Therapeutic Apheresis Procedures Research Articles

Beyond traditional venous access: Midline catheter use in pediatric apheresis.

The objective of this study was to assess the use of midline catheters as venous access for apheresis procedures in pediatric patients. A retrospective analysis of medical records was conducted from September 2019 to June 2022 to evaluate the safety and efficacy of midline catheters for therapeutic pediatric apheresis. During the study period, a total of 121 procedures were inserted in 22 unique patients. The age of the subjects ranged from 2.7 to 21 years. The blood flow rates achieved with midline catheters met or exceeded the recommended rates for apheresis in children (40 mL/min), by the Wilcoxon signed-rank test (p < 0.0001). There was one episode of catheter-related thrombosis, but no cases of bloodstream infection or catheter dislodgement were reported. In conclusion, this study supports the use of midline catheters as a safe and effective alternative for venous access during therapeutic and donor apheresis procedures in pediatric patients.

Therapeutic apheresis in kidney transplantation: Emerging trends.

The use of therapeutic apheresis (TA) either as stand-alone or adjunctive treatment in kidney transplantation has increased over the years to become a leading indication. This study shows recent trends in indications for TA related to kidney transplantation, adverse events, and patient outcome in this cohort. This is a retrospective cohort review of adults who received TA for kidney transplant-related indications from January 1, 2017, to December 31, 2022, at the University of Virginia Medical Centre, Charlottesville, VA, USA. Data extracted include basic demographics, indication for apheresis, number of procedures, procedure characteristics, procedure-related adverse events (complications), and serum ionized calcium and serum creatinine. Data were analyzed using statistical package for social sciences (SPSS 2022 IBM Inc). Data from a total of 131 patients who received 860 TA procedures were analyzed. Indications for TA were antibody-mediated rejection (65.5%), recurrent focal segmental glomerulosclerosis (15%), thrombotic microangiopathy (5%), desensitization for ABO incompatibility (4.5%) and for HLA-incompatibility (4.5%), and recurrent IgA nephropathy (1%). Some adverse events were encountered in 16.7% of the procedures and include hypocalcemia (7%), vascular access malfunction (0.7%), hypotension (1.2%), arrhythmia (0.6%), and depletion coagulopathy (0.6%). The overall case mortality rate was 8.4% over the 6-year period. There was one death recorded on machine during TA resulting in a procedure-mortality rate of 0.12%. Antibody-mediated rejection was the most common indication for TA related to kidney transplantation. Adverse events were minor and patient survival over the time was within usual limits.

The Italian registry of therapeutic apheresis in SISTRA: Year of activity 2022

Therapeutic apheresis refers to a group of extracorporeal blood processing procedures used in the treatment of a variety of systemic diseases. These complex procedures are burdened by adverse reactions related to both procedures and underlying medical conditions.Given the importance of centralizing the collection and the analysis of information on therapeutic apheresis, the Italian National Blood Center (NBC), at the request of the Italian Scientific Society of Hemapheresis and Cell Manipulation (SIdEM), implemented the Italian Registry of Therapeutic Apheresis (IRTA) including it in the Information System of Transfusion Services (SISTRA), coordinated by the NBC.In 2022, a total of 34,702 therapeutic apheresis procedures was carried out in 8,781 patients, including paediatric patients, with an average of 3.9 procedures per patient. The 2022 IRTA data indicate that the patient with hematological and/or neurological disorders mainly turns to the apheresis centers. These results confirm the IRTA data from years 2020 and 2021. In the hematological field, the apheresis centers supply hematopoietic stem cells collection for autologous transplantation as well as mononuclear cell collection for extracorporeal photopheresis. With regard to the neurological field, myasthenia, chronic inflammatory demyelinating polyneuropathy and Guillain-Barré syndrome along with other neurological pathologies related to immune disorders are the most treated.In conclusion, this manuscript presents 2022 activity data of IRTA providing institutions and scientific societies with a wide range of information including type and number of therapeutic procedures, adverse events and patients’ outcome.

Validating Recorded EHR and Actual Weight: Single Institution Study

Abstract Introduction/Objective Our hemapheresis clinic performs outpatient and inpatient therapeutic apheresis procedures including red blood cell exchange and therapeutic plasma exchange. Accurate height, weight, and hematocrit are required for calculating replacement fluid volumes for both procedures. Our practice has been using the patient’s most recent weight recorded in the EHR. The purpose of this quality improvement project is to validate concordance between patients’ actual body weight and documented body weight. Methods/Case Report STUDY DESIGN AND DATA COLLECTION We performed this quality improvement project in our hemapheresis clinic. The study focused on weight variations impacting calculations for apheresis volume requirements. Data were collected from March 20th, 2023 – April 20th, 2023. Patients receiving red blood cell exchange or therapeutic plasma exchange were randomly selected and weighed prior to the procedure on a calibrated scale. The most recently recorded weight in the EHR was also collected. Non-ambulatory patients or patients receiving phlebotomy or stem cell collection were excluded from the study. Statistical Analysis: Statistical analyses were performed using R Statistical Software (Foundation for Statistical Computing, Vienna, Austria). We compared means of two observations using a paired t-test. P values less than 0.05 were considered to be statistically significant to test null hypothesis. Results (if a Case Study enter NA) A total of 40 patient data were collected. Seventeen male and 23 female patients were weighed and recorded. The mean value of EHR weight is 70.56kg and that of clinic weight is 71.41kg (P=0.08701). The weight discrepancy was calculated in comparison with EHR recorded weight and it was transformed to weight discrepancy by percentage using d(clinic weight -EHR weight)/clinic weight*100. Out of 40 patients, 33 patients had weight discrepancy by percentage between 0 to 4%. Conclusion Patient body weight is an important factor in calculating the replacement volume requirements in therapeutic apheresis. It is often prescribed based on the recorded EHR weight. In our data, we have shown that the weight discrepancy is not significant and therefore EHR recorded weight is reliable in replacement volume calculation. Our study is subject to several limitations that it was conducted for one month in a single institution and the sample size is not large. However, our study is novel in describing the relationship between recorded patient data and the actual patient data.

Therapy plans for therapeutic apheresis in Epic HealthLink.

A common required duty of pathology resident physicians while rotating on transfusion medicine is the medical oversight of the therapeutic apheresis service. A task often performed on this clinical medicine service is formulating and writing orders for therapeutic apheresis procedures. The EpicCare tool called the therapy plan provides unique advantages over a standard electronic order set for therapeutic apheresis. Transfusion medicine physicians, apheresis nurses, pharmacists, and information technology professionals collaborated to create therapy plans for three therapeutic apheresis procedures: plasmapheresis, red cell exchange, and photopheresis. Therapy plans were implemented and have been well-received for several years. Over a six-year time period, a total of 613 therapy plans were created and signed. We speculate that this implementation may have increased both physician efficiency and patient safety. This article reports our experience using therapy plans in EpicCare in order to raise awareness of this tool and to serve as an encouragement for wider adoption.

Single center experience of therapeutic plasma exchange in a resource-constrained setting: A study of trends in scope and complications.

Therapeutic apheresis procedures are becoming an increasingly integral part of modern medical practice, be it as a part of therapy or pre-conditioning regimes for solid organ transplants. In our center, we follow the American Society for Apheresis (ASFA) guidelines for categorizing these procedures. However, lack of a centralized registry for therapeutic apheresis in India, lack of consolidated data as well as a resource-constrained setting prevent it from being utilized to its full potential. This study was a retrospective analysis of therapeutic plasma exchange (TPE) procedures performed from January 2015 to October 2022 in the Department of Transfusion Medicine at a large tertiary care hospital in North India. All consecutive TPE procedures were included. Overall and specialty-wise scoring for all patients was performed. Mean scores were calculated. A total of 1434 procedures were performed during the study duration of 7 years. These procedures were performed for 284 different patients. Majority of the procedures were referred from nephrology (895 of 1434, 62.4%), followed by neurology, gastroenterology, and liver transplant teams, hematology, critical care, rheumatology, pediatrics, and internal medicine. Complete response, partial response, and no-response were observed in 1077 (75.1%), 201 (14%), and 156 (10.9%) procedures respectively. Only 14 procedures reported adverse effects. Increasing effectiveness of TPE in a number of procedures and a variety of indications has broadened its scope, while the small number of adverse events, when supervised by trained Transfusion Medicine physicians has made TPE a more viable and safer alternative to other treatment modalities.

Plasma exchange and COVID 19

Plasma exchange and COVID 19

Long-COVID, Metabolic and Endocrine Disease.

In the aftermath of the corona pandemic, long-COVID or post-acute COVID-19 syndrome still represents a great challenge, and this topic will continue to represent a significant health problem in the coming years. At present, the impact of long-COVID on our health system cannot be fully assessed but according to current studies, up to 40% of people who have been infected with SARS-CoV-2 suffer from clinically relevant symptoms of long-COVID syndrome several weeks to months after the acute phase. The main symptoms are chronic fatigue, dyspnea, and various cognitive symptoms. Initial studies have shown that people with overweight and diabetes mellitus have a higher risk of developing long-COVID associated symptoms. Furthermore, repeated treatment of acute COVID-19 and long-COVID with steroids can contribute to long-term metabolic and endocrine disorders. Therefore, a structured program with rehabilitation and physical activity as well as optimal dietary management is of utmost importance, especially for patients with metabolic diseases and/or long-COVID. Furthermore, the removal of autoantibodies and specific therapeutic apheresis procedures could lead to a significant improvement in the symptoms of long-COVID in individual patients.

Therapeutic apheresis and non‐blood donor related apheresis current practices at various blood centres of healthcare organisations of India: A brief online survey

AbstractObjectivesTo determine the variability in therapeutic apheresis (TA) and non‐blood donor related apheresis practices, and the extent of expertise and knowledge of blood centre staff.BackgroundApheresis activity that was earlier limited to therapeutic plasma exchange (TPE) and donor apheresis at few centres in India has seen remarkable surge involving many centres practising TA and non‐blood donor related apheresis. The decentralised transfusion medicine practice in country has resulted in wide variability of knowledge and practice of TA. An online survey was conducted to achieve study objectives.Study design and methodsA 22 questionnaire survey was sent to the 215 blood centres through e‐mail link focussing on three aspects; basic information of the participating centres, details of TA procedures and education and training levels of the staff.ResultsMajority (71.9%) of centres were teaching institutions among analysed 57 centres. TPE (85.9%) and therapeutic cytapheresis (71.9%) were the most common TA procedures. The clinical haematology (68.4%) followed by neurology (64.9%) were the specialities utilising TA. The 64.9% centres used continuous flow cell separator and central venous access (52%) was preferred vascular access. A combination of normal saline, fresh frozen plasma and 5% albumin replacement fluid was first choice. Doctors involved in TA were trained in apheresis during their MD/DNB degree, but no structured training program existed for other category of staff.ConclusionThere was a wide variability in TA practice in India and a dedicated training program for all categories of staff was emphasised by majority of participants.

The Italian registry of therapeutic apheresis enters the information system of transfusion services - SISTRA

The National Blood Centre (NBC) at the request of the Italian Scientific Society of Haemapheresis and Cell Manipulation (SIdEM) has funded and developed a software dedicated to the collection of data related to therapeutic apheresis procedures, known as the Italian Registry of Therapeutic Apheresis (IRTA). Although on a voluntary basis, participation in the registry was widespread. The data collected includes type and number of procedures, patients treated and their outcomes, and reported adverse events to the procedures.For the years 2019 and 2020, the therapeutic apheresis procedure was widely used in the field of haematology, transplantation and rheumatology and was mainly associated with mild adverse events, thus showing a high level of safety. In addition to allowing the competent institution to monitor an important activity in the transfusion medicine field, the Registry is a new starting point for collaboration between transfusion centres distributed throughout the national territory and could encourage the design of major clinical trials.

Ultrasound-based criteria for adequate peripheral venous access in therapeutic apheresis procedures.

Apheresis procedures require adequate vascular access to achieve adequate inlet flow rates. Central dialysis-type catheters are often used in apheresis, despite their multiple risks. Peripheral venous access is a safe and effective option for many patients. We previously demonstrated that ultrasound guidance reduces central venous catheter use in apheresis patients; however, no validated criteria for preprocedural evaluation of peripheral veins exist. Here, we hypothesized that ultrasound-based criteria could predict the adequacy of a peripheral vein for apheresis procedures. In this pilot cohort study, we reviewed the procedural outcomes for 50 cases of peripheral venous procedures that used our ultrasound-based criteria. Of the procedures that met our criteria, 96% (46/48) were successfully completed. Overall, our criteria had 100% sensitivity, 50% specificity, 96% positive predictive value, and 100% negative predictive value. Our criteria justify an evidence-based ultrasound-guided standard for evaluation of peripheral venous access for apheresis procedures.

Strategies to Aid Identification of Apheresis PowerFlow Ports: A Case Report

IntroductionThe PowerFlow implantable apheresis intravenous port is a venous access device for therapeutic apheresis procedures. In this case review article, we identify key similarities and differences between apheresis PowerFlow ports and traditional ports. We also list strategies that emergency departments can implement to aid in correct port identification. MethodsUsing a case review format, we describe the clinical presentation of a 33-year-old female with neuromyelitis optica who was evaluated in the emergency department for an acute exacerbation. She had a history of outpatient apheresis procedures that made use of bilateral PowerFlow ports. Mistaken for a conventional port, the right PowerFlow port was accessed with a Huber needle rather than the appropriate catheter-over-needle device. On infusion of intravenous fluids, the patient experienced pain and swelling. Ultimately, the port malfunctioned and was eventually replaced. ResultsA subsequent root cause analysis identified opportunities for education and aids to improve port identification. To this end, strategies were implemented to appropriately identify the PowerFlow port using at least 2 of the following methods: (1) look in the patient’s chart for record of an implantable apheresis intravenous port; (2) check the port identification card, bracelet, or keychain issued at insertion; (3) palpate the port to look for the rounded top and hollow concave entry point; and (4) use x-ray or fluoroscopy to identify radiopaque port markers. ConclusionWhen a patient with a history of apheresis procedures presents with an implanted port, steps should be taken to ensure correct identification and access.

Reimbursement for therapeutic apheresis devices and procedures for using the healthcare insurance system in Japan.

The aim of this paper was to explain the insurance coverage status of therapeutic apheresis (excluding CHDF) in Japan, alongside the social system of medical reimbursement and concerns regarding the future sustainability of the healthcare system. Insurance schemes and premiums differed for individuals at different levels in the society (eg, municipal residents, employees, and public servants). Insurance premiums and their rates varied depending on the total household income, the number of people living together, age, and the place of residence. In addition, the medical expense subsidies for children through public expenditure were also described. Japan's generous insurance system and multiple medical expense subsidies provide financial support for patients. With Japan's history of medical expense subsidies based on the policy of supporting intractable diseases, we have established an environment where all citizens can receive therapeutic apheresis when needed if they are affected by a disease for which insurance coverage is indicated.

A New Solid-Phase Immunosorbent for Selective Binding of Desmoglein 3 Autoantibodies in Patients with Pemphigus Vulgaris.

Autoantibodies, immunoglobulins G (IgG) against the desmosomal proteins desmogleins 1 and 3, play a significant role in the pathogenesis of pemphigus vulgaris. The basic therapy for pemfigus includes systemic corticosteroids, but their use should be as brief as possible because of the severe side effects. In cases of corticosteroid- resistant pemfigus, adjuvant therapy, in particular extracorporeal methods, is used. The most effective and safest extracorporeal therapy is immunosorbtion. Immunosorbtion is based on the removal of pemphigus antibodies from the blood using an affinity sorbent during a therapeutic apheresis procedure. Existing immunosorbents are nonselective and increase the risk of infection. We designed an immunosorbent based on an agarose matrix, Affi-Gel 15, and human recombinant desmoglein 3, as a ligand, for a selective removal of autoantibodies from pemphigus patients’ sera. It was shown on a pemphigus experimental model in vivo (neonatal Balb/c mouse model) and in vitro that the immunosorbent can effectively remove desmoglein 3-associated autoantibodies. The experimental results demonstrate that the solid-phase matrix immunosorbent Affi-Gel 15–Dsg3 is a promising product for the development of pemphigus therapy.

PMD25 COMPARING ECONOMIC IMPACT OF CENTRIFUGAL AND MEMBRANE THERAPEUTIC PLASMA EXCHANGE IN A SINGLE INSTITUTION IN THAILAND

Therapeutic plasma exchange (TPE) is one of the therapeutic apheresis procedures where it removes pathogenic substances that cause the underlying disease such as autoantibodies and circulating immune complexes from the plasma. TPE continued to play a key role in management of various diseases and remained as the treatment choice as per 2016 guidelines of the American Society of Apheresis for Guillan-Barré syndrome, ANCA associated rapidly progressive glomerulonephritis, thrombotic thrombocytopenic purpura and renal transplantation, to name a few. TPE can be performed using two techniques; membrane or centrifugal. This study examined the cost associated with these techniques from payer perspective. TPE utilization and cost data were collected from nephrology and hematology department in Rajavithi Hospital, Bangkok. A cost benefit analysis model was developed using micro-costing approach with the following cost component; device acquisition, maintenance, consumables, venous access, replacement fluids, labor. Data on procedure efficiency and clotting frequency were sought from published literatures. Clotting was defined as requiring filter replacement to continue procedure. The model assumed similar clinical outcome in these techniques. A total of 96 TPE procedures were performed in Rajavithi hospital. Out of these, 72 procedures were used membrane plasma filter for plasma exchange. The estimated cost per procedure for centrifugal and membrane TPE was USD 285 (THB 8942), rounded to nearest integer, and USD 982 (THB 30,797), respectively. Plasma exchange with membrane technique cost the payer additional USD 63,864 (THB 2,002,759) annually. Clotting of the plasma filter resulted in USD 230 (THB 7211) per procedure. The economic evaluation between these two plasma exchange techniques showed centrifugal TPE had a better cost benefit than membrane TPE. For a hospital with similar characteristics, we expect positive economic impact with application of centrifugal TPE.

Evaluation of health and quality of life in apheresis patients – data from the WAA register

Objective: The World Apheresis Association (WAA) register contains data from more than 89 000 apheresis procedures in more than 12,000 patients. The aim of this study was to evaluate functional health and quality of life (QoL) in patients during apheresis treatment. Material and methods: Estimates of health condition (HC) were made in 40,445 and of QoL in 22112 apheresis procedures. This study focused on a 10-step graded evaluation of HC (scale from: ‘bedridden, unable to eat’ to a level of ‘athletic competition’) and self-assessment of QoL (scale from: worst ever ‘0’ to best ever ‘10’). Data were compared in relation to various apheresis procedures and if the patient underwent the first or subsequent apheresis procedure. Results: Of the patients treated with plasma exchange (PEX) with centrifugation technique (n = 15787) 10% were ‘bedridden, unable to come out of bed’ while for patients treated with plasma filtration technique (n = 1018) the percentage was 27%. During the first procedure these figures were 16% and 30%, respectively. Self-estimates of QoL were graded ‘zero’ or ‘1’ in 1.6% of patients during the first apheresis procedure; At the first contact patients undergoing PEX graded like this in 4.3%. Conclusion: Many of the patients undergoing apheresis treatment have poor HC and QoL at the start of therapy. Of all therapeutic apheresis procedures patients undergoing PEX had the lowest score of QoL.

Vascular access practices for therapeutic apheresis: Results of a survey.

Obtaining vascular access (VA) is a critical part of the therapeutic apheresis (TA) treatment plan. Currently, there are no guidelines for VA decision-making and maintenance related to TA procedures. A 28-question survey to gather qualitative information regarding VA practices was distributed to the American Society for Apheresis (ASFA) 2018 Annual Meeting attendees and all ASFA members for voluntary participation. The descriptive analyses were reported as the number and frequency of responses for each question. Total participation was 206 with 147 (71.4%) answering some or all 16 VA focused questions. The majority of respondents were nurses or physicians (89.0%) at sites providing ≥100 procedures. The most common TA procedures were plasma exchange, red cell exchange, and leukocytapheresis. The VA evaluation was predominantly performed by the TA service (80.3%, 118/147). The majority of TA physicians and/or providers do not insert (91.7%, 132/144) or remove (81.2%, 117/143) VA catheters. When an emergent TA procedure is needed, the majority of respondents felt <2 hours was an acceptable turnaround time for VA placement (64.3%, 92/143). The most common anticoagulant for locking catheters and/or ports was heparin. The majority of TA services (54.3%, 76/140) collect data on aborted procedures due to catheter/line/port problems unrelated to infection, but only 41.4% (58/140) collect data on infections. VA contributes significantly to the overall risks associated with and the safety of TA. Our survey shows that there is substantial variation but common themes in TA VA practices. Several areas for future research may be identified.

Pediatric Tandem Therapeutic Apheresis: A Multidisciplinary Approach.

The epidemiology, safety, and efficacy of pediatric multiple tandem extracorporeal therapies are not well understood. We conducted a retrospective chart review of therapeutic apheresis (TA) from January 1, 2012 to October 31, 2015. We collected procedural/clinical demographics, American Society for Apheresis (ASFA) indication, complications, and mortality. One hundred eighty tandem TA procedures were performed in 53 patients. Median age was 9 years (range: 2 months to 21 years) with a median weight of 28 kg (range: 6-170.3 kg) with nine patients weighing < 10 kg. Forty-five percent of patients were in tandem with continuous veno-venous hemofiltration (CVVH), 21% cardiopulmonary bypass (CPB), 4% extracorporeal membrane oxygenation (ECMO), and 11% had multiple extracorporeal therapies (CVVH and ECMO). Common indications were solid organ transplant (50% cardiac, 13% renal) and sepsis-induced thrombocytopenia-associated multiple organ failure (26%). Equipment (4%) and patient (4%) complications occurred, with rare failure (1%) and no procedure-related mortality. Tandem procedures are used in critically ill pediatric patients with higher morbidity and mortality (21%) than typical TA patients. The high percentage of patients outside of category I or II (83%) underscores the emerging nature of tandem extracorporeal therapies and need for further investigation.

Italian Registry of Therapeutic Apheresis

Since the 80s the Italian Society of Apheresis and Cell Manipulation (SIdEM) started to monitor the adverse events of therapeutic apheresis (TA) procedures. In subsequent years other variables were added and a national TA registry was created, with a fluctuating adhesion over the years. From 2010 to 2013 the Registry was shared with the Italian Society of Nephrology (SIN): the collection method required data of each patient and a lack of adhesion was observed, mainly because of a heavy workload needed to fill out all the fields. SIdEM was then forced to simplify the form by collecting aggregated data. At the same time, the Italian Privacy Authority (IPA) gave a negative opinion on the use of the SIdEM-SIN registry because it did not prevent the possibility to identify the patients and raised the question whether a national registry could be managed by a scientific society or if it should be under the control of the Regulatory Authority (CNS - National Blood Centre). Since 2015 SIdEM has continued to collect aggregated data, with a simple form sent to each Italian TA unit. Today the main limitation of our Registry is the absence of informatic and financial support and the main limit of all TA Registries is represented by the voluntary adhesion, which can be limited by lack of time and interest or reluctance to show and share own data. In the last year SIdEM has started to work with the CNS in order to implement and integrate the Registry into the Information System of the Transfusion Units (SISTRA), a system that monitors the activities of the whole Italian blood system.The hypothesis of a Global Registry is fascinating. In order to have the greatest adhesion it should be easy and fast to fill in and, possibly, based on aggregated data.

Epidemiology of therapeutic apheresis with a multidisciplinary approach at a high volume pediatric center.

Therapeutic apheresis (TA) is used inconsistently in pediatric populations. We seek to define our multidisciplinary institutional practice. We conducted a retrospective chart review of patients receiving TA from January 1, 2012 through October 31, 2015. Data collected included demographics, American Society of Apheresis (ASFA) indication, complications, and mortality. Over 46 months, 1198 TA procedures were conducted on 289 patients ranging in age from 5 months to 21 years with weights ranging from 4.76 to 170.3 kg (16 procedures in patients <10 kg). The procedures were 86% therapeutic plasma exchange, 10% red blood cell exchange, 4% extracorporeal photopheresis, and 5 leukocytapheresis procedures. TA was initiated in different clinical environments: 41% outpatient, 37% intensive care, 15% general inpatient, and 7% operating room. The ASFA category (6th edition) indications for the 1198 procedures included: 44% category I, 25% category II, 23% category III, a single category IV procedure, and the remainder (8%) uncategorized by ASFA. The rate of procedure failure and procedure-related mortality are 1 and 0%, respectively. Case mortality rate was 4%. At a large volume pediatric hospital, TA is commonly used and can be performed safely in a variety of settings by a multidisciplinary team. This demographic review catalogs the number and type of procedures performed as a second-line therapy or on the basis of limited evidence. Additional collaborative investigation is needed to evaluate unique implications of TA in pediatrics to maximize efficacy while preserving safety.