Investigator-initiated clinical trial of stabilizer device: A novel intracranial exchange guidewire for neuroendovascular treatments.

BACKGROUND: Neuroendovascular procedures, especially those involving significant vessel tortuosity, giant intracranial aneurysms, or distally located lesions, frequently necessitate exchange methods. However, exchange maneuvers pose a risk of inadvertent vessel injury. To address these challenges, a Stabilizer device was developed and evaluated for its efficacy and safety. This clinical trial aimed to assess the efficacy and safety of the Stabilizer device in facilitating the navigation of neuroendovascular devices to target lesions in cases where the exchange technique was necessary. METHODS: This was a single-arm, prospective, open-label, multicenter clinical trial performed at nine different sites. It focused on investigating the use of the Stabilizer device for treating intracranial aneurysms and atherosclerosis. RESULTS: A total of 31 patients were enrolled across nine centers in Japan from July 21, 2022, to March 10, 2023. The study enrolled 24 (77.4%) patients with intracranial aneurysms and seven (22.6%) patients with intracranial artery stenosis. Majority of the target lesions were in the middle cerebral artery territory (83.9%). The Stabilizer device was used to exchange for 0.027-inch catheters, intermediate catheters, PTA balloons, and Wingspan stent system. The Stabilizer device demonstrated 100% technical success rate. While three complications related to the treatment were noted, there were no complications related to the device, including any vascular damage. CONCLUSIONS: This is the first multicenter clinical trial that investigated and demonstrated technical efficacy as well as overall safety profile of the Stabilizer device in neuroendovascular procedures where the use of an exchange method was necessary.

It Is Necessary to Pay Attention to Where the Pcom Originate from the Aneurysm to Treat with FD.

Objective With the expansion of indications of flow diverter (FD) for cerebral aneurysms, FD placement for posterior communicating artery (Pcom) aneurysms has been approved. However, it is controversial whether Pcom aneurysms should be treated with FD or not. In this study, we report the outcome of FD treatment for Pcom aneurysms in Japan. Materials and Methods We retrospectively analyzed 36 patients with 38 aneurysms treated with FD placement for Pcom aneurysms between 2015 and 2021 in our hospital. We divided our cases into complete occlusion (CO) and non-CO groups. And we extracted contributing factors to CO using multivariate analysis. We also compared the complications rate among the three types of FDs. Results CO was obtained in 29 cases (79.3%), and complications were observed in 3 cases (7.9%). Multivariate analysis revealed that the type of Pcom branch from the aneurysmal dome was a significant factor contributing to CO (odds ratio: 0.0052, 95% confidence interval 0.000048-0.584, p = 0.029). In terms of complications, complication rate was significantly higher in the Flow-Redirection Endoluminal Device (FRED) group ( p = 0.0491). Conclusion The outcome for Pcom aneurysms treated by FD was acceptable. When treating, we must pay attention to where Pcom originates. Achieving CO with FD is difficult for aneurysms where the Pcom branches from the dome. Furthermore, when treating Pcom aneurysms with FRED, it is necessary to be careful about thromboembolic complications.

Trends and Progress in Neuroendovascular Treatment in Japan: Japanese Registry of Neuroendovascular Therapy (JR-NET) 4. Main Report.

We reported the main results of the Japanese Registry of Neuroendovascular Therapy (JR-NET) 4, a nationwide surveillance of therapy (NET) in Japan from January 2015 to December 2019. JR-NET 4 registered consecutive patients who underwent NETs by Japan Society of Neuroendovascular Therapy (JSNET) -certified specialists. The primary endpoint was functional independence (mRS score of 0-2) at 30 days post-NET, with secondary endpoints focusing on technical success and major adverse events within 30 days.A total of 63,230 patients and 60,354 NET procedures from 166 participating centers were analyzed. During the study period, NET cases have consistently increased, with an increase in the proportion of elderly patients. A significant trend shift was observed in the distribution of NET procedures, with endovascular treatment for acute ischemic stroke that showed a dramatic increase in 5 years. This trend aligns with key randomized clinical trials from 2015 that presented the efficacy of this treatment. Clinical outcomes at 30 days posttreatment revealed that endovascular treatment for acute ischemic stroke and other NETs maintained safety and effectiveness despite varying prevalence of functional independence between target diseases. The study also observed a steady increase in emergency treatment cases, reflecting the increase in acute ischemic stroke, a time-sensitive medical condition.This comprehensive surveillance highlights the trend of NET practices in Japan, driven by clinical evidence and advancements in treatment devices. Although these findings were specific to Japan, they offer valuable insights into the broader trends in NETs and acute stroke care.

Endovascular Treatment of Bifurcation Aneurysms with the Woven EndoBridge: Product Features and Selected Results of Off-Label Use.

Treatment for wide-neck bifurcation cerebral aneurysms (WNBAs) is widely performed by endovascular treatment as well as open surgical clipping. However, due to factors such as the shape and size of the aneurysms, as well as the anatomical features of surrounding branch vessels, there are some cases in which simple coiling or conventional adjunctive techniques, such as balloon-assisted or neck bridge stent-assisted coiling, are not sufficient to achieve a satisfactory cure. Against this backdrop, the device known as the Woven EndoBridge (WEB) (MicroVention, Aliso Viejo, CA, USA) was developed and can be deployed directly into the aneurysm for treatment. Over a decade has passed since its development, and it is now used in many countries worldwide. This review provides insights into the evolution of the WEB device from its development to the date of this writing, highlighting the unique features of the device and its treatment indications. Additionally, it discusses the posttreatment course, perspectives on recurrence and retreatment, imaging assessments, and potential off-label use based on numerous studies primarily conducted in Europe and the USA.

A Single-Center Experience of Mechanical Thrombectomy for Cancer-Associated Ischemic Stroke.

Objectives: Cancer-associated ischemic stroke tends to extend over multiple vascular territories and develops under poor general conditions. Owing to the rarity of such cases and poor prognoses, no comprehensive studies on mechanical thrombectomy for cancer-associated ischemic stroke have been reported in Japan. The present study investigated the radiological and clinical characteristics of mechanical thrombectomy in patients with cancer-associated ischemic stroke at our institution. Methods: We retrospectively reviewed 108 patients who underwent mechanical thrombectomy for large cerebral artery occlusion between January 1, 2021, and October 31, 2022, at our institution. The characteristics of mechanical thrombectomy in the cancer-associated ischemic stroke group were compared with those in the control group. Results: Of the 108 patients (112 procedures), seven patients (eight procedures) with clinically diagnosed cancer-associated ischemic stroke underwent mechanical thrombectomy. Of the eight procedures, six were performed during hospitalization. In contrast, only 10 of 104 procedures were performed in the control group. The in-hospital onset rate was higher in the cancer-associated ischemic stroke group (75.0%) compared to that in the controls (9.6%); p <0.001. The puncture-to-reperfusion time was significantly longer in the cancer-associated ischemic stroke group in comparison to that in the controls with a median interquartile range of 69 minutes (60.0-82.0 minutes) and 59.5 minutes (44.5-69.3 minutes), respectively (p <0.01). However, the rates of successful recanalization defined as thrombolysis in cerebral infarction ≥2b were not significantly different between the cancer-associated ischemic stroke group and controls with values of 62.5% and 79.8%, respectively (p = 0.250). Of the eight cases in the cancer-associated ischemic stroke group, only one (12.5%) had a good outcome on a modified Rankin Scale score of 0 to 2 at discharge, in contrast to 23 of the 104 (23.1%) cases in the controls (p = 0.523). Histopathological examination of six retrieved thrombi in the cancer-associated stroke group using hematoxylin and eosin staining revealed that only one case showed an erythrocyte-dominant thrombus while five displayed a fibrinoplatelet-dominant component. Conversely, 65 of 92 retrieved thrombi in the control group were erythrocyte dominant. Cancer was pathologically diagnosed in four of seven patients, all of which were adenocarcinomas. Conclusion: Cancer-associated ischemic stroke tends to occur during hospitalization. Coagulation disorders associated with cancer, especially adenocarcinoma, may be related to the formation of thrombi with fibrinoplatelet-dominant components, leading to ischemic stroke. The procedural time for mechanical thrombectomy in cancer-associated ischemic stroke tends to be longer.

Prognostic Determinants of Anterior Large Vessel Occlusion in Acute Stroke in Elderly Patients.

This study investigated prognostic factors in elderly patients (80 years and older) undergoing mechanical thrombectomy (MT) for anterior circulation large vessel occlusion (LVO) in acute stroke treatment. Of 59 cases, 47.5% achieved a favorable outcome (mRS ≤ 3) at three months, with a mortality rate of 20.3%. Factors associated with better outcomes included younger age, lower admission National Institute of Health Stroke Scale (NIHSS) scores, lower N-terminal pro-brain natriuretic peptide (NT-proBNP) and D-dimer levels, the presence of the first pass effect (FPE), and successful recanalization. However, logistic regression showed that only lower admission NIHSS scores were significantly correlated with favorable outcomes. In addition, this study suggests that lower admission NT-proBNP and D-dimer levels could potentially serve as prognostic indicators for elderly LVO patients undergoing MT.