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1.
Expert Rev Med Devices ; 16(11): 989-997, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31648570

ABSTRACT

Background: Saline is not biocompatible with saphenous vein grafts and does not protect against ischemia reperfusion injury. We compared normal heparinized saline with DuraGraft, a new graft-storage solution, in in-vitro and ex-vivo assays to evaluate the effects on cells and vascular graft tissue.Methods: Human saphenous vein (HSV) segments and isolated pig mammary veins (PMVs) were flushed and submerged in heparinized DuraGraft or heparinized saline for prespecified times. Following exposure, HSV segments were evaluated for viability and tissue morphology, and PMVs underwent histological assessments, to evaluate vein morphology and effects on the vascular endothelium. The performance of saline versus DuraGraft was compared in an ISO-compliant biocompatibility assay for cytotoxicity.Results: Loss of HSV graft-cell viability was observed as early as 15 minutes post-exposure to saline whereas viability was maintained up to 5 hours' exposure to DuraGraft. Histological analyses performed with PMVs demonstrated endothelial damage in PMVs stored in saline. Cytotoxicity assays demonstrated that saline-induced microscopically visible cell damage occurred within 60 minutes. DuraGraft-treated cells did not show evidence of damage or reactivity.Conclusions: Normal saline caused damage to vascular endothelium, loss of graft cell viability, and mediated cell damage; no evidence of damage or reactivity was observed in DuraGraft-exposed cells.


Subject(s)
Blood Vessel Prosthesis , Coronary Artery Bypass , Intraoperative Care , Saphenous Vein/transplantation , Aged , Animals , Cell Death , Cell Line , Female , Humans , Male , Mammary Glands, Animal/blood supply , Mice , Platelet Endothelial Cell Adhesion Molecule-1/metabolism , Swine , von Willebrand Factor/metabolism
2.
Int J Cardiol ; 217: 85-91, 2016 Aug 15.
Article in English | MEDLINE | ID: mdl-27179213

ABSTRACT

OBJECTIVE: The HAS-BLED, ATRIA, and HEMORR2HAGES risk scores were created to evaluate individual bleeding risk in atrial fibrillation (AF). We sought to estimate and compare the predictive ability of these scores for major hemorrhage in AF, including elderly (≥80years) and non-elderly (<80years) patients. METHODS: This cross-sectional study is based on the French National Hospital Database (PMSI), which covers the entire French population. Data from all patients with an AF diagnosis in 2012 were extracted. Demographic and comorbidity data were used to calculate the three bleeding risk scores for each patient. Patients hospitalized with a principal diagnosis of major bleeding were identified. RESULTS: Of the 533,044 AF patients identified, 53.2% were ≥80years; 7013 patients (1.3%) were hospitalized for a bleeding event (1785 for intracranial hemorrhage). Bleeding occurred more frequently in patients with higher HAS-BLED, HEMORR2HAGES, and ATRIA scores. In patients ≥80years, the c-statistics did not differ (p=0.27) between HAS-BLED (0.54; 95% confidence interval [CI]: 0.53-0.54), HEMORR2HAGES (0.53; 95% CI: 0.53-0.54), and ATRIA (0.53; 95% CI: 0.52-0.54). In patients <80years, HAS-BLED (0.59; 95% CI: 0.58-0.60) had a slightly higher c-statistic than HEMORR2HAGES (0.56; 95% CI: 0.55-0.57) and ATRIA (0.55, 95% CI: 0.55-0.56) (p<0.0001). CONCLUSIONS: Given its simplicity and similar performance, HAS-BLED may be an attractive alternative to HEMORR2HAGES for estimation of bleeding risk in AF patients <80years. However, accurate determination of bleeding risk among the elderly is difficult with existing risk-prediction scores, indicating a clear need for improvement in their clinical utility.


Subject(s)
Atrial Fibrillation/diagnosis , Intracranial Hemorrhages/diagnosis , Aged , Aged, 80 and over , Atrial Fibrillation/complications , Cross-Sectional Studies , Female , Humans , Inpatients , Intracranial Hemorrhages/etiology , Male , Predictive Value of Tests , ROC Curve , Retrospective Studies , Risk Assessment
3.
PLoS One ; 10(3): e0121429, 2015.
Article in English | MEDLINE | ID: mdl-25816146

ABSTRACT

BACKGROUND: The risk of venous thromboembolism (VTE) can be reduced by appropriate use of anticoagulant prophylaxis. VTE prophylaxis does, however, remain substantially underused, particularly among acutely ill medical inpatients. We sought to evaluate the clinical and economic impact of increasing use of American College of Chest Physicians (ACCP)-recommended VTE prophylaxis among medical inpatients from a US healthcare system perspective. METHODS AND FINDINGS: In this retrospective database cost-effectiveness evaluation, a decision-tree model was developed to estimate deaths within 30 days of admission and outcomes attributable to VTE that might have been averted by use of low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH). Incremental cost-effectiveness ratio was calculated using "no prophylaxis" as the comparator. Data from the ENDORSE US medical inpatients and the US nationwide Inpatient Sample (NIS) were used to estimate the annual number of eligible inpatients who failed to receive ACCP-recommended VTE prophylaxis. The cost-effectiveness analysis indicated that VTE-prevention strategies would reduce deaths by 0.5% and 0.3%, comparing LMWH and UFH strategies with no prophylaxis, translating into savings of $50,637 and $25,714, respectively, per death averted. The ENDORSE findings indicated that 51.1% of US medical inpatients were at ACCP-defined VTE risk, 47.5% of whom received ACCP-recommended prophylaxis. By extrapolating these findings to the NIS and applying cost-effectives analysis results, the full implementation of ACCP guidelines would reduce number of deaths (by 15,875 if using LMWH or 10,201 if using UFH), and was extrapolated to calculate the cost reduction of $803M for LMWH and $262M for UFH. CONCLUSIONS: Efforts to improve VTE prophylaxis use in acutely ill inpatients are warranted due to the potential for reducing VTE-attributable deaths, with net cost savings to healthcare systems.


Subject(s)
Anticoagulants/therapeutic use , Heparin/therapeutic use , Pre-Exposure Prophylaxis/economics , Venous Thromboembolism/prevention & control , Anticoagulants/economics , Cost-Benefit Analysis , Critical Care/economics , Cross-Sectional Studies , Heparin, Low-Molecular-Weight/therapeutic use , Humans , Pre-Exposure Prophylaxis/methods , Prospective Studies , United States , Venous Thromboembolism/economics
4.
Circ Cardiovasc Qual Outcomes ; 8(2 Suppl 1): S12-20, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25714828

ABSTRACT

BACKGROUND: Among patients with atrial fibrillation (AF), women are at higher risk of stroke than men. Using prospective cohort data from a large global population of patients with nonvalvular AF, we sought to identify any differences in the use of anticoagulants for stroke prevention in women and men. METHODS AND RESULTS: This was a prospective multicenter observational registry with 858 randomly selected sites in 30 countries. A total of 17 184 patients with newly diagnosed (≤6 weeks) nonvalvular AF and ≥1 additional investigator-defined stroke risk factor(s) were recruited (March 2010 to June 2013). The main outcome measure was the use of anticoagulants (vitamin K antagonists, factor Xa inhibitors, and direct thrombin inhibitors) for stroke prevention at AF diagnosis. Of 17 184 patients enrolled, 43.8% were women. More women than men were at moderate-to-high risk of stroke (CHADS2 score ≥2: 65.1% versus 54.7%). Rates of anticoagulant use were not different overall (60.9% of men versus 60.8% of women) and in patients with a CHADS2 score ≥2 (adjusted odds ratio for women versus men, 1.00; 95% confidence interval, 0.92-1.09). In patients at low risk (CHA2DS2-VASc of 0 in men and 1 in women), 41.8% of men and 41.1% of women received an anticoagulant. In patients at high risk (CHA2DS2-VASc score ≥2), 35.4% of men and 38.4% of women did not receive an anticoagulant. CONCLUSIONS: These contemporary global data show that anticoagulant use for stroke prevention is no different in men and women with nonvalvular AF. Thromboprophylaxis was, however, suboptimal in substantial proportions of men and women, with underuse in those at moderate-to-high risk of stroke and overuse in those at low risk. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Fibrinolytic Agents/therapeutic use , Stroke/prevention & control , Aged , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/mortality , Female , Fibrinolytic Agents/adverse effects , Health Status Disparities , Humans , Male , Middle Aged , Prospective Studies , Registries , Risk Assessment , Risk Factors , Sex Factors , Stroke/diagnosis , Stroke/etiology , Stroke/mortality , Treatment Outcome
5.
Eur Heart J Cardiovasc Pharmacother ; 1(3): 198-204, 2015 07.
Article in English | MEDLINE | ID: mdl-27533996

ABSTRACT

Platelet activation and aggregability play a key role in the genesis of arterial thrombus secondary to plaque rupture. For coronary patients, inhibition of platelet function is crucial to decrease the rate of major adverse cardiac events but may expose them to excess bleeding risk. Switching P2Y12 inhibitors is common, yet the clinical consequences are unknown. The aim of this review is to provide an overview of the evidence from randomized, clinical trials and epidemiological studies, with a focus on the optimal duration of dual antiplatelet therapy (DAPT) and appropriate agent and dose selection. The report discusses the latest evidence regarding switching therapies during DAPT, the potential benefits of a personalized strategy, management of the preoperative period, and other clinical perspectives in this complex and rapidly changing field. Ongoing trials will be useful to answer to some important unresolved questions.


Subject(s)
Coronary Artery Disease/surgery , Coronary Thrombosis/drug therapy , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Postoperative Complications/drug therapy , Purinergic P2Y Receptor Antagonists/therapeutic use , Coronary Thrombosis/etiology , Drug Therapy, Combination , Humans
6.
Arch Cardiovasc Dis ; 107(8-9): 452-61, 2014.
Article in English | MEDLINE | ID: mdl-25128934

ABSTRACT

BACKGROUND: Improvements in the treatment of coronary artery disease mean that an increasing number of patients survive acute cardiovascular events and live as outpatients with or without anginal symptoms. AIM: To determine the characteristics and management of contemporary outpatients with stable coronary artery disease in Western Europe, and to compare France with the other Western European countries. METHODS: CLARIFY (prospeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease) is an international, prospective, observational, longitudinal study. Between November 2009 and July 2010, 32,954 adult outpatients with stable coronary artery disease (defined as a history of documented myocardial infarction [of >3 months], prior coronary revascularization, chest pain with myocardial ischaemia, or coronary stenosis of>50% proven by angiography) were enrolled in 45 countries. The demographics and management of CLARIFY patients enrolled in France were compared with those enrolled in other Western European countries (Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland and the UK). RESULTS: Of the 14,726 patients enrolled in Western Europe (mean age 66.2 [10.2] years; 79.6% male), 2432 (16.5%) were from France. The use of aspirin was lower in France than in other Western European countries (74.5% vs. 86.9%, respectively), whereas use of thienopyridines (48.5% vs. 21.7%), oral anticoagulants (12.3% vs. 9.0%) and lipid-lowering drugs (95.8% vs. 92.5%) was higher. Beta-blockers were used in 73% of both groups. Angina was less prevalent in France (6.3% vs. 15.5%) and French patients showed higher levels of physical activity than their counterparts in Western Europe. CONCLUSIONS: The management of patients with stable CAD in France appears favourable, with good adherence to guideline-based therapies, but there remains room for improvement in terms of symptom and risk factor control.


Subject(s)
Ambulatory Care , Coronary Artery Disease/drug therapy , Practice Patterns, Physicians' , Aged , Cardiovascular Agents/therapeutic use , Coronary Artery Disease/diagnosis , Coronary Artery Disease/epidemiology , Drug Utilization Review , Female , France/epidemiology , Guideline Adherence , Humans , Longitudinal Studies , Male , Middle Aged , Practice Guidelines as Topic , Prevalence , Prospective Studies , Registries , Risk Factors , Time Factors , Treatment Outcome
7.
J Bone Miner Res ; 29(1): 260-7, 2014 Jan.
Article in English | MEDLINE | ID: mdl-23794198

ABSTRACT

Antiosteoporosis medication (AOM) does not abolish fracture risk, and some individuals experience multiple fractures while on treatment. Therefore, criteria for treatment failure have recently been defined. Using data from the Global Longitudinal Study of Osteoporosis in Women (GLOW), we analyzed risk factors for treatment failure, defined as sustaining two or more fractures while on AOM. GLOW is a prospective, observational cohort study of women aged ≥55 years sampled from primary care practices in 10 countries. Self-administered questionnaires collected data on patient characteristics, fracture risk factors, previous fractures, AOM use, and health status. Data were analyzed from women who used the same class of AOM continuously over 3 survey years and had data available on fracture occurrence. Multivariable logistic regression was used to identify independent predictors of treatment failure. Data from 26,918 women were available, of whom 5550 were on AOM. During follow-up, 73 of 5550 women in the AOM group (1.3%) and 123 of 21,368 in the non-AOM group (0.6%) reported occurrence of two or more fractures. The following variables were associated with treatment failure: lower Short Form 36 Health Survey (SF-36) score (physical function and vitality) at baseline, higher Fracture Risk Assessment Tool (FRAX) score, falls in the past 12 months, selected comorbid conditions, prior fracture, current use of glucocorticoids, need of arms to assist to standing, and unexplained weight loss ≥10 lb (≥4.5 kg). Three variables remained predictive of treatment failure after multivariable analysis: worse SF-36 vitality score (odds ratio [OR] per 10-point increase, 0.85; 95% confidence interval [CI], 0.76-0.95; p = 0.004); two or more falls in the past year (OR, 2.40; 95% CI, 1.34-4.29; p = 0.011), and prior fracture (OR, 2.93; 95% CI, 1.81-4.75; p < 0.0001). The C statistic for the model was 0.712. Specific strategies for fracture prevention should therefore be developed for this subgroup of patients.


Subject(s)
Bone Density Conservation Agents/therapeutic use , Fractures, Bone/epidemiology , Osteoporosis, Postmenopausal/drug therapy , Accidental Falls , Aged , Comorbidity , Diphosphonates/therapeutic use , Female , Fractures, Bone/prevention & control , Humans , Longitudinal Studies , Middle Aged , Osteoporosis, Postmenopausal/epidemiology , Prospective Studies , Risk Factors , Treatment Failure
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