Human immunodeficiency virus type 1 incidence among blood donors in France, 1992 through 2006: use of an immunoassay to identify recent infections

BACKGROUND: In France, blood donations found to be positive for the presence of human immunodeficiency virus type 1 (HIV-1) are further tested to detect recent infections (≤180 days) using an enzyme immunoassay (EIA-RI) developed in 2002. The characteristics of recently infected donors, estimates of HIV-1 incidence, and the residual risk of transfusion-transmitted HIV-1 are presented, in both first-time and repeat donors. STUDY DESIGN AND METHODS: Of the 1027 donations found to be HIV-1–positive between 1992 and 2006, a total of 459 could be retrospectively tested with the EIA-RI. Multivariate analysis was performed to determine the donor characteristics associated with recent infection. Incidence rates and residual risk obtained with the EIA-RI were compared to classical cohort estimates derived from repeat donor histories. RESULTS: Of the 459 HIV-1–positive donors studied, 105 (22.9%; 95% confidence interval [CI], 19.2-27.0) were identified as recently infected. Factors independently associated with recent infection were repeat donor status (adjusted odds ratio [AOR], 4.0; 95% CI, 2.4-6.9) and non-B subtypes (AOR, 2.0; 95% CI, 1.2-3.6). Incidence decreased from 4.3 (95% CI, 1.9-9.4) in 1992 through 1994 to 1.3 (95% CI, 0.6-2.8) per 105 in 2004 through 2006 in first-time donors and from 3.2 (95% CI, 2.0-5.0) to 0.8 (95% CI, 0.4-1.4) per 105 in repeat donors. Incidence and residual risk estimates were similar to those obtained with the classical cohort method. CONCLUSION: This study suggests that the EIA-RI can be used to estimate HIV-1 incidence in a population with low HIV incidence. The estimated HIV-1 incidence in the blood donor population confirms the extremely low risk (1 in 3,350,000 donations) of HIV-infected blood donations entering the blood supply in France

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Simultaneous Detection of Hepatitis C Virus (HCV) Core Antigen and Anti-HCV Antibodies Improves the Early Detection of HCV Infection

To evaluate whether a new enzyme immunoassay developed for the simultaneous detection of hepatitis C virus (HCV) core antigen (Ag) and anti-HCV antibodies (anti-HCV Ab) (Monolisa HCV Ag/Ab ULTRA; Bio-Rad) could improve the early detection of HCV infection, we compared its sensitivity to that of anti-HCV, HCV core Ag, and HCV RNA assays. The populations studied included 12 blood donor samples positive for HCV RNA and HCV core Ag but negative for anti-HCV antibodies and 23 hemodialysis patients who developed anti-HCV Ab (seroconversion) during the follow-up. From these 23 individuals, 83 samples sequentially collected prior to seroconversion and 108 samples collected after seroconversion were tested. Six of 12 blood donations were positive by the HCV Ag/Ab assay. In the hemodialysis cohort, the 24 HCV RNA-negative samples were negative by the HCV Ag/Ab assay and 23 of the 59 HCV RNA-positive samples (39%) were positive. The HCV Ag/Ab assay detected HCV infection on average 21.6 days before the most sensitive antibody assay. The HCV Ag/Ab assay did not detect HCV infection as early as the HCV RNA assay (mean delay, 30.3 days) or HCV Ag assay (mean delays, 27.9, and 16.3 days by the HCV core Ag quantification assay and the HCV Ag blood screening assay, respectively). This new assay provides a notable improvement for the early detection of HCV infection during the so-called window period compared with anti-HCV Ab assays and could be a useful alternative to HCV RNA detection or HCV core Ag assays for diagnosis or blood screening when nucleic acid technologies or HCV core Ag detection are not implemented

Isolated left ventricular non-compaction in adults: clinical and echocardiographic features in 105 patients. Results from a French registry.

International audienceAIMS: The clinical features, prognosis, and even definition of left ventricular non-compaction (LVNC) are still the subject of much debate. The aim of this registry was to describe the clinical, echocardiographic, and prognostic features of LVNC in France. The main endpoint was to assess clinical and echocardiographic predictors of adverse outcome, defined as death or heart transplantation. METHODS AND RESULTS: Between 2004 and 2006, 154 suspected cases of LNVC were identified from a nationwide survey in France. The diagnosis of LVNC was confirmed in 105 cases by echocardiographic evaluation in a core laboratory. Clinical and echocardiographic data for the 105 cases of LVNC are presented. Left ventricular non-compaction was first detected from heart failure symptoms in 45 patients, rhythm disorders in 12, and familial screening in 8. Left ventricular ejection fraction (LVEF) was < 30% in 46% of patients, but ≥ 50% in 16%. The latter had less symptoms of severe heart failure (11 vs. 54%, P = 0.001), but similar extension of the NC zone. During 2.33 ± 1.47 years of follow-up, several complications occurred, including severe heart failure in 33 patients, transplantation in 9, ventricular arrhythmia in 7, embolic events in 9, and death in 12. Factors associated with death or heart transplantation were NYHA 3 or 4 (HR = 6.69; P = 0.0007), high LV filling pressures (HR = 7.59; P = 0.001), LVEF (HR = 0.93; P = 0.006), and hospitalization for heart failure (HR = 13.55; P < 0.0001). CONCLUSION: In this large reported series of LVNC, we observed that: (i) Left ventricular non-compaction was detected by familial screening in asymptomatic patients in 8% of cases. (ii) Left ventricular non-compaction was frequently over-diagnosed by echocardiography. (iii) Patients identified as LVNC presented with a high risk of severe complications, transplantation or death and needed close follow-up

Neurological disorders in essential thrombocythemia

Patients with essential thrombocythemia often complain of various subjective neurological symptoms. This prospective study aims to assess their incidence and response to therapy. Among 37 consecutive patients with essential thrombocythemia, 11 presented with neurological symptoms. Among them 4 had thrombotic events, 7 complained of transient or fluctuating subjective symptoms, and one had both. Brain magnetic resonance imagery failed to detect any substratum in patients with subjective symptoms. JAK2V617F mutation was found in 9 of 11 patients with neurological symptoms versus 14 of 26 patients without symptoms. Ten patients received low-dose aspirin for these symptoms: complete resolution was observed in 3, improvement with persisting episodes in 2, and resistance to aspirin in 2 patients, in whom addition of cytoreductive therapy became necessary to resolve those disabling symptoms

Human immunodeficiency virus type 1 incidence among blood donors in France, 1992 through 2006: use of an immunoassay to identify recent infections

International audienceBACKGROUND: In France, blood donations found to be positive for the presence of human immunodeficiency virus type 1 (HIV-1) are further tested to detect recent infections (≤180&nbsp;days) using an enzyme immunoassay (EIA-RI) developed in 2002. The characteristics of recently infected donors, estimates of HIV-1 incidence, and the residual risk of transfusion-transmitted HIV-1 are presented, in both first-time and repeat donors. STUDY DESIGN AND METHODS: Of the 1027 donations found to be HIV-1–positive between 1992 and 2006, a total of 459 could be retrospectively tested with the EIA-RI. Multivariate analysis was performed to determine the donor characteristics associated with recent infection. Incidence rates and residual risk obtained with the EIA-RI were compared to classical cohort estimates derived from repeat donor histories. RESULTS: Of the 459 HIV-1–positive donors studied, 105 (22.9%; 95% confidence interval [CI], 19.2-27.0) were identified as recently infected. Factors independently associated with recent infection were repeat donor status (adjusted odds ratio [AOR], 4.0; 95% CI, 2.4-6.9) and non-B subtypes (AOR, 2.0; 95% CI, 1.2-3.6). Incidence decreased from 4.3 (95% CI, 1.9-9.4) in 1992 through 1994 to 1.3 (95% CI, 0.6-2.8) per 105 in 2004 through 2006 in first-time donors and from 3.2 (95% CI, 2.0-5.0) to 0.8 (95% CI, 0.4-1.4) per 105 in repeat donors. Incidence and residual risk estimates were similar to those obtained with the classical cohort method. CONCLUSION: This study suggests that the EIA-RI can be used to estimate HIV-1 incidence in a population with low HIV incidence. The estimated HIV-1 incidence in the blood donor population confirms the extremely low risk (1 in 3,350,000 donations) of HIV-infected blood donations entering the blood supply in France.</p

Mid-term outcome of de novo lesions vs. in stent restenosis treated by intravascular lithotripsy procedures: Insights from the French Shock Initiative

International audienceBackground: Intravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified coronary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion.Methods: Prospective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as <30% residual stenosis without severe angiographic complications. Event rates were analysed for the cohort and for DNL and ISR procedures separately.Results: A total of 220 lesions were treated (76.7% DNL and 23.3% ISR) in 202 patients. Procedural success was achieved in 95.5% of patients (DNL group: 96.5%; ISR group: 92.0%). In-hospital MACE occurred in 6.4% of cases, mainly driven by periprocedural infarctions. The rate of MACE-free survival at 1 year was 86.6% in the overall cohort. Rates of target vessel (TVR) and lesion (TLR) revascularisation were 6.4% and 2.5%, respectively. The 1-year MACE rate was 91.5% in DNL group and 83.8% in ISR group.Conclusions: In this large all-comers IVL cohort, rates of in-hospital and 1-year MACE were moderate. The safety and efficiency of IVL was comparable in DNL and ISR lesions. A comparative study of the impact of IVL on outcomes appears warranted