6-month Angiographic Follow-up Research Articles

Flow-Diverting Devices in the Treatment of Vertebral Artery Aneurysms: Insights into Efficacy and Safety from a Systematic Review and Meta-analysis.

The objective of this study is to conduct a systematic review and meta-analysis aimed at evaluating the efficacy and safety of flow-diverting devices (FDs) treatment for intracranial vertebral artery (VA) aneurysms. We searched PubMed, Web of Science, OVID, and Embase for English-language studies up to February 2024 and included clinical studies on FD treatment of intracranial VA aneurysms. Sensitivity analysis evaluated outcome stability. Of 2273 articles, 29 studies involving 541 aneurysms treated with FDs were included. Based on the Methodological Index for Non-Randomized Studies (MINORS), six were high-quality and 23 moderate quality. FD treatment showed a 95% rate of favorable clinical outcomes (95% CI, 89-99%), 81% (95% CI, 74-88%) complete aneurysmal occlusion, 4% (95% CI, 2-7%) ischemic complication incidence, 1% (95% CI, 0-3%) hemorrhagic complication incidence, 95% (95% CI, 87-100%) posterior inferior cerebellar artery (PICA) preservation, and 6% (95% CI, 3-10%) in-stent stenosis or occlusion across clinical and angiographic follow-up periods of 13.62months (95% CI, 10.72-16.52) and 11.85months (95% CI, 9.36-14.33), respectively. Subgroup analyses, based on a 12-month angiographic follow-up threshold, indicated no statistically significant differences in rates of complete aneurysm occlusion, PICA preservation, or in-stent stenosis or occlusion incidence (p > 0.05) between subgroups. Moreover, significant differences were observed in clinical and angiographic outcomes between ruptured and unruptured aneurysms, particularly in hemorrhagic complications (p < 0.05), without significant disparity in ischemic complications (p > 0.05). The results' stability was confirmed via sensitivity analysis. FDs treatment for VA aneurysms is efficacious and safe, offering high rates of positive clinical and angiographic outcomes with minimal complications, underscoring FDs' viability as a treatment option for VA aneurysms. The study was registered with PROSPERO (registration number: CRD42024499894).

Does Small Aneurysm Size (

Long-term safety and efficacy outcomes of Surpass Evolve flow diverter (SEFD) in treatment of intracranial aneurysms are lacking. Factors predicting complete aneurysm occlusion are elusive in literature. A retrospective review of all consecutive aneurysms treated with SEFD from February 2020 to July 2022, at a single comprehensive stroke center. Fifty-one patients with 80 aneurysms were included. Mean target aneurysm size was 5.6 mm and mean neck-width 3.42 mm. Small aneurysms (<10 mm) were 75% (n=60), while 25% were >10 mm. Unruptured were 71 (88.7%), previously ruptured were 8 (10%), and partially thrombosed 2.3% (n=1). Mean SEFDs used per patient were 1.07 and 40% (n=22) procedures were performed transradially. Mean procedure time was 59.1 minutes. The technical success rate for device deployment was 100%. Raymond Roy (RR) class I occlusion at 6 month (n=73) was seen among 56.2% (n=41), at 1 year (n=35) among 85.7% (n=30) and at 2 year (n=18) among 88.8% (n=16) aneurysms. Aneurysm size <10 mm significantly predicted RR-I occlusion outcome (odds ratio [OR]: 2.16; confidence interval [CI]: 0.02-4.29) at 6 months. Age, gender, smoking status, hypertension, location of aneurysm, and rupture status did not predict RR-I occlusion outcome. No mortality or permanent neurological morbidity was observed in the cohort. Major complications seen in 7.2% (n=4) patients were stent thrombosis (n=1, 1.8%), carotid-cavernous fistula (n=1, 1.8%) and transient ischemia in 2 (3.6%). Non-flow limiting stenosis was observed in 3 (5.4%) patients. SEFD gives good aneurysm occlusion rates with favorable long-term safety profile and low rate of thromboembolic complications. Small aneurysm size (<10 mm) was associated with complete aneurysm occlusion at 6-month angiographic follow-up. As Surpass Evolve is a newer generation Flow diverter of the Stryker Surpass FDs, with its improved design and applicability in intracranial aneurysms, we believe that more physicians will be encouraged to use this device worldwide.

Clinical prediction factors of nonchronic total occlusion lesion progression in patients with unstable angina receiving percutaneous coronary intervention for chronic total occlusion lesions

BackgroundIn this study, we investigated clinical prediction factors of nonchronic total occlusion lesion (NCTOL) progression in patients who underwent percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions. MethodsIn total, 450 patients with unstable angina (mean age = 57.1 ± 9.2 years) who underwent PCI for CTO lesions between January 2016 and December 2018 at Beijing Anzhen Hospital were enrolled in this study. A clinical and angiographic follow-up examination was performed 12 months postoperatively. The patients were divided into NCTOL progression (145 cases) and control (305 cases) groups based on the outcome of the 12-month angiographic follow-up. The clinical and angiographic features of the participants were analyzed. ResultsThe adenosine diphosphate-induced platelet aggregation (ADP-IPA) rate and levels of lipoprotein (a) (Lp(a)) in the NCTOL progression group were significantly higher than those in the control group (51.89 ± 14.81 vs. 39.63 ± 17.12, P < 0.01; 0.22 ± 0.26 vs. 0.14 ± 0.18, P < 0.05, respectively). Logistic regression showed that the ADP-IPA rate (odds ratio = 1.047, 95 % confidence interval: 1.014–1.082, P = 0.005) and Lp(a) (odds ratio = 11.972, 95 % confidence interval: 1.230–116.570, P = 0.033) were independent predictors of NCTOL progression. Partial correlation analysis demonstrated that the ADP-IPA rate was positively correlated with NCTOL progression (r = 0. 351, P < 0.001). Receiver operating characteristic curve showed that the boundary point of the ADP-IPA rate to predict NCTOL progression was 30 % (sensitivity, 86.2 %; specificity, 68.9 %). ConclusionsNCTOL progression is an important cause of recurrent PCI in patients with coronary artery disease after PCI for CTO lesions. The ADP-IPA rate is a useful predictor for NCTOL progression in patients with unstable angina who undergo PCI for CTO lesions.

Analysis of the incidence and influencing factors associated with binary restenosis of target lesions after drug-coated balloon angioplasty for patients with in-stent restenosis

BackgroundDrug-coated balloon (DCB) is a novel and effective device for coronary artery disease patients with in-stent restenosis (ISR). However, the incidence and possible influencing factors associated with binary restenosis have not yet been adequately assessed.MethodsThe data are extracted from a prospective, multicenter, randomized controlled trial. A total of 211 patients with ISR were enrolled at 13 centers from August 2017 to October 2018 and treated with DCB. At the 9-month coronary angiographic follow-up, patients were divided into restenosis and non-restenosis groups, and demographic data, lesion features, and laboratory tests were retrospectively reviewed. Furthermore, logistic regression analysis was used to identify possible influencing factors.ResultsAll patients successfully underwent treatment, and 166 patients with 190 lesions took part in angiography follow-ups at 9 months. Of these, 41 patients with 44 target lesions developed restenosis following treatment, and the incidence of ISR was 24.7%. There were significant differences in the average length of target lesions and the number of multivessel lesions and fasting plasma glucose (FBG) between the two groups (p < 0.05). Demographic data, cardiac risk factors, left ventricular ejection fractions (LVEF), blood routine tests, biochemical tests, and other features of devices and lesions showed no difference. Logistic regression analyses showed that FBG > 6.1 mmol/L (OR: 7.185 95% CI: 2.939–17.567 P < 0.001) and length of lesion (OR:1.046 95% CI: 1.001–1.093 P = 0.046) were associated risk factors.ConclusionsThe longer length of lesions, more target lesions and FBG > 6.1 mmol/L per individual may be characteristics of patients showing ISR following treatment. Studies with larger sample size, and more complete follow-up data are needed in the future to expend on these findings.Trial registrationNo.: NCT04213378, first posted date (30/12/2019).

Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions

BackgroundNon stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. MethodsThis was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. ResultsA total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. ConclusionThe novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.

A Rare Presentation of Coronary Aneurysm following Bare-metal Stent

We present a case of post-percutaneous transluminal coronary angioplasty with a bare-metal stent to the right coronary artery (RCA). He presented with acute ST-elevation inferior wall myocardial infarction. Coronary angiography showed an aneurysm of proximal RCA extending from the proximal end of the stent to the distal end. There was a 90% discrete lesion beyond the stent with TIMI III flow. The development of coronary artery aneurysms (CAAs) was reported even before the era of stents. CAA can develop after plain balloon angioplasty, after directional coronary atherectomy, and after bare-metal and drug-eluting stents also but not after coronary angiography. Kachru et al. reported an incidence of 0.2% (4 of 2408) per DES without routine angiographic follow-up and Rha et al. reported an incidence of 1.7% (five out of 296) per patient at 6-month routine angiographic follow-up. CAA is an uncommon and often accidental finding, we report a case of CAA which presented as acute myocardial infarction mimicking stent thrombosis.

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

BackgroundThe 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...

Resolute onyx stent more effective than wingspan stent at preventing procedural complications and long-term restenosis.

Angioplasty and stenting is a treatment option for patients with medically refractory symptomatic intracranial atherosclerotic disease (sICAD). Currently the Wingspan Stent System (WSS) is the only FDA approved device for this indication. We find the Resolute (R) Onyx Stent, a drug-eluting balloon mounted stent (DES), a better alternative to the WSS for treatment of sICAD. Herein, we present our findings comparing the two stents based on our single center experience. A prospectively maintained neuro-endovascular databased was queried for patients between January 2013 to June 2021. Inclusion criteria for patients included sICAD with failed medical management, and intracranial stenting with either R-Onyx DES or WSS, including patients treated within 7 days of their last stroke. Primary outcomes were assessed via the occurrence of ischemic or hemorrhagic stroke or death within 72 h of the procedure. Secondary outcomes consisted of recurrent stroke or significant in-stent restenosis evaluated by a clinical or angiographic follow-up at 6 months. A total of 184 patients, average age 61.26 (SD = 12.53) (44% women), were eligible for analysis with 58 having R-onyx DES and 126 having WSS. Within 72 h, the primary outcome was observed in 1.7% (n = 1) of patients in the R-onyx DES group and 6.3% (n = 8) of patients in the WSS group (p = 0.089). Among 41 angiographic and clinical follow-ups in the R-onyx DES group, none had a recurrent stroke, while among 101 patients who had follow-up in the WSS group, 8.9% (n = 9) had a stroke (p = 0.024). At a 6-month angiographic follow-up, there was a significantly lower rate of symptomatic in-stent restenosis among the R-onyx DES group with 1.7% (n = 1) compared with 21.4% (n = 27) in the WSS group (p = 0.0003). R-onyx DES is more effective than WSS in treating sICAD with low rates of periprocedural complications and long-term strokes and symptomatic in-stent restenosis. Future prospective randomized multicenter trials are needed.

Standalone Flow Diversion Therapy Effectively Controls Rebleeding of Acutely Ruptured Internal Carotid Artery Trunk (Nonbranching) Microaneurysms.

Flow diversion is a promising option in selected patients with acutely ruptured microaneurysms. In this article, we reviewed our experience. Patients with acute spontaneous subarachnoid hemorrhage (SAH) after rupture of a blister-like or saccular microaneurysm (≤2 mm maximal diameter) at a nonbranching ICA site treated from January 2016 to June 2019 using flow diversion as standalone therapy were included in this study. An EVD was usually placed preventively. Antiplatelet effects of pre-procedure DAPT were evaluated (target PRU, 80–160). After the intervention, DAPT was continued for ≥6 months, aspirin—indefinitely. Angiographic controls were obtained. Fifteen patients (12 female; mean age, 46.4 years) with 15 ruptured ICA microaneurysms (mean diameter, 1.8 mm) were included. An EVD was placed in 12 patients (75%) before DAPT administration and stenting. PRU values immediately before FDS were 1–134 (mean, 72.1). One patient died 27 days after flow diversion due to a suspected fulminant pulmonary embolism. Aneurysms were completely occluded at the 6–12-month angiographic follow-up in 14/14 surviving patients, with no rebleeding at a mean of 14 months. Late mRS was 0–2 in 13/14 patients and 3 in one due to sequelae of the original hemorrhage. Flow diversion provided robust aneurysm rebleeding control. Angiographic follow-up confirmed complete aneurysm occlusion in all the cases.

Flow-diverter stents in the early management of acutely ruptured brain aneurysms: effective rebleeding protection with low thromboembolic complications.

Flow-diverter stents (FDSs) are not generally used for the management of acutely ruptured aneurysms with associated subarachnoid hemorrhage (SAH). Herein, the authors present their experience with FDSs in this scenario, focusing on the antiplatelet regimen, perioperative management, and outcome. The authors retrospectively reviewed their institutional database for the treatment and outcomes of all patients with acutely ruptured aneurysms and associated SAH from July 2010 to September 2018 who had received an FDS implant as stand-alone treatment within 4 days after diagnosis. The protocol with the use of flow diversion in these patients includes a low threshold for placement of external ventricular drains before stenting, followed by the administration of aspirin and clopidogrel with platelet testing before stent implantation. With this approach, the risk of hemorrhage and stent-related thrombus formation is limited. Demographic, clinical, technical, and imaging data were analyzed. Overall, 76 patients (61% females, mean age 42.8 ± 11.3 years) met the inclusion criteria. FDS implantation was performed a median of 2 days after diagnosis. On average, 1.05 devices were used per procedure. There was no procedural mortality directly attributed to the endovascular intervention. Procedural device-related clinical complications were recorded in a total of 6 cases (7.9%) and resulted in permanent neurological morbidity in 2 cases (2.6%). There was complete immediate aneurysm occlusion in 11 patients (14.5%), and persistent aneurysm filling was seen in 65 patients (85.5%). Despite this, no patient presented with rebleeding from the target aneurysm. There was an excellent clinical outcome in 62 patients (81.6%), who had a 90-day modified Rankin Scale score of 0-2. Among the 71 survivors, total or near-total occlusion was observed in 64/67 patients (95.5%) with a 3- to 6-month angiographic follow-up and in all cases evaluated at 12 months. Five patients (6.6%) died during follow-up for reasons unrelated to the procedure or new hemorrhage. Flow diversion is an effective therapeutic strategy for the management of select acutely ruptured aneurysms. Despite low rates of immediate aneurysm occlusion after FDS implantation, the device exerts an important protective effect. The authors' experience confirmed no aneurysm rerupture, high rates of delayed complete occlusion, and complication rates that compare favorably with the rates obtained using other techniques.

Delayed Anastomotic Occlusion after Direct Revascularization in Adult Hemorrhagic Moyamoya Disease.

Delayed anastomotic occlusion occurred in a considerable proportion of hemorrhagic moyamoya disease (MMD) patients undergoing direct revascularization. This study aimed to investigate the predictors and outcomes of delayed anastomotic occlusion in adult hemorrhagic MMD. The authors retrospectively reviewed 87 adult hemorrhagic MMD patients. Univariate and multivariate logistic regression analyses were performed. After an average of 9.1 ± 6.9 months of angiographic follow-up, the long-term graft patency rates were 79.8%. The occluded group had significantly worse angiogenesis than the non-occluded group (p < 0.001). However, the improvement of dilated anterior choroidal artery–posterior communicating artery was similar (p = 0.090). After an average of 4.0 ± 2.5 years of clinical follow-up, the neurological statues and postoperative annualized rupture risk were similar between the occluded and non-occluded groups (p = 0.750; p = 0.679; respectively). In the multivariate logistic regression analysis, collateral circulation Grade III (OR, 4.772; 95% CI, 1.184–19.230; p = 0.028) and preoperative computed tomography perfusion (CTP) Grade I–II (OR, 4.129; 95% CI, 1.294–13.175; p = 0.017) were independent predictors of delayed anastomotic occlusion. Delayed anastomotic occlusion in adult hemorrhagic MMD might be a benign phenomenon. Good collateral circulation (Grade III) and compensable preoperative intracranial perfusion (CTP Grade I–II) are independent predictors for this phenomenon. Moreover, the delayed anastomotic occlusion has no significant correlations with the long-term angiographic and neurological outcomes, except neoangiogenesis.

Cognitive outcomes after unruptured intracranial aneurysm treatment with endovascular coiling

BackgroundWe aimed to determine the effects of endovascular coiling of unruptured intracranial aneurysms (UIAs) on cognition to inform treatment decisions. We present the first study using the Montreal Cognitive Assessment...

Everolimus-Eluting Second-Generation Stents for Treatment of De Novo Lesions in Patients with Cardiac Allograft Vasculopathy.

BackgroundCardiac allograft vasculopathy is a major cause of cardiac allograft rejection. Percutaneous coronary intervention has become the main form of treatment of significant focal lesions. Despite the significance of the problem, data remain scarce. With a large population of transplant recipients undergoing coronary angiography at our center, we decided to analyze the implications of the use of everolimus-eluting second-generation stents by performing 6-month clinical and angiographic follow-up.Material/MethodsFrom December 2012 and August 2019, 319 patients after heart transplantation undergoing coronary angiography at our institution were analyzed. Subsequently, 22 patients underwent de novo angioplasty with second-generation everolimus-eluting stents. The primary study endpoint was angiographic restenosis as evaluated by quantitative coronary angiography. Secondary outcomes included binary restenosis, target lesion revascularization, and cardiac death during the follow-up period (6 months).ResultsPatient comorbidities included hypertension (77.3%), type 2 diabetes mellitus (68.2%), dyslipidemia (68.2%), and obesity (31.8%). Primary success was obtained in all of the treated lesions. The analysis of quantitative coronary angiography after 6-month follow-up revealed low late lumen loss (0.22±0.40). Significant restenosis was observed in 1 of the cases. There were no deaths in the 6-month observation period.ConclusionsIn the analyzed population, invasive strategy with second-generation everolimus-eluting stents for de novo lesions in cardiac allograft vasculopathy resulted in a low rate of binary restenosis, low late lumen loss, and no deaths during the 6-month follow-up.

A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China.

Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions. Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses. At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group. In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis. ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.

Comparison of 9-Month Angiographic Follow-Up and Long-Term Clinical Outcomes of Biodegradable Polymer Drug-Eluting Stents and Second-Generation Durable Polymer Drug-Eluting Stents in Patients Undergoing Single Coronary Artery Stenting.

The durable polymers (DP) used in first-generation drug-eluting stents (DESs) were associated with long-term cardiovascular events, and thus biodegradable polymer DESs (BP-DESs) and second-generation DP-DESs were designed to overcome this problem. In this study, we compared angiographic follow-up and long-term clinical outcomes between patients who received BP-DESs or second-generation DP-DESs. We enrolled 436 patients with single coronary lesions who received a second-generation DP-DES or BP-DES between June 2009 and October 2012. All patients received follow-up angiography when new clinical events developed or at 9 months after index stenting. All participants received follow-up for 5 years. There were no significant differences in patient and lesion characteristics between the two groups. The 9-month angiographic follow-up showed a lower net gain in the second-generation DP-DES group (2.19 mm vs. 2.41 mm, p = 0.040), but a similar binary restenosis rate between the two groups (5.4% vs. 8.7%, p = 0.276). During the 5-year follow-up period, no significant differences were observed between the two groups in major adverse cardiac events (MACEs), cardiovascular death, nonfatal myocardial infarction (MI), target vessel revascularization (TVR), all revascularization, stent thrombosis (ST), or MACE-free survival. No significant differences were observed in cardiovascular death, nonfatal MI, TVR, all revascularization, ST, or MACE-free survival between the patients undergoing single coronary artery stenting with BP-DESs and second-generation DP-DESs.

Predicting factors of angiographic aneurysm occlusion after treatment with WEB (Woven EndoBridge) device: A single-center experience with mid-term follow-up

Background and purpose Flow disruption with WEB is increasingly used for the treatment of intracranial aneurysms. We examined factors leading to aneurysm occlusion and WEB shape change during a mid-term follow-up. Materials and methods Patients with a minimum 12-month angiographic follow-up were included. Through a univariate and multivariate analysis, independent predictors of adequate occlusion (RR1/RR2) and WEB shape change (decrease of the height of the device) were assessed. Results Eighty-six patients/aneurysms were included. The mean size was 5.5 mm (range: 3–11.5 mm). The most common locations were MCA (43/86 = 50%), BT (13/86 = 15.1%), and AcomA (12/86 = 14%). Twenty-one patients (21/86 = 24%) presented acute SAH. Immediate and long-term RR1/RR2 occlusion rates were 49% (42/86) and 80% (68/86), respectively. WEB shape change was detected among 22% (19/86) of cases. At the binary logistic regression, wide ostium (≥ 4 mm) (OR = 0.2, 95% CI = 0.01–1, P = 0.04) and regular aneurysm morphology (OR = 5.9, 95% CI = 1.4–24, P = 0.01) were independent factors of incomplete and adequate aneurysm occlusion, respectively. In addition, irregular morphology (OR = 5.4, 95% CI = 1.4–19, P = 0.01) and wide ostium (OR = 9.8, 95% CI = 1.6–60, P = 0.03) significantly increased the probability of the WEB shape change. Decrease of the WEB height was higher among incomplete occluded aneurysms (6/12 = 50% vs 13/74 = 17.5%), but it was not an independent prognosticator of occlusion at the multivariate model. Conclusions The likelihood of good occlusion was 5 times lower in the presence of a wide ostium, whereas aneurysms with regular morphology were 6 times more likely to be occluded. WEB shape modification was strongly influenced by the aneurysm shape and ostium size, and it was not independently associated with the angiographic occlusion ( Fig. 1 , Fig. 2 , Fig. 3 ).

Early postmarket results with PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experience.

Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device. This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications. A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A1 segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a device-related intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2. PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist's armamentarium, especially with regard to its off-label use.

Predicting Factors of Angiographic Aneurysm Occlusion after Treatment with the Woven EndoBridge Device: A Single-Center Experience with Midterm Follow-Up.

Flow disruption with the Woven EndoBridge is increasingly used for the treatment of intracranial aneurysms. We examined factors leading to aneurysm occlusion and Woven EndoBridge shape change during a midterm follow-up. Patients with a minimum 12-month angiographic follow-up were included. Through a univariate and multivariate analysis, independent predictors of adequate occlusion (Raymond-Roy 1/Raymond-Roy 2) and Woven EndoBridge shape change (decrease of the height of the device) were assessed. Eighty-six patients/aneurysms were included. The aneurysm mean size was 5.5 mm (range, 3-11.5 mm). The most common locations were the MCA (43/86 = 50%), basilar tip (13/86 = 15.1%), and anterior communicating artery (12/86 = 14%). Twenty-one patients (21/86 = 24%) had acute SAH. Immediate and long-term Raymond-Roy 1/Raymond-Roy 2 occlusion rates were 49% (42/86) and 80% (68/86), respectively. Woven EndoBridge shape change was detected among 22% (19/86) of cases. At binary logistic regression, wide ostium (≥4 mm) (OR = 0.2; 95% CI, 0.01-1; P = .04) and regular aneurysm morphology (OR = 5.9; 95% CI, 1.4-24; P = .01) were independent factors of incomplete and adequate aneurysm occlusion, respectively. In addition, irregular morphology (OR = 5.4; 95%CI, 1.4-19; P = .01) and a wide ostium (OR = 9.8; 95% CI, 1.6-60; P = .03) significantly increased the probability of the Woven EndoBridge shape change. Decrease of the Woven EndoBridge height was more common among incompletely occluded aneurysms (6/12 = 50% versus 13/74 = 17.5%), but it was not an independent prognosticator of occlusion at the multivariate model. The likelihood of good occlusion was 5 times lower in the presence of a wide ostium, whereas aneurysms with regular morphology were 6 times more likely to be occluded. Woven EndoBridge shape modification was strongly influenced by the aneurysm shape and ostium size, and it was not independently associated with the angiographic occlusion.

Safety and efficacy of the Neuroform Atlas for stent-assisted coiling of intracranial aneurysms: A multicenter experience

ObjectiveClinical data on the new Neuroform Atlas stent for treatment of intracranial aneurysms is limited. We report our experience in stent-assisted coiling procedures of complex, predominantly wide-necked aneurysms. MethodsThis is a retrospective study of consecutive patients treated with the Neuroform Atlas stent between August 2014 and November 2018 at three German tertiary care centers. We evaluated the complication rate, clinical outcome and angiographic result at mid-term follow-up. ResultsThirty-seven aneurysms (elective: 23, previous subarachnoid hemorrhage: 14) were treated in 37 patients (mean age: 59.4 years, 62.2% females). Stent-assisted coiling was successful in all cases, achieving immediate complete aneurysm occlusion by coiling in 83.8% and neck remnants in 16.2%. At 6-month angiographic follow-up, complete aneurysm occlusion was obtained in 80.8% (21/26), neck remnants in 11.5% (3/26) and aneurysm remnants in 7.7% (2/26). Retreatment was necessary in 7.7%. Ischemic stroke occurred in one patient (2.7%). At 6-month clinical follow-up, procedure-related permanent morbidity was 2.7%. ConclusionsOur results demonstrate that treatment of intracranial aneurysms with the Neuroform Atlas stent is associated with low morbidity and a high aneurysm occlusion rate at mid-term follow-up. Further studies will be necessary to confirm our results.

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

IntroductionThe Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment...