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

Abstract

BackgroundThe 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).ObjectiveThis study aims to evaluate the SEsl preclinical results and describe its first clinical application.MethodsFirst, 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.ResultsIn 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.ConclusionThe SEsl showed promising preclinical results across three models. However, in its present form, it is not suitable for clinical application.Trial numberIRB UMCU 10/154.

Long-term feasibility of the new sutureless excimer laser-assisted non-occlusive anastomosis clip in a pig model

“…In previous studies on the SELANA slide (SEsl), the same comparison was made [ 9 – 11 ]. After determining the pre-clinical feasibility of the SEsl, the clinical application however failed due to the formation of a pseudoaneurysm [ 12 ]. Following extensive evaluation of the clinical case, essential changes were made to the device, which led to the SEcl design.…”

“…In previous studies on the SELANA slide (SEsl), the same comparison was made [9][10][11]. After determining the preclinical feasibility of the SEsl, the clinical application however failed due to the formation of a pseudoaneurysm [12].…”

“…Therefore, we developed a sutureless, mechanical anastomotic connection device, the SELANA slide (SEsl). The SEsl was proven feasible in laboratory and animal experiments [9][10][11] but failed during human application on the basis of formation of a pseudo aneurysm due to traction during insertion and translation in the ICA [12]. After careful evaluation of this clinical case, critical changes were made to the design to create an improved device: the SELANA clip (SEcl).…”

Innovations in the Surgery of Cerebral Aneurysms: Enhanced Visualization, Perfusion, and Function Monitoring

“…A sutureless variant of the ELANA-the SELANA slide-showed a preclinical success and clinical application started. Unfortunately, it was not shown suitable for clinical applications [62].…”

Editorial: The feasibility of the new sutureless excimer laser–assisted non-occlusive anastomosis clip in a rabbit model

“…This is why the Utrecht group has sought to develop a sutureless alternative for their laser-assisted technique of non-occlusive anastomosis between 2004 and 2010. The results on their first version were published in 2009 and the first clinical application was published in 2018 [4]. Here, the basic idea was to replace the sutured ring with a slide on which the graft is mechanically fixed and which is then pushed and anchored via two pins into the recipient vessel.…”