Adverse events in autologous blood donation and plasmapheresis - a 6-year analysis in 28,244 patients with 50,542 donations

Background: 6-year analysis of adverse events (AE) in a preoperative autolo gous deposit (PAD) program. Patients and Methods: This analysis was perform ed in 28,244 patients who underwent major bone and joint surgery from 1989 to 1994 and who took part in our PAD program. Patients were included into t he PAD program if eligible for elective surgery with supposed blood loss re quiring blood transfusion. Patient's physical status was rated according to the ASA score. Blood or plasma volume donated was replaced routinely, most ly with polygeline. Monitoring during donation included ECG (lead II) and n oninvasive blood pressure recording. Oxygen (2 l/min) was applied via nasal sponges. AE were rated as mild (grade I), moderate (grade II), severe (gra de III), and fatal (grade IV). All AE happening in the blood bank were take n into account; additionally, all grade III and grade IV AE occurring withi n 24 h after PAD were considered, independent of a relationship between PAD and AE. AE were analyzed in relation to age and ASA status of the patients . Data were evaluated using descriptive statistics, chi-square test, and Sp earman rank correlation; statistical significance was considered. for p < 0 .05. Results: 28,244 patients underwent 50,542 PAD sessions and donated a t otal of 132,093 autologous units. A total of 588 AE happened; i.e. in 2.08% of all participating patients and in 1.17% of all donations (not units obt ained!). With increasing ASA score, i.e. with worsening of the patient's ph ysical status, the frequencies of mild and moderate AE decreased. 65.9% (n = 388) of all AE: were considered as mild, 33.2% (n = 195) were rated as mo derate, 0.51% (n = 3) were graded as severe, and 0.34% (n = 2) were fatal. No overall relation between patients' age and frequency of AE could be demo nstrated. However, patients over 70 years (21.1%) accounted for 30.7% of AE (p < 0.05). The rate of AE associated with autologous plasmapheresis was 3 ,4-times higher than that associated with autologous blood donation. With o ne exception, all severe and fatal AE were found in patients over 70 years with ASA score III and a history of cardio- or cerebrovascular diseases. Al l these patients had undergone autologous plasmapheresis. Conclusion: The o verall frequency of AE in our PAD program was not higher than that reported for homologous programs, However, severe and fatal AE exclusively happened in patients who underwent autologous plasmapheresis. Therefore, in elderly patients and in those with concomitant cardio- or cerebrovascular diseases the indication for participation in a PAD/autologous plasmapheresis progra m has to be made very cautiously and by weighing pros and cons.