Aims To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM‐HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes. Methods and results Outpatients with HFrEF in the ESC‐EORP‐HFA Long‐Term Heart Failure (HF‐LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM‐HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM‐HF and guideline criteria, respectively. Absent PARADIGM‐HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub‐optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub‐optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM‐HF and guidelines. One‐year heart failure hospitalization was higher (12% and 17% vs. 12%) and all‐cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM‐HF. Conclusions Among outpatients with HFrEF in the ESC‐EORP‐HFA HF‐LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM‐HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM‐HF enalapril group.
We sought to evaluate the impact of experience and proficiency with radial approach (RA) on clinical outcomes of percutaneous coronary interventions (PCI) performed via femoral approach (FA) in the “real-world” national registry. A total of 539 invasive cardiologists performing PCIs in 151 invasive cardiology centers in Poland between 2014 and 2017 were included. Proficiency threshold was set at >300 PCIs during four consecutive years per individual operator. The majority of operators performed >75% of all PCIs via RA (449 (65.4%)), 143 (20.8%) in 50–75% of cases, 62 (9.0%) in 25–50% and only 33 (4.8%) invasive cardiologists were using RA in <25% of all PCIs. Operators with the highest proficiency in RA were associated with increased risk of periprocedural death, stroke and bleeding complications at access site during angiography via FA. Similarly, higher prevalence of periprocedural mortality during PCI with FA was observed in most experienced radial operators as compared to other groups. The detrimental effect of FA utilization by the most experienced radial operators was observed in both stable angina and acute coronary syndromes. Higher experience and utilization of RA might be linked to worse outcomes of PCIs performed via femoral artery in both stable and acute settings.
Background Both unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI) are still classified together in non-ST-elevation acute coronary syndromes despite the fact they substantially differ in both clinical profile and prognosis. The aim of the present study was to evaluate contemporary clinical characteristics and outcomes of unstable angina patients after percutaneous coronary intervention (PCI) in comparison with stable angina and NSTEMI in Swietokrzyskie District of Poland in years 2015–2017. Methods A total of 7187 patients after PCI from ORPKI Registry (38% with diagnosis of unstable angina) were included into the analysis. Impact of clinical presentation (unstable angina, stable angina, NSTEMI, STEMI) on three-year outcomes were determined. Results Unstable angina patients were older than stable angina but younger than NSTEMI individuals. In unstable angina group, the percentage of previous myocardial infarction (MI), PCI or coronary artery bypass grafting (CABG) was the highest among all analyzed groups. In three-year observation, the risk of death as well as MI and MACE in unstable angina after PCI was higher than stable angina angina but considerably lower than in the NSTEMI group. Multivariate analysis confirmed that prognosis in NSTEMI was substantially worse in comparison with unstable angina [relative risk (RR) 1.365, 95% confidence interval (CI): 1.126–1.655, P = 0.0015]. On the contrary in unstable angina and stable angina patients, the impact of diagnosis on mortality risk was similar (RR 1.189, 95% CI: 0.932–1.518, P = 0.1620). Parallel results were observed in respect of MI and MACE. Independent predictors of death or MACE were: age, kidney disease, hypertension, diabetes, previous stroke or previous PCI. Conclusion Three-year prognosis in unstable angina was considerable better in comparison with NSTEMI. On the contrary, after adjustment for baseline differences, the outcomes (death, MI, MACE) in unstable angina and stable angina patients were comparable.
BACKGROUND Previous studies have suggested that low operator and institutional volume may be associated with an increased risk of adverse events in patients undergoing percutaneous coronary intervention (PCI). AIMS The aim of the study was to assess the relationship between operator volume and procedure related mortality in the emergent and elective settings. METHODS Data were obtained from a national registry of PCIs, maintained in cooperation with the Association of Cardiovascular Interventions of the Polish Cardiac Society. Registry data for the period from January 2014 to December 2017 were collected. During the study, there were 162 active catheterization laboratories, in which a total of 456 732 PCIs were performed. RESULTS The median number of PCIs performed in a single laboratory was 2643.5 (interquartile range [IQR], 1875-3598.5) over 4 years. The median number of PCIs performed by a single operator was 557 (IQR, 276.25-860.5) per year. We did not confirm a significant relationship between the operator volume and mortality in the overall group of patients treated with emergency and elective PCI. However, we noted a lower mortality rate for high volume operators (odds ratio [OR], 0.79; 95% CI, 0.63-0.99; P = 0.04). When the operator volume was assessed as a continuous variable, there was a trend toward significance (OR, 0.94; 95% CI; 0.88-1.0007; P = 0.052) in patients treated with emergency PCI. CONCLUSIONS High operator volume was associated with a lower periprocedural mortality rate than low operator volume in patients undergoing PCI due to acute coronary syndromes.
COVID-19 causes thromboembolic complications that affect the patient’s prognosis. COVID‑19 vaccines significantly improve the prognosis for the course of the infection. The aim of this study was to evaluate the impacts of patient characteristics, including COVID-19 vaccinations, on perioperative mortality in acute coronary syndrome in Poland during the pandemic. We analyzed the data of 243,515 patients from the National Registry of Invasive Cardiology Procedures (Ogólnopolski Rejestr Procedur Kardiologii Inwazyjnej [ORPKI]). In this group, 7407 patients (21.74%) had COVID-19. The statistical analysis was based on a neural network that was verified by the random forest method. In 2020, the most significant impact on prognosis came from a diagnosis of unstable angina, a short period (<2 h) from pain occurrence to first medical contact, and a history of stroke. In 2021, the most significant factors were pre-hospital cardiac arrest, female sex, and a short period (<2 h) from first medical contact to coronary angiography. After adjusting for a six-week lag, a diagnosis of unstable angina and psoriasis were found to be relevant in the data from 2020, while in 2021, it was the time from the pain occurrence to the first medical contact (2–12 h) in non-ST segment elevation myocardial infarction and the time from first contact to balloon inflation (2–12 h) in ST-segment elevation myocardial infarction. The number of vaccinations was one of the least significant factors. COVID-19 vaccination does not directly affect perioperative prognosis in patients with acute coronary syndrome.
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