Apheresis Activities Research Articles

Acute pancreatitis due to severe hypertriglyceridemia in the COVID-19 era: The role of therapeutic plasma exchange

The psychosocial consequences of the COVID-19 pandemic caused multifaceted challenges in clinical and therapeutic practices. This was the case at the Therapeutic Apheresis Unit of the Padua University Hospital too.Several published reports describe the increase in alcohol and food addiction diseases. In this context, during the last months, the Padua Therapeutic Apheresis Unit treated many more patients with acute pancreatitis due to severe hypertriglyceridemia with therapeutic plasma exchange than in the previous ten years. Furthermore, retrospective cohort studies have been recently published describing the onset of acute pancreatitis during the COVID-19 infection even if, to date, there is still insufficient evidence to estabilish a direct causality.Anyway, the COVID-19 pandemic translated into changes of the overall disease prevalence scenario and therefore the Padua Therapeutic Apheresis Unit will need to reorganise its Therapeutic Apheresis activity.

Apheresis activity in Spain: A survey of the Spanish Apheresis Group

The Spanish Apheresis Group is a scientific association of physicians and nurses representing most of the medical centers in the country that are involved in apheresis. The group developed a survey in order to get information about the types and number of apheresis procedures performed in Spain. We received responses from 66 centers and we were able to collect data from at least one center of each autonomous region. There were 7 centers (11%) that did not perform any kind of apheresis procedures, 26 (39%) centers performed therapeutic apheresis procedures only, 18 (27%) centers performed apheresis donations only, and 15 (23%) centers performed both types of apheresis procedures. Regarding therapeutic apheresis in adult patients, plasma exchange (34%) and stem cell collections (30%) were the two therapeutic procedures most frequently reported, followed by erythrocytapheresis (13%) and extracorporeal photochemotherapy (11%). Regarding apheresis donation, our survey showed that the most frequent was multicomponent donation (45%) followed by plasmapheresis (28%) and single plateletapheresis (21%). When analyzing the current instrumentation for performing apheresis procedures, centers used the Spectra, Optia, and Trima devices (TerumoBCT) as the most frequent ones, followed by the MCS+(Haemonetics), Amicus (Fenwal), and Fresenius devices. In conclusion, we report here the first nationwide survey performed in Spain in order to get information about apheresis activities in our country. The survey is representative of Spain because we were able to collect data from at least one center from each of the different 17 autonomous regions, and we found a wide variety of therapeutic and donation procedures, as well as instrumentation used.

20 Donor apheresis activities around the world: results of an international survey

20 Donor apheresis activities around the world: results of an international survey

The Italian Sidem Registry for Apheresis: An Overview of the 2005 Statistics

Data collection on apheresis activities in Italy throughout 2005 including techniques, types of blood cell separators, clinical indications and adverse effects was performed by means of a standardized questionnaire. These data provided by 83 Apheresis Units from 16 Italian regions, albeit rough, are sufficiently informative, mainly in comparison with previous surveys on these statistics (1997 and 2000). In 2005 a total number of 204,746 apheresis procedures were carried out, with a clear-cut prevalence of apheresis production (87.7%), performed by 66 out of 83 Apheresis Units (79.5). Lombardy, Veneto and Tuscany were the most active regions for therapeutic apheresis (51.1% of the total national procedures). An increasing number in extracorporeal photochemotherapy as compared to the 2000 national survey (3,386 vs. 704 procedures) is the most striking observation to emerge from the 2005 data collection on therapeutic apheresis in Italy. Adverse effects, predominantly mild ones (i.e., paresthesia due to citrate-induced hypocalcemia), occurred in 0.12% of apheresis production and 6.04 of therapeutic sessions, particularly in the course of peripheral blood stem cell collection (20.79%), as already reported in the 2000 national survey.

World apheresis registry report

The establishment of national apheresis registries has been helpful to learn about therapeutic profiles and adverse event incidences. During 2003, the World Apheresis Registry was established and centers from all countries were invited to participate to register their apheresis activities (at www.iml.umu.se/medicin). Material In this paper, we will report and analyze the first data retrieved from three centers, in 2 European countries, that registered a total of 388 therapeutic apheresis treatments in 122 patients, 95% due to acute indications. Statistical analyses were performed using an independent Student t-test and Fisher’s test. A p-value of less than 0.05 was considered significant. Results Fifty percent of the treated patients were women. The mean age of the patients was 51 years (±17, range 16–84) and there was no difference between genders (w 50.4, m 51.6 years). Diagnoses for treatment were mainly neurological and vasculitis. In 63% peripheral access was used with a central double lumen catheter, 22% in the jugular vein, 8% in the subclavian vein and 6% the femoral vein. Significant inter-center differences were seen in regard to the access used. The main technique used was centrifugation for conventional plasma exchange (86%), while other modes were leukapheresis, erythrapheresis, platelet apheresis, LDL-apheresis and adsorption of antibodies. Citrate was the only anticoagulant in 92%. During plasma exchange procedures using centrifugation, replacement was by albumin only (58%) or plasma, the latter often in combination with albumin (42%). Adverse events (AEs) were noted in 11% of the procedures. Patients with hypocalcaemia side effects with tingling sensations were included in those data as mild AE and as moderate AEs if they received calcium (Ca) medication. No patient died due to adverse effects. A mild AE was present in 1.8% and moderate in 8.5%. During two procedures (0.5%), the AE was considered severe and therefore the procedure was interrupted. If those with AEs due to lower calcium were removed from analyses, 6.4% had AEs. Significantly more AEs were found when plasma was used as a replacement fluid ( p = 0.017, RR 2.05, CI 1.17–3.60). There were no differences in the incidence of AEs between genders. The number of procedures was too small to allow sub analyses of AEs in relation to the diagnoses. Adverse events were not related to the procedure used ( p = 0.095). Those who received additional Ca infusion during the procedure had no AEs (40 sessions) while the others who received no prophylactic Ca had an AE on 45 occasions ( p = 0.0141, RR 1.116, CI 1.08–1.15). Conclusion Data from the registry shows that centers have various approaches to apheresis. One can learn from each other’s experience to reduce side effects and improve efficacy. From these data we noted that prophylactic Ca infusion reduced side effects.

Apheresis activity in Venezuela

Interest for apheresis activity has been growing in Venezuela. In 1976 there were only a few devices; in 2003, 80 apheresis machines performed 27,675 donor apheresis procedures and 547 therapeutic procedures countrywide. We report the activity at the Metropolitan Blood Bank (the largest one of the country) in the period 1999-2003: 597 therapeutic procedures were performed in 171 patients, during 212 crisis episodes. The average age was 38 +/- 16 years, 65% male and 35% female. Most of the therapeutic procedures were therapeutic plasma exchange for hematology diseases (mainly thrombotic thrombocitopenic purpura and hemophilia inhibitors), including 184 therapeutic procedures with the Autopheresis-C (Baxter Healthcare Corp., Deerfield, IL). Most common adverse effects (3.9%) were hypotension and allergic reactions to the plasma.

National survey of apheresis activity in Italy (2000)

Data collection on apheresis in Italy throughout 2000, including techniques, machines, clinical indications and adverse effects, has been performed by means of a standardized questionnaire. These data provided from 102 Apheresis Units from 19 Italian regions, albeit rough, are sufficiently informative. In 2000 a total number of 164,943 apheresis procedures has been carried out, with a clear-cut prevalence of productive apheresis (90.8%), that has been performed by all Apheresis Units. Lombardy, Venetia and Liguria have been the most active regions for therapeutic apheresis (54.0% of the total activity). Adverse events, predominantly mild ones (i.e., paresthesia due to citrate-induced hypocalcemia) have occurred in 0.59% of productive and in 6.75% of therapeutic apheresis sessions, particularly in the course of peripheral blood stem cell collection (13.0%).

Effect of Awareness of a Randomized Controlled Trial on Use of Experimental Therapy

Use of experimental therapies during but outside of randomized controlled trials (RCTs) has not been studied. To determine whether initiation of an RCT leads to increased use of the experimental therapy outside the trial. Data on national apheresis use during 3 Canadian RCTs for multiple sclerosis (1986-1988), thrombotic thrombocytopenic purpura (1982-1988), and myeloma cast nephropathy (1998-2000) were obtained from 19 major medical centers in Canada. The multiple sclerosis and myeloma cast nephropathy trials had data on apheresis use for 3 years prior to and during the trials, which permitted a time-series analysis to determine the impact of the RCTs on the use of apheresis. The ongoing myeloma cast nephropathy trial provided data on the number of patients inside and outside of the RCTs in trial and nontrial centers. Initial and follow-up questionnaires were sent to 24 Canadian physicians in trial and nontrial centers to determine if they had noted an increase in apheresis activity during the trials and, if so, their explanation for it. Change in number of patients undergoing apheresis for thrombotic thrombocytopenic purpura, multiple sclerosis, and myeloma cast nephropathy prior to and during the respective RCTs compared with all patients undergoing apheresis during the same periods. During all 3 RCTs, there were large increases in use of apheresis. The majority of the increased use of apheresis was outside of the trials: for multiple sclerosis, 30 of 49 patients per year (61% of increase); thrombotic thrombocytopenic purpura, 49 of 56 patients per year (72% of increase); and myeloma cast nephropathy, 60 of 72 patients per year (57% of increase). The myeloma cast nephropathy study noted that this increase occurred in both nontrial and trial centers. Among questionnaire respondents (n = 22; 92% response rate), most physicians noted an increase in apheresis activity during the trials and attributed it to a "jumping-the-gun" phenomenon. During 3 Canadian RCTs, apheresis increased, but most of the increase occurred outside the trials. This behavior during an RCT, in the absence of clear efficacy, can be termed jumping the gun.

National survey of hemapheresis practice in Turkey (1998)

The Turkish Apheresis Group has maintained a national registry for apheresis activities since 1997. The hemapheresis practice of Turkey in 1998 is summarized in brief detail in this article. A total of 30,136 apheresis procedures were performed at 31 different apheresis centers. At 10 centers, 145 peripheral blood stem cell (PBSC) apheresis were performed on 82 patients in allogeneic setting and at 17 centers, 981 PBSC apheresis were performed on 271 patients in autologous setting. Frequently observed adverse effects during PBSC apheresis were mild tremor and chills, paresthesia and nausea in 15% of the patients and donors. Vascular access complications, particularly observed in autologous setting due to central venous catheters were encountered in 10% of the procedures. Eight hundred and sixty-nine therapeutic plasma exchange procedures were performed at 21 centers on 172 patients, most commonly for neurological disorders and thrombotic thrombocytopenic purpura (TTP)/hemolyic uremic syndrome (HUS). Therapeutic cytapheresis procedures like leukapheresis, plateletapheresis and erythrocyte apheresis were performed especially for cytoreduction in myeloproliferative disorders. A total of 204 cytapheresis procedures (66% leukapheresis, 33% plateletapheresis and 1% erythrocytapheresis) were performed on 134 patients in 15 centers. Donor plateletapheresis was the most used apheresis procedure, reaching a total of 28.016 in 1998. Many university hospitals and a few state hospitals are performing above-mentioned apheresis procedures with great success and acceptable side effects. According to these data we are planning prospective trials and will establish National Standards of Practice.

A Preliminary Survey of the Apheresis Activity in Italy: A Perspective for the Italian Registry of Apheresis

Data collection on the apheresis activity in Italy throughout 1997 was performed by means of a standardized questionnaire. These data, provided by 96 Apheresis Units from 13 Italian regions, albeit rough, are sufficiently informative. In 1997, a total number of 170,373 apheresis sessions was carried out, with a clear-cut prevalence of productive apheresis (92%) that was performed by all Apheresis Units. Lombardy, Venetia and Latium were the most active regions for therapeutic apheresis (56% of total activity).

The use of plasma as a replacement fluid in plasma exchange. Canadian Apheresis Group.

The Canadian Apheresis Group has maintained a national registry of apheresis activities for the past 16 years. Since 1991, the use of plasma as a replacement fluid in plasma exchange has been recorded. Six years of data from the registry on the use of plasma as a replacement fluid were analyzed. Plasma was used in more than 25 percent of all plasma exchange procedures. Of 41,519 plasma exchange procedures reported, 11,970 used plasma alone or in combination with albumin. In 1991, 1026 (78%) of these procedures used plasma appropriately for either thrombotic thrombocytopenic purpura (TTP) or adult hemolytic uremic syndrome (HUS); between 1992 and 1996, these numbers were 1043 (81%), 1570 (86%), 1171 (87%), 2192 (92%), and 2741 (90%), respectively. In the remaining procedures, frozen or cryosupernatant plasma was administered to 326 patients for a total of 40 diseases other than TTP or HUS. In those diseases for which plasma was administered as the sole replacement fluid, no disease appears to justify such treatment without the existence of an associated condition requiring specific replenishment of some plasma component. Further evaluation of the specific indications for the use of plasma as a replacement fluid in plasma exchange is required for diseases other than TTP or HUS.

Reactions on a diamond surface

Data collection on apheresis activities in Italy throughout 2015 including techniques, clinical indications and adverse effects was performed by means of a SidEM model questionnaire (aggregate data). These data provided by 67 Apheresis Units from 17 Italian regions, albeit rough, are sufficiently informative, mainly in comparison with previous surveys on these statistics. PEx has been the most frequent technique for plasma removal/treatment (11787 procedures) followed by LDL-apheresis (927 procedures). ECP/photopheresis has been the most frequent cytapheresis procedure: 6,606 session, mainlyby using the off-line technique.Main indications for therapeutic apheresis are neurologic diseases, thrombotic microangiopathy and solid organ transplantation humoral rejection.The apheresis support activity to haematopoietic stem cell transplantation , the PBSC collection has been documented by 53 center: 3254 procedures in 2259 patients. Over all results have been positive: over 80% get better with therapy. Adverse effects, predominantly mild ones (i.e., paresthesia due to citrate-induced hypocalcemia), occurred in 7.9% of therapeutic sessions, of wich only 83 have been classified as severe (0.4%).

Experience of a combined apheresis, blood collection, and blood transfusion unit in a large tertiary care medical center

The Barnes Hospital Apheresis Blood Collection and Blood Transfusion Unit is part of Barns Hospital Blood Bank. Because of its size and complexity, we report our experience which may be useful to administrators and physicians involved in the planning or management of similar services. From 1985 through 1988 we collected platelets from 1,976 different donors, the majority of which (87%) were community donors. Sixty-nine percent of 1,976 donors donated in 1988 an average of 4.9 times. Of 6,568 apheresis products collected. 1.1% were discarded because of positive screening tests and 0.7% were discarded because of outdating or presence of fibrin clot. In 1988 a total of nine cell separators were used. All donor apheresis were done with seven blood separators, and on average a separator produced an apheresis product every 4.5 worked hours. All therapeutic apheresis (338) were done on two separators. Most of them (88%) were performed during work hours. In 1988 donor and therapeutic apheresis were done by 17 1/2 full-time employees (FTEs) during work hours. Considering the Workload Unit Value per procedure given by the College of American Pathologists (CAP) and that each FTE worked 1,864 hours per year, the worked hour productivity for donor and therapeutic apheresis was 78.2%. Blood collections, therapeutic bleeds, and outpatient transfusions (1,127, 114 and 1,745 respectively) were accomplished by two FTEs, for a worked hour productivity of 35.5%. Because 95.1% of total worked units was produced by efficient donor and therapeutic apheresis activities, overall efficiency remained high at 73.8%.