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Little instruction in writing manuscripts for peer review is provided in nursing school or medical school. To relatively inexperienced would‐be authors, including junior physicians and allied health professionals, this avenue of professional communication may sometimes seem to be unattainable. Yet many of them are energetic and insightful, and have the potential to make contributions to the literature. This article aims to provide an explanation of the components of the peer review manuscript and advice regarding how to go about writing one so as to overcome the writer's block that inexperienced authors may frequently experience. [ABSTRACT FROM AUTHOR]

The venerable clinical case report has been largely reduced to the status of commodity in the present age of dedicated case report journals. Top‐line clinical journals may discourage or even refuse to accept clinical case reports due to their potential adverse effect on the impact factor of the journal. But while the traditional clinical case report, that presents a case history and attempts to extrapolate a lesson from it, may have fallen out of favor, there remains a need for astute clinical observations that serve to stimulate the generation of hypotheses and may lead, ultimately, to medical breakthroughs. Clinicians are very much capable of employing scientific reasoning when approaching an unusual clinical situation. By remaining up to date with the literature, and determining, at the outset of the case, what lessons may be learned from it, they can formulate a scientific approach, using clinical methods, to result in meaningful contributions to the literature in top‐line journals. [ABSTRACT FROM AUTHOR]

The process of publishing original work in a peer review journal is not complete at the point where the manuscript is first submitted. The journal editors will submit the manuscript to peer review whereby outside experts are asked to vet the manuscript for scientific merit, originality and quality. Reviewers' comments are meant to help authors strengthen their manuscripts for potential publication. Authors benefit from this feedback and should approach the reviewers as volunteer consultants rather than as critics. Authors should respond to all reviewers' comments, completely and politely addressing the points raised. This article is meant to assist junior or inexperienced authors to understand the process of peer review and to function effectively within the process in order to succeed in having their manuscripts published. [ABSTRACT FROM AUTHOR]

Writing a manuscript for peer review is an art for which little formal preparation is provided during the education of physicians, scientists, and allied health professionals. At the same time, publishing their work may be central to their career ambitions. This article provides an explanation of the purpose and expected content of the components of a peer review manuscript and advice regarding how to go about writing one. It aims to somewhat demystify the process of scientific writing and render it accessible to more members of the American Society for Apheresis. [ABSTRACT FROM AUTHOR]

We sought to optimize direct intravenous infusion of calcium gluconate (CaGlu) for maintaining plasma ionized calcium concentration ([Ca2+]) and preventing hypocalcemic reactions during 34 consecutive 1‐volume therapeutic plasma exchanges (TPEs) in eight patients. CaGlu, 2 g in 50 mL of 0.9% NaCl, was prepared by our hospital pharmacy and infused at either 1.0 or 1.6 g/h during alternate TPE. Plasma [Ca2+] was monitored at intervals of 20 to 30 minutes. At 1 g/h of CaGlu, plasma [Ca2+] fell by 8.35% after 40 to 50 minutes and then plateaued. At 1.6 g/h of CaGlu, plasma [Ca2+] fell by 6% after 20 to 30 minutes and then plateaued. The difference at 40 to 50 minutes was significant (P =.015). Hypocalcemic reactions were noted in three patients during 5 of 17 TPE at 1.0 g/h (all after 40 to 60 minutes) but 0 of 17 TPE at 1.6 g/h (P =.044). CaGlu at 1.6 g/h stabilized plasma [Ca2+] and appears to prevent hypocalcemic reactions during TPE. [ABSTRACT FROM AUTHOR]

We prospectively evaluated the Bard PowerFlow Implantable Apheresis IV Port in four patients undergoing outpatient therapeutic plasma exchange over 18 to 97 days. Three had bilateral internal jugular access ports, and one had a single left internal jugular access port for the inlet line with return via antecubital vein. Two patients receiving 5% albumin as replacement fluid achieved peak inlet flow of 99 ± 5 mL/min and 101 ± 6 mL/min, and peak plasma flow of 53 ± 6 and 47 ± 6 mL/min, respectively. Two patients receiving plasma as replacement fluid achieved peak inlet flow of 46 ± 7 and 85 ± 4 mL/min and peak plasma flow of 27 ± 3 and 35 ± 4 mL/min, respectively. Apheresis nurses accessed the ports on the first attempt in all procedures. Pressure alarms occurred in 6 of 47 procedures and were easily resolved by lowering the inlet rate by 10% in 5 of them. The PowerFlow shows promise as an implantable venous access device for apheresis. [ABSTRACT FROM AUTHOR]

We compared two methods of calcium gluconate infusion to maintain plasma ionized calcium ([Ca2+]) during therapeutic plasma exchange (TPE) performed using the Spectra Optia Apheresis System. Method A, our legacy method, consisted of adding 5 mL of 10% calcium gluconate to each 500 mL bottle of 5% albumin replacement fluid. Method B used an accessory IV infusion of calcium gluconate (2 g in 50 mL of 0.9% NaCl starting at 25 mL/h). Plasma [Ca2+] was measured at 20‐minute intervals, and symptoms of hypocalcemia were recorded during TPE. Baseline [Ca2+] was the same (P = 0.616), as was total acid citrate dextrose Formula A used (P = 0.865), with either method. TPE with method A used 2.62 ± 0.52 g of calcium gluconate vs 1.13 ± 0.27 g with method B (P < 0.001). [Ca2+] remained stable with method A (P = 0.251), but fell on average by 5% with method B (P < 0.05). Hypocalcemic symptoms were reported in 0 of 23 TPE with method A and 2 of 24 TPE with method B. We conclude that both methods A and B prevent a symptomatic fall in plasma [Ca2+] during TPE. Method B requires significantly less calcium gluconate than does method A. [ABSTRACT FROM AUTHOR]

Increasing survival of patients with sickle cell anemia (SCA) well into adulthood results in a rising likelihood of developing hematological malignancy. High‐dose chemotherapy with autologous hematopoietic progenitor cell (HPC) rescue is standard of care for several hematological malignancies, but the risk of severe or life‐threatening vaso‐occlusive phenomena during filgrastim mobilization of HPC for collection poses a potential barrier to this approach. We report the use of automated red cell exchange in preparation for filgrastim mobilization in a patient with homozygous SCA. Red cell exchange was repeated just prior to high‐dose chemotherapy to mitigate the need for red cell transfusion during bone marrow reconstitution. The patient experienced no vaso‐occlusive phenomena throughout the entire episode of care and did not become iron overloaded. This approach should be considered for all patients with homozygous or compound heterozygous sickle cell disease who are candidates for auto‐HPC rescue therapy. [ABSTRACT FROM AUTHOR]

Abstract: Background: Platelet donors receive 40 mmol or more of IV citrate anion during donation. When plasma ionized calcium ([Ca2+]) falls by ∼20%, half of the donors report symptoms of hypocalcemic toxicity. Citrus juices contain clinically relevant amounts of citrate anion. We asked whether citrus juice can lower [Ca2+] thus potentially contributing to hypocalcemic toxicity. Method: Six volunteers were given 20.4 mmol of citrate anion as grapefruit juice or orange juice. Capillary blood obtained by fingerstick was analyzed for [Ca2+] using an iSTAT point‐of‐care blood analyzer. [Ca2+] was measured at baseline and then 30, 60, 120, and 180 minutes after drinking juice. Subjects were tested with the alternative juice on a subsequent day. The outcome measure was the percent change in plasma [Ca2+] from baseline. Results: [Ca2+] fell −2.2% to −11.5% in four of six subjects 30 minutes after drinking grapefruit juice. The effect persisted up to 3 hours. [Ca2+] fell −2.1% to −12.2% in four of six subjects 30‐60 minutes after drinking orange juice. The effect abated after 2 hours. We could not correlate gender or body surface area to these findings. Summary and Conclusions: Citrus juice may lower [Ca2+] for 2‐3 hours. This could add to the effect of IV citrate infusion during platelet donation, thus worsening the expected fall in [Ca2+]. This, in turn, would likely increase the rate and severity of hypocalcemic toxicity. It is prudent to advise platelet donors to avoid high citrate anion beverages, such as citrus juice, for at least 4 hours prior to donation. [ABSTRACT FROM AUTHOR]

Abstract: Hypocalcemic toxicity, because of return of citrate anion to the donor, is the major toxicity of apheresis platelet donation. Oral calcium carbonate, given prophylactically at the start of donation, has shown limited ability to alleviate this toxicity. We examined whether repeated prophylactic doses of calcium carbonate, or of a liquid preparation containing calcium citrate, calcium phosphate, and vitamin D3, would be more effective at preventing symptoms of hypocalcemic toxicity. Symptoms were reported by 48% of donors who received no prophylaxis and 60% of donors who received 1000 mg of oral calcium carbonate at the start of, and every 20 minutes during, donation (P = 0.711). Only 19.2% of donors who received the liquid preparation (1000 mg calcium, 1000 IU vitamin D3) reported symptoms (P = 0.040 versus no prophylaxis, P = 0.039 versus calcium carbonate). This difference was not because of gender, weight, age, or blood volume of the donor. Neither calcium preparation prevented a measurable fall in plasma ionized calcium during donation. We conclude that liquid calcium citrate/calcium phosphate/vitamin D3 provides effective prophylaxis against hypocalcemic toxicity during platelet donation, however it does not prevent a fall in plasma ionized calcium. [ABSTRACT FROM AUTHOR]

Therapeutic plasma exchange (TPE) and hemopoietic progenitor cell (HPC) collection are apheresis procedures that can safely be performed in tandem with hemodialysis. Despite the return of citrate-anticoagulated blood to the patient during HPC collection, it is not necessary to administer supplemental calcium during these procedures because the ionized calcium concentration is restored as the returning blood passes through the dialyzer. It is not known whether this applies to TPE, in which a mixture of blood and pharmaceutical albumin, an avid binder of plasma ionized calcium, is returned to the patient through the dialyzer. We report on three dialysis-dependent patients who required TPE and underwent tandem treatments without supplemental calcium in the apheresis circuit. Overall, ionized calcium fell 4-12% ( P = 0.0.024) and patients reported no symptoms of hypocalcemic toxicity. Tandem hemodialysis/TPE can be performed without supplemental calcium in the apheresis circuit. J. Clin. Apheresis 32:154-157, 2017. © 2016 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Therapeutic leukapheresis can control the white blood cell count (WBC) of pregnant women with chronic myelogenous leukemia (CML) who have hyperleukocytosis without leukostasis. The medical justification for this treatment has not been objectively documented. We report a 27-year-old woman, diagnosed with CML at 10-week gestation, who developed severe dyspnea on exertion. A workup that included chest CT and echocardiography with a bubble study detected no cardiopulmonary pathology to explain her symptoms, and thus she was referred for leukapheresis. Prior to her first leukapheresis, which lowered her WBC from 154 × 103/μL to 133 × 103/μL, her oxygen saturation (SpO2) on room air decreased from 98 to 93% during 100 feet of slow ambulation and she was dyspneic. Just after the leukapheresis, her dyspnea on exertion was much improved and her SpO2 remained at 98% with repeat ambulation. Spirometry and lung volume studies obtained before and after her first leukapheresis demonstrated 32 and 31% improvements in forced vital capacity and forced expiratory volume in 1 s respectively, a 25% increase in functional residual capacity, and a 142% improvement in expiratory reserve volume. Residual volume decreased by almost 20%. Three times in a week, leukapheresis was continued until her WBC was controlled with interferon α-2b approximately 4 weeks later. Her dyspnea had completely resolved. She gave birth by elective caesarean section to a healthy boy at 32 weeks. Corroboration of symptom relief by leukapheresis with physiological data may justify such treatment in pregnant patients with CML. J. Clin. Apheresis 31:393-397, 2016. © 2015 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Mantle cell lymphoma is an aggressive malignant B-cell disorder that often presents with a leukemic picture. Circulating lymphoma cell morphology may vary from small round mature-appearing lymphocytes resembling the lymphocytes of chronic lymphocytic leukemia to large prolymphocytoid or blastoid cells. Rare reports of hyperleukocytosis with leukostasis, treated with leukocytapheresis, are described in patients with prolymphocytoid or blastoid morphology. We report an 88 year old woman with mantle cell lymphoma, hyperleukocytosis (WBC > 400 × 103/µL) with severe respiratory compromise but without interstitial or alveolar infiltrates on radiograph or computerized tomography of the chest. She was afebrile and had no central nervous system signs. Circulating lymphoma cell morphology was predominantly of the small lymphocyte type. A two-whole-blood-volume leukocytapheresis reduced her WBC from 465 to 221 × 103/µL in 150 min. Her respiratory rate decreased from 28/min to 18/min and her arterial oxygen saturation (SpO2) rose from 91% to 97% on 6 L/min of oxygen by nasal cannula. Severe breathlessness before the procedure abated completely by the end of the procedure. Respiratory compromise may occur in mantle cell lymphoma with hyperleukocytosis with a mature lymphoma cell phenotype, even without a clear picture of leukostasis. Although the ultimate survival of the patient depends on treatment with chemotherapy, leukocytapheresis for alleviation of symptoms may be warranted and should be considered. Respiratory status and response to leukocytapheresis should be documented with physiological measurements. J. Clin. Apheresis 31:398-402, 2016. © 2015 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Sirolimus is an immunosuppressant used to prevent graft versus host disease in allogeneic hematopoietic stem cell transplant recipients. It has a large volume of distribution (12±7.5 l/kg) and within the intravascular space ~95% of it is bound to red blood cells. Because of potential toxic effects at high trough levels, therapeutic drug monitoring is recommended for sirolimus. We present a case of severe hepatic dysfunction due to Hepatitis B and sirolimus toxicity, in a 51-year-old male stem cell transplant recipient. An automated red cell exchange decreased his blood sirolimus level from 22.6 to 10.3 ng/ml (55% reduction) and improved his liver enzymes. Re-equilibration of sirolimus from other compartments to the blood necessitated a series of four red cell exchanges, after which the sirolimus level was 4.7 ng/ml. Although the patient ultimately succumbed to multiorgan failure, red cell exchange may be considered for acute removal of sirolimus in selected patients. J. Clin. [ABSTRACT FROM AUTHOR]

Background Recent retrospective studies indicate that D− recipients of D+ apheresis platelets ( PLTs) are not alloimmunized to D. Our hospital policy is to offer RhIG to D− women of childbearing age who received D+ apheresis PLTs but not to other D− recipients of D+ apheresis PLTs. We instituted prospective surveillance of the D− recipients who were not given RhIG. Study Design And Methods All apheresis PLT recipients were prospectively entered into a database that recorded the patient's age, sex, diagnosis, D status, apheresis PLT transfusions, and antibody screen results from before and after PLT transfusions. Data are reported for PLTs transfused between October 16, 2012, and April 16, 2014, and antibody screens obtained through June 16, 2014. The analysis excludes neonates; women not more than 50 years of age; and patients who also received D+ red blood cells, received only D− PLTs, received RhIG, were previously alloimmunized to D, and did not have a follow-up antibody screen after the first D-incompatible apheresis PLT transfusion. Results A total of 158 of 1107 apheresis PLT recipients were D−. Seventy-nine were eligible for analysis based on the exclusion criteria listed above. None became alloimmunized to D during the observation interval. In 45 (57%) cases the last follow-up antibody screen was obtained at least 4 weeks after the first D-incompatible apheresis PLT transfusion. Conclusion Prospective surveillance confirms prior retrospective observations that D− patients do not appear to risk D alloimmunization after receiving D+ apheresis PLTs. [ABSTRACT FROM AUTHOR]

Apheresis has been used to lower the parasite burden of patients with Loa loa infection, but there are no reports regarding how to do this using modern, continuous flow equipment with a currently available program. A 23-year-old female refugee from Cameroon with known Loa loa infection presented to our Emergency Department with acute mental status changes and a picture of encephalitis. Lumbar puncture revealed Loa loa in her cerebrospinal fluid. Her midday blood microfilaria count was 15,000/mL. Because treatment with diethylcarbamazine was under consideration, we were asked to lower her parasite burden using apheresis. One single 2-total blood volume apheresis using the mononuclear cell program (without hydroxyethyl starch) on a COBE® Spectra Apheresis System decreased the microfilarial load from 15,000/mL to 10,666/mL, a 29% reduction. J. Clin. Apheresis 32:200-202, 2017. © 2016 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Background Group AB plasma, which lacks anti- A and anti- B isohemagglutinins, is issued for emergency transfusion when a patient's ABO group is unknown, but the relative scarcity of group AB blood donors limits its availability. We sought to establish a thawed plasma inventory to improve the rapid availability of plasma in the emergency release setting but were concerned about potential wastage of group AB plasma. Study Design and Methods Recognizing that plasma-incompatible apheresis platelets are routinely transfused and only rarely result in hemolytic reactions if the donor is blood group O, and considering that group A plasma would be compatible with approximately 85% of our patient population, we instituted an emergency release policy whereby thawed group A plasma is issued to all patients of unknown blood group or if compatible plasma is not available. ABO-compatible plasma is then issued, if needed, once the patient's blood group is determined. We prospectively assessed the outcomes of all patients who received incompatible plasma under our policy. Results During the first 5 years under this policy, 385 emergency release requests for plasma were received by our blood bank. Among them, 23 group B or AB patients met criteria for receiving a median of 2 units of incompatible group A plasma. No hemolytic transfusion reactions or other adverse events related to transfusion were seen in any of these 23 patients. Conclusion We propose that group A plasma may be an acceptable alternative to AB plasma as the first option in the emergency release setting. [ABSTRACT FROM AUTHOR]

Autologous hemopoietic progenitor cell (HPC) collection is the most frequent indication for an apheresis procedure in patients with multiple myeloma, up to 10% of whom may also require hemodialysis because of myeloma kidney. We investigated whether HPC collection could be performed in tandem with hemodialysis, to avoid extra outpatient visits for extracorporeal procedures, without compromising the efficacy of the hemodialysis, the HPC collection efficiency (CE) or patient safety. Four dialysis-dependent patients with multiple myeloma underwent 5 large volume leukapheresis HPC collections in tandem with hemodialysis. Under our protocol, all of the blood processed through the apheresis instrument was dialyzed against a standard calcium-rich bath prior to being returned to the patient, therefore no supplemental calcium was needed. No significant changes in pulse rate ( P = 0.625) or mean arterial pressure ( P = 0.188) were noted between the start and end of the procedures. The patients exhibited no signs or symptoms of hypocalcemia or other adverse effects. Calculated urea reduction ratios ranged between 62.5 and 73.9%, and HPC CE was between 53 and 84% for 4 of the 5 procedures, indicating that there was no compromise of either procedure when performed in tandem. Ionized calcium measured at the beginning, midpoint and end of every procedure did not change ( P = 0.954). The two patients who proceeded to autologous HPC transplant engrafted on Days 11 and 10, respectively. We conclude that autologous HPC collection can safely be performed in tandem with hemodialysis without compromising the efficacy of dialysis, HPC CE, or patient safety. J. Clin. Apheresis 29:83-89, 2014. © 2013 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Several neurologic disorders have been treated with therapeutic plasma exchange (TPE). Case reports, case series, and clinical trials have published results regarding the outcomes in such patients. The data gathered have been used to formulate evidence-based guidelines, which can be used to guide therapy in patients with these neurological disorders. Adequately designed and powered randomized controlled trials have proven the efficacy of TPE in some disease entities, while other diseases are lacking such data. In the latter, decisions for the use of TPE must be made using the limited published data available. In this review, we discuss the published evidence regarding the use of TPE in neurological disorders, focusing on the most recent guidelines published by the American Society of Apheresis in 2010 and the American Academy of Neurology in 2011. [ABSTRACT FROM AUTHOR]

Because of recent insights into the pathogenesis of age-related bone loss, we investigated whether intermittent parathyroid hormone (PTH) administration antagonizes the molecular mechanisms of the adverse effects of aging on bone. Parathyroid hormone produced a greater increase in vertebral trabecular bone mineral density and bone volume as well as a greater expansion of the endocortical bone surface in the femur of 26- when compared to 6 -month-old female C57BL/6 mice. Moreover, PTH increased trabecular connectivity in vertebrae, and the toughness of both vertebrae and femora in old, but not young, mice. Parathyroid hormone also increased the rate of bone formation and reduced osteoblast apoptosis to a greater extent in the old mice. Most strikingly, PTH reduced reactive oxygen species, p66Shc phosphorylation, and expression of the lipoxygenase Alox15, and it increased glutathione and stimulated Wnt signaling in bone of old mice. Parathyroid hormone also antagonized the effects of oxidative stress on p66Shc phosphorylation, Forkhead Box O transcriptional activity, osteoblast apoptosis, and Wnt signaling in vitro. In contrast, administration of the antioxidants N-acetyl cysteine or pegylated catalase reduced osteoblast progenitors and attenuated proliferation and Wnt signaling. These results suggest that PTH has a greater bone anabolic efficacy in old age because in addition to its other positive actions on bone formation, it antagonizes the age-associated increase in oxidative stress and its adverse effects on the birth and survival of osteoblasts. On the other hand, ordinary antioxidants cannot restore bone mass in old age because they slow remodeling and attenuate osteoblastogenesis by interfering with Wnt signaling. [ABSTRACT FROM AUTHOR]

Aging or glucocorticoid excess decrease bone strength more than bone mass in humans and mice, but an explanation for this mismatch remains elusive. We report that aging in C57BL/6 mice was associated with an increase in adrenal production of glucocorticoids as well as bone expression of 11β-hydroxysteroid dehydrogenase (11β-HSD) type 1, the enzyme that activates glucocorticoids. Aging also decreased the volume of the bone vasculature and solute transport from the peripheral circulation to the lacunar-canalicular system. The same changes were reproduced by pharmacologic hyperglucocorticoidism. Furthermore, mice in which osteoblasts and osteocytes were shielded from glucocorticoids via cell-specific transgenic expression of 11β-HSD type 2, the enzyme that inactivates glucocorticoids, were protected from the adverse effects of aging on osteoblast and osteocyte apoptosis, bone formation rate and microarchitecture, crystallinity, vasculature volume, interstitial fluid, and strength. In addition, glucocorticoids suppressed angiogenesis in fetal metatarsals and hypoxia inducible factor-1α transcription and vascular endothelial growth factor production in osteoblasts and osteocytes. These results, together with the evidence that dehydration of bone decreases strength, reveal that endogenous glucocorticoids increase skeletal fragility in old age as a result of cell autonomous effects on osteoblasts and osteocytes leading to interconnected decrements in bone angiogenesis, vasculature volume, and osteocyte-lacunar-canalicular fluid. [ABSTRACT FROM AUTHOR]

Neurologic disorders constitute the largest group of indications for therapeutic plasma exchange. Although some of the traditional indications are supported by properly designed randomized trials, others are not. This article provides a critical look at the evidence in support of the assignment by ASFA of Category I or II indications to neurologic disorders in its most recent (2007) evaluation of therapeutic apheresis. J. Clin. Apheresis, 2008. © 2008 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To improve antimicrobial use in patients receiving long-term care (LTC). DESIGN: Prospective, quasi-experimental before–after assessment of the effects of physician education and guideline implementation. SETTING: Public LTC and acute care hospital. PARTICIPANTS: Twenty salaried internists who provided most of the medical care to LTC patients. INTERVENTION: National guidelines, hospital resistance data, and physician feedback were incorporated into a series of four teaching sessions presented over 18 months and into booklets detailing institutional guidelines on the optimal management of common LTC infection syndromes. MEASUREMENTS: One hundred randomly selected LTC patients treated with antimicrobials were reviewed before these interventions were implemented and 100 after, and measures of the quality of care were compared. The effect of the interventions on antimicrobial days and starts were also assessed using interrupted time series analysis. RESULTS: Charted clinical abnormalities met guideline diagnostic criteria (62% vs 38%, P=.006), and initial therapy agreed with guideline recommendations (39% vs 11%, P<.001), more often in the post- than in the preintervention cohort. Mean census-adjusted monthly LTC antimicrobial days fell 29.7%, and antimicrobial starts fell 25.9% during the intervention period; both decreases were sustained during the 2-year postintervention period. CONCLUSION: The teaching and guideline intervention improved the quality and reduced the quantity of antimicrobial use in LTC patients. [ABSTRACT FROM AUTHOR]

The American Society for Apheresis (ASFA) Apheresis Applications Committee is charged with a review and categorization of indications for therapeutic apheresis. This elaborate process had been undertaken every 7 years resulting in three prior publications in 1986, 1993, and 2000 of 'The ASFA Special Issues.' This article is the integral part of the Fourth ASFA Special Issue. The Fourth ASFA Special Issue is significantly modified in comparison to the previous editions. A new concept of a fact sheet has been introduced. The fact sheet succinctly summarizes the evidence for the use of therapeutic apheresis. A detailed description of the fact sheet is provided. The article consists of 53 fact sheets devoted to each disease entity currently categorized by the ASFA. Categories I, II, and III are defined as previously in the Third Special Issue. However, a few new therapeutic apheresis modalities, not yet approved in the United States or are currently in clinical trials, have been assigned category P (pending) by the ASFA Clinical Categories Subcommittee. The diseases assigned to category IV are discussed in a separate article in this issue. J. Clin. Apheresis., 2007 © 2007 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

The American Society for Apheresis (ASFA) Committee on Clinical Applications systematically and critically reviews published information on the use of therapeutic apheresis in clinical practice. On the basis of this review, selected diseases are assigned one of five categories (category I, II, III, IV, and P). The diseases, which were classified as category IV indications, and the rationale for such assignment are reviewed in this article. The diseases assigned to category I, II, III, and newly created category P are discussed in a separate article in this issue. J. Clin. Apheresis, 2007 © 2007 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

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The Guillian Barré syndrome is an acute inflammatory disorder for which plasma exchange is effective treatment. Up to 10% relapse after plasma exchange suggesting that treatment sometimes finishes before disease activity has resolved. We studied whether plasma fibrinogen, an inflammatory marker, might be used to determine when to discontinue plasma exchange in patients with acute Guillain-Barré syndrome. We conducted a post-hoc analysis of apheresis database and hospital records of patients treated with plasma exchange for acute Guillain-Barré syndrome during 1999-2004. Data were analyzed from 28 patients who underwent a total of 29 courses of plasma exchange for acute Guillain-Barré syndrome. The mean (±SD) plasma fibrinogen concentration was 422.5 (±96.4) mg/dl at the time of presentation and, in 17 of the 29, it was above 400 mg/dl (reference range 200-400). Twenty of the 21 patients whose fibrinogen fell by more than 30% from baseline by the time of the final plasma exchange treatment had neurological improvement. There was improvement in only 3 of the 8 instances where fibrinogen decreased by less than 30% by the end of plasma exchange therapy. A ≥30% decrease in fibrinogen by the conclusion of plasma exchange was significantly associated with sustained neurological improvement ( P = 0.0025). The plasma fibrinogen level appears to reflect disease activity in acute Guillain-Barré syndrome. A <30% fall in fibrinogen level despite plasma exchange may indicate the need to continue plasma exchange to maximize the benefit of treatment or minimize the risk of relapse. Therapeutic plasma exchange need not be extended when plasma fibrinogen remains ≥30% below its level at presentation by the time of the final planned plasma exchange procedure. J Clin Apheresis 2005. © 2005 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

Information on the safety of mobilization and collection of peripheral blood progenitor cells (PBPC) in patients with advanced coronary heart disease (CHD) is limited. We report herein our early experience with patients participating in a Phase I trial of injection of autologous CD 34+ cells into threatened, ischemic myocardium for neovascularization and symptom relief in patients with chronic refractory myocardial ischemia. All patients had advanced inoperable CHD despite the best medical therapy. Granulocyte colony stimulating factor (G-CSF, 5 μg/kg/day) was administered subcutaneously for 5 days for mobilization of CD34+ cells into the peripheral blood. PBPCs were collected in the outpatient apheresis suite on day 5. Nine patients from our institution were evaluable. Adverse effects of mobilization included: increase in frequency and/or intensity of angina in 8 patients (88.8%); bone pain in 7 patients (77.7%); headaches in 4 patients (44.4%); 2 patients (22%) were hospitalized. Collection phase toxicities included: tingling in 5 patients (55.5%) and angina in 3 patients (33%). All procedures were completed without new myocardial infarction, congestive heart failure, or death. The median peripheral blood CD34+ cell count on day 5 of G-CSF was 21 cells/μl (range10-40 cells/μl). A median of 1.65 × 106 CD34+ cells/kg (range: 0.13-3.0 × 106/kg) were harvested. We conclude that mobilization and collection of PBPC in patients with advanced CHD can be safely performed as an outpatient procedure. Apheresis professionals should be aware of the intensity and frequency of angina in this patient population. J. Clin. Apheresis 2005. © 2005 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

M-proteins are monoclonal immunoglobulins or immunoglobulin fragments that aberrantly accumulate in the plasma. Hemodialysis (HD) patients with M-proteins may, under certain circumstances, also need therapeutic plasma exchange (TPE). We employed a protocol for tandem TPE/HD in patients with M-protein disorders. We followed the urea reduction ratio (URR), a measure of the efficiency of HD, to compare the effect of TPE on HD efficiency during tandem procedures versus the efficiency of HD performed as a stand-alone procedure in the same patients. Three men (J.M., R.T., M.M.) underwent 23, 80, and 25 tandem TPE/HD over 3, 17, and 7 months, respectively, almost all in the outpatient setting. Mean whole blood flow rate (in ml/min) was slower during hemodialysis alone than during TPE/HD for J.M. (289 ± 24 vs. 332 ± 22, P < 0.0001) and R.T. (310 ± 20 vs. 367 ± 15, P < 0.0001) but not for M.M. (395 ± 65 vs. 404 ± 62, P = 0.6844). URR was equivalent during hemodialysis alone and during TPE/HD for J.M. (54 ± 4.2 vs. 58 ± 1.4, P = 0.3333), R.T. (69 ± 4.9 vs. 70 ± 2.5, P = 0.9804), and M.M. (71 ± 2.4 vs. 67 ± 1.5, P = 0.1143). J.M.'s renal function recovered sufficiently to permit discontinuation of hemodialysis. R.T. experienced both subjective and objective improvement of his arthritic symptoms. M.M. achieved hemostatic control but ultimately died of amyloidosis. TPE/HD is feasible using disparate pieces of equipment when the therapeutic plasma exchange circuit is connected in parallel with the low-pressure side of the hemodialysis circuit. Our experience illustrates that therapeutic plasma exchange did not adversely impact hemodialysis when the two procedures were performed in tandem. J. Clin. Apheresis 2005.© 2005 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

To compare routine glove use by healthcare workers for all residents, without use of contact-isolation precautions, with contact-isolation precautions for the care of residents who had vancomycin-resistant enterococci or methicillin-resistantStaphylococcus aureusisolated from a clinical cultureRandom allocation of two similar sections of the skilled-care unit to one of the infection-control strategies during an 18-month study period.Skilled-care unit of a 667-bed acute- and long-term care facility.All residents present or admitted to the skilled-care unit from June 1, 1998, through December 7, 1999.Resident acquisition of four antimicrobial-resistant organisms (methicillin-resistantStaphylococcus aureus, vancomycin-resistant enterococci, or extended-spectrumβ-lactamase-producingKlebsiella pneumoniaeorEscherichia coli). All isolates were strain typed. The facility level costs associated with each strategy were estimated.Resident acquisition of antimicrobial-resistant organisms was no different in the glove-use and isolation-precautions sections (31 episodes (1.5 per 1,000 resident-days) vs 38 episodes (1.6 per 1,000 resident-days)). Acquisition of either of two prevalentK. pneumoniaestrains was more likely (P=.06) in residents in the isolation-precautions section. The estimated costs of contact-isolation precautions were 40% greater than those of routine glove use.There was a similar frequency of transmission of antimicrobial-resistant bacteria in the two study sections; there was evidence for resident-to-residentK. pneumoniaetransmission in the isolation-precautions section. Routine glove use for healthcare workers, which decreases resident social isolation and healthcare facility costs, may be preferable in many long-term care facilities. [ABSTRACT FROM AUTHOR]

We presented the results of our prospective trial of the Bard CathLink® 20 in outpatient therapeutic plasma exchange in May 2000. Since the close of that study, three of the original subjects and one additional subject have received continuous outpatient treatment using the device. We report herein on its long-term use. Four patients with demyelinating polyneuropathy underwent outpatient plasma exchange of 1-1¼ plasma volumes using Bard CathLink® 20 venous access devices for up to 2½ years. Treatment schedules varied according to the status of the patient's neuropathy. Four men (age 59, 60, 76, 79) underwent 55, 56, 38, and 41 plasma exchanges over 18.5, 18, 20, and 38.5 months, respectively, all in the outpatient setting. Ninety-one percent were completed in <150 min (mean 120 ± 28 min) with 3,783 ± 314 ml of plasma removed. Mean access flow rates were approximately 70 ± 11 ml/min. Plasma flow rates were approximately 38 ± 6 ml/min. (During our original 6-month prospective trial, access and plasma flow rates were approximately 54 and 32 ml/min, respectively). There were no adverse effects resulting from use of the CathLink® and no hospitalizations were needed for plasma exchange. Pressure alarms were infrequent. Access and plasma flow rates achieved with the CathLink® 20 have increased by about 30 and 16%, respectively, with long-term use. The conclusion from our prospective trial of this device, that it could conveniently be used for long-term outpatient plasma exchange, is supported by our follow-up experience. J. Clin. Apheresis 19:180-184, 2004. © 2004 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

Background: Hereditary antithrombin (AT) deficiency is associated with a significant risk of venous thromboembolism. Patients with this disorder frequently require long-term anticoagulation. Discontinuation of anticoagulation for childbirth or surgery may carry a substantial thrombotic risk. For this reason, replacement with AT concentrate has been used when anticoagulation is interrupted. A new recombinant human AT concentrate, produced using transgenic technology, has recently been developed.Study Design and Methods: Human recombinant AT (rhAT) was provided by GTC Biotherapeutics, Inc. on a compassionate-use basis for five patients with hereditary AT deficiency who underwent six surgical procedures. Patients were treated perioperatively. Dosing was determined individually by the investigators with a goal of maintaining an AT activity of 80 to 150 percent.Results: There was no clinical evidence of thrombosis or bleeding. Four of the five patients had postoperative duplex ultrasound studies of the lower extremities, which showed no evidence of acute thrombosis. Four patients were tested for antirecombinant rhAT antibodies postoperatively and were negative.Conclusion: These case reports indicate that rhAT can provide effective support for AT-deficient patients who undergo surgery. Further study of this product is needed to define optimal dosing and further assess clinical response. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To determine the frequency of and risk factors for colonization of skilled-care unit residents by several antimicrobial-resistant bacterial species, methicillin-resistant Stuphylococcus aweus (MRSA), vancomycin-resistant enterococcus (VRE), or extended-spectrum-B-lactamase-producing (ESBL-producing) (ceftazidime resistant) Klebsiella pneumoniae or Escherichia coli . DESIGN: Point-prevalence survey and medical record review. SETTING: The skilled-care units in one healthcare facility. PARTICIPANTS: 120 skilled-care unit residents. MEASUREMENTS: Colonization by each of the four antimicrobial-resistant pathogens during a point-prevalence survey, using rectal, nasal, gastrostomy-tube site, wound, and axillary cultures, June 1–3, 1998; 117 (98%) had at least one swab collected and 1 14 (95%) had a rectal swab collected. Demographic and clinical characteristics were evaluated as risk factors for colonization. All isolates were strain typed by pulsed-field gel electrophoresis of total genomic deoxyribonucleic acid. RESULTS: Of 117 participants, 50 (43%) were culture positive for ≥1 antimicrobial-resistant pathogen: MRSA (24%), ESBL-producing K. pneumoniae (18%) or E. coli (15%), and VRE (3.5%). Of 50 residents culture positive for any of these four antimicrobial-resistant species, 13 (26%) were colonized by more than one resistant species; only three (6%) were on contact-isolation precautions at the time of the prevalence survey. Risk factors for colonization varied by pathogen: total dependence on healthcare workers (HCWs) for activities of daily living (ADLs) and antimicrobial receipt for MRSA, total dependence on HCWs for ADLs for ESBL-producing K. pneumoniae , and antimicrobial receipt for VRE. No significant risk factors were identified for colonization by ESBL-producing E. coli. Among colonized patients, there was a limited number of strain types for MRSA (24 patients, 4 strain types) and ESBL-producing K. pneumoniae (21 patients, 3... [ABSTRACT FROM AUTHOR]