The everolimus eluting Synergy MegatronTM drug-eluting stent platform: Early outcomes from the European Synergy MegatronTM Implanters' Registry.

BACKGROUND: The Synergy MegatronTM is an everolimus-drug eluting stent that may offer advantages in the treatment of aorto-ostial disease and large proximal vessels. AIMS: To report the short- to medium-term clinical outcomes from the European Synergy MegatronTM Implanters' Registry. METHODS: This registry was an investigator-initiated study conducted at 14 European centers. The primary outcome was target lesion failure (TLF), defined as the composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularisation. RESULTS: Five hundred seventy-five patients underwent PCI with MegatronTM between 2019 and 2021. Patients were 69 ± 12 years old, 26% had diabetes mellitus, 24% had moderate-severe left ventricular impairment and 59% presented with an acute coronary syndrome. 15% were deemed prohibitively high risk for surgical revascularisation. The target vessel involved the left main stem in 55%, the ostium of the RCA in 13% and was a true bifurcation (Medina 1,1,1) in 50%.  At 1 year, TLF was observed in 40 patients, with 26 (65%) occurring within the first 30 days. The cumulative incidence of TLF was 4.5% at 30 days and 8.6% (95% CI 6.3-11.7) at 1 year. The incidence of stent thrombosis was 0.5% with no late stent thromboses. By multivariate analysis, the strongest independent predictors of TLF were severe left ventricular impairment (HR 3.43, 95% CI: 1.67-6.76, p < 0.001) and a target vessel involving the left main (HR 4.00 95% CI 1.81-10.15 p = 0.001). CONCLUSIONS: Use of the Synergy MegatronTM everolimus eluting stent in a 'real-world' setting shows favorable outcomes at 30 days and 1 year.

Treatment Strategies and Outcomes of Emergency Left Main Percutaneous Coronary Intervention.

Emergency percutaneous coronary intervention of the left main (LM ePCI) coronary artery necessitated by acute coronary syndrome is associated with a high risk of mortality. However, optimal treatment strategies and related outcomes remain undefined in this group. We undertook a multi-center, retrospective, observational cohort study of consecutive patients requiring LM ePCI between 2011 and 2018 and reported the coronary anatomy, treatment strategies, outcomes, and predictors of mortality. A total of 116 consecutive cases were included. Patients were predominantly male (85%) with a median age of 68.0 years; 12 patients (10%) had previous coronary artery bypass grafting. ST-elevation was noted in 76 (66%); 30 (26%) presented with an out-of-hospital cardiac arrest (OOHCA) and 47 (41%) with cardiogenic shock. The most frequent pattern of disease was Medina 1,1,1, seen in 59 patients (51%). The commonest revascularization strategy was provisional stenting (95 cases, 82%) with improved or thrombolysis in myocardial infarction 3 flow seen in 85 cases (73%). All-cause mortality was 35% at 30 days, rising to 58% at 5 years. Adverse predictors of 30-day mortality included presentation with cardiogenic shock (p = 0.018) and OOHCA (p = 0.020), whereas improved flow and/or thrombolysis in myocardial infarction 3 flow in both circumflex and left anterior descending artery afforded a better prognosis (p = 0.028). In conclusion, patients who underwent LM ePCI are a high-risk subgroup and commonly present with cardiogenic shock and OOHCA. Provisional stenting appears to be the preferred option with the successful restoration of coronary flow in most cases despite complex anatomy. High 30-day mortality is driven by the presence of cardiogenic shock, OOHCA, and failure to restore or improve coronary flow.

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.

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.

Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters' Registry.

OBJECTIVES: The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. BACKGROUND: The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. METHODS: Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. RESULTS: A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. CONCLUSIONS: This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.

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.

Vascular calcification and hypertension: cause and effect.

Vascular calcification is an active and regulated process which is integral to cardiovascular disease and intimately linked to hypertension. Dysfunctional vascular smooth muscle cells, microvesicles, and dysregulated mineralization inhibitors play key roles in the calcification process, which occurs in the vessel intima in association with atherosclerosis as well as in the vessel media during ageing. Historically hypertension was considered a risk factor promoting atherosclerosis and associated intimal calcification. However, it is now recognized that not all vascular calcification occurs with atherosclerosis, and calcification of the vessel media is associated with arterial stiffening and is a major cause of isolated systolic hypertension in the elderly. Importantly, vascular calcification, regardless of its anatomical site, is an independent risk factor for cardiovascular mortality. Therefore, understanding the factors and mechanisms driving these processes will provide novel therapeutic targets for its prevention and perhaps ultimately its regression.