTO PCI may improve clinical outcomes in a wider population than are currently being offered therapy.

Comparison of general anaesthesia and non-general anaesthesia approach in transfemoral transcatheter aortic valve implantation.

OBJECTIVE: Performing 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. METHODS: The 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. RESULTS: 2243 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. CONCLUSION: Procedure 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.

Contemporary trends in cardiogenic shock: Incidence, intra-aortic balloon pump utilisation and outcomes from the London Heart Attack Group.

BACKGROUND: Cardiogenic shock remains a major cause of morbidity and mortality in patients with ST-segment elevation myocardial infarction. We aimed to assess the current trends in cardiogenic shock management, looking specifically at the incidence, use of intra-aortic balloon pump therapy and outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. METHODS AND RESULTS: We undertook an observational cohort study of 21,210 ST-segment elevation myocardial infarction patients treated between 2005-2015 at the eight Heart Attack Centres in London, UK. Patients' details were recorded at the time of the procedure into local databases using the British Cardiac Intervention Society percutaneous coronary intervention dataset. There were 1890 patients who presented with cardiogenic shock. The primary outcome was all-cause mortality at a median follow-up of 4.1 years (interquartile range: 2.2-5.8 years). Increasing rates of cardiogenic shock were seen over the course of the study with consistently high mortality rates of 45-70%. A total of 685 patients underwent intra-aortic balloon pump insertion during primary percutaneous coronary intervention for cardiogenic shock with decreasing rates over time. Those patients undergoing intra-aortic balloon pump therapy were younger, more likely to have poor left ventricular function and less likely to have had previous percutaneous coronary intervention compared to the control group. Procedural success rates were similar (86.0% vs 87.1%, p=0.292) although crude, in-hospital major adverse cardiac event rates were higher (43.8% vs 33.7%, p<0.0001) in patients undergoing intra-aortic balloon pump therapy. Kaplan-Meier analysis demonstrated significantly higher mortality rates in patients receiving intra-aortic balloon pump therapy (50.9% intra-aortic balloon pump vs 39.9% control, p<0.0001) during the follow-up period. After multivariate Cox analysis (hazard ratio 1.04, 95% confidence interval 0.62-1.89) and the use of propensity matching (hazard ratio: 1.29, 95% confidence interval: 0.68-1.45) intra-aortic balloon pump therapy was not associated with mortality. CONCLUSION: Cardiogenic shock treated by percutaneous coronary intervention is increasing in incidence and remains a condition associated with high mortality and limited treatment options. Intra-aortic balloon pump therapy was not associated with a long-term survival benefit in this cohort and may be associated with increased early morbidity.

Inception of the 'endocarditis team' is associated with improved survival in patients with infective endocarditis who are managed medically: findings from a before-and-after study.

Objective: Despite 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. Methods: We 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. Results: The 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). Conclusions: A 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.

Percutaneous Device Closure of Paravalvular Leak: Combined Experience From the United Kingdom and Ireland.

BACKGROUND: Paravalvular leak (PVL) occurs in 5% to 17% of patients following surgical valve replacement. Percutaneous device closure represents an alternative to repeat surgery. METHODS: All UK and Ireland centers undertaking percutaneous PVL closure submitted data to the UK PVL Registry. Data were analyzed for association with death and major adverse cardiovascular events (MACE) at follow-up. RESULTS: Three hundred eight PVL closure procedures were attempted in 259 patients in 20 centers (2004-2015). Patient age was 67±13 years; 28% were female. The main indications for closure were heart failure (80%) and hemolysis (16%). Devices were successfully implanted in 91% of patients, via radial (7%), femoral arterial (52%), femoral venous (33%), and apical (7%) approaches. Nineteen percent of patients required repeat procedures. The target valve was mitral (44%), aortic (48%), both (2%), pulmonic (0.4%), or transcatheter aortic valve replacement (5%). Preprocedural leak was severe (61%), moderate (34%), or mild (5.7%) and was multiple in 37%. PVL improved postprocedure (P<0.001) and was none (33.3%), mild (41.4%), moderate (18.6%), or severe (6.7%) at last follow-up. Mean New York Heart Association class improved from 2.7±0.8 preprocedure to 1.6±0.8 (P<0.001) after a median follow-up of 110 (7-452) days. Hospital mortality was 2.9% (elective), 6.8% (in-hospital urgent), and 50% (emergency) (P<0.001). MACE during follow-up included death (16%), valve surgery (6%), late device embolization (0.4%), and new hemolysis requiring transfusion (1.6%). Mitral PVL was associated with higher MACE (hazard ratio [HR], 1.83; P=0.011). Factors independently associated with death were the degree of persisting leak (HR, 2.87; P=0.037), New York Heart Association class (HR, 2.00; P=0.015) at follow-up and baseline creatinine (HR, 8.19; P=0.001). The only factor independently associated with MACE was the degree of persisting leak at follow-up (HR, 3.01; P=0.002). CONCLUSION: Percutaneous closure of PVL is an effective procedure that improves PVL severity and symptoms. Severity of persisting leak at follow-up is independently associated with both MACE and death. Percutaneous closure should be considered as an alternative to repeat surgery.

Outcome of 1051 Octogenarian Patients With ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: Observational Cohort From the London Heart Attack Group.

BACKGROUND: ST-segment elevation myocardial infarction is increasingly common in octogenarians, and optimal management in this cohort is uncertain. This study aimed to describe the outcomes of octogenarians with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention. METHODS AND RESULTS: We analyzed 10 249 consecutive patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention between 2005 and 2011 at 8 tertiary cardiac centers across London, United Kingdom. The primary end point was all-cause mortality at a median follow-up of 3 years. In total, 1051 patients (10.3%) were octogenarians, with an average age of 84.2 years, and the proportion increased over the study period (P=0.04). In-hospital mortality (7.7% vs 2.4%, P<0.0001) and long-term mortality (51.6% vs 12.8%, P<0.0001) were increased in octogenarians compared with patients aged <80 years, and age was an independent predictor of mortality in a fully adjusted model (hazard ratio 1.07, 95% CI 1.07-1.09, P<0.0001). Time-stratified analysis revealed an increasingly elderly and more complex cohort over time. Nonetheless, long-term mortality rates among octogenarians remained static over time, and this may be attributable to improved percutaneous coronary intervention techniques, including significantly higher rates of radial access and lower bleeding complications. Variables associated with bleeding complications were similar between octogenarian and younger cohorts. CONCLUSIONS: In this large registry, octogenarians undergoing primary percutaneous coronary intervention had a higher rate of complications and mortality compared with a younger population. Over time, octogenarians undergoing primary percutaneous coronary intervention increased in number, age, and complexity. Nevertheless, in-hospital outcomes were reasonable, and long-term mortality rates were static.

Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: St Jude Medical, Friends of the Heart Foundation, and Medtronic.