Seraph® 100 Microbind® Affinity Blood Filter and Use in Group A Streptococcus Sepsis: A Case Report
Abstract:
The Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single-use extracorporeal broad-spectrum sorbent hemoperfusion device authorized by FDA under Emergency Use Authorization (EUA) for multi-organ failure in COVID-19. According to recent studies, the filter has been shown to decrease morbidity, mortality, and intensive care unit (ICU) length of stay (LOS) in both adult and pediatric populations and has mainly been assessed for its efficacy in the management of COVID-19. Use of the Seraph 100 Microbind Affinity Blood Filter is only available under EUA. Here, we present a case of a 26-year-old female who developed septic shock and disseminated intravascular coagulation (DIC) secondary to Group A Streptococcus infection. The Seraph 100 Filter was utilized on the 3rd day of her ICU admission. Her shock state resolved in less than 24 hours after utilizing the Seraph 100 filter. Although her length of stay was prolonged due to complications secondary to DIC, use of the Seraph 100 filter was instrumental in helping her survive her critical illness. This case provides an example of how the Seraph 100 filter can be a useful tool for critically ill patients with multi-organ failure secondary to infectious causes other than COVID-19.
Introduction:
The Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single-use extracorporeal broad-spectrum sorbent hemoperfusion device authorized by FDA under EUA. Indications for use include laboratory-confirmed and symptomatic COVID-19 and life-threatening diseases defined as respiratory failure, septic shock, and/or multiple-organ dysfunction or failure. According to recent studies, the filter has been shown to decrease morbidity, mortality, and ICU length of stay (LOS) in both adult and pediatric populations with COVID-19 [1] [2]. To our knowledge the Seraph 100 filter has not been used as an adjunct therapy in managing septic shock due to Group A Streptococcus.
Case Report:
A 26-year-old (G1P0) female presented to the Emergency Department (ED) in active labor. She was 39 weeks and 3 days pregnant. She had an uncomplicated vaginal delivery other than a grade 2 tear which was repaired. She returned to the same ED three days after discharge with fever, tachycardia, respiratory distress, abdominal pain, diarrhea, and purpuric skin lesions. She was immediately admitted to MICU for impending septic shock and concerns for DIC. Initial labs at the outside hospital were notable for platelet count of 10,000, lactate of 9mmol/L, serum creatinine of 2.0mg/dL (baseline creatinine 0.5mg/dL). She began receiving treatment for HELLP syndrome and was started on IVIG in addition to broad-spectrum antibiotics and IV fluid resuscitation. She was intubated for increased work of breathing and worsening metabolic acidosis. Initial blood cultures done at the outside hospital were positive for Group A Streptococcus (GAS).
She was transferred the next day to our quaternary care center for further treatment of DIC, septic shock, renal failure and concerns for toxic shock syndrome. She was promptly initiated on continuous renal replacement therapy (CRRT) upon arrival due to high doses of norepinephrine and vasopressin and worsening anuric renal failure. She was taken emergently to the OR for a total abdominal hysterectomy with bilateral salpingectomy for source control and then transferred to the Surgical ICU. No retained products of conception were found. On POD#1, ICU Day 2, her vasopressor requirements continued to increase, and intravenous epinephrine was added. She also received methylene blue and hydroxocobalamin as salvage therapy. Veno-arterial extracorporeal membrane oxygenation (ECMO) evaluation was requested due to concerns for possible cardiogenic shock, however, her shock state was determined to be purely septic and V-A ECMO was not initiated.
Currently, FDA Emergency Use Authorization (EUA) for the Seraph Filter is only applicable to patients with COVID-19. However, on ICU Day 3, emergent use for the Seraph Filter was granted for our patient and was added to her CRRT circuit. No anticoagulation was used during CRRT due to ongoing DIC, and 8 filters had to be exchanged due to clotting within the CRRT circuit. By ICU day 4, she was able to be weaned off all vasopressors. Her blood counts continued to improve, and she was extubated on ICU day 7. She was eventually transitioned off CRRT to intermittent hemodialysis (IHD). Her total ICU length of stay was 29 days, but this was due to various other complications unrelated to her initial shock state which rapidly resolved after Seraph Filter was initiated.
Discussion:
Our patient is the first case of septic shock from GAS that was successfully treated with the Seraph Filter. She required a total of 8 Seraph Filters during her CRRT run. This was due to circuit clotting, which was due in part to avoidance of heparin due to ongoing pancytopenia from DIC and slow flow rates due to her poor hemodynamics. The filter clotting issues were resolved after adjusting her vasopressor dosages and increasing the CRRT flow rates. Our patient had no allergies to any component of the Seraph Filter and did not face any adverse events after the filter was implemented.
The Seraph Filter does not affect the plasma concentration of certain antibiotics, which is crucial in a critical care setting as doses need to be closely monitored and reviewed frequently [3], [4]. Early intervention with the Seraph Filter in patients with bacteremia may result in clearing bloodstream infections [4]. A four-hour dialysis session with a 40% reduction in pathogen removal can result in a > 99% pathogen elimination [5]. One case report about an adolescent who was a deceased donor kidney transplant recipient suffering from disseminated adenoviral disease was able to show that the Seraph Filter was able to expedite the recovery process [7]. Pathogens and pro-inflammatory molecules play a significant role in sepsis-induced immune dysregulation, mitochondrial damage, and coagulation disorders leading to organ failure. The mechanism by which the Seraph Filter works is using heparin to bind these pathogens and inflammatory molecules through a process called hemadsorption. This allows for the safe and effective removal of pathogens, whether used alone or attached to a circuit (hemodialysis). Clinical outcomes can be improved by decreasing the concentration of these pathogens and pro-inflammatory molecules [6].
To our knowledge, no current studies or case reports discuss the use of the Seraph Filter specifically with GAS bacteremia in humans. Further studies with larger sample sizes would be able to properly quantify the true benefit of the Seraph Filter in ICU patients across different demographics.
Conclusion:
This patient recovered from GAS septic shock using the Seraph 100 filter. There were no adverse reactions when using the filter. This case provides an example of how the Seraph 100 filter can be used in the future to improve patient outcomes in an ICU setting in clinical conditions other than COVID-19.
References:
Chitty SA, Mobbs S, Rifkin BS, Stogner SW, Lewis MS, Betancourt J, DellaVolpe J, Abouzahr F, Wilhelm AM, Szerlip HM, Parikh A, Gaeta RM, Rivera I, Park C, Levi B, Anesi GL, Alcover KC, Arnold TB, Howard JT, Sharma K, Pratt KP, Stewart IJ, Chung KK. A Multicenter Evaluation of the Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19. Crit Care Explor. 2022 Mar 25;4(4):e0662.
Merrill KA, Krallman KA, Loeb D, Standage SW, Mattoon D, Shan D, Goldstein SL, Schuh MP. First-Time Use of the Seraph® 100 Microbind® Affinity Blood Filter in an Adolescent Patient with Severe COVID-19 Disease: A Case Report. Case Rep Nephrol Dial. 2023 Jan 27;13(1):1-6.
https://www.fda.gov/media/137105/download
de Geus HRH, Smeets T, Hoek RAS, Endeman H, Hunfeld N. The Seraph®-100 Microbind Affinity Blood Filter Does Not Affect Vancomycin, Tacrolimus, and Mycophenolic Acid Plasma Concentrations. Blood Purif. 2021;50(6):971-975.
Eden G, Schmidt JJ, Büttner S, Kümpers P, Hafer C, Rovas A, Koch BF, Schmidt BMW, Kielstein JT. Safety and efficacy of the Seraph® 100 Microbind® Affinity Blood Filter to remove bacteria from the blood stream: results of the first in human study. Crit Care. 2022 Jun 17;26(1):181.
Ronco, C., Chawla, L., Husain-Syed, F. et al. Rationale for sequential extracorporeal therapy (SET) in sepsis. Crit Care 27, 50 (2023). https://doi.org/10.1186/s13054-023-04310-2
Li, D.S., Burke, T.M., Smith, J.M. et al. Use of the Seraph® 100 Microbind® Affinity Blood Filter in an adolescent patient with disseminated adenoviral disease. Pediatr Nephrol 39, 331–335 (2024).
https://www.fda.gov/media/137102/download
https://extheramedical.com/seraph-100-microbind-affinity-blood-filter/