Description of Event or Problem · 1
ANTERIOR SPINAL ARTERY INFARCTION [ANTERIOR SPINAL ARTERY SYNDROME], BAE WAS PERFORMED IN THE 5TH TO 8TH INTERCOSTAL ARTERIES AND THE LEFT LATERAL THORACIC ARTERY [OFF LABEL USE]. CASE DESCRIPTION: (B)(6). A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM) AND IODIZED OIL (LIPIODOL), BOTH FROM AN UNSPECIFIED DATE, AT AN UNSPECIFIED DOSE, FOR BRONCHIAL ARTERIAL EMBOLIZATION (BAE). MEDICAL HISTORY INCLUDED MICROSCOPIC POLYANGIITIS AT THE AGE OF (B)(6), LUNG CANCER, LEFT UPPER LOBECTOMY AT THE AGE OF (B)(6), PULMONARY ASPERGILLOSIS. THE PATIENT PREVIOUSLY TOOK STEROID FOR MICROSCOPIC POLYANGIITIS AT THE AGE OF (B)(6). A (B)(6) WOMAN. AT THE AGE OF (B)(6), MICROSCOPIC POLYANGIITIS WAS POINTED OUT AND STEROID WAS ADMINISTERED. AT THE AGE OF (B)(6), LEFT UPPER LOBECTOMY WAS PERFORMED FOR LUNG CANCER. AFTER THAT, THE PATIENT WAS FOLLOWED UP FOR PULMONARY ASPERGILLOSIS. THE PATIENT NOTICED BLOODY SPUTUM AND HAD DYSPNOEA 4 DAYS AFTER THAT. THEREFORE, THE PATIENT VISITED THE EMERGENCY DEPARTMENT OF THE AUTHOR'S HOSPITAL. SINCE THE PATIENT HAD BLOODY SPUTUM ON ARRIVAL AT THE HOSPITAL, AND RECURRENCE OF PREEXISTING PULMONARY ASPERGILLOSIS WAS SUSPECTED ON CT (COMPUTERIZED TOMOGRAPHY) FINDINGS, THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. ALTHOUGH THE PATIENT WAS FOLLOWED UP WITH RECEIVING ANTIFUNGAL MEDICATION, THE PATIENT HAD A LARGE AMOUNT OF HAEMOPTYSIS ON THE 3RD HOSPITAL DAY. AS ESTABLISHING THE AIRWAY BECAME DIFFICULT, THE PATIENT WAS PLACED UNDER MANAGEMENT WITH INTUBATION. CLINICAL COURSE: AS HAEMORRHAGE DUE TO ASPERGILLOSIS IN THE LEFT UPPER LUNG FIELD WAS SUSPECTED, A RIGHT BRONCHUS WAS INTUBATED. ON THE SAME DAY, EMERGENCY BAE (BRONCHIAL ARTERIAL EMBOLIZATION) WAS PERFORMED FOR HAEMOPTYSIS. BAE WAS PERFORMED IN THE 5TH TO 8TH INTERCOSTAL ARTERIES AND THE LEFT LATERAL THORACIC ARTERY WITH IODIZED OIL (LIPIODOL) AND GELATIN SPONGE DUE TO FINDINGS OF EXTRAVASATION. AS HAEMOPTYSIS IMPROVED TO OOZING IN EXTENT, THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE ICU (INTENSIVE CARE UNIT). SEDATIVE MANAGEMENT WAS PERFORMED FOR REST AND HAEMOSTASIS FOR APPROXIMATELY 10 DAYS, AND THEN THE DOSE OF SEDATING MEDICINE WAS TAPERED. WHEN THE LEVEL OF CONSCIOUSNESS WAS RESTORED TO THE EXTENT THAT THE PATIENT HAD GOOD RAPPORT, THE PATIENT COMPLAINED THAT THE PATIENT COULD NOT MOVE BOTH LOWER LIMBS. PHYSICAL FINDINGS SHOWED THAT THERE WAS NO ABNORMAL FINDING IN THE MOTOR SYSTEM OF THE UPPER LIMBS, BUT THAT WEAKNESS WAS NOTED IN THE LOWER LIMBS WITH THE MMT (MANUAL MUSCLE TEST) SCORES OF 2 ON THE RIGHT SIDE AND 1 ON THE LEFT SIDE. MORBID REFLEXES SUCH AS BABINSKI REFLEX AND CHADDOCK REFLEX WERE OBVIOUSLY POSITIVE ON BOTH SIDES. TRACHEOSTOMY WAS PERFORMED TO CONTROL THE AIRWAY. SINCE THE PATIENT'S COMMUNICATION WAS LIMITED AT THIS POINT, IT WAS DIFFICULT TO ASSESS SENSORY DISTURBANCE ADEQUATELY. AFTER SEVERAL DAYS, WEAKNESS IN THE LOWER LIMBS DID NOT IMPROVE. T2WI (T2-WEIGHTED IMAGES) OF THORACIC SPINE MRI (MAGNETIC RESONANCE IMAGING), WHICH WAS PERFORMED TO SEARCH FOR THE CAUSE, SHOWED HIGH SIGNAL LESION SUGGESTING ANTERIOR SPINAL ARTERY INFARCTION IN THE TH3-4 (3RD TO 4TH THORACIC VERTEBRAE). SUBSEQUENTLY, WHEN THE PATIENT BECAME ABLE TO COMMUNICATE, THE PATIENT WAS FOUND TO HAVE DISSOCIATIVE SENSORY DISTURBANCE IN THE LOWER LIMBS, PREDOMINANTLY ON THE LEFT SIDE. WHILE ANTIPLATELET OR ANTICOAGULANT MEDICINE WAS NOT INDICATED DUE TO THE PAST HISTORY OF HAEMOPTYSIS, AND TREATMENT WITH CONCENTRATED GLYCERIN/FRUCTOSE (GLYCEOL) OR STEROID WAS NOT PERFORMED BECAUSE IT WAS CONSIDERED THAT MORE THAN 10 DAYS HAD ALREADY PASSED AFTER THE ONSET OF THE DISEASE, REHABILITATION INTERVENTION ALONE WAS CONDUCTED. MRI, WHICH WAS PERFORMED AFTER THAT, SHOWED NO MARKED CHANGE. AS MICTURITION DESIRE DISAPPEARED, IT BECAME NECESSARY TO CONTROL URINATION WITH PLACEMENT OF A URETHRAL CATHETER. THE ACTION TAKEN WITH ABSORBABLE GELATIN AND IODIZED OIL AS WELL AS THE OUTCOME OF THE EVENT WAS NOT REPORTED. ALTHOUGH NERVE LESION DUE TO MICROSCOPIC POLYANGIITIS WAS CONSIDERED FOR DIFFERENTIAL DIAGNOSIS, IT WAS PROBABLY CONSIDERED THAT THE OBSTRUCTING MATERIALS DUE TO BAE ORIGINATING FROM THE LESION ON MRI CAUSED INFARCTION IN THE REGION OF THE ANTERIOR SPINAL ARTERY IN THIS CASE. BECAUSE THE MANAGEMENT WITH INTUBATION WAS PERFORMED IN A RESTING STATE, DETECTION OF PARALYSIS WAS DELAYED AND THERAPEUTIC INTERVENTION COULD NOT BE PERFORMED. NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED. CASE COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS LITERATURE REPORT, THE USE OF SUSPECT PRODUCTS ABSORBABLE GELATIN (GELFOAM) AND IODIZED OIL (LIPIODOL) USED FOR BRONCHIAL ARTERIAL EMBOLIZATION (BAE) IN THIS ELDERLY PATIENT WITH HISTORY OF LUNG CANCER AND PREVIOUS LEFT UPPER LOBECTOMY, POSSIBLY RESULTING IN AN ANTERIOR SPINAL ARTERY INFARCTION, IS A POSSIBLE COMPLICATION AND OFF LABEL USE AND/OR CONTRAINDICATED USE OF THE SUSPECT PRODUCTS. THE SUGGESTION WAS THAT THE OBSTRUCTING MATERIALS DUE TO BAE ORIGINATING FROM THE LESION ON MRI CAUSED INFARCTION IN THE REGION OF THE ANTERIOR SPINAL ARTERY IN THIS CASE. THE ASSESSMENT THAT THE SUSPECT PRODUCTS CAUSED THE EVENTS REMAINS SPECULATIVE AS NO STUDIES WERE CONDUCTED WHICH WOULD PROVE THE MECHANISM OF THE EVENT, OR THE SUBSTANCES INVOLVED IN LEADING TO THE INFARCTION. OF NOTE, THE PATIENT'S UNDERLYING MICROSCOPIC POLYANGIITIS MAY HAVE HAD A CONTRIBUTORY ROLE IN THE SPINAL ARTERY INFARCTION IN THIS PATIENT. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. (B)(6).