scholarly journals The Effects of Granulocyte Colony-Stimulating Factor in Patients with a Large Anterior Wall Acute Myocardial Infarction to Prevent Left Ventricular Remodeling: A 10-Year Follow-Up of the RIGENERA Study

2020 ◽  
Vol 9 (4) ◽  
pp. 1214
Author(s):  
Antonio Maria Leone ◽  
Domenico D’Amario ◽  
Francesco Cannata ◽  
Francesca Graziani ◽  
Josip A. Borovac ◽  
...  

Background: the RIGENERA trial assessed the efficacy of granulocyte-colony stimulating factor (G-CSF) in the improvement of clinical outcomes in patients with severe acute myocardial infarction. However, there is no evidence available regarding the long-term safety and efficacy of this treatment. Methods: in order to evaluate the long-term effects on the incidence of major adverse events, on the symptom burden, on the quality of life and the mean life expectancy and on the left ventricular (LV) function, we performed a clinical and echocardiographic evaluation together with an assessment using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Seattle Heart Failure Model (SHFM) at 10-years follow-up, in the patients cohorts enrolled in the RIGENERA trial. Results: thirty-two patients were eligible for the prospective clinical and echocardiography analyses. A significant reduction in adverse LV remodeling was observed in G-CSF group compared to controls, 9% vs. 48% (p = 0.030). The New York Heart Association (NYHA) functional class was lower in G-CSF group vs. controls (p = 0.040), with lower burden of symptoms and higher quality of life (p = 0.049). The mean life expectancy was significantly higher in G-CSF group compared to controls (15 ± 4 years vs. 12 ± 4 years, p = 0.046. No difference was found in the incidence of major adverse events. Conclusions: this longest available follow-up on G-CSF treatment in patients with severe acute myocardial infarction (AMI) showed that this treatment was safe and associated with a reduction of adverse LV remodeling and higher quality of life, in comparison with standard-of-care treatment.

Author(s):  
Jing Li ◽  
Rachel P Dreyer ◽  
Xi Li ◽  
Xue Du ◽  
Nicholas S Downing ◽  
...  

Background: The incidence of acute myocardial infarction (AMI) is growing rapidly in China, but there is limited information about the patient experience in the post-acute period. Specifically, long-term outcomes and patient-reported outcomes (PROs), including quality of life, symptoms and mood, after AMI, have not been systematically studied in China. Objectives: To conduct a nationwide prospective study following patients after AMI that 1) measures long-term clinical outcomes, PROs, cardiovascular risk factor control and adherence to medications for secondary prevention; and 2) identifies patient characteristics and hospital attributes that are associated with these outcomes. Methods: The China PEACE Prospective Study of AMI has recruited 4000 consecutive patients from 55 hospitals across China and is following them for 1-year. The first patient was enrolled in December 2012, and the last follow-up visit is scheduled for June 2015. After obtaining informed consent from patients, we abstracted details of their medical history, treatment, and in-hospital outcomes from medical charts. We conducted comprehensive baseline interviews characterizing patient demographics, risk factors, clinical presentation, and healthcare utilization. In addition, we used validated PRO instruments to measure quality of life, symptoms, mood, sleep, cognition and sexual activity. Follow-up interviews, measuring PROs, medication adherence and risk factor control were conducted at 1-, 6-, and 12-months after discharge. At these interviews, patients were asked to self-report major health events and to provide supporting materials (e.g., hospital discharge record for a readmission), which were subsequently validated by a National Coordinating Center. Blood and urine samples were obtained at baseline and 12-month follow-up, and stored for further biomarker analysis and genetic studies. To complement these patient-level data, we surveyed participating hospitals to characterize their facilities, processes and organizational learning culture. Together, these data will be used to identify factors associated with various outcomes following AMI. Conclusion: This study is uniquely positioned to generate new information regarding patient experience and determinants of outcomes after AMI in China.


Author(s):  
Rachel P Dreyer ◽  
Kelly M Strait ◽  
Judith H Lichtman ◽  
Nancy Lorenze ◽  
Gail D'Onofrio ◽  
...  

Background: Despite the excess risk of mortality in young women following acute myocardial infarction (AMI), little effort has been made to describe their long-term outcomes, particularly with respect to their health status (symptoms, function and quality of life). Accordingly, we assessed gender differences in 1-year health status outcomes after AMI. Methods: Data was used from the VIRGO study, an observational cohort of patients aged ≤55 years with AMI in the US and Spain (n=3,501, 67% women). Clinical data was abstracted from medical records and health status was obtained through patient interviews at the time of hospitalization and at 1-year later [Short Form 12 (SF-12) and the Seattle Angina Questionnaire (SAQ)]. Patient scores were categorized as “bad” if they had below average scores on the SF-12 components, had a score below 100 on the SAQ physical limitations (PL) or the SAQ angina frequency (AF), or had a score below 75 on the SAQ quality of life (QOL) at either baseline or 1-year. Patients were classified as having a “poor” outcome for a measure if they had a “bad” score at both baseline and 1-year or had a “bad” score at 1-year. Logistic regression models were used to assess factors associated with having a “poor” outcome for each scale. Results: The median age was 48 years (IQR: 44, 52). Women were more likely to present with diabetes (39% vs. 27%), obesity (51% vs. 45%), stroke (5% vs. 2%), heart failure (5% vs. 2%), lung disease (13% vs. 5%), and depression (48% vs. 24%, all P values <0.0001). Women were more likely to have “poor outcomes” compared with men (SF-12 PCS 46% vs. 30%; SF-12 MCS 47% vs. 30%; SAQ AF 32% vs. 25%; SAQ PL 29% vs. 20%; SAQ QOL 42% vs. 28%, all p-values <0.001). Female gender, prior AMI/percutaneous coronary intervention/coronary artery bypass grafting, and smoking within 30 days were independent predictors of having a “poor” outcome for all health status measures. Specifically, women had an increased odds of having a “poor” outcome on the SF-12 PCS (OR=2.05; 95% CI 1.69, 2.48), MCS (OR=1.98; 95% CI 1.65, 2.39), SAQ AF (OR=1.39; 95% CI 1.15, 1.67), SAQ PL (OR=1.62; 95% CI 1.32, 1.99) and the SAQ QOL scale (OR=1.84; 95% CI 1.53, 2.22), as compared with men. Conclusion: Compared with men, young women are more likely to have “poor” health status outcomes after AMI. This information is critically important in developing targets for gender-specific interventions to improve young women’s recovery post AMI.


2018 ◽  
Vol 64 (9) ◽  
pp. 853-860 ◽  
Author(s):  
Roberta da Silva Teixeira ◽  
Bruna Medeiros Gonçalves de Veras ◽  
Kátia Marie Simões e Senna ◽  
Rosângela Caetano

SUMMARY INTRODUCTION Heart failure due to an acute myocardial infarction is a very frequent event, with a tendency to increase according to improvements in the treatment of acute conditions which have led to larger numbers of infarction survivors. OBJECTIVE The aim of this study is to synthesize the evidence, through a systematic review, on efficacy and safety of the device in patients with this basic condition. METHODS Studies published between January 2002 and October 2016 were analysed, having as reference databases Embase, Medline, Cochrane Library, Lilacs, Web of Science and Scopus. The selection of studies, data extraction and methodological quality assessment of studies were examined by two independent reviewers, with disagreements resolved by consensus. RESULTS Only prospective studies without control group were identified. Six studies were included, with averages of 34 participants and follow-up of 13 months. Clinical, functional, hemodynamic and quality of life outcomes were evaluated. The highest mortality rate was 8.4% with 12-month follow-up for unspecified cardiovascular reasons, and heart failure rehospitalization was 29.4% with 36-month follow-up. Statistically significant improvements were found only in some of the studies which evaluating changes in left ventricular volume indices, the distance measured by the six-minute walk test, New York Heart Association functional classification, and quality of life, in pre and post-procedure analysis. CONCLUSIONS The present review indicates that no available quality evidence can assert efficacy and safety of PARACHUTE® in the treatment of heart failure after apical or anterior wall myocardial infarction.


2008 ◽  
Vol 2 (4) ◽  
pp. 240-249 ◽  
Author(s):  
Jay Jagannathan ◽  
David O. Okonkwo ◽  
Hian Kwang Yeoh ◽  
Aaron S. Dumont ◽  
Dwight Saulle ◽  
...  

Object The management strategies and outcomes in pediatric patients with elevated intracranial pressure (ICP) following severe traumatic brain injury (TBI) are examined in this study. Methods This study was a retrospective review of a prospectively acquired pediatric trauma database. More than 750 pediatric patients with brain injury were seen over a 10-year period. Records were retrospectively reviewed to determine interventions for correcting ICP, and surviving patients were contacted prospectively to determine functional status and quality of life. Only patients with 2 years of follow-up were included in the study. Results Ninety-six pediatric patients (age range 3–18 years) were identified with a Glasgow Coma Scale score < 8 and elevated ICP > 20 mm Hg on presentation. The mean injury severity score was 65 (range 30–100). All patients were treated using a standardized head injury protocol. The mean time course until peak ICP was 69 hours postinjury (range 2–196 hours). Intracranial pressure control was achieved in 82 patients (85%). Methods employed to achieve ICP control included maximal medical therapy (sedation, hyperosmolar therapy, and paralysis) in 34 patients (35%), ventriculostomy in 23 patients (24%), and surgery in 39 patients (41%). Fourteen patients (15%) had refractory ICP despite all interventions, and all of these patients died. Seventy-two patients (75%) were discharged from the hospital, whereas 24 (25%) died during hospitalization. Univariate and multivariate analysis revealed that the presence of vascular injury, refractory ICP, and cisternal effacement at presentation had the highest correlation with subsequent death (p < 0.05). Mean follow-up was 53 months (range 11–126 months). Three patients died during the follow-up period (2 due to infections and 1 committed suicide). The mean 2-year Glasgow Outcome Scale score was 4 (median 4, range 1–5). The mean patient competency rating at follow-up was 4.13 out of 5 (median 4.5, range 1–4.8). Univariate analysis revealed that the extent of intracranial and systemic injuries had the highest correlation with long-term quality of life (p < 0.05). Conclusions Controlling elevated ICP is an important factor in patient survival following severe pediatric TBI. The modality used for ICP control appears to be less important. Long-term follow-up is essential to determine neurocognitive sequelae associated with TBI.


2021 ◽  
Vol 8 ◽  
Author(s):  
Robin Hofmann ◽  
Tamrat Befekadu Abebe ◽  
Johan Herlitz ◽  
Stefan K. James ◽  
David Erlinge ◽  
...  

Background: After decades of ubiquitous oxygen therapy in all patients with acute myocardial infarction (MI), recent guidelines are more restrictive based on lack of efficacy in contemporary trials evaluating hard clinical outcomes in patients without hypoxemia at baseline. However, no evidence regarding treatment effects on health-related quality of life (HRQoL) exists. In this study, we investigated the impact of routine oxygen supplementation on HRQoL 6–8 weeks after hospitalization with acute MI. Secondary objectives included analyses of MI subtypes, further adjustment for infarct size, and oxygen saturation at baseline and 1-year follow-up.Methods: In the DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6–12 h or ambient air. In this prespecified analysis, patients younger than 75 years of age with confirmed MI who had available HRQoL data by European Quality of Life Five Dimensions questionnaire (EQ-5D) in the national registry were included. Primary endpoint was the EQ-5D index assessed by multivariate linear regression at 6–10 weeks after MI occurrence.Results: A total of 3,086 patients (median age 64, 22% female) were eligible, 1,518 allocated to oxygen and 1,568 to ambient air. We found no statistically significant effect of oxygen therapy on EQ-5D index (−0.01; 95% CI: −0.03–0.01; p = 0.23) or EQ-VAS score (−0.57; 95% CI: −1.88–0.75; p = 0.40) compared to ambient air after 6–10 weeks. Furthermore, no significant difference was observed between the treatment groups in EQ-5D dimensions. Results remained consistent across MI subtypes and at 1-year follow-up, including further adjustment for infarct size or oxygen saturation at baseline.Conclusions: Routine oxygen therapy provided to normoxemic patients with acute MI did not improve HRQoL up to 1 year after MI occurrence.Clinical Trial Registration:ClinicalTrials.gov number, NCT01787110.


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