Therapeutic Apheresis and Dialysis 11(5):341–362 doi: 10.1111/j.1744-9987.2007.00507.

x © 2007 International Society for Apheresis

Apheresis Technologies and Clinical Applications: The 2005 International Apheresis Registry
Paul S Malchesky,1 Anna P Koo,2 Gerald A Roberson,2 Angela T Hadsell,1 and Lisa A Rybicki2
1

The International Center for Artificial Organs and Transplantation, Painesville, and 2Cleveland Clinic, Cleveland, OH, USA

Abstract: The developments in apheresis technologies and techniques and their clinical applications worldwide are technologically, sociologically, and economically motivated. In past apheresis surveys the statistics have highlighted both the differences by geographic region in clinical practice and in the types of technologies utilized. While a national view of apheresis is very important, an international view may be more representative overall of this therapeutic modality than national results that are highly dependent on the local economics and the available technologies. These regional differences have provided a basis for scientific and clinical assessment of these apheresis technologies and their clinical outcomes, and have impacted the marketing and business developments of new technologies worldwide. The results of the International Apheresis Registry for 2005 reporting from 22 centers on 5

continents are presented. The survey collected data exclusively via a secure internet website on 1133 patients for a total of 6501 treatments. Unlike our prior registries, information on stem cell infusions was gathered. Information gathered included patient demographics, medical history, treatment diagnoses, treatment specifics (type, methodology, access type, anticoagulants, drugs, and equipment usage), side-effects, clinical response, and payment provider. As in the prior International Apheresis Registries for 1983, 2000, and 2002 the survey results highlight the regional differences in apheresis usage and treatment methodologies, indicating that an international overview of apheresis may be more representative of the impact of this therapeutic modality. Key Words: Registry, Survey, Therapeutic apheresis.

Survey statistics of apheresis have shown both the differences by geographic region in clinical practices and in the types of technologies utilized (1–4). In 1983, the first International Apheresis Registry was conducted and reported (1), following a pilot, to demonstrate the feasibility of collecting such data and assessing the data collection methodology (5). The data collected indicated regional differences with regards to the apheresis technologies that were applied and the disease states for which they were used. In 2001, the results of the 2000 International Apheresis Registry was reported (3), and in 2004 so were
Received March 2007; revised March 2007. Address correspondence and reprint requests to Dr Paul S Malchesky, The International Center for Artificial Organs and Transplantation, 10 W. Erie Street, Suite 200, Painesville, OH, USA. Email: Paulsmalchesky@aol.com Presented in part at the 6th World Congress of the International Society for Apheresis held March 2–4, 2007 in Yokohama, Japan.

the results of the 2002 International Apheresis Registry (4). This survey was carried out to assess the present state of apheresis, the technologies utilized, and its clinical applications. These results were presented in part at the 6th World Congress of the International Society for Apheresis held March 2–4, 2007, in Yokohama, Japan. METHODS A copy of the electronic questionnaire form is given in the Appendix I. This electronic form is similar to the paper and electronic forms used in the 1983, 2000, and 2002 Registries; this was to allow comparison with the results of these prior years. Unlike our prior registries, information on stem cell infusions was gathered. The form requests patient information including demographics, medical history, specifics of the treatment, response to apheresis, and payment provider for the year 2005. For many of the 341

342
TABLE 1. Geographical distribution
Region/country Europe Austria Germany Croatia Lithuania Asia Turkey Taiwan Korea India China Malaysia Japan North America USA Canada Australia New South Wales Central/South America Argentina Brazil Venezuela Total Centers 5 1 2 1 1 9 3 1 1 1 1 1 1 4 3 1 1 1 3 1 1 1 22 Patients 281 118 84 57 22 504 231 90 43 41 54 43 2 263 260 3 79 79 6 4 1 1 1133

PS Malchesky et al. each region, results are listed in order of the country that submitted the largest number of patients to the country that submitted the smallest number of patients. Categorical variables are summarized as frequency counts, with or without percentages. Continuous variables are summarized as the sample size, mean, standard deviation, and median. All data were analyzed using SAS software (SAS Institute, Cary, NC, USA). Because all questions may not have been answered completely for any patient, the numbers reported do not always total 6501 treatments or 1133 patients.

Treatments 3155 1898 704 443 110 1935 670 462 321 228 124 121 9 959 857 102 429 429 23 15 8 0 6501

RESULTS Table 2 outlines data on race and gender for which both race and gender were noted on the questionnaire. Male subjects, unlike that in the previous registry (4), outnumbered females (54.9% vs. 45.1%). Caucasian was the predominant treated race of the patients treated, with Asian being the second largest. Table 3 shows descriptive statistics of age and the months from primary diagnosis to first apheresis treatment. The mean age of patients at the time of their first apheresis treatment was 45 years, similar to that in the previous registry (4). The Central/South American region had the lowest mean age of 21 years for the patient’s first treatment while the Australian region had the oldest at 50 years. The mean interval from primary diagnosis to the first apheresis treatment was 14.0 months, varying from a high of 23.8 months for the Australian region to a low of 1.0 months for the Central/South American region. The mean number of months from primary diagnosis to the first apheresis treatment was appreciably lower than the 34.6 months found in 2002 (4) and the 31.6 found in 2000 (3). Table 4 shows the reason for treatment (i.e. treatment diagnosis) for the 942 patients reported. The percentages represent the percentage of patients within each region. The most common treatment diagnosis categories overall were the nervous system (32.5%), neoplasms (20.1%), and circulatory system (10.6%). Some regional differences are noteworthy. In particular, for the European region, endocrine/ nutrition/metabolic/immunity ranked second as a treatment diagnosis and blood/blood-forming organs ranked third in the Australian region. This ranking of the most common treatment diagnosis categories differed somewhat from the 2002 survey (4), which ranked the treatment diagnoses as nervous system, endocrine/nutrition/metabolic/immunity, and then musculoskeletal system.
© 2007 International Society for Apheresis

questions on the form, drop down menus were used to facilitate answering the question. This data solicitation study was approved by the Institutional Review Board (IRB) of the Cleveland Clinic and was compliant with the Health Insurance Portability and Accountability Act (HIPAA). In soliciting responses, 805 emails were sent to apheresis center personnel. Through this notification, the individuals were referred to a secure website (https:// clinapps.bio.ri.ccf.org/apheresis/) through which they were provided instructions on how to enter patient data. Participation in this survey was completely voluntary and participants were informed that no compensation would be provided. In order to complete this survey and summarize the results, the deadline for the submission of all data for the reporting year of 2005 was November 15, 2006. From the opening of the website for the collection of data from January 2006 through to its closure, reminders were sent out periodically to the potential participating directors of centers. In total, data responses were received from 22 centers (30 persons) on 1133 patients receiving 6501 treatments (see Appendix II). The data will be described according to regions as Asia, Europe, North America, Australia, or Central/South America where the regions are classified as in previous surveys. Table 1 outlines the geographic distribution of the survey responders as the number of responding centers, the number of patients submitted by each center, and the number of treatments given. Within
Ther Apher Dial, Vol. 11, No. 5, 2007

5 3.2 9.0 0.1 1.9 0.2 3.0 0.1 10.2 7.0 28.4 0.3 0.6 9.3 2. which was similar to the 84.5 20.0 0.3 6.0 0.0 3.1 20.7 2.3 0.9 7. and North American regions in the top or highest ranked treatment diagnosis of myasthenia gravis.0 5.8 0.1 28.5 17.0 0.0 27.8 0.0 7.1 0.2 0.7 0.2 3.0 2.0 0.6 3.9 1.2005 International Apheresis Registry TABLE 2. Vol.7 13.2 45.3 1. Multiple myeloma was the distant second ranked diagnosis and Guillain–Barré the third ranked predominantly due to the number of cases reported from the Asian TABLE 4.0 0.0 0.0 40.4 17.0 0.5% found in the 2002 survey (4).0 0.0 36.3 0.6 6.0 6. Particularly noteworthy are the differences by region and the dominance of the Asian.0 0.8 0.0 0.4 3.4 45.0 0.4 0.2 0.0 0.9 39.6 0.4 100 N America N 30 24 17 8 6 0 1 8 10 2 0 9 0 0 0 115 % 26.9 14. Treatment diagnosis for 942 patients Europe Category Nervous system Neoplasma Circulatory system Blood/blood-forming organs Endocrine/nutrition/metabolic/ immunity Musculoskeletal system Digestive system Genitourinary system Symptoms/signs Injury/poisoning Skin & subcutaneous tissue diseases Congenital anomalies Respiratory system Infectious/parasitic diseases Mental disorders Total N 89 34 14 28 42 2 0 6 16 5 8 0 1 1 0 246 % 36.0 0.7 11.0 0.5 1.8 48.8 18.0 0.1 0.5% for 905 patients reported.0 0.2 0.8 5.3 57.0 100 N 306 189 100 87 66 49 32 32 31 24 10 9 3 2 2 942 Total % 32.0 100 C/S America N 1 0 2 1 0 0 0 0 1 0 0 0 0 0 0 5 % 20.6 79.1 N America 63 15. TABLE 3.3 25.0 0.0 17.0 85.3 2.0 5. ‡Percentage according to 1124 patients.0 58.0 100 Australia N 18 38 2 14 2 1 0 1 1 0 2 0 0 0 0 79 % 22.7 1. Table 6 outlines the top 10 treatment diagnoses and number of patients treated by region and in total.0 0.0 0.2 0.5 1.0 20.3 0.2 0.9 0.1 100 0 0 0 0 0 0 0 100 0 0 0 0 0 0 0 Percentage according to region and gender.1 3.3 0.2 0.2 13.0 0.8 0.1 Asia 216 6.0 1.8 0. No.0 1. European. Overall the percent match was 86.0 1.2 Table 5 outlines the patients whose primary diagnosis matches the treatment diagnosis.0 10.0 0.0 2.7 0.8 7.8 43.0 0.0 0.1 7.1 3.0 0. 2007 .5 0.4 0.8 48.0 2.7 6.0 1.9 10.0 0.0 0.0 0.4 0.5 C/S America 3 1. Race and gender by region for 1124 patients Europe Gender/race Male Caucasian Oriental Malaysian Black Australia/Oceania Hispanic Nat Am Indian Other Female Caucasian Oriental Malaysian Black Australia/Oceania Hispanic Nat Am Indian Other † 343 Asia † N America % † Australia † C/S America † Total N 617 449 119 10 17 13 4 1 4 507 325 118 34 17 9 2 0 2 %‡ 54.0 0.2 0.6 Total 490 14.1 2.4 3. Age and interval from diagnosis to apheresis Variable/region Age (years) Europe Asia N America Australia C/S America Total N 278 503 262 79 5 1127 Mean 48 43 46 50 21 45 SD 17 18 17 18 18 18 Median 48 44 47 12 12 46 Months from primary diagnosis to first apheresis treatment Europe 171 21.0 0.1 6.9 10.0 0.5 0.4 25.2 N 140 0 0 0 0 0 0 0 136 0 0 0 0 0 0 0 % N 140 114 10 0 0 0 0 1 90 115 33 0 0 0 0 0 N 141 2 0 17 0 3 1 1 76 1 0 17 0 2 0 0 % N 27 3 0 0 13 1 0 2 19 2 1 0 9 0 0 2 % N 1 0 0 0 0 0 0 0 4 0 0 0 0 0 0 0 % † 100 0 0 0 0 0 0 0 100 0 0 0 0 0 0 0 52.4 0.2 100 © 2007 International Society for Apheresis Ther Apher Dial.0 0. 11.0 0.4 0.5 0.0 100 N 168 93 65 36 16 46 31 17 3 17 0 0 2 1 2 497 Asia % 33.2 3.1 0.0 0.5 Australia 37 23. 5.2 0.5 2.6 0.4 6.5 1.3 0.0 8.3 13.2 1.0 4.0 20.4 37.8 48.0 3.5 1.2 0.0 0.

3% of the types of treatments for Ther Apher Dial. Patients may have received more than one type of solution.2 88. the mean total treated volume was 3. lymphoplasmapheresis. as well as the disease states treated. The average number of cells removed in cytapheresis was 11. the mean plasma treatment volume was 6.0 ¥ 1010. Table 11 describes the average volume of plasma exchange. plasma treatments. Table 9 shows the number (also shown in Table 8) and percentage of patients who received each type of treatment. The European region reported the highest number of treatments per patient of 11. Also in the 2002 survey (4) myasthenia gravis was ranked as the top treated diagnosis.3%. Table 7 outlines the top 10 treatment diagnoses by the number of treatments. which was mainly reflective of the larger number of patients reported in the European region and their high average treatment volume of 7. 11. The Asian region also reported that over 43% of its treatments were by plasma treatment. The average volume treated with whole blood adsorption was 6. and most often from the European region. most patients received greater than 10 treatments. For stem cell infusions.5 ¥ 106/kg. more than twice the mean volume used in plasma exchange. In this registry we first collected data on stem cell infusion. 5.1 L. Australian. The mean volume exchanged was 3. for which data was first collected in this registry.6 L.1% of the patients were treated by cytapheresis or lymphoplasmapheresis. Vol. single infusions were assumed as data was not collected.3% of patient treatments but 25. These were followed by electrolyte solution and then plasma expander solution. while more than 95% of the treatments for hypercholesterolemia were reported from the European region. In contrast to the previous survey (4). and payment provider. Most patients received 1–5 treatments for plasma exchange.0 L. or cytapheresis. The differences in ranking between the treatment diagnosis (Table 6) and the treatment diagnosis according to the number of treatments (Table 7) suggest that the differences in the treatment requirements by disease categories are related to the treatment requirements for the disease. Only 4. By far. Plasma exchange and plasma treatment accounted for 67. but the number of patients reported was only two. the largest numbers of treatments were for myasthenia gravis. plasma treatment. and stem cell infusions. whole blood adsorption. the only regions reporting this form of treatment. Technology availability in the different regions influences the type of treatment provided to the patients.3 89. For the European region. 2007 . response to apheresis. and then thrombotic thrombocytopenic purpura (TTP).0) where about 65% of all the procedures were by plasma treatment or whole blood adsorption.7 L. with the North American region reporting the highest of 20. followed by hypercholesterolemia. Stem cell infusion. Plasmapheresis (PP) procedures as plasma exchange (PE) and plasma treatment were the most common treatment modalities with over 82% of the reported treatment on 67% of all patients.8 (the mean of all regions was 6. This is down from the previous registry (4) where the percentage was 93. therefore the categories are not mutually exclusive.3 ¥ 106/kg. For whole blood adsorption reported only from the Asian and European regions.0 L. For plasma treatment.9 87.344 PS Malchesky et al. No. was used in 25. The average volume processed in lymphoplasmapheresis was 4.9 40. Patients whose primary diagnosis matches the treatment diagnosis Region Europe Asia N America Australia C/S America Total Ntotal 245 497 79 79 5 905 # Match 199 442 69 71 2 783 % Match 81. No plasma treatment or whole blood adsorption procedures were reported in the North American.8 L for the Asian and European regions. Table 10 shows the frequencies and percentages of the number of treatments noted for each patient. Table 8 shows the total number of each type of treatment and the number of patients who received each treatment. the patients reported. Albumin solution was the most common replacement solution by nearly two times more than fresh frozen plasma.0 86. and Central/South American regions. For stem cell infusions the average number of cells were 9. nearly more than double all the other regions reporting. Only the European and Asian regions reported patient whole blood adsorption and plasma treatment procedures suggesting the limited availability of such treatment technologies outside these regions.4 ¥ 1011 and for lymphoplasmapheresis 5. the next most common replacement solution. the © 2007 International Society for Apheresis TABLE 5. which represented only 4.5 and European regions. as well as the highest numbers of such treatments in any region by far.7% of the patients. The majority of treatments for myasthenia gravis came from the Asian and European regions.6% of all patients. Table 12 shows the number of treatments per replacement solution and the number of patients who received them. and lymphoplasmapheresis and average number of cells for cytapheresis.

blood/bloodforming organs (6) Hodgkin’s disease (4) Congenital anomalies (9) Guillain–Barré syndrome (8) Multiple myeloma (8) 7 TTP (12) 8 Multiple myeloma (11) 9 non-Hodgkin’s lymphoma (39) Other circulatory system dis. noncutaneous (12) Hyperviscosity syndrome (8) Symptoms/signs (3) Cerebral flow alteration (1) Myasthenia gravis (1315) Hypercholesterolemia (900) TTP (606) 4 MS (125) 5 Symptoms/signs (102) 6 Hyperlipidemia (95) Guillain–Barré syndrome (272) Chronic relapsing polyneuropathy (197) MS (154) Symptoms/signs (154) Motor neuron dis. 11. thrombotic thrombocytopenic purpura. Vol.. TTP. multiple sclerosis. rapidly progressive glomerulonephritis.. (84) Systemic lupus erythematosus (73) Other GU system disease (68) Other nervous system disease (50) RPGN (50) Multiple myeloma (138) Factor VIII inhibitor of antibodies (125) Kidney transplant complications (118) 345 Ther Apher Dial. RPGN. 2007 dis. genitourinary. subcutaneous. MS. (9) Multiple myeloma (9) Guillain–Barré syndrome (8) Other neoplasm (8) 7 Guillain–Barré syndrome (42) Thrombocytopenia (31) Hyperviscosity syndrome (52) Other skin/subq tissue disease (25) non-Hodgkin lymphoma (15) Leukemia (11) 8 9 Other circulatory system disease (27) Hemolytic anemia (24) Hypercholesterolemia (23) 10 Guillain–Barré syndrome (84) Other dis. thrombotic thrombocytopenic purpura.TABLE 6. . MS. disease(s). No. TABLE 7. TTP. blood/bloodforming organs (55) Hemolytic-uremic syndrome (50) Thrombocytopenia (45) Guillain–Barré syndrome (138) Rheumatoid arthritis (115) Kidney transplant complications (85) Other circulatory system dis. GU. 5. subq. multiple sclerosis. subcutaneous. (37) Hypercholesterolemia (34) Symptoms/signs (31) Hyperviscosity syndrome (29) 10 Other skin/subq tissue dis. (8) Hemolytic-uremic syndrome (7) Hypertriglyceridemia (7) Rheumatoid arthritis (19) non-Hodgkin’s lymphoma (16) Hyperviscosity syndrome (15) Chronic relapsing polyneuropathy (3) Hemolytic anemia (3) MS (3) Myeloma kidney (3) Guillain–Barré syndrome (2) Leukemia (2) TTP (2) dis. subq. Top 10 treatment diagnoses according to number of treatments for 5809 treatments Asia TTP (182) Myasthenia gravis (158) N America Australia C/S America Total Rank Europe 1 2005 International Apheresis Registry 2 Myasthenia gravis (514) TTP (195) Chronic relapsing polyneuropathy (109) TTP (73) Myasthenia gravis (70) 3 Hypercholesterolemia (861) Myasthenia gravis (573) TTP (156) Factor VIII inhibitor of antibodies (158) Multiple myeloma (49) Symptoms/signs (43) Vasculitis. disease(s). Top 10 treatment diagnoses according to number of patients for 942 patients Asia Myasthenia gravis (189) Multiple myeloma (59) N America Australia C/S America Total Rank Europe 1 2 3 Myasthenia gravis (54) Hypercholesterolemia (28) Symptoms/signs (16) Guillain–Barré syndrome (54) TTP (51) Leukemia (43) Myasthenia gravis (118) Other circulatory system disease (34) Multiple myeloma (32) TTP (14) Myasthenia gravis (13) Symptoms/signs (10) 4 – – – – – – non-Hodgkin’s lymphoma (15) Chronic relapsing polyneuropathy (9) Hyperviscosity syndrome (8) Multiple myeloma (8) Vasculitis/non-cutaneous (2) Cerebral flow alteration (1) Hyperviscosity syndrome (1) Symptoms/signs (1) 5 Guillain–Barré syndrome (15) Leukemia (13) © 2007 International Society for Apheresis 6 Leukemia (22) Cryoglobulinemia (4) Myasthenia gravis (4) Leukemia (6) MS (12) Guillain–Barré syndrome (29) Systemic lupus erythematosus (26) TTP (23) Chronic myelogenous leukemia (7) Other dis.

or other means. LDL.3%) (0%) (0%) Australia 36 0 0 3 0 33 0 1 73 (49.7%) (3.0%) (0%) (0%) (25. whether by central vein. ads.6%) (0.7%) (2.9%) (23. As noted in the Japanese Registries (6.7%) of the patients were on steroids only. percentage of treatments using electrolyte solution were the highest. 11.4%) (2.0%) (0%) (0%) N America 87 0 0 8 0 144 0 0 239 (36.346 PS Malchesky et al.7%) (0%) 205 190 3 23 0 80 0 0 501 Asia (40. Table 18 shows the number of treatments per blood access method and the number of patients who received each method. regional differences were notable. or femoral vein. 5. TABLE 9.2% were reported as taking no steroids or immunosuppressives for their therapy and nearly one-fourth (23. granulocyte colony stimulating factor.2%) (0. the plasma membrane separators. however. peripheral vein.8 C/S America.9%) (37.3%) (0%) (0%) (4. Number of treatments (number of patients treated).2%) (0%) (1.0 N America.0%) (9.1%) (0%) (45. sorption.8 Europe. Vol.2%) (25. 5.4%) (0%) (0%) (3.6%) (0.9%) (0. Table 14. and Table 17 the sorptive plasma treatment products.7%) (7. RT. Table 16 the plasma membrane treatment products. Table 19 reports the anticoagulant and drug usages. adsorption. 4. Table 13 summarizes the equipment types reported. this drug is widely used in a large number of centers for anticoagulation.9 Asia.9%) (0.0 total.1%) . The use of the anticoagulant drug nafamostat mesilate was reported only in the Asian region and only for one patient.6%) (4. 66. Average number of treatments/patient: 11. 2007 © 2007 International Society for Apheresis Europe 145 64 26 7 2 21 2 0 267 (54. Differences in drug regimes in the different regions most likely are related to treatment diagnosis differences in their patient populations. G-CSF.0%) (0%) (0%) (0%) (0%) Total 476 254 29 42 2 278 2 1 1084 (43.6%) (0%) (16.3%) (24. 5.7).9 Australia. low-density lipoprotein. Number and percentage of patients receiving each type of treatment Treatment Plasma exchange only Plasma treatment only Whole blood adsorption only Cytapheresis only Lymphoplasmapheresis only Stem cell infusion only Plasma exchange & whole blood ads Plasma exchange & stem cells Number of patients ads. plasma sorption and plasma membrane treatment.9%) (0. Treatments Treatment Plasma exchange only Plasma treatment only Whole blood adsorption only LDL hemoperfusion Endotoxin hypoperfusion Other type Cytapheresis only Lymphoplasmapheresis only Stem cell infusion only Autologous Prep-chemo Prep-G-CSF Prep-unspecified Allogenic Prep-chemo Prep-chemo & RT Prep-G-CSF Prep-unspecified Plasma exchange & whole blood ads† Plasma exchange & autologous stem cells All treatments † Europe 979 1391 658 271 0 387 35 26 21 19 18 1 0 2 0 0 2 0 45 0 3155 (145) (64) (26) (10) (0) (16) (7) (2) (21) (19) (18) (1) (0) (2) (0) (0) (2) (0) (2) (0) (267) Asia 953 840 13 12 1 0 49 0 80 58 56 0 2 22 15 4 0 3 0 0 1935 (205) (190) (3) (2) (1) (0) (23) (0) (80) (58) (56) (0) (2) (22) (15) (4) (0) (3) (0) (0) (501) N America 802 0 0 0 0 0 13 0 144 126 0 0 126 18 0 0 0 18 0 0 959 (87) (0) (0) (0) (0) (0) (8) (0) (144) (126) (0) (0) (126) (18) (0) (0) (0) (18) (0) (0) (239) Australia 391 0 0 0 0 0 3 0 33 32 29 3 0 1 0 0 1 0 0 2 429 (36) (0) (0) (0) (0) (0) (3) (0) (33) (32) (29) (3) (0) (1) (0) (0) (1) (0) (0) (1) (73) C/S America 20 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0 23 (3) (0) (0) (0) (0) (0) (1) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (4) Total 3145 2231 671 283 1 387 103 26 278 235 103 4 128 43 15 4 3 21 45 2 6501 (476) (254) (29) (12) (1) (16) (42) (2) (278) (235) (103) (4) (128) (43) (15) (4) (3) (21) (2) (1) (1084) Whole blood adsorption for all 45(2) was LDL hemoperfusion.3%) (0%) (60. Anticoagulation by citrate and heparin were the predominant forms. Table 15 the plasma treatment methods of membrane filtration (cascade filtration).4%) C/S America 3 0 0 1 0 0 0 0 4 (75. radiation therapy. Venous access methods were by far the most dominant methods. adsorption. TABLE 8. Of all patients. 3. Only the Asian and European regions reported treatments by membrane plasma separation. No. Notable also was the use of arterial puncture in the Asian region only. Significant regional differences exist in the small amount of data collected in this survey and regional differences are reflective of the technologies available in the various regions. 6. Ther Apher Dial.

71.2 14.8% of the patients received support from the government for their treat© 2007 International Society for Apheresis ment.8 25. and outcomes for a specific disease or device application. Response to apheresis was determined objectively.1 78. at least in part.0 Australia N 15 8 14 (37) 0 0 0 (0) 0 0 0 (0) 3 0 0 (3) 0 0 (0) 34 (34) % 40. of patients) (28) Cytapheresis 1–5 6–10 >10 (No.0 N 303 104 72 (479) 168 38 48 (254) 6 3 22 (31) 38 3 1 (42) 1 1 (2) 279 (279) Total 347 % 63. national for data collection within a specific country.2 1.7 0. The Australian and Central/ South American regions reported receiving support from the government at 100%.8 C/S America N 1 2 0 (3) 0 0 0 (0) 0 0 0 (0) 1 0 0 (1) 0 0 (0) 0 % 33.0 23. The North American region reported the highest private insurance payment of 55.0 50. A brief description of various registries recently published will be given and then a discussion will be made on this InternaTher Apher Dial.3 84. and 9.0 – – – – – – – – 50. procedures. noted in Table 21.3 0. whereas the North American region reported only 36. whereas 10.7% were reported as not assessable.8%) of the patients showed improvement. of patients) 5 1 1 (7) 14.3 N 162 29 14 (205) 106 27 3 (190) 2 1 0 (3) 21 2 0 (23) 0 0 (0) 80 (80) Asia % 79. 2007 . where blood access difficulties and hypotension were the most frequent sideeffects or complications reported. of treatments Plasma exchange 1–5 6–10 >10 (No.4 14.7 71.1 24 Lymphoplasmapheresis 1–5 1 >10 1 (No.2005 International Apheresis Registry TABLE 10.0 71.0 50.6 37.0 – – – – – – – – – 19.3 21.6 – – – – – – – – – 66. of patients) N 85 38 24 (147) 8 11 45 (64) % 57. this relates to the predominant use of citrate reported and the dominance of centrifugal equipment used.1% and the Asian region the highest self/family payment provider of 12. show that nearly 75% (74.8 N America N 40 27 20 (87) 0 0 0 (0) 0 0 0 (0) 8 0 0 (8) 0 0 (0) 144 (144) % 46. Blood access difficulties and hypotension were also reported frequent complications of the procedures. which is typically used with citrate anticoagulation.1%.3 8. This differs from the 2002 registry (4).9 16.0 12.3 91. paresthesia. The European region reported the highest hospital/ institution payment provider of 18.0 100 100 100 100 – 100 Table 20 shows the number of occurrences of each side-effect or complication during the treatment and up to 2 h after its cessation.3 66. No deaths were reported in this survey year. of patients) Plasma treatment 1–5 6–10 >10 (No. of patients) (2) Stem cell infusion 1–5 (No. Apheresis registries may be specific for data collection on a designated disease and/or a specific protocol or product specific for data collection on a specific device trial.7 33.3 9. 11. These results were nearly comparable to the last survey (4).2 70.1 15.4%.9 Whole blood adsorption 1–5 4 6–10 2 >10 22 (No.0 100 0 0 100 0 0 100 0 0 90.7% government payment and the European region 51. Vol. Citrate-related complications were among the highest (citrate-induced.5 17. and hypocalcemia). of patients) 21 (21) 50.7 15. The reported response to apheresis and payment provider.3 7. techniques.6 66.0 31. with the exception of the higher percentage of responses that were not assessable. in 82.7 0. Number of treatments given per patient Europe No. DISCUSSION Apheresis registries are a collection of information on apheresis patients.5 7.5 21.3 14. No. or international for data collection across countries and continents.0 14.2%. 5.1%.2 6.0 18.4% indicated that their condition remained the same. which was similar to that reported in the last survey (4) of 71.5% of cases.

5 PS Malchesky et al. Vol. and transplant rejection (117). the most frequent diseases treated were hematology (>30%) followed by neurology (about 30%). plasma (20.2 N America 3 20.3 22.2 Asia 204 2. The top diseases treated by numbers are TTP/hemolyticuremic syndrome (HUS) (2477).8%. No. The French Apheresis Registry of 2003 (9) reported on 91 centers with 942 patients having 9837 procedures. neurological (40%) and others.2 Australia 36 2. hypercholesterolemia (174). Germany. but it does not report manufacturers of devices. Philippines. of which 0. Italy. The German Society for Transfusion Medicine and Immunohematology collects data on hemapheresis procedures and their side-effects on a voluntary basis. cryosupernatant plasma (5144 L).2 Total 469 3.2 Australia 34 4.7 3.7 N America 0 – – Australia 0 – – C/S America 0 – – Total 31 6.0%) used predominantly with filtration.8 6.0 – 7. and low molecular weight heparin (8. side-effects. Venezuela.6 Asia 190 2.0 14.8 Asia 5 5. 5.1 3. Reported complications were 1. the method of anticoagulation by citrate. Substitution fluids were albumin substitutes (31.8 2.0 Stem cell infusion – average number of cells (¥106/kg) Europe 20 8.4%). of which l1.1 2.0 0. 8561 procedures were reported.0 Lymphoplasmapheresis – average volume (liters) Europe 2 4. Japan.8 Whole blood adsorption – average volume (liters) Europe 28 7. and fresh frozen plasma (2059 L).0 Asia 0 – – N America 0 – – Australia 0 – – C/S America 0 – – Total 2 5.7%) with heparin (22. France.7 0.1 – – 7. Specific discussion will be made to the most recent reports of registries from Canada. The Canadian Apheresis Registry of 2002 (8) reported on 42 centers with 898 cases. Centrifugal techniques were predominant (62%) with plasma treatment increasing over time (24. For blood component collections. the Rheopheresis Registry. acute Guillain–Barré syndrome (185). myeloma (228). or no substitution fluids (19.0 Lymphoplasmapheresis – average number of cells (¥1010) Europe 2 5.7 – – – 3.7 0.0 0.8 1.0 1.0 7.0 Plasma exchange – average volume (liters) Europe 142 3. with hypotension most common (0. or other specific details. Hungary.8 – – – 4.0 Asia 0 – – N America 0 – – Australia 0 – – C/S America 0 – – Total 2 4.0 7. Reportedly.0 – – – – 5. Germany has no official apheresis registry (10).9 N America 0 – Australia 0 – C/S America 0 – Total 254 3.5 8. Waldenstrom’s macroglobulinemia (633).9%).4 20. up from 2003.5 N America 0 – – Australia 0 – – C/S America 0 – – Total 12 11.3 Cytapheresis – average number of cells (¥10 ) Europe 7 15.0 Plasma treatment – average volume (liters) Europe 64 6.7%). These are followed by dermatology.0 – – – – 4.6%). Its population was 82 million at the time of reporting.0 0.5 10.9%.2 2. Treating 30 disease types.0 3.7 0. vasculitis.8 2. and substitution fluids used included albumin (11 135 L).0 3. Over the years there had reportedly been a decline in neurological diseases treated and an increase in hematological diseases treated.9 0. 2007 . The methods of apheresis included centrifugation and plasma exchange.9 1. such as collagen-vascular and renal.0 4. Note was made that the plasma exchange cost is CDN $950.8 C/S America 0 – – Total 136 9. cryoglobulinemia (321). The most frequent disease types treated were hematological (55%).2 Asia 3 3.2 4. and the World Apheresis Registry (see Tables 22–24).3% were whole blood treatment). Goodpasture’s syndrome (160).0 4. Reporting for 2004 were 97 centers with 1021 patients having 10 700 procedures. Canada then had a population of 30 million inhabitants.9 C/S America 3 2. Reporting for 2003. © 2007 International Society for Apheresis Median 3.4% had severe reactions.348 TABLE 11.6 0. chronic inflammatory demyelinating polyneuropathy (586).0 0. Anticoagulation was by citrate (61. and endocrinology in the range of 10–13% each. the United States of America (USA). The population of France was 60 million in 2003.0 3. 11.0 3.6 25.0 – – 5. the Paul Ehrlich Institute reports. Ther Apher Dial.0 5.8%). albumin (27.7 Asia 79 11.2 12.0 7. myasthenia gravis (1309). Treatment volume and cells Variable/region N Mean SD 0. Reported side-effects were 12% of procedures.0 5.9 N America 84 3.5 11 tional Apheresis Registry.7%).6 5. vascular access was predominately (>54%) by peripheral vein. of which 1330 were on whole blood and 1107 by adsorption). They noted increased numbers of treatments for TTP and HUS (189 patients with 2315 sessions) and familial hypercholesterolemia (114 patients with 2440 sessions.

2005 International Apheresis Registry TABLE 12. Spectra LRS Baxter (Fenwal) CD 3000/3000 Plus Kuraray Baxter (Fenwal) Amicus Baxter (Fenwal) Autopheresis C Dideco Hemaplex BT900 B Braun Diapact B Braun Dialog Excorim (Fresenius) Freseuius 4008 ADS Fresenius AS 104. Plasma membrane separator Type Asahi Bellco Cobe Fresenius Gambro Kuraray Toray Hospal Prisma TPE set Europe 0 0 4 275 302 0 0 46 (0) (0) (2) (39) (47) (0) (0) (15) Asia 129 47 0 8 0 693 34 0 (44) (21) (0) (2) (0) (149) (6) (0) N America 0 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) (0) Australia 0 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) (0) C/S America 0 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) (0) Total 129 47 4 283 302 693 34 46 (44) (21) (2) (41) (47) (149) (6) (15) Number of treatments (number of patients treated). Replacement solution Solution Albumin solution Fresh frozen plasma Electrolyte solution Plasma expander solution Purified protein fraction Plasma products Other SD plasma (Octaplas) Albumin & plasma expander Red blood cells Albumin & normal saline Fresh frozen plasma & albumin Normal saline Cryosupernatant Saline & plasma expander Not specified Europe 535 383 28 0 0 0 87 67 0 5 0 14 0 0 1 0 (91) (61) (9) (0) (0) (0) (20) (9) (0) (5) (0) (5) (0) (0) (1) (0) Asia 839 506 442 132 0 4 27 0 0 0 23 0 0 4 0 0 (209) (108) (85) (34) (0) (1) (5) (0) (0) (0) (3) (0) (0) (1) (0) (1) N America 510 268 0 0 3 1 100 0 60 0 0 0 0 0 0 40 (62) (33) (0) (0) (1) (1) (17) (0) (7) (0) (0) (0) (0) (0) (0) (10) Australia 319 78 0 0 0 0 25 0 0 19 0 0 6 0 0 0 (35) (3) (0) (0) (0) (0) (8) (0) (0) (7) (0) (0) (1) (0) (0) (0) C/S America 20 0 0 0 0 0 6 0 0 6 0 0 0 0 0 0 (3) (0) (0) (0) (0) (0) (1) (0) (0) (1) (0) (0) (0) (0) (0) (0) 349 Total 2223 1235 470 132 3 5 245 67 60 30 23 14 6 4 1 40 (400) (205) (94) (34) (1) (2) (51) (9) (7) (13) (3) (5) (1) (1) (1) (11) Number of treatments (number of patients treated). 204 Fresenius Comtec Haemonetics PCS2 System Hospal Prisma Kaneka Medicap ADA Otsuka Adamonitor MN6-N Therakos UVAR XTS Other Fresenius Dali Dideco Excell Pro Fresenius 4008-H Prometheus System Not specified Europe 0 264 0 0 0 85 0 290 0 333 177 67 11 15 58 26 5 35 133 95 95 0 0 0 (0) (48) (0) (0) (0) (18) (0) (45) (0) (43) (9) (13) (6) (5) (20) (5) (1) (5) (8) (3) (3) (0) (0) (0) Asia 12 301 46 533 125 0 228 147 10 0 12 435 86 0 0 0 2 0 0 22 0 8 8 6 (1) (39) (24) (124) (78) (0) (41) (55) (4) (0) (2) (112) (37) (0) (0) (0) (1) (0) (0) (5) (0) (1) (2) (2) N America 0 1112 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 (0) (262) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) Australia 0 523 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 (0) (79) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) C/S America 0 0 0 0 0 0 0 0 0 0 0 21 0 0 0 0 0 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (4) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) Total 12 2200 46 533 125 85 228 437 10 333 189 523 97 15 58 26 7 35 133 117 95 8 8 6 (1) (428) (24) (124) (78) (18) (41) (100) (4) (43) (11) (129) (43) (5) (20) (5) (2) (5) (8) (8) (3) (1) (2) (2) Number of treatments (number of patients treated). TABLE 13. No. 2007 . Vol. solvent/detergent. 5. © 2007 International Society for Apheresis Ther Apher Dial. TABLE 14. 11. SD. Equipment type Equipment Asahi Plasauto Gambro BCT COBE Spectra.

althoughmost are believed to be performed by nephrologists. 2007 © 2007 International Society for Apheresis . and 614 photophereses. Plasma treatment method Method Cascade Sorption Other Fractionated plasma sep/adsorption PDF Centrifuge Unspecified Europe 0 56 0 0 0 0 0 (0) (3) (0) (0) (0) (0) (0) Asia 709 49 16 8 7 0 1 (143) (21) (8) (2) (5) (0) (1) N America 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) Australia 0 0 1 0 0 1 0 (0) (0) (1) (0) (0) (1) (0) C/S America 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) Total 709 105 17 8 7 1 1 (143) (24) (9) (2) (5) (1) (1) Number of treatments (number of patients treated). Plasma membrane treatment product Product Asahi Fresenius Kuraray Toray Europe 0 28 0 0 (0) (2) (0) (0) Asia 129 9 721 11 (44) (2) (155) (2) N America 0 0 0 0 (0) (0) (0) (0) Australia 0 0 0 0 (0) (0) (0) (0) C/S America 0 0 0 0 (0) (0) (0) (0) Total 129 37 721 11 (44) (4) (155) (2) Number of treatments (number of patients treated). and that new treatment therapies are evaluated in pilot studies but require randomized trials to prove efficacy. 4982 units of red blood cells were collected (4. 410 507 transfusion units for fresh frozen plasma (FFP) were produced by plasmapheresis. 227 096 transfusion units of platelets were collected by plateletpheresis. 5. 1292 erythrocytaphereses. 11. and 8213 single transplantation units of peripheral blood stem cells. Sorptive plasma treatment method Method Kuraray Other Fresenius Dali Immunosorba Immunosorba. In 2002 the German Community Transfusion Services performed 3078 plasmaphereses. It is recognized that many routine preparative and therapeutic procedures are carried out in Germany. No. TABLE 17. TABLE 15. Therapeutic apheresis procedures are not formally registered.45 million units were collected by whole blood donation). Blood access method Method Peripheral veno-venous Central venous Femoral vein Arterio-venous fistula/shunt Arterial puncture Other Port-a-cath Unspecified Europe 731 617 8 83 0 0 0 0 (87) (84) (2) (6) (0) (0) (0) (0) Asia 480 842 464 50 113 5 0 5 (135) (206) (126) (14) (20) (1) (0) (1) N America 140 863 47 65 0 0 0 0 (43) (206) (13) (5) (0) (0) (0) (0) Australia 209 187 27 26 0 26 26 0 (48) (29) (2) (1) (0) (2) (2) (0) C/S America 6 15 0 0 0 0 0 0 (1) (3) (0) (0) (0) (0) (0) (0) Total 1566 2524 546 224 113 31 26 5 (314) (528) (143) (26) (20) (3) (2) (1) Number of treatments (number of patients treated). Vol. TABLE 16. For preparative hemapheresis in Germany in 2002. 1658 leukocytaphereses. 1 090 329 L of apheresis plasma were collected for fractionation. 299 immunoadsorptions. Ther Apher Dial.350 PS Malchesky et al. TABLE 18. Protein A Dideco Medicap Unspecified Europe 0 151 95 42 14 0 0 0 (0) (6) (3) (2) (1) (0) (0) (0) Asia 15 14 0 0 0 8 2 4 (4) (4) (0) (0) (0) (1) (1) (2) N America 0 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) (0) Australia 0 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) (0) C/S America 0 0 0 0 0 0 0 0 (0) (0) (0) (0) (0) (0) (0) (0) Total 15 165 95 42 14 8 2 4 (4) (10) (3) (2) (1) (1) (1) (2) Number of treatments (number of patients treated).

angiotensin converting enzyme.0 85. ACE.7 59. access site Bleeding. signs and symptoms.7 8. %.0 0.9 29.2 0.9 33.9 0. MI. of which 26 were treated by plasma exchange and four by cytapheresis.1 50. Side-effects or complications following treatment Side-effect/complication Hypotension Blood access difficulties Bleeding.0 0.4 38.7 0.7 0. number of patients. Anticoagulants and drugs Europe Type Anticoagulants Citrate only Heparin only Heparin & citrate None Other (saline solution) Nafamostat mesilate No.3 0. No.5 32.4 1. A national survey of hemapheresis practice in Hungary for the years 2001–2004 was reported primarily to review the costs reimbursed (11).0 C/S America N 5 0 0 1 0 0 6 4 1 1 0 6 % 83. 792–983 patients incurred 2544–3121 treatments for 30 different diseases. fresh frozen plasma.2 23.4 0.7 16.5 3.4 4.5 10.2005 International Apheresis Registry TABLE 19.0 N 680 289 119 40 4 1 1133 750 268 91 24 1133 Total 351 % 60. 2007 .4 0. 5.6 6. percentage of patients. The reimbursed cost per treatment was 680–860 EUR over the years. Vol.0 2. Sx.7 5.0 0.0 0.1 39.7 16.2 N America N 263 0 0 0 0 0 263 224 23 14 2 263 % 100 0 0 0 0 0 Australia N 73 0 6 0 0 0 79 79 0 0 0 79 % 92.0 0.0 16.2 8.3 0. FFP. myocardial infarction.6 0.8 100 0 0 0 66.0 N 269 196 3 35 0 1 504 300 162 22 20 504 Asia % 53.4 0. of patients Drugs None Steroids only Steroids & immunosuppressants Immunosuppressive only No.9 0.1 4.0 25.0 7. Hungary’s population was 10 million. TABLE 20. other site Shock Fever/chills Circuit clotting Allergic reaction Hemolysis Pain other than at access site Respiratory distress Death ACE-inhibitor related Sx Arrhythmia/tachycardia/MI Citrate-induced reaction Device-related malfunction Headache Hypocalcemia Hypertension Nausea Paresthesia Other Cramps Vomiting Anxiety Back pain Dyspnea Epigastric pain Hypothermia Hysteric reaction Pulmonary edema FFP bag rupture Europe 32 51 3 4 1 8 28 20 0 2 5 0 0 6 25 8 4 2 6 1 15 4 0 0 0 0 0 1 0 1 1 1 (13) (21) (2) (1) (1) (7) (19) (11) (0) (2) (5) (0) (0) (3) (6) (6) (2) (2) (2) (1) (6) (4) (0) (0) (0) (0) (0) (1) (0) (1) (1) (1) Asia 62 77 10 5 4 52 1 22 0 6 5 0 0 16 0 43 16 3 1 25 11 6 0 3 0 1 1 0 1 0 0 0 (41) (52) (10) (4) (4) (33) (1) (19) (0) (5) (5) (0) (0) (14) (0) (23) (14) (2) (1) (24) (8) (6) (0) (3) (0) (1) (1) (0) (1) (0) (0) (0) N America 14 36 1 0 0 3 0 39 1 6 1 0 0 4 106 0 4 107 0 19 99 4 3 0 1 0 0 0 0 0 0 0 (9) (24) (1) (0) (0) (3) (0) (9) (1) (6) (1) (0) (0) (3) (90) (0) (4) (86) (0) (11) (82) (4) (3) (0) (1) (0) (0) (0) (0) (0) (0) (0) Australia 84 29 3 0 0 1 0 0 0 0 2 0 2 1 130 0 3 91 0 17 131 3 3 0 0 0 0 0 0 0 0 0 (25) (11) (2) (0) (0) (1) (0) (0) (0) (0) (1) (0) (1) (1) (31) (0) (1) (23) (0) (7) (35) (1) (1) (0) (0) (0) (0) (0) (0) (0) (0) (0) C/S America 1 0 0 0 0 0 0 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 (1) (0) (0) (0) (0) (0) (0) (2) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) Total 193 193 17 9 5 64 29 87 1 14 13 0 2 27 261 51 27 203 7 62 256 17 6 3 1 1 1 1 1 1 1 1 (89) (108) (15) (5) (5) (44) (20) (41) (1) (13) (12) (0) (1) (21) (127) (29) (21) (113) (3) (43) (131) (15) (4) (3) (1) (1) (1) (1) (1) (1) (1) (1) Number of episodes (number of patients).0 66.2 19.1 N. © 2007 International Society for Apheresis Ther Apher Dial. of patients N 70 93 110 4 4 0 281 143 82 54 2 281 % 24.1 1.5 0. 11.

Vol. 5. hypercholesterolemia (26).4 2.5 18 Objective 110 47.1 9.0 55.1 10.9 5.4 29. acute Guillain–Barré (1855). Reported side-effects were 6. Methodologies included plasma exchange (49. and or anticoagulants used.8 24.6 – No.3 46.3 – 43.0 3.5 1.4 3. cytapheresis (17.1 0. low-density lipoprotein (LDL)-apheresis (3.1 71.8%). of patients) (234) (341) Payment provider Self/family Private insurance Government Hospital/institution Other (Total no. Of 2820 patients from 102 centers reported there are 5.8 13. myasthenia gravis (635).0 0.5 12. The top diseases treated by numbers of treatments for the period were myasthenia gravis (2114).352 PS Malchesky et al. No.4 4.7 4.4 procedures per patient. and others (3176). Guillain– Barré (563). Note was made that Protein A columns were not available and no specific mention was made of the technologies. and HUS (498).7%). Guillain–Barré (105).3%). myasthenia gravis (68). Also reported was that 1043 autologous stem cell collections were carried out. The top diseases treated were myasthenia gravis.0 C/S America N 4 0 0 0 1 (5) 0 0 5 (5) 0 0 4 0 0 (4) % 80. Italy had a population of 58 million in the year 2000.0 20.0 0. and immunoadsorption (0.0 – 98. the diseases treated were cryoglobulinemia (132).8 10. and others (486).3 22. of treatments/ million inhabitants 285 178 85 312 262 92 9 191 356 13 21 Ther Apher Dial. gammopathies (1302).7 5.7 Type Response to apheresis Improvement Same Worsening Treatment discontinued Not assessable (Total no. of which 0.9 53.2 0 0 100 17.7 2. number of patients.1 2.0 0. the diseases treated were cryoglobulinemia (934).0 5.8 7.0 0. TTP (64). Response to apheresis and payment provider Europe Asia % 70. of patients) 1 81 142 50 2 (276) 0.4 2. By the number of procedures. which represented 60% of total costs per year.0 17.5 21.4 18. %.0%).0 6. cascade plasma filtration (5.8 13. 11.5 – 2.5 284 (Total no. TABLE 21. The Italian Society for Hemapheresis reported for 2000 on 15 202 therapeutic treatments and 149 741 productive (donor) procedures (12).3 13.1%). replacement fluids. TTP (1121). Therapeutic apheresis procedures by country Patients Canada France Germany Hungary Italy Japan Philippines USA Sweden Turkey Venezuela 898 1021 – 983 1477 – 194 – 439 172 – Treatments 8561 10 700 6941 3120 15 205 11 697 735 48 221 3562 869 547 Population (million) 30 60 82 10 58 127 83 252 10 67 26 Cases/million inhabitants 30. acute Guillain–Barré.75%.1 N America N 57 3 2 4 4 (70) 15 21 31 (67) 0 27 18 1 3 (49) % 81. The authors felt that the data collected are underreported with data predominately lacking from dialysis and intensive TABLE 22.7 Australia N 48 19 4 8 0 (79) 11 26 42 (79) 0 0 79 0 0 (79) % 60.1 0 0 100 0 0 0 0 100 0 0 6. percentage of patients.7 N 285 47 9 5 11 (357) % 79. glomerulonephritis (28). glomerulonephritis (137). By the number of patients.7 4.0 0.9 32.2 2.3 11.9 2. TTP.1 0. hypercholesterolemia (552). gammopathies. and HUS.8 0.7 61 11 410 20 0 (502) 5.5 27.0 55.1 36. TTP (607).4 31. no mention was made of the sideeffects experienced.4 83.3 2.89% was noted as severe. of patients) N 195 13 1 7 60 (276) Response to apheresis (above question) based upon: Subjective 83 35.3 25.0 N 589 82 16 24 76 (787) 127 196 403 (726) 62 119 653 71 5 (910) Total % 74.0 39 Both 41 17.5 N.2 81.3 51. 2007 © 2007 International Society for Apheresis .7 0. Further.

PE. 2007 . Macroglobulinemias TTP. arterio-venous. cryoglobulinemia. Plateletpher. Fulm.TABLE 23. Familial Hypercholesterolemia Myasthenia Gravis Guillain–Barré Fam. systemic lupus erythematosus. HUS. Cryoglobulinemia. Hematological.SLE. TTP.89% Severe FFP – – – – Crystalloids/Albumin/21% – – – Methods 2005 International Apheresis Registry Canada France Germany Hungary Italy Citrate/Heparin/LMW Heparin – – Heparin/Citrate Albumin/Cryosupernatant plasma/FFP Albumin substitutes/ Albumin/Plasma – – – Japan Philippines USA Nafamostat mesilate/Hep. Hep. No. TTP USA Venezuela 1991 2003 Cryo. Malig. Guillain–Barré. Ex. Malig. Leukemia. Guillain–Barré. RA. low molecular weight. SLE. SLE. fulminant.. myasthenia gravis. Neurological. T-cell Lymphoma – TTP. fresh frozen plasma. 5. MG Fam. HUS. HUS Guillain–Barré. National view of therapeutic apheresis continued Vascular access – Peripheral vein – – AV fistula/Central vein – – – – Citrate Anticoagulation Substitution fluids Side effects 12% 0. Hyperchol.4% Severe 1. RPGN. HUS. MG. MG...9–6. Hyperchol.4% Hypotension – – 2. FFP. TTP Fam.. TTP. Hyperchol. Hepatitis Polyradiculoneuropathy. National view of therapeutic apheresis Cases 898 942/1021 – 792–983 2820/1477 – 194 – – 48 221 547 – – 735 8561 9837/10 700 6941 2544–3120 15 202/15 285 11 697 Hematological. heparin. Vascular/Renal Hematological./Cytapheresis Plasma Ex. Hyperchol. exchange. TABLE 24. Ulcerative Colitis. Renal/Metabolic/ Immunologic Guillain–Barré. SLE. Hyperchol./ Photopheresis Centrifugation/Plasma Exchange AV. malignant rheumatoid arthritis. LMW. Guillain– Barré. Fulm. plasma exchange. MG Fam. MG.. Cryo. Neurological Guillain–Barré. Myasthenia Gravis. rapidly progressive glomerulonephritis. plateletpheresis.. Vol. RA.75% 0. thrombotic thrombocytopenic purpura. Cryo. 353 Ther Apher Dial./Cytapheresis/ Cascade Filtration Membrane Filtration/ Adsorption/Centrifugation Plasma Exchange Centrifugation/PE/Plateletpher. familial hypercholesterolemia. TTP Gammopathies..9% 0. MG./ LMW Heparin/Citrate – – Venezuela Centrifugation/Plasma Exchange Centrifugation/Plasma Treatment – Plasma Ex. SLE. Hepatic failure Procedures Diseases by frequency Diseases by # Reporting year 30 60 82 10 58 127 73–83 252 26 Population (million) © 2007 International Society for Apheresis Canada France Germany Hungary Italy Japan Philippines 2002 2003/04 2002 2001–2004 2000/1994–2004 1995 2002 1994–2004 Neurological. Cryo. 11. hemolytic-uremic syndrome.. Fam.

5.6% by Protein A immunoadsorption. The top disease states treated were neurological (54%). In 1995 the top treated diseases by number of patients were familial hypercholesterolemia (173).7%).5%).7%.7% by LDL cholesterol dextran sulfate). note was made © 2007 International Society for Apheresis care units. while whole blood treatment was carried out in 2.5 procedures per patient.7.2% of procedures. Substitution fluids used by center were crystalloids (40. with five deaths reported (4 with PE). 266 centers (94% from the US) reported on 48 221 therapeutic procedures and 330 702 donor procedures (2). Effectiveness reported was for familial hypercholesterolemia 91% and postoperative hepatic failure 26%. Vascular access in 13. TTP. low molecular weight heparin (37. direct polymyxin B hemoperfusion (76. and outcome data were not collected. In 2002 Japan.354 PS Malchesky et al. The most common indications were acute or chronic inflammatory demyelinating polyradiculoneuropathy. bilirubin adsorption (45. alcemia.%).43% of procedures. with the most frequent being hypotension.2%). LDL plasma adsorption (51.1%). systemic lupus. and 9. The methods used by centers reporting were centrifugation (6.7%). The top treated diseases by number of procedures were familial hypercholesterolemia (2929). Guillain–Barré (153). postoperative hepatic failure (144). cryofiltration (8. lupus nephritis (813). myasthenia gravis.4%). fulminant hepatitis (145). fulminant hepatitis (947).6%).9%). hematological (32%). available technologies (they do not have adsorption columns. Reporting by percent of centers for 1995. Plasma exchange was performed for 56. For 8 of 10 centers reporting through the Philippine Society of Hematology and Blood Transfusion.6%) for 1961 patients with 15 670 procedures (estimated 26% of all procedures) on 100 disease types (6). nutrition and immunologic. and TTP. albumin (69. metabolic.3%). membrane filtration (50– 55%). cryoglobulinemia. ulcerative colitis (1864). FFP and albumin (19. and FFP plus albumin (6. leukocytosis/thrombocytosis. heparin (83. and rheumatoid arthritis (857). reimbursement.4% were performed by filtration. In the US. The top three disease categories treated were: endocrine. heparin was used in 86% of centers reporting and nafamostat mesilate in 69%.6%) immunoadsorption (46.1%). 11.85% of cases by photopheresis. Cytapheresis were performed in only 0. and chronic inflammatory demyelinating polyneuropathy.1%). The most prevalent diseases treated were Guillain–Barré by plasmapheresis.9%). By procedures most performed in 2002 they reported ulcerative colitis (2263). reported for 1995 on 164 centers (11. Substitution fluids used were fresh frozen plasma (73. Japan.4% of centers.6% of total procedures. down from 1995 (7). membrane filtration (63. and citrate (5. Anticoagulation was predominately with heparin (82%). and effective from 55. For the years 1994–2004.1%).7%). double filtration (63. Reported responses to apheresis for the centers were very effective from 14.19%. and others (9. reported 11 697 procedures.0%).7% by cascade filtration. FFP (20. Limitations reported were economics.8%). gastrointestinal. Reported side-effects were 2. and education of apheresis. Therapeutic apheresis procedures in Italy are performed primarily in nephrology units. predominately by plasma exchange (91%).5%). renal/metabolic (7%).9%). By the number of procedures.1%).1%). As anticoagulants. filters or photopheresis machines). myasthenia gravis. malignant rheumatoid arthritis (1821). centrifugal equipment was used predominantly in plasma exchange procedures. No.4%). In 2005 in a report on the status of therapeutic apheresis in the US (15). 12. The preference was for plasma exchange. albumin (31. Plateletpheresis was the most prevalent donor procedure. and granulocytapheresis (43. familial hypercholesterolemia (1796). Twenty-one percent of cases had side-effects. with a population of 125 million.5% by a central venous catheter.4% of centers. combined heparin and citrate (9. and other systemic lupus erythematosus (SLE) (766). and myasthenia gravis.6%). the methods used were adsorption (30–50%). Side-effects reported were hypotension at 0. Vol. 194 patients were treated with 735 procedures. leukocytapheresis (40. the top treated diseases were familiar hypercholesterolemia. the Italian Society for Nephrology reported (13) 15 205 treatments (believed to be 10% of total) on 1477 patients from 44 centers.7%). and citrate (4. having a population of 127 million. the top diseases treated were Guillain–Barré. and urticaria and allergic reactions 0. systemic lupus. Apheresis statistics from the Philippines (73–83 million inhabitants) were reported for the period of 1994–2004 (14).4% was by an arterio-venous fistula and 10. and cutaneous T-cell lymphoma by photopheresis. By the number of patients.5%). cryoglobulinemia. of which 50. Guillain–Barré. and endotoxic shock (125). or 10. or 2. Plasma treatment was employed in 40.1% of procedures (14. and autoimmune (5%). and centrifugation (<5. 2007 . Anticoagulation used by centers reporting were nafamostat mesilate (91. shock and hypocTher Apher Dial. malignant rheumatoid arthritis (1050). In the United States survey by the American Society for Apheresis in 1991 (US population then 252 million). direct charcoal hemoperfusion (38.9%. leukemias by cytapheresis. and neurological and sensory.

The time needed to enter patient data continues to be a major issue for busy physicians and their assistants. We are deeply indebted to all the Centers and Collaborative Persons that supported this Registry (See Appendix II for a listing of the participating hospitals and clinics and collaborative persons). Of the 805 people solicited. Based on the estimated populations in the various regions. Patient selection relates to multiple factors. The geographic distribution of the individual survey responders can have a very important influence on the results reported. A 60% improvement in visual activity was reported. The 2004 report (17) included 28 centers in 11 countries performing 1808 procedures. equipment choice. From a review of the national registries particular note can be made that the diagnoses for which apheresis is applied varies country by country most likely as a function of medical evidence. trends over time. 2007 . Citrate anticoagulant was used in greater than 80% of the cases and albumin substitution in greater than 80%. one should be considerate of the above noted issues. and there exists a need for trained personnel and education of physicians on clinical indicators. and 2002 (4) surveys. and the country’s reimbursement policies. and stem cell harvest (15%). Conclusions made were that centers have various approaches to apheresis. followed by Asians. personal communication). The top treatment diagnosis category was nervous system disorders. 12-center trial. technical personnel resources and equipment available. 80% were by plasma exchange by centrifugal means for TTP and hemophilia inhibitors. Plasmapheresis accounted for 82. Guillain–Barré. Of the therapeutic procedures. Blood access was peripheral for 65% and central for 24%. 2000 (3). No. and regulatory (FDA) approvals impact the field. 11. the most ever reported in this survey format.9%. The treatment diagnosis and treatment response influence the frequency of treatments. reported in 2003 that it had 80 apheresis machines. Since August 1999. and drug usage. with hypotension and allergic reaction to plasma the most common. the mean age of treatment was 45 years. Acute indications accounted for 80% of the procedures and 12% for chronic indications. personal communication). The World Apheresis Association Registry objectives are to assess apheresis activity with regard to indications.41% (0. service providers are blood centers and nephrology-based. as in previous surveys. Vol.51% discontinued and 6. which is 57% of that reported in 2002 (4). including the physician’s experience and knowledge of apheresis. Adverse events were 3. multiple myeloma. 439 patients were enrolled (Occulogix. Note was made that the procedure costs are US $975 and the average annual salary is US $1910. and reimbursement. the highest treatment populations were Caucasians. Considering the voluntary nature of this survey. medical evidence of efficacy of the treatment. The top treatment diseases were myasthenia gravis. The format of the questionnaire used for this survey was similar to that used for the 1983 (1). a total of 185 patients were enrolled in randomized. We believe that a serious impediment to the collection of data is the voluntary reporting. As in 2002. dialysis ward. 5. placebo controlled. regional differences were noted. and even the diseases treated. and techniques used nationally and internationally to reduce the risks/ adverse events and to improve treatment quality. as in the previous registry. In the review of this survey and its results. Fifty-five percent of the patients were women and 45% men.54% with vascular access problems). and TTP. the individual clinician’s expertise. Venezuela. As in the previous survey this survey was conducted through a secure dedicated website. and. Adverse events were 5. Certainly providing some incentive other than depending on the ultra-kindness and academic interests of the respondents would be helpful. including the types of equipment. This survey was based on 1133 patients. The number of treatments was 6501. As in previous registries. The availability of technologies © 2007 International Society for Apheresis 355 impacts the procedural methodologies used. Rheopheresis is a membrane plasma filtration procedure to treat microcirculatory disorders such as dry/ nonexudative age-related muscular degeneration (AMD) (R Klingel. the centers reporting from the various countries are not necessarily proportional to the patient numbers reported.3% of all patients treated. number of treatments per patient. treatment indications and applications depend on the type of apheresis center (blood center. The largest total Ther Apher Dial. with an average age of 53 years.7% of all reported treatments on 67. A Rheopheresis RheoNet Registry has been developed to report rheopheresis procedures. anticoagulation. and performed 27 675 donor and 547 therapeutic apheresis procedures (16).7% response rate reporting from 22 centers on 5 continents. or apheresis center). data was received from 30 people representing a 3. It was noted that the US is not technologically advanced. double-blind. with a population of 26 million. we consider the response rate acceptable. Patient selection most likely is a major influence in the regional differences noted in treatment type.2005 International Apheresis Registry that controlled clinical trials drive indications for therapeutic apheresis and technology.

J Clin Apheresis 2005. Present status of therapeutic apheresis in Japan: survey report. followed by plasma treatment (34. Russo GE. may contribute to a better understanding of apheresis practices and can lead to the development of better clinical practices worldwide. Transfus Apher Sci 2005. Rock G. The Canadian apheresis registry. Miami. Haemapheresis activities in Germany. Scientific Committee. Narciso CT. or other reasons. for the French Registry Cooperative Group. 15. Moog R. Presented at World Apheresis Association Annual Congress held May 5–8. In this survey. Donadel C. but only in the Asian and European regions where these technologies are widely available. in comparison to the national survey results reported. and Guillain–Barré 5. J Clin Apheresis 2005. May 5–8. Transfus Apher Sci 2003. Transfus Apher Sci 2004. National survey of apheresis activity in Italy (2000).20:101–8. Jpn J Apher 2005. FL. CAAN. Malchesky PS. (Survey Subcommittee. Also noteworthy was that whole blood sorption procedures accounted for 10. Shimizu M. 4. Only a small percentage of patients were treated by cytapheresis or lymphoplasmapheresis (about 4% and comparable to the previous survey). The International Apheresis Registry: a progress report. which accounts for its regional differences. 2007 © 2007 International Society for Apheresis . Traci Coss and Carol Malchesky. Ther Apher Dial. Sutton D. Passalacqua S. Apheresis activity in Venezuela. Korach J-M.24:110–18. Ther Apher Dial 2007. number of treatments were by plasma exchange (48. 8. Rostock. Malchesky PS. We are appreciative of the financial support of Kaneka and Therakos that permitted updating the on-line data collection program. Plasma treatment by membrane filtration and sorption continue to be important forms of therapy. whether related to economics. A report from the Apheresis Study Group of the Italian Society of Nephrology. 2. Clark B. Vicarioto M. CAG. and 64. This international survey. 6. 11. Hadsell AT.30:61–71. Rybicki LA.2:172–81.20:95–100. 13.20:123–5. Leatherman JR. Saltiel C. 1984. Koo AP.2% in 1983).11:22–9. 10. OH: ISAO Press. Blood access continues to be a clinical procedural issue and in this survey citrate-related complications were higher than previously reported. Malchesky PS. 5. French Apheresis Registry. Drug use relates to treatment diagnosis. 16. the percentage of patients noted as showing improvement was nearly comparable at 74. Roberson GA. Ther Apher 2001. Nosé Y. Cleveland.356 PS Malchesky et al. Japanese Society for Apheresis). In: Nosé Y. 61–7. Jako J. Vol.33:3–9. William GW. 2004. Nosé Y. Staffolani E. Ther Apher Dial 2004.8: 124–43. Delivery of therapeutic apheresis services in the United States.8% (78. Replacement solutions varied and most likely relate to the disease state treated and technology applied. TTP 11. Therapeutic Apheresis: a Critical Look. Germany.0 times on average per patient. The average number of treatments per patient was 6. Tsuda H. The choice of anticoagulant type is likely to be related to the equipment type used (centrifugal or membrane plasma separation). Malchesky PS. World Apheresis Registry. 3.0. An understanding of these differences. Ide K. 7.Stem cell infusion data was first collected in this survey on about 26% of the patients reported. Transfus Apher Sci 2005. Sanaka T. 73. 9.11:173–82. Society for Apheresis. Payment provider remained comparable to 2002. Stegmayr B. hypercholesterolemia 26.9 times. Malchesky PS. 5. Smith JW. technology. Marson P. Ther Apher 1998. Albumin solution was the most frequently used replacement solution.3% of all procedures. 2005. Kiprov DD. Busnach G et al. 14. the site where the apheresis is carried out (blood or dialysis center). Compared to the previous survey. Apheresis technologies and clinical applications: the 2002 International Apheresis Registries.0 times per patient. The International Apheresis Registry: results of 1983 second pilot. Artif Organs 1987. Skibinski CI. Malchesky PS. continues to show regional differences.4%).8:96–101. The Center and the authors are particularly thankful and indebted to those medical directors and institutions who so willingly participated in this survey (see Appendix II). Acknowledgments: This study was carried out under the auspices of the International Center for Artificial Organ and Transplantation (ICAOT) as part of its ongoing Technology Assessment Program and the International REFERENCES 1. National survey of hemapheresis practice in Hungary 2001–2004.1% in 2000. disease demographics.8% in 2002. of the top treated diseases by number of treatments. J Clin Apheresis 2005. Skibinski CI.3%). USA. and James Liu of the Department of Quantitative Health Sciences at the Cleveland Clinic for supporting this activity. Koo AP. De Silvestro G. We also especially thank the staff of the International Center for Artificial Organs and Transplantation. Apheresis technologies and clinical applications: the 2000 International Apheresis Registry. The Italian Registry for Therapeutic Apheresis. myasthenia gravis was treated 7. Therapeutic apheresis in the Philippines. Presented at the 5th World Congress of the ISFA. 11.5 times. Rybicki LA. and the choice of the physician in charge. 17. Belak M. eds. J Clin Apheresis 1993. 12. No. Summary of results of 1991 ASFA apheresis survey. Williams GW.5:193–206.32:283–6.29:167–77.

2007 . No. 5. Vol.2005 International Apheresis Registry APPENDIX I: ONLINE DATA ENTRY FORMS FOR THE 2005 INTERNATIONAL APHERESIS REGISTRY 357 © 2007 International Society for Apheresis Ther Apher Dial. 11.

2007 © 2007 International Society for Apheresis . No.358 PS Malchesky et al. 5. 11. Ther Apher Dial. Vol.

2005 International Apheresis Registry 359 © 2007 International Society for Apheresis Ther Apher Dial. 11. 5. 2007 . Vol. No.

5. 2007 © 2007 International Society for Apheresis . Vol.360 PS Malchesky et al. No. Ther Apher Dial. 11.

2005 International Apheresis Registry 361 © 2007 International Society for Apheresis Ther Apher Dial. 5. Vol. No. 11. 2007 .

Ferda Tekinturhan Joselito B Brandao Norella C Kong Omar A Trabadelo Jun-Feng Liu Rakesh Srivastava Frithjof Blessing. Kyou-Sup Han Jiann-Horng Yeh Carole Y Davis Kes Petar Kurt Derfler. Japan Liverpool. 5. Santariskiu Clinics City. Antanas Griskevicius Department. Austria Farmington. Leo J McCarthy Anna P Koo Birol Guvenc. Australia Erlangen. Germany Seoul. IN. Eun Young Song. Korea Taipei. Martin Jansen. Taiwan Toronto. Osman Ilhan Christiane M Saltiel Umut S Bayrakci. Lithu Ther Apher Dial. Malaysia Buenos Aires.362 PS Malchesky et al. University of Erlangen-Nuremberg Seoul National University Hospital Shin Kong Wu Ho-Su Memorial Hospital St Michael’s Hospital University Hospital Center Zagreb University Hospital Vienna University of Connecticut Health Center Vilnius University Hospital. Argentina Shanghai. Germany Tokyo. No. Ontario Zagreb. Meltum Bay. institution Ankara University School of Medicine Banco Metropolitano de Sangre Baskent University Medical Faculty Clarian Health Partners Cleveland Clinic Cukurova University Balcali Hospital Hospital Alemao Oswaldo Cruz Hospital UKM Hospital de Hospital de Niños Ricardo Gutierrez Huashan Hospital ISA Institute for Apheresis and Research Center Klinikum Grosshadern Koto Hospital Liverpool Hospital Medizinische Klinik III. Croatia Vienna. Önder Arslan. Gerda C Leitner Andre Kaplan Judita Audzijoniene. Turkey Indianapolis. India Grosshadern. Thomas Bosch Noriaki Shimada Phillip Wearden Juergen Rech Ji-Weon Seo. Vol. Turkey Saõ Paulo. China Delhi. Venezuela Ankara. OH. APPENDIX II: COLLABORATING PERSONS AND INSTITUTIONS Participant Mutlu Arat. Brazil Kuala Lumpur. USA Cleveland. Turkey Caracas. USA Vilnius. USA Adana. 11. Ilknur Kozanoglu Vicki L Graves. 2007 © 2007 International Society for Apheresis . CT. Erol Ayyildiz. NSW. country Ankara.

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