Modeling complete removal of risk assessment questions in the USA predicts the risk of HIV exposure in blood recipients could increase despite the use of nucleic acid testing.

BACKGROUND AND OBJECTIVES: The safety of the blood supply in a number of countries is achieved by interventions that include behaviour-based time-limited or indefinite deferrals and screening of donated units for transfusion-transmitted infections. The relatively high sensitivity of nucleic acid testing (NAT) used in blood donor screening has raised the question of whether such time-based deferrals can be eliminated in favour of individual risk assessment. MATERIALS AND METHODS: Data on the annual number of incident human immunodeficiency virus (HIV) infections associated with various behaviours and on the performance characteristics of NAT applied to donor screening were used to model the number of potentially infected units that might escape detection in the worst-case scenario in which individual risk assessment was implemented, but was not effective as a screening tool, and donors did not otherwise self-select for lower risk. RESULTS: In the absence of effective individual risk-based screening or donor self-selection, the model predicts that in the United States, an additional 39 (95% CI 35-43) HIV-infected units would escape detection by nucleic acid testing, potentially capable of exposing approximately 68 (95% CI 61-75) individuals to the risk of HIV infection through the administration of prepared blood components. CONCLUSION: Despite some inherent uncertainty, the worst-case scenario of completely ineffective individual risk assessment, absence of donor self-selection and increased reliance on NAT for blood screening is estimated to be associated with an approximately fourfold increase in the risk of HIV exposure through transfusion in the United States.

Clotting factor product administration and same-day occurrence of thrombotic events, as recorded in a large healthcare database during 2008-2013.

BACKGROUND: Thrombotic events (TEs) are serious adverse events that can occur following administration of clotting factors (CFs). OBJECTIVES: To evaluate occurrence of same-day TEs for different CF products and potential risk factors. METHODS: A retrospective cohort study of individuals exposed to CF products during 2008-2013 was conducted using a large commercial insurance database. CF products were identified by procedure codes, and TEs were ascertained via diagnosis codes. Crude same-day TE rates (per 1000 persons exposed) were estimated overall and by congenital factor deficiency (CFD) status, CF products, age and gender. Multivariable logistic regression analyses were used to control for confounding. Laboratory analysis was used to compare the procoagulant activities of FIX products. RESULTS: Of 3801 individuals exposed to CFs, 117 (30.8 per 1000) had same-day TEs recorded. The crude same-day TE rate was higher for CF users without CFD, 70.2 (102 of 1452), as compared with those with CFD, 6.4 (15 of 2349) (RR, 11.0; 95% CI, 6.4-18.9). For individuals without CFD, a significantly increased same-day TE risk was identified for factor IX complex (OR, 6.92; 95% CI, 3.11-15.40), factor VIIa (OR, 9.42; 95% CI, 4.99-17.78) and other products when compared with fibrin sealant. An increased risk of a TE was found with older age (≥ 45 years), history of TEs and underlying health conditions. The laboratory identified elevated procoagulant activity in Profilnine(®) and Benefix(®) . CONCLUSIONS: The study shows an increased same-day TE risk for CF users without CFD and suggests substantial off-label CF use. The study findings also show elevated same-day TE rates for different CF products and suggest the importance of product properties and patient factors.

Establishment of the first international repository for transfusion-relevant bacteria reference strains: ISBT working party transfusion-transmitted infectious diseases (WP-TTID), subgroup on bacteria.

BACKGROUND: Bacterial contamination of platelet concentrates (PCs) still remains a significant problem in transfusion with potential important clinical consequences, including death. The International Society of Blood Transfusion Working Party on Transfusion-Transmitted Infectious Diseases, Subgroup on Bacteria, organised an international study on Transfusion-Relevant Bacteria References to be used as a tool for development, validation and comparison of both bacterial screening and pathogen reduction methods. MATERIAL AND METHODS: Four Bacteria References (Staphylococcus epidermidis PEI-B-06, Streptococcus pyogenes PEI-B-20, Klebsiella pneumoniae PEI-B-08 and Escherichia coli PEI-B-19) were selected regarding their ability to proliferate to high counts in PCs and distributed anonymised to 14 laboratories in 10 countries for identification, enumeration and bacterial proliferation in PCs after low spiking (0·3 and 0·03 CFU/ml), to simulate contamination occurring during blood donation. RESULTS: Bacteria References were correctly identified in 98% of all 52 identifications. S. pyogenes and E. coli grew in PCs in 11 out of 12 laboratories, and K. pneumoniae and S. epidermidis replicated in all participating laboratories. The results of bacterial counts were very consistent between laboratories: the 95% confidence intervals were for S. epidermidis: 1·19-1·32 × 10(7) CFU/ml, S. pyogenes: 0·58-0·69 × 10(7) CFU/ml, K. pneumoniae: 18·71-20·26 × 10(7) CFU/ml and E. coli: 1·78-2·10 × 10(7) CFU/ml. CONCLUSION: The study was undertaken as a proof of principle with the aim to demonstrate (i) the quality, stability and suitability of the bacterial strains for low-titre spiking of blood components, (ii) the property of donor-independent proliferation in PCs, and (iii) their suitability for worldwide shipping of deep frozen, blinded pathogenic bacteria. These aims were successfully fulfilled. The WHO Expert Committee Biological Standardisation has approved the adoption of these four bacteria strains as the first Repository for Transfusion-Relevant Bacteria Reference Strains and, additionally, endorsed as a project the addition of six further bacteria strain preparations suitable for control of platelet contamination as the next step of enlargement of the repository.

In vitro evaluation of the protective role of human antibodies to West Nile virus (WNV) produced during natural WNV infection.

BACKGROUND: West Nile virus (WNV) is endemic in the United States and transmissible by transfusion. Since 2003, the US blood supply has been screened by nucleic-acid tests (NAT) for WNV in minipools (MP-NAT) of 6 or 16 specimens. WNV infection begins with low-level viremia detectable only by individual testing (ID-NAT) and no detectable WNV antibodies. Viremia then increases to levels detectable by MP-NAT, and antibodies become detectable; later, viremia decays to levels detectable only by ID-NAT before becoming undetectable. All but 1 documented WNV transmission by transfusion involved blood components negative for WNV antibodies, raising the question whether WNV antibody-positive blood components with low levels of WNV RNA are infectious. METHODS: Specimens from 102 viremic donors with and without WNV antibodies were used to investigate infectivity in cultures of Vero cells and human monocyte-derived macrophages (MDMs). RESULTS: In Vero cell culture, 54 (74%) of 73 WNV antibody-negative specimens and 10 (36%) of 28 WNV antibody-positive specimens were infectious. In a random subset of 20 specimens tested in MDM culture, 7 (88%) of 8 WNV antibody-positive specimens and 12 (100%) of 12 WNV antibody-negative specimens were infectious. CONCLUSION: WNV antibodies do not always protect susceptible cells from WNV infection in vitro. RNA positivity in the presence of antibody cannot be ignored as a theoretical risk for blood recipients and needs further investigation.

Enterobacter cloacae bloodstream infections traced to contaminated human albumin.

In August 1996, a patient in Kansas developed an Enterobacter cloacae bloodstream infection (BSI) shortly after receiving Albuminar, a brand of human albumin. Albuminar contamination was suspected. A case-control study of patients with primary gram-negative bacterial BSIs showed that patients with E. cloacae BSIs were significantly more likely than patients with non-E. cloacae gram-negative BSIs to have received Albuminar within 3 days of developing their BSIs (3 of 5 vs. 0 of 9; OR, undefined; P=.03). The E. cloacae isolate from the Kansas patient was found by pulsed-field gel electrophoresis to be identical to the isolate from the patient's Albuminar vial, to isolates from 2 previously unopened Albuminar vials, and to an isolate from a Wisconsin patient who had received Albuminar. A worldwide recall of approximately 116,000 Albuminar vials took place. This multistate outbreak was detected because of clinical astuteness and prompt reporting. Combined epidemiological and laboratory approaches are valuable when investigating potentially contaminated blood components and plasma derivatives.

Revision surgical hair restoration: repair of undesirable results.

Surgical hair restoration has been performed as a treatment for male pattern hair loss for more than 40 years. Although techniques have changed dramatically over the past several years, making it possible to achieve natural-appearing results, there are still many patients with unacceptable outcomes. These patients may have had procedures performed in the past with antiquated techniques or performed recently with substandard techniques. The causes of unfavorable results can be classified into one of three categories: technical errors, poor planning, or complications. The results in these patients can be dramatically improved through a number of different reparative surgical techniques. The majority of these techniques can be performed in an office outpatient setting. More than 40 patients unsatisfied with previous surgical hair restoration have been treated with the different techniques reviewed in this article. All patients had successful outcomes with significant improvement in appearance. Despite the increased challenges when performing reparative surgery, outcomes were favorable in all patients, with small to significant improvements in appearance achieved. Some of these challenges include the limited supply of donor hairs, reduced scalp laxity, and theoretically reduced vascularity due to scarring and transected blood vessels, and patient skepticism. Furthermore, the few complications that occurred were minor and correctable, including one case each of poor hair growth associated with extensive small graft (consisting of one to four hairs) transplanting, and of scalp scarring associated with the removal and primary closure of a large number of "plug" grafts (typically grafts 3 to 4 mm in size consisting of seven or more hairs) in a single procedure.

The "electric" otoplasty.

The goal of otoplasty in the treatment of prominauris is symmetrical restoration of the ears to an aesthetic position with respect to the side of the head. Most commonly, this is accomplished by the creation or enhancement of the antihelical fold. In addition, reduction in the projection of the conchal bowl may be required with manipulation of the antihelical fold. While myriad techniques exist to correct the poorly formed antihelical fold, most involve cartilage weakening and suture placement. Herein we describe a simple and effective technique for cartilage weakening using electrocautery. Using this technique, otoplasty can be performed in a reproducible fashion with a low incidence of complications. In the more than 60 patients treated with this technique, there were no complications related to the use of the electrocautery, and excellent results were consistently obtained.

Management of infraorbital dark circles. A significant cosmetic concern.

Despite the frequency with which it occurs, little has been written in the scientific literature on the treatment of infraorbital dark circles. I have developed a technique that simultaneously treats the 2 contributing causes of these circles: hyperpigmentation of skin and pseudoherniation of orbital fat. The technique involves simultaneous transconjunctival blepharoplasty and deep-depth phenol chemical peel. Successful outcomes have been obtained in patients with Fitzpatrick classification skin types 1 to 5, with a low incidence of complications. Adequate preoperative counseling regarding prolonged erythema and careful postoperative monitoring with, if necessary, medical intervention are essential if both surgeon and patient are to be satisfied with the outcomes.

Tropism, coreceptor use, and phylogenetic analysis of both the V3 loop and the protease gene of three novel HIV-1 group O isolates.

HIV-1 has been subdivided into two groups, M and O, based on phylogenetic analysis. To better understand the pathogenesis of group O viruses, we studied biologic and genetic characteristics of two primary isolates from Spain, ES1158.1 and ES1159.1, and one from the United States, MD.1. After viral isolation, we studied the replication kinetics in peripheral blood mononuclear cells (PBMCs) and macrophages, as well as in different cell lines. All three isolates could replicate in both PBMCs and macrophages. Because no syncytium formation was detected in the MT-2 cell line, viruses were classified as non-syncytium inducing (NSI). All three isolates used the CCR5 coreceptor for entry into the human osteosarcoma (HOS) CD4 cells. Phylogenetic analysis of V3 loop sequences showed that ES1158.1 and ES1159.1 isolates were closely related to the ANT70 strain, whereas MD.1 isolate clustered with the MVP-5180 strain in the same branch. Interestingly, all viruses appeared to be more closely related to the MVP-5180 strain when the protease gene was analyzed, although accessible sequences of this region are very limited.