Preclinical success but clinical failure of the sutureless excimer laser-assisted non-occlusive anastomosis (SELANA) slide.

ABSTRACT

BACKGROUND: The excimer laser-assisted non-occlusive anastomosis (ELANA) has been developed for intracranial bypass without the need for temporary recipient occlusion. We designed and tested a sutureless variant of the ELANA-the SELANA slide (SEsl). OBJECTIVE: This study aims to evaluate the SEsl preclinical results and describe its first clinical application. METHODS: First, in a cadaver study, 28 SEsl anastomoses were compared with 28 ELANA anastomoses. Second, in an acute rabbit model, 90 SEsl anastomoses were compared with 30 ELANA anastomoses. Finally, in a surviving pig model, 38 SEsl bypasses were created. To evaluate the clinical efficacy of the SEsl, we then treated one patient with a giant, right-sided middle cerebral artery (MCA) aneurysm with an intracranial-intracranial SEsl bypass and parent vessel occlusion. RESULTS: In preclinical studies, the SEsl anastomosis was shown to be equivalent or superior to the ELANA in terms of associated ease, patency, and bleeding complications. However, clinical application in rigid and arteriosclerotic receiving arteries was problematic. Although bypass creation and aneurysm occlusion were technically successful and the patient was postoperatively well, a pseudoaneurysm formed postoperatively at the internal carotid artery anastomosis and bled. Subsequent treatment failed and the patient did not survive. CONCLUSION: The SEsl showed promising preclinical results across three models. However, in its present form, it is not suitable for clinical application. TRIAL NUMBER IRB UMCU 10/154.