Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study.

BACKGROUND: Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE. METHODS: The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality. RESULTS: In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0-2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4-9.0] mm, and the median neck width was 3.6 [2.7-5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4-12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively. CONCLUSION: These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs.

Assessment of Aptamer-Targeted Contrast Agents for Monitoring of Blood Clots in Computed Tomography and Fluoroscopy Imaging.

Objective: Random formation of thrombi is classified as a pathological process that may result in partial or complete obstruction of blood flow and limited perfusion. Further complications include pulmonary embolism, thrombosis-induced myocardial infraction, ischemic stroke, and others. Location and full delineation of the blood clot are considered to be two clinically relevant aspects that could streamline proper diagnosis and treatment follow-up. In this work, we prepared two types of X-ray attenuating contrast formulations, using fibrinogen aptamer as the clot-seeking moiety. Methods: Two novel aptamer-targeted formulations were designed. Iodine-modified bases were directly incorporated into a fibrinogen aptamer (iodo-FA). Isothermal titration calorimetry was used to confirm that these modifications did not negatively impact target binding. Iodo-FA was tested for its ability to produce concentration-dependent contrast enhancement in a phantom CT. It was subsequently tested in vitro with clotted human and swine blood. This allowed for translation into ex vivo testing, using fluoroscopy. FA was also used to functionalize gold nanoparticles (FA-AuNPs), and contrast capabilities were confirmed. This formulation was tested in vitro using clotted human blood in a CT scan. Results: Unmodified FA and iodo-FA demonstrated a nearly identical affinity toward fibrin, confirming that base modifications did not impact target binding. Iodo-FA and FA-AuNPs both demonstrated excellent concentration-dependent contrast enhancement capabilities (40.5 HU mM-1 and 563.6 HU µM-1, respectively), which were superior to the clinically available agent, iopamidol. In vitro CT testing revealed that iodo-FA is able to penetrate into the blood clots, producing contrast enhancement throughout, while FA-AuNPs only accumulated on the surface of the clot. Iodo-FA was thereby translated to ex vivo testing, confirming target-binding associated accumulation of the contrast material at the location of the clot within the dilation of the external carotid artery. This resulted in a 34% enhancement of the clot. Conclusions: Both iodo-FA and FA-AuNPs were confirmed to be effective contrast formulations in CT. Targeting of fibrin, a major structural constituent of thrombi, with these novel contrast agents would allow for higher contrast enhancement and better clot delineation in CT and fluoroscopy.

Dural Substitutes Differentially Interfere with Imaging Quality of Sonolucent Transcranioplasty Ultrasound Assessment in Benchtop Model.

BACKGROUND: Sonolucent cranioplasty implants were recently introduced into clinical practice and tested for use with transcranioplasty ultrasound (TCUS). In situations where dural substitutes (DSs) are needed during closure, such as in extracranial-intracranial bypass, it is unclear if the DS influences the imaging quality of TCUS. The aim of this study was to assess the influence of DSs on imaging quality during TCUS assessment with sonolucent cranioplasty. METHODS: A tofu vascular brain model was constructed with a ClearFit implant in between 2 layers of tofu. Injection of saline solution through a 6-F Envoy DA XB endovascular catheter (6-F Envoy DA XB) inserted into the deeper tofu layer mimicked an intracranial vessel. TCUS image quality, including Doppler, with 4 different DSs (DuraGen, Durepair, DuraMatrix-Onlay, DuraMatrix Suturable) placed under the cranioplasty was compared against a control by 2 examiners. A literature search of MEDLINE and EMBASE was conducted to find previous reports of acoustic properties of DSs. RESULTS: TCUS assessment including Doppler was feasible with the model in longitudinal and axial planes, and the pulsatile particle injection was visualized in real time. DuraGen and Durepair showed Doppler quality and picture detail comparable to the control, while the DuraMatrix-Onlay and DuraMatrix Suturable were inferior to the control. The literature search yielded only 1 previous report on acoustic properties of DSs. CONCLUSIONS: DSs interfere differentially with imaging quality during TCUS assessment. However, these results are based on a benchtop model and need to be further assessed in the clinical setting.

Safety, Feasibility, and Patient-Rated Outcome of Sonolucent Cranioplasty in Extracranial-Intracranial Bypass Surgery to Allow for Transcranioplasty Ultrasound Assessment.

OBJECTIVE: We sought to analyze the safety and feasibility of elective sonolucent cranioplasty in the setting of extracranial-to-intracranial (EC-IC) bypass surgery to monitor bypass patency using ultrasound. METHODS: Patients who underwent direct EC-IC bypass surgery agreed to sonolucent cranioplasty at the time of surgery and received a sonolucent polymethyl methacrylate (PMMA) implant. Besides monitoring clinical outcome, all patients received transcranioplasty ultrasound (TCUS) on postoperative day 1 and at last follow-up. In addition, bypass patency was confirmed using catheter angiogram and fit of implant using computed tomography. Patient-rated outcome was assessed through phone questionnaire. RESULTS: EC-IC bypass surgery with PMMA cranioplasty was successful in all 7 patients with patent bypasses on postoperative angiogram. Direct TCUS was feasible in all patients, and bypass patency was monitored. There were no complications such as postoperative hemorrhagic/ischemic complications related to the bypass procedure in this patient population, as well as no complications related to the PMMA implant. Postoperative computed tomography showed favorable cosmetic results of the PMMA implant in both the pterional area for superficial temporal artery-middle cerebral artery bypasses and parietooccipital area for occipital artery-middle cerebral artery bypasses as confirmed by high-rated overall patient satisfaction with favorable cosmetic, pain, and sensory patient-rated outcomes. CONCLUSIONS: In this study we were able to show that this novel technique is safe, allows for patency assessment of the EC-IC bypass using bedside TCUS technique, and is cosmetically satisfying for patients.

Cognitive Sequelae of Unruptured and Ruptured Intracranial Aneurysms and their Treatment: Modalities for Neuropsychological Assessment.

BACKGROUND: Cognitive sequelae frequently follow subarachnoid hemorrhage (SAH) and include deficits across multiple domains of executive function. This factor affects overall functional outcomes negatively, especially in younger patients. Several clinical correlates predict development and severity of cognitive dysfunction after SAH. Hypothetical mechanisms of cognitive dysfunction in the absence of radiographic lesion include cerebral hypoperfusion and blood breakdown products, resulting in perturbed interneuronal communication and network synchrony, excitotoxicity, and altered microRNA expression. METHODS: The PubMed database was searched for articles discussing cognitive outcomes in patients with unruptured and ruptured intracranial aneurysmal disease, sequelae of treatment, and modalities for neuropsychologic testing. RESULTS: Treatment of unruptured intracranial aneurysms, although capable of preventing SAH, comes with its own set of complications and may also affect cognitive function. Neuropsychological tests such as the Montreal Cognitive Assessment, Mini-Mental Status Examination, and others have proved useful in evaluating cognitive decline. Studies using functional neurologic imaging modalities have identified regions with altered activation patterns during various cognitive tasks. The sum of research efforts in this field has provided useful insights and an initial understanding of cognitive dysfunction after aneurysm treatment and SAH that should prove useful in guiding and rendering future investigations more fruitful. CONCLUSIONS: Development of finer and more sensitive neuropsychological tests in evaluating the different domains of cognitive function after aneurysm treatment and SAH in general will be useful in accurately determining outcomes after ictus and comparing efficacy of different therapeutic strategies.

Prolapse of the Pipeline embolization device in aneurysms: incidence, management, and outcomes.

OBJECTIVE The Pipeline embolization device (PED) is frequently used in the treatment of anterior circulation aneurysms, especially around the carotid siphon, with generally excellent results. However, the PED has its own unique technical challenges, including the occurrence of device foreshortening or migration leading to prolapse into the aneurysm. The authors sought to determine the incidence of this phenomenon, the rescue strategies, and outcomes. METHODS Four institutional databases of neuroendovascular procedures were reviewed for cases of intracranial aneurysms treated with PEDs. Patient and aneurysm data as well as angiographic imaging were reviewed for all cases involving device prolapse into the aneurysm. RESULTS A total of 413 intracranial aneurysms were treated with PEDs during the study period, by 5 neurointerventionalists. Large and giant aneurysms (≥ 2 cm) accounted for 32 of these aneurysms. Among these 32 PEDs, prolapse into the aneurysm occurred in 3 patients, with 1 of these PEDs successfully rescued and the other 2 left in situ. No patients suffered any severe complications. The 2 patients in whom the PEDs were left in situ remained on antiplatelet therapy. CONCLUSIONS The PED may foreshorten or migrate during or after deployment, leading to prolapse into the aneurysm. This phenomenon appears to be associated with large and giant aneurysms, vessel tortuosity, short landing zones, and use of balloon angioplasty. Future study and follow-up is needed to further evaluate this phenomenon, but some of the observations and techniques described in this paper may help to prevent or salvage prolapsed devices.

Evaluation of C-arm CT metal artifact reduction algorithm during intra-aneurysmal coil embolization: Assessment of brain parenchyma, stents and flow-diverters.

PURPOSE: Flat panel C-arm CT images acquired in the interventional suite provide valuable information regarding brain parenchyma, vasculature, and device status during the procedure. However, these images often suffer from severe streak artifacts due to the presence of metallic objects such as coils. These artifacts limit the capability to make diagnostic inferences and thus need to be reduced for better image interpretation. The main purpose of this paper is to systematically evaluate the accuracy of one such C-arm CT based metal artifact reduction (MAR) algorithm and to demonstrate its usage in both stent and flow diverter assisted coil embolization procedures. METHODS: C-arm CT images routinely acquired in 24 patients during coil embolization procedure (stent-assisted (12) and flow-diverter assisted (12)) were included in this study in a retrospective fashion. These images were reconstructed without and with MAR algorithm on an offline workstation and compared using quantitative image analysis metrics. This analysis was carried out to assess the improvements in both brain parenchyma and device visibility with MAR algorithm. Further, ground truth reference images from phantom experiments and clinical data were used for accurate assessment. RESULTS: Quantitative image analysis of brain parenchyma showed uniform distribution of grayscale values and reduced image noise after MAR correction. The line profile plot analysis of device profile in both phantom and clinical data demonstrated improved device visibility with MAR correction. CONCLUSIONS: MAR algorithm successfully reduced streak artifacts from coil embolization in all cases, thus allowing more accurate assessment of devices and adjacent brain parenchyma.