THE LDL-APHERESIS (LDL-A) WITH LIPOSORBER LA-15 SYSTEM WAS APPLIED TO A (B)(6) YEARS OF AGE FEMALE PATIENT (HD), WITH DIABETES MELLITUS (DM) AND DEMENTIA, FOR THE TREATMENT OF HER ARTERIO SCLEROSIS OBLITERANS (ASO). IN THE FIRST LDL-A OF THE PT, SHE DEVELOPED A SEVERE HYPOTENSION WITH A SHOCK SYMPTOM AT AROUND 10-15 MINUTES AFTER STARTING THE PROCEDURE (AT 11:07 AM), AND THE PROCEDURE WAS IMMEDIATELY TERMINATED. THE PT FELL INTO A TEMPORARY CARDIAC ARREST AND AN AUTOMATED EXTERNAL DEFIBRILLATOR (AED) WAS APPLIED, SALINE WAS INFUSED I.V., AND HER BLOOD PRESSURE (BP) GRADUALLY ELEVATED AND STAYED AT 70-80 MMHG (AT AROUND 12:00). HER BP RECOVERED TO 120 MMHG AND SHE WAS PUT ON A HD PROCEDURE (12:20) AND COMPLETED THE HD WITHOUT PROBLEM (AT 15:30). ON THE SAME DAY, HER CARDIO THORACIC RATIO (CTR) WAS CONFIRMED NORMAL BY AN X-RAY EXAMINATION AND SHE WENT HOME WITH NO AFTEREFFECT OF THE INCIDENT. THE PT WAS ADMINISTERED WITH AN ACE-INHIBITOR (LOKOPOOL: LISINOPRIL), AND THE LDL-A ON THIS DAY WAS CONDUCTED AFTER ONE WEEK-CESSATION OF THE ACE-INHIBITOR.
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Patient 1
ANAPHYLACTOID REACTIONS WITH SEVERE HYPOTENSION INCLUDING SHOCK ARE KNOWN AS ONE OF SIDE EFFECTS, ESPECIALLY IN PATIENTS WHO ARE CONCOMITANTLY TREATED WITH ACE-INHIBITORS, WHICH ARE ATTRIBUTED TO THE DEXTRAN SULFATE-CELLULOSE GELS OR THE INGREDIENT OF THE "LIPOSORBER LA-15 LDL ADSORPTION COLUMNS". IN (B)(6), PATIENTS BEING TREATED WITH ANY ACE-INHIBITOR IS CONTRAINDICATED TO THE LDL-APHERESIS (LDL-A) WITH THIS DEVICE. IN OUR INVESTIGATION, THE PATIENT (PT) WAS PRESCRIBED WITH AN ACE-INHIBITOR, "LOKOPOOL", AND THE PT WAS APPLIED TO THE LDL-A WITH THIS DEVICE AFTER ONE WEEK-CESSATION OF THE ACE-INHIBITOR. THE PT IS ON CHRONIC HEMODIALYSIS (HD) WITH RENAL FAILURE, AND THE EFFECTIVENESS OF THE ACE-INHIBITOR HAD REMAINED LONGER THAN USUAL, AND ONE WEEK-CESSATION SEEMED INSUFFICIENT TO ELIMINATE THE INFLUENCE OF THE ACE-INHIBITOR. HER SECOND LDL-A WITH THIS DEVICE WAS SUCCESSFULLY DONE TWO WEEKS AFTER THIS EVENT WITH CONTINUOUS CESSATION OF THE ACE-INHIBITOR BY USING NAFAMOSTAT MESILATE, "FUTHAN", AS AN ANTICOAGULANT. ACCORDINGLY, WE BELIEVE THAT THE EVENT WAS CAUSED BY A USE ERROR TO USE THE DEVICE AGAINST CONTRA-INDICATION AND NOT BE ANY DEFECT OR MALFUNCTION OF THE DEVICE. THE ACTUAL DEVICE USED WAS NOT AVAILABLE FOR OUR FURTHER INVESTIGATION.