Table for Optimization and Monitoring of Cerebral Aneurysm Therapy (TOMCAT)

Abstract

Several unsolved problems in the treatment of cerebral aneurysms remain that could be addressed in a large multicenter registry. The Table for Optimization and Monitoring of Cerebral Aneurysm Therapy (TOMCAT) was launched to monitor the quality of care in the participating centers (http://www.aneurysma-studie.de). Case record forms (CRFs) were developed in consensus between neuroradiologists and neurosurgeons. CRFs were collected locally and sent to the Center for Neurologic Studies (“Zentrum fur Neurologische Studien” [ZNS]) in Essen, Germany. Initial clinical grade was assessed according to the World Federation of Neurological Surgeons' (WFNS) classification and outcome by the modified Rankin Scale (mRS). An mRS score ≤ 1 was defined as good outcome. After completion of a lead-in phase the database was read out for analysis. Rates of complications and of aneurysm remnants were calculated for anatomic localizations, aneurysm anatomy, and clinical presentation (WFNS). TOMCAT was launched as prospective registry within a single center in 03/2006. With inclusion of more centers, an enrollment rate of 20 patients per month was achieved. A total of 487 patients were included. Complete treatment information was available for 315 (64.7%). In case of completed CRFs, twelve patients were untreated, 278 were treated endovascularly (EVT, among them 86 unruptured aneurysms), and 25 surgically. Stent or balloon remodeling techniques were applied in 3.6% and 3.1% of cases, respectively. Bioactive coils were used in 14.4%. In EVT, the rate of procedural aneurysm perforation was 2.3% (2/86) in unruptured and 4.3% (8/186) in ruptured aneurysms. In unruptured aneurysms the rate of permanent neurologic complications was 3.4%. The rate of residual aneurysms was 14.2%, especially in large and MCA (middle cerebral artery) aneurysms. During the lead-in phase of TOMCAT, a stable enrollment could be established. However, as not all treated patients in the single centers are sent to the central database, only preliminary conclusions can be made. First, there is a low complication rate in unruptured aneurysms. Second, MCA aneurysms still appear to represent a challenge due to high rates of complications and residual aneurysms. Third, no difference was observed in the safety profiles of bare coils and of bioactive coils. An improvement of the data collection is launched with simplified datasets and an alternative electronic submission method together with online analysis tools.