Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort

Grade III Coronary Artery Perforation Following PCI and Unusual Stent Graft Delivery System

Koronarne perforacije su retke ali izuzetno neugodne komlikacije perkutanih intervencija. Perforacije koronarnh arterija trećeg stepena po Elisu predstvaljaju najozbiljniju formu perforacija i zahtevaju hitno zbrinjavanje. Često je neophodno uraditi perikardiocentezu i primeniti brojne interventne tehnike kako bismo rešili perforaciju. Stentovi prekriveni politetrafluoroetilenom(PTFE) postali su jedno od najčešće korišćenih perkutanih rešenja, ali su njihove mane visoki profil i slaba fleksibilnost. U našem slučaju, pokušali smo da poboljšamo plasiranje PTFE stenta montiranjem na metalni stent, koji smo iskoristili kao nosač

Association of coronary ischemia estimated by fractional flow reserve and psychological characteristics of patients

Introduction : Psychological characteristics of patients, depression, stress and anxiety are recognized as important confounding risk factors for ischemic heart disease. However, the impact of psychological characteristics on coronary ischemia and vice versa remain poorly understood. Aim: To demonstrate the interplay of psychological characteristics, depression, stress and anxiety with coronary ischemia estimated with fractional flow reserve (FFR). Material and methods : From 2014 to 2016, 147 patients who were planned for FFR measurement were included in this study. Psychological characteristics of patients were evaluated using the Depression, Anxiety and Stress Scale 21 items (DASS 21) self-report questionnaire. Results : Comparing the FFR ischemic vs. FFR non-ischemic groups, a significant difference was observed regarding results achieved for the depression, anxiety and stress scales. Multivariate logistic regression analysis was used to model the correlation between FFR and the DAS scale. It was clear, when controlling for previous myocardial infarction, that FFR was significant in all analyses. However, when the Canadian Cardiovascular Society grading of angina pectoris (CCS) class was entered in the model, FFR was not a significant predictor of anxiety, but was significant in other analysis. Conclusions : Higher degrees of the psychological characteristics depression, stress and anxiety were observed in the group of patients with coronary ischemia, corresponding to lower fractional flow values

Fractional Flow Reserve and Quality-of-Life Improvement After Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease

Whether the benefit in quality of life (QOL) after percutaneous coronary intervention depends on the severity of the stenosis as determined by fractional flow reserve (FFR) remains unknown. This study sought to investigate the relationship between FFR values and improvement in QOL

Fractional flow reserve and quality-of-life improvement after percutaneous coronary intervention in patients with stable coronary artery disease

\u3cp\u3eBACKGROUND: Whether the benefit in quality of life (QOL) after percutaneous coronary intervention depends on the severity of the stenosis as determined by fractional flow reserve (FFR) remains unknown. This study sought to investigate the relationship between FFR values and improvement in QOL. METHODS: From the FAME 1 and 2 trials (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation), we identified 706 stable patients with coronary artery disease who had at least 1 lesion with an FFR≤0.80 that was treated with percutaneous coronary intervention and 185 patients with coronary artery disease who had no lesion with an FFR≤0.80 and were treated medically who served as a reference group. QOL was assessed by the European Quality of Life-5 Dimensions index at baseline, 1 month, and 1 year. We assessed the relationship between QOL improvement (defined as the change in European Quality of Life-5 Dimensions index from baseline) and FFR as a continuous value and according to abnormal FFR tertile. RESULTS: QOL improved significantly after percutaneous coronary intervention in each abnormal FFR tertile, whereas it did not change in the reference group. The lowest abnormal FFR subgroup had the greatest improvement in QOL at 1 month (P<0.001). In mixed-effects models for repeated measures, lower FFR (P=0.002 for 1 month and 0.049 for 1 year), greater delta FFR (P=0.021 for 1 month and 0.025 for 1 year), and higher angina class (P=0.001 for 1 month and < 0.001 for 1 year) were associated with the greatest magnitude of QOL improvement at both 1 month and 1 year. CONCLUSIONS: Among patients with stable coronary artery disease, FFR and angina severity predict QOL improvement after percutaneous coronary intervention.\u3c/p\u3

Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled chart-1 clinical trial

Aims Cardiopoietic cells, produced through cardiogenic conditioning of patients\u27 mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. Methods and results This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n= 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving> 24 million mesenchymal stem cells (n= 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n= 157) or sham procedure (n= 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n= 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value> 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. Conclusion The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted

Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease

BACKGROUND: The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone. METHODS: In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS: Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event. CONCLUSIONS: In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone