Neuroprotective effects of dynamic bubble trap use in patients undergoing pulmonary endarterectomy: a two-arm randomized controlled trial

BACKGROUND: During cardiosurgical procedures that use extracorporeal circulation (ECC), a variety of neurological complications can occur, and postoperative cognitive deficits remain an unsolved problem. Among the sources of these complications are intraoperatively detectable cerebral microemboli, which mainly consist of air. This study’s purpose was to assess neuroprotective effects of reducing these gaseous microemboli using a dynamic bubble trap (DBT) in patients undergoing pulmonary endarterectomy (PEA) for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). METHODS: Patients undergoing PEA were randomly assigned to receive either a DBT (n=47) or no additional device (controls, n=46) during ECC. Neuropsychological testing was performed before and 3 months after PEA. The primary endpoint was cognitive improvement in the DBT group (n=29) compared with the control group (n=42). As secondary endpoint, ischemic brain micro-lesions were analyzed on postoperative days 6 through 10 using diffusion-weighted magnetic resonance imaging (MRI). RESULTS: Analysis of interaction effects revealed improved performance in visual long-term memory (P=0.008, η(2)=0.099), verbal long-term memory (P=0.030, η(2)=0.067), verbal short-term memory (P=0.014, η(2)=0.083), and attention and processing speed (P=0.043, η(2)=0.056) from pre- to post-testing in the DBT group compared to control group. In MRI, postoperative ischemic micro-lesions could only be detected in one patient; another patient suffered a severe bihemispheric embolic stroke. CONCLUSIONS: DBT positively influences memory function after PEA. This effect is most likely caused by the reduction of gaseous microemboli. TRIAL REGISTRATION: This study is registered in the German Clinical Trials Register, ID: DRKS00021499.