High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial.

INTRODUCTION: The objective of the study is to determine if high-frequency (1 kHz) spinal cord stimulation (SCS) is better than low-frequency SCS for pain relief in chronic limb-threatening ischemia (CLTI). METHODS: HEAL-SCS trial was designed as an open-label, parallel-group, single-center randomized study with a 1:1 allocation ratio. The trial was conducted in Meshalkin National Medical Research Center between August 2018 and February 2020. Total 56 patients underwent screening, 50 were enrolled, 6 were rejected. The participants were randomized into 2 cohorts of 25 patients each by an external coordinator using an online tool. A neurosurgeon and a vascular surgeon both examined all patients and estimated the pain intensity using visual analog scale (VAS), quality of life with short-form-36 health survey (SF-36), and functional status by walking impairment questionnaire (WIQ) at 3 and 12 months. Tissue perfusion was evaluated for 34 patients using transcutaneous oxygen tension measurement (TcPO2) at baseline and in 12 months. RESULTS: All 50 patients (84% men, median age 66.5 y.o) were available for primary outcome assessment 3 and 12 months after implantation. Intention-to-treat analysis demonstrated comparative advantage of HF-SCS over LF-SCS at 3 months with mean VAS score 2.8 (95% CI, 2.4; 3.2) and 3.3 (95% CI, 3.0; 3.6), respectively (p = 0.031). Clinical superiority of HF-SCS persisted at 12-month follow-up (p < 0.001). HF-SCS produced significantly greater pain relief by WIQ at 3 (p < 0.001) and 12 months (p = 0.009). Despite stair-climbing ability was better in HF-SCS group (p = 0.02), no significant difference between groups was found at 1-year post-op in terms of speed (p = 0.92) and distance scores (p = 0.68). Accordingly, the general and mental health domains of SF-36 were significantly better in HF-SCS at 12 months. Despite a tendency toward better resting oxygen pressure in HF-SCS group, there was no intergroup difference by TcPO2 (p = 0.076). Only 1 patient (2%) required above-the-knee amputation at 10 months after LF-SCS implantation. CONCLUSION: High-frequency SCS provides better pain relief, life quality, and functional performance in patients with CLTI during short-term follow-up. The lack of perfusion difference between high-frequency and conventional SCS requires further examination to the possible long-term advantages of the method.

Superselective transvenous embolization with Onyx and n-BCA for vein of Galen aneurysmal malformations with restricted transarterial access: safety, efficacy, and technical aspects.

PURPOSE AND METHODS: Superselective transvenous embolization (TVE) with liquid embolic agents is a new concept in treatment of vein of Galen aneurysmal malformations (VGAM). We performed ten sessions of TVE in VGAM patients with restricted transarterial access. In this paper, we assessed clinical and angiographic outcomes of the proposed treatment and discussed three different TVE techniques with regard to morphology of the shunt and outflow tract. Safety and avoidance-of-complication tips were also discussed. RESULTS: Patient age ranged from 4 to 51 months. There were eight patients with choroidal VGAMs, seven of them were successfully treated with Onyx, and in one case, transvenous catheterization failed. In three cases, adjunctive coiling of draining vein was performed. In three cases, normal deep cerebral veins were connected to the outflow part of malformation; they were preserved during embolization in all cases. Six-month follow-up angiography demonstrated angiographic cure in six cases, and partial occlusion in one. There were two patients with mural VGAMs: both were treated with n-BCA. Partial occlusion was achieved in both cases. There was no procedure-related permanent morbidity or mortality. Oculomotor deficit due to quadrigeminal ischemia occurred in one case, and resolved completely after 3 weeks. CONCLUSION: TVE with liquid embolic agents is a safe and effective salvage method for VGAMs with restricted transarterial access, previously considered as poor candidates for endovascular treatment.

Rheological Properties of Non-Adhesive Embolizing Compounds-The Key to Fine-Tuning Embolization Process-Modeling in Endovascular Surgery.

The study of polymers' rheological properties is of paramount importance both for the problems of their industrial production as well as for their practical application. Two polymers used for embolization of arteriovenous malformations (AVMs) are studied in this work: Onyx-18® and Squid-12®. Viscosity curve tests and computational fluid dynamics (CFD) were used to uncover viscosity law as a function of shear rate as well as behavior of the polymers in catheter or pathological tissue models. The property of thermal activation of viscosity was demonstrated, namely, the law of dependence of viscosity on temperature in the range from 20 °C to 37 °C was established. A zone of viscosity nonmonotonicity was identified, and a physical interpretation of the dependence of the embolic polymers' viscosity on the shear rate was given on the basis of Cisco's model. The obtained empirical constants will be useful for researchers based on the CFD of AVMs. A description of the process of temperature activation of the embolic polymers' viscosity is important for understanding the mechanics of the embolization process by practicing surgeons as well as for producing new prospective embolic agents.

Numerical Assessment of the Risk of Abnormal Endothelialization for Diverter Devices: Clinical Data Driven Numerical Study.

Numerical modeling is an effective tool for preoperative planning. The present work is devoted to a retrospective analysis of neurosurgical treatments for the occlusion of cerebral aneurysms using flow-diverters and hemodynamic factors affecting stent endothelization. Several different geometric approaches have been considered for virtual flow-diverters deployment. A comparative analysis of hemodynamic parameters as a result of computational modeling has been carried out basing on the four clinical cases: one successful treatment, one with no occlusion and two with in stent stenosis. For the first time, a quantitative assessment of both: the limiting magnitude of shear stresses that are necessary for the occurrence of in stent stenosis (MaxWSS > 1.23) and for conditions in which endothelialization is insufficiently active and occlusion of the cervical part of the aneurysm does not occur (MaxWSS < 1.68)­has been statistacally proven (p < 0.01).

Stent-assisted coiling of cerebral aneurysms: multi-center analysis of radiographic and clinical outcomes in 659 patients.

INTRODUCTION: The endovascular stent-assisted coiling approach for the treatment of cerebral aneurysms is evolving rapidly with the availability of new stent devices. It remains unknown how each type of stent affects the safety and efficacy of the stent-coiling procedure. METHODS: This study compared the outcomes of endovascular coiling of cerebral aneurysms using Neuroform (NEU), Enterprise (EP), and Low-profile Visualized Intraluminal Support (LVIS) stents. Patient characteristics, treatment details and angiographic results using the Raymond-Roy grade scale (RRGS), and procedural complications were analyzed in our study. RESULTS: Our study included 659 patients with 670 cerebral aneurysms treated with stent-assisted coiling (NEU, n=182; EP, n=158; LVIS, n=330) that were retrospectively collected from six academic centers. Patient characteristics included mean age 56.3±12.1 years old, female prevalence 73.9%, and aneurysm rupture on initial presentation of 18.8%. We found differences in complete occlusion on baseline imaging, defined as RRGS I, among the three stents: LVIS 64.4%, 210/326; NEU 56.2%, 95/169; EP 47.6%, 68/143; P=0.008. The difference of complete occlusion on 10.5 months (mean) and 8 months (median) angiographic follow-up remained significant: LVIS 84%, 251/299; NEU 78%, 117/150; EP 67%, 83/123; P=0.004. There were 7% (47/670) intra-procedural complications and 11.5% (73/632) post-procedural-related complications in our cohort. Furthermore, procedure-related complications were higher in the braided-stents vs laser-cut, P=0.002. CONCLUSIONS: There was a great variability in techniques and choice of stent type for stent-assisted coiling among the participating centers. The type of stent was associated with immediate and long-term angiographic outcomes. Randomized prospective trials comparing the different types of stents are warranted.

Initial experience with precipitating hydrophobic injectable liquid in cerebral arteriovenous malformations.

BACKGROUND: Precipitating hydrophobic injectable liquid is a newly introduced liquid embolic agent for endovascular embolization with some technical advantages over other liquid embolic agents. We present our initial experience with precipitating hydrophobic injectable liquid in the endovascular treatment of cerebral arteriovenous malformations. METHODS: From October 2015 to January 2018, 27 patients harboring cerebral arteriovenous malformations underwent endovascular embolization with precipitating hydrophobic injectable liquid 25. Clinical features, angiographic results, procedural details, complications, and follow-up details were retrospectively analyzed. RESULTS: Twenty-seven patients with cerebral arteriovenous malformations were included. Total obliteration in one endovascular session was confirmed for 14/27 (52%) patients. Partial embolization was attained in 13 patients (48%) in whom staged treatment with following radiosurgery or surgery was planned. No mortality was recorded in this series. Complications during or after the embolization occurred in six of 27 (22.2%) patients. CONCLUSION: In our initial experience, precipitating hydrophobic injectable liquid has acceptable clinical outcome comparable to other liquid embolic agents. Although this is the largest reported study in arteriovenous malformation treatment with precipitating hydrophobic injectable liquid, further studies are needed to validate its safety and efficacy.

A2, M2, P2 aneurysms and beyond: results of treatment with pipeline embolization device in 65 patients.

BACKGROUND: Intracranial aneurysms located in the distal vessels are rare and remain a challenge to treat through surgical or endovascular interventions. OBJECTIVE: To describe a multicenter approach with flow diversion using the pipeline embolization device (PED) for treatment of distal intracranial aneurysms. METHODS: Cases of distal intracranial aneurysms defined as starting on or beyond the A2 anterior cerebral artery, M2 middle cerebral artery, and P2 posterior cerebral artery segments were included in the final analysis. RESULTS: 65 patients with distal aneurysms treated with the PED were analyzed. Median aneurysm size at the largest diameter was 7.0 mm, 60% were of a saccular morphology, and 9/65 (13.8%) patients presented in the setting of acute rupture. Angiographic follow-up data were available for 53 patients, with a median follow-up time of 6 months: 44/53 (83%) aneurysms showed complete obliteration, 7/53 (13.2%) showed reduced filling, and 2/53 (3%) showed persistent filling. There was no association between patient characteristics, including aneurysm size (P=0.36), parent vessel diameter (P=0.27), location (P=0.81), morphology (P=0.63), ruptured status on admission (P=0.57), or evidence of angiographic occlusion at the end of the embolization procedure (P=0.49). Clinical outcome data were available for 60/65 patients: 95% (57/60) had good clinical outcome (modified Rankin Scale score of 0-2) at 3 months. CONCLUSIONS: This large multicenter study of patients with A2, M2, and P2 distal aneurysms treated with the PED showed that flow diversion may be an effective treatment approach for this rare type of vascular pathology. The procedural compilation rate of 7.7% indicates the need for further studies as the flow diversion technology constantly evolves.

Experience using pipeline embolization device with Shield Technology in a patient lacking a full postoperative dual antiplatelet therapy regimen.

Utilization of flow diverting devices is accompanied with dual antiplatelet therapy to reduce the risk of thromboembolic events, even though this increases the risk of hemorrhagic complications. The updated Pipeline Flex embolization device with Shield Technology has been created using a phosphorylcholine coating that reduces thrombogenicity and possibly reduces the need for dual antiplatelet therapy. However, because of the potential risk to patients of utilizing a pipeline embolization device without dual antiplatelet therapy, the pipeline embolization device with Shield Technology has not been tested in human subjects without dual antiplatelet therapy, and its contribution to preventing thromboembolic events is therefore unknown. We report a case in which a patient, following complications that limited his absorption of dual antiplatelet therapy, had low levels of dual antiplatelet therapy medications in his bloodstream following treatment for an intracranial aneurysm with a pipeline embolization device with Shield Technology. The patient recovered without signs of luminal stenosis or thromboembolic event.

Flow diversion versus parent artery occlusion with bypass in the treatment of complex intracranial aneurysms: Immediate and short-term outcomes of the randomized trial.

OBJECTIVE: We performed prospective randomized comparison of clinical and surgical outcomes of flow diversion versus PVO and bypass in patients with complex anterior circulation aneurysms. PATIENTS AND METHODS: Open, prospective, randomized, parallel group, multicenter study of complex intracranial aneurysms treatment was conducted. Patients with complex intracranial aneurysms of anterior circulation with neck is more than 4 mm wide, dome/neck ratio is equal or less than 2:1, which is suitable for flow diversion and occlusion with bypass were included in the study. A total of 111 potential participants were enrolled since March 2015. Additional propensity score matching was performed with 40 patients in each group selected for analysis. RESULTS: 39 out of 40 patients (97.5%) from matched FD group reached good clinical outcome. In the matched bypass group acceptable outcome was achieved in 32 (80%) out of 40 patients (difference between groups p = 0.029). The morbidity and mortality rates were 15% and 5%, respectively. Difference in the rates of favorable outcomes, compared by χ2 met statistical significance (p = 0.014). The rate of complete aneurysm occlusion at 6 months was 42.5% in the FD group and 95% in surgical group (p < 0.0001). The rate of complete occlusion at 12 months was 65% in the FD group and 97.5% in surgical group. The difference between groups was still significant (p = 0.001). There were no significant differences between groups by occurrence of ischemic (p = 0.108) and hemorrhagic (p = 0.615) complications. CONCLUSION: The study demonstrated superior clinical outcomes for endovascular flow diversion in comparison with bypass surgery in treatment of complex aneurysms. Though, both techniques grant similar percentage of major neurologic complications and comparable cure rate for cranial neuropathy. Nevertheless, flow diversion is associated with significantly lower early obliteration rate, thus possesses patient for risks of prolonged dual antiplatelet regimen and delayed rupture. Hence, it's important to stratify patient by the natural risk of aneurysm rupture prior to treatment selection.

Assessment of periprocedural hemodynamic changes in arteriovenous malformation vessels by endovascular dual-sensor guidewire.

Endovascular embolization is an important modality in the treatment of brain AVMs. Nowadays staged embolization is the method of choice for the prevention of perioperative hemorrhagic complications. Current theory suggests that simultaneous occlusion of more than 60% of AVM volume induces significant redistribution local blood flow. That, in turn, may lead to hemorrhage due to AVM rupture. Aside from angiographic findings, there is still no method that predicts the degree of safe partial embolization. Intraluminal measurement of flow velocity and pressure in the vicinity of the AVM nidus might allow detecting the changes in local hemodynamics. That can provide a valuable data and shed the light on the origin of vascular catastrophes. Ten patients underwent 12 embolization sessions with intraluminal flow velocity and pressure monitoring. The measurements were performed by dual-sensor guidewire. The "Combomap" (Volcano) system with Combowire microguidewires was chosen for measurements, as there is a documented experience of safe use of said guidewires in the cerebral vasculature. The findings observed during the study matched empirical data as well as the current physiological hypothesis of AVM hemorrhage. In conjunction with DSA runs, intraluminal flow velocity and pressure monitoring has the potential to become a valuable tool in AVM treatment.