Health budget implications of mechanical thrombectomy for acute ischaemic stroke in Australia.

INTRODUCTION: This research evaluates the budget impact of treating acute ischaemic stroke (AIS) using a combination of mechanical thrombectomy (MT) with stent retrievers (SR) and intravenous tissue-plasminogen activator (IV-tPA) in Australia. METHODS: This study examined the economic impact over five years for a patient cohort based on the number of patients treated with MT+ IV-tPA in Australia 2021, versus treatment with IV-tPA alone. A budget impact (BI) model was developed to project direct medical costs (economic impact) of IV-tPA+ MT with SR vs. Intravenous tissue-plasminogen activator alone over a five-year period (2021-2025 inclusive) from a healthcare perspective. The model is composed of a short-run decision tree model based on a 3-month post-treatment modified Rankin Scale (mRS) from the EXTEND-IA study and a published long-run Markov state transition model. Acute, mid-term and long-term care costs were projected based on anticipated mRS scores from the EXTEND-IA trial. Estimated yearly and cumulative budget impact were reported to indicate the economic impact of the two treatment strategies for AIS in the Australian healthcare system. RESULTS: MT+IV-tPA had a greater budgetary impact than IV-tPA alone, with annual savings starting at Year 1 and continuing through to Year 5. Cost savings of 21% or approximately $36 million can be achieved over five years for the patient cohort treated in Australia in 2021. Each MT procedure performed delivers approximately $3280 in annual health system savings per patient. CONCLUSION: Treatment of AIS with a combination of MT+IV-tPA generates significant savings in the Australian healthcare system compared with IV-tPA alone.

Transradial versus transfemoral access for diagnostic cerebral angiography: frequency of acute MRI findings in 500 consecutive patients at a single center.

BACKGROUND: The frequency of clinically symptomatic and asymptomatic diffusion-weighted imaging (DWI) hyperintense lesions and their correlation with the transradial artery (TRA) approach is unclear. OBJECTIVE: To assess the frequency of abnormal diffusion restriction foci on DWI following cerebral angiography (digital subtraction angiography (DSA)) with the TRA or transfemoral artery (TFA) approach and identify predictors of DWI restriction foci. METHODS: We analysed data from consecutive diagnostic cerebral angiograms obtained between January 2021 and October 2023 at a single tertiary center. MRI DWI was performed 2 hours after DSA. Patients underwent neurological assessment periprocedurally, as well as prior to discharge. RESULTS: 500 patients were analysed; 277 (55%) procedures were performed via TRA and 223 (45%) via TFA. Overall, 74 (14.8%) patients had abnormal findings in the postprocedure MRI DWI. A higher incidence of positive DWI findings was noted in the TRA group, with 46 (16.6%) patients, compared with 28 (12.6%) in the TFA group (P=0.21). Symptomatic events occurred in seven (2.5%) of the TRA group and in two (0.9%) of the TFA cohort (P=0.31). At 60 days, the neurological deficit rate was one (0.4%) for the TRA group and one (0.4%) for the TFA group. Procedure time was the only significant predictor of DWI restriction (OR=1.04 per minute; P=0.0001). CONCLUSION: Although there were more symptomatic or asymptomatic embolic events with TRA than with the TFA approach following elective cerebral angiography, this was not significantly different. We recommend the choice of vascular access based on patient anatomy and characteristics, aimed at improving care through enhanced safety.

Safety and efficacy of adjunctive intra-arterial antithrombotic therapy during endovascular thrombectomy for acute ischemic stroke: a systematic review and meta-analysis.

BACKGROUND: Half of patients who achieve successful recanalization following endovascular thrombectomy (EVT) for acute ischemic stroke experience poor functional outcome. We aim to investigate whether the use of adjunctive intra-arterial antithrombotic therapy (AAT) during EVT is safe and efficacious compared with standard therapy (ST) of EVT with or without prior intravenous thrombolysis. METHODS: Electronic databases were searched (PubMed/MEDLINE, Embase, Cochrane Library) from 2010 until October 2023. Data were pooled using a random-effects model and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Risk of bias was assessed using ROBINS-I and ROB-2. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes were successful recanalization (modified Thrombolysis In Cerebral Infarction (TICI) 2b-3), symptomatic intracranial hemorrhage (sICH), and 90-day mortality. RESULTS: 41 randomized and non-randomized studies met the eligibility criteria. Overall, 15 316 patients were included; 3296 patients were treated with AAT during EVT and 12 020 were treated with ST alone. Compared with ST, patients treated with AAT demonstrated higher odds of functional independence (46.5% AAT vs 42.6% ST; OR 1.22, 95% CI 1.07 to 1.40, P=0.004, I2=48%) and a lower likelihood of 90-day mortality (OR 0.71, 95% CI 0.61 to 0.83, P<0.0001, I2=20%). The rates of sICH (OR 1.00, 95% CI 0.82 to 1.22,P=0.97, I2=13%) and successful recanalization (OR 1.09, 95% CI 0.84 to 1.42, P=0.52, I2=76%) were not significantly different. CONCLUSION: The use of AAT during EVT may improve functional outcomes and reduce mortality rates compared with ST alone, without an increased risk of sICH. These findings should be interpreted with caution pending the results from ongoing phase III trials to establish the efficacy and safety of AAT during EVT.

Vanguard Study: Initial experience with the new fourth generation Pipeline Vantage Flow Diverter (PVFD): 6-month results, technical and clinical considerations.

BACKGROUND: The Pipeline Embolization Device has proven to be a safe and effective device for the treatment of intracranial aneurysms. The Pipeline Vantage Flow Diverter (PVFD) with Shield Technology is the new fourth generation of this implant, with modifications made compared to previous iterations. We aimed to evaluate the mechanical properties and clinical safety and efficacy of this device. METHODS: Vanguard is a single arm, single center, prospective study. Between April 2021 and April 2023, all consecutive patients with an unruptured aneurysm treated with Pipeline Vantage flow-diverting stents were included. There were no aneurysm size or location exclusion criteria. Safety (neurological serious adverse events) and efficacy (device deployment and aneurysm occlusion) were independently reviewed. Imaging follow-up data, and immediate, early (<30 days), and delayed (>30 days) neurological serious adverse events were independently assessed. RESULTS: 101 consecutive patients with a total of 115 aneurysms were included. The aneurysms were situated in the anterior (90.4%) or posterior (9.6%) circulations. A total of 124 devices were implanted. The deployment success rate was 100%. In four (4.0%) cases post-deployment angioplasty was required to optimize device wall apposition. Occlusion rates at 1 month were 54.7%, at 3 months 72.1%, and at 6 months 81.7%. Morbidity and mortality were 4.9% and 0%, respectively, at 6 months. Eight cases (6.9%) demonstrated in-stent stenosis, four of which had 'fish mouth' deformity. CONCLUSION: Initial results of the new generation PVFD for unruptured intracranial aneurysm treatment demonstrate overall satisfactory device performance, safety profile, and effectiveness.

Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms.

BACKGROUND: Robotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases. OBJECTIVE: To evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms. METHODS: This prospective, international, multicenter study enrolled patients with brain aneurysms that required endovascular coiling and/or stent-assisted coiling. The primary effectiveness endpoint was defined as successful completion of the robotic-assisted endovascular procedure without any unplanned conversion to manual treatment with guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. The primary safety endpoint included intraprocedural and periprocedural events. RESULTS: The study enrolled 117 patients (74.4% female) with mean age of 56.6 years from 10 international sites,. Headache was the most common presenting symptom in 40/117 (34.2%) subjects. Internal carotid artery was the most common location (34/122, 27.9%), and the mean aneurysm height and neck width were 5.7±2.6 mm and 3.5±1.4 mm, respectively. The overall procedure time was 117.3±47.3 min with 59.4±32.6 min robotic procedure time. Primary effectiveness was achieved in 110/117 (94%) subjects with seven subjects requiring conversion to manual for procedure completion. Only four primary safety events were recorded with two intraprocedural aneurysm ruptures and two strokes. A Raymond-Roy Classification Scale score of 1 was achieved in 71/110 (64.5%) subjects, and all subjects were discharged with a modified Rankin Scale score of ≤2. CONCLUSIONS: This first-of-its-kind robotic-assisted neurovascular trial demonstrates the effectiveness and safety of the CorPath GRX System for endovascular embolization of cerebral aneurysm procedures. TRIAL REGISTRATION NUMBER: NCT04236856.

World federation of interventional and therapeutic neuroradiology (WFITN) federation assembly neurointerventional surgery safety checklist.

Over the last 10 years, there has been a rise in neurointerventional case complexity, device variety and physician distractions. Even among experienced physicians, this trend challenges our memory and concentration, making it more difficult to remember safety principles and their implications. Checklists are regarded by some as a redundant exercise that wastes time, or as an attack on physician autonomy. However, given the increasing case and disease complexity along with the number of distractions, it is even more important now to have a compelling reminder of safety principles that preserve habits that are susceptible to being overlooked because they seem mundane. Most hospitals have mandated a pre-procedure neurointerventional time-out checklist, but often it ends up being done in a cursory fashion for the primary purpose of 'checking off boxes'. There may be value in iterating the checklist to further emphasize safety and communication. The Federation Assembly of the World Federation of Interventional and Therapeutic Neuroradiology (WFITN) decided to construct a checklist for neurointerventional cases based on a review of the literature and insights from an expert panel.

Transradial versus transfemoral arterial approach for cerebral angiography and the frequency of embolic events on diffusion weighted MRI.

BACKGROUND: The radial artery approach has become popular as a 'radial first' strategy for arterial access in neuroangiography and neurointerventions. Recent studies have shown that transradial arterial access (TRA) for cerebral angiography has been associated with reduced access site complication rates and improved patient satisfaction compared with transfemoral access (TFA). The goal of this study was to evaluate the presence of abnormal MRI diffusion weighted imaging (DWI) foci following DSA and correlate their frequency with TRA or TFA. METHODS: We prospective analyzed 200 consecutive adult DSAs performed from January 2021 to January 2022, at a single tertiary center. RESULTS: Of the 200 consecutive diagnostic cerebral angiograms, 51% were performed via TRA and 49% were performed via TFA. Of the TRA cerebral angiograms, 17.5% demonstrated at least one hyperintense focus on MRI DWI. Of the TFA procedures, 5.2% were considered positive. One patient (0.5%) in the TRA group experienced a minor neurologic deficit postoperatively that had not completely resolved at 90 days after the procedure and no neurologic deficits occurred in the TFA group. CONCLUSIONS: Despite the proven benefit of TRA over TFA in neurointervention, the number of MRI DWI restriction foci were significantly more frequent during cerebral angiography when TRA was selected. Although the number of clinically symptomatic events were minimal, the widespread use of the technique may become clinically relevant. Further studies contrasting the TRA and TFA techniques will be beneficial for cerebral angiography.

First clinical experience with the new Surpass Evolve flow diverter: technical and clinical considerations.

OBJECTIVE: To describe the results in patients treated with the Surpass Evolve (SE) device, the new generation of Surpass flow diverters. METHODS: Twenty-five consecutive patients (20 women, average age 58 years), with anterior or posterior circulation aneurysms treated with SEs in two early-user centers, were included. Device properties and related technical properties, imaging and clinical follow-up data, and intraprocedural, early (<30 days) and delayed (>30 days) neurological complications, further divided into minor (silent/non-permanent) and major (permanent) complications, were recorded and analyzed. RESULTS: Twenty-nine SEs were successfully implanted in all subjects to treat 26 aneurysms using an 0.027" microcatheter with an average of 1.2 stents per patient. No intraprocedural thromboembolic or hemorrhagic complications were seen. At clinical follow-up, 24/25 (96%) patients had a modified Rankin Score of 0-2. Mortality was 0%. Imaging follow-up, available in 22/25 (88%) patients (median follow-up time 4 months), showed a complete aneurysm occlusion in 13/23 (57%) imaged lesions. Minor, transitory neurological deficits were recorded in 5/25 (20%) patients. One (4%) major complication was seen in one patient (4%) with a left-sided hemispheric stroke on postprocedural day 4 due to an acute stent thrombosis. CONCLUSIONS: Preliminary experience in patients demonstrates a good performance of the SE. This newly designed implant maintains the engineering characteristics of Surpass flow diverters, including precise placement due to its lower foreshortening and a high mesh density, yet can be deployed through a significantly lower-profile delivery system.