Description of Event or Problem · 0
AS A MANDATED REPORTER, I SUBMIT EXCERPTS FROM AN ARTICLE PUBLISHED ONLINE BY CAMBRIDGE UNIVERSITY PRESS: (B)(6). I DO SO BECAUSE ECT DEVICE MANUFACTURERS ARE NEGLIGENT IN SUBMITTING POST-MARKET SURVEILLANCE IN A TIMELY FASHION. "DUE TO THE LACK OF LONG-TERM STUDIES, IT REMAINS UNKNOWN WHETHER THESE EARLY ECT-INDUCED GMV [GRAY MATTER VOLUME] CHANGES ARE PERSISTENT OVER TIME. ALL PARTICIPANTS WERE PART OF THE MÜNSTER NEUROIMAGING COHORT RECRUITED FROM (B)(6) 2010 TO (B)(6) 2018. THE FINAL STUDY SAMPLE INCLUDES N = 50 INPATIENTS WITH ACUTE MDD OF WHICH N = 17 PATIENTS UNDERWENT ECT AND N = 33 RECEIVED TREATMENT AS USUAL (TAU), MEANING INPATIENT TREATMENT WITH MEDICATION AND PSYCHOTHERAPY. ADDITIONALLY, N = 21 HEALTHY CONTROLS (HC) WERE RECRUITED THROUGH PUBLIC NOTICES AND NEWSPAPER ANNOUNCEMENTS. EXCLUSION CRITERIA FOR ALL PARTICIPANTS WERE ANY NEUROLOGICAL ABNORMALITIES OR PREVIOUS TRAUMATIC HEAD INJURY, ORGANIC MENTAL DISORDERS, CHRONIC MEDICAL DISEASES, BENZODIAZEPINE INTAKE AT STUDY TIME OR MRI CONTRAINDICATIONS. PATIENTS IN THE ECT GROUP WERE DEFINED AS TREATMENT-RESISTANT ACCORDING TO BERLIM AND TURECKI (BERLIM & TURECKI, 2007), AS THEY FAILED TO RESPOND TO AT LEAST TWO ADEQUATE ANTIDEPRESSANT TRIALS. THEY RECEIVED ADJUVANT PSYCHOPHARMACOLOGICAL MEDICATION DURING THE ECT SERIES. PATIENTS IN THE TAU GROUP NEVER RECEIVED ECT BEFORE T0 NOR AT ANY TIME BETWEEN STUDY TIME POINTS. FURTHER EXCLUSION CRITERION FOR HC WAS ANY LIFE TIME DIAGNOSIS OF PSYCHIATRIC DISORDER ACCORDING TO THE SCID-I (WITTCHEN ET AL., 1997). ADDITIONALLY, HC SCORED BELOW CUT-OFFS FOR CLINICALLY REMARKABLE DEPRESSIVE SYMPTOMS ON THE BDI I (BECK & STEER, 1987) AND THE HDRS (HAMILTON, 1960) AT ALL THREE TIME POINTS. ALL PATIENTS IN THE ECT GROUP STAYED AT INPATIENT TREATMENT DURING THE WHOLE ECT SERIES. USING THE THYMATRON IV SYSTEM (SOMATICS INC., LAKE BLUFF, IL), BRIEF PULSE ECT WAS CONDUCTED TWO OR THREE TIMES A WEEK. STARTING WITH NINE TO TWELVE SESSIONS OF ECT, SESSIONS WERE CONTINUED IF PATIENTS DID NOT EXPERIENCE SYMPTOM RELIEF. WHILE ELECTRODE PLACEMENT IN ONE PATIENT WAS NOT RECORDED, THE OTHER 16 PATIENTS IN THE ECT GROUP INITIALLY RECEIVED RIGHT UNILATERAL ECT. IN TWO PATIENTS, ECT TREATMENT WAS SWITCHED TO BILATERAL ECT AS UNILATERAL TREATMENT FAILED TO ACHIEVE SUFFICIENT SYMPTOM IMPROVEMENT. STRUCTURAL DATA OF ALL PARTICIPANTS WERE OBTAINED USING A RESEARCH DEDICATED 3-TESLA-MRI. GRAY MATTER SEGMENTS WERE MODULATED BY NON-LINEAR COMPONENTS ONLY TO PRESERVE ACTUAL GM VALUES LOCALLY (MODULATED GM VOLUMES). ACCORDING TO THE DEFINITION OF AT LEAST 50% DECREASE ON THE HDRS TOTAL SCORE FROM T0 TO T1, THERE WERE 58.8% (N = 10) RESPONDERS AND 41.2% (N = 7) NON-RESPONDERS TO ECT. STRENGTHENING PREVIOUS FINDINGS, OUR RESULTS REVEAL THAT GMV IN REGIONS WITH INITIAL ECT-INDUCED GMV INCREASE DECLINE OVER THE COURSE OF 2 YEARS AFTER ECT. NO SUCH EFFECTS WERE OBSERVED IN CONTROL GROUPS. SHORT-TERM GMV INCREASE CORRELATED WITH IMMEDIATE AND DELAYED SYMPTOM INCREASE, WHILE LONG-TERM GMV DECREASE CORRELATED WITH POOR LONG-TERM DEPRESSIVE OUTCOME. OUR RESULTS EXTEND PREVIOUS FINDINGS BY SUGGESTING THAT GMV INCREASES FOLLOWING ECT ARE TEMPORARY, AS GMV SIGNIFICANTLY DECREASES OVER 2 YEARS IN THE ECT GROUP. THESE CHANGES WERE ALSO EVIDENT WHEN CONTROLLING FOR DEPRESSION SEVERITY. NO SUCH CHANGES WERE OBSERVED IN CONTROL GROUPS. EXPLORATORY CORRELATION ANALYSES IN THE ECT GROUP REVEALED THAT THOSE WITH THE LARGEST SHORT-TERM GMV INCREASE HAD THE STRONGEST LONG-TERM GMV DECLINE. THEREBY, WE OBSERVED GLOBAL GMV INCREASES FOLLOWING ECT, FOLLOWED BY GLOBAL GMV DECREASES IN THE SAME AREAS 2 YEARS LATER. THOUGH THESE RESEARCHERS DID NOT EXPLICITLY DESCRIBE WHAT LOSS OF GRAY MATTER VOLUME MEANS, THE CLEVELAND CLINIC STATES, "GREY MATTER DECREASES (ATROPHIES) WHEN ITS NERVE CELLS DIE. A COMMON CAUSE OF GREY MATTER NERVE CELL DEATH IS A LACK OF BLOOD FLOW TO THE CELLS. AS THESE CELLS ARE CONSTANTLY WORKING, THEY REQUIRE A LARGE SUPPLY OF OXYGEN (THROUGH YOUR BLOOD) TO FUNCTION EFFICIENTLY. CONDITIONS RELATED TO GREY MATTER DAMAGE INCLUDE: ALZHEIMER'S DISEASE, PARKINSON'S DISEASE, MULTIPLE SCLEROSIS (MS), AND TRAUMATIC BRAIN INJURY. HTTPS://MY.CLEVELANDCLINIC.ORG/HEALTH/BODY/24831-GREY-MATTER IN OTHER WORDS, LOSS OF GRAY MATTER VOLUME THAT DID NOT OCCUR IN CONTROLS INDICATES ECT CAUSES CONTINUOUS AND PROGRESSIVE BRAIN DAMAGE. LEST WE FORGET, 21 CFR PART 882 (PAGES 66120-1) STATES: "IF A PMA IS NOT FILED WITHIN 90 DAYS AFTER THE ISSUANCE OF A FINAL ORDER, AND THE DEVICE IS NOT DISTRIBUTED FOR INVESTIGATIONAL USE UNDER AN IDE, THE DEVICE IS DEEMED TO BE ADULTERATED WITHIN THE MEANING OF SECTION 501(F)(1)(A) OF THE FD&C ACT, & SUBJECT TO SEIZURE & CONDEMNATION UNDER SECTION 304 OF THE FD&C ACT (21 U.S.C. 334) IF ITS DISTRIBUTION CONTINUES. "IF A PMA FOR A CLASS III DEVICE IS NOT FILED WITH FDA BY MARCH 26, 2019, THE DEVICE WILL BE DEEMED ADULTERATED UNDER SECTION 501(F) OF THE FD&C ACT. "IF A 510(K) AMENDMENT IS NOT SUBMITTED BY (B)(6), 2019 OR IF FDA DETERMINES THAT THE AMENDMENT DOES NOT DEMONSTRATE COMPLIANCE WITH THE SPECIAL CONTROLS, THE DEVICE MAY BE CONSIDERED ADULTERATED UNDER SECTION 501 (F)(1)(A) OF THE FD&C ACT, AND SUBJECT TO SEIZURE AND CONDEMNATION UNDER SECTION 304 OF THE FD&C ACT (21 U.S.C. 334) IF ITS DISTRIBUTION CONTINUES. OTHER ENFORCEMENT ACTIONS INCLUDE BUT ARE NOT LIMITED TO, THE FOLLOWING: SHIPMENT OF DEVICES IN INTERSTATE COMMERCE WILL BE SUBJECT TO INJUNCTION; INDIVIDUALS RESPONSIBLE FOR SUCH SHIPMENT WILL BE SUBJECTED TO PROSECUTION. WITHOUT PMA & PDP, FDA SHOULD HAVE DEEMED ECT DEVICES ADULTERATED IN (B)(6) 2019.