Use of a dual lumen port for automated red cell exchange in adults with sickle cell disease

Shrestha, Anuj; Jawa, Zeeshan; Koch, Kathryn L.; Rankin, Amy B.; Xiang, Qun; Padmanabhan, Anand; Karafin, Matthew S.; Field, Joshua J.

doi:10.1002/jca.21393

Cited by 29 publications

(39 citation statements)

References 11 publications

(13 reference statements)

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“…Implantable ports are a well‐tolerated, long‐term option in patients expected to undergo regular exchanges because of a reduced care burden on the patient and infection rate (up to 10x less than central venous catheters) due to their subcutaneous placement . However, previous studies have reported an increased complication rate and decreased flow rates in comparison to temporary central venous catheters …”

Section: Introductionmentioning

confidence: 99%

Indwelling ports for prophylactic RBC exchanges in sickle cell patients: Comparison of bard and vortex ports

Lawicki

Craig-Owens

Bream

et al. 2018

J of Clinical Apheresis

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Introduction Red blood cell exchange (RCE) procedures are commonly used for stroke prevention in sickle cell disease (SCD) patients. We compared two different dual lumen ports used for RCE because differences between the port and catheter design may lead to functional variance. Methods We reviewed the RCE parameters of SCD patients following implantable port placement encountered at a single institution. Five Vortex and four Bard ports were used and compared. Patients were followed for 1‐24 exchange procedures over 3‐26 months performed between 2013 and 2015. Results Nine patients underwent 124 RCE procedures with no failures. A total of 74 exchanges used Vortex ports with a mean flow rate of 45.2 mL/min while 50 exchanges used Bard ports with a mean flow rate of 42.1 mL/min which was a significant difference (P = .002). A total of 85 exchanges with tPA administration preprocedure had a mean flow rate of 43.8 mL/min while 39 exchanges without had a mean flow rate of 45.4 mL/min which was not a significant difference (P = .19). Conclusion Both the Bard and Vortex ports functioned well during our study period with no treatment failures, no significant complications requiring removal or replacement, and adequate mean flow rates. While the difference in mean flow rates was statistically significant between Vortex and Bard ports, there may not be a practical difference in performance. There also does not appear to be a significant benefit in flow rates with preprocedure tPA. We conclude that both ports may be a satisfactory choice for vascular access in SCD patients expected to undergo regularly scheduled RCE.

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Section: Introductionmentioning

confidence: 99%

Indwelling ports for prophylactic RBC exchanges in sickle cell patients: Comparison of bard and vortex ports

Lawicki

Craig-Owens

Bream

et al. 2018

J of Clinical Apheresis

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“…These include access via a peripheral vein, temporary central venous catheter (CVC) access (via subclavian, jugular or femoral veins), placement of indwelling double‐lumen ports (e.g. Vortex), or the creation of arteriovenous fistulas . A broad consensus is that, where possible, a peripherally placed device should be the first choice for elective therapeutic apheresis procedures (TAs).…”

Section: Introductionmentioning

confidence: 99%

Is peripheral access for apheresis procedures underutilized in clinical practice?—A single centre experience

Putensen

Leverett

Bhavika

et al. 2016

J of Clinical Apheresis

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“…Of the other 24 studies, 14 were single-armed studies that reported absolute or ‘before and after data’, with seven published as full peer-reviewed studies [24–30] and seven as conference abstracts [31–37]. Two were single-armed studies on manual exchange, both published as conference abstracts [38, 39].…”

Section: Review Of Clinical Effectiveness Evidencementioning

confidence: 99%

“…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%

“…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. Comparative data peripheral to decision problemShrestha et al [30], retrospective observational study, USAAdults with SCD ( n = 29) on scheduled RBCxCobe SpectraMedium methodological quality with poor reporting. Aim was comparison of two types of venous access

aRBCx automated red blood cell exchange, dRBCx depletion red blood cell exchange, EAC external assessment centre, mRBCx manual red blood cell exchange, RBCx red blood cell exchange, SCA sickle cell anaemia, SCD sickle cell disease, TUT top-up transfusion

a Some studies reported in two or more papers.

…”

Section: Review Of Clinical Effectiveness Evidencementioning

confidence: 99%

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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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Use of a dual lumen port for automated red cell exchange in adults with sickle cell disease

Cited by 29 publications

References 11 publications

Indwelling ports for prophylactic RBC exchanges in sickle cell patients: Comparison of bard and vortex ports

Indwelling ports for prophylactic RBC exchanges in sickle cell patients: Comparison of bard and vortex ports

Is peripheral access for apheresis procedures underutilized in clinical practice?—A single centre experience

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

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