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1.
J Clin Apher ; 35(1): 25-32, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31705563

RESUMO

IMPORTANCE: Neuromyelitis optica/neuromyelitis optica spectrum disorder patients' response to therapeutic plasma exchange (TPE) is currently incompletely characterized. OBJECTIVE: Our study aims to understand the clinical status improvement of neuromyelitis optica/neuromyelitis optica spectrum disorder patients treated with TPE. DESIGN, SETTING, AND PARTICIPANTS: This is a multicenter retrospective study conducted between 1 January 2003 and 31 July 2017 at 13 US hospitals performing apheresis procedures. Subjects studied were diagnosed with neuromyelitis optica/neuromyelitis optica spectrum disorder who received TPE during presentation with acute disease. MAIN OUTCOMES AND MEASURES: The primary outcome was clinical status improvement in patients treated with TPE. Secondary measures were procedural and patient characteristics associated with response to treatment. RESULTS: We evaluated 114 patients from 13 institutions. There was a female predilection. The largest ethnic group affected was non-Hispanic Caucasian. The average age of diagnosis was 43.1 years. The average time to diagnosis was 3.1 years. On average, five procedures were performed during each treatment series. The most commonly performed plasma volume exchange was 1.0 to 1.25 using 5% albumin as replacement fluid. Most patients (52%) did not require an additional course of TPE and noted "mild" to "moderate" clinical status improvement. Maximal symptom improvement appeared by the fourth or fifth TPE treatment. CONCLUSION AND RELEVANCE: TPE improved the clinical status of patients. Adults responded more favorably than children. Procedural characteristics, including number of TPEs, plasma volume exchanged, and replacement fluid used, were similar between institutions. TPE was well-tolerated and had a low severe adverse event profile.

3.
Vox Sang ; 2019 Dec 26.
Artigo em Inglês | MEDLINE | ID: mdl-31879973

RESUMO

BACKGROUND: Acquired haemophilia A (AHA), with potentially high risk of morbidity and mortality, occurs as a result of inhibitors against factor VIII. Bleeding due to AHA can be treated with activated prothrombin complex concentrate (aPCC), recombinant activated factor VII (rFVIIa) or recently, recombinant porcine-sequence factor VIII (rpFVIII). We extended our previous cost-effectiveness analysis (CEA) comparing rpFVIII against the available traditional options. METHODS: For high-titred, haemorrhaging AHA patients treated with either aPCC, rFVIIa or rpFVIII, over the course of 6-days, a Markov simulation was conducted to evaluate the outcomes when these patients transitioned into any of the four following health states: (1) continuous bleeding, (2) thrombosis, (3) stop bleeding and (4) death, with states (2), (3) and (4) modelled as absorbing states. All model parameters were obtained from the medical literature, except the costs of aPCC, rFVIIa and the factor VIII assay, which came from our institutional data. RESULTS: Excluding the cost of the initial treatment on day 0, the total subsequent treatment cost of rFVIIa was substantially more than the costs of aPCC and rpFVIII ($13 925 vs. $1778 vs. $6957, respectively). The average quality-adjusted life days (QALDs) gained from rpFVIII was lowest (4·89 vs. 4·9 for rFVIIa and 4·91 for aPCC). Overall, aPCC dominated the other two treatments. The model was determined to be robust across the tested ranges for all input variables. CONCLUSION: Based on this economic model, for AHA patients with high titres who were bleeding, aPCC was the most cost-effective treatment option and may be considered for use if there is no clinical contraindication.

4.
Presse Med ; 48(11 Pt 2): 338-346, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31679897

RESUMO

Therapeutic plasma exchange (TPE) has been used as a treatment modality in many autoimmune disorders, including neurological conditions, such as Guillain-Barre syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The American Society for Apheresis (ASFA) publishes its guidelines on the use of therapeutic apheresis every 3 years based on published evidence to assist physicians with both the medical and technical aspects of apheresis consults. The ASFA Guidelines included the use of TPE in both GBS and CIDP as an acceptable first-line therapy, either alone and/or in conjunction with other therapeutic modalities. In this article, we briefly reviewed GBS and CIDP, discussed the role of apheresis in these conditions as well as various technical aspects of the TPE procedure, such as apheresis calculation, number of volume exchange, replacement fluid, and management of potential complications.


Assuntos
Síndrome de Guillain-Barré/terapia , Troca Plasmática/métodos , Polirradiculoneuropatia Desmielinizante Inflamatória Crônica/terapia , Humanos , Guias de Prática Clínica como Assunto
5.
Transfus Apher Sci ; 58(6): 102652, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31672466

RESUMO

The AABB recently posted a bulletin (19-02) regarding their recommendations for the use of group O red blood cells (RBCs) during trauma. Though group O Rh(D)-negative RBC units are considered the 'safest', the demand of such units often exceeds the supply. Therefore, O Rh(D)-positive units are often used during the first parts of a massive transfusion protocol (MTP) or patients with particularly severe hemorrhage are switched over from O Rh(D)-negative to O Rh(D)-positive RBC units in order to preserve the O Rh(D)-negative supply. In light of these limitations, it is important to understand the risk of such policies to the patient. The reported risk of alloimmunization after exposure to Rh(D)-positive RBCs ranges widely from 3 to 70%. In response, we performed a retrospective review of 1,198 patients in our institution that had a MTP activation due to trauma. Of those patients, we focused on Rh(D)-negative patients that received at least 1 unit of Rh(D)-positive RBCs. Seventy-two patients met the criteria for inclusion, accounting for 6% of the total population. Of the 72 Rh(D)-negative patients, we identified 17% that formed new Rh group antibodies after exposure to Rh(D)-positive RBCS. All 10 of our alloimmunized patients (two of which were females of childbearing age) formed anti-D, while 3 patients also formed either anti-E or anti-C. Since this was a retrospective review, we did not perform repeated antibody screens for the entire study period, but did review all records for the entire period. We did note that we were more likely to detect an novel alloantibody if more antibody screens were performed during the patient's initial stay and during follow-up visits. We conclude that providing Rh(D) negative patients Rh(D) positive RBC units is not without risk and policies regarding such provisions should be carefully considered. As RBC shortages continue to be a part of daily practice, such issues may continue to be a challenge for the blood bank community.

6.
J Clin Apher ; 34(5): 607-612, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31166036

RESUMO

Apheresis is defined as the removal of blood from the body, its separation into constituent components, and removal or manipulation of one of these components prior to intravascular return with or without the addition of replacement fluid. Patients undergoing therapeutic apheresis often have multiple comorbidities, potentially affecting their hemodynamic status. Thus, a thorough understanding of apheresis principles and calculations is required for the performance of safe, efficacious, and successful procedures. The performance of simple transfusions or red blood cell exchange procedures is additionally complicated by the difficulties inherent in the procurement of compatible blood products, and the emphasis on minimizing exposure to unnecessary blood products. It is essential that apheresis physicians be able to accurately evaluate the risks/benefits inherent in the procedural options and efficiently stratify patients to the optimal therapeutic modality. The formulas requisite for performing therapeutic apheresis calculations are herein reviewed.

7.
J Clin Apher ; 34(3): 171-354, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31180581

RESUMO

The American Society for Apheresis (ASFA) Journal of Clinical Apheresis (JCA) Special Issue Writing Committee is charged with reviewing, updating and categorizing indications for the evidence-based use of therapeutic apheresis (TA) in human disease. Since the 2007 JCA Special Issue (Fourth Edition), the committee has incorporated systematic review and evidence-based approaches in the grading and categorization of apheresis indications. This Eighth Edition of the JCA Special Issue continues to maintain this methodology and rigor in order to make recommendations on the use of apheresis in a wide variety of diseases/conditions. The JCA Eighth Edition, like its predecessor, continues to apply the category and grading system definitions in fact sheets. The general layout and concept of a fact sheet that was introduced in the Fourth Edition, has largely been maintained in this edition. Each fact sheet succinctly summarizes the evidence for the use of TA in a specific disease entity or medical condition. The Eighth Edition comprises 84 fact sheets for relevant diseases and medical conditions, with 157 graded and categorized indications and/or TA modalities. The Eighth Edition of the JCA Special Issue seeks to continue to serve as a key resource that guides the utilization of TA in the treatment of human disease.


Assuntos
Remoção de Componentes Sanguíneos/métodos , Medicina Baseada em Evidências/normas , Humanos , Terapêutica/métodos , Estados Unidos , Redação
8.
Ther Apher Dial ; 2019 Jun 18.
Artigo em Inglês | MEDLINE | ID: mdl-31211482

RESUMO

High-quality evidence supporting clinical practice is lacking in apheresis. A potential source of evidence is provided by abstracts submitted to the Annual Meetings of the American Association of Blood Banks (AABB) and the American Society for Apheresis (ASFA). However, there is potential for study conclusions to be altered significantly following abstract presentations prior to publications in peer-reviewed journals. Therefore, we evaluated the discordance rate between apheresis-related meeting abstracts and their corresponding published articles. Abstracts accepted to either AABB or ASFA Annual Meetings from 2005 to 2012 and corresponding PubMed-indexed peer-reviewed articles' abstracts published prior to 9/2014 were reviewed for altered methods, results, and conclusions. When present, changes were evaluated for clinical significance. During the 8-year period, 198 out of 1152 abstracts were published as peer-reviewed articles. Of these, 36 (18.2%) presented discordant results, six of which (16.7%) were potentially clinically significant. An alteration in results (58.3%) was the leading reason for discordance. The discordance rate for ASFA abstracts was significantly higher (HR = 4.69, P = 0.0028) than the AABB ones. However, clinically significant alterations occurred more frequently among AABB abstracts (P = 0.025). Approximately 18% of meeting abstracts demonstrated alterations prior to publication in peer-reviewed journals. Given that approximately one in six changes represented clinically significant alterations, potentially affecting clinical practice, we recommend caution when modifying one's clinical practice based on abstract presentations at Annual Meetings. Future studies involving abstracts from both the International Society for Apheresis and the World Apheresis Association should also be performed.

9.
Transfus Apher Sci ; 58(3): 237-246, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31085053

RESUMO

The American Society for Apheresis (ASFA) regularly publishes evidence-based guidelines, with the most recent edition in 2016, to assist the requesting and/or apheresis physicians with the evaluation of therapeutic apheresis. Given that therapeutic plasma exchange (TPE) is one of the most common therapeutic apheresis procedures, in this review, we discuss the rationale of TPE in both ASFA category I (first-line therapy) and II (second-line therapy) indications. However, the ASFA Guidelines usually provide little guidance with regard to scheduling/urgency issues. Given that mobilizing resources to perform apheresis after-hours may be expensive and challenging, we classified the urgency of the procedures in this review into 3 distinct groups: emergent (i.e. TPE should be started as soon as possible, preferably within 4-6 h upon request), urgent (i.e. TPE should be initiated within 24 h of request), and routine (i.e. TPE may be performed during regular working hours) based on our experiences in clinical practices. A brief discussion of the technical aspects as well as important considerations for an apheresis consultation is also provided.


Assuntos
Remoção de Componentes Sanguíneos/métodos , Troca Plasmática/métodos , Humanos , Sociedades Médicas , Estados Unidos
12.
J Neurotrauma ; 36(2): 222-229, 2019 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-29848170

RESUMO

Traumatic microvascular injury (tMVI) is a universal endophenotype of traumatic brain injury (TBI) that is responsible for significant neurological morbidity and mortality. The mechanism underlying tMVI is not fully understood. The present study aims to determine plasma levels of von Willebrand factor (VWF), a disintegrin and metalloprotease with thrombospondin type 1 repeats (ADAMTS) 13 activity, and human neutrophil peptides (HNP) 1-3 and to correlate these biomarkers with functional outcomes after moderate-severe TBI. Thirty-one consecutive TBI patients (Glasgow Coma Scale [GCS] range, 3-12) were enrolled into the study between February 2010 and November 2014. Blood samples were collected on 0, 1, 2, 3, and 5 days after admission and analyzed for plasma levels of VWF antigen (VWFAg), collagen-binding activity (VWFAc), ADAMTS13 activity, and HNP1-3 proteins. Mean values of plasma VWFAg, VWFAc, and HNP1-3 were significantly increased in TBI patients compared to those in healthy controls (n = 30). Conversely, mean plasma values of ADAMTS13 activity in TBI patients were significantly decreased during the first 2 days after admission. This resulted in a dramatic reduction in the ratio of ADAMTS13 activity to VWFAg or ADAMTS13 to VWFAc in all 5 post-TBI days. Cluster analysis demonstrated that high median plasma levels of VWFAg and HNP1-3 were observed in the cluster with a high mortality rate. These results demonstrate that a relative deficiency of plasma ADAMTS13 activity, resulting from activation of neutrophils and endothelium, may contribute to the formation of microvascular thrombosis and mortality after moderate-severe TBI.

13.
Vox Sang ; 114(1): 63-72, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30499154

RESUMO

BACKGROUND: Acquired haemophilia A (AHA) is an autoimmune bleeding disorder with significant morbidity and mortality. Bleeding AHA patients with high titre inhibitors can be treated with either activated prothrombin complex concentrate (aPCC) or recombinant activated factor VII (rFVIIa). Given that both replacement therapies have inherent benefits and limitations, a cost-effectiveness analysis (CEA) was performed in this population to compare rFVIIa with aPCC. METHODS: In high-titered AHA patients with bleeding treated with either aPCC or rFVIIa, during a 5-day study period, a Markov model was developed such that these patients were transitioned into four different health states: (1) continuous bleeding, (2) thrombosis, (3) stop bleeding and (4) death, with states (2), (3) and (4) modelled as absorbing states. Model parameters, including probabilities, health utility index and costs, were gathered from the medical literature, except for the costs of aPCC and rFVIIa, which were obtained from our institutional data. RESULTS: During the 5-day period, the total treatment cost of rFVIIa was substantially more than the cost of aPCC ($13 635 vs. $1741). The average quality-adjusted life days (QALDs) gained for rFVIIa were slightly lower compared to aPCC (4·08 vs. 4·09). Overall, aPCC prevailed over rFVIIa. Sensitivity analysis confirmed the robustness of the model across tested ranges of all input variables. CONCLUSION: In high-titered AHA patients with bleeding, aPCC is a cost-effective treatment option when compared to rFVIIa. Thus, aPCC may be considered in these patients, if available, and provided there is no clinical contraindication.


Assuntos
Análise Custo-Benefício , Fator VIIa/uso terapêutico , Hemofilia A/economia , Hemorragia/economia , Protrombina/uso terapêutico , Fator VIIa/economia , Hemofilia A/complicações , Hemofilia A/tratamento farmacológico , Hemorragia/tratamento farmacológico , Hemorragia/etiologia , Humanos , Protrombina/economia
14.
J Clin Apher ; 34(4): 482-486, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30548646

RESUMO

Many vascular access options, such as subcutaneous ports, are currently on the market for use in both medication infusion and for procedures, such as therapeutic plasma exchange and extracorporeal photopheresis. We compared the cost and time necessary to complete apheresis procedures using either Angiodynamic's Vortex or Bard's PowerFlow subcutaneous ports by reviewing our experience on two patients undergoing long-term apheresis treatments with at least 10 procedures with each type of port. We analyzed the cost of needles and thrombolytic therapy, staff time, overall procedure length, and the total time the patient was in the apheresis unit. We also compared flow rates and alarm rates between the two ports. In this small pilot study, use of the PowerFlow port resulted in significant cost and time savings, with mixed results for flow rates. Our results need to be confirmed in a larger patient population prior to recommending wide implementation of Bard's PowerFlow port.


Assuntos
Remoção de Componentes Sanguíneos/instrumentação , Cateteres Venosos Centrais/normas , Pacientes Ambulatoriais , Remoção de Componentes Sanguíneos/economia , Humanos , Projetos Piloto , Fatores de Tempo
15.
Lab Med ; 50(2): 208-211, 2019 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-30169652

RESUMO

Heparin-induced thrombocytopenia (HIT) is a not-uncommon adverse effect of heparin exposure, with potentially serious and/or fatal thrombotic consequences. Recent studies looking at the off-label use of fondaparinux for HIT show similar efficacy and adverse-effect profiles, as well as improved costs, compared with some commonly used direct thrombin inhibitors. Although routine laboratory monitoring of fondaparinux-specific anti-Xa levels typically is not recommended, we present a case report that suggests fondaparinux monitoring may be needed in patients with hepatic impairment causing acquired antithrombin deficiency. We performed daily assessment of antithrombin- and fondaparinux-specific anti-Xa levels in a 50-year-old female of unknown ethnicity to ensure that fondaparinux dosing was maintained within an acceptable range. With this management strategy, the patient experienced no thrombotic or hemorrhagic complications during the hospital admission or the following 2 months in outpatient treatment.


Assuntos
Anticoagulantes/uso terapêutico , Fondaparinux/uso terapêutico , Trombocitopenia/tratamento farmacológico , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Monitoramento de Medicamentos , Feminino , Fondaparinux/administração & dosagem , Heparina/efeitos adversos , Humanos , Pessoa de Meia-Idade , Curva ROC , Trombocitopenia/induzido quimicamente
16.
Haematologica ; 104(1): 166-175, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30171022

RESUMO

Immune-mediated thrombotic thrombocytopenic purpura is characterized by severe thrombocytopenia and microangiopathic hemolytic anemia. It is primarily caused by immunoglobin G type autoantibodies against ADAMTS13, a plasma metalloprotease that cleaves von Willebrand factor. However, reliable markers predictive of patient outcomes are yet to be identified. Seventy-three unique patients with a confirmed diagnosis of immune-mediated thrombotic thrombocytopenic purpura between April 2006 and December 2017 were enrolled from the Univeristy of Alabama at Birmingham Medical Center. Clinical information, laboratory values, and a panel of special biomarkers were collected and/or determined. The results demonstrated that the biomarkers associated with endothelial injury (e.g., von Willebrand factor antigen and collagen-binding activity), acute inflammation (e.g., human neutrophil peptides 1-3 and histone/deoxyribonucleic acid complexes), and activation of the complement alternative pathway (e.g., factors Bb and iC3b) were all significantly increased in patients with acute immune-mediated thrombotic thrombocytopenic purpura compared to those in the healthy controls. Moreover, failure to normalize platelet counts within 7 days or failure to markedly reduce serum lactate dehydrogenase by day 5, low total serum protein or albumin, and high serum troponin levels were also predictive of mortality, as were the prolonged activated partial thromboplastin time, high fibrinogen, and elevated serum lactate dehydrogenase, Bb, and sC5b-9 on admission. These results may help to stratify patients for more intensive management. The findings may also provide a framework for future multicenter studies to identify valuable prognostic markers for immune-mediated thrombotic thrombocytopenic purpura.

17.
ACS Chem Neurosci ; 10(1): 132-142, 2019 01 16.
Artigo em Inglês | MEDLINE | ID: mdl-30134661

RESUMO

Anti-NMDA ( N-methyl-d-aspartate) receptor (anti-NMDAR) encephalitis is one of the most common paraneoplastic encephalitides. It occurs in both sexes, across all age ranges, and may occur in the presence or absence of an associated tumor. Its pathogenesis and clinical presentation relate to the presence of IgG1 or IgG3 antibodies targeting the NR1 subunit of the NMDA receptor, leading to a disinhibition of neuronal excitatory pathways. Initial clinical manifestations may be nonspecific, resembling a viral-like illness; however, with disease progression, symptoms can become quite severe, including prominent psychiatric features, cognitive problems, motor dysfunction, and autonomic instability. Anti-NMDAR encephalitis may even result in death in severe untreated cases. Diagnosis can be challenging, given that initial laboratory and radiographic results are typically nonspecific. The majority of patients respond to first or second-line treatments, although therapeutic options remain limited, usually consisting of tumor removal (if there is confirmation of an underlying malignancy) in conjunction with prompt initiation of immunosuppressive medications along with intravenous immunoglobulins and/or plasma exchange. Although the clinical presentation of anti-NMDAR encephalitis overlaps with several other more common neurological and psychiatric disorders, early diagnosis and treatment is essential for a positive prognosis. Here, we concisely review the pathogenesis, diagnosis, and clinical management of this disease.

18.
J Clin Apher ; 33(5): 616-618, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30176070

RESUMO

Many practitioners believe in the phenomenon of being labeled either a "black cloud" or "white cloud" while on-call. A "white-cloud" physician is usually defined as one who sees fewer cases while a "black-cloud" is one who often receives more cases. To evaluate these phenomena, a 35-month prospective study was designed to evaluate the number of times apheresis staff was involved with emergent apheresis procedures at a large institution in the off hours between 10 pm and 7 am, since this is the time period when significant resources have to be mobilized to perform the procedure. During the study period, 92 emergent procedures (or "black-cloud" events, 8.6%) occurred. The median time between two consecutive "black-cloud" events was 9 days (range: 1-45 days). We found that there is no statistically significant association between the occurrence of "black-cloud" events and attending physicians (P = .99), nurses who had 56 or more days on-call during the course of the study (P = .28), year (P = .85), day of the week (P = .099), month (P = .57), or season of the year (P = .47). Therefore, the findings from this prospective 35-month confirmation study did not support the common perception that physicians or nurses maybe either "black clouds" or "white clouds." It is important that this meaningful result be shared with apheresis practitioners given that the label of being a "black cloud" may have undesirable psychological implications to the physicians and nurses.


Assuntos
Remoção de Componentes Sanguíneos , Corpo Clínico Hospitalar , Admissão e Escalonamento de Pessoal , Feminino , Humanos , Masculino , Superstições
19.
Transfusion ; 58(8): 1965-1972, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-30198607

RESUMO

BACKGROUND: A prior practice survey revealed variations in the management of patients with sickle cell disease (SCD) and stressed the need for comprehensive guidelines. Here we discuss: 1) common indications for red blood cell exchange (RCE), 2) options for access, 3) how to prepare the red blood cells (RBCs) to be used for RCE, 4) target hemoglobin (Hb) and/or hematocrit (Hct) and HbS level, 5) RBC depletion/RCE, and 6) some complications that may ensue. STUDY DESIGN AND METHODS: Fifteen physicians actively practicing apheresis from 14 institutions representing different areas within the United States discussed how they manage RCE for patients with SCD. RESULTS: Simple transfusion is recommended to treat symptomatic anemia with Hb level of less than 9 g/dL. RCE is indicated to prevent or treat complications arising from the presence of HbS. The most important goals are reduction of HbS while also preventing hyperviscosity. The usual goals are a target HbS level of not more than 30% and Hct level of less than 30%. CONCLUSION: Although a consensus as to protocol details may not be possible, there are areas of agreement in the management of these patients, for example, that it is optimal to avoid hyperviscosity and iron overload, that a target Hb S level in the range of 30% is generally desirable, and that RCE as an acute treatment for pain crisis in the absence of other acute or chronic conditions is ordinarily discouraged.


Assuntos
Anemia Falciforme/terapia , Transfusão de Eritrócitos/métodos , Viscosidade Sanguínea , Gerenciamento Clínico , Hemoglobina Falciforme/análise , Humanos , Sobrecarga de Ferro/prevenção & controle , Estados Unidos
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