The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology-First Multicenter Experience in 161 Patients.

BACKGROUND AND PURPOSE: Flow diverters with antithrombotic coatings are increasingly used to improve the safety of flow diverter treatments of intracranial aneurysms. This study aimed to investigate the safety and short-term efficacy of the new FRED X flow diverter. MATERIALS AND METHODS: Medical charts and procedural and imaging data of a consecutive series of patients with intracranial aneurysms who were treated with the FRED X at 9 international neurovascular centers were retrospectively analyzed. RESULTS: One hundred sixty-one patients (77.6% women; mean age, 55 years) with 184 aneurysms (11.2% acutely ruptured) were included in this study. Most aneurysms were located in the anterior circulation (77.0%), most frequently at the ICA (72.7%). The FRED X was successfully implanted in all procedures. Additional coiling was performed in 29.8%. In-stent balloon angioplasty was necessary in 2.5%. The rate of major adverse events was 3.1%. Thrombotic events occurred in 7 patients (4.3%) with 4 intra- and 4 postprocedural in-stent thromboses, respectively (1 patient had both peri- and postprocedural thrombosis). Of these thrombotic events, only 2 (1.2%) led to major adverse events (ischemic strokes). Postinterventional neurologic morbidity and mortality were observed in 1.9% and 1.2%, respectively. The rate of complete aneurysm occlusion after a mean follow-up of 7.0 months was 66.0%. CONCLUSIONS: The new FRED X is a safe and feasible device for aneurysm treatment. In this retrospective multicenter study, the rate of thrombotic complications was low, and the short-term occlusion rates are satisfactory.

Widening the Indications for Intrasaccular Flow Disruption: WEB 17 in the Treatment of Aneurysm Locations Different from Those in the Good Clinical Practice Trials.

BACKGROUND AND PURPOSE: The safety and efficacy of the Woven EndoBridge (WEB) device has been shown in multiple good clinical practice trials, whereas aneurysm locations in these trials were restricted to bifurcation aneurysms located at the circle of Willis (MCA bifurcation, ICA bifurcation, anterior communicating artery, basilar artery tip). Our aim was to evaluate angiographic and clinical results with the WEB 17 in aneurysm locations that were excluded from the good clinical practice trials, assuming that the angiographic and clinical results are similar to those of the good clinical practice trials for aneurysms in traditional locations. MATERIALS AND METHODS: We performed retrospective analysis of immediate and follow-up results of aneurysms in locations outside the good clinical practice trials in which the WEB 17 was used on an intention-to-treat approach. RESULTS: Between June 2017 and May 2020, forty-seven aneurysms in 44 patients met the inclusion criteria. Aneurysm locations were the ICA posterior communicating artery in 19 (40.3%), the ICA paraophthalmic or choroidal locations in 4 (8.6%), anterior cerebral artery A2 segment in 13 (27.7%), MCA M1 segment in 2 (4.3%), posterior cerebral artery P2 segment in 2 (4.3%), PICA in 3 (6.4%), and the superior cerebellar artery in 4 (8.4%) cases. The procedure-related morbidity and mortality rates in the entire series were 0.0%. The early and late (<12 and >12 months) complete occlusion rates were 63.9% (23/36) and 77.8% (14/18), respectively. CONCLUSIONS: The WEB 17 is safe and effective in aneurysm locations different from the traditional bifurcation aneurysms included in the good clinical practice trials. Further studies will help to define the entire spectrum of aneurysm morphologies and locations suitable for the WEB 17.

Acute Endovascular Stroke Treatment in Germany in 2019 : Results from a Nationwide Database.

PURPOSE: Since the incidental discovery and systematic introduction of mechanical endovascular stroke treatment in 2015 there are few reports about the real-life situation in daily clinical practice. The aim of this study was to evaluate the mechanical thrombectomy data documented in the quality assurance database of the German Society for Interventional Radiology and Minimally Invasive Therapy (DeGIR) and the German Society of Neuroradiology (DGNR) in 2019. METHODS: We retrospectively analyzed the clinical and procedural data of all mechanical thrombectomies that were entered into the voluntary nationwide database in 2019. The information of each procedure was provided on a standardized web-based data sheet. Data were exported and analyzed by a group of experts on behalf of the DGNR. RESULTS: A total of 13,840 data sets from 158 participating centers could be analyzed. Mean age of the patients was 74 ± 13 years; 53.9% were female. Vessel occlusion was located in the anterior circulation in 87.4%, in the posterior circulation in 10.7%. On hospital admission, the median National Institutes of Health Stroke Scale (NIHSS) was 14 (lower/upper quartile 10/19); at hospital discharge, median NIHSS had dropped to 9 (lower/upper quartile 2/12; p < 0.001). Recanalization of the occluded vessel segment was successful (TICI 2b + 3) in 88.4%. The reported complication rate was 7.3%, with subarachnoid hemorrhage as the most frequent complication (3.4%), followed by parenchymal hemorrhage (1.7%) and embolization in new territories (1.2%). Overall, the median time interval from symptom onset to hospital admission was 94 min (quartiles 59/180 min), the median time from hospital admission to groin puncture was 74 min (lower/upper quartile 47/103 min), and the median duration of the procedure 43 min (lower/upper quartile 25.2/73.2 min). A comparison between primary and secondary referral revealed a significant faster symptom-to-intervention time for primary referrals, whereas in-house workflows showed no significant difference. CONCLUSION: The analysis represents the largest documented cohort of acute stroke patients treated by thrombectomy. The documentation allows for a detailed evaluation of procedural, clinical, logistic and radiation exposure data and might be used for monitoring the quality of the treatment on a nationwide scale.

Initial Experience with Surpass Evolve Flow Diverter in the Treatment of Intracranial Aneurysms.

BACKGROUND AND PURPOSE: The principle of flow diversion has revolutionized the treatment of brain aneurysms. In this study, we report our experience of the new Surpass Evolve (SE) flow diverter in the treatment of intracranial aneurysms. MATERIAL AND METHODS: Patients were treated with the SE as first-line therapy between May 2019 and June 2020 at 2 experienced institutions. Inclusion criteria were wide-necked, blister-like, or fusiform/dissecting aneurysms in the anterior and posterior circulation. Primary endpoint was technical success defined as favorable navigation to the target vessel and successful deployment of the SE. Secondary endpoints were favorable aneurysm occlusion defined as O'Kelly Marotta (OKM) scale C1-3 + D on follow-up, procedure-related complications and retreatment. RESULTS: A total of 46 aneurysms in 42 patients were treated with 57 SE flow diverters. Median aneurysm size was 6.6 mm (IQR 4.0-12.2 mm) with a median neck width of 4 mm (IQR 2.2-5.4 mm). On admission, 6 (13%) aneurysms were ruptured and 41 (89%) were located in the anterior circulation. The primary endpoint was reached in 96%. Median follow-up was 116 days (IQR 92-134 days) and available for 36/46 (78%) aneurysms. Favorable aneurysm occlusion was seen in 31/36 (86%) aneurysms and 27/36 (75%) were occluded completely. Parent artery occlusion appeared in 3 (3%) patients on follow-up and 2 aneurysms (6%) required additional treatment due to insufficient closure. CONCLUSION: The new SE flow diverter is safe and seems to be effective with promising occlusion rates at short-term follow-up.

Complication Rates Using CASPER Dual-Layer Stents for Carotid Artery Stenting in Acute Stroke : A 3-Year Single Center Experience.

BACKGROUND AND PURPOSE: The number of acute and early stent occlusions after emergency stenting of the internal carotid artery (ICA) in patients with tandem lesions is unclear and only mentioned in a small number of publications, ranging from 0-20%. A recent article by Yilmaz et al. reported a high rate of acute in-stent occlusions of 45% within 72 h after deployment of CASPER dual layer stents. METHODS: All patients with acute ischemic stroke treated with a CASPER stent between August 2014 and April 2018 were retrospectively evaluated for occlusion rates, periinterventional medication and early complications. A total of 66 patients, 45 with tandem pathologies and 21 with proximal ICA stenosis only were enrolled. RESULTS: Thrombotic complications occurred in 16 out of 66 patients (24%) and hemorrhagic complications in 8/66 (12%) and 15 of the 16 thrombotic complications and 7/8 symptomatic intracranial hemorrhages (sICH) occurred in patients with tandem lesions and accessory intracranial thrombectomy. Of the patients with sICH five were treated in a prolonged or unknown time window. In patients with intraprocedural thrombotic complications ultrasound imaging showed patent stents in 13 of the 14 patients CONCLUSIONS: The CASPER stent system showed a high technical success rate in patients with acute stroke. The number of patients with sICH was not higher than the numbers reported in the published literature despite the early use of Gp IIb/IIIA inhibitors, whereas the number of thrombotic complications was smaller than that reported in recent studies. The majority of sICH occurred in patients treated because of tandem lesions in an unknown or prolonged time window.

Treatment of Ruptured and Unruptured Intracranial Aneurysms with WEB 17 Versus WEB 21 Systems : Comparison of Indications and Early Angiographic Outcomes.

BACKGROUND: The concept of intrasaccular flow diversion using the Woven EndoBridge (WEB) device changed the traditional endovascular concept for wide-necked bifurcation aneurysms. The latest technical advancement resulted in the WEB 17 system, a softer device composed of fewer wires which enables treatment of smaller more distally located aneurysms by using smaller microcatheters as compared to the WEB 21 system. OBJECTIVE: This retrospective observational study aimed to evaluate and compare the angiographic and clinical results achieved with WEB 21 and WEB 17 in aneurysm morphologies eligible for both systems (maximum width 3-6 mm). METHODS: Between August 2014 and August 2019 a total of 63 and 130 aneurysms with a maximum width of 3-6 mm were treated with either WEB 21 and WEB 17, respectively, at 2 neurovascular centers. Cases were analyzed based on a comparison regarding aneurysm size, location and rupture status. RESULTS: The technical success, the periprocedural complication rate and the rate of additional devices used showed no relevant differences between the two groups. Aneurysms treated with the WEB 17 system were smaller and more frequently distally located. The overall complete occlusion rate at 3 months was higher in the WEB 17 group (65.5% versus 55.1%). The superiority of complete aneurysm occlusion achieved with WEB 17 was statistically significant in the subgroup of unruptured middle cerebral artery aneurysms. CONCLUSION: The use of WEB 17 expands the treatment indications for intrasaccular flow-diversion towards smaller and more distally located aneurysms with a safety profile comparable with that of the WEB 21.

Periprocedural Safety and Feasibility of the New LVIS EVO Device for Stent-Assisted Coiling of Intracranial Aneurysms: An Observational Multicenter Study.

BACKGROUND AND PURPOSE: Stent-assisted treatment techniques can be an effective treatment option for intracranial aneurysms. The aim of this study was to evaluate the periprocedural feasibility and safety of the new LVIS EVO stent for the treatment of intracranial aneurysms. MATERIALS AND METHODS: Patients with intracranial aneurysms treated with the LVIS EVO in 11 European neurovascular centers were retrospectively reviewed. Patient and aneurysm characteristics, procedural parameters, immediate grade of occlusion, and technical and clinical complications were assessed. RESULTS: Fifty-seven patients with 59 aneurysms were treated with the LVIS EVO device; 57.6% of the aneurysms were incidental; 15.3% were acutely ruptured; 15.3% were recanalized or residual aneurysms; and 11.9% were treated for symptoms other than acute hemorrhage. The most frequent aneurysm locations were the middle cerebral artery (25.4%) and the anterior communicating artery (22.0%). The rate of immediate successful deployment was 93.2%. In 6.8% (n = 4) of cases, additional in-stent angioplasty was needed. The immediate complete occlusion rate was 54.2%, while there was a residual aneurysm in 35.6% and a residual neck in 10.2%. Periprocedural technical complications occurred in 7/59 treatments (11.9%; the most frequent technical complication [n = 3] was thrombus formation), which all resolved completely without clinical sequelae. Postprocedural neurologic complications occurred after 4/59 treatments (6.8%; 2 transient ischemic attacks, 1 minor stroke, 1 major stroke), of which only 1 persistent complication was directly related to the procedure (minor stroke in the vascular territory distal to the stent). CONCLUSIONS: The LVIS EVO stent is a safe, feasible device for the treatment of intracranial aneurysms.

[Interdisciplinary neurovascular networks: state of the art]. / Interdisziplinäre neurovaskuläre Netzwerke: eine Standortbestimmung.

BACKGROUND: In order to treat the complete spectrum of neurovascular diseases at a high level of quality, which goes beyond the purely acute treatment of stroke, the German Stroke Society (DSG) together with the German Societies for Neurosurgery and Neuroradiology developed a certification procedure for neurovascular networks (NVN). Structurally, a NVN consists of a coordinating center with at least three neurovascular network partners with a certified stroke unit. From 2018 to 2020 a total of 15 NVN have so far been audited and certified according to this new standard. OBJECTIVE: How efficient are the NVN? Are high standards maintained? MATERIAL AND METHODS: The reports of the audits were analyzed. The data were taken from the period 2017-2019. RESULTS: The 15 NVN treated a total of 86,510 stroke patients in the years examined and were networked with a total of 107 partner clinics, which were situated an average of 25 km from the coordinating center and transferred a total of 2726 patients. The coordinating centers performed 2463 thrombectomies and treated 2383 patients with nontraumatic intracerebral bleeding. In 712 patients with acute aneurysmatic subarachnoid hemorrhages endovascular treatment was carried out and clipping in 401. The audit was successful in the majority of the NVN. CONCLUSION: The certification process of NVN has been successfully established and the audits proved to be a useful instrument for quality control and improvement. The 15 NVN are highly efficient and treat more than one quarter of stroke patients in German stroke units.

Endovascular Thrombectomy of Calcified Emboli in Acute Ischemic Stroke: A Multicenter Study.

BACKGROUND AND PURPOSE: Large intracranial vessel occlusion due to calcified emboli is a rare cause of major stroke. We assessed the prevalence, imaging appearance, the effectiveness of mechanical thrombectomy, and clinical outcome of patients with large-vessel occlusion due to calcified emboli. MATERIALS AND METHODS: We performed a retrospective analysis of clinical and procedural data of consecutive patients who underwent mechanical thrombectomy due to calcified emboli in 7 European stroke centers. RESULTS: We screened 2969 patients, and 40 patients matched the inclusion criteria, accounting for a prevalence of 1.3%. The mean maximal density of the thrombus was 327 HU (range, 150-1200 HU), and the mean thrombus length was 9.2 mm (range, 4-20 mm). Four patients had multiple calcified emboli, and 2 patients had an embolic event during an endovascular intervention. A modified TICI score of ≥2b was achieved in 57.5% (23/40), with minimal-to-no reperfusion (modified TICI 0-1) in 32.5% (13/40) and incomplete reperfusion (modified TICI 2a) in 10% (4/40). Excellent outcome (mRS 0-1) was achieved in only 20.6%, functional independence (mRS 0-2) in 26.5% and 90-day mortality was 55.9%. CONCLUSIONS: Acute ischemic stroke with large-vessel occlusion due to calcified emboli is a rare entity in patients undergoing thrombectomy, with considerably worse angiographic outcome and a higher mortality compared with patients with noncalcified thrombi. Good functional recovery at 3 months can still be achieved in about a quarter of patients.

Two-Center Experience in the Endovascular Treatment of Intracranial Aneurysms Using the Woven EndoBridge 17 Device Including Midterm Follow-Up Results: A Retrospective Analysis.

BACKGROUND AND PURPOSE: The Woven EndoBridge device proved its effectiveness in the treatment of ruptured and unruptured intracranial aneurysms as a stand-alone device. Before 2016, Woven EndoBridge deployment required at least a 0.021-inch microcatheter. In 2016, a smaller device, the Woven EndoBridge 17 with finer size increments that used a 0.017-inch microcatheter, was introduced. We retrospectively analyzed our initial and follow-up results with the Woven EndoBridge 17 in ruptured and unruptured aneurysms. MATERIALS AND METHODS: One hundred twenty-seven intracranial aneurysms in 117 patients were scheduled for treatment with the Woven EndoBridge 17 between June 2017 and February 2019. Twenty-nine aneurysms were ruptured. RESULTS: Treatment was performed as intended in 124 of 127 cases (97.6%). Additional devices such as stents or coils were used in 12 cases (9.7%). Five thromboembolic complications and 1 hemorrhagic complication were encountered, resulting in clinical deterioration in 2 patients. The overall morbidity and mortality in the entire series have been 1.7% and 0.0% to date, respectively. The follow-up results at 3 and 12 months revealed complete occlusion in 76.1% (70/92) and 78.0% (32/41). CONCLUSIONS: The Woven EndoBridge 17 device is safe in the treatment of small broad-based aneurysms without the general need for additional devices. The low complication rate and the promising follow-up results underline the value of this technique in a growing range of endovascular treatment options for intracranial aneurysms.

Endovascular Treatment of Unruptured MCA Bifurcation Aneurysms Regardless of Aneurysm Morphology: Short- and Long-Term Follow-Up.

BACKGROUND AND PURPOSE: The optimal treatment of unruptured middle cerebral aneurysms is still under debate. Although today almost any aneurysm can be treated endovascularly, there is a lack of data comparing endovascular and microsurgical repair of MCA aneurysms. The aim of our analysis is to provide data on the efficacy, clinical outcome, complications and re-treatment rates of endovascular treatment of this subtype of aneurysms. MATERIALS AND METHODS: Between May 2008 and July 2017, endovascular treatment of 1184 aneurysms in 827 patients was performed in our department. Twenty-four percent of these aneurysms were located at the MCA, and 150 unruptured MCA bifurcation aneurysms treated with coiling, stent-assisted-coiling, or endovascular flow diverter (WEB device) were identified for this retrospective data analysis. Ninety-six percent of all aneurysms, ruptured and unruptured, were treated by an endovascular approach, which yields a low selection bias for aneurysms suitable for endovascular treatment. Follow-up examinations were performed after 12 and 36 months and then every 1-3 years after embolization. Procedures were analyzed for periprocedural complications, outcome, and retreatment rate of the WEB (n = 38) and coiling with (n = 45) or without stent assistance (n = 67). RESULTS: The procedure-associated good clinical outcome (mRS ≦ 2) was 89.9%, and the mortality rate was 2.7%. Short-term follow-up good clinical outcome/mortality rates were 91.3%/0.7%. At discharge, 137 patients had an mRS of 0-2 (91.3%) and 13 had an mRS of 3-6 (8.7%). The retreatment rate was significantly higher in the WEB group (21.1%) compared with the coiling group with (5.9%) or without (2.2%) stent placement (P < .05). CONCLUSIONS: Regardless of the architecture of MCA bifurcation aneurysms, the endovascular treatment can be performed with low morbidity/mortality rates. The higher retreatment rate in the WEB group correlates with the learning curve in choosing the right device size.

European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study.

BACKGROUND AND PURPOSE: Endoluminal reconstruction with flow-diverting stents represents a widely accepted technique for the treatment of complex intracranial aneurysms. This European registry study analyzed the initial experience of 15 neurovascular centers with the Flow-Redirection Intraluminal Device (FRED) system. MATERIALS AND METHODS: Consecutive patients with intracranial aneurysms treated with the FRED between February 2012 and March 2015 were retrospectively reviewed. Complications and adverse events, transient and permanent morbidity, mortality, and occlusion rates were evaluated. RESULTS: During the defined study period, 579 aneurysms in 531 patients (median age, 54 years; range, 13-86 years) were treated with the FRED. Seven percent of patients were treated in the acute phase (≤3 days) of aneurysm rupture. The median aneurysm size was 7.6 mm (range, 1-36.6 mm), and the median neck size 4.5 mm (range, 1-30 mm). Angiographic follow-up of >3 months was available for 516 (89.1%) aneurysms. There was progressive occlusion witnessed with time, with complete occlusion in 18 (20%) aneurysms followed for up to 90 ± 14 days, 141 (82.5%) for 180 ± 20 days, 116 (91.3%) for 1 year ± 24 days, and 122 (95.3%) aneurysms followed for >1 year. Transient and permanent morbidity occurred in 3.2% and 0.8% of procedures, respectively. The overall mortality rate was 1.5%. CONCLUSIONS: This retrospective study in real-world patients demonstrated the safety and efficacy of the FRED for the treatment of intracranial aneurysms. In most cases, treatment with a single FRED resulted in complete angiographic occlusion at 1 year.

Two-Center Experience in the Endovascular Treatment of Ruptured and Unruptured Intracranial Aneurysms Using the WEB Device: A Retrospective Analysis.

BACKGROUND AND PURPOSE: The safety and efficacy of the Woven EndoBridge (WEB) device for the treatment of cerebral aneurysms has been investigated in several studies. Our objective was to report the experience of 2 neurovascular centers with the WEB device in the treatment of broad-based intracranial aneurysms, including the technical feasibility and safety as well as short- and midterm angiographic and clinical follow-up-results. MATERIALS AND METHODS: We performed a retrospective analysis of all ruptured and unruptured aneurysms treated with a WEB device (WEB Single-Layer and Single-Layer Sphere) between August 2014 and February 2017. Primary outcome measures included the feasibility of implantation and the angiographic outcome. Secondary outcome measures included the clinical outcome at discharge and procedural complications. RESULTS: One hundred two aneurysms in 101 patients, including 37 (36.3%) ruptured aneurysms, were treated with the WEB device. Implantation was successful in 98 (96.1%) aneurysms. Additional devices (stents/coils) were necessary in 15.3% (15/98) of aneurysms. Procedural complications occurred in 4.9% (5/102). Of these, 4 were thromboembolic events and 1 was an intraprocedural rupture. Angiographic follow-up at 3 and 12 months was available for 79.6% (78/98) and 50.0% (49/98) of all aneurysms to date, respectively, showing a sufficient aneurysm occlusion in 80.7% (63/78) at 3 months and 77.6% (38/49) at 12 months. Delayed aneurysm ruptures have not been observed during the follow-up period to date. CONCLUSIONS: The WEB device offers a safe and effective treatment option for broad-based intracranial aneurysms without the need for dual antiplatelet therapy.

State of Practice: Endovascular Treatment of Acute Aneurysmal SAH in Germany.

BACKGROUND AND PURPOSE: Acute aneurysmal SAH is a severe disease that requires prompt treatment. Endovascular coiling and neurosurgical clipping are established treatment options. Our intention was to determine the state of current practice in acute aneurysmal SAH treatment in Germany, with emphasis on logistic and temporal aspects. MATERIALS AND METHODS: We interviewed 74 German university and nonuniversity hospitals with an anonymous questionnaire comprising 15 questions concerning the practice of treatment and diagnostics of acute aneurysmal SAH at their respective institutions. The response rate was 74% among all institutions (55/74); among university hospitals, 77%; and among nonuniversity hospitals, 72%. RESULTS: The majority of all aneurysms were treated endovascularly (66% of acute aneurysmal SAH, 66% of unruptured aneurysms). Treatment on weekends was provided by 100% of endovascular and 96% of neurosurgical facilities. Average patients with acute aneurysmal SAH were not treated during the night (98%). Seventy percent of endovascular and 78% of neurosurgical treatments were not started later than 8:00 pm. Fifty-three percent of hospitals would not start a same-day diagnostic angiography in acute aneurysmal SAH if treatment was scheduled for the following day. Eighty-two percent of all centers performed DSA after clipping to evaluate the treatment results. CONCLUSIONS: Our survey gives a detailed summary of the current practice of endovascular treatment and related topics in acute aneurysmal SAH in Germany and also reveals considerable changes in practice in comparison with older data.

[Percutaneous Phil™-Embolization for Preoperative Therapy of Carotid Body Paragangliomas]. / Perkutane Phil™-Embolisation zur präoperativen Therapie von Karotis-Paragangliomen.

Introduction: Paragangliomas are rare tumors representing a therapeutic challenge. In particular, the surgical removal may lead to life-threatening bleeding. The preoperative percutaneous embolization is an alternative that allows a high closure rate of tumor-feeding vessels in a short intervention time and thus significantly reduces intraoperative bleeding probability. Complete tumor resection is facilitated thereby. The use of a new non-adhesive liquid embolic agent is presented here. Methods: A 50-year old patient presented with 4 cm large paraganglioma of the carotid body (Shamblin II). A percutaneous embolization with 7 ml PHIL™ (injectable precipitating hydrophobic liquid) was performed preoperatively. 24 h later the complete surgical resection of the tumor was performed. Results: A good distribution of the liquid embolic agent could be achieved over the entire tumor. Intraoperative resection of the tumor was much easier and faster due to low bleeding tendency over the entire surface of the tumor. Total blood loss was less than 50 ml. All adjacent nerve and arterial structures could be spared. Postoperative nerve function was normal and the patient was discharged on the 4th postoperative day. Conclusion: The combination of percutaneous embolization and surgical resection provides a safe combination in the treatment of advanced carotid body paragangliomas. The use of a novel liquid embolic agent may possibly further optimize the therapy.

Treatment of Intra- and Extracranial Aneurysms Using the Flow-Redirection Endoluminal Device: Multicenter Experience and Follow-Up Results.

BACKGROUND AND PURPOSE: Flow diversion emerged as a crucial treatment option for intracranial aneurysms. We report a multicenter retrospective analysis of the safety and efficacy in the treatment of intracranial aneurysms with the Flow-Redirection Endoluminal Device (FRED) flow diverter, a dual-layer flow-modulation device. MATERIALS AND METHODS: All intracranial aneurysms treated with the FRED between March 2013 and February 2016 at 4 neurovascular centers were included. Angiographic and clinical results were retrospectively analyzed, including all follow-up examinations. Aneurysms were unruptured in 44 cases, whereas 8 treatments were due to an acute SAH from the target aneurysm. RESULTS: Successful implantation of the FRED was possible in 96.2% (50/52) of cases. At 3-month follow-up, complete occlusion was determined in 58.1% (25/43) and near-complete in 25.6% (11/43). At 12-month follow-up, aneurysm occlusion was complete in 75.0% (27/36) and near-complete in 22.2% (8/36). The overall acute and late thromboembolic and hemorrhagic complication rate was 17.3% (9/52), with a permanent treatment-related morbidity and mortality of 4.0% (2/50) and 2.0% (1/50), respectively, to date. CONCLUSIONS: The FRED device offers an effective tool in the treatment of intracranial aneurysms. The dual-layer design promotes contemporary and stable long-term occlusion rates. Sufficient device expansion should be documented by angiographic CT. Further studies might help to identify a more optimal antiplatelet regimen to avoid thromboembolic complications during the follow-up period.

[Not Available]. / IQWiG Arbeitspapier GA15-02: "Stents zur Behandlung intrakranieller Stenosen: VISSIT Studie und Akutbehandlung in Deutschland". Kommentar des Berufsverbandes der Neuroradiologen (BDNR), der Deutschen Gesellschaft für Neuroradiologie (DGNR), der Deutschen Gesellschaft für Neurologie (DGN) und der Deutschen Schlaganfall-Gesellschaft (DSG).

There is an ongoing discussion about reimbursement of stent-angioplasty for the treatment of intracranial stenoses in Germany. The discussion was initiated by the statutory health insurance companies after publication of the SAMMPRIS study results, which were in favor for medical management compared to stent-angioplasty with the Wingspan® stent system. A report (Rapid report N14-01) mainly based on SAMMPRIS was written by the German Institute for Quality and Efficiency in Health Care (IQWiG) and serves as a basis for the decision-making process. This report was previously commented by the medical societies involved. Limitations of the SAMMPRIS trial and vital indications for intracranial stenting were outlined in this comment (acute vessel occlusion, hemodynamic impairment, recurrent symptoms under medical treatment). Currently also emergency stent procedures are a matter of debate. In this context a second IQWiG report was commissioned (GA 15 - 02) addressing the results of the VISSIT trial, the transferability of the results of the first report to emergency treatments and the practice of emergency intracranial stent treatment in Germany. Regarding transferability of results the main conclusion was that there was no evidence that the results of the studies analyzed for the first report (mainly SAMMPRIS) could not be transferred to emergency treatments. From a medical professional and scientific standpoint it is inacceptable to compare outcomes of a secondary prophylactic treatment with emergency procedures. The analysis of emergency treatments in Germany based on retrospective case series with a cumulative number of 31 patients. Since most emergency procedures are performed in a clinical context and are not necessarily subject to scientific evaluation, this does not reflect current practice in Germany. The first part of this statement briefly outlines the design of SAMMPRIS and VISSIT and the interpretation of the trial results from a professional perspective. The current state of discussion regarding reimbursement of intracranial stenting is summarized. The second section contains a detailed comment on the current IQWiG report GA15-02 "Stents for the treatment of intracranial artery stenosis: VISSIT study and acute treatment in Germany".