| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN NEUROENDOSCOPE | ENDOSCOPE, NEUROLOGICAL | MEDTRONIC NEUROSURGERY | GWG | UNKNOWN-ES | UNKNOWN-ES | UNKNOWN | * | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-04-04 | 0 | 1. D; 2. H; 3. R |
Patient 1
PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
ALEXANDER G. WEIL, MD , FRCSC , ARIA FALLAH, MD , MS C, FRCSC , PARTHASARATHI CHAMIRAJU, MD , JOHN RAGHEB, MD , AND SANJIV BHATIA, MD. ENDOSCOPIC THIRD VENTRICULOSTOMY AND CHOROID PLEXUS CAUTERIZATION WITH A RIGID NEUROENDOSCOPE IN INFANTS WITH HYDROCEPHALUS. JOURNAL OF NEUROSURGERY PEDIATRICS 17 (2016). DOI: 10.3171/2015.5.PEDS14692. OBJECTIVE COMBINING ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) WITH CHOROID PLEXUS CAUTERIZATION (CPC) HAS BEEN SHOWN TO IMPROVE THE SUCCESS RATE COMPARED WITH ETV ALONE IN INFANTS (LESS THAN 24 MONTHS) WITH HYDROCEPHALUS WHO WERE TREATED IN DEVELOPING COUNTRIES. THE AUTHORS SOUGHT TO EVALUATE THE SAFETY AND EFFICACY OF THIS PROCEDURE, USING A RIGID NEUROENDOSCOPE, IN A SINGLE NORTH AMERICAN CENTER, AND TO ASSESS WHETHER THE ETV SUCCESS SCORE (ETVSS), THE CURE CHILDREN?S HOSPITAL OF UGANDA ETVSS (CCHU ETVSS), AND OTHER PRE- AND INTRAOPERATIVE VARIABLES COULD PREDICT SUCCESS. METHODS THE AUTHORS PERFORMED A RETROSPECTIVE REVIEW OF CONSECUTIVE ETV/CPC PROCEDURES PERFORMED USING A RIGID NEUROENDOSCOPE TO TREAT INFANTILE HYDROCEPHALUS. THE INFANTS UNDERWENT THE PROCEDURE AT MIAMI CHILDREN?S HOSPITAL BETWEEN JANUARY 2007 AND 2014, WITH AT LEAST ONE POSTOPERATIVE FOLLOW-UP. DURATION OF FOLLOW-UP OR TIME TO FAILURE OF ETV/CPC, THE PRIMARY OUTCOME MEASURE, WAS DOCUMENTED. A REPEAT CSF DIVERSION PROCEDURE OR DEATH WAS CONSIDERED AS A FAILURE OF ETV/CPC. THE TIME TO EVENT WAS MEASURED USING A KAPLAN-MEIER ANALYSIS. THE AUTHORS ANALYZED ETVSS, CCHU ETVSS, AND PRE- AND INTRAOPERATIVE VARIABLES TO DETERMINE THEIR SUITABILITY TO PREDICT SUCCESS. RESULTS EIGHTY-FIVE PATIENTS (45 BOYS) WITH A MEAN AGE OF 4.3 MONTHS (RANGE 1 DAY TO 20 MONTHS) UNDERWENT ETV/CPC. ETIOLOGY INCLUDED INTRAVENTRICULAR HEMORRHAGE OF PREMATURITY IN 44 PATIENTS (51.7%), MY ELOMENINGOCELE (MMC) IN 7 (8.2%), CONGENITAL AQUEDUCTAL STENOSIS IN 12 (14.1%), CONGENITAL COMMUNICATING HYDROCEPHALUS IN 6 (7.1%), DANDY-WALKER COMPLEX IN 6 (7.1%), POSTINFECTIOUS HYDROCEPHALUS IN 5 (5.8%), AND OTHER CAUSE IN 5 (5.8%). SIX PROCEDURE-RELATED COMPLICATIONS OCCURRED IN 5 (5.8%) PATIENTS, INCLUDING 2 HYGROMAS, 1 CSF LEAK, AND 3 INFECTIONS. THERE WERE 3 MORTALITIES IN THIS COHORT. ETV/CPC WAS SUCCESSFUL IN 42.1%, 37.7%, AND 36.8% OF PATIENTS AT 6, 12, AND 24 MONTHS FOLLOW-UP, RESPECTIVELY. THE MEDIAN (95% CI) TIME TO ETV/CPC FAILURE WAS 4.0 MONTHS (0.9?7.1 MONTHS). IN UNIVARIATE ANALYSES, BOTH THE ETVSS (HAZARD RATIO [HR] 1.03; 95% CI 1.01?1.05; P = 0.004) AND CCHU ETVSS (HR 1.48; 95% CI 1.04?2.09; P = .028) WERE PREDICTIVE OF OUTCOME FOLLOWING ETV/CPC. IN MULTIVARIATE ANALYSIS, THE PRESENCE OF PREPONTINE SCARRING WAS ASSOCIATED WITH ETV/CPC FAILURE (HR 0.34; 95% CI 0.19?0.63; P
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OUTCOMES OF THE STUDY, COMPLICATIONS WERE NOT RELATED TO ANY DEVICE MALFUNCTION. IN SOME CASES, THE CHANNEL NEUROENDOSCOPES WERE USED TO EXECUTE THE PROCEDURE, BUT THE COMPLICATIONS WERE NOT RELATED TO THE DEVICE.