The Sutureless Excimer Laser Anastomosis Clip Pilot Study: a feasibility and safety study.

BACKGROUND: The excimer laser-assisted non-occlusive anastomosis (ELANA) bypass technique may have the advantage of its non-occlusive design in the treatment of last-resort cases where endovascular treatment or direct clipping is considered to be unsafe. However, the technique remains technically challenging. Therefore, a sutureless ELANA Clip device (SEcl) was developed to simplify the technique avoiding tedious anastomosis stitching in depth. The present study investigates the clinical feasibility and safety of the SEcl technique. METHODS: Three patients with complex and large aneurysms in the anterior circulation were selected after multidisciplinary consensus that the aneurysms were too complex for endovascular or direct clipping treatment options. Bypass surgery was considered as a last-resort treatment option, and after preoperative evaluation and informed consent, SEcl bypass surgery was performed. Applicability, technical aspects and patient outcomes are assessed. RESULTS: All aneurysms were excluded from the circulation. The creation of the intracranial anastomosis was easier and faster. No device-related serious adverse events were encountered, and all outcomes were favorable (one patient stable Modified Rankin Scale, two patients improved). CONCLUSION: The SEcl anastomosis technique is feasible and, considering the severity of the disease, relatively safe. It can be considered a treatment option in very difficult-to treat last-resort aneurysm cases. From this study, further developments in minimizing clip size and application in cardiac surgery are initiated.

Histological and magnetic resonance imaging assessment of Liqoseal in a spinal in vivo pig model.

BACKGROUND: Liqoseal (Polyganics, B.V.) is a dural sealant patch for preventing postoperative cerebrospinal fluid (CSF) leakage. It has been extensively tested preclinically and CE (Conformité Européenne) approved for human use after a first cranial in-human study. However, the safety of Liqoseal for spinal application is still unknown. The aim of this study was to assess the safety of spinal Liqoseal application compared with cranial application using histology and magnetic resonance imaging characteristics. METHODS: Eight female Dutch Landrace pigs underwent laminectomy, durotomy with standard suturing and Liqoseal application. Three control animals underwent the same procedure without sealant application. The histological characteristics and imaging characteristics of animals with similar survival times were compared to data from a previous cranial porcine model. RESULTS: Similar foreign body reactions were observed in spinal and cranial dura. The foreign body reaction consisted of neutrophils and reactive fibroblasts in the first 3 days, changing to a chronic granulomatous inflammatory reaction with an increasing number of macrophages and lymphocytes and the formation of a fibroblast layer on the dura by day 7. Mean Liqoseal plus dura thickness reached a maximum of 1.2 mm (range 0.7-2.0 mm) at day 7. CONCLUSION: The spinal dural histological reaction to Liqoseal during the first 7 days was similar to the cranial dural reaction. Liqoseal did not swell significantly in both application areas over time. Given the current lack of a safe and effective dural sealant for spinal application, we propose that an in-human safety study of Liqoseal is the logical next step.

Spinal fixation after laminectomy in pigs prevents postoperative spinal cord injury.

BACKGROUND: A safe, effective, and ethically sound animal model is essential for preclinical research to investigate spinal medical devices. We report the initial failure of a porcine spinal survival model and a potential solution by fixating the spine. METHODS: Eleven female Dutch Landrace pigs underwent a spinal lumbar interlaminar decompression with durotomy and were randomized for implantation of a medical device or control group. Magnetic resonance imaging (MRI) was performed before termination. RESULTS: Neurological deficits were observed in 6 out of the first 8 animals. Three of these animals were terminated prematurely because they reached the predefined humane endpoint. Spinal cord compression and myelopathy was observed on postoperative MRI imaging. We hypothesized postoperative spinal instability with epidural hematoma, inherent to the biology of the model, and subsequent spinal cord injury as a potential cause. In the subsequent 3 animals, we fixated the spine with Lubra plates. All these animals recovered without neurological deficits. The extent of spinal cord compression on MRI was variable across animals and did not seem to correspond well with neurological outcome. CONCLUSION: This study shows that in a porcine in vivo model of interlaminar decompression and durotomy, fixation of the spine after lumbar interlaminar decompression is feasible and may improve neurological outcomes. Additional research is necessary to evaluate this hypothesis.

Safety and biodegradability of a synthetic dural sealant patch (Liqoseal) in a porcine cranial model.

Background: Liqoseal consists of a watertight layer of poly(ester)ether urethane and an adhesive layer containing polyethylene glycol-N-hydroxysuccinimide (PEG-NHS). It is designed to prevent cerebrospinal fluid (CSF) leakage after intradural surgery. This study assessed the safety and biodegradability of Liqoseal in a porcine craniotomy model. Methods: In 32 pigs a craniotomy plus durotomy was performed. In 15 pigs Liqoseal was implanted, in 11 control pigs no sealant was implanted and in 6 control pigs a control dural sealant (Duraseal or Tachosil) was implanted. The safety of Liqoseal was evaluated by clinical, MRI and histological assessment. The degradation of Liqoseal was histologically estimated. Results: Liqoseal, 2 mm thick before application, did not swell and significantly was at maximum mean thickness of 2.14 (±0.37) mm at one month. The foreign body reaction induced by Liqoseal, Duraseal and Tachosil were comparable. Liqoseal showed no adherence to the arachnoid layer and was completely resorbed between 6 and 12 months postoperatively. In one animal with Liqoseal, an epidural fluid collection containing CSF could not be excluded. Conclusion: Liqoseal seems to be safe for intracranial use and is biodegradable. The safety and performance in humans needs to be further assessed in clinical trials.

Final Results of the Prospective Multicenter Excimer Laser-Assisted High-Flow Bypass Study on the Treatment of Giant Anterior Circulation Aneurysms.

BACKGROUND: Both conventional bypass utilizing temporary recipient vessel occlusion and the excimer laser-assisted nonocclusive anastomosis (ELANA) bypass technique are possible strategies in the treatment of giant aneurysms. These treatments have only been studied in single institutional retrospective studies. The potential advantage of the ELANA technique is the absence of temporary occlusion of major arteries, decreasing the risk of intraoperative ischemia. OBJECTIVE: To investigate the risks and potential benefits of high-flow bypass surgery for giant and complex aneurysms of the anterior cerebral circulation. In addition, the effectiveness of the ELANA bypass procedure in the treatment of these aneurysms is determined. METHODS: A total of 37 patients were included in 8 vascular neurosurgical centers in the United States, Canada, and Europe. A 30-d postoperative bypass follow-up was studied by using digital subtraction angiography and/or magnetic resonance angiography and computed tomography angiography to assess patency as well as by clinical monitoring in all patients. RESULTS: In 35 patients, an ELANA high-flow bypass was performed and the aneurysm treated. Four patients had remaining neurological deficits after 30 d caused by stroke (11.4%). These strokes were not related to the ELANA anastomosis device. CONCLUSION: This study does not prove that the ELANA technique has an advantage over conventional bypass techniques, but it appears to be an acceptable alternative to conventional transplanted high-flow bypass in this very-difficult-to-treat patient group, especially in select patients whom cannot be bypassed using conventional means in which temporary occlusion is considered to be not recommended.

Usefulness of Sealants for Dural Closure: Evaluation in an In Vitro Model.

BACKGROUND: Cerebrospinal fluid (CSF) leakage occurs in 4% to 32% of cranial surgeries and is associated with significant patient burden and expense. The use of sealant as an adjunct to primary dural closure is assumed to help prevent CSF leakage. OBJECTIVE: To examine the utility of different sealants for dural closure using an in Vitro model. METHODS: We evaluated 9 commonly used dural sealants, including Tachosil (Takeda Inc, Osaka, Japan), Adherus (Hyperbranch Inc, Durham, North Carolina), Duraform (Codman, Raynham, Massachusetts), Tissudura (Baxter, Deerfield, Illinois), Hemopatch (Baxter), TissuePatchDural (Tissuemed, Leeds, United Kingdom), Tisseel (Baxter), Duragen Secure (Integra, Plainsboro, New Jersey), and Duraseal, (Integra). Sealants were tested in 2 novel in Vitro setups using fresh porcine dura: the first tested the acute burst pressure of a sealed 3-mm gap, while the second examined resistance to a pressure wave mimicking intracranial pressure for 72 h. RESULTS: Adherus showed the highest mean burst pressure (87 ± 47 mmHg) followed by Tachosil (71 ± 16 mmHg) and Duraseal (51 ± 42 mmHg); these were the only 3 sealants showing burst pressures above normal physiological intracranial pressure. In the 72-h setup, only Adherus and Duraseal maintained appropriate sealing for the duration of the experiment. Tachosil released from the dura after 1.4 h (95% confidence interval, -1.8-4.7). CONCLUSION: Given the high cost of sealants and the results of this study, we advocate a critical attitude toward sealant application as an adjunct to classic dural closure.