Robotic-assisted intracranial aneurysm treatment: 1 year follow-up imaging and clinical outcomes

BackgroundThe use of robotics in medicine may enable increased technical accuracy, reduced procedural time and radiation exposure, and remote completion of procedures. We have previously described the first-in-human, robotic-assisted cerebral aneurysm treatment using the CorPath GRX Robotic System. In this report we discuss our early experiences and outcomes using this robotic device for endovascular treatment of intracranial aneurysms using stent-assisted coil embolization and flow diversion.MethodsThe patient and disease characteristics, procedural details, and follow-up imaging and clinical outcomes of consecutive patients undergoing robotically-assisted intracranial aneurysm embolization between November 2019 and February 2020 are presented.ResultsSix patients underwent robotically-assisted embolization of intracranial aneurysms. Four of the patients were treated with a neck-bridging stent (with or without coiling) and two patients were treated with a flow-diverting stent. Two patients were treated in the subacute period of subarachnoid hemorrhage and four patients were treated electively. All of the procedures could be completed robotically and there was no need for unplanned manual intervention. The technical success rate of the procedures was 100%. There was no morbidity or mortality associated with the procedures. One year follow-up imaging showed that four aneurysms were completely obliterated (Raymond-Roy Occlusion Classification (RROC) class I) and the remaining two were occluded with a residual neck (RROC class II).ConclusionsThe Corpath GRX Robotic System demonstrated a precise control over the microcatheter, wire and stent during aneurysm treatment. Robotic neuro-procedures seem to be safe and effective and demonstrate stable occlusion results in the midterm follow-up.

Factors associated with in-stent stenosis after cerebral aneurysm embolization using a Pipeline embolization device

Background Flow-diverting (FD) stents, with or without coiling, are a mainstay in endovascular treatment of intracranial aneurysms (IAs). One observed complication from flow diverter stent (FDS) insertion has been in-stent stenosis. Though previously studied in the short-term period, the long-term history of this complication has yet to be described. Methods We performed a retrospective cohort study of consecutive IAs treated with Pipeline Embolization Device (PED), with or without coiling, at our centre between September 2014 and December 2018 that had at least one digital subtraction angiogram (DSA) during follow-up. In-stent stenosis was measured from DSA images, and associated patient and procedural characteristics were analysed. Results 94 patients treated with PED for IA were identified. On initial DSA during follow-up, 52 patients (55.3%) had in-stent stenosis within the PED. Of these 52 patients, 17 had a second DSA during follow-up. In this 2nd DSA, improvement and/or stable in-stent stenosis was seen 16 patients (94.1%). One patient in this group had worsening in-stent stenosis had a vertebrobasilar junction FD stent. Of the patients without in-stent stenosis on initial DSA, 15 had a second DSA during follow-up. Only one of these patients (6.7%) had new appearance of in-stent stenosis (measuring 5%). Multivariate analysis found statin use to be predictive of in-stent stenosis (p = 0.020, Odds ratio = 0.279 and 95% confidence interval = 0.095–0.821). Conclusions In-stent stenosis after FDS placement was seen in 53.2% of cases, which had between 1–50% of stenosis. 82.4% had resolution/improvement of their stenosis. Statin use was protective of in-stent stenosis.

Endovascular therapy for posterior communicating artery-infundibular dilatation aneurysms

Objective: The purpose of this study was to explore the effect of endovascular therapy on posterior communicating artery-infundibular dilatation aneurysms. Methods: A total of 15 patients with ruptured aneurysms caused by posterior communicating artery-infundibular dilatation who were treated in our neurosurgical center from January 2015 to December 2018were included in this study. They were performed with bilateral internal carotid angiography and vertebral angiography and treated with endovascular method. The modified Rankin Scale (mRS) was used for clinical follow-up for 18 months. Results: There were 10 patients in the posterior communicating artery-infundibular dilatation aneurysms with non-fetal posterior cerebral artery. Among them, 8 patients were treated with coil-alone embolization. Immediate imaging showed infundibular dilation residual in 6 cases and no contrast filling in either infundibular dilation or aneurysm in 2 case. Another 2 were treated with stent-assisted coiling embolization, and immediate imaging showed no contrast filling. Of the 5 patients in posterior communicating artery-infundibular dilatation aneurysms with fetal posterior cerebral artery, 4 were only coiled in the aneurysm sack with contrast filling in infundibular cones, and 2 were treated with stent assisted coiling. Among the 10 patients with non-fetal posterior cerebral artery, 3 showed recurrence, 4 showed stable images, 2 were also stable with no contrast filling in infundibular dilation or aneurysm and 1 was lost to follow-up. Among the 5 patients with fetal posterior cerebral artery, 1 showed stable images, 3 showed recurrence and 1 was lost to follow-up. Conclusions: For posterior communicating artery-infundibular dilatation aneurysms with non-fetal posterior cerebral artery, stent-assisted coiling of aneurysm embolization combined with occlusion of cones is effective to prevent or reduce recurrence.

Abstract 1122‐000113: Periprocedural Safety of Intracranial Aneurysm Embolization with Extra Soft Coils: Interim Analysis of SURF Study

Introduction : Coiling with extra soft coils is a widely accepted safe and durable treatment option for intracranial aneurysms but lacks prospective real‐world outcomes. Extra soft coils are specifically designed as fill and finish coils. The primary objective of the SURF study, a postmarket registry, is to assess the real‐world experience of extra soft coils as fill and finish coils to support adequate aneurysm occlusion at 1‐year follow‐up. This study is an interim analysis of periprocedural safety results and ramp‐up of a trial during the COVID‐19 pandemic. Methods : The SURF trial is a postmarket, prospective, multicenter, single‐arm, observational trial aiming to enroll about 800 patients. Patients undergoing embolization of intracranial aneurysm with an extra soft coil as the finishing coil were enrolled at 34 centers globally from November 2019 through July 20, 2021, and will be followed up for approximately 1 year. During the first wave of COVID‐19 in the US, enrollment was behind expectations but has caught up with projections as of July 2020. The primary safety endpoints for this interim analysis were serious adverse events (SAEs) within 24 hours after the procedure and device‐related SAEs up to 7 days after the procedure or to discharge. Results : This interim analysis is for 346 enrolled patients, characterized by a mean age of 60.1 years and being predominantly (73.1%) female. Medical history included 62.4% of patients with hypertension and 18.2% of patients with a previous history of stroke. The most common aneurysm locations were the internal carotid artery (35.2%) and the anterior cerebral artery (31.1%). Unassisted coiling was the modality of choice in 49.6% of procedures, followed by stent‐assisted coiling in 30.0% and balloon‐assisted coiling in 16.9%. The rate of SAEs within 24 hours after the procedure was 7.8% (27/346; 95% CI, 5.0%‐10.6%). Device‐related SAEs occurred in 1.4% (5/346; 95% CI, 0.2%‐2.7%) of patients up to 7 days after the procedure or to discharge. The rate of major ipsilateral stroke up to discharge was 0.6% (2/346; 95% CI, 0.0%‐1.4%), and the rate of symptomatic intracerebral hemorrhage was 1.4% (5/346; 95% CI, 0.2%‐2.7%), including 2 intraprocedural ruptures and 3 patients who had ruptured aneurysm at baseline and had intraventricular and intracerebral hemorrhage. Patient follow‐up is ongoing. Conclusions : We report interim outcomes from the SURF study. This postmarket registry evaluates the safety of extra soft coils as fill and finish coils in the treatment of intracranial aneurysms. Trial ramp‐up, despite temporary delay during the initial COVID‐19 wave, has been progressing along with expectations.

Specifics of endovascular embolization for cerebral aneurysmsin the acute period of subarachnoid hemorrhage

Aim – to assess the benefits of modern methods for endovascular occlusion of ruptured cerebral aneurysms in the acute period of subarachnoid hemorrhage (SAН). Materials and methods. Medical records of patients undergoing treatment in the acute period of aneurysmal SAН between 2010–2021 were analyzed. 2 groups were formed: I – the use of standard surgical catheters, minimal use of adjunctive techniques for aneurysm embolization (2010–2016), II – routine use of triaxial access systems, intraarterial infusion of nimodipine, active use of adjunctive techniques for aneurysm embolization, intraoperative antiplatelet therapy immediately after aneurysm occlusion – 500 mg of solution Acelysin administrated intravenously (2017–2021). The severity of SAН according to the Hunt–Hess, Fisher scales, the treatment outcome according to the modified Rankin Scale (mSR), the location and size of aneurysms and intraoperative complications were analyzed. Results. There were 156 observations in group I, 91 – in group II. The median age was 48.26 years in group I, 51.44 years – in group II. On the basis of gender status, there was a majority of women in both groups. Aneurysms of the anterior cerebral-anterior communicating artery complex predominated in both groups; the internal carotid artery was the second most frequent localization. The severity of SAН according to the generally accepted scales (Hunt–Hess, Fisher) did not differ significantly. Coil embolization was used in 100 % of cases, balloon-assisted coiling was used in 6.48 % in group I and in 14.80 % – in group II, stent-assisted coiling – in 2.56 % and 9.30 %, respectively, distal access catheter with the triaxial system was not used in group I and it was performed in 57.4 % of cases in group II. Pharmacoangioplasty using nimodipine solution was used in 16.6 % in group I and in 22.2 % in group II. Intravenous drip infusion of 0.5 g Acelysin was performed immediately after aneurysm occlusion in 22.2 % of cases in group II. Intraoperative aneurysm rupture was observed in 5.1 % in group I and in 1.1 % in group II. Distal coil migration or into the maternal artery occurred in 6.41 % in group I and in 2.20 % in group II. Thromboembolic complications were noted in 7.69 % and in 2.20 %, respectively. The mean value of dysfunction degree on mSR amounted to 2.27 in group I and 1.45 – in group II. A good treatment outcome (mRS score 1–2) was defined in 71.2 % of observations in group I and in 87.9 % – in group II. The death rate was 12.82 % and 7.62 %, respectively. Conclusions. Routine use of triaxial access systems and intraarterial pharmacoplasty with nimodipine allow adequate prevention of mechanically induced vasospasm during catheterization of the aneurysm cavity. The triaxial access system stability provides better control of the microguidewire and microcatheters reducing the risk of aneurysmal wall perforation during catheterization. The use of adjunctive techniques for embolization of ruptured cerebral aneurysms in the acute period of SAH and prophylactic infusion of Acelysin solution after aneurysm occlusion significantly reduces the incidence of thromboembolic complications. The earliest possible occlusion of a ruptured cerebral aneurysm is not only the prevention of re-rupture, but also expands the possibilities of intensive care for preventing secondary complications of SAH.

The Woven EndoBridge (WEB) device: feasibility, techniques, and outcomes after FDA approval

OBJECTIVE Wide-neck bifurcation cerebral aneurysms have historically required either clip ligation or stent- or balloon-assisted coil embolization. This predicament led to the development of the Woven EndoBridge (WEB) aneurysm embolization system, a self-expanding mesh device that achieves intrasaccular flow disruption and does not require antithrombotic medications. The authors report their operative experience and 6-month follow-up occlusion outcomes with the first 115 aneurysms they treated via WEB embolization. METHODS The authors reviewed the first 115 cerebral aneurysms they treated by WEB embolization after FDA approval of the WEB embolization device (from February 2019 to January 2021). Data were collected on patient demographics and clinical presentation, aneurysm characteristics, procedural details, postembolization angiographic contrast stasis, and functional outcomes. RESULTS A total of 110 patients and 115 aneurysms were included in our study (34 ruptured and 81 unruptured aneurysms). WEB embolization was successful in 106 (92.2%) aneurysms, with a complication occurring in 6 (5.5%) patients. Contrast clearance was seen in the arterial phase in 14 (12.2%) aneurysms, in the capillary phase in 16 (13.9%), in the venous phase in 63 (54.8%), and no contrast was seen in 13 (11.3%) of the aneurysms studied. Follow-up angiography was performed on 60 (52.6%) of the aneurysms, with complete occlusion in 38 (63.3%), neck remnant in 14 (23.3%), and aneurysmal remnant in 8 (13.3%). Six (5.5%) patients required re-treatment for persistent aneurysmal residual on follow-up angiography. CONCLUSIONS The WEB device has been successfully used for the treatment of both unruptured and ruptured wide-neck bifurcation aneurysms by achieving intrasaccular flow diversion. Here, the authors have shared their experience with its unique technical considerations and device size selection, as well as critically reviewed complications and aneurysm occlusion rates.

Early institutional experience using the TracStar Large Distal Platform in endovascular flow diversion

Introduction The delivery of flow-diverting stents (FDS) necessitates a degree of catheter support beyond that required for endovascular coiling. The TracStar Large Distal Platform (LDP) is a novel 0.088″ platform intended for navigation into the intracranial internal carotid artery (ICA). We present an early institutional experience using the TracStar LDP in 44 cases of endovascular aneurysm embolization using FDS. Methods Inclusion criteria for this single-center retrospective review encompassed all patients >18 years of age who were treated for intracranial aneurysms. Procedural success was defined as successful stent deployment using the TracStar LDP. Other outcomes included periprocedural complications, use of an intermediate catheter, length of stay, and discharge disposition. Results The TracStar LDP was utilized in 44 consecutive FDS cases in 42 patients. Cavernous segment aneurysms constituted the majority of cases (12/42; 28.6%), followed by posterior communicating artery (8/42; 19.0%) and supraclinoid aneurysms (8/42; 19.0%). Successful FDS deployment was achieved in 43/44 cases. The LDP achieved stable positioning within the ascending cavernous ICA in 63.6% of cases. A biaxial system was utilized in 54.5% of cases. There was one complication potentially related to use of the TracStar LDP, which was an asymptomatic ICA vessel dissection managed conservatively. Conclusions The TracStar LDP is safe and effective during use in the endovascular treatment of intracranial aneurysms with a FDS. Access to the ascending portion of the cavernous ICA was regularly achieved, and the platform allowed for both biaxial and triaxial configurations.