SPECTRA OPTIA
Report
- Report Number
- 1722028-2025-00195
- Event Type
- Death
- Date Received
- August 25, 2025
- Date of Event
- September 9, 2017
- Report Date
- August 25, 2025
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583123205
- PMA / PMN Number
- K183081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONTINUED FROM B.5: SOME ADVERSE EVENTS ARE REPORTED DURING LEUKAPHERESIS. AML PATIENTS CAN EXPERIENCE THROMBOCYTOPENIA AND BLEEDING, AS A SIGNIFICANT NUMBER OF PLATELETS ARE OFTEN REMOVED.11 A RECENT STUDY SUGGESTED THAT CLOSE MONITORING OF PLATELETS IS NEEDED TO AVOID BLEEDING COMPLICATIONS IN PATIENTS WHO ARE ALREADY THROMBOCYTOPENIC.8 SPECIFICALLY, THE SPECTRA OPTIA IS KNOWN FOR PLATELET LOSS, THUS EXPLAINING THE NEED FOR PLATELET TRANSFUSIONS IN THE PATIENT DETAILED IN THIS REPORT. ADDITIONALLY, VENOUS THROMBOSIS OR HEMORRHAGE MAY OCCUR AS A CONSEQUENCE OF THE LARGE BORE CATHETER INSERTION.12 NEVERTHELESS, THE PROCEDURE IS SAFELY PERFORMED IN THE MAJORITY OF CASES.13 THE PATIENT IN THIS REPORT INCREASINGLY RELIED ON TRANSFUSIONS AS THE HOSPITALIZATION PROGRESSED. HOWEVER, NO ADVERSE EFFECTS WERE DIRECTLY LINKED TO THE LEUKAPHERESIS PROCEDURES. THE SUBDURAL HEMATOMA WAS THOUGHT TO BE DUE TO AML AND HEPARIN ANTICOAGULATION. THERE WERE MULTIPLE PROCEDURES OVER MULTIPLE DAYS AND THE PATIENT OUTCOME WAS DEATH. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, ALTHOUGH PER CURRENT INFORMATION THERE IS NO DETECTABLE MALFUNCTION WITH THE TERUMO BCT DEVICE OR ALLEGATION OF A MALFUNCTION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. INVESTIGATION: SINCE THIS WAS A CASE STUDY PUBLISHED IN 2017; THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE THE PURPOSE OF THE JOURNAL ARTICLE STUDY IS NOTED IN THE ARTICLE ABSTRACT: ABSTRACT: BACKGROUND: ACUTE MYELOID LEUKEMIA (AML) IS A MALIGNANCY CHARACTERIZED BY RAPID CLONAL PROLIFERATION OF MYELOID PRECURSORS, WHICH CAN RESULT IN HYPERLEUKOCYTOSIS. LEUKAPHERESIS CAN BE USED TO RAPIDLY REDUCE THE WHITE BLOOD CELL COUNT (WBC). HOWEVER, THE ONLY FDA CLEARED DEVICE FOR WBC DEPLETION, THE COBE SPECTRA, WILL NO LONGER BE SUPPORTED BY THE MANUFACTURER IN 2017, AND THERE ARE FEW STUDIES COMPARING DIFFERENT METHODS OF LEUKAPHERESIS. CASE REPORT: A 68-YEAR-OLD AFRICAN AMERICAN FEMALE WAS ADMITTED TO THE HOSPITAL FOR RELAPSE OF HER AML. LABORATORY DATA DEMONSTRATED A WBC COUNT OF 291600/LL AND FLOW CYTOMETRY OF THE PERIPHERAL BLOOD DEMONSTRATED 85% MYELOID BLASTS. LEUKAPHERESIS WAS ORDERED TO HELP TREAT THE LEUKOSTASIS. METHODS: THREE DIFFERENT APHERESIS PROTOCOLS WERE USED TO ACHIEVE CYTOREDUCTION: SPECTRA OPTIA MONONUCLEAR COLLECTION (MNC) PROTOCOL, SPECTRA OPTIA GRANULOCYTE COLLECTION (PMN) PROTOCOL, AND THERAKOS CELLEX BUFFY COAT COLLECTION WITHOUT RETURN. DUE TO DIFFERENT INLET FLOWRATES, THE PROCEDURES WERE EVALUATED BASED ON THE NUMBER OF WBCS COLLECTED AND VOLUME OF BLOOD PROCESSED (VBP). RESULTS: THE SPECTRA OPTIA PMN COLLECTED THE MOST WBCS AND COLLECTED NEARLY AS MANY WBCS PER VBP AS THE THERAKOS CELLEX, WHICH HAD THE HIGHEST VALUE. CONCLUSION: TO OUR KNOWLEDGE, WE ARE REPORTING THE FIRST USE OF THERAKOS CELLEX AND SPECTRA OPTIA PMN PROTOCOL FOR WBC DEPLETION. WHILE THE SPECTRA OPTIA GRANULOCYTE PROTOCOL SHOWED THE BEST PERFORMANCE FOR THIS AML PATIENT, FURTHER STUDIES WILL BE NEEDED TO COMPARE THE SPECTRA OPTIA PMN PROTOCOL TO THE MNC PROTOCOL FOR AML PATIENTS. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: ACUTE MYELOID LEUKEMIA (AML) IS A MALIGNANCY CHARACTERIZED BY RAPID CLONAL PROLIFERATION OF MYELOID PRECURSORS (INCLUDING BLASTS) IN THE BONE MARROW, BLOOD, AND PERIPHERAL TISSUES. APPROXIMATELY 5¿20% OF AML PATIENTS HAVE HYPER LEUKOCYTOSIS OR EXTREME HYPERLEUKOCYTOSIS (DEFINED AS 50¿ 100 K OR >100 K WHITE BLOOD CELLS (WBCS)/ML, RESPECTIVELY), WHICH IS ASSOCIATED WITH INCREASED MORBIDITY AND MORTALITY. LARGE BLAST SIZE, RIGIDITY, AND AGGREGATION LEAD TO INCREASED BLOOD VISCOSITY (HYPERVISCOSITY), WHICH CAUSES STASIS IN SMALL BLOOD VESSELS. COMPARED TO LYMPHOID BLASTS, MYELOID BLASTS ARE LARGER, LESS DEFORMABLE, AND ARE MORE LIKELY TO INDUCE ENDOTHELIAL CELL ADHESION MOLECULE EXPRESSION. THUS, THEY ARE MORE LIKELY TO CAUSE HYPERVISCOSITY. LEUKOSTASIS, ALSO CALLED SYMPTOMATIC HYPERLEUKOCYTOSIS, IS A MEDICAL EMERGENCY WITH SIGNS/SYMPTOMS OF DECREASED TISSUE PERFUSION, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), INTRACRANIAL HEMORRHAGE, RESPIRATORY, OR NEUROLOGICAL DISTRESS. INTRACRANIAL HEMORRHAGE AND RESPIRATORY FAILURE ARE THE MOST COMMON CAUSES OF MORTALITY. THE PROBABILITY OF LEUKOSTASIS CAN BE DETERMINED USING A CLINICAL GRADING SCALE. THE MANAGEMENT OF HYPERLEUKOCYTOSIS INCLUDES CHEMOTHERAPY/CYTOREDUCTION WITH SUPPORTIVE CARE. REGARDING AML PATIENTS, CYTOREDUCTIVE AGENTS SUCH AS HYDROXYUREA AND/OR CYTARABINE CAN ALSO BE USED. TO PREVENT TUMOR LYSIS SYNDROME, ALLOPURINOL, HYDRATION, AND RESPIRATORY SUPPORT CAN BE PROVIDED. ALTERNATIVELY, LEUKAPHERESIS CAN BE USED TO RAPIDLY REMOVE WBCS IN PREPARATION FOR CHEMOTHERAPY TO REDUCE THE RISK OF TUMOR LYSIS SYNDROME. IF LEUKAPHERESIS IS USED, CHEMOTHERAPY SHOULD NOT BE DELAYED, OR THERE CAN BE RAPID REACCUMULATION OF BLASTS. ACCORDING TO THE 2016 AMERICAN SOCIETY FOR APHERESIS (ASFA) GUIDELINES, LEUKAPHERESIS CAN BE PERFORMED FOR PROPHYLACTIC OR SYMPTOMATIC HYPERLEUKOCYTOSIS IF WBC COUNT >100 000/LL. A SINGLE 1.5-2.0 TOTAL BLOOD VOLUME (TBV) LEUKAPHERESIS CAN REDUCE THE LEUKOCYTE COUNT BY 30%-60%. FOR SYMPTOMATIC HYPERLEUKOCYTOSIS, LEUKAPHERESIS IS AN AFSA CATEGORY II INDICATION AND SHOULD BE CONTINUED DAILY, UNTIL THE BLAST COUNT IS <50¿ 100 K/ML AND CLINICAL MANIFESTATIONS RESOLVE. FOR PATIENTS REQUIRING PROPHYLAXIS, LEUKAPHERESIS IS AN AFSA CATEGORY III INDICATION AND SHOULD BE CONTINUED DAILY UNTIL THE BLAST COUNT IS <100 K/ML. MOST AML PATIENTS REQUIRE A MEDIAN OF 1¿2 LEUKAPHERESIS PROCEDURES TO ACHIEVE THE TARGET WBC COUNT. RETROSPECTIVE STUDIES HAVE SHOWN THAT LEUKAPHERESIS CAN REDUCE EARLY MORTALITY IN AML PATIENTS. WHILE THE COBE SPECTRA IS FOOD AND DRUG ADMINISTRATION (FDA) CLEARED FOR WBC DEPLETION, IT IS NO LONGER AVAILABLE AT MOST INSTITUTIONS BECAUSE THIS DEVICE HAS BEEN PHASED OUT AND WILL NO LONGER BE SUPPORTED BY THE MANUFACTURER AFTER DECEMBER 2017. AS OF APRIL 2017, THE NEWER SPECTRA OPTIA IS STILL PENDING FDA CLEARANCE FOR A WBC DEPLETION MODALITY. HOWEVER, THERE ARE FEW STUDIES COMPARING VARIOUS LEUKAPHERESIS PROTOCOLS. THEREFORE THE AIM OF THIS STUDY IS FOR THE AUTHORS TO REPORT THEIR EXPERIENCE TRYING TO OPTIMIZE CYTOREDUCTION IN AN AML PATIENT USING THREE DIFFERENT LEUKAPHERESIS PROTOCOLS: SPECTRA OPTIA MONONUCLEAR COLLECTION (MNC) PROTOCOL, SPECTRA OPTIA GRANULOCYTE COLLECTION (PMN) PROTOCOL, AND THERAKOS CELLEX BUFFY COAT COLLECTION WITHOUT RETURN AND WITHOUT METHOXSALEN/PHOTOACTIVATION. THIS ARTICLE IS A CASE STUDY OF A 68-YEAR-OLD AFRICAN AMERICAN FEMALE (HEIGHT: 163 CM, WEIGHT: 70.6 KG) WAS ADMITTED TO OUR HOSPITAL FOR RELAPSE OF AML, WHICH HAD ORIGINALLY TRANSFORMED FROM PRIMARY MYELOFIBROSIS (PMF). THE PATIENT HAD RECEIVED INDUCTION CHEMOTHERAPY (7 + 3 REGIMEN) AND WAS BEING CARED FOR IN A NURSING HOME. HOWEVER, THE PATIENT DEVELOPED ALTERED MENTAL STATUS (AMS), WEAKNESS, AND FATIGUE, AND WAS TRANSPORTED TO A COMMUNITY HOSPITAL WHERE SHE WAS DIAGNOSED WITH RELAPSED AML, TUMOR LYSIS SYNDROME, AND SEPSIS DUE TO PNEUMONIA AND A URINARY TRACT INFECTION. THE PATIENT WAS TRANSFERRED TO THE AUTHOR¿S HOSPITAL FOR TREATMENT BY THE ONCOLOGY SERVICE. LABORATORY DATA WERE AS FOLLOWS: WBC COUNT 252 K/LL, BLAST CELL COUNT 217 K/LL, HEMOGLOBIN (HGB) 8.5 G/DL, PLATELET (PLT) COUNT OF 45 K/LL, CREATININE (CR) OF 3.63 MG/DL, AND URIC ACID OF 29.6 MG/DL (REFERENCE RANGE, 2.6-6.0). THE PATIENT WAS TREATED WITH HYDROXYUREA, RASBURICASE, ALLOPURINOL, IV HYDRATION, VANCOMYCIN/PIPERACILLIN-TAZOBACTAM, AND A BONE MARROW BIOPSY WAS SCHEDULED. OVERNIGHT, THE PATIENT EXPERIENCED TACHYPNEA AND TACHYCARDIA AND THE RAPID RESPONSE TEAM WAS CALLED TO STABILIZE THE PATIENT. THE PATIENT WAS INTUBATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. REPEAT LABORATORY DATA WERE AS FOLLOWS: WBC COUNT 292 K/LL AND BLAST CELL COUNT OF 242 K/LL. FLOW CYTOMETRY OF THE PERIPHERAL BLOOD DEMONSTRATED AML WITH 85% MYELOBLASTS (NOT MONOBLASTS). AS THE PATIENT WAS SYMPTOMATIC, IT WAS DETERMINED THAT LEUKAPHERESIS SHOULD BE IMPLEMENTED TO MANAGE LEUKOSTASIS, AND THE BONE MARROW BIOPSY PROCEDURE WAS DELAYED. THE CLINICAL DECISION WAS TO DELAY CHEMOTHERAPY USING DECITABINE OR AZACYTIDINE UNTIL THE WBC COUNT WAS <50 K/LL. ADDITIONALLY, THE NEPHROLOGY SERVICE DIAGNOSED ACUTE ON CHRONIC KIDNEY INJURY DUE TO SUSPECTED ACUTE URIC ACID NEPHROPATHY AND ORDERED CONTINUOUS VENOVENOUS HEMOFILTRATION (CVVH). LEUKAPHERESIS PROCEDURES WERE PERFORMED AT BEDSIDE USING THE SPECTRA OPTIA (LAKEWOOD, CO) MNC SET, OR THE SPECTRA OPTIA GRANULOCYTE (PMN) IDL SET, OR THE THERAKOS CELLEX (EXTON, PA). HYDROXYETHYL STARCH (HES), METHOXSALEN, AND PHOTOACTIVATION WERE NOT USED. A FEMORAL DUAL-LUMEN HEMODIALYSIS CATHETER WAS CONNECTED TO THE APHERESIS MACHINE USING ASEPTIC TECHNIQUE FOR EACH PROTOCOL. ANTICOAGULANT CITRATE DEXTROSE SOLUTION A (ACD-A) WAS USED WITH THE SPECTRA OPTIA PROCEDURES. THE ENDPOINT OF EACH PROCEDURE DEPENDED ON THE APHERESIS WORKLOAD FOR THE GIVEN DAY, THE AVAILABILITY OF AN APHERESIS NURSE, AND THE PATIENT¿S SCHEDULE OF MEDICAL PROCEDURES. THE WBC COUNT OF THE COLLECTION BAGS WAS OBTAINED BY MIXING THE BAG CONTENTS AND THEN USING A NEEDLE AND SYRINGE TO TRANSFER SEVERAL MILLILITERS (ML) TO A LAVENDER TOP ETHYLENEDIAMINETETRAACETIC ACID (EDTA) TUBE FOR TESTING WITH A HEMATOLOGY ANALYZER. USING THE WBC CONCENTRATION AND THE BAG VOLUME, THE WBC COUNT PER THE BAG WAS CALCULATED. DUE TO DIFFERENT INLET FLOW RATES, THE PROCEDURES WERE EVALUATED BASED ON THE NUMBER OF WBCS COLLECTED AND VOLUME OF BLOOD PROCESSED (VBP). HEMATOLOGY VALUES OF THE PATIENT WERE COLLECTED AT LEAST 4 HOURS AFTER THE COMPLETION OF THE LEUKAPHERESIS PROCEDURE WERE RECORDED. REGARDING TERUMO BCT PRODUCT, SPECTRA OPTIA THE FIRST LEUKAPHERESIS WAS PERFORMED USING THE SPECTRA OPTIA MNC PROTOCOL. BECAUSE THE PATIENT WOULD REMAIN HYPOTENSIVE THROUGHOUT THE HOSPITALIZATION (BLOOD PRESSURE OF 80/40 SECONDS), THE INLET FLOW RATES WERE RELATIVELY SLOW (35¿45 ML/MIN), WHILE THE INLET TO ANTICOAGULANT RATIO (INLET/ AC) WAS 12.0. THE LEUKAPHERESIS WAS TERMINATED EARLY DUE TO A MIDPROCEDURE HGB OF 5.6 G/DL, DECREASE FROM 7.8 G/DL PRIOR TO THE PROCEDURE. THE HGB DECREASE WAS ATTRIBUTED TO HEMODILUTION DUE TO THE TRANSFUSION OF 5 UNITS OF FRESH FROZEN PLASMA (FFP) TO REVERSE WARFARIN ANTICOAGULATION (FOR A MECHANICAL HEART VALVE) IN ORDER TO PLACE THE FEMORAL LINE. THE VBP WAS 5.5 L (RUNTIME 145 MINUTES) AND 80 ML WERE COLLECTED. THE PATIENT¿S WBC COUNT DECREASED FROM 292 K/LL TO 203 K/LL, WHILE THE BLAST CELL COUNT DECREASED FROM 242 TO 183 K/LL. THE PLT COUNT DROPPED FROM 45 TO 24 K, SO ONE UNIT OF APHERESIS PLTS WAS TRANS- FUSED. BECAUSE THE PROCEDURE TERMINATED EARLY, THE NUMBER OF WBCS COLLECTED IN THE BAG WAS NOT DETERMINED. IN ADDITION, BECAUSE THE HEMATOCRIT VALUE INPUT INTO THE MACHINE WAS SUBSTANTIALLY DIFFERENT FROM THE ACTUAL HEMATOCRIT, THIS LEUKAPHERESIS PROCEDURE WAS NOT COMPARED TO THE OTHER PROCEDURES. ON THE FOLLOWING DAY BACTERIAL, FUNGAL, AND VIRAL CULTURES WERE PERFORMED; HOWEVER, NO ORGANISMS WOULD BE IDENTIFIED. LATER THAT DAY, LEUKAPHERESIS WAS PERFORMED USING THE SPECTRA OPTIA VIA THE MNC PROTOCOL. THE INLET FLOW RATE OF 12¿ 45 ML/MIN AND INLET/AC RATIO REMAINED AT 12. THE VBP WAS 8.7 L (RUNTIME 243 MINUTES) AND 380 ML WERE COLLECTED WITHOUT COMPLICATIONS. THE LEUKAPHERESIS BAG CONTAINED 1.65 X 1011 WBCS. HOWEVER, THE PATIENT¿S WBC COUNT INCREASED FROM 203 TO 251 K/LL (23% INCREASE), WHILE THE BLAST CELL COUNT INCREASED FROM 183 TO 195 K/LL (6% INCREASE). AFTER THE PROCEDURE, THE PLT COUNT WAS 32 K, SO A UNIT OF APHERESIS PLTS WAS TRANSFUSED. ON THE ENSUING DAY, ONE UNIT OF RBCS WAS TRANSFUSED TO ACHIEVE THE MINIMUM 27% HEMATOCRIT NEEDED TO PERFORM THE THERAKOS CELLEX BUFFY COAT EXTRACTION PROCEDURE. ON THE SUBSEQUENT DAY, THE FOURTH LEUKAPHERESIS WAS PERFORMED USING THE SPECTRA OPTIA PMN. THE PROCEDURE WAS PERFORMED WITH AN INLET FLOW RATE OF 47 ML/MINUTE AND INLET/ AC RATIO OF 13. THE VBP WAS 6.8 L (RUNTIME 147 MINUTES) AND 498 ML WERE COLLECTED WITHOUT COMPLICATIONS. THE LEUKAPHERESIS BAG CONTAINED 2.39 X 1011 WBCS. THE WBC COUNT DECREASED FROM 132 TO 102 K/LL (22% DECREASE), AND THE BLAST CELL COUNT DECREASED FROM 111 TO 71 K/LL (36% DECREASE). AFTER THE PROCEDURE, PLT COUNT WAS 23 K. A FIFTH LEUKAPHERESIS PROCEDURE WAS SCHEDULED FOR THE NEXT DAY. HOWEVER, THE PATIENT WAS NOTED TO HAVE UNEQUAL PUPILS WITH A LARGE, NON-REACTIVE PUPIL IN THE LEFT EYE AND LEFT SIDED PTOSIS. A CT SCAN OF THE HEAD SHOWED ACUTE ON CHRONIC SUBDURAL HEMATOMA WITH MILD LEFT DESCENDING TRANSTENTORIAL HERNIATION AND MIDLINE SHIFT, WHICH WOULD REQUIRE NEUROSURGERY. BECAUSE OF THE BLEEDING AND A PARTIAL THROMBOPLASTIN TIME (PTT) OF 81.9 SECONDS (REFERENCE RANGE, 28.0¿35.7) HEPARIN, WHICH WAS USED AS ANTICOAGULATION FOR THE MECHANICAL HEART VALVE, WAS DISCONTINUED. IN ADDITION, ONE UNIT OF RBCS AND TWO UNITS OF APHERESIS PLTS WERE TRANSFUSED. SOON AFTER, THE FAMILY REQUESTED WITHDRAWAL OF CARE. THE PATIENT WAS EXTUBATED AND SOON AFTER DIED. IN TOTAL, THE FOUR LEUKAPHERESIS PROCEDURES HELPED DECREASE THE WBC COUNT BY 65.1% AND THE BLAST COUNT BY 70.7%. HOWEVER, CHEMOTHERAPY WAS NEVER INITIATED BECAUSE THE WBC COUNT WAS NEVER <50 K/LL. THE COMPARISONS REVEALED SEVERAL INTERESTING PRELIMINARY FINDINGS. REGARDING THE SPECTRA OPTIA MNC, THIS PROCEDURE TOOK THE LONGEST (>4 HOURS), BUT RESULTED IN A SECOND HIGHEST NUMBER OF COLLECTED WBCS. THE RATIO OF COLLECTED WBCS TO VBP WAS THE LOWEST OF THE THREE PROCEDURES. MOST APHERESIS CENTERS EXPECT TO USE THE SPECTRA OPTIA MNC WHEN THE COBE SPECTRA IS NO LONGER SUPPORTED. HOWEVER, IT IS STILL NOT FDA CLEARED FOR WBC DEPLETION. SURPRISINGLY, THE SPECTRA OPTIA PMN HAD THE BEST OVERALL PERFORMANCE. IT COLLECTED MOST WBCS AND TOOK SLIGHTLY <2.5 HOURS. THE RATIO OF WBCS COLLECTED TO VBP WAS JUST SLIGHTLY LESS THAN THE THERAKOS CELLEX, WHICH HAD THE HIGHEST RATIO. AML PATIENTS CAN EXPERIENCE THROMBOCYTOPENIA AND BLEEDING, AS A SIGNIFICANT NUMBER OF PLATELETS ARE OFTEN REMOVED. A RECENT STUDY SUGGESTED THAT CLOSE MONITORING OF PLATELETS IS NEEDED TO AVOID BLEEDING COMPLICATIONS IN PATIENTS WHO ARE ALREADY THROMBOCYTOPENIC.8 SPECIFICALLY, THE SPECTRA OPTIA IS KNOWN FOR PLATELET LOSS, THUS EXPLAINING THE NEED FOR PLATELET TRANSFUSIONS IN THE PATIENT DETAILED IN THIS REPORT. ADDITIONALLY, VENOUS THROMBOSIS OR HEMORRHAGE MAY OCCUR AS A CON- SEQUENCE OF THE LARGE BORE CATHETER INSERTION. NEVERTHELESS, THE PROCEDURE IS SAFELY PERFORMED IN THE MAJORITY OF CASES. THE PATIENT IN THIS REPORT INCREASINGLY RELIED ON TRANSFUSIONS AS THE HOSPITALIZATION PROGRESSED. HOWEVER, NO ADVERSE EFFECTS WERE DIRECTLY LINKED TO THE LEUKAPHERESIS PROCEDURES. THE SUBDURAL HEMATOMA WAS THOUGHT TO BE DUE TO AML AND HEPARIN ANTICOAGULATION. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THESE COMPLAINTS. THE AUTHORS STATED THAT NO ADVERSE EFFECTS WERE DIRECTLY LINKED TO THE LEUKAPHERESIS PROCEDURES. THE SUBDURAL HEMATOMA WAS THOUGHT TO BE DUE TO AML AND HEPARIN ANTICOAGULATION. THE PATIENT WAS EXTUBATED AND SHORTLY AFTER, DIED. THERE WAS NO TIMELINE PROVIDED BETWEEN CESSATION OF THE PROCEDURE AND PATIENT EXPIRY. A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE THROMBOCYTOPENIA. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT IS LIKELY DUE TO ONE OR A COMBINATION OF THE POSSIBLE CAUSES LISTED BELOW:* PATIENT'S UNDERLYING DISEASE STATE* INLET FLOW RATE WAS SET TOO HIGH* CLUMPING IN THE EXTRACORPOREAL SYSTEM* RUNNING A LENGTHY PROCEDURE* COLLECT FLOW RATE WAS SET TOO HIGH* A DILUTIONAL EFFECT ON THE POST PROCEDURE SAMPLE DUE TO THE VOLUME OF INFUSED ACDA A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE ANEMIA/ BLEEDING. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT IS LIKELY DUE TO ONE OR A COMBINATION OF THE POSSIBLE CAUSES LISTED BELOW:* PATIENT'S UNDERLYING DISEASE STATE* PATIENT'S BLOOD PHYSIOLOGY INTERFERES WITH SEPARATION OF CELLULAR COMPONENTS (I.E. ABNORMAL RBCS, HYPERVISCOUS PLASMA)* INACCURATE ENTRY OF THE PATIENT'S HEMATOCRIT* INLET FLOW RATE WAS TOO HIGH TO ADEQUATELY SEPARATE RED CELLS FROM BUFFY COAT CITATION: CLINE, A., JAJOSKY, R., SHIKLE, J., & BOLLAG, R. (2017). COMPARING LEUKAPHERESIS PROTOCOLS FOR AN AML PATIENT WITH SYMPTOMATIC LEUKOSTASIS. JOURNAL OF CLINICAL APHERESIS, 33(3), 396¿400. HTTPS://DOI.ORG/10.1002/JCA.21588.
LOT NUMBER, MANUFACTURE DATE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: CLINE, A., JAJOSKY, R., SHIKLE, J., & BOLLAG, R. (2017). COMPARING LEUKAPHERESIS PROTOCOLS FOR AN AML PATIENT WITH SYMPTOMATIC LEUKOSTASIS. JOURNAL OF CLINICAL APHERESIS, 33(3), 396¿400. HTTPS://DOI.ORG/10.1002/JCA.21588.
PER JOURNAL ARTICLE "COMPARING LEUKAPHERESIS PROTOCOLS FOR AN AML PATIENT WITH SYMPTOMATIC LEUKOSTASIS. JOURNAL OF CLINICAL APHERESIS" BY CLINE, A., JAJOSKY, R., SHIKLE, J., & BOLLAG, R. BACKGROUND: ACUTE MYELOID LEUKEMIA (AML) IS A MALIGNANCY CHARACTERIZED BY RAPID CLONAL PROLIFERATION OF MYELOID PRECURSORS, WHICH CAN RESULT IN HYPERLEUKOCYTOSIS. LEUKAPHERESIS CAN BE USED TO RAPIDLY REDUCE THE WHITE BLOOD CELL COUNT (WBC). HOWEVER, THE ONLY FDA CLEARED DEVICE FOR WBC DEPLETION, THE COBE SPECTRA, WILL NO LONGER BE SUPPORTED BY THE MANUFACTURER IN 2017, AND THERE ARE FEW STUDIES COMPARING DIFFERENT METHODS OF LEUKAPHERESIS. CASE REPORT: A 68-YEAR-OLD AFRICAN AMERICAN FEMALE WAS ADMITTED TO THE HOSPITAL FOR RELAPSE OF HER AML. LABORATORY DATA DEMONSTRATED A WBC COUNT OF 291 600/LL AND FLOW CYTOMETRY OF THE PERIPHERAL BLOOD DEMONSTRATED 85% MYELOID BLASTS. LEUKAPHERESIS WAS ORDERED TO HELP TREAT THE LEUKOSTASIS. METHODS: THREE DIFFERENT APHERESIS PROTOCOLS WERE USED TO ACHIEVE CYTOREDUCTION: SPECTRA OPTIA MONONUCLEAR COLLECTION (MNC) PROTOCOL, SPECTRA OPTIA GRANULOCYTE COLLECTION (PMN) PROTOCOL, AND THERAKOS CELLEX BUFFY COAT COLLECTION WITHOUT RETURN. DUE TO DIFFERENT INLET FLOW RATES, THE PROCEDURES WERE EVALUATED BASED ON THE NUMBER OF WBCS COLLECTED AND VOLUME OF BLOOD PROCESSED (VBP). RESULTS: THE SPECTRA OPTIA PMN COLLECTED THE MOST WBCS AND COLLECTED NEARLY AS MANY WBCS PER VBP AS THE THERAKOS CELLEX, WHICH HAD THE HIGHEST VALUE. CONCLUSION: TO OUR KNOWLEDGE, WE ARE REPORTING THE FIRST USE OF THERAKOS CELLEX AND SPECTRA OPTIA PMN PROTOCOL FOR WBC DEPLETION. WHILE THE SPECTRA OPTIA GRANULOCYTE PROTOCOL SHOWED THE BEST PERFORMANCE FOR THIS AML PATIENT, FURTHER STUDIES WILL BE NEEDED TO COMPARE THE SPECTRA OPTIA PMN PROTOCOL TO THE MNC PROTOCOL FOR AML PATIENTS. THE LEUKAPHERESIS WAS TERMINATED EARLY DUE TO A MIDPROCEDURE HGB OF 5.6 G/DL, DECREASE FROM 7.8 G/DL PRIOR TO THE PROCEDURE. THE HGB DECREASE WAS ATTRIBUTED TO HEMODILUTION DUE TO THE TRANSFUSION OF 5 UNITS OF FRESH FROZEN PLASMA (FFP) TO REVERSE WARFARIN ANTICOAGULATION (FOR A MECHANICAL HEART VALVE) IN ORDER TO PLACE THE FEMORAL LINE. THE VBP WAS 5.5 L (RUNTIME 145 MINUTES) AND 80 ML WERE COLLECTED. THE PATIENT¿S WBC COUNT DECREASED FROM 292 K/LL TO 203 K/LL, WHILE THE BLAST CELL COUNT DECREASED FROM 242 TO 183 K/LL (FIGURE 1). THE PLT COUNT DROPPED FROM 45 TO 24 K, SO ONE UNIT OF APHERESIS PLTS WAS TRANSFUSED. BECAUSE THE PROCEDURE TERMINATED EARLY, THE NUMBER OF WBCS COLLECTED IN THE BAG WAS NOT DETERMINED. IN ADDITION, BECAUSE THE HEMATOCRIT VALUE INPUT INTO THE MACHINE WAS SUBSTANTIALLY DIFFERENT FROM THE ACTUAL HEMATOCRIT, THIS LEUKAPHERESIS PROCEDURE WAS NOT COMPARED TO THE OTHER PROCEDURES. ON THE SUBSEQUENT DAY, THE FOURTH LEUKAPHERESIS WAS PERFORMED USING THE SPECTRA OPTIA PMN. THE PROCEDURE WAS PERFORMED WITH AN INLET FLOW RATE OF 47 ML/MINUTE AND INLET/ AC RATIO OF 13. THE VBP WAS 6.8 L (RUNTIME 147 MINUTES) AND 498 ML WERE COLLECTED WITHOUT COMPLICATIONS. THE LEUKAPHERESIS BAG CONTAINED 2.39 3 1011 WBCS. THE WBC COUNT DECREASED FROM 132 TO 102 K/LL (22% DECREASE), AND THE BLAST CELL COUNT DECREASED FROM 111 TO 71 K/LL (36% DECREASE). AFTER THE PROCEDURE, PLT COUNT WAS 23 K. A FIFTH LEUKAPHERESIS PROCEDURE WAS SCHEDULED FOR THE NEXT DAY. HOWEVER, THE PATIENT WAS NOTED TO HAVE UNEQUAL PUPILS WITH A LARGE, NON-REACTIVE PUPIL IN THE LEFT EYE AND LEFT SIDED PTOSIS. A CT SCAN OF THE HEAD SHOWED ACUTE ON CHRONIC SUBDURAL HEMATOMA WITH MILD LEFT DESCENDING TRANSTENTORIAL HERNIATION AND MIDLINE SHIFT, WHICH WOULD REQUIRE NEUROSURGERY. BECAUSE OF THE BLEEDING AND A PARTIAL THROMBOPLASTIN TIME (PTT) OF 81.9 SECONDS (REFERENCE RANGE, 28.0¿35.7) HEPARIN, WHICH WAS USED AS ANTICOAGULATION FOR THE MECHANICAL HEART VALVE, WAS DISCONTINUED. IN ADDITION, ONE UNIT OF RBCS AND TWO UNITS OF APHERESIS PLTS WERE TRANSFUSED. SOON AFTER, THE FAMILY REQUESTED WITHDRAWAL OF CARE. THE PATIENT WAS EXTUBATED AND SOON AFTER DIED.
PER JOURNAL ARTICLE "COMPARING LEUKAPHERESIS PROTOCOLS FOR AN AML PATIENT WITH SYMPTOMATIC LEUKOSTASIS. JOURNAL OF CLINICAL APHERESIS" BY CLINE, A., JAJOSKY, R., SHIKLE, J., & BOLLAG, R. BACKGROUND: ACUTE MYELOID LEUKEMIA (AML) IS A MALIGNANCY CHARACTERIZED BY RAPID CLONAL PROLIFERATION OF MYELOID PRECURSORS, WHICH CAN RESULT IN HYPERLEUKOCYTOSIS. LEUKAPHERESIS CAN BE USED TO RAPIDLY REDUCE THE WHITE BLOOD CELL COUNT (WBC). HOWEVER, THE ONLY FDA CLEARED DEVICE FOR WBC DEPLETION, THE COBE SPECTRA, WILL NO LONGER BE SUPPORTED BY THE MANUFACTURER IN 2017, AND THERE ARE FEW STUDIES COMPARING DIFFERENT METHODS OF LEUKAPHERESIS. CASE REPORT: A 68-YEAR-OLD AFRICAN AMERICAN FEMALE WAS ADMITTED TO THE HOSPITAL FOR RELAPSE OF HER AML. LABORATORY DATA DEMONSTRATED A WBC COUNT OF 291 600/LL AND FLOW CYTOMETRY OF THE PERIPHERAL BLOOD DEMONSTRATED 85% MYELOID BLASTS. LEUKAPHERESIS WAS ORDERED TO HELP TREAT THE LEUKOSTASIS. METHODS: THREE DIFFERENT APHERESIS PROTOCOLS WERE USED TO ACHIEVE CYTOREDUCTION: SPECTRA OPTIA MONONUCLEAR COLLECTION (MNC) PROTOCOL, SPECTRA OPTIA GRANULOCYTE COLLECTION (PMN) PROTOCOL, AND THERAKOS CELLEX BUFFY COAT COLLECTION WITHOUT RETURN. DUE TO DIFFERENT INLET FLOW RATES, THE PROCEDURES WERE EVALUATED BASED ON THE NUMBER OF WBCS COLLECTED AND VOLUME OF BLOOD PROCESSED (VBP). RESULTS: THE SPECTRA OPTIA PMN COLLECTED THE MOST WBCS AND COLLECTED NEARLY AS MANY WBCS PER VBP AS THE THERAKOS CELLEX, WHICH HAD THE HIGHEST VALUE. CONCLUSION: TO OUR KNOWLEDGE, WE ARE REPORTING THE FIRST USE OF THERAKOS CELLEX AND SPECTRA OPTIA PMN PROTOCOL FOR WBC DEPLETION. WHILE THE SPECTRA OPTIA GRANULOCYTE PROTOCOL SHOWED THE BEST PERFORMANCE FOR THIS AML PATIENT, FURTHER STUDIES WILL BE NEEDED TO COMPARE THE SPECTRA OPTIA PMN PROTOCOL TO THE MNC PROTOCOL FOR AML PATIENTS. THE LEUKAPHERESIS WAS TERMINATED EARLY DUE TO A MIDPROCEDURE HGB OF 5.6 G/DL, DECREASE FROM 7.8 G/DL PRIOR TO THE PROCEDURE. THE HGB DECREASE WAS ATTRIBUTED TO HEMODILUTION DUE TO THE TRANSFUSION OF 5 UNITS OF FRESH FROZEN PLASMA (FFP) TO REVERSE WARFARIN ANTICOAGULATION (FOR A MECHANICAL HEART VALVE) IN ORDER TO PLACE THE FEMORAL LINE. THE VBP WAS 5.5 L (RUNTIME 145 MINUTES) AND 80 ML WERE COLLECTED. THE PATIENT¿S WBC COUNT DECREASED FROM 292 K/LL TO 203 K/LL, WHILE THE BLAST CELL COUNT DECREASED FROM 242 TO 183 K/LL (FIGURE 1). THE PLT COUNT DROPPED FROM 45 TO 24 K, SO ONE UNIT OF APHERESIS PLTS WAS TRANSFUSED. BECAUSE THE PROCEDURE TERMINATED EARLY, THE NUMBER OF WBCS COLLECTED IN THE BAG WAS NOT DETERMINED. IN ADDITION, BECAUSE THE HEMATOCRIT VALUE INPUT INTO THE MACHINE WAS SUBSTANTIALLY DIFFERENT FROM THE ACTUAL HEMATOCRIT, THIS LEUKAPHERESIS PROCEDURE WAS NOT COMPARED TO THE OTHER PROCEDURES. ON THE SUBSEQUENT DAY, THE FOURTH LEUKAPHERESIS WAS PERFORMED USING THE SPECTRA OPTIA PMN. THE PROCEDURE WAS PERFORMED WITH AN INLET FLOW RATE OF 47 ML/MINUTE AND INLET/ AC RATIO OF 13. THE VBP WAS 6.8 L (RUNTIME 147 MINUTES) AND 498 ML WERE COLLECTED WITHOUT COMPLICATIONS. THE LEUKAPHERESIS BAG CONTAINED 2.39 3 1011 WBCS. THE WBC COUNT DECREASED FROM 132 TO 102 K/LL (22% DECREASE), AND THE BLAST CELL COUNT DECREASED FROM 111 TO 71 K/LL (36% DECREASE). AFTER THE PROCEDURE, PLT COUNT WAS 23 K. A FIFTH LEUKAPHERESIS PROCEDURE WAS SCHEDULED FOR THE NEXT DAY. HOWEVER, THE PATIENT WAS NOTED TO HAVE UNEQUAL PUPILS WITH A LARGE, NON-REACTIVE PUPIL IN THE LEFT EYE AND LEFT SIDED PTOSIS. A CT SCAN OF THE HEAD SHOWED ACUTE ON CHRONIC SUBDURAL HEMATOMA WITH MILD LEFT DESCENDING TRANSTENTORIAL HERNIATION AND MIDLINE SHIFT, WHICH WOULD REQUIRE NEUROSURGERY. BECAUSE OF THE BLEEDING AND A PARTIAL THROMBOPLASTIN TIME (PTT) OF 81.9 SECONDS (REFERENCE RANGE, 28.0¿35.7) HEPARIN, WHICH WAS USED AS ANTICOAGULATION FOR THE MECHANICAL HEART VALVE, WAS DISCONTINUED. IN ADDITION, ONE UNIT OF RBCS AND TWO UNITS OF APHERESIS PLTS WERE TRANSFUSED. SOON AFTER, THE FAMILY REQUESTED WITHDRAWAL OF CARE. THE PATIENT WAS EXTUBATED AND SOON AFTER DIED. SOME ADVERSE EVENTS ARE REPORTED DURING LEUKAPHERESIS. AML PATIENTS CAN EXPERIENCE THROMBOCYTOPENIA AND BLEEDING, AS A SIGNIFICANT NUMBER OF PLATELETS ARE OFTEN REMOVED.11 A RECENT STUDY SUGGESTED THAT CLOSE MONITORING OF PLATELETS IS NEEDED TO AVOID BLEEDING COMPLICATIONS IN PATIENTS WHO ARE ALREADY THROMBOCYTOPENIC.8 SPECIFICALLY, THE SPECTRA OPTIA IS KNOWN FOR PLATELET LOSS, THUS EXPLAINING THE NEED FOR PLATELET TRANSFUSIONS IN THE PATIENT DETAILED IN THIS REPORT. ADDITIONALLY, VENOUS THROMBOSIS OR HEMORRHAGE MAY OCCUR AS A CONSEQUENCE OF THE LARGE BORE CATHETER INSERTION.12 NEVERTHELESS, THE PROCEDURE IS SAFELY PERFORMED IN THE MAJORITY OF CASES.13 THE PATIENT IN THIS REPORT INCREASINGLY RELIED ON TRANSFUSIONS AS THE HOSPITALIZATION PROGRESSED. HOWEVER, NO ADVERSE EFFECTS WERE DIRECTLY LINKED TO THE LEUKAPHERESIS PROCEDURES. THE SUBDURAL HEMATOMA WAS THOUGHT TO BE DUE TO AML AND HEPARIN ANTICOAGULATION. THERE WERE MULTIPLE PROCEDURES OVER MULTIPLE DAYS AND THE PATIENT OUTCOME WAS DEATH. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, ALTHOUGH PER CURRENT INFORMATION THERE IS NO DETECTABLE MALFUNCTION WITH THE TERUMO BCT DEVICE OR ALLEGATION OF A MALFUNCTION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434997 | SPECTRA OPTIA | SPECTRA OPTIA IDL SET | LKN | TERUMO BCT | 05020583123205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other |