The evaluation of a new apheresis device for automated red blood cell exchange procedures in patients with sickle cell disease

Quirolo, Keith; Bertolone, Salvatore; Hassell, Kathryn L.; Howard, Thomas H.; King, Karen E.; Rhodes, Diane K.; Bill, Jerry

doi:10.1111/trf.12891

Cited by 21 publications

(32 citation statements)

References 21 publications

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“…In a series of 75 RBCX sessions performed with the SO device in 72 patients, Quirolo et al observed a higher AE rate with the depletion protocol (22.7%) than without (16.0%). However, this discrepancy can be explained by the different designs of the studies.…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have described the performances of the SO device when using the RBCX technique associated (SO/DE) or not (SO) with the depletion step for patients with SCA . These studies showed similar performance of SO compared to CSP both associated and not associated with DE.…”

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confidence: 99%

“…These studies showed similar performance of SO compared to CSP both associated and not associated with DE. However, the number of RBCPs saved when using SO/DE has not been accurately evaluated since previous studies focused mainly on the performance and safety of the SO/DE technique . The main aim of this study was to compare the number of RBCPs saved between the SO/DE and the SO or the CSP device, both without depletion step.…”

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confidence: 99%

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

et al. 2019

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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.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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

et al. 2019

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“…The EAC focussed on results from the six comparative studies with manual RBC exchange [18–23] because these provided the most useful data relevant to the decision problem, and the peer-reviewed single-armed studies of the Spectra Optia [28] and Cobe Spectra systems [24, 26, 27, 29, 30], as these studies were fully reported and provided useful supporting data. Details of these studies are summarised in Table 1.…”

Section: Review Of Clinical Effectiveness Evidencementioning

confidence: 99%

“…No analytical data reported Masera et al [27], retrospective data review, ItalyChildren with SCD ( n = 34) at high risk for vaso-occlusive complicationsCobe SpectraMedium methodological quality but poorly reported. Results poorly generalisable Quirolo et al [28], retrospective observational study, USAAdults and older children with SCD ( n = 60)I: Spectra OptiaC: Spectra Optia (dRBCx)(Subgroup analysis)High quality with good reporting. Key paper in determining Spectra Optia resource use Sarode et al [29], retrospective observational study, USAAdults with SCA ( n = 20), stable with history of thrombotic strokeI: Cobe Spectra (dRBCx)C: Cobe Spectra (standard)(Historic controls)Medium methodology with good reporting.…”

Section: Review Of Clinical Effectiveness Evidencementioning

confidence: 99%

Spectra Optia® for Automated Red Blood Cell Exchange in Patients with Sickle Cell Disease: A NICE Medical Technology Guidance

Willits

Cole

Jones

et al. 2017

Appl Health Econ Health Policy

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The Spectra Optia® automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the National Institute for Health and Care Excellence, which uses its Medical Technologies Advisory Committee to make recommendations. The company (Terumo Medical Corporation) produced a submission making a case for adoption of its technology, which was critiqued by the Newcastle and York external assessment centre. Thirty retrospective observational studies were identified in their clinical submission. The external assessment centre considered these were of low methodological and reporting quality. Most were single-armed studies, with only six studies providing comparative data. The available data showed that, compared with manual red blood cell exchange, Spectra Optia reduces the frequency of exchange procedures as well as their duration, but increases the requirement for donor blood. However, other clinical and patient benefits were equivocal because of an absence of robust clinical evidence. The company provided a de novo model to support the economic proposition of the technology, and reported that in most scenarios Spectra Optia was cost saving, primarily through reduced requirement of chelation therapy to manage iron overload. The external assessment centre considered that although the cost-saving potential of Spectra Optia was plausible, the model and its clinical inputs were not sufficiently robust to demonstrate this. However, taking the evidence together with expert and patient advice, the Medical Technologies Advisory Committee considered Spectra Optia was likely to save costs, provide important patient benefits, and reduce inequality, and gave the technology a positive recommendation in Medical Technology Guidance 28.

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Iron in blood cells: Function, relation to disease, and potential for magnetic separation

Barua

Ciannella

Tijani

et al. 2023

Biotech & Bioengineering

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Iron in blood cells has several physiological functions like transporting oxygen to cells and maintaining iron homeostasis. Iron is primarily contained in red blood cells (RBCs), but monocytes also store iron as these cells are responsible for the recycling of senescent RBCs. Iron also serves an important role related to the function of different leukocytes. In inflammation, iron homeostasis is dependent on cytokines derived from T cells and macrophages. Fluctuations of iron content in the body lead to different diseases. Iron deficiency, which is also known as anemia, hampers different physiological processes in the human body. On the other hand, genetic or acquired hemochromatosis ultimately results in iron overload and leads to the failure of different vital organs. Different diagnoses and treatments are developed for these kinds of disorders, but the majority are costly and suffer from side effects. To address this issue, magnetophoresis could be an attractive technology for the diagnosis (and in some cases treatment) of these pathologies due to the paramagnetic character of the cells containing iron. In this review, we discuss the main functions of iron in blood cells and iron‐related diseases in humans and highlight the potential of magnetophoresis for diagnosing and treating some of these disorders.

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The evaluation of a new apheresis device for automated red blood cell exchange procedures in patients with sickle cell disease

Abstract: The SO performed effectively and safely for both the RBCX procedure and the RBCX depletion/exchange procedure.

Cited by 21 publications

References 21 publications

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

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

Spectra Optia® for Automated Red Blood Cell Exchange in Patients with Sickle Cell Disease: A NICE Medical Technology Guidance

Iron in blood cells: Function, relation to disease, and potential for magnetic separation

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