Value of intravenous alteplase before thrombectomy among patients with tandem lesions and emergent carotid artery stenting: A subgroup analysis of the SWIFT DIRECT trial.

BACKGROUND AND PURPOSE: The value of intravenous thrombolysis (IVT) in eligible tandem lesion patients undergoing endovascular treatment (EVT) is unknown. We investigated treatment effect heterogeneity of EVT + IVT versus EVT-only in tandem lesion patients. Additional analyses were performed for patients undergoing emergent internal carotid artery (ICA) stenting. METHODS: SWIFT DIRECT randomized IVT-eligible patients to either EVT + IVT or EVT-only. Primary outcome was 90-day functional independence (modified Rankin Scale score 0-2) after the index event. Secondary endpoints were reperfusion success, 24 h intracranial hemorrhage rate, and 90-day all-cause mortality. Interaction models were fitted for all predefined outcomes. RESULTS: Among 408 included patients, 63 (15.4%) had a tandem lesion and 33 (52.4%) received IVT. In patients with tandem lesions, 20 had undergone emergent ICA stenting (EVT + IVT: 9/33, 27.3%; EVT: 11/30, 36.7%). Tandem lesion did not show treatment effect modification of IVT on rates of functional independence (tandem lesion EVT + IVT vs. EVT: 63.6% vs. 46.7%, non-tandem lesion EVT + IVT vs. EVT: 65.6% vs. 58.2%; p for interaction = 0.77). IVT also did not increase the risk of intracranial hemorrhage  among tandem lesion patients (tandem lesion EVT + IVT vs. EVT: 34.4% vs. 46.7%, non-tandem lesion EVT + IVT vs. EVT: 33.5% vs. 26.3%; p for interaction = 0.15). No heterogeneity was noted for other endpoints (p for interaction > 0.05). CONCLUSIONS: No treatment effect heterogeneity of EVT + IVT versus EVT-only was observed among tandem lesion patients. Administering IVT in patients with anticipated emergent ICA stenting seems safe, and the latter should not be a factor to consider when deciding to administer IVT before EVT.

Evaluation of mechanical thrombectomy in acute ischemic stroke related to a distal arterial occlusion: A randomized controlled trial.

RATIONALE: Mechanical thrombectomy (MT) associated with the best medical treatment (BMT) has recently shown efficacy for the management of acute ischemic stroke (AIS) secondary to a large vessel occlusion. However, evidence is lacking regarding the benefit of MT for more distal occlusions. AIM: To evaluate the efficacy in terms of good clinical outcome at 3 months of MT associated with the BMT over the BMT alone in AIS related to a distal occlusion. METHODS: The DISCOUNT trial is a multicenter open-label randomized controlled trial involving French University hospitals. Adult patients (⩾18 years) with an AIS involving the anterior or posterior circulation secondary to a distal vessel occlusion within 6 h of symptom onset or within 24 h if no hyperintense signal on fluid attenuation inversion recovery acquisition will be randomized 1:1 to receive either MT associated with the BMT (experimental group) or BMT alone (control group). The number of patients to be included is 488. STUDY OUTCOMES: The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin scale (mRS) ⩽2 and evaluated by an independent assessor blinded to the intervention arm. Secondary outcomes include recanalization of the occluded vessel within 48 h, angiographic reperfusion in the experimental group, 3-month excellent clinical outcome (mRS ⩽ 1), all adverse events, and death. A cost utility analysis will estimate the incremental cost per quality-adjusted life year (QALY) gained. DISCUSSION: If positive, this study will open new insights in the management of AISs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05030142 registered on 1 September 2021.

Safety and effectiveness of the LVIS and LVIS Jr devices for the treatment of intracranial aneurysms: Final results of the LEPI multicenter cohort study.

BACKGROUND: The Low profile visualized intraluminal support (LVIS)/LVIS Jr is a self-expanding braiding stent for the treatment of intracranial aneurysm. This study is to determine the safety and effectiveness of the LVIS/LVIS Jr for the treatment of intracranial aneurysms in a real-world setting. METHODS: This prospective, observational, multicenter study enrolled patients with unruptured, ruptured and recanalized intracranial aneurysms treated with the LVIS stents, between February 2018 to December 2019. Primary endpoint was the cumulative morbidity and mortality rate (CMMR) assessed at 12 months follow-up (FU). RESULTS: A total of 130 patients were included (62.3 % women, mean age 55.9 ± 11.4) on an intention-to-treat basis. Four patients (3.1 %) had 2 target aneurysms; 134 total aneurysms were treated. The aneurysms were mainly located on the middle cerebral artery (41/134; 30.6 %) and the anterior communicating artery (31/134; 23.1 %). The CMMR at 1 year linked to the procedure and/or device was 4.6 % (6/130). The overall mortality was 1.5 % (2/130), none of these deaths adjudged as being linked to the procedure and/or device. All aneurysms (134/134, 100 %) were successfully treated with LVIS stent and/or other devices. At a mean FU of 16.8 months post-procedure, complete/nearly complete occlusion was achieved in 112 aneurysms (92.6 %), and only 3 patients (2.5 %) required aneurysm retreatment. CONCLUSION: This study provides evidence that the LVIS/LVIS Jr devices are safe and effective in the treatment of complex intracranial aneurysms, with very high rates of adequate occlusion at FU. These angiographic results are stable over time with an acceptable complication rate. TRIAL REGISTRATION: ClinicalTrial.gov under NCT03553771.

Longitudinal radiological follow-up of individual level non-ischemic cerebral enhancing lesions following endovascular aneurysm treatment.

BACKGROUND: Non-ischemic cerebral enhancing (NICE) lesions following aneurysm endovascular therapy are exceptionally rare, with unknown longitudinal evolution. OBJECTIVE: To evaluate the radiological behavior of individual NICE lesions over time. METHODS: Patients included in a retrospective national multicentric inception cohort were analyzed. NICE lesions were defined, using MRI, as delayed onset punctate, nodular, or annular foci enhancements with peri-lesion edema, distributed in the vascular territory of the aneurysm treatment, with no other confounding disease. Lesion burden and the longitudinal behavior of individual lesions were assessed. RESULTS: Twenty-two patients were included, with a median initial lesion burden of 36 (IQR 17-54) on the first MRI scan. Of the 22 patients with at least one follow-up MRI scan, 16 (73%) had new lesions occurring mainly within the first 200 weeks after the date of the procedure. The median number of new lesions per MRI was 6 (IQR 2-16). Among the same 22 patients, 7 (32%) had recurrent lesions. The median persistent enhancement of a NICE lesion was 13 weeks (IQR 6-30). No factor was predictive of early regression of enhancement activity with lesion regression kinetics mainly being patient-dependent. CONCLUSIONS: The behavior of individual NICE lesions was found to be highly variable with an overall patient-dependent regression velocity.

Endovascular treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial.

OBJECTIVE: The role of endovascular treatment in the management of patients with brain arteriovenous malformations (AVMs) remains uncertain. AVM embolization can be offered as stand-alone curative therapy or prior to surgery or stereotactic radiosurgery (SRS) (pre-embolization). The Treatment of Brain AVMs Study (TOBAS) is an all-inclusive pragmatic study that comprises two randomized trials and multiple registries. METHODS: Results from the TOBAS curative and pre-embolization registries are reported. The primary outcome for this report is death or dependency (modified Rankin Scale [mRS] score > 2) at last follow-up. Secondary outcomes include angiographic results, perioperative serious adverse events (SAEs), and permanent treatment-related complications leading to an mRS score > 2. RESULTS: From June 2014 to May 2021, 1010 patients were recruited in TOBAS. Embolization was chosen as the primary curative treatment for 116 patients and pre-embolization prior to surgery or SRS for 92 patients. Clinical and angiographic outcomes were available in 106 (91%) of 116 and 77 (84%) of 92 patients, respectively. In the curative embolization registry, 70% of AVMs were ruptured, and 62% were low-grade AVMs (Spetzler-Martin grade I or II), while the pre-embolization registry had 70% ruptured AVMs and 58% low-grade AVMs. The primary outcome of death or disability (mRS score > 2) occurred in 15 (14%, 95% CI 8%-22%) of the 106 patients in the curative embolization registry (4 [12%, 95% CI 5%-28%] of 32 unruptured AVMs and 11 [15%, 95% CI 8%-25%] of 74 ruptured AVMs) and 9 (12%, 95% CI 6%-21%) of the 77 patients in the pre-embolization registry (4 [17%, 95% CI 7%-37%] of 23 unruptured AVMs and 5 [9%, 95% CI 4%-20%] of 54 ruptured AVMs) at 2 years. Embolization alone was confirmed to occlude the AVM in 32 (30%, 95% CI 21%-40%) of the 106 curative attempts and in 9 (12%, 95% CI 6%-21%) of 77 patients in the pre-embolization registry. SAEs occurred in 28 of the 106 attempted curative patients (26%, 95% CI 18%-35%, including 21 new symptomatic hemorrhages [20%, 95% CI 13%-29%]). Five of the new hemorrhages were in previously unruptured AVMs (n = 32; 16%, 95% CI 5%-33%). Of the 77 pre-embolization patients, 18 had SAEs (23%, 95% CI 15%-34%), including 12 new symptomatic hemorrhages [16%, 95% CI 9%-26%]). Three of the hemorrhages were in previously unruptured AVMs (3/23; 13%, 95% CI 3%-34%). CONCLUSIONS: Embolization as a curative treatment for brain AVMs was often incomplete. Hemorrhagic complications were frequent, even when the specified intent was pre-embolization before surgery or SRS. Because the role of endovascular treatment remains uncertain, it should preferably, when possible, be offered in the context of a randomized trial.

Vertebroplasty versus bracing in acute vertebral compression fractures: A prospective randomized trial.

BACKGROUND: The treatment of stable vertebral compression fractures remains controversial. OBJECTIVE: To compare the efficacy of vertebroplasty and bracing for acute vertebral compression fractures. METHODS: We conducted a prospective, randomized, non-blinded, single-center study. Adult participants were randomized to undergo vertebroplasty or bracing. Both groups were stratified by age. The primary outcome was functional disability (Roland-Morris disability questionnaire [RMDQ]). Secondary outcomes were pain intensity (Visual Analogue Scale [VAS]), and change in vertebral body height and kyphosis angle. Outcomes were assessed on day 2, and 1, 3 and 6 months after treatment. RESULTS: Ninety-nine people were included, 51 in the vertebroplasty group and 48 in the brace group. Treatment was performed within 2 weeks of the trauma. On day 2 post-treatment, pain was lower in the vertebroplasty group (mean [SD] 2.3 [1.5] versus 3.4 [2.1], p = 0.004) but the difference was no longer significant at 6 months. Functional disability was significantly lower in the vertebroplasty than brace group at all time-points (RMDQ score 7.5 [5.7] vs 11.4 [5.3], p<0.001 at 1 month). At 6 months, the increase in kyphosis angle was smaller in the vertebroplasty than the brace group (+1.5°versus +4°, p<0.001). CONCLUSION: In people with acute vertebral compression fractures, the immediate effect of vertebroplasty was greater than that of bracing on pain and function, and for restoring sagittal balance. At 6 months, the superiority of vertebroplasty decreased, except for the maintenance of sagittal balance. DATABASE REGISTRATION: ClinicalTrials.gov number, NCT01643395.

Carotid artery direct access for mechanical thrombectomy: the Carotid Artery Puncture Evaluation (CARE) study.

BACKGROUND: In acute ischemic stroke due to anterior large vessel occlusion (AIS-LVO), accessing the target occluded vessel for mechanical thrombectomy (MT) is sometimes impossible through the femoral approach. We aimed to evaluate the safety and efficacy of direct carotid artery puncture (DCP) for MT in patients with failed alternative vascular access. METHODS: We retrospectively analyzed data from 45 stroke centers in France, Switzerland and Germany through two research networks from January 2015 to July 2019. We collected physician-centered data on DCP practices and baseline characteristics, procedural variables and clinical outcome after DCP. Uni- and multivariable models were conducted to assess risk factors for complications. RESULTS: From January 2015 to July 2019, 28 149 MT were performed, of which 108 (0.39%) resulted in DCP due to unsuccessful vascular access. After DCP, 77 patients (71.3%) had successful reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) score ≥2b) and 28 (25.9%) were independent (modified Rankin Scale (mRS) score 0-2) at 3 months. 20 complications (18.5%) attributed to DCP occurred, all of them during or within 1 hour of the procedure. Complications led to extension of the intubation time in the intensive care unit in 7 patients (6.4%) and resulted in death in 3 (2.8%). The absence of use of a hemostatic closure device was associated with a higher complication risk (OR 3.04, 95% CI 1.03 to 8.97; p=0043). CONCLUSION: In this large multicentric study, DCP was scantly performed for vascular access to perform MT (0.39%) in patients with AIS-LVO and had a high rate of complications (18.5%). Our results provide arguments for not closing the cervical access by manual compression after MT.

Patient and aneurysm factors associated with aneurysm recanalization after coiling.

BACKGROUND: One limitation of the endovascular treatment of intracranial aneurysms is aneurysm recanalization. The Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) study is a prospective multicenter cohort study evaluating the factors associated with recanalization after endovascular treatment. METHODS: The current analysis is focused on patients treated by coiling or balloon-assisted coiling (BAC). Postoperative, mid-term vascular imaging, and evolution of aneurysm occlusion were independently evaluated by two neuroradiologists. A 3-grade scale was used for aneurysm occlusion (complete occlusion, neck remnant, and aneurysm remnant) and for occlusion evolution (improved, stable, and worsened). Recanalization was defined as any worsening of aneurysm occlusion. RESULTS: Between December 2013 and May 2015, 16 French neurointerventional departments enrolled 1289 patients. A total of 945 aneurysms in 908 patients were treated with coiling or BAC. The overall rate of aneurysm recanalization at mid-term follow-up was 29.5% (95% CI 26.6% to 32.4%): 28.9% and 30.3% in the coiling and BAC groups, respectively. In multivariate analyses factors independently associated with recanalization were current smoking (36.6% in current smokers vs 24.5% in current non-smokers (OR 1.8 (95% CI 1.3 to 2.4); p=0.0001), ruptured status (31.9% in ruptured aneurysms vs 25.1% in unruptured (OR 1.5 (95% CI 1.1 to 2.1); p=0.006), aneurysm size ≥10 mm (48.8% vs 26.5% in aneurysms <10 mm (OR 2.6 (95% CI 1.8 to 3.9); p<0.0001), wide neck (32.1% vs 25.8% in narrow neck (OR 1.5 (95% CI 1.1 to 2.1); p=0.02), and MCA location (34.3% vs 28.3% in other locations (OR 1.5 (95% CI 1.0 to 2.1); p=0.04). CONCLUSIONS: Several factors are identified by the ARETA study as playing a role in aneurysm recanalization after coiling: current smoking, aneurysm status (ruptured), aneurysm size (≥10 mm), neck size (wide neck), and aneurysm location (middle cerebral artery). This finding has important consequences in clinical practice. TRIAL REGISTRATION NUMBER: URL: http://www. CLINICALTRIALS: gov; Unique Identifier: NCT01942512.

Non-ischemic cerebral enhancing lesions after intracranial aneurysm endovascular repair: a retrospective French national registry.

BACKGROUND: Non-ischemic cerebral enhancing (NICE) lesions are exceptionally rare following aneurysm endovascular therapy (EVT). OBJECTIVE: To investigate the presenting features and longitudinal follow-up of patients with NICE lesions following aneurysm EVT. METHODS: Patients included in a retrospective national multicentre inception cohort were analysed. NICE lesions were defined, using MRI, as delayed onset punctate, nodular or annular foci enhancements with peri-lesion edema, distributed in the vascular territory of the aneurysm EVT, with no other confounding disease. RESULTS: From a pool of 58 815 aneurysm endovascular treatment procedures during the study sampling period (2006-2019), 21/37 centres identified 31 patients with 32 aneurysms of the anterior circulation who developed NICE lesions (mean age 45±10 years). Mean delay to diagnosis was 5±9 months, with onset occurring a month or less after the index EVT procedure in 10 out of 31 patients (32%). NICE lesions were symptomatic at time of onset in 23 of 31 patients (74%). After a mean follow-up of 25±26 months, 25 patients (81%) were asymptomatic or minimally symptomatic without disability (modified Rankin Scale (mRS) score 0-1) at last follow-up while 4 (13%) presented with mild disability (mRS score 2). Clinical follow-up data were unavailable for two patients. Follow-up MRI (available in 27 patients; mean time interval after onset of 22±22 months) demonstrated persistent enhancement in 71% of cases. CONCLUSIONS: The clinical spectrum of NICE lesions following aneurysm EVT therapy spans a wide range of neurological symptoms. Clinical course is most commonly benign, although persistent long-term enhancement is frequent.

Immediate post-operative aneurysm occlusion after endovascular treatment of intracranial aneurysms with coiling or balloon-assisted coiling in a prospective multicenter cohort of 1189 patients: Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) Study.

BACKGROUND: Coiling, including balloon-assisted coiling (BAC), is the first-line therapy for ruptured and unruptured aneurysms. Its efficacy can be clinically evaluated by bleeding/rebleeding rate after coiling, and anatomically evaluated by aneurysm occlusion post-procedure and during follow-up. We aimed to analyze immediate post-coiling aneurysm occlusion and associated factors within the Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) population. METHODS: Between December 2013 and May 2015, 16 neurointerventional departments prospectively enrolled participants treated for ruptured and unruptured aneurysms (ClinicalTrials.gov: NCT01942512). Participant demographics, aneurysm characteristics, and endovascular techniques were recorded. In patients with aneurysms treated by coiling or BAC, immediate post-operative aneurysm occlusion was independently evaluated by a core lab using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: Of 1135 participants (age 53.8±12.8 years, 754 women (66.4%)), 1189 aneurysms were analyzed. Treatment modality was standard coiling in 645/1189 aneurysms (54.2%) and BAC in 544/1189 (45.8%). Immediate post-operative aneurysm occlusion was complete occlusion in 57.8%, neck remnant in 34.4%, and aneurysm remnant in 7.8%. Adequate occlusion (complete occlusion or neck remnant) was significantly more frequent in aneurysms with size <10 mm (93.1% vs 86.3%; OR 1.8, 95% CI 1.1 to 3.2; p=0.02) and in aneurysms with a narrow neck (95.8% vs 89.6%; OR 2.5, 95% CI 1.5 to 4.1; p=0.0004). Patients aged <70 years had significantly more adequate occlusion (92.7% vs 87.2%; OR 1.9, 95% CI 1.1 to 3.4; p=0.04). CONCLUSIONS: Immediately after aneurysm coiling, including BAC, adequate aneurysm occlusion was obtained in 92.2%. Age <70 years, aneurysm size <10 mm, and narrow neck were factors associated with adequate occlusion. TRIAL REGISTRATION NUMBER: NCT01942512, http://www.clinicaltrials.gov.

Delayed thromboembolic events after coiling of unruptured intracranial aneurysms in a prospective cohort of 335 patients.

BACKGROUND: Coiling is the first-line treatment for the management of unruptured intracranial aneurysms (UIAs), but delayed thromboembolic events (TEEs) can occur after such treatment. ARETA (Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm) is a prospective multicenter study conducted to analyze aneurysm recanalization. We analyzed delayed TEEs in the UIA subgroup. METHODS: Sixteen neurointerventional departments prospectively enrolled patients treated for ruptured and unruptured aneurysms between December 2013 and May 2015. Participant demographics, aneurysm characteristics, and endovascular techniques were recorded. Data were analyzed from participants with UIA treated by coiling or balloon-assisted coiling. We assessed the rates, timing, management, clinical outcomes, and risk factors for delayed TEEs using univariable and multivariable analyses. RESULTS: The rate of delayed TEEs was 2.4% (95% CI 1.0% to 4.6%) in patients with unruptured aneurysms, with all events occurring in the week following the procedure. In multivariate analysis, two factors were associated with delayed TEEs: autosomal dominant polycystic kidney disease (ADPKD): 20.0% in patients with ADPKD vs 1.9% in patients without ADPKD (OR 27.3 (95% CI 3.9 to 190.2), p=0.0008) and post-procedure aneurysm remnant: 9.4% in patients with post-procedure aneurysm remnant vs 1.6% in patients with adequate occlusion (OR 9.9 (95% CI 1.0 to 51.3), p=0.006). We describe modalities of management as well as clinical outcomes. CONCLUSIONS: Delayed TEE is a relatively rare complication after coiling of UIAs. In this series, all occurred in the week following the initial procedure. Two factors were associated with delayed TEE: ADPKD and aneurysm remnant at procedure completion. CLINICAL TRIAL REGISTRATION: NCT01942512.

Rebleeding and bleeding in the year following intracranial aneurysm coiling: analysis of a large prospective multicenter cohort of 1140 patients-Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study.

BACKGROUND: Endovascular treatment is the first line therapy for the management of ruptured and unruptured intracranial aneurysms, but delayed aneurysm rupture leading to bleeding/rebleeding can occur subsequently. ARETA (Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm) is a prospective, multicenter study conducted to analyze aneurysm recanalization. We analyzed delayed bleeding and rebleeding in this large cohort. METHODS: 16 neurointerventional departments prospectively enrolled patients treated for ruptured and unruptured aneurysms between December 2013 and May 2015 (ClinicalTrials.gov: NCT01942512). Participant demographics, aneurysm characteristics and endovascular techniques were recorded. Data were analyzed from participants with ruptured or unruptured aneurysms treated by coiling or balloon-assisted coiling. Rates of bleeding and rebleeding were analyzed and associated factors were studied using univariable and multivariable analyses. RESULTS: The bleeding rate was 0.0% in patients with unruptured aneurysms and 1.0% (95% CI 0.3% to 1.7%) in patients with ruptured aneurysms. In multivariate analysis, two factors were associated with rebleeding occurrence: incomplete aneurysm occlusion after initial treatment (2.0% in incomplete aneurysm occlusion vs 0.2% in complete aneurysm occlusion, OR 10.2, 95% CI 1.2 to 83.3; p=0.03) and dome-to-neck ratio (1.5±0.5 with rebleeding vs 2.2±0.9 without rebleeding, OR 0.2, 95% CI 0.04 to 0.8; p=0.03). Modalities of management of aneurysm rebleeding as well as clinical outcomes are described. CONCLUSIONS: Aneurysm coiling affords good protection against bleeding (for unruptured aneurysms) and rebleeding (for ruptured aneurysms) at 1 year with rates of 0.0% and 1.0%, respectively. Aneurysm occlusion and dome-to-neck ratio are the two factors that appear to play a role in the occurrence of rebleeding.

Intraoperative Complications of Endovascular Treatment of Intracranial Aneurysms with Coiling or Balloon-assisted Coiling in a Prospective Multicenter Cohort of 1088 Participants: Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study.

Background Thromboembolic events and intraoperative rupture are the most frequent neurologic complications of intracranial aneurysm coiling. Their frequency has not been evaluated in recent series. Purpose To provide an analysis of complications, clinical outcome, and participant and aneurysm risk factors after aneurysm coiling or balloon-assisted coiling within the Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm, or ARETA, cohort. Materials and Methods Sixteen neurointerventional departments prospectively enrolled participants treated for ruptured and unruptured aneurysms between December 2013 and May 2015. Participant demographics, aneurysm characteristics, and endovascular techniques were recorded. Data were analyzed from participants within the overall cohort treated with coiling or balloon-assisted coiling for a single aneurysm. Rates of neurologic complications were analyzed, and associated factors were studied by using univariable analyses (Student t test, χ2 test, or Fisher exact test, as appropriate) and multivariable analyses (logistic regressions). Results A total of 1088 participants (mean age ± standard deviation, 54 years ± 13; 715 women [65.7%]) were analyzed. Thromboembolic events and intraoperative rupture were reported in 113 of 1088 participants (10.4%) and 34 of 1088 participants (3.1%), respectively. Poor clinical outcome (defined as modified Rankin Scale score of 3-6) was reported in 29 of 113 participants (25.7%) with thromboembolic events and in 11 of 34 participants (32.4%) with intraoperative rupture (P = .44). Factors associated with thromboembolic events were female sex (odds ratio [OR], 1.7; 95% confidence interval [CI]: 1.1, 2.8; P = .02) and middle cerebral artery location (OR, 1.9; 95% CI: 1.2, 3.0; P = .008). Factors associated with intraoperative rupture were anterior communicating artery location (OR, 2.2; 95% CI: 1.1, 4.7; P = .03) and small aneurysm size (OR, 3.0; 95% CI: 1.5, 6.3; P = .003). Conclusion During aneurysm coiling or balloon-assisted coiling, thromboembolic events were more frequent than were intraoperative rupture. Both complications were associated with poor clinical outcome in a similar percentage of participants. Risk factors for thromboembolic events were female sex and middle cerebral artery location. Risk factors for intraoperative rupture were small aneurysm size and anterior cerebral or communicating artery location. © RSNA, 2020.

Flow Diverters for Intracranial Aneurysms: The DIVERSION National Prospective Cohort Study.

Background and Purpose- Flow diverters are used for endovascular therapy of intracranial aneurysms. We did a nationwide prospective study to investigate the safety and effectiveness of flow diversion at 12 months. Methods- DIVERSION was a national prospective cohort study including all flow diverters placement between October 2012 and February 2014 in France. The primary end point was the event-free survival rate at 12 months, defined as the occurrence of morbidity (intracranial hemorrhage, ischemic stroke, noncerebral hemorrhage, or neurological deficit due to mass effect), retreatment, or death within 12 months post-treatment. A quality control was carried out on 100% of the collected data and of at least 10% of the included patients in each center, chosen at random. All reported serious events were adjudicated by an independent Data Safety and Monitoring Board. Satisfactory occlusion was defined as 3 or 4 on Kamran scale by an independent imaging core laboratory at 12 months. Results- We enrolled 398 patients harboring 477 intracranial aneurysms. At least 1 morbidity-mortality event was noted in 95 of 408 interventions representing an event-free survival rate of 75.7% (95% CI, 71.1-79.7). The rate of permanent-related serious events and mortality was 5.9% and 1.2% at 12 months, respectively. Multivariate analysis showed that high baseline blood pressure (hazard ratio, 2.54; 95% CI, 1.35-4.79; P=0.039), diabetes mellitus (hazard ratio, 3.70; 95% CI, 1.60-8.6; P=0.0022), and larger aneurysms (hazard ratio, 1.07; 95% CI, 1.04-1.11; P<0.0001) were associated with the occurrence of a neurological deficit. The satisfactory occlusion rate at 12 months was 79.9%, and the absence of high baseline blood pressure (odds ratio, 2.01; 95% CI, 1.12-3.71; P=0.0193) and postprocedural satisfactory occlusion (odds ratio, 2.75; 95% CI, 1.49-5.09; P=0.0012) were associated with a 12-month satisfactory occlusion. Conclusions- A satisfactory occlusion was achieved in almost 80% of cases after flow diverter treatment with a permanent-related serious event and mortality rates of 5.9% and 1.2% at 12 months, respectively.

Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol.

INTRODUCTION: Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS. METHODS AND ANALYSIS: Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0-2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7. ETHICS AND DISSEMINATION: The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal. TRIAL REGISTRATION NUMBER: NCT03229148.

Periprocedural safety and technical outcomes of the new Silk Vista Baby flow diverter for the treatment of intracranial aneurysms: results from a multicenter experience.

PURPOSE: The aim of our study was to assess the technical success and the safety of this new low-profile flow diverter Silk Vista Baby (SVB) by evaluating the intraprocedural and periprocedural complication rate. MATERIAL/METHODS: Clinical, procedural, and angiographic data were analyzed. RESULTS: 41 consecutive patients (28 women; age average 50.5 years) with 43 aneurysms were treated with SVB. Aneurysm sizes were classified by their maximum diameter, with an average size of 9.5 mm (range 2-30 mm). Thirty-four cases were unruptured. five aneurysms previously ruptured, had recurrence after the initial coiling. There were two ruptured cases. Aneurysms' locations were: M1 segment (five cases), M2 segment (three cases), M3 segment (one case), middle cerebral artery (MCA) bifurcation (six cases), carotid-T (two cases), anterior communicating artery/A1/A2 (11 cases), pericallosal artery (four cases), supraclinoid ICA (two cases), PCom (one case), V4 segment (three cases), PCA (three cases), SCA (one case), and PICA (one case). We had five intraprocedural complications which resolved without clinical consequences and three events postprocedural events. Initial occlusion rates were: eight aneurysms (18.6%) were completely occluded, five aneurysms (11.6%) showed near-complete occlusion, four cases (9.3%) showed incomplete filling, and 26 cases (60.4%) showed persisting filling. The mRS score at discharge from the hospital did not change from the admission mRS score. CONCLUSION: Our study demonstrated that the use of the new low-profile flow diverter, SVB device, for the treatment of intracranial aneurysms is feasible and technically safe.

Association of Time From Stroke Onset to Groin Puncture With Quality of Reperfusion After Mechanical Thrombectomy: A Meta-analysis of Individual Patient Data From 7 Randomized Clinical Trials.

Importance: Reperfusion is a key factor for clinical outcome in patients with acute ischemic stroke (AIS) treated with endovascular thrombectomy (EVT) for large-vessel intracranial occlusion. However, data are scarce on the association between the time from onset and reperfusion results. Objective: To analyze the rate of reperfusion after EVT started at different intervals after symptom onset in patients with AIS. Design, Setting, and Participants: We conducted a meta-analysis of individual patient data from 7 randomized trials of the Highly Effective Reperfusion Using Multiple Endovascular Devices (HERMES) group. This is a multicenter cohort study of the intervention arm of randomized clinical trials included in the HERMES group. Patients with anterior circulation AIS who underwent EVT for M1/M2 or intracranial carotid artery occlusion were included. Each trial enrolled patients according to its specific inclusion and exclusion criteria. Data on patients eligible but not enrolled (eg, refusals or exclusions) were not available. All analyses were performed by the HERMES biostatistical core laboratory using the pooled database. Data were analyzed between December 2010 and April 2015. Main Outcomes and Measures: Successful reperfusion was defined as a modified thrombolysis in cerebral infarction score of 2b/3 at the end of the EVT procedure adjusted for age, occlusion location, pretreatment intravenous thrombolysis, and clot burden score and was analyzed in relation to different intervals (onset, emergency department arrival, imaging, and puncture) using mixed-methods logistic regression. Results: Among the 728 included patients, with a mean (SD) age of 65.4 (13.5) years and of whom 345 were female (47.4%), decreases in rates of successful reperfusion defined as a thrombolysis in cerebral infarction score of 2b/3 were observed with increasing time from admission or first imaging to groin puncture. The magnitude of effect was a 22% relative reduction (odds ratio, 0.78; 95% CI, 0.64-0.95) per additional hour between admission and puncture and a 26% relative reduction (odds ratio, 0.74; 95% CI, 0.59-0.93) per additional hour between imaging and puncture. Conclusions and Relevance: Because the probability of reperfusion declined significantly with time between hospital arrival and groin puncture, we provide additional arguments for minimizing the intervals after symptom onset in anterior circulation acute ischemic stroke.

SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results.

BACKGROUND AND PURPOSE: Flow diversion is an innovative and increasingly used endovascular treatment for intracranial aneurysms. Its initial evaluation with the first devices available showed good efficacy of this treatment with variable safety results. The Flow Direction Endoluminal Device (FRED) has a specific design and was evaluated in a single-arm, multicenter, prospective, Good Clinical Practice study: SAFE (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment). This analysis reports clinical results at 1 year and anatomical results at 6 months and 1 year. METHODS: Patients with unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. A Clinical Event Committee and a Core Laboratory independently evaluated clinical outcome and anatomical results. RESULTS: Thirteen interventional neuroradiology centers included 103 patients/aneurysms. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral or anterior communicating artery in 9 (8.7%), and middle cerebral artery in 8 (7.8%). Most aneurysms were small (<10 mm) in 71 patients (68.9%). Cumulative 1-year mortality and morbidity rates were 2/103 (1.9%) and 3/103 (2.9%), respectively, one death being related to cancer. At 1 year, anatomical results were: complete occlusion in 66/90 patients (73.3%), neck remnant in 7/90 patients (7.8%), and aneurysm remnant in 17/90 patients (18.9%). CONCLUSIONS: SAFE study analysis at 1 year confirms the excellent safety profile of the FRED device for aneurysm treatment, with low morbidity and mortality rates (2.9% and 1.9%, respectively) and demonstrates its efficacy (adequate occlusion in 73/90 (81.1%)). CLINICAL TRIAL REGISTRATION: Unique identifier: NCT02921698; Results.

One-year efficacy and safety of the Trufill DCS Orbit and Orbit Galaxy detachable coils in the endovascular treatment of intracranial aneurysms: Results from the TRULINE study.

Background and purpose No series reported the mid-term results of Trufill DCS Orbit and Orbit Galaxy detachable coils with independent evaluation. We present the one-year safety and efficacy of these coils in real-life routine clinical practice. Methods A total of 167 patients with 167 aneurysms (39.1% ruptured) were enrolled in the prospective TRULINE study. The primary endpoint was the safety, assessed by the combined morbidity-mortality rate observed since the time of the procedure and up to one-year follow-up. For safety, primary analyses were performed on intent-to-treat population (attempted coils procedure) and all adverse events have been reviewed by an independent Data Safety Monitoring Board. For efficacy, primary analyses were performed on the per-protocol population (patients treated with more than 70% of Trufill coils and not retreated during the follow-up period) and an independent core laboratory evaluated angiographic results. Results At one-year post-procedure, neurologic impairment was observed in 6.5% (95% confidence interval: 3.5-11.8) of the patients, and 2.6% (95% confidence interval: 1.0-6.8) had a permanent neurological deterioration. Three deaths were observed, unrelated to the procedure or coils. At one year, complete occlusion was seen in 52 aneurysms (54.2%), neck remnant in 28 aneurysms (29.2%), and aneurysm remnant in 16 aneurysms (16.7%). During the one-year follow-up, the overall incidence of recurrence was 30.2% with a mean interval of 13.8 ± 4.5 months and the retreatment for major recanalization was needed in nine patients (6.3%). Conclusions The TRULINE study confirms that endovascular coiling with Trufill DCS Orbit and Orbit Galaxy detachable coils is safe and effective.