COBE SPECTRA
Report
- Report Number
- 1722028-2022-00414
- Event Type
- Injury
- Date Received
- December 20, 2022
- Date of Event
- March 18, 2022
- Report Date
- December 20, 2022
- Manufacturer
- TERUMO BCT
- Product Code
- GKT
- UDI-DI
- 05020583706101
- PMA / PMN Number
- BK080035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: LIN Y, PARK Y, KHANAL A, ET AL. A COMPARISON OF FOUR LEUKAPHERESIS METHODS TO HARVEST AN OPTIMAL DOSE OF CD34+ CELLS: A SINGLE CENTER EXPERIENCE. EUROPEAN JOURNAL OF HAEMATOLOGY. 2022;109(6):711-718. DOI:10.1111/EJH.13856 INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.2, H.6 AND H.11 AND CORRECTED INFORMATION IN D.1, D.2A, D.4 AND G.4. INVESTIGATION: LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. PRODUCT EVALUATION: PART EVALUATION IS NOT FEASIBLE FOR THIS JOURNAL ARTICLE INVESTIGATION BECAUSE THERE ARE MANY MONTHS BETWEEN COLLECTION OF DATA, TO PEER REVIEW, TO FINAL PUBLICATION. INVESTIGATIONAL DETAILS: THE PURPOSE OF THE JOURNAL ARTICLE STUDY IS NOTED IN THE ARTICLE ABSTRACT: BACKGROUND: CHEMOKINE RECEPTOR CXCR4 ANTAGONIST PLERIXAFOR (PX) AS WELL AS HIGH VOLUME (HV) LEUKAPHERESIS HAVE BEEN SHOWN TO REDUCE HEMATOPOIETIC STEM PROGENITOR CELL (HSPC) MOBILIZATION FAILURE RATES. HOWEVER, NO DIRECT COMPARISONS OF SUCH METHODS CURRENTLY EXISTS. METHODS AND MATERIALS: WE COMPARED THE HSPC COLLECTION YIELD BASED ON BASAL PERIPHERAL BLOOD CD34+ CELL NUMBERS IN PATIENTS DIAGNOSED WITH MULTIPLE MYELOMA OR NON-HODGKIN'S LYMPHOMA UNDERGOING AUTOLOGOUS STEM CELL TRANSPLANTATION IN A RETROSPECTIVE CHART REVIEW. THE LEUKAPHERESIS METHODS USED INCLUDED HV VERSUS REGULAR VOLUME (RV) WITH OR WITHOUT PX. THERE WERE 116 PATIENTS IN THE STUDY GROUP WHILE THE HISTORICAL CONTROL GROUP HAD 34 PATIENTS. RESULTS AND CONCLUSIONS: CONTROL GROUP UNDERWENT RV LEUKAPHERESIS WITHOUT PX. ADDITION OF PX OR HV IN THE STUDY GROUP FAILED TO DISPLAY SIGNIFICANT IMPROVEMENT IN CD34+ CELL COLLECTION YIELD; HOWEVER, WHEN BASAL CD34+ CELL NUMBERS WERE TAKEN INTO ACCOUNT, BOTH PX + RV AND HV WITHOUT PX INCREASED CD34+ CELL COLLECTION YIELD. THE COLLECTION FAILURE RATES OF HV WITHOUT PX GROUP WERE COMPARABLE TO PX + RV WHEN THE BASAL CD34+ CELL NUMBERS WERE OVER 20/L. OF INTEREST, MULTIVARIATE LINEAR REGRESSION ANALYSIS DID NOT DETECT ANY SIGNIFICANT DIFFERENCE BETWEEN HV VERSUS PX + RV OR OTHER LEUKAPHERESIS METHODS IN CD34 YIELDS OR COLLECTION FAILURE RATES FROM A SINGLE COLLECTION AFTER CONTROLLING FOR OTHER FACTORS (SEX, AGE, OR UNDERLYING DISEASE). IN MULTIVARIATE ANALYSIS, PRE APHERESIS CD34+ CELL NUMBER WAS SIGNIFICANTLY AND POSITIVELY ASSOCIATED WITH THE CD34+ CELL YIELDS FROM A SINGLE APHERESIS. IN OUR STUDIES, THE MAJORITY OF PATIENTS CAN BE RESCUED WITHOUT PX BY HV ALONE AS A POTENTIAL COST SAVING APPROACH. IN SUMMARY, TREND IN OUR STUDIES REFLECTS THAT BOTH PX AND HV ARE CAPABLE OF REDUCING THE MOBILIZATION FAILURE RATES EXCEPT THE POOREST MOBILIZERS, WHICH WILL NEED TO BE VALIDATED IN LARGER STUDIES. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: REGARDING TERUMO BCT PRODUCT, COBE SPECTRA APHERESIS DEVICE, MULTIPLE ADVERSE REACTIONS WERE REPORTED. THE AUTHORS COMPARED THE CD34+ CELL COLLECTION YIELD AND COST EFFECTIVENESS WITH OR WITHOUT PLERIXAFOR (PX), FOLLOWED BY VARIOUS LEUKAPHERESIS METHODS TO HARVEST AUTOLOGOUS GRAFT IN MULTIPLE MYELOMA (MM) AND NON-HODGKIN'S LYMPHOMA (NHL) PATIENTS IN A SINGLE CENTER UTILIZING RETROSPECTIVE CHART REVIEW. PATIENTS WERE 18 YEARS AND OLDER WITH HEMATOLOGIC MALIGNANCIES UNDERGOING AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT). REPORTS OF CENTRAL LINE SITE PAIN, TACHYCARDIA AND PARESTHESIA/TINGLING WERE RELATIVELY COMMON ADVERSE EFFECTS OF FOUR LEUKAPHERESIS METHODS TESTED WITHIN THIS STUDY. IN 4.4% OF ALL COLLECTIONS, PATIENTS EXPERIENCED SOME DEGREE OF NUMBNESS AND/OR TINGLING OF FINGERS, TOES OR LIPS, WHICH WERE READILY RESOLVED WITH CALCIUM REPLACEMENT (ORALLY OR INTRAVENOUSLY). THE HIGH VOLUME (HV) LEUKAPHERESIS GROUP EXPERIENCED RELATIVELY MORE ADVERSE EFFECTS COMPARED TO REGULAR VOLUME (RV) LEUKAPHERESIS, MOST OF WHICH WERE HYPOTENSION AND DIZZINESS (5% VS. 1.9%), PACKED RED BLOOD CELL TRANSFUSION (5% VS. 3.8%) AND PLATELET TRANSFUSION (22.5% VS. 3.8%). ON THE OTHER HAND, RV VERSUS HV LEUKAPHERESIS IN COMBINATION WITH PX RESULTED IN MORE ELECTROLYTE DISTURBANCE REQUIRING ELECTROLYTE (POTASSIUM OR MAGNESIUM OR BOTH) REPLACEMENT (25.7% VS. 12.5%) THAN HV. THE CURRENT RECOMMENDED STRATEGY FOR MOBILIZATION AND COLLECTION OF AUTOLOGOUS STEM CELL IS BY USE OF G-CSF WITH OR WITHOUT THE AID OF PX, FOLLOWED BY LEUKAPHERESIS. THE COMBINATION OF PX WITH VARIOUS METHODS OF LEUKAPHERESIS HAS NOT BEEN WELL STUDIED. ONE HUNDRED SIXTEEN PATIENTS (78 WITH MM AND 38 WITH NHL) WERE INCLUDED IN THE STUDY GROUP AND 34 PATIENTS (25 WITH MM AND 9 WITH NHL) SERVED AS THE CONTROL GROUP. THE CONTROL GROUP UNDERWENT RV LEUKAPHERESIS WITHOUT PX. FOR THE STUDY GROUP THERE WERE 191 HSPC PRODUCTS COLLECTED BY APHERESIS FROM 116 PATIENTS. THE AUTHORS CONCLUDED THAT BOTH PX AND HV LEUKAPHERESIS MAY REDUCE THE MOBILIZATION FAILURE RATES TO REACH THE MINIMUM CD34+ CELL YIELDS REQUIRED FOR AN ASCT. THE DATA SUGGESTS THAT EXCEPT FOR THE POOREST MOBILIZERS HAVING BASAL CD34+ CELL NUMBERS <20/L, HV APHERESIS METHOD CAN SERVE AS A COST-EFFECTIVE SUBSTITUTE TO PX TO HARVEST THE MINIMUM NUMBER OF CD34+ CELLS FOR ASCT WITHOUT EXERTING ADDITIONAL SIDE EFFECTS. SINCE THIS WAS A JOURNAL PUBLICATION TO COMPARE FOUR LEUKAPHERESIS METHODS TO HARVEST AN OPTIMAL DOSE OF CD34+ CELLS INVOLVING 116 PATIENTS BETWEEN 2009 AND 2014, 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. A RISK ASSESSMENT WAS CONDUCTED FOR THIS FAILURE. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF 4.8%. SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. VASOVAGAL INCIDENTS OCCUR AROUND 0.5% OF PROCEDURES. THE REACTIONS GENERALLY MANIFEST AS PALLOR AND DIAPHORESIS. IN A FULL BLOWN ATTACK, THE REACTION PROGRESSES FROM PALLOR AND SWEATING TO PULSE SLOWING AND BLOOD PRESSURE DECREASING. MORE SEVERE VASOVAGAL REACTIONS MAY INCLUDE NAUSEA, VOMITING, AND/OR CONVULSIONS. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF 4.8%. SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. TRANSIENT HYPOCALCEMIA ASSOCIATED WITH APHERESIS IS USUALLY WELL TOLERATED. SYMPTOMS OFTEN SHOW AS PARESTHESIA (TINGLING) BUT PATIENTS MAY ALSO EXPERIENCE UNUSUAL TASTE, NAUSEA, LIGHTHEADEDNESS, SHIVERING, AND TREMORS. SEVERE HYPOCALCEMIA MAY ALSO CAUSE MUSCLE CONTRACTIONS AND CAN PROGRESS TO TETANY AND SEIZURES IF HYPOCALCEMIA ESCALATES AND IS NOT CORRECTED. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, MISCELLANEOUS REACTIONS SUCH AS DELAYED COMPLICATIONS OF APHERESIS INCLUDE HEMORRHAGE, THROMBOSIS, INFECTION RELATED TO ACCESS LINES OR BLOOD COMPONENTS, ANEMIA, AND PROTEIN DEPLETION. THERAPEUTIC APHERESIS PROCEDURES MAY LEAD TO MAJOR PHYSIOLOGIC CHANGES, INCLUDING HYPOCALCEMIA CAUSED BY CITRATE INFUSION, HEMODYNAMIC CHANGES ASSOCIATED WITH FLUID SHIFTS, AND DEPLETION OF CELLULAR AND PLASMA CONSTITUENTS. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, WITH CURRENT CENTRIFUGAL TECHNOLOGY, REDUCTIONS IN PLATELET COUNT ARE USUALLY MODEST, AND LEVELS QUICKLY RETURN TO BASELINE. IN A SEVERELY THROMBOCYTOPENIC PATIENT, HOWEVER, SUCH A LOSS MAY MASK THE BEGINNING OF PLATELET RECOVERY. SIMILARLY, THE SMALL AMOUNT OF RED CELLS LOST IN THE APHERESIS CIRCUIT MAY BE MORE APPARENT IN AN ANEMIC PATIENT WHO HAS MEAGER PRODUCTION CAPACITY AND WHO IS RECEIVING MULTIPLE PROCEDURES. ALTHOUGH GENERALLY WELL TOLERATED, THE LARGE-VOLUME LEUKOCYTAPHERESIS FOR STEM CELL COLLECTIONS IN PATIENTS OFTEN RESULTS IN A DECLINE IN HEMATOCRIT AND PLATELET COUNT, PARTICULARLY BECAUSE SOME RED CELLS AND PLATELETS ARE INCIDENTALLY REMOVED WITH THE STEM CELLS (SEE ATTACHMENT, THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, PGS 28-33 IN CONTENT TAB). ACCORDING TO ANTICOAGULATION TECHNIQUES IN APHERESIS: FROM HEPARIN TO CITRATE AND BEYOND (LEE, ET AL), SEVERAL METABOLIC COMPLICATIONS OTHER THAN HYPOCALCEMIA HAVE BEEN DESCRIBED WITH CITRATE ADMINISTRATION INCLUDING HYPOMAGNESEMIA, METABOLIC ALKALOSIS, HYPOKALEMIA, AND CHANGES IN PARATHYROID HORMONE LEVELS (PTH). THESE METABOLIC COMPLICATIONS ARE CITRATE MEDIATED AND OFTEN RELATED TO CITRATE INFUSION RATES OR DONOR CHARACTERISTICS. THE GENERATION OF A METABOLIC ALKALOSIS CONTRIBUTES TO THE DEVELOPMENT OF HYPOKALEMIA. FOR EXAMPLE, THE SIMULTANEOUS DEVELOPMENT OF METABOLIC ALKALOSIS AND HYPOKALEMIA, WITH SERUM POTASSIUM LEVELS LESS THAN 3.0 MEQ/L, HAS BEEN FOUND TO OCCUR FREQUENTLY IN PATIENTS WITH TTP AFTER PLASMA EXCHANGE. METABOLIC ALKALOSIS DIRECTLY INDUCES HYPOKALEMIA, AS HIGH SERUM BICARBONATE LEVELS CAUSE A COMPENSATORY SHIFT OF HYDROGEN IONS OUT OF THE INTRACELLULAR COMPARTMENT IN EXCHANGE FOR POTASSIUM. THE CONCURRENT PRESENCE OF HYPOCALCEMIA AND HYPOMAGNESEMIA ALSO CONTRIBUTES TO THE DEVELOPMENT OF HYPOKALEMIA, AS THE DEVELOPMENT OF CITRATE-INDUCED HYPOCALCEMIA HAS BEEN FOUND TO BE STRONGLY ASSOCIATED WITH THE SUBSEQUENT DEVELOPMENT OF CITRATE-INDUCED HYPOKALEMIA (SEE ATTACHMENT PGS 6-7 IN CONTECT TAB). ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE REPORTED CITRATE REACTIONS. THESE REACTIONS OCCUR DUE TO DECREASED IONIZED CALCIUM IN CIRCULATION AS A RESULT OF EXOGENOUS CITRATE ADMINISTERED DURING THE APHERESIS PROCEDURE AND ARE INFLUENCED BY PATIENT PHYSIOLOGY, THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, THE CITRATE CONTENTS IN THE REPLACEMENT FLUID, AND/OR THE LENGTH OF THE PROCEDURE. TRANSIENT HYPOCALCEMIA ASSOCIATED WITH APHERESIS IS USUALLY WELL TOLERATED. SYMPTOMS OFTEN SHOW AS PARASETHESIA (TINGLING) BUT PATIENTS MAY ALSO EXPERIENCE UNUSUAL TASTE, NAUSEA, LIGHTHEADEDNESS, SHIVERING, AND TREMORS. THESE SYMPTOMS MAY BE TREATED WITH ORAL OR INTRAVENOUS CALCIUM SUPPLEMENTS OR BY ADJUSTING THE AC INFUSION RATE. THEREFORE A DEFINITIVE ROOT CAUSE FOR THE HYPOCALCAEMIA REPORTED COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR THE ALLEGED CITRATE REACTION INCLUDE BUT ARE NOT LIMITED TO AC MANAGEMENT DURING THE PROCEDURE, PATIENT DISEASE STATE, AND/OR PATIENT SENSITIVITY TO ANTICOAGULANT. THE REPORTED HYPOTENSION IS A COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS PROCEDURES. THEY ARE TYPICALLY CAUSED BY THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, FLUID SHIFT, BLOOD LOSS, LENGTH OF THE PROCEDURE, PATIENT'S SENSITIVITY TO THE PROCEDURE AND/OR HEMODYNAMIC STRESS OF THE PROCEDURE. A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE PANCYTOPENIA (PLATELET LOSS). 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 BLOOD PHYSIOLOGY INFLUENCED THE COLLECTED PRODUCT * INLET FLOW RATE WAS SET TOO HIGH * CLUMPING IN THE EXTRACORPOREAL SYSTEM * RUNNING A LENGTHY PROCEDURE * A DILUTIONAL EFFECT ON THE POST PROCEDURE SAMPLE DUE TO THE VOLUME OF INFUSED ACDA * SIDE EFFECTS OF MOBILIZATION REGIMEN A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE PANCYTOPENIA (RBC LOSS). 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 BLOOD PHYSIOLOGY INTERFERES WITH SEPARATION OF CELLULAR COMPONENTS AND CHAMBER TRIGGERING (I.E. ABNORMAL RBCS, HYPERVISCOUS PLASMA) * LOW TOTAL BLOOD VOLUME OR LOW HEMATOCRIT * INADEQUATE BLOOD PRIME * THE PRESENCE OF A SMALL BUFFY COAT WHICH RESULTED IN RED CELLS GETTING COLLECTED ALONG WITH THE TARGET CELLS. * INACCURATE ENTRY OF THE PATIENT'S HEMATOCRIT * INLET FLOW RATE WAS TOO HIGH TO ADEQUATELY SEPARATE RED CELLS FROM BUFFY COAT * IMPROPER LOADING OF THE CHANNEL INTO THE FILLER * SIDE EFFECTS OF MOBILIZATION REGIMEN A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE HYPOKALEMIA/HYPOMAGNESEMIA. THESE METABOLIC COMPLICATIONS ARE CITRATE MEDIATED AND OFTEN RELATED TO CITRATE INFUSION RATES OR PATIENT CHARACTERISTICS. THE GENERATION OF A METABOLIC ALKALOSIS CONTRIBUTES TO THE DEVELOPMENT OF HYPOKALEMIA. FOR EXAMPLE, THE SIMULTANEOUS DEVELOPMENT OF METABOLIC ALKALOSIS AND HYPOKALEMIA, WITH SERUM POTASSIUM LEVELS LESS THAN 3.0 MEQ/L, HAS BEEN FOUND TO OCCUR FREQUENTLY IN PATIENTS WITH TTP AFTER PLASMA EXCHANGE. METABOLIC ALKALOSIS DIRECTLY INDUCES HYPOKALEMIA, AS HIGH SERUM BICARBONATE LEVELS CAUSE A COMPENSATORY SHIFT OF HYDROGEN IONS OUT OF THE INTRACELLULAR COMPARTMENT IN EXCHANGE FOR POTASSIUM. THE CONCURRENT PRESENCE OF HYPOCALCEMIA AND HYPOMAGNESEMIA ALSO CONTRIBUTES TO THE DEVELOPMENT OF HYPOKALEMIA, AS THE DEVELOPMENT OF CITRATE-INDUCED HYPOCALCEMIA HAS BEEN FOUND TO BE STRONGLY ASSOCIATED WITH THE SUBSEQUENT DEVELOPMENT OF CITRATE-INDUCED HYPOKALEMIA. ARTICLE CITATION: LIN Y, PARK Y, KHANAL A, ET AL. A COMPARISON OF FOUR LEUKAPHERESIS METHODS TO HARVEST AN OPTIMAL DOSE OF CD34+ CELLS: A SINGLE CENTER EXPERIENCE. EUROPEAN JOURNAL OF HAEMATOLOGY. 2022;109(6):711-718. DOI:10.1111/EJH.13856
THE JOURNAL ARTICLE, 'A COMPARISON OF FOUR LEUKAPHERESIS METHODS TO HARVEST AN OPTIMAL DOSE OF CD34+ CELLS: A SINGLE CENTER EXPERIENCE', A RETROSPECTIVE STUDY ANALYZED DATA FOR PATIENTS 18 YEARS AND OLDER WITH HEMATOLOGIC MALIGNANCIES (MULTIPLE MYELOMA (MM), HODGKIN'S LYMPHOMA AND NON-HODGKIN'S LYMPHOMA (NHL)) UNDERGOING AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT). 116 PATIENTS (78 WITH MM AND 38 WITH NHL) WERE INCLUDED IN THE STUDY GROUP AND 34 PATIENTS (25 WITH MM AND 9 WITH NHL) SERVED AS THE CONTROL GROUP. LEUKAPHERESES WERE PERFORMED USING THE SPECTRA APHERESIS DEVICE. THE LEUKAPHERESIS METHODS USED INCLUDED HIGH VOLUME (HV) LEUKAPHERESIS VERSUS REGULAR VOLUME (RV) WITH OR WITHOUT ANTAGONIST PLERIXAFOR (PX). AMONG ALL HSPC MOBILIZATION AND COLLECTION PROCEDURES, IN 4.4% OF ALL COLLECTIONS, PATIENTS EXPERIENCED SOME DEGREE OF NUMBNESS AND/OR TINGLING OF FINGERS, TOES OR LIPS, WHICH WERE READILY RESOLVED WITH CALCIUM REPLACEMENT (ORALLY OR INTRAVENOUSLY). OVERALL, HV LEUKAPHERESIS GROUP EXPERIENCED RELATIVELY MORE ADVERSE EFFECTS COMPARED TO RV LEUKAPHERESIS, MOST OF WHICH WERE HYPOTENSION AND DIZZINESS (5% VS. 1.9%), PACKED RED BLOOD CELL TRANSFUSION (5% VS. 3.8%) AND PLATELET TRANSFUSION (22.5% VS. 3.8%). ON THE OTHER HAND, RV VERSUS HV LEUKAPHERESIS IN COMBINATION WITH PX RESULTED IN MORE ELECTROLYTE DISTURBANCE REQUIRING ELECTROLYTE (POTASSIUM OR MAGNESIUM OR BOTH) REPLACEMENT (25.7% VS. 12.5%) THAN HV. INDIVIDUAL PATIENT INFORMATION IS NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY OF EVENTS. THE LEUKAPHERESIS SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.
THE JOURNAL ARTICLE, 'A COMPARISON OF FOUR LEUKAPHERESIS METHODS TO HARVEST AN OPTIMAL DOSE OF CD34+ CELLS: A SINGLE CENTER EXPERIENCE', A RETROSPECTIVE STUDY ANALYZED DATA FOR PATIENTS 18 YEARS AND OLDER WITH HEMATOLOGIC MALIGNANCIES (MULTIPLE MYELOMA (MM), HODGKIN'S LYMPHOMA AND NON-HODGKIN'S LYMPHOMA (NHL)) UNDERGOING AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT). 116 PATIENTS (78 WITH MM AND 38 WITH NHL) WERE INCLUDED IN THE STUDY GROUP AND 34 PATIENTS (25 WITH MM AND 9 WITH NHL) SERVED AS THE CONTROL GROUP. LEUKAPHERESES WERE PERFORMED USING THE SPECTRA APHERESIS DEVICE. THE LEUKAPHERESIS METHODS USED INCLUDED HIGH VOLUME (HV) LEUKAPHERESIS VERSUS REGULAR VOLUME (RV) WITH OR WITHOUT ANTAGONIST PLERIXAFOR (PX). AMONG ALL HSPC MOBILIZATION AND COLLECTION PROCEDURES, IN 4.4% OF ALL COLLECTIONS, PATIENTS EXPERIENCED SOME DEGREE OF NUMBNESS AND/OR TINGLING OF FINGERS, TOES OR LIPS, WHICH WERE READILY RESOLVED WITH CALCIUM REPLACEMENT (ORALLY OR INTRAVENOUSLY). OVERALL, HV LEUKAPHERESIS GROUP EXPERIENCED RELATIVELY MORE ADVERSE EFFECTS COMPARED TO RV LEUKAPHERESIS, MOST OF WHICH WERE HYPOTENSION AND DIZZINESS (5% VS. 1.9%), PACKED RED BLOOD CELL TRANSFUSION (5% VS. 3.8%) AND PLATELET TRANSFUSION (22.5% VS. 3.8%). ON THE OTHER HAND, RV VERSUS HV LEUKAPHERESIS IN COMBINATION WITH PX RESULTED IN MORE ELECTROLYTE DISTURBANCE REQUIRING ELECTROLYTE (POTASSIUM OR MAGNESIUM OR BOTH) REPLACEMENT (25.7% VS. 12.5%) THAN HV. INDIVIDUAL PATIENT INFORMATION IS NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY OF EVENTS. THE LEUKAPHERESIS SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2700820 | COBE SPECTRA | COBE SPECTRA AUTOPBSC SET, ISBT | GKT | TERUMO BCT | 10310 | 05020583706101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |