In Focus
Haemovigilance in therapeutic apheresis
Patient-centred perspectives
Vijay Kumawat
National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, India
Therapeutic apheresis (TA) represents a group of complex procedures involving segregation of blood components of interest involved in disease pathophysiology and return of the components to the patient which are not to be removed/exchanged.
The American Society for apheresis (ASFA) guidelines recommend TA as treatment for various disorders across many clinical specialities1. The major categories of TA and clinical specialties are shown in Table 1.1
Table 1: Major categories of TA and Clinical specialties utilizing TA
Adverse events related to TA
The TA procedures are associated with adverse events like any other medical procedure and can be broadly categorized in the following categories.
- Complications due to primary illness
- Apheresis procedure-related
- Replacement fluid associated
- Vascular access-related
Numerous factors including the patient's diagnosis and clinical condition, number and frequency of procedures, type of apheresis equipment, replacement fluids, anticoagulation used, technical expertise available and choice of vascular access can determine the frequency and severity of complications arising from TA2. The adverse event during TA in the published literature ranges between 4.3 to 12.9%. Still, few studies had reported adverse event frequency as low as 0.02 and high as 50 per cent among the various patient population3-5. This broader range of adverse event rates necessitates investigating factors influencing it.
Current state of haemovigilance for TA and need assessment
The current haemovigilance systems do not specifically monitor adverse events related to TA. The uniform criteria for recognition, grading, documentation, and reporting has potential to increase apheresis physicians' or apheresis operators’ awareness of potential adverse events that can built capability to better prepare for the procedure, severe events can be prevented, and result in fewer adverse events in long run2. It is also essential to recognize the nature and timeline of adverse events that occur during each TA cycle. This understanding is also important to develop & enable effective and favourable outcome of any adverse event for patient's undergoing TA6.
There is an upward trend in the patients with emerging and expanding clinical utility of TA. Still, management and communication protocols are variable or even doesn’t exist particularly in low- and middle-income countries (LMIC); the processes vary from institute/ hospital to another hospital, negligible or merely visible infection prevention control policy adherence, and inconsistent or absent health quality management systems are major obstacles to optimize the therapeutic benefit of TA and limiting adverse events7 The adverse events are known to increase the length of hospital stay and a significant increase in the healthcare cost8, 9. The increased cost is either borne by the patient or insurance or government. A standardized hemovigilance program for TA is the need of the hour to initiate and develop a systematic approach for establishing and monitoring the safety of the TA program at the national as well as international level.
Possible broader utility of haemovigilance for TA
The hemovigilance program can identify and minimize preventable adverse events of TA and can help to make it cost-effective. The newer TA techniques and newly introduced apheresis instruments for clinical use in the future can be evaluated for patient safety against hemovigilance data, helping regulatory agencies make evidence-based decisions. The recommendations based on data analysis can be used to educate physicians on the evidence-based application of TA and safety of the various apheresis procedures can help to accept TA widely, ultimately benefiting the larger patient population10.
References
1. Connelly-Smith L, Alquist CR, Aqui NA, Hofmann JC, Klingel R, Onwuemene OA, et al. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice - Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Ninth Special Issue. J Clin Apher. 2023; 38 (2): 77-278.
2. Kundrapu S, Datla S, Griffin V, Maitta RW. Adverse events during apheresis: A 10-year experience at a tertiary academic medical center. J Clin Apher. 2019; 34 (5): 528-536.
3. Saltiel C. Apheresis activity in Venezuela. J Clin Apher. 2005; 20(2) :95-100.
4. Michon B, Moghrabi A, Winikoff R, Barrette S, Bernstein ML, Champagne J, et al. Complications of apheresis in children. Transfusion. 2007; 47(10): 1837-42.
5. Norda R, Stegmayr BG; Swedish Apheresis Group. Therapeutic apheresis in Sweden: update of epidemiology and adverse events. Transfus Apher Sci. 2003; 29(2): 159-66
6. Ishihara T, Inoue S, Takagi Y, Shimomura T, Sagami Y, Katayama S, et al. Adverse events in therapeutic apheresis: a single center survey of various therapies. Ther Apher Dial. 2010; 14(6): 589-95.
7. Poole C, Strydom C, van der Berg K, Vrielink H. Taking therapeutic apheresis services to patients in South Africa: An eight year review of SANBS mobile therapeutic apheresis service, 2013-2020. Transfus Apher Sci. 2021; 60(3): 103167.
8. Tessier L, Guilcher SJT, Bai YQ, Ng R, Wodchis WP. The impact of hospital harm on length of stay, costs of care and length of person-centred episodes of care: a retrospective cohort study. CMAJ. 2019; 191(32): E879-E885.
9. Carey K, Stefos T. Measuring the cost of hospital adverse patient safety events. Health Econ. 2011; 20(12): 1417-30.
10. Eichbaum Q, Smid WM, Crookes R, Naim N, Mendrone A Jr, Marques JF Jr, et al. Apheresis in developing countries around the World. J Clin Apher. 2015; 30(4): 238-46.
