Ex vivo evaluation of a multilayered sealant patch for watertight dural closure: cranial and spinal models.

Cerebrospinal fluid leakage is a frequent complication after cranial and spinal surgery. To prevent this complication and seal the dura watertight, we developed Liqoseal, a dural sealant patch comprising a watertight polyesterurethane layer and an adhesive layer consisting of poly(DL-lactide-co-ε-caprolactone) copolymer and multiarmed N-hydroxylsuccinimide functionalized polyethylene glycol. We compared acute burst pressure and resistance to physiological conditions for 72 h of Liqoseal, Adherus, Duraseal, Tachosil, and Tisseel using computer-assisted models and fresh porcine dura. The mean acute burst pressure of Liqoseal in the cranial model (145 ± 39 mmHg) was higher than that of Adherus (87 ± 47 mmHg), Duraseal (51 ± 42 mmHg) and Tachosil (71 ± 16 mmHg). Under physiological conditions, cranial model resistance test results showed that 2 of 3 Liqoseal sealants maintained dural attachment during 72 hours as opposed to 3 of 3 for Adherus and Duraseal and 0 of 3 for Tachosil. The mean burst pressure of Liqoseal in the spinal model (233 ± 81 mmHg) was higher than that of Tachosil (123 ± 63 mmHg) and Tisseel (23 ± 16 mmHg). Under physiological conditions, spinal model resistance test results showed that 2 of 3 Liqoseal sealants maintained dural attachment for 72 hours as opposed to 3 of 3 for Adherus and 0 of 3 for Duraseal and Tachosil. This novel study showed that Liqoseal is capable of achieving a strong watertight seal over a dural defect in ex vivo models.

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

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.