Purpose
To assess the safety and short-term occlusion rates in procedures using the p64 MW hydrophilic polymer-coated (HPC) flow diverter (FD) with prasugrel single antiplatelet therapy (SAPT) for ...the treatment of anterior circulation saccular aneurysms.
Methods
We retrospectively identified patients who underwent treatment of one or more intracranial anterior circulation saccular aneurysms between March 2020 and December 2021 with a p64 MW HPC FD and prasugrel SAPT with verified P2Y12 platelet receptor inhibition. Patients diagnosed with fusiform, dissecting, or recently ruptured aneurysms were excluded. Periprocedural and postprocedural complications, clinical outcomes, and angiographic follow-up results were evaluated.
Results
One hundred and two patients with 132 intracranial aneurysms met the inclusion criteria. Previous or concomitant treatments (e.g., coil occlusion) had been performed on 18 of these aneurysms. The technical success rate (i.e., implantation of the intended FD) was 100% with an average of 1.1 devices implanted per patient. Periprocedural and postprocedural complications occurred in 13.6% and 6.8% of these patients, respectively. No mortality or permanent clinical deterioration (i.e., modified Rankin scale score ≥ 3) were reported. Early follow-up digital subtraction angiography revealed aneurysmal occlusion rates of 72.6% and 83.8% at four and nine months, respectively.
Conclusions
The implantation of a p64 MW HPC FD with prasugrel SAPT is safe and results in rapid, reliable and effective aneurysmal occlusion.
Flow diverters are important tools for the treatment of intracranial aneurysms. We report a retrospective evaluation of the safety and efficacy of p64, a fully resheathable, detachable flow diverter, ...in the endovascular treatment of intracranial sidewall aneurysms.
Results of 121 patients with 130 aneurysms (median neck size, 3 mm; median fundus size, 4 mm), treated from April 2012 through October 2014, were analyzed. Aneurysms were unruptured or beyond the acute SAH phase. Thirteen aneurysms were located in the posterior circulation. Twenty-three aneurysms had previous saccular treatment but no previous parent vessel stent placement. In 19 aneurysms, a combination of coiling and flow diversion was performed.
Successful p64 deployment was achieved in 127/130 aneurysms. The average number of p64s used was 1.1 per aneurysm. The rates of transient and permanent morbidity and mortality were 5%, 1.7%, and 0.8%, respectively. Three-month DSA follow-up in 123/130 aneurysms showed complete occlusion in 58.5%. Nine-month DSA follow-up in 93/106 (87.7%) eligible aneurysms showed complete occlusion in 79.6%. Late follow-up (median, 496 days) has already been performed in 35 aneurysms, showing complete occlusion in 30 (85.7%).
p64 offers an efficacious treatment option for intracranial sidewall aneurysms with a high aneurysm occlusion and an acceptable complication rate. The possibility of repositioning or removing the device was an advantage. The higher attenuation may lead to fewer devices per case and early aneurysm occlusion. Long-term follow-up data are pending.
Data from recent reports have indicated that mechanical thrombectomy may have potential as a treatment for acute ischemic stroke. The purpose of this study was to assess the safety and performance of ...the Penumbra System (PS): a novel mechanical device designed to reduce clot burden in acute stroke due to large-vessel occlusive disease.
A prospective, single arm, independently monitored and core laboratory adjudicated trial enrolled subjects with an acute neurologic deficit consistent with acute stroke, presenting within 8 hours of symptom onset and an angiographically verified occlusion (Thrombolysis in Myocardial Infarction TIMI grade 0 or 1) of a treatable intracranial vessel. The primary end point was revascularization of the target vessel to TIMI grade 2 or 3. Secondary end points were the proportion of subjects who achieved a modified Rankin Scale (mRS) score of 2 or less or a 4-point improvement on the National Institutes of Health Stroke Scale (NIHSS) score at 30-day follow-up, as well as all-cause mortality.
Twenty-three subjects were enrolled, and 21 target vessels were treated in 20 subjects by the PS. At baseline, mean age was 60 years, mean mRS score was 4.6, and mean NIHSS score was 21. Postprocedure, all 21 of the treated vessels (100%) were successfully revascularized by the PS to TIMI 2 or 3. At 30-day follow-up, 9 subjects (45%) had a 4-point or more NIHSS improvement or an mRS of 2 or less. The all-cause mortality rate was 45% (9 of 20), which is lower than expected in this severe stroke cohort, where 70% of the subjects at baseline had either an NIHSS score of more than 20 or a basilar occlusion.
Thus, early clinical experience suggests that the PS allows revascularization in certain subjects experiencing acute ischemic stroke.
Background
Dual antiplatelet therapy is a pre-requisite for flow diverter (FD) implantation. The purpose of this study was to assess the thrombogenicity of the p48 FD, coated with the newly developed ...phenox Hydrophilic Polymer Coating (p48_HPC, phenox GmbH, Germany) in comparison with uncoated p48 FDs in an in vitro flow model (Chandler Loop).
Methods
p48 and p48_HPC FDs were implanted into silicon tubes filled with whole human blood and incubated at 37 °C under pulsating flow. After 120 min, platelet count was determined in the blood. Platelet activation markers (PAR1) and formation of microparticles were analyzed in a flow cytometer. Fluorescence microscopy of CD42a positive cells and scanning electron microscopy was used to detect adherent platelets on the wire surface.
Results
Platelets in contact with the uncoated p48 FDs are significantly more activated than those incubated with p48_HPC (73 ± 9% vs. 65 ± 6%,
p
< 0.05) and release more microparticles (1.8 ± 0.5 vs. 1.4 ± 0.4,
p
< 0.05). The platelet count after 120-min circulation in the Chandler Loop was significantly lower for the uncoated p48 compared to the p48_HPC indicating significantly greater adherence of the platelets to the p48 (71 ± 8% vs. 87 ± 5%,
p
< 0.05). SEM and fluorescent antibody imaging revealed minimal platelet adherence to the surface of the p48_HPC compared to the uncoated p48.
Conclusion
The pHPC coating significantly reduces thrombogenicity of the p48 FD. This may help to reduce the risk of thromboembolic complications when using these devices. A reduction in antiplatelet therapy may be possible.
Background
The aim of this study was to evaluate long-term outcomes in patients who underwent carotid artery stenting (CAS) for symptomatic or asymptomatic high-grade stenosis.
Methods
A total of ...1158 patients (asymptomatic,
n
= 636; symptomatic,
n
= 522) underwent CAS at our center between 2009 and 2020. A total of 560 patients or contacts (asymptomatic,
n
= 316; symptomatic,
n
= 244) were interviewed by telephone to evaluate long-term outcomes with a mean follow-up of 5 years. Mortality from all causes, myocardial infarction, and stroke, as well as comorbidities influencing their occurrence, including overall survival and stroke-free survival, were examined.
Results
The overall survival rate for all-cause mortality was 91.6% at 1 year, 77.1% at 5 years, and 55.7% at 10 years. A total of 39 (6.9%) patients had an ischemic stroke during long-term follow-up. The stroke-free survival rates at 1 year, 5 years, and 10 years were 97.9%, 92.7%, and 86.6%, respectively. Stroke-free survival and overall survival did not differ significantly between the symptomatic and asymptomatic groups (overall survival,
p
= 0.304; stroke-free survival,
p
= 0.336). Regular physical activity reduced the risk of stroke and death and was associated with better long-term clinical outcomes. Age at treatment and diabetes mellitus were statistically significantly associated with death during follow-up.
Conclusion
Long-term follow-up data confirmed the effectiveness and durability of CAS as a therapy option for both symptomatic and asymptomatic patients. In patient selection for CAS, special consideration should be paid to patient age, ability to engage in physical activity, and diabetes mellitus.
Spread of thrombus material in previously unaffected vessels is a potential hazard of mechanical thrombectomy, but it has not yet been investigated in detail, to our knowledge. Our purpose was to ...evaluate the frequency and relevance of these events in mTE of M1 occlusions.
We retrospectively reviewed all patients treated for isolated M1 occlusion between January 2008 and July 2012. Angiographic images were analyzed to assess emboli in anterior cerebral artery branches induced by mTE and associated devices. Recanalization attempts in the ACA were reported as well as technical success and adverse events of rescue therapies. ACA infarcts on follow-up imaging served as a surrogate for clinical relevance. ACA infarcts were quantified volumetrically and assessed visually for involvement of motor or supplementary motor areas.
New ACA emboli occurred in 12 of 105 (11.4%) M1 recanalization procedures and were caused by a stent-retriever in 11 intances. Attempts to recanalize the ACA were made in 6 patients and were deemed technically successful in 5 with no adverse events. We detected 6 (5.7%) new infarcts on follow-up imaging with an average volume of 26.9 cm(3). Involvement of motor or supplementary motor areas was seen in 4 (3.8%) cases. Three patients developed ACA infarcts despite successful endovascular ACA recanalization.
The frequency of ACA emboli in mTE of M1 occlusions is relevant, causing ACA infarcts in 5.7% of patients; 3.8% of emboli were likely to hamper motor-function recovery. Endovascular recanalization of major ACA branches reduced the incidence of infarcts with no adverse events.
Purpose
Idiopathic intracranial hypertension (IIH) is a disorder of increased intracranial pressure in the absence of any known causative factor. Sinus stenosis is common in these patients. Stenting ...of stenotic dural sinuses has gained popularity as a treatment option, since these stenoses may contribute to an obstruction of the venous return, and, thereby may contribute to IIH via an increase in venous sinus pressure. We evaluated the safety and efficacy of endovascular treatment in IIH with venous sinus stenosis.
Methods
Fifty-one patients with IIH underwent stenting. Median age was 40 years. Clinical manifestation was headache in 74.5% of the patients and visual obscurations in 78.5%. Papilledema was present in 50/51 patients (98%), and lumbar puncture documented elevated CSF opening pressure in all but one patient (98%). Sinus stenoses were observed in all patients.
Results
Endovascular treatment was successfully performed in all patients. There were no major complications encountered (i.e., live threatening or causing a deterioration of a patient’s condition equivalent to mRS 3–6). Improvement or resolution of papilledema was observed in 88% of the patients, and 84% reported improvement or resolution of the headache. Follow-up angiographies were performed in 48 patients at a median interval of 49 months and demonstrated in stent-stenosis or a de novo stenosis in 12 patients, eight of them needed re-treatment.
Conclusion
Venous sinus stenting is a safe and effective alternative to other invasive treatments (e.g., optic nerve sheath fenestration, CSF diversion) in patients with IIH. The majority of patients have a persistent clinical benefit.
The technology available for the endovascular treatment of intracranial aneurysms is rapidly evolving. Both current and future devices are described. This includes, among others, UNO for parent ...vessel occlusion, the Medina device for saccular filling, the Comaneci device for remodeling, pCONus for assisted coil occlusion, and WEB and pCANvas for intrasaccular flow disruption. Perspectives of further development such as surface coating for increased radioopacity and decreased thrombogenicity are explained.
•A high degree of suspicion is required to detect basilar artery perforator aneurysms.•Repeat catheter angiography and 3D rotational angiography should be performed.•There is a low risk for ...re-haemorrhage and perforator infarction with flow diversion.•Flow diversion appears a safe and viable treatment option.
Basilar perforator artery aneurysms (BAPA’s) are an under-recognised cause of sub-arachnoid haemorrhage (SAH). We present our single centre experience of BAPA’s and review of the literature.
We performed a retrospective review of our prospectively maintained database to identify all BAPA’s that presented acute SAH between February 2009 and February 2018.
We identified 9 patients (male = 7), each with a single aneurysm, and average age 55 ± 9.7 years. All aneurysms were small, 2.1 ± 0.5 mm (range 1–3 mm). Three aneurysms were not detected on initial angiography. Six aneurysms were treated with flow diversion, 3 were managed conservatively. No repeat haemorrhage occurred in the flow diverted patients. One patient treated conservatively suffered a repeat haemorrhage and died (mRS 6). Follow up imaging (n = 7), at average 5.6 months (range 3–12 months), showed complete occlusion in all the flow-diverted aneurysms and no change in one conservatively managed patient. There was no evidence of perforator infarction on the follow-up post treatment imaging. Clinical follow-up data was available in 8 patients, 6 of whom (75%) had a good outcome (mRS ≤ 2).
A high index of suspicion is required to diagnose BAPA. Flow diversion can be used to treat BAPA’s with acceptable risk of perforator infarction and low risk of repeat haemorrhage.
Non-saccular aneurysms of the posterior fossa are an uncommon pathology with no clear treatment strategy. The use of flow-diverting stents (FDS) has had mixed results. We sought to evaluate our ...experience of FDS for the treatment of this pathology.
We retrospectively reviewed our database of prospectively collected information for all patients treated only with flow diversion for an unruptured non-saccular aneurysm of the posterior circulation between February 2009 and April 2016. The aneurysms were classified as dolichoectasia, fusiform or transitional, and imaging characteristics including maximal diameter, disease vessel segment, MRI features (intra-aneurysmal thrombus, T1 hyperintensity in the aneurysmal wall, infarctions in the territory of the posterior circulation, and mass effect) were recorded alongside clinical and follow-up data.
We identified 56 patients (45 men) with 58 aneurysms. The average age of the patients was 63.5 years. Twenty-two patients were symptomatic from the aneurysms at presentation. The majority of the lesions were vertebrobasilar in location (44.8%) with isolated vertebral lesions representing 29.3% of aneurysms. Transitional aneurysms were the most common (48.2%). The mean maximal diameter of the aneurysms was 11 mm. Angiographic exclusion of the aneurysms was seen in 57.4% of aneurysms with follow-up (n=47). During the follow-up period nine patients died.
Treatment of non-saccular aneurysms of the posterior fossa is technically possible. Early treatment, particularly of the fusiform and transitional subtypes, is recognized, as is treatment prior to the development of symptoms. A 'watch and wait' strategy with regular imaging follow-up could be employed for asymptomatic dolichoectasia.
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