Cost-effectiveness of endovascular treatment versus best medical management in basilar artery occlusion stroke: A U.S. healthcare perspective.

INTRODUCTION: Two recent studies showed clinical benefit for endovascular treatment (EVT) in basilar artery occlusion (BAO) stroke up to 12 h (ATTENTION) and between 6 and 24 h from onset (BAOCHE). Our aim was to investigate the cost-effectiveness of EVT from a U.S. healthcare perspective. MATERIALS AND METHODS: Clinical input data were available for both trials, which were analyzed separately. A decision model was built consisting of a short-run model to analyze costs and functional outcomes within 90 days after the index stroke and a long-run Markov state transition model (cycle length of 12 months) to estimate expected lifetime costs and outcomes from a healthcare and a societal perspective. Incremental cost-effectiveness ratios (ICER) were calculated, deterministic (DSA) and probabilistic (PSA) sensitivity analyses were performed. RESULTS: EVT in addition to best medical management (BMM) resulted in additional lifetime costs of $32,063 in the ATTENTION trial and lifetime cost savings of $7690 in the BAOCHE trial (societal perspective). From a healthcare perspective, EVT led to incremental costs and effectiveness of $37,389 and 2.0 QALYs (ATTENTION) as well as $3516 and 1.9 QALYs (BAOCHE), compared to BMM alone. The ICER values were $-4052/QALY (BAOCHE) and $15,867/QALY (ATTENTION) from a societal perspective. In each trial, PSA showed EVT to be cost-effective in most calculations (99.9%) for a willingness-to-pay threshold of $100,000/QALY. Cost of EVT and age at stroke represented the greatest impact on the ICER. DISCUSSION: From an economic standpoint with a lifetime horizon, EVT in addition to BMM is estimated to be highly effective and cost-effective in BAO stroke.

Cost-effectiveness of WEB Embolization, Coiling and Stent-assisted Coiling for the Treatment of Unruptured Intracranial Aneurysms.

PURPOSE: Information about the cost-effectiveness of a certain treatment is relevant for decision-making and healthcare providers. This study compares the cost-effectiveness of the novel Woven Endobridge (WEB) for intracranial aneurysm treatment with conventional coiling and stent-assisted coiling (SAC) from the perspective of the German Statutory Health Insurance. METHODS: A patient-level simulation was constructed to simulate 55-year-old patients with an unruptured middle cerebral artery aneurysm (size: 3-11 mm) considering WEB treatment, coiling or SAC in terms of morbidity, angiographic outcome, retreatment, procedural and rehabilitation costs and rupture rates. Incremental cost-effectiveness ratios (ICERs) were calculated as costs per quality-adjusted life years (QALYs) and costs per year with neurologic morbidity avoided. Uncertainty was explored with deterministic and probabilistic sensitivity analyses. The majority of data were obtained from prospective multi-center studies and meta-analyses of non-randomized studies. RESULTS: In the base case, lifetime QALYs were 13.24 for the WEB, 12.92 for SAC and 12.68 for coiling. Lifetime costs were 20,440 € for the WEB, 23,167 € for SAC, and 8200 € for coiling. Compared to coiling, the ICER for the WEB was 21,826 €/QALY, while SAC was absolutely dominated by WEB. Probabilistic sensitivity analysis revealed that at a willingness-to-pay of ≥ 30,000 €/QALY, WEB was the preferred treatment. Deterministic sampling showed that the discount rate, material costs and retreatment rates had the largest impact on the ICERs. CONCLUSION: The novel WEB showed at least comparable cost-effectiveness to SAC for treatment of broad-based unruptured aneurysms. Considering all three modalities, coiling had the least costs; however this modality is often not appropriate for the treatment of wide-necked aneurysms.

CT-like MR-derived Images for the Assessment of Craniosynostosis and other Pathologies of the Pediatric Skull.

PURPOSE: To evaluate the diagnostic value of CT-like images based on a 3D T1-weighted spoiled gradient echo-based sequence (T1SGRE) for the visualization of the pediatric skull and the identification of pathologies, such as craniosynostosis or fractures. METHODS: In this prospective study, 20 patients with suspected craniosynostosis (mean age 1.26 ± 1.38 years, 10 females) underwent MR imaging including the T1SGRE sequence and 2 more patients were included who presented with skull fractures (0.5 and 6.3 years, both male). Additionally, the skull of all patients was assessed using radiography or CT in combination with ultrasound. Two radiologists, blinded to the clinical information, evaluated the CT-like images. The results were compared to the diagnosis derived from the other imaging modalities and intraoperative findings. Intrarater and interrater agreement was calculated using Cohen's κ. RESULTS: Of the 22 patients 8 had a metopic, 4 a coronal and 2 a sagittal craniosynostosis and 2 patients showed a complex combination of craniosynostoses. The agreement between the diagnosis based on the T1SGRE and the final diagnosis was substantial (Cohen's κ = 0.92, 95% confidence interval (CI) 0.77-1.00 for radiologist 1 and κ = 0.76, CI 0.51-1.00 for radiologist 2). Of the patients with fractures, one presented with a ping pong fracture and one with a fracture of the temporal bone. Both radiologists could identify the fractures using the T1SGRE. CONCLUSION: The visualization of the pediatric skull and the assessment of sutures using a CT-like T1SGRE MR-sequence is feasible and comparable to other imaging modalities, and thus may help to reduce radiation exposure in pediatric patients. The technique may also be a promising imaging tool for other pathologies, such as fractures.

Comparative assessment of woven endobridge embolization and standard coil occlusion for the treatment of ruptured basilar tip aneurysms.

PURPOSE: Endovascular coil occlusion represents the standard treatment for basilar tip aneurysms. Recently, this role has been rivalled by intrasaccular flow disruptors across numerous centres. We retrospectively compared WEB embolization and coiling for the treatment of ruptured basilar tip aneurysms. METHODS: Patients treated with WEB or coiling at four neurovascular centres were reviewed. Procedure-related complications, clinical outcome, and angiographic results were retrospectively compared. RESULTS: The study included 23 patients treated with the WEB (aneurysm size: 6.6 ± 1.9 mm) and 56 by coiling (aneurysm size: 6.7 ± 2.5 mm). Stent-assistance was more often necessary with coiling than with WEB embolization (32% vs. 4%, p = 0.009). A modified Rankin scale score ≤ 2 at discharge had 21 (37.5%) patients in the coiling group and 12 (52.2%) in the WEB group (p = 0.235). Immediate complete and adequate occlusion rates were 52% for the WEB and 87% for coiling. At short-term follow-up, these rates were 87% for the WEB and 72% for coiling, respectively. There was no delayed aneurysm re-bleeding during follow-up. CONCLUSION: Both coiling and WEB seem to prevent rebleeding in ruptured BTA aneurysms. WEB embolization required less frequently stent-support than coiling, potentially advantageous for SAH patients to avoid anti-platelet therapy in the light of concomitant procedures like ventricular drainage.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study.

BACKGROUND: The CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study. METHODS: The CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients with 60 ruptured aneurysms of the anterior and posterior circulation. The study was conducted with an independent assessment of safety outcomes and imaging. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. Fifty-three aneurysms (88.3%) had a broad base with a dome to neck ratio <2 (mean 1.6). Of these, 46 patients were evaluated by an independent core laboratory with follow-up imaging performed at 12 months or before eventual retreatment. At 1 year, 19/46 aneurysms (41.3%) were completely occluded (Raymond-Roy grade I), 21/46 (45.7%) had a residual neck and 6/46 (13.0%) had residual aneurysm filling. Adequate occlusion was reported in 40/46 (87%) aneurysms. Six patients underwent target aneurysm retreatment. CONCLUSIONS: The CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms.

Cost-Effectiveness of Endovascular Thrombectomy in Childhood Stroke: An Analysis of the Save ChildS Study.

BACKGROUND AND PURPOSE: The Save ChildS Study demonstrated that endovascular thrombectomy (EVT) is a safe treatment option for pediatric stroke patients with large vessel occlusions (LVOs) with high recanalization rates. Our aim was to determine the long-term cost, health consequences and cost-effectiveness of EVT in this patient population. METHODS: In this retrospective study, a decision-analytic Markov model estimated lifetime costs and quality-adjusted life years (QALYs). Early outcome parameters were based on the entire Save ChildS Study to model the EVT group. As no randomized data exist, the Save ChildS patient subgroup with unsuccessful recanalization was used to model the standard of care group. For modeling of lifetime estimates, pediatric and adult input parameters were obtained from the current literature. The analysis was conducted in a United States setting applying healthcare and societal perspectives. Probabilistic sensitivity analyses were performed. The willingness-to-pay threshold was set to $100,000 per QALY. RESULTS: The model. RESULTS: yielded EVT as the dominant (cost-effective as well as cost-saving) strategy for pediatric stroke patients. The incremental effectiveness for the average age of 11.3 years at first stroke in the Save ChildS Study was determined as an additional 4.02 lifetime QALYs, with lifetime cost-savings that amounted to $169,982 from a healthcare perspective and $254,110 when applying a societal perspective. Acceptability rates for EVT were 96.60% and 96.66% for the healthcare and societal perspectives. CONCLUSIONS: EVT for pediatric stroke patients with LVOs resulted in added QALY and reduced lifetime costs. Based on the available data in the Save ChildS Study, EVT is very likely to be a cost-effective treatment strategy for childhood stroke.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study.

BACKGROUND: The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. METHODS: The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. CONCLUSIONS: The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.

The clinical value of ceMRA versus DSA for follow-up of intracranial aneurysms treated by coil embolization: an assessment of occlusion classifications and impact on treatment decisions.

OBJECTIVE: The aim of this study was a detailed analysis of the value of contrast-enhanced magnetic resonance angiography (ceMRA) compared to digital subtraction angiography (DSA) for follow-up imaging of intracranial aneurysms treated by coil embolization. METHODS: Patients with coiled aneurysms and follow-up exams including both DSA and 3 T ceMRA were retrospectively identified. In blinded readings, both modalities were graded according to the modified Raymond-Roy classification (MRRC) and the Meyers scale. Additionally, readers were asked to make a decision regarding retreatment/follow-up based on the respective imaging findings. RESULTS: The study comprised 92 patients harboring 102 coiled aneurysms. There was good intermethod agreement of DSA and ceMRA concerning both the MRRC (κ = 0.64) and the Meyers scale (κ = 0.74). Agreement regarding occlusion of < 90% of the aneurysm (Meyers grade ≥ 2) was very good (κ = 0.87). Regarding the detection of a remnant with contrast between the coil mass and the aneurysm wall (MRRC IIIb), there were 12 discrepant findings and agreement was good (κ = 0.70). Comparing treatment/follow-up decisions, the two methods agreed very well (κ = 0.92). In seven patients with discrepant treatment decisions, the authors concurred with DSA in four cases and with ceMRA in three cases when evaluating both modalities together. Interval aneurysm growth was found in more cases with ceMRA (n = 19) than with DSA (n = 16). CONCLUSIONS: CeMRA is very unlikely to miss a relevant aneurysm remnant and thus could be suitable as the primary follow-up method. In case of remnant growth or recurrence, however, additional DSA might be required to guide treatment decisions. KEY POINTS: • There is high accordance between ceMRA and DSA regarding the evaluation of intracranial aneurysms treated by endovascular coil embolization, but closer analysis also revealed relevant differences. • CeMRA could be suitable as the primary follow-up imaging modality, potentially eliminating the need for routine DSA. • DSA will still be required in case of aneurysm remnant growth or recurrence as detected by ceMRA.

Comparative in vitro study of five mechanical embolectomy systems: effectiveness of clot removal and risk of distal embolization.

INTRODUCTION: We report an in vitro study comparing the effectiveness of clot removal and clot fragmentation of five embolectomy systems. METHODS: A flow model was embolized with fresh and old thrombi, occluding an inner diameter of 2-5 mm simulating internal carotid artery (ICA), basilar artery (BA) and middle cerebral artery (MCA) branch occlusion. Embolectomy was performed using five retrieval systems: CATCH (Balt), Merci retriever (Concentric), InTime and Attracter (Boston Scientific), and the Phenox Clot Retriever (Phenox). Clot removal and evidence and type of thrombus fragmentation and distal embolization were recorded. RESULTS: There were no observable differences attributable to thrombus age. The Merci, CATCH and Phenox Clot Retriever were equally able to mobilize and remove thrombi with the exception of one particularly firm clot. There were marked differences in terms of thrombus fragmentation and distal embolization. All devices produced micro- and macrofragments during penetration and retrieval. The Phenox Clot Retriever was able to filter fragments. The InTime and Attracter devices failed to retrieve thrombi in this model and achieved partial removal at best with a tendency towards thrombus displacement and fragmentation. CONCLUSION: Within limits, the experimental setup was appropriate for generating occlusions of diameter 2-5 mm of various lengths, simulating ICA, BA and MCA thromboembolism. In this model, thrombus mobilization appeared to be less dependent upon the individual design of the retrieval system than on thrombus fragmentation. The ability to prevent distal embolization is, however, strongly dependent on the ability of a thrombectomy device to capture fragments that are generated during removal of the device.