Description of Event or Problem · 1
JOURNAL REFERENCE: MERELLO M, TENCA E, LLORET SP, ET AL. PROSPECTIVE RANDOMIZED 1-YEAR FOLLOW-UP COMPARISON OF BILATERAL SUBTHALAMOTOMY VERSUS BILATERAL SUBTHALAMIC STIMULATION AND THE COMBINATION OF BOTH IN PARKINSON'S DISEASE PATIENTS: A PILOT STUDY. BR J NEUROSURG. 2008;22(3): 415-422. IT HAS BEEN SUGGESTED THAT POTENTIAL RISK OF HEMIBALLISMUS AFTER SUBTHALAMOTOMY MAKES DBS PREFERABLE TO ABLATION FOR IPD TREATMENT; HOWEVER, COST AND THE NEED FOR REGULAR ELECTRODE CONTROL HAVE ALSO BEEN OBSERVED AS DISADVANTAGES TO STIMULATION. THE OBJECTIVE WAS TO COMPARE EFFICACY AND SAFETY OF DIFFERENT SURGICAL APPROACHES TO STN, IN A PROSPECTIVE RANDOMIZED PILOT STUDY. SIXTEEN CONSECUTIVE IPD PATIENTS RANDOMIZED TO RECEIVE EITHER: BILATERAL STN-DBS (BS GROUP), BILATERAL SUBTHALAMOTOMY (BL GROUP), OR UNILATERAL SUBTHALAMOTOMY PLUS CONTRALATERAL STN-DBS IMPLANTATION (L/S GROUP), AND FOLLOWED FOR 12 MONTHS AFTER SURGERY. REPORTABLE EVENT: ONE PT IN THE BS GROUP PRESENTED A LARGE SUBCORTICAL BRAIN HAEMATOMA. A CANNULA FOR THE DBS CATHETER INTRODUCED, AT WHICH TIME THE PT SUDDENLY DEVELOPED A FACIAL DEVIATION, LOSS OF CONSCIOUSNESS AND PROGRESSIVE HEMIPLEGIA. THE CANNULA WAS REMOVED AND AN INTEROPERATIVE MRI SCAN PERFORMED CONFIRMING A THALAMIC HAEMATOMA. A FEW HRS LATER, CLINICAL DETERIORATION AND PROGRESSIVE WORSENING OF THE HAEMATOMA, CONFIRMED BY A NEW MRI SCAN, REQUIRED THE PT TO UNDERGO OPEN SURGERY FOR EVAL. THE PT DIED FROM CLINICAL COMPLICATIONS AFTER 20 DAYS IN INTENSIVE CARE. SEE MFG REPORT 2182207200805745.