ORIGINAL ARTICLE |
https://doi.org/10.5005/jp-journals-10089-0079 |
Feasibility and Safety of Implementing Membrane-based Plasma Exchange in a Low-volume Center: Retrospective Single Center Experience Over 3 Years Including Multidisciplinary Survey among Clinicians
1Department of Intensive Care Service, Westmead Hospital, New South Wales, Australia
2–7,10Department of Intensive Care Medicine, Ng Teng Fong General Hospital, Singapore
8,9Department of Medicine, Ng Teng Fong General Hospital, Singapore
Corresponding Author: Xiao Jiang, Department of Intensive Care Service, Westmead Hospital, New South Wales, Australia, Phone: +61 88905555, e-mail: xiaoj2015@gmail.com
Received on: 24 July 2023; Accepted on: 04 October 2023; Published on: 30 October 2023
ABSTRACT
Background: Membranous therapeutic plasma exchange (mTPE) is less commonly used in Singapore compared to centrifuge TPE. Our study aimed to investigate the feasibility and safety of mTPE as a new service in a low-volume TPE center that was familiar and experienced with the continuous renal replacement therapy (CRRT) technique.
Materials and methods: This was a single-center retrospective study of patients who underwent mTPE from 1st May 2018 to 31st July 2021, conducted at a 34-bedded mixed intensive care unit (ICU) in Singapore. Clinical data and mTPE details, including adverse events, were collected for all sessions. Multidisciplinary surveys of specialists and nurses involved were conducted thereafter in August 2021.
Results: During the study period, a total of 53 mTPE sessions were done for 10 patients, of which eight (80%) were female. Of a total of 53 sessions, filter clotting despite anticoagulation occurred in seven (13%) sessions. The adverse event rate was 11.3% of all sessions. A survey of five specialists and 12 ICU nurses indicated a smooth referral process, a short setup time, and easy hands-on in implementing mTPE as a new service in the ICU.
Conclusion: Our results show the feasibility and safety of introducing mTPE as a new service in ICU settings in a low-volume TPE center, with the specific logistical advantage of short training time in view of familiarity and experience with the CRRT technique. This also provided the ability to continue uninterrupted service during the pandemic and maybe a future direction for similar ICUs.
How to cite this article: Jiang X, Kansal A, Kansal MG, et al. Feasibility and Safety of Implementing Membrane-based Plasma Exchange in a Low-volume Center: Retrospective Single Center Experience Over 3 Years Including Multidisciplinary Survey among Clinicians. J Acute Care 2023;2(2):54–60.
Source of support: Nil
Conflict of interest: None
Keywords: Feasibility, Intensive care unit, Membrane-based, Plasma exchange, Safety
INTRODUCTION
Therapeutic plasma exchange (TPE) is a procedure used clinically to separate plasma from blood cellular components via extracorporeal circuits and then replace it with specific fluids. It is often applied as the first line or adjunct therapy for diseases mediated by antibodies, abnormal plasma proteins, cytokines, or protein-bound toxins.1 TPE can be done via two mechanisms-centrifuge or membranous filtration.2 Centrifugal TPE (cTPE) requires an apheresis machine to separate plasma depending on centrifugation speed and time interval, while membranous TPE (mTPE) is done with the continuous renal replacement therapy (CRRT) machine with a specific filter (Fig. 1). Both methods are well-established in clinical practice globally.
Figs 1A and B: Comparison of (A) Centrifuge; and (B) Membrane-based PE
Compared to cTPE, mTPE had a lower plasma extraction ratio (20–30%) for mTPE vs 80% for cTPE); the plasma exchanging efficiency has been shown to be similar due to its high sieving coefficient (0.97) as of TPE 2000 filter.3 A previous randomized crossover study comparing mTPE (Diapact) and cTPE (Spectra Optia) showed that the two systems were equally safe and effective in removal of immunoglobulin G and blood cells, but cTPE was more effective in removing larger fibrinogen protein and took less time for both preparation and procedure.4 Similar finding was also reported in a German retrospective study of 185 patients.5 On the other hand, mTPE has generated interest due to its logistical advantage of utilizing existing CRRT machines and nursing resources with minimum additional training required. Previous studies range from care reports to retrospective studies from centers with well-established mTPE services of a wide range of sample sizes.6-8
In Singapore, cTPE is usually provided by renal or hematology service in a general ward or intensive care unit (ICU) setting, and mTPE is less common. Due to the service limitations of our ICU, in the first 3 years, patients requiring TPE had to be transferred to another hospital with the inherent risks of interhospital transportation for critically ill patients. Subsequently, TPE service in our ICU was introduced in May 2018. mTPE was selected as the modality of choice in our ICU in view of the nursing and medical teams’ familiarity and experience with the CRRT technique (our unit conducts 120–180 CRRT sessions per year). This was particularly useful during the subsequent coronavirus disease 2019 (COVID-19) pandemic, where interhospital transportation was limited.
We conducted this retrospective study to investigate the feasibility and safety of mTPE as a new service in a low-volume center that was familiar and experienced with the CRRT technique. In addition, we conducted a survey among the specialists and nurses to collect their subjective views of the feasibility of the new service.
MATERIALS AND METHODS
The study was conducted at our ICU. Nurses with >5 years of ICU experience and competent with CRRT were enrolled for mTPE training supported by a vendor (Baxter, United States of America), using an mTPE training kit and on-job-training competency checklist. In May 2018, before the first mTPE case, 15 ICU nurses were competent with mTPE, and a further 20 more nurses were trained in the following 3 years.
We retrospectively reviewed all mTPE sessions performed in our unit from 1st May 2018 to 31st July 2021. The diagnosis of the primary disease and indication for PE was recommended by the relevant specialists and intensive care specialists. Patients undergoing mTPE sessions included critically ill patients requiring hemodynamic or/and ventilatory support, as well as noncritically ill patients who were admitted to ICU only for the duration of the TPE session. mTPE sessions were carried out only by ICU nurses trained in CRRT and mTPE, as stated earlier, under the supervision of intensivists. The Machine and the filter used were Prismaflex and TPE 2000 (Baxter, United States of America), respectively. Heparin was used for anticoagulation if there was no contraindication. Heparin was given as an intravenous bolus dose of 10–20 units/kg body weight, followed by an infusion of 5–10 units/kg body weight/hour.
All eligible patient’s electronic medical records were reviewed. The following data was collected—age (years), sex, weight (kg), height (cm), body mass index (kg/m2), diagnosis, laboratory markers such as hematocrit (%), Sequential Organ Failure Assessment (SOFA) score at ICU admission, mTPE indication, and mTPE prescription-related data—duration of therapy (hours), number of filters used, type and volume of replacement fluid (L), treatment time (minutes), and the exchanged plasma volume (mL), anticoagulation usage (yes or no), technical issues, adverse events, and mortality at hospital discharge.
Surveys of 12 ICU nurses and five specialists involved in all mTPE sessions were conducted with an online survey via an institution-approved platform, form.gov.sg, in August 2021.
Statistical analysis was performed using the Statistical Package for the Social Sciences version 26 (International Business Machines Corporation, New York, United States of America). Categorical variables were expressed as actual numbers and percentages (%). Continuous variables that were normally distributed were expressed as mean ± standard deviation, and those not normally distributed were expressed as median with 25th and 75th interquartile range (IQR). A p-value of <0.05 was considered statistically significant.
The study was approved by the National Healthcare Group Domain Specific Review Board (DSRB) with reference number 2022/00209. Informed consent was waived as it was a retrospective collection of existing data. Data analysis was done after de-identifying patients.
RESULTS
Over the 3-year period, 55 sessions of membranous PE were performed for 10 patients. The mean age was 57.4 ± 14.3 years; eight (80%) were female patients, the mean SOFA score at ICU admission was 5 ± 2.1, and four (40%) patients were on concurrent renal replacement therapy due to acute kidney injury.
Details of the clinical diagnosis and subspecialty involvement distribution are shown in Figure 2. Antineutrophil cytoplasmic antibodies (ANCA) associated vasculitis (n = 3, 30%) was the most common diagnosis. There was one patient with severe COVID-19 pneumonia, cytokine release syndrome (CRS), and hemophagocytic lymphohistiocytosis (HLH) treated with PE.
Figs 2A and B: Distribution of (A) Clinical diagnosis; and (B) Subspecialty involvement
The mean number of mTPE sessions per patient was 5 ± 2.4, and the mean duration per session was 4 ± 0.82 hours. A total of 36 (68%) sessions were done with heparin as an anticoagulant. Around 37 (70%) sessions used a combination of 5% albumin with fresh frozen plasma (FFP) as replacement fluid. Crystalloid fluid (Plasma-Lyte) was used in five sessions. A summary of mTPE treatment for each case is shown in Table 1. A breakdown detail of individual mTPE sessions is available in Table 2.
| Case no. | Diagnosis | Gender | Age | Number of sessions | Hours per session* | No. of filters | 5% Alb (L) | FFP (L) | Plasma-Lyte (L) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Anti-GBM | F | 58 | 7 | 4.5 (4–4.5) | 8 | 22.5 | 8 | / |
| 2 | Anti-GBM | M | 59 | 10 | 6 (6–6) | 10 | 49 | 1 | 9.5 |
| 3 | ANCA vasculitis | F | 64 | 5 | 4.5 (4.5–4.5) | 5 | 22.5 | 0.25 | / |
| 4 | SLE flare | F | 25 | 5 | 5 (5–5) | 5 | 12 | 8.5 | / |
| 5 | SLE flare | F | 60 | 1 | 4 (4–4) | 1 | 2 | 1 | / |
| 6 | COVID-19, CRS, HLH | M | 51 | 3 | 6 (3–6) | 4 | 6 | 7 | / |
| 7 | ANCA vasculitis | F | 75 | 5 | 4 (4–4) | 5 | 10 | 10 | / |
| 8 | ANCA vasculitis | F | 70 | 7 | 3 (3–3) | 7 | 13.5 | 6 | / |
| 9 | CAPS | F | 45 | 5 | 4 (4–4) | 5 | 13 | 4 | 3 |
| 10 | Anti-GBM | F | 71 | 5 | 4 (3–4) | 5 | 11 | 8 | / |
*Median (IQR: 25–75); Alb, albumin; ANCA, antineutrophil cytoplasmic antibodies; CAPS, catastrophic antiphospholipid syndrome; COVID-19, coronavirus disease 2019; CRS, cytokine release syndrome; F, female; FFP, fresh frozen plasma; GBM, glomerular basement membrane; HLH, hemophagocytic lymphohistiocytosis; L, liter; M, male; SLE, systemic lupus erythematosus
| Case | Episode | Duration of therapy (hours) | 5% albumin (mL) | FFP (mL) | Plasma-Lyte | Anticoagulation, 0 = no, 1 = heparin | No. of filters used |
|---|---|---|---|---|---|---|---|
| 1 | 1 | 4.5 | 4500 | 0 | 0 | 1 | 1 |
| 2 | 4.5 | 3000 | 1500 | 0 | 1 | 1 | |
| 3 | 4 | 3000 | 1060 | 0 | 1 | 1 | |
| 4 | 4.5 | 3000 | 1500 | 0 | 1 | 1 | |
| 5 | 4.5 | 3000 | 1500 | 0 | 1 | 2 | |
| 6 | 4 | 3000 | 880 | 0 | 1 | 1 | |
| 7 | 4.5 | 3000 | 1500 | 0 | 1 | 1 | |
| 2 | 1 | 6 | 4500 | 0 | 4000 | 1 | 1 |
| 2 | 6 | 2500 | 500 | 3000 | 1 | 1 | |
| 3 | 6 | 2500 | 0 | 2500 | 1 | 1 | |
| 4 | 6 | 5000 | 0 | 0 | 1 | 1 | |
| 5 | 6 | 5000 | 500 | 0 | 1 | 1 | |
| 6 | 6 | 5500 | 0 | 0 | 1 | 1 | |
| 7 | 6 | 6000 | 0 | 0 | 1 | 1 | |
| 8 | 6 | 6000 | 0 | 0 | 1 | 1 | |
| 9 | 6 | 6000 | 0 | 0 | 1 | 1 | |
| 10 | 6 | 6000 | 0 | 0 | 1 | 1 | |
| 3 | 1 | 4.5 | 4500 | 250 | 0 | 1 | 1 |
| 2 | 4.5 | 4500 | 0 | 0 | 1 | 1 | |
| 3 | 4.5 | 4500 | 0 | 0 | 1 | 1 | |
| 4 | 4.5 | 4500 | 0 | 0 | 1 | 1 | |
| 5 | 4.5 | 4500 | 0 | 0 | 1 | 1 | |
| 4 | 1 | 5 | 3000 | 1500 | 0 | 1 | 1 |
| 2 | 5 | 2000 | 2000 | 0 | 1 | 1 | |
| 3 | 5 | 2000 | 2000 | 0 | 1 | 1 | |
| 4 | 5 | 2500 | 1500 | 0 | 1 | 1 | |
| 5 | 5 | 2500 | 1500 | 0 | 1 | 1 | |
| 5 | 1 | 4 | 2000 | 1000 | 0 | 0 | 1 |
| 6 | 1 | 6 | 2000 | 3000 | 0 | 1 | 2 |
| 2 | 3 | 2000 | 1000 | 0 | 1 | 1 | |
| 3 | 6 | 2000 | 3000 | 0 | 1 | 1 | |
| 7 | 1 | 4 | 2000 | 2000 | 0 | 0 | 1 |
| 2 | 4 | 2000 | 2000 | 0 | 0 | 1 | |
| 3 | 4 | 2000 | 2000 | 0 | 0 | 1 | |
| 4 | 4 | 2000 | 2000 | 0 | 0 | 1 | |
| 5 | 4 | 2000 | 2000 | 0 | 0 | 1 | |
| 8 | 1 | 3 | 2000 | 500 | 0 | 1 | 1 |
| 2 | 3 | 1500 | 500 | 0 | 1 | 1 | |
| 3 | 3 | 2000 | 1000 | 0 | 0 | 1 | |
| 4 | 3 | 2000 | 1000 | 0 | 0 | 1 | |
| 5 | 3 | 2000 | 1000 | 0 | 0 | 1 | |
| 6 | 3 | 2000 | 1000 | 0 | 0 | 1 | |
| 7 | 3 | 2000 | 1000 | 0 | 0 | 1 | |
| 9 | 1 | 4 | 4000 | 0 | 0 | 1 | 1 |
| 2 | 4 | 2000 | 2000 | 0 | 0 | 1 | |
| 3 | 4 | 2000 | 2000 | 0 | 0 | 1 | |
| 4 | 4 | 2500 | 0 | 1500 | 0 | 1 | |
| 5 | 4 | 2500 | 0 | 1500 | 0 | 1 | |
| 10 | 1 | 4 | 2000 | 2000 | 0 | 1 | 1 |
| 2 | 4 | 2000 | 2000 | 0 | 1 | 1 | |
| 3 | 4 | 3000 | 1000 | 0 | 0 | 1 | |
| 4 | 4 | 2000 | 2000 | 0 | 0 | 1 | |
| 5 | 3 | 2000 | 1000 | 0 | 1 | 1 |
Out of a total of 53 mTPE sessions, six adverse events (11.3%) were recorded during or in-between therapy sessions—one (1.9%) fluid-responsive hypotension, one (1.9%) transient sinus bradycardia without blood pressure compromise, and one (1.9%) transfusion reaction to FFP (rash) require antihistamine treatment; two (3.8%) events of fluid overload occurred post-TPE in two patients with concurrent renal failure (cases 2 and 10), case 2 received noninvasive ventilation and case 10 received extra session of hemodialysis for fluid removal; one (1.9%) per rectal bleeding with no hemodynamic compromise occurred in one case after the fifth mTPE, whose post therapy international normalized ratio raised to 2.34 from 1.22 necessitating extra-FFP transfusion and colonoscopy. Diagnosis of cytomegalovirus colitis was made subsequently based on positive tissue polymerase chain reaction via endoscopic biopsy.
Filter clotting on anticoagulation occurred in seven (13%) sessions; five were at the end of the session, and two were in the middle of therapy where repriming of the circuit was required. Hence, a total of 55 filters were used for the 53 sessions. A blood leaking alarm occurred in one session, which was deemed a false alarm subsequently by the clinician as there was no blood seen in tubing or in fluid bags.
Among 10 patients, seven (70%) had a favorable response to mTPE, with an improvement of primary organ dysfunction such as diffuse alveolar hemorrhage (DAH) and renal failure. Six patients (60%) were discharged home stable from the hospital. Four (40%) patients died, of which two deaths were related to unresolved primary pathology (cases 5 and 6), and the remaining two were due to illness not directly related to primary diseases (case 2: nosocomial pneumonia; case 7: lower gastrointestinal tract bleeding occurred many weeks post-mTPE). Details of progress and outcomes are shown in Table 3.
| No. | Diagnosis | Organ dysfunction | SOFA score | RRT | Progress | Outcome at hospital discharge |
|---|---|---|---|---|---|---|
| 1 | Anti-GBM | DAH | 3 | N | DAH resolved | Discharged home |
| 2 | Anti-GBM | DAH, renal failure | 5 | Y | DAH resolved Anti-GBM titer turned negative | Death |
| 3 | ANCA vasculitis | Renal failure | 4 | N | Renal recovery | Discharged home |
| 4 | SLE flare | DAH | 2 | N | DAH resolved | Discharged Home |
| 5 | SLE flare | Renal failure, cardiomyopathy | 9 | N | STEMI in ICU | Death |
| 6 | COVID, HLH | Renal failure, myelodepression | 7 | Y | Later diagnosed with NK cell lymphoma | Death |
| 7 | ANCA vasculitis | DAH, renal failure | 5 | N | DAH resolved Renal Recovery | Death |
| 8 | ANCA vasculitis | DAH, renal failure | 5 | N | DAH resolved Renal recovery | Discharged home |
| 9 | CAPS | Renal failure, encephalopathy | 8 | Y | Improving mental status Renal recovery: off dialysis | Discharged home |
| 10 | Anti-GBM | Renal failure | 6 | Y | Reduction in antibody titer Dialysis dependent | Discharged home |
ANCA, antineutrophil cytoplasmic antibodies; CAPS, catastrophic antiphospholipid syndrome; COVID-19, coronavirus disease 2019; CRS, cytokine release syndrome; DAH, diffuse alveolar hemorrhage; HLH, hemophagocytic lymphohistiocytosis; GBM, glomerular basement membrane; N, No; NK cell, naturalkiller cell; SLE, systemic lupus erythematosus; STEMI, ST elevation myocardial infarction; Y, yes
Five specialists (two from renal medicine, one from respiratory medicine, one from rheumatology, and one from intensive medicine) and 12 senior ICU nurses responded to the survey. Three (60%) specialists rated it as “very easy,” and two (40%) rated it as “easy” in terms of referring their patients to the ICU for PE. Among 12 ICU nurses, five (42%) estimated that 45–60 minutes was required to set up the mTPE machine and circuit, four (33%) estimated it as 30–45 minutes, and three (25%) estimated it as 20–30 minutes. Six (50%) nurses thought setting up mTPE machines was “neither easy nor difficult.” Seven (58%) nurses thought conducting the mTPE procedure was easier when compared to CRRT. Details of the survey are shown in Figure 3.
Figs 3A and B: Specialist and nursing survey
DISCUSSION
We present results from retrospective data analysis of a 3-year experience of mTPE from a low-volume single center. Our results show the feasibility and safety of introducing mTPE as a new service in ICU settings in a low-volume center, with the specific logistical advantage of short training time and the ability to provide uninterrupted service during the pandemic.
Our study of mTPE showed good feasibility in the ICU setting. Almost 90% of our patients had autoimmune diseases, and DAH was the most common indication to initiate TPE in our study. These indications were mostly category 1 indications, in adherence with the American Society for Apheresis 2019 guideline.9 There has been a study showing the mortality benefit of TPE in severe COVID-19 pneumonia-related CRS.10 In our study, mTPE was used in one case of severe COVID-19 pneumonia with CRS and HLH. Around 70% of patients achieved an improvement in primary organ dysfunction, and one patient (10%) had a reduction in antibody titer but remained in dialysis-dependent renal failure after completing therapy. The cause hospital mortality rate was 40%. This is similar to a large 10-year ICU cohort from Turkey, where 46% of the patients were with sepsis and multiorgan failure (category III indication); the mortality was 61.6% in the septic group and 47.5% in the nonseptic group.11
Our study showed an adverse event rate of 11.3% from 55 sessions; most events were minor. Our incidence of adverse events is similar to previous studies: 5–36%, depending on the disease severity, year of report, and definition of adverse events.12 Hypotension has previously been reported with an incidence of 1–6.9%, followed by electrolytes disturbance (2.9–7.8%).13,16 Interestingly, a previous large registry data showed a higher rate of adverse events in mTPE than in cTPE.17 However, among the ICU population, the adverse event rate has been observed to be similar between mTPE and cTPE (31.7 vs 23.7%, p = 0.19).18 There were severe adverse events reported specifically related to filters used in mTPE, such as hemolysis, filter rupture, and complement activation.12 Randomized controlled trials are needed to compare further the clinical safety of mTPE and cTPE.
Filter clotting occurred in 13% of our sessions despite heparin anticoagulation, but most of them happened near the end of therapy; hence, only two extra filters were required. One previous study had shown that lower blood flow rates and higher patient weight were associated with increased filter clotting, and prefilter heparin administration did not reduce the incidence of filter clotting.19 Higher blood flow could be considered, especially in obese patients. Our study did not specifically look at factors predisposing to filter clotting.
The mean treatment time in our study was 4 ± 0.82 hours/session. Around 50% of nurses estimated the preparation time was 45–60 minutes for one mTPE session, and seven out of 12 of them believed that mTPE was easier when compared to CRRT.
The introduction of mTPE rather than cTPE as a new service to a new ICU may have many advantages. Firstly, the utilization of existing CRRT machines was estimated to have cost savings of around 700 USD per session in a previous study.20 Secondly, it shortened the time needed for nursing training. Nurses from our unit with >5 years of ICU experience and competence in CRRT were enrolled in mTPE training. Due to staff familiarity with the CRRT machine, an average of 2–3 hours of training time were required for one nurse to be competent. It enabled us to be ready for the very first mTPE session in May 2018, when 15 nurses were already trained and competent in mTPE. These resource-saving advantages showed much more value in the subsequent pandemic time; they helped our ICU to expand our capacity and service in a timely manner as cross-hospital transfer was limited.
Our study shows good feasibility and safety to implement mTPE as a new service in an ICU in a low-volume center, with the specific logistical advantage of short training time and the ability to provide uninterrupted service during the pandemic. Our study has certain limitations, too. Firstly, ours was a single-center retrospective study including 10 patients; however, we do report data from a total of 55 sessions. Similarly, our study size is too small to comment on the efficacy of mTPE treatments. Secondly, patients were only followed up until hospital discharge hence, data on long-term mortality was not available. Thirdly, though the SOFA score was included at admission, other severity parameters, such as vasopressor usage and ventilator days, were not collected.
CONCLUSION
Our results show the feasibility and safety of introducing mTPE as a new service in ICU settings in a low-volume TPE center, with the specific logistical advantage of short training time in view of familiarity and experience with the CRRT technique. mTPE can be safely performed in an ICU with a low incidence of complications. This also provided the ability to continue uninterrupted service during the pandemic and maybe a future direction for similar ICUs.
DATA AVAILABILITY STATEMENT
The study data are available on request from the corresponding author. The data are not publicly available due to patient confidentiality.
ETHICS STATEMENT
The study was approved by the National Healthcare Group DSRB with reference number 2022/00209 and conducted in accordance with the Declaration of Helsinki. Data analysis was done after de-identifying patients. Informed consent was waived as it was a retrospective collection of existing data.
ORCID
Xiao Jiang https://orcid.org/0000-0002-5684-7505
ACKNOWLEDGMENT
The authors would like to acknowledge the hard work and contribution of all colleagues from the Departments of Medicine, Intensive Care, and Nursing for implementing and continuing mTPE service in the unit.
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