Automatic depletion with Spectra Optia allows a safe 16% reduction of red blood cell pack consumption in exchanged sickle cell anemia patients

Abstract

BACKGROUND Chronic red blood cell exchanges (RBCXs) are frequently used to prevent complications in patients with sickle cell anemia, but the scarcity of matched red blood cell packs (RBCPs) is a serious concern. The main goal of this study was to compare the number of RBCPs used during RBCXs between the Spectra Optia (SO) device (with the automatic depletion step) and the former Cobe Spectra (CSP) device. STUDY DESIGN AND METHODS The performances and safety of 300 SO sessions using the automatic depletion step (SO/DE) in 50 patients with sickle cell anemia under a chronic transfusion program over a 1‐year period were prospectively analyzed. The numbers of RBCPs saved using this protocol compared to the SO device without depletion and to the CSP device were determined. RESULTS The SO/DE protocol appeared to be safe, as only 5% and 17% of the sessions were characterized by a significant decrease in blood pressure and increase in heart rate (grade 2 adverse events), respectively. Postapheresis hematocrit and fraction of cells remaining reached expected values. The SO/DE protocol required 16% fewer RBCPs compared to SO without depletion, allowing a mean saving of 12 RBCPs per patient and per year and 13% fewer compared to CSP device. Interestingly, the saving was more important for patients with high total blood volume and/or high preapheresis hematocrit. CONCLUSION The SO/DE protocol is an efficient, safe and cost‐effective procedure for patients with sickle cell anemia under a chronic transfusion program.

Automated red blood cell depletion: Results from a validation trial of the Fenwal Amicus new red blood cell depletion program

“…Only reports on RBC exchange procedures in sickle cell anemia (SCA) have appraised that particular feature beside the fraction of cell remaining accuracy on different apheresis platforms. In SCA, the control of the final HCT in neurovascular complications is essential as it is stressed in recent reviews 18,19 . Quirolo et al 20 reported a prospective single arm study on 72 SCA patients, with 60 procedures on the Spectra Optia (RBC exchange and RBCd/RBC exchange).…”

“…In SCA, the control of the final HCT in neurovascular complications is essential as it is stressed in recent reviews. 18,19 Quirolo et al 20 reported a prospective single arm study on 72 SCA patients, with 60 procedures on the Spectra Optia (RBC exchange and RBCd/RBC exchange). As secondary endpoint, the difference between the postprocedure HCT and targeted final HCT was on average 1.03 ± 0.07 considered as similar (95% CI).…”

Safety and benefits of automated red cell depletion‐exchange compared to standard exchange in patients with sickle cell disease undergoing chronic transfusion

“…This study was one of two 3,7 that used saline replacement, which may have contributed to the hypotension event rate. The other two 4,8 studies used hydroxyethyl starch or albumin replacement instead of saline and found no increased adverse events compared to standard RCE.…”

“…In 2013, an automated IHD‐RCE procedure of isovolemic RBC reduction followed by standard exchange was approved by the US Food and Drug Administration on the Spectra Optia device (Terumo BCT), thus facilitating easy performance of the IHD‐RCE procedure. A study of 30 patients comparing the Optia IHD‐RCE procedure to standard RCE confirmed the need for 13% fewer RBC units compared to a standard RCE but did not observe a concurrent increase in interval between procedures 4 . One other full‐text study 5 has been published comparing the two procedure types but did not directly examine RBC savings or interprocedure interval.…”

“…There is also equipoise regarding the safety of IHD‐RCE in regard to the transient Hct decrease and whether clinically significant hypotension occurs, which may lead to increased stroke risk 6 . Only one 7 of four studies 3,4,7,8 examining adverse reactions with IHD‐RCE found a possibly increased incidence of hypotension; while an incidence of 7% in procedures with Spectra Optia was reported, hypotension was not defined, and comparison to standard RCE was not reported. This study was one of two 3,7 that used saline replacement, which may have contributed to the hypotension event rate.…”