scholarly journals Prognostic value of clinically important deterioration in COPD: IMPACT trial analysis

2021 ◽  
pp. 00663-2020
Author(s):  
MeiLan K Han ◽  
Gerard J Criner ◽  
Mark T Dransfield ◽  
David MG Halpin ◽  
Christine E Jones ◽  
...  
Keyword(s):  
Health Status ◽  
Clinical Outcomes ◽  
Prognostic Value ◽  
Phase Iii ◽  
Severe Exacerbation ◽  
Increased Risk ◽  
Unit Increase ◽  
Clinically Important Deterioration ◽  
The Impact

IntroductionClinically important deterioration (CID) is a multicomponent measure for assessing disease worsening in chronic obstructive pulmonary disease (COPD). This analysis investigated the prognostic value of a CID event on future clinical outcomes, and effect of single-inhaler triple versus dual therapy on reducing CID risk in patients in the IMPACT trial.MethodsIMPACT was a Phase III, double-blind, 52-week multicenter trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomised 2:2:1 to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg, FF/VI 100/25 µg, or UMEC/VI 62.5/25 µg. CID at the timepoint of interest was defined as: a moderate/severe exacerbation, or ≥100 mL decrease in trough forced expiratory volume in 1 s or deterioration in health status (≥4.0 unit increase in St George's Respiratory Questionnaire total score or ≥2.0 unit increase in COPD Assessment Test score) from baseline. A treatment-independent post hoc prognostic analysis compared clinical outcomes up to Week 52 in patients with/without a CID by Week 28. A prospective analysis evaluated time-to-first CID with each treatment.ResultsPatients with a CID by Week 28 had significantly increased exacerbation rates after Week 28, smaller improvements in lung function and health status at Week 52 (all p<0.001), and increased risk of all-cause mortality after Week 28 versus patients who were CID-free. FF/UMEC/VI significantly reduced CID risk versus dual therapies (all p<0.001).ConclusionsPrevention of short-term disease worsening was associated with better long-term clinical outcomes. FF/UMEC/VI reduced CID risk versus dual therapies; this effect may improve long-term prognosis in this population.FundingGSK (CTT116855/NCT02164513).

scholarly journals One‐year clinically important deterioration and long‐term clinical course in Japanese patients with COPD: a multicenter observational cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuki Abe ◽  
Masaru Suzuki ◽  
Hironi Makita ◽  
Hirokazu Kimura ◽  
Kaoruko Shimizu ◽  
...  
Keyword(s):  
Cohort Study ◽  
Disease Progression ◽  
Clinical Outcomes ◽  
Japanese Patients ◽  
Drop Out ◽  
Chronic Obstructive ◽  
First Year ◽  
Severe Exacerbation ◽  
Clinically Important Deterioration

Abstract Background Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression. The aim of this study was to investigate the relationships between 1-year CID and the following long-term clinical outcomes in Japanese patients with COPD who have been reported to have different characteristics compared to the Westerners. Methods Among Japanese patients with COPD enrolled in the Hokkaido COPD cohort study, 259 patients who did not drop out within the first year were analyzed in this study. Two definitions of CID were used. Definition 1 comprised ≥ 100 mL decrease in forced expiratory volume in 1 s (FEV1), ≥ 4-unit increase in St George’s Respiratory Questionnaire (SGRQ) score from baseline, or moderate or severe exacerbation. For Definition 2, the thresholds for the FEV1 and SGRQ score components were doubled. The presence of CID was evaluated within the first year from enrollment, and analyzed the association of the presence of CID with following 4-year risk of exacerbations and 9-year mortality. Results Patients with CID using Definition 1, but not any single CID component, during the first year had a significantly worse mortality compared with those without CID. Patients with CID using Definition 2 showed a similar trend on mortality, and had a shorter exacerbation-free survival compared with those without CID. Conclusions Adoption of CID is a beneficial and useful way for the assessment of long-term disease progression and clinical outcomes even in Japanese population with COPD. The definition of CID might be optimized according to the characteristics of COPD population and the observation period for CID.

scholarly journals The Impact of Successful Chronic Total Occlusion Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Real World

2020 ◽  
Author(s):  
Xuhe Gong ◽  
Li Zhou ◽  
Xiaosong Ding ◽  
Hui Chen ◽  
Hongwei Li
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Coronary Artery ◽  
Clinical Outcomes ◽  
Real World ◽  
Cardiac Death ◽  
Coronary Intervention ◽  
Increased Risk ◽  
Percutaneous Coronary ◽  
The Impact

Abstract Background: Coronary chronic total occlusions (CTOs) are correlated with increased risk of adverse clinical outcomes. The optimal treatment strategy for CTO has not been well established. We sought to examine the impact of CTO percutaneous coronary intervention (PCI) on long-term clinical outcome in the real world.Methods: A total of 592 consecutive patients with CTO in Beijing Friendship Hospital from June 2017 to December 2019 were enrolled, 29 patients were excluded due to Coronary artery bypass grafting (CABG). After exclusion, 563 patients were divided into the no-revascularized group (CTO-NR group, n=263) and successful revascularized group (CTO-R group, n=300). The primary endpoint was cardiac death; Secondary endpoint was major adverse cardiac and cerebrovascular events (MACCE), a composite of all-cause death, cardiac death, recurrent myocardial infarction, target lesion revascularization, re-hospitalization, heart failure, and stroke.Results: Percent of Diabetes mellitus (53.2% vs 39.7), Chronic kidney disease (8.7% vs 3.7%), CABG history (7.6% vs 1%), three vessel disease(96.2% vs 90%) and left main coronary artery disease (25.1% vs 13.7%) was significantly higher in the CTO-NR group than in success PCI group (all P<0.05). Moreover, the CTO-NR group has lower EF (0.58±0.11 vs 0.61±0.1, p=0.001) and FS (0.31±0.07 vs 0.33±0.07, p=0.002). At a median follow-up of 12 months, CTO revascularization was superior to CTO no-revascularization in terms of cardiac death (adjusted hazard ratio [HR]: 0.27, 95% conference interval [CI] 0.11-0.64). The superiority of CTO revascularization was consistent for MACCE (HR: 0.55, 95% CI 0.35-0.79). At multivariable Cox hazards regression analysis, CTO revascularization remains one of the independent predictors of lower risk of cardiac death and MACCE.Conclusions: Successful revascularization by PCI may bring more clinical benefits. The presence of LVEF＜0.5 and LM-disease was associated with an incidence of cardiac death; CTO revascularization was a protected predictor of cardiac death.

scholarly journals One-year Clinically Important Deterioration and Long-Term Clinical Course in Japanese patients with COPD: A Multicenter Observational Cohort Study

2021 ◽  
Author(s):  
Yuki Abe ◽  
Masaru Suzuki ◽  
Hironi Makita ◽  
Hirokazu Kimura ◽  
Kaoruko Shimizu ◽  
...  
Keyword(s):  
Cohort Study ◽  
Disease Progression ◽  
Clinical Outcomes ◽  
Japanese Patients ◽  
Drop Out ◽  
Chronic Obstructive ◽  
First Year ◽  
Severe Exacerbation ◽  
Clinically Important Deterioration

Abstract Background: Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression. The aim of this study was to investigate the relationships between 1-year CID and the following long-term clinical outcomes in Japanese patients with COPD who have been reported to have different characteristics compared to the Westerners.Methods: Among Japanese patients with COPD enrolled in the Hokkaido COPD cohort study, 259 patients who did not drop out within the first year were analyzed in this study. Two definitions of CID were used. Definition 1 comprised ≥100 mL decrease in forced expiratory volume in 1 second (FEV1), ≥4-unit increase in St George’s Respiratory Questionnaire (SGRQ) score from baseline, or moderate or severe exacerbation. For Definition 2, the thresholds for the FEV1 and SGRQ score components were doubled. The presence of CID was evaluated within the first year from enrollment, and analyzed the association of the presence of CID with following 4-year risk of exacerbations and 9-year mortality.Results: Patients with CID using Definition 1, but not any single CID component, during the first year had a significantly worse mortality compared with those without CID. Patients with CID using Definition 2 showed a similar trend on mortality, and had a shorter exacerbation-free survival compared with those without CID.Conclusions: Adoption of CID is a beneficial and useful way for the assessment of long-term disease progression and clinical outcomes even in Japanese population with COPD. The definition of CID might be optimized according to the characteristics of COPD population and the observation period for CID.

scholarly journals Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease

2021 ◽  
Author(s):  
Rutao Wang ◽  
Scot Garg ◽  
Chao Gao ◽  
Hideyuki Kawashima ◽  
Masafumi Ono ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Coronary Revascularization ◽  
Long Term Outcomes ◽  
Vital Status ◽  
Increased Risk ◽  
Artery Disease ◽  
The Impact

Abstract Aims To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). Methods The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. Results Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08–1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83–1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p-interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11–4.23, p < 0.001) compared to those without CVD. Conclusions The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. Trial registration SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050. Graphic abstract

Impact of Hybrid Operating Rooms on Long-Term Clinical Outcomes Following Fenestrated and Branched Endovascular Aortic Repair

2021 ◽  
pp. 152660282199672
Author(s):  
Giovanni Tinelli ◽  
Marie Bonnet ◽  
Adrien Hertault ◽  
Simona Sica ◽  
Gian Luca Di Tanna ◽  
...  
Keyword(s):  
Operating Room ◽  
Clinical Outcomes ◽  
Cox Regression ◽  
Statistical Significance ◽  
Aortic Aneurysms ◽  
Study Patient ◽  
Cox Regression Analysis ◽  
Significant Difference ◽  
The Impact

Purpose: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. Materials and Methods: Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. Results: A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. Conclusion: Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.

scholarly journals Impact of Diagnosed and Undiagnosed Respiratory Pseudomonas on VAP and VAE During Long-Term Acute Care

2020 ◽  
Vol 41 (S1) ◽  
pp. s258-s259
Author(s):  
James Harrigan ◽  
Ebbing Lautenbach ◽  
Emily Reesey ◽  
Magda Wernovsky ◽  
Pam Tolomeo ◽  
...  
Keyword(s):  
Bacterial Community ◽  
Acute Care ◽  
Statistical Significance ◽  
Rrna Gene ◽  
Care Hospital ◽  
16S Sequencing ◽  
Increased Risk ◽  
Wide Range ◽  
The Impact

Background: Clinically diagnosed ventilator-associated pneumonia (VAP) is common in the long-term acute-care hospital (LTACH) setting and may contribute to adverse ventilator-associated events (VAEs). Pseudomonas aeruginosa is a common causative organism of VAP. We evaluated the impact of respiratory P. aeruginosa colonization and bacterial community dominance, both diagnosed and undiagnosed, on subsequent P. aeruginosa VAP and VAE events during long-term acute care. Methods: We enrolled 83 patients on LTACH admission for ventilator weaning, performed longitudinal sampling of endotracheal aspirates followed by 16S rRNA gene sequencing (Illumina HiSeq), and bacterial community profiling (QIIME2). Statistical analysis was performed with R and Stan; mixed-effects models were fit to relate the abundance of respiratory Psa on admission to clinically diagnosed VAP and VAE events. Results: Of the 83 patients included, 12 were diagnosed with P. aeruginosa pneumonia during the 14 days prior to LTACH admission (known P. aeruginosa), and 22 additional patients received anti–P. aeruginosa antibiotics within 48 hours of admission (suspected P. aeruginosa); 49 patients had no known or suspected P. aeruginosa (unknown P. aeruginosa). Among the known P. aeruginosa group, all 12 patients had P. aeruginosa detectable by 16S sequencing, with elevated admission P. aeruginosa proportional abundance (median, 0.97; IQR, 0.33–1). Among the suspected P. aeruginosa group, all 22 patients had P. aeruginosa detectable by 16S sequencing, with a wide range of admission P. aeruginosa proportional abundance (median, 0.0088; IQR, 0.00012–0.31). Of the 49 patients in the unknown group, 47 also had detectable respiratory Psa, and many had high P. aeruginosa proportional abundance at admission (median, 0.014; IQR, 0.00025–0.52). Incident P. aeruginosa VAP was observed within 30 days in 4 of the known P. aeruginosa patients (33.3%), 5 of the suspected P. aeruginosa patients (22.7%), and 8 of the unknown P. aeruginosa patients (16.3%). VAE was observed within 30 days in 1 of the known P. aeruginosa patients (8.3%), 2 of the suspected P. aeruginosa patients (9.1%), and 1 of the unknown P. aeruginosa patients (2%). Admission P. aeruginosa abundance was positively associated with VAP and VAE risk in all groups, but the association only achieved statistical significance in the unknown group (type S error <0.002 for 30-day VAP and <0.011 for 30-day VAE). Conclusions: We identified a high prevalence of unrecognized respiratory P. aeruginosa colonization among patients admitted to LTACH for weaning from mechanical ventilation. The admission P. aeruginosa proportional abundance was strongly associated with increased risk of incident P. aeruginosa VAP among these patients.Funding: NoneDisclosures: None

Insulin resistance induced by long-term sleep deprivation in rhesus macaques can be attenuated by Bifidobacterium

2021 ◽  
Author(s):  
Ying Zhao ◽  
Yan Shu ◽  
Ning Zhao ◽  
Zili Zhou ◽  
Xiong Jia ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Circadian Rhythm ◽  
Blood Glucose ◽  
Glucose Metabolism ◽  
Sleep Deprivation ◽  
Rhesus Macaques ◽  
Intravenous Glucose ◽  
Increased Risk ◽  
The Impact

Long-term sleep deprivation (SD) is a bad lifestyle habit, especially among specific occupational practitioners, characterized by circadian rhythm misalignment and abnormal sleep/wake cycles. SD is closely associated with an increased risk of metabolic disturbance, particularly obesity and insulin resistance. The incretin hormone, glucagon-like peptide-1 (GLP-1), is a critical insulin release determinant secreted by the intestinal L-cell upon food intake. Besides, the gut microbiota participates in metabolic homeostasis and regulates GLP-1 release in a circadian rhythm manner. As a commonly recognized intestinal probiotic, Bifidobacterium has various clinical indications regarding its curative effect. However, few studies have investigated the effect of Bifidobacterium supplementation on sleep disorders. In the present study, we explored the impact of long-term SD on the endocrine metabolism of rhesus monkeys and determined the effect of Bifidobacterium supplementation on the SD-induced metabolic status. Lipids concentrations, body weight, fast blood glucose, and insulin levels increased after SD. Furthermore, after two months of long-term SD, the intravenous glucose tolerance test (iVGTT) showed that the glucose metabolism was impaired and the insulin sensitivity decreased. Moreover, one month of Bifidobacterium oral administration significantly reduced blood glucose and attenuated insulin resistance in rhesus macaques. Overall, our results suggested that Bifidobacterium might be used to alleviate SD-induced aberrant glucose metabolism and improve insulin resistance. Also, it might help in better understanding the mechanisms governing the beneficial effects of Bifidobacterium.

Impact of the Ebola epidemic on clinical outcomes of HIV-infected soldiers and their dependents in Sierra Leone

2018 ◽  
Vol 30 (2) ◽  
pp. 106-112 ◽  
Author(s):  
Elizabeth Nagel ◽  
Michael J Blackowicz ◽  
Foday Sahr ◽  
Olamide D Jarrett
Keyword(s):  
Clinical Outcomes ◽  
Sierra Leone ◽  
Repeated Measures ◽  
Disease Outbreaks ◽  
Armed Forces ◽  
Hiv Treatment ◽  
Hiv Care ◽  
Increased Risk ◽  
The Republic ◽  
The Impact

The impact of the 2014–2016 Ebola epidemic in West Africa on human immunodeficiency virus (HIV) treatment in Sierra Leone is unknown, especially for groups with higher HIV prevalence such as the military. Using a retrospective study design, clinical outcomes were evaluated prior to and during the epidemic for 264 HIV-infected soldiers of the Republic of Sierra Leone Armed Forces (RSLAF) and their dependents receiving HIV treatment at the primary RSLAF HIV clinic. Medical records were abstracted for baseline clinical data and clinic attendance. Estimated risk of lost to follow-up (LTFU), default, and number of days without antiretroviral therapy (DWA) were calculated using repeated measures general estimating equations adjusted for age and gender. Due to missing data, 262 patients were included in the final analyses. There was higher risk of LTFU throughout the Ebola epidemic in Sierra Leone compared to the pre-Ebola baseline, with the largest increase in LTFU risk occurring at the peak of the epidemic (relative risk: 3.22, 95% CI: 2.22–4.67). There was an increased risk of default and DWA during the Ebola epidemic for soldiers but not for their dependents. The risk of LTFU, default, and DWA stabilized once the epidemic was largely resolved but remained elevated compared to the pre-Ebola baseline. Our findings demonstrate the negative and potentially lasting impact of the Ebola epidemic on HIV care in Sierra Leone and highlight the need to develop strategies to minimize disruptions in HIV care with future disease outbreaks.

scholarly journals Interleukin-1 Receptor Antagonist Synthesis by Peripheral Blood Mononuclear Cells

2000 ◽  
Vol 11 (11) ◽  
pp. 2114-2121
Author(s):  
VAIDYANATHAPURAM S. BALAKRISHNAN ◽  
CHRISTOPHER H. SCHMID ◽  
BERTRAND L. JABER ◽  
SVETLOZAR N. NATOV ◽  
ANDREW J. KING ◽  
...  
Keyword(s):  
Relative Risk ◽  
Receptor Antagonist ◽  
Clinical Outcomes ◽  
Peripheral Blood ◽  
Interleukin 1 ◽  
Peripheral Blood Mononuclear ◽  
Interleukin 1 Receptor Antagonist ◽  
Increased Risk

Abstract. Proinflammatory cytokines have been implicated in the short- and long-term morbidity experienced by hemodialysis (HD) patients. The present study, which is based on long-term follow-up of a cohort of 37 patients, relates peripheral blood mononuclear cell (PBMC) interleukin-1 receptor antagonist (IL-1Ra) synthesis (a reliable marker of IL-1β synthesis in HD patients) and plasma levels of an acute phase reactant, lipopolysaccharide binding protein (LBP), to clinical outcomes. In July 1993, predialysis blood samples from these patients were collected and IL-1Ra synthesis by PBMC and plasma LBP was measured. Hospital records were reviewed and patient follow-up data were obtained until December 1997 (54 mo) or death, whichever occurred earlier. The effect of age, diabetes, endotoxin- and IgG-stimulated IL-1Ra synthesis, and plasma LBP levels on mortality was assessed using the Cox proportional hazard regression model. Poisson regression was used to determine potential relationships between the number of outcome events and each continuous risk factor. Twenty-two patients (59%) died during the follow-up period. Mortality was unrelated to IL-1Ra synthesis but did increase with age (relative risk, 1.05/yr; P = 0.01) and diabetes (relative risk, 3.00/yr; P = 0.03). Cardiovascular event rates were higher among older individuals and in those with higher endotoxin-stimulated PBMC IL-1Ra synthesis. Cardiovascular events increased with plasma LBP levels in the range of 9,000 to 12,000 pg/ml but then seemed to decrease. In contrast, older age and low IgG-stimulated IL-1Ra synthesis were associated with an increased risk of infectious events. The results of this study demonstrate an interesting link between stimulus-dependent variability in IL-1Ra synthesis by PBMC and clinical outcomes among patients on chronic HD and provide interesting targets for therapeutic interventions in this vulnerable patient population.

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