Development of a Risk Prediction Nomogram for Carotid Re-Stenosis in the One Year RECAST Registry.

OBJECTIVE: The long term benefit of carotid angioplasty and stenting (CAS) can be reduced by recurrent stroke related to in stent re-stenosis (ISR). An individualised predictive tool is needed to identify ISR events. A nomogram for individual risk assessment of ISR ≥ 70% after CAS is proposed. METHODS: A national observational, prospective, multicentre registry was conducted between January 2015 and December 2020. Cohorts of patients with symptomatic or asymptomatic severe carotid stenosis who underwent CAS with a follow up of at least one year after CAS were included. Duplex ultrasound was used to assess in stent re-stenosis. Pre-operative factors were compared between the non-ISR and ISR groups. Kaplan-Meier and Cox regression were used for variable selection. The nomogram was formulated and validated by concordance indices and calibration curves. An in stent re-stenosis risk table was generated for risk stratification. RESULTS: A total of 354 patients were included in the analysis. The ISR rate of ≥ 70% was 7.6% (n = 27). Peripheral arterial disease (hazard ratio [HR] 3.18, 95% confidence interval [CI] 1.23 - 8.24, p = .017), anterior communicating artery absence (HR 3.38, 95% CI 1.27 - 8.94, p = .016), diabetes mellitus (HR 3.34, 95% CI 1.21 - 9.26, p = .020), female sex (HR 2.99, 95% CI 1.04 - 8.60, p = .041), and pre-procedure pathological ultrasound vasoreactivity (HR 3.87, 95% CI 1.43 -10.50, p = .008), as independent risk factors for ISR of ≥ 70%, were included in the nomogram. The concordance index at 12 and 24 months was 0.83. In low risk groups, ISR of ≥ 70% occurred in 4.8% of patients during follow up compared with 56.2% of patients in the high risk groups (p < .001). CONCLUSION: The nomogram and risk evaluation score have good predictive ability for ISR. They can be used as practical clinical tools for individualised risk assessment.

Seasonal patterns and associations in the incidence of acute ischemic stroke requiring mechanical thrombectomy.

BACKGROUND: In order to identify risk periods with an increased demand in technical and human resources, we tried to determine patterns and associations in the incidence of acute ischemic stroke due to embolic large vessel occlusions (eLVO) requiring mechanical thrombectomy (MT). METHODS: We conducted a time series analysis over a 9-year period (2010-2018) based on observational data in order to detect seasonal patterns in the incidence of MT due to eLVO (n = 2628 patients). In a series of sequential negative binominal regression models, we aimed to detect further associations (e.g., temperature, atmospheric pressure, air pollution). RESULTS: There was a 6-month seasonal pattern in the incidence of MT due to eLVO (p = 0.024) peaking in March and September. Colder overall temperature was associated with an increase in MT due to eLVO (average marginal effect [AME], [95% CI]: -0.15 [-0.30-0.0001]; p = 0.05; per °C). A current increase in the average monthly temperature was associated with a higher incidence of MT due to eLVO (0.34 [0.11-0.56]; p = 0.003). Atmospheric pressure was positively correlated with MT due to eLVO (0.38 [0.13-0.64]; p = 0.003; per hectopascal [hPa]). We could detect no causal correlation between air pollutants and MT due to eLVO. CONCLUSIONS: Our data suggest a 6-month seasonal pattern in the incidence of MT due to eLVO peaking in spring and early autumn. This might be attributed to two different factors: (1) a current temperature rise (comparing the average monthly temperature in consecutive months) and (2) colder overall temperature. These results could help to identify risk periods requiring an adaptation in local infrastructure.

Recanalization of Emergent Large Intracranial Vessel Occlusion through Intravenous Thrombolysis: Frequency, Clinical Outcome, and Reperfusion Pattern.

BACKGROUND: According to a recent meta-analysis, 1 out of 10 patients with emergent large intracranial vessel occlusion (ELVO) causing stroke have recanalization after intravenous thrombolysis (IVT) alone. However, rate, clinical outcome, and recanalization pattern of this phenomenon are poorly understood. OBJECTIVES AND METHODS: Patients with ELVO recanalized only by IVT were analyzed, and frequency of recanalization, clinical outcome, safety variables, and reperfusion pattern were assessed. These patients were compared to a group of patients with ELVO who underwent endovascular thrombectomy with or without prior IVT. RESULTS: Successful or sufficient recanalization after IVT alone occurred in 81 of 760 patients (10.6%) with ELVO who had been referred for endovascular thrombectomy. These 81 patients (group 1) were compared to a group of patients receiving endovascular thrombectomy with prior IVT (group 2) or without (group 3). A good clinical outcome at 90 days was seen in 61.7% of patients in group 1, 32.2% in group 2, and 34.5% in group 3 (p < 0.001). The 3 groups had no significant differences in intracranial hemorrhage. IVT was not independently associated with symptomatic intracranial hemorrhage, parenchymal hematoma, or subarachnoid hemorrhage. Mortality at 90 days was 9.9% in group 1, 20.7% in group 2, and 29.6% in group 3 (p < 0.001). After adjusting for all relevant variables, outcome and mortality differences were nonsignificant. No difference in the rate of successful reperfusion (modified treatment in cerebral ischemia [mTICI] 2b/3) was found. A reperfusion mTICI 3 was achieved in 18.5% in group 1, 60.7% in group 2, and 57.1% in group 3 (p < 0.001). Patients in group 1 had lower chance of achieving a complete recanalization (mTICI 3) compared to patients in group 2, OR 0.15 (95% CI 0.08-0.29) and in group 3, OR 0.17 (95% CI 0.09-0.32; p < 0.001). CONCLUSIONS: Primary IVT in ELVO caused a recanalization rate of 10.6%, making endovascular treatment either unnecessary or impossible. Early recanalization of ELVO with only IVT is associated with a 61.7% independence rate at 90 days and similar successful reperfusion rates (mTICI2b/3) compared to ELVO treated with endovascular treatment, with or without previous IVT. However, recanalization only through IVT achieves a lower rate of mTICI 3 reperfusion when compared to endovascular treatment.

Evaluation of safety, efficacy and clinical outcome after endovascular treatment of aneurysmal subarachnoid hemorrhage in coil-first setting. A 10-year series from a single center.

INTRODUCTION: The endovascular treatment (EVT) of ruptured cerebral aneurysms has been widely adopted after the publication of the International Subarachnoid Aneurysm Trial. In this study, we sought to evaluate the safety and efficacy of the EVT for ruptured aneurysms based on 10-year series from a single center with coil-first strategy. METHODS: All patients with aneurysmal subarachnoid hemorrhage (aSAH) treated between 2007 and 2016 were retrospectively reviewed and divided according to initial treatment into an EVT and a microsurgical clipping (MSC) group. Clinical and radiological findings at presentation, treatment modalities and procedural complications were recorded. The angiographic and clinical outcome was compared between the two groups. RESULTS: A total of 587 patients with aSAH were reviewed (452 EVT, 135 MSC). There were no significant differences in mean age or the Hunt and Hess grades. Parenchymal hemorrhage (PH) was more frequent in the MSC. Procedure related complications of the acute treatment were recorded in 5.5% and 32% in the EVT and MSC, respectively. The rate of retreatment was 21.9% in the EVT and 5.9% in the MSC. Late rehemorrhage was not observed in either group. There was no significant difference in the clinical outcome between the two treatment groups after adjustment for other prognostic factors. CONCLUSION: The majority of ruptured intracranial aneurysms can be managed via an endovascular approach in the acute phase with excellent safety profile and good efficacy. Despite the high rate of reperfusion after primary endovascular approach, retreatment has a very low rate of complications and the rate of recurrent hemorrhage is very low.

Endovascular treatment of acute internal carotid artery dissections: technical considerations, clinical and angiographic outcome.

INTRODUCTION: In acute internal carotid artery dissection (a-ICAD) with concomitant intracranial large vessel occlusion or haemodynamic impairment, the effectiveness of medical treatment is limited and endovascular therapy (EVT) can be considered. Feasibility, safety and outcome of EVT in a-ICAD are not well described yet. METHODS: From an institutional database, we retrospectively selected consecutive patients treated for a-ICAD between January 2007 and July 2015. We assessed recanalization results defining <50 % residual stenosis and mTICI ≥2b as successful. Procedural adverse events and symptomatic haemorrhages were reported as well as clinical outcome at 90 days defining a mRS ≤2 as favourable. Follow-up angiographies were reviewed and retreatments reported. RESULTS: In the defined period, 73 patients (mean age 48 years (31-73), mean NIHSS 11 (0-27)) received EVT for a-ICAD. The majority (60 %) had tandem occlusions. Cervical artery reconstruction was successful in 100 % and intracranial thrombectomy in 85 %. Thrombus formation (18 %) and thromboembolism (20 %) were the most frequent adverse events but clinically relevant only in 8 %. Symptomatic haemorrhage occurred in 5 %. Clinical outcome was favourable in 64 %, with a lower chance after tandem occlusion (55 vs. 79 %, p = 0.047). Death rate was 10 %. None of the patients developed recurrent ischaemic symptoms, but control angiography revealed abnormal findings of the reconstructed ICA in 38 % leading to retreatment in 17 %. CONCLUSION: EVT of a-ICAD is feasible with a predominantly favourable clinical outcome. Improvement of devices and techniques is warranted to reduce the risk of thrombus formation and thromboembolism during treatment and insufficient vessel wall healing thereafter.

Clinical experience with the pREset stent retriever for the treatment of acute ischemic stroke--a review of 271 consecutive cases.

INTRODUCTION: The purpose of this study was to evaluate the safety and efficacy of the pREset stent retriever in a real-world clinical setting. METHODS: Patients treated with pREset were selected from a prospectively maintained single-center database. A TICI score ≥2b after ≤3 passes was regarded as successful recanalization. All device-related complications and their clinical significance were reported. Parenchymal hematomas (PH) were classified according to ECASS, adding focal and diffuse subarachnoid hemorrhage (SAH) as categories. A 90-day mRS of 0-2 was defined as favorable outcome. In addition, we separately analyzed patients treated with >3 pREset passes and patients receiving other rescue maneuvers. RESULTS: We included 271 patients. Successful recanalization was achieved in 76.4 %. Device-related complications occurred in 9.2 % of which 2.2 % were clinically significant. PH I, PH II, focal SAH, and diffuse SAH was observed in 5.2, 4.8, 12.2, and 2.2 %, respectively. A total of 39.5 % of patients had favorable clinical outcome. Considering treatments with >3 pREset passes or other rescue procedures, an additional 8.5 and 9.3 % of target vessels were recanalized. The chance of favorable clinical outcome decreased significantly with any kind of rescue therapy. In addition, the rate of PH I was significantly higher in patients treated with >3 pREset passes, whereas all other types of hemorrhage showed no difference. CONCLUSION: In terms of safety and effectiveness, pREset performed comparably to other stent retriever devices. To avoid futile recanalization and potential additional harm, escalation of therapy beyond three thrombectomy passes should only be performed after careful individual consideration of each case.

Tirofiban versus aspirin to prevent in-stent thrombosis after emergent carotid artery stenting in acute ischemic stroke.

BACKGROUND: Several antithrombotic treatments during emergent carotid artery stenting (eCAS) have been proposed, but an appropriate protocol to balance risk-benefit is not well known. OBJECTIVE: To investigate the efficacy and safety of tirofiban compared with aspirin in patients with acute ischemic stroke undergoing eCAS. METHODS: We conducted a retrospective single-center study of the prospective ARTISTA Registry, including patients with atherosclerotic internal carotid artery occlusion treated with eCAS. Two groups, according to antiplatelet drug, were studied: aspirin (250-500 mg single-dose) versus tirofiban (500 µg bolus+200 µg/h). Primary outcomes were the rate of in-stent thrombosis and symptomatic intracranial hemorrhage (sICH) within the first 24 hours. RESULTS: During the period 2019-2023, 181 patients were included, 103 received aspirin, 78 tirofiban; 149 (82.3%) had tandem lesions. The primary efficacy outcome occurred in 9 (9.4%) in the aspirin group, as compared with 1 (1.3%) in the tirofiban group (adjusted odds ratio (aOR)=0.11, 95% CI 0.01 to 0.98; P=0.048). The primary safety outcome was detected in 12 (11.7%) in the aspirin group, as compared with 2 (2.6%) in the tirofiban group (aOR=0.16, 95% CI 0.03 to 0.87; P=0.034). The tirofiban group presented a lower risk of parenchymal hemorrhage (18 (17.4%) vs 4 (5.2%), aOR=0.27, 95% CI 0.09 to 0.88; P=0.029) and an increased rate of excellent recanalization (expanded Treatment in Cerebral Infarction (eTICI) 2c-3) (50 (48.5%) vs 54 (69.2%); aOR=2.15, 95% CI 1.12 to 4.13; P=0.02). There were no differences in functional outcomes or mortality at 3 months. CONCLUSIONS: Periprocedural antithrombotic therapy with tirofiban was associated with a lower risk of in-stent thrombosis and sICH at 24 hours from eCAS compared with aspirin. Prospective randomized clinical trials are needed to confirm our results.

Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial).

RATIONALE: In-stent reocclusion after endovascular therapy has a negative impact on outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Optimal antiplatelet therapy approach in these patients to avoid in-stent reocclusion is yet to be elucidated. AIMS: To assess efficacy and safety of intravenous tirofiban versus intravenous aspirin in patients undergoing MT plus carotid stenting in the setting of AIS due to TL. SAMPLE SIZE ESTIMATES: Two hundred forty patients will be enrolled, 120 in every treatment arm. METHODS AND DESIGN: A multicenter, prospective, randomized, controlled (aspirin group), assessor-blinded clinical trial will be conducted. Patients fulfilling the inclusion criteria will be randomized at MT onset to the experimental or control group (1:1). Intravenous aspirin will be administered at a 500-mg single dose and tirofiban at a 500-mcg bolus followed by a 200-mcg/h infusion during the first 24 h. All patients will be followed for up to 3 months. STUDY OUTCOMES: Primary efficacy outcome will be the proportion of patients with carotid in-stent thrombosis within the first 24 h after MT. Primary safety outcome will be the rate of symptomatic intracranial hemorrhage. DISCUSSION: This will be the first clinical trial to assess the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL. TRIAL REGISTRATION: The trial is registered as NCT05225961. February, 7th, 2022.

Predictors of outcome after mechanical thrombectomy for anterior circulation large vessel occlusion in patients aged ≥80 years.

BACKGROUND: There is uncertainty about the role of endovascular recanalization procedures for the treatment of acute ischemic stroke in patients aged ≥80 years. Therefore, careful patient selection is mandatory. Our aim was to find valid predictors of clinical outcome after mechanical thrombectomy (mTE) based on the sparse information available in the emergency setting. METHODS: We included consecutive patients aged ≥80 years treated by mTE for anterior circulation thromboembolic vessel occlusion in our department between January 2008 and January 2013. Successful recanalization was defined as a thrombolysis in cerebral infarction (TICI) score of 2b or 3. The rates of parenchymal hemorrhage types I (PHI) and II (PHII) according to the ECASS definition and the rate of focal and diffuse subarachnoid hemorrhage (SAH) were reported. A modified Ranking scale (mRS) score of 0-2 at 90 days was defined as a favorable outcome. We evaluated the influence of gender, smoking habits, atrial fibrillation, diabetes, hypertension, hyperlipidemia, coronary artery and peripheral artery disease, National Institutes of Health Stroke Scale (NIHSS) score, Totaled Health Risks in Vascular Events (THRIVE) score, Alberta Stroke Program Early CT Score (ASPECTS), and duration of symptoms on favorable outcome. Significant predictors were then included in a stepwise logistic regression analysis. Odds ratios (OR), 95% confidence intervals (CI), and receiver operating characteristics (ROC) curves were calculated. p < 0.05 was considered statistically significant. RESULTS: In the defined period, we treated 109 patients aged ≥80 years with 116 occluded anterior circulation target vessels. Successful recanalization was achieved in 87.9% of the targets. The rates of PHI, PHII, and focal and diffuse SAH were 6.4, 5.5, 12.8, and 7.3%, with an overlap between PH and SAH. The combined rate of PHII and/or diffuse SAH was 9.2%. Despite good recanalization rates and reasonable rates of hemorrhage, only 19 patients (17.4%) were functionally independent at 90 days. An additional 12 patients (11.0%) suffered from moderate disability (mRS score 3), 26 (23.9%) were severely disabled (mRS score 4-5) and 52 (47.7%) were deceased. NIHSS, ASPECTS, and THRIVE scores significantly predicted a favorable outcome. Stepwise logistic regression identified NIHSS (OR 0.89; 95% CI 0.82-0.96; p = 0.009) and ASPECTS (OR 2.27; 95% CI 1.28-4.02; p = 0.005) as independent predictors. The ROC area was 0.81. CONCLUSION: ASPECTS and NIHSS were independent predictors of a favorable outcome in patients aged ≥80 years after mTE for anterior circulation large vessel occlusion and may support decision making with regard to the treatment modality. Since the chances of gaining functional independence are limited, careful consideration of each individual case is mandatory. Further studies comparing endovascular and standard treatment in octogenarians are warranted.

Safety and efficacy of tirofiban in acute ischemic stroke due to tandem lesions undergoing mechanical thrombectomy: A multicenter randomized clinical trial (ATILA) protocol.

Background: In-stent thrombosis after mechanical thrombectomy (MT) worsen outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Although an optimal antiplatelet therapy is needed, the best approach to avoid in-stent thrombosis is yet to be elucidated. Hypothesis: Low-dose intravenous tirofiban is superior to intravenous aspirin in avoiding in-stent thrombosis in patients undergoing MT plus carotid stenting in the setting of AIS due to TL. Methods: The ATILA-trial is a multicenter, prospective, phase IV, randomized, controlled (aspirin group as control), assessor-blinded clinical trial. Patients fulfilling inclusion criteria (AIS due to TL, ASPECTS ⩾ 6, pre-stroke modified Rankin Scale ⩽2 and onset <24 h) will be randomized (1:1) at MT onset to experimental (intravenous tirofiban) or control group (intravenous aspirin). Intravenous aspirin will be administered at a 500 mg single dose and tirofiban at a 500 µg bolus followed by a 200 µg/h infusion during first 22 h. All patients will be followed up to 3 months. Sample size estimated is 240 patients. Outcomes: The primary efficacy outcome is the proportion of patients with carotid in-stent thrombosis within the first 24 h after MT. The primary safety outcome is the rate of symptomatic intracranial hemorrhage. Secondary outcomes include functional independence defined as modified Rankin Scale 0-2, proportion of patients undergoing rescue therapy due to in-stent aggregation during MT and carotid reocclusion at 30 days. Discussion: ATILA-trial will be the first clinical trial regarding the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL. Trial registration: NCT0522596.

Pipeline embolization device (PED) for neurovascular reconstruction: initial experience in the treatment of 101 intracranial aneurysms and dissections.

INTRODUCTION: The purpose of this study was to evaluate the safety and efficacy of the recently available flow diverter "pipeline embolization device" (PED) for the treatment of intracranial aneurysms and dissections. METHODS: Eighty-eight consecutive patients underwent an endovascular treatment of 101 intracranial aneurysms or dissections using the PED between September 2009 and January 2011. The targeted vessels include 79 (78%) in the anterior circulation and 22 (22%) in the posterior circulation. We treated 96 aneurysms and 5 vessel dissections. Multiple devices were implanted in 67 lesions (66%). RESULTS: One technical failure of the procedure was encountered. Immediate exclusion of the target lesion was not observed. Angiographic follow-up examinations were carried out in 80 patients (91%) with 90 lesions and revealed complete cure of the target lesion(s) in 47 (52%), morphological improvement in 32 lesions (36%), and no improvement in 11 lesions (12%). Six major complications were encountered: one fatal aneurysm rupture, one acute and one delayed PED thrombosis, and three hemorrhages in the dependent brain parenchyma. CONCLUSION: Our experience reveals that the PED procedure is technically straightforward for the treatment of selected wide-necked saccular aneurysms, fusiform aneurysms, remnants of aneurysms, aneurysms with a high likelihood of failure with conventional endovascular techniques, and dissected vessels. While vessel reconstruction, performed after dissection, is achieved within days, remodeling of aneurysmal dilatations may take several months. Dual platelet inhibition is obligatory. Parenchymal bleeding into brain areas dependent on the target vessel is uncommon.

Results of the pToWin Study: Using the pCONUS Device for the Treatment of Wide-Neck Intracranial Aneurysms.

Coil embolization has become a well-established option for the treatment of intracranial aneurysms. Yet, wide-neck bifurcation aneurysms (WNBAs) remain a challenge. The pCONUS is the first generation of a stent-like implant for the bridging of WNBAs to enable coiling. The pToWin study was a prospective, single-arm, multicenter study conducted to analyze the safety and efficacy of the pCONUS in the treatment of WNBAs. The primary effectiveness endpoint was the rate of adequate occlusion of the aneurysm at 3-6 and 7-12 months. The primary safety endpoint was the occurrence of major ipsilateral stroke or neurological death during the follow-up. A total of 115 patients were included. Aneurysm locations were the middle cerebral artery in 52 (45.2%), the anterior communicating artery in 35 (30.4%), the basilar artery in 23 (20%), the internal carotid artery terminus in three (2.6%), and the pericallosal artery in two (1.7%) patients. Treatment was successfully performed in all but one patient. The morbi-mortality rate was 1.9% and 2.3% at 3-6 and 7-12 months, respectively. Of the aneurysms, 75.0% and 65.6% showed adequate occlusion at 3-6 and 7-12 months, respectively. pCONUS offers a safe and reasonably effective treatment of WNBAs, demonstrated by acceptable adequate aneurysm occlusion and low rates of adverse neurologic events.

Endovascular Treatment of Posterior Circulation Saccular Aneurysms With the p64 Flow Modulation Device: Mid-and Long-Term Results in 54 Aneurysms From a Single Center.

Objective: Flow diverter (FD) stents have become one of the most common tools for treating intracranial aneurysms; however, their role in treating posterior circulation aneurysms is still discussed with controversy. In this study, we evaluated the safety and effectiveness of p64 FD for the treatment of saccular, unruptured aneurysms in the posterior circulation over a long-term follow-up period in a single center. Methods: From our prospectively maintained database, we retrospectively identified patients who underwent treatment of an intracranial saccular aneurysm arising from the posterior circulation with ≥1 p64 FD implanted or attempted between October 2012 and December 2019. Aneurysms could have been treated with prior or concomitant saccular treatment (e.g., coiling, intra-aneurysmal flow diversion). Aneurysms with parent vessel implants other than p64, fusiform aneurysms, and dissections were excluded. Peri- and postprocedural complications, clinical outcome, and clinical and angiographic follow-up results were evaluated. Results: In total, 54 patients (45 female, 9 male; mean age 55.1 years) with 54 intracranial aneurysms met the inclusion criteria. In 51 cases (94.4%), one p64 was implanted; in 2 cases (3.7 %), two p64s were implanted; in one case, deployment of the p64 was not feasible. Procedural complications occurred in 3.7% and postprocedural complications in 9.3 %, respectively. Hemorrhagic complications occurred in 2/54 patients (3.7%), thereof one fatal parenchymal hemorrhage. Ischemic complications were observed in 5/54 patients (9.3%). Early, mid-term, and long-term angiographic follow-up examinations showed complete or near-complete aneurysm occlusion, defined according to the O'Kelly -Marotta (OKM) scale as OKM C + D in 56, 75.6, and 82.9 %, respectively. Asymptomatic side vessel occlusions occurred in 3.8%, each during the first follow-up. Conclusions: The implantation of a p64 FD is a safe and effective device for endovascular treatment of posterior circulation saccular aneurysms with a high success rate and low morbi-mortality.

Flow Diversion for Reconstruction of Intradural Vertebral Artery Dissecting Aneurysms Causing Subarachnoid Hemorrhage-A Retrospective Study From Four Neurovascular Centers.

Objective: Dissecting aneurysms (DAs) of the vertebrobasilar territory manifesting with subarachnoid hemorrhage (SAH) are associated with significant morbi-mortality, especially in the case of re-hemorrhage. Sufficient reconstruction of the affected vessel is paramount, in particular, if a dominant vertebral artery (VA) is impacted. Reconstructive options include stent-assisted coiling and flow diversion (FD). The latter is technically less challenging and does not require catheterization of the fragile aneurysm. Our study aims to report a multicentric experience with FD for reconstruction of DA in acute SAH. Materials and Methods: This retrospective study investigated 31 patients (age: 30-78 years, mean 55.5 years) who had suffered from SAH due to a DA of the dominant VA. The patients were treated between 2010 and 2020 in one of the following German neurovascular centers: University Hospital Leipzig, Katharinenhospital Stuttgart, BG Hospital Bergmannstrost Halle/Saale, and Heinrich-Braun-Klinikum Zwickau. Clinical history, imaging, implanted devices, and outcomes were reviewed for the study. Results: Reconstruction with flow-diverting stents was performed in all cases. The p64 was implanted in 14 patients; one of them required an additional balloon-expandable stent to reconstruct severe stenosis in the target segment. One case demanded additional liquid embolization after procedural rupture, and in one case, p64 was combined with a PED. Further 13 patients were treated exclusively with the PED. The p48MW-HPC was used in two patients, one in combination with two additional Silk Vista Baby (SVB). Moreover, one patient was treated with a single SVB, one with a SILK+. Six patients died [Glasgow Outcome Scale (GOS) 1]. Causes of death were periprocedural re-hemorrhage, thrombotic occlusion of the main pulmonary artery, and delayed parenchymal hemorrhage. The remaining three patients died in the acute-subacute phase related to the severity of the initial hemorrhage and associated comorbidities. One patient became apallic (GOS 2), whereas two patients had severe disability (GOS 3) and four had moderate disability (GOS 4). Eighteen patients showed a complete recovery (GOS 5). Conclusion: Reconstruction of VA-DA in acute SAH with flow-diverting stents is a promising approach. However, the severity of the condition is reflected by high overall morbi-mortality, even despite technically successful endovascular treatment.

First-Pass Reperfusion by Mechanical Thrombectomy in Acute M1 Occlusion: The Size of Retriever Matters.

Introduction: Single-pass complete reperfusion using stent retrievers has been shown to improve functional outcome in patients with large vessel occlusion strokes. The aim of this study was to investigate the optimal size of stent retrievers to achieve one-pass complete reperfusion by mechanical thrombectomy. Methods: The study evaluated the results of aspiration-assisted mechanical thrombectomy of acute isolated occlusion of the middle cerebral artery in the M1 segment with a novel 5 × 40-mm stent retriever compared to the usual 4 × 20-mm device. Reperfusion status was quantified using the Thrombolysis In Cerebral Infarction (TICI) scale. We hypothesized that thrombectomy of M1 occlusions with 5 × 40-mm stent retriever yields higher rates of complete first-pass reperfusion (FP) (TICI ≥2c after one pass) and successful or modified FP (mFP) (TICI ≥2b after one pass) than thrombectomy with 4 × 20. We included isolated M1 occlusions treated with pRESET 5 × 40 (phenox) as first-choice device for thrombectomy and compared with M1 occlusions treated with pRESET 4 × 20. We excluded patients with additional occlusions or tandem stenosis or who received an intracranial stent or angioplasty as a part of the endovascular treatment. Results: One hundred thirteen patients were included in the 4 × 20 group and 57 patients in the 5 × 40 group. The 5 × 40 group achieved higher FP compared to 4 × 20 group [61.4% (35 of 57 patients) vs. 40.7% (46 of 113), respectively; adjusted odds ratio (OR) and 95% confidence interval (95% CI) = 2.20 (1.08-4.48), p = 0.030] and a higher mFP [68.4%, 39 of 57 patients vs. 48.7%, 55 of 113; adjusted OR (95% CI) = 2.11 (1.04-4.28), p = 0.037]. Frequency of successful reperfusion (TICI ≥2b) was similar in both groups (100 vs. 97.3%), but frequency of complete reperfusion (TICI ≥2c) was higher in the 5 × 40 group [82.5 vs. 61.9%, adjusted OR (95% CI) = 2.47 (1.01-6.04), p = 0.047]. Number of passes to achieve reperfusion was lower in the 5 × 40 group than in the 4 × 20 group [1.6 ± 1.1 vs. 2 ± 1.4, p = 0.033; adjusted incidence rate ratio (95% CI) = 0.84 (0.69-1.03), p = 0.096]. Modified Rankin scale at 90 days was similar in 5 × 40 and 4 × 20 groups. Conclusions: The size of stent retriever matters in acute M1 occlusions treated with aspiration-assisted mechanical thrombectomy. A longer stent retriever with a larger nominal diameter achieves a higher complete and successful FP and higher successful reperfusion compared to a shorter stent retriever.

Endovascular Treatment of Anterior Circulation Aneurysms With the p64 Flow Modulation Device: Mid- and Long-Term Results in 617 Aneurysms From a Single Center.

BACKGROUND: Flow diverters have become an important tool in the treatment of intracranial aneurysms, especially when dealing with difficult-to-treat or complex aneurysms. The p64 is the only fully resheathable and mechanically detachable flow diverter available for clinical use. OBJECTIVE: To evaluate the safety and effectiveness of p64 for the treatment of intracranial saccular unruptured aneurysms arising from the anterior circulation over a long-term follow-up period. METHODS: We retrospectively reviewed our prospectively maintained database to identify all patients who underwent treatment for an intracranial saccular (unruptured or beyond the acute hemorrhage phase) aneurysm arising from the anterior circulation with ≥1 p64 between December 2011 and December 2019. Fusiform aneurysms and dissections were excluded. Aneurysms with prior or concomitant saccular treatment (eg, coiling and clipping) were included. Aneurysms with parent vessel implants other than p64 were excluded. Anatomic features, intraprocedural complications, clinical outcome, as well as clinical and angiographic follow-ups were all recorded. RESULTS: In total, 530 patients (388 females; median age 55.9 yr) with 617 intracranial aneurysms met the inclusion criteria. The average number of devices used per aneurysm was 1.1 (range 1-3). Mean aneurysm dome size was 4.8 mm (range 1-27 mm). Treatment-related morbimortality was 2.4%. Early, mid-term, and long-term angiographic follow-up showed complete or near-complete aneurysm occlusion in 76.8%, 89.7%, and 94.5%, respectively. CONCLUSION: Treatment of intracranial saccular unruptured aneurysms of the anterior circulation using p64 is a safe and effective treatment option with high rate of occlusion at long-term follow-up and low morbimortality.

Use of pCONUS HPC for the treatment of unruptured wide-necked bifurcation aneurysms: early clinical experience using single antiplatelet therapy.

BACKGROUND: In recent years, a growing number of stents and stent-like devices have become available to facilitate the treatment of challenging aneurysms. However, the need for dual antiplatelet therapy can limit their use, especially in ruptured aneurysms. The hydrophilic polymer coating (pHPC, phenox) is a novel glycan-based multilayer polymer that reduces platelet adhesion. This study aims to report our initial experience using the pCONUS HPC device for the treatment of unruptured wide-necked bifurcation aneurysms (WNBA) using acetylsalicylic acid (ASA) as single antiplatelet therapy (SAPT). METHODS: We retrospectively identified all patients who were treated with the pCONUS HPC for unruptured WNBA in a multi-staged procedure using ASA as SAPT. Records were made of periprocedural complications, clinical outcome and angiographic and clinical follow-up. RESULTS: We identified 15 patients with 15 WNBA. The average age was 69 years old (range, 41-76). Seven aneurysms were located in the middle cerebral artery, five in the anterior communicating artery, two at the basilar tip and one in the posterior communicating artery. Immediate post-treatment angiography showed five aneurysms with modified Raymond-Roy classification (mRRC) grade I and four aneurysms with mRRC grade II. There were no haemorrhagic complications. Four patients developed thrombus formation during the second treatment session, all of them completely resolving after administration of glycoprotein IIb/IIIa antagonists. Angiographic follow-up data were available for 10 patients and showed adequate occlusion (mRRC I or II) in eight aneurysms (80%). In-stent stenosis was observed in one patient whereas two patients showed de novo stenosis in one of the efferent branches. CONCLUSIONS: This early experience on the use of the pCONUS HPC device suggests that it can be useful for treating unruptured WNBA under ASA as SAPT. Further investigation with a randomised treatment registry and larger cohort is needed.

The p48 Flow Modulation Device with Hydrophilic Polymer Coating (HPC) for the Treatment of Acutely Ruptured Aneurysms: Early Clinical Experience Using Single Antiplatelet Therapy.

BACKGROUND: Flow diversion (FD) remains a potential treatment option following aneurysmal subarachnoid hemorrhage (aSAH) when standard options may not be feasible. However, it should not be considered a first-line treatment due to the need for dual antiplatelet therapy (DAPT). The hydrophilic polymer coating on the p48MW flow diverter (HPC, phenox) is a surface modification that inhibits platelet adhesion. This study aims to report on our early single-center experience using the p48MW HPC (phenox) flow diverter with single antiplatelet therapy (SAPT) following an aSAH. MATERIALS AND METHODS: We retrospectively identified all patients who had been treated with the p48MW HPC for aSAH under SAPT. All patients treated within 30 days following an aSAH were included. Any occurrence of thromboembolic and hemorrhagic complications was recorded alongside angiographic and clinical follow-up details. RESULTS: Eight patients were identified. The mean interval between aSAH and FD was 6 days. Of the eight ruptured aneurysms, one was blister-like, one saccular, one mycotic, and the remaining five were dissecting aneurysms. Intraprocedural transient thrombus formation was observed in four patients (50%). Stent thrombosis was observed in one patient (12.5%) on day 3 with spontaneous recanalization after being switched onto DAPT. None of the aneurysms rebled after treatment. Two patients died due to cerebral vasospasm. Complete aneurysm occlusion had been achieved in all but one patient at angiographic follow-up (average 6 months). CONCLUSIONS: This small series highlights the possibility and limitations of using the p48MW HPC with SAPT in ruptured aneurysms. Randomized trials with longer follow-up in larger cohorts are underway.

The p48 MW flow modulation device for treatment of unruptured, saccular intracranial aneurysms: a single center experience from 77 consecutive aneurysms.

BACKGROUND: The p48 MW Flow Modulation Device (phenox, Bochum Germany) is a low profile flow diverter stent (FDS), designed for implantation into intracranial arteries with a diameter of less than 3.5 mm. OBJECTIVE: To evaluate the safety and efficacy of the p48 MW FDS in the treatment of unruptured aneurysms located at intracranial arteries with less than 3.5 mm diameter based on a retrospective analysis from a single tertiary neurovascular center. METHODS: A prospectively maintained database was retrospectively reviewed to identify all cases of intracranial saccular aneurysms treated electively with the p48 MW device. Records were made of basic demographics, aneurysmal characteristics, interventional procedures, adverse events, clinical outcomes and occlusion rates on angiographic follow-ups. RESULTS: A total of 77 aneurysms and 74 patients were included. The mean size of the treated aneurysms was 3.5 ± 2.4 mm and the mean aspect ratio was 1.3 ± 0.4. A total of 80 endovascular procedures were performed with a total of 12 (15%) adverse events leading to two (2.5%) permanent morbidities/mortalities. Technical issues were encountered in 3 (3.9%) cases. Adequate occlusion of the treated aneurysm was recorded in 55.6% and 63.9% on the first and latest available DSA follow-ups, respectively. There were no cases of side-branch occlusion. CONCLUSIONS: The p48 MW is an easy-to-use implant with very good safety margins. Side branch occlusion and significant in-stent stenosis are infrequently encountered. The time from implantation to sufficient aneurysm occlusion takes longer than with FDS with lower porosity.

Use of the pCONus HPC as an adjunct to coil occlusion of acutely ruptured aneurysms: early clinical experience using single antiplatelet therapy.

BACKGROUND: Coil occlusion has become the standard treatment for many ruptured aneurysms. However, specific aneurysm structures pose technical difficulties and may require the use of adjunctive neck-bridging devices, which necessitate the use of dual antiplatelet therapy. The hydrophilic polymer coating (pHPC, phenox) is a surface modification that inhibits platelet adhesion. OBJECTIVE: To present initial experience with the pCONUS HPC device as an adjunct to coil embolization for ruptured aneurysms using single antiplatelet therapy (SAPT). METHODS: All patients who were treated with the pCONUS HPC for ruptured aneurysms using SAPT were retrospectively identified. The occurrence of thromboembolic and hemorrhagic complications was recorded together with the angiographic and clinical follow-up details. RESULTS: Fifteen patients were identified (nine female) with a median age of 54 years (range 27-81). Six aneurysms were located at the anterior communicating artery, five at the middle cerebral artery bifurcation, two at the basilar artery bifurcation, one at the posterior communicating artery, and one involving the intradural internal carotid artery. Ten patients (66.6%) achieved modified Raymond-Roy classification I or II at post-treatment angiography, with 45.5% of patients having adequate occlusion (defined as complete occlusion or neck remnant) at follow-up. All patients received acetylsalicylic acid (ASA) as SAPT before and after the procedure. Intraprocedural thrombus formation was seen in three patients (20%), resolving in two patients after a bolus dose of eptifibatide, and one treated with mechanical aspiration. No clinical or radiological consequences were seen. There were no recurrent aneurysm ruptures. One patient died owing to cerebral vasospasm. CONCLUSION: This initial clinical experience highlights the possibility and limitations of using the pCONUS HPC device in the treatment of complex ruptured aneurysm with ASA as SAPT. Randomized trials with longer follow-up in larger cohorts are underway.