DERIVO® Embolisation Device

DERIVO® Embolisation Device

The Derivo® embolisation device (DED) is a new-generation flow diverter designed to treat intracranial aneurysms, consisting of a flexible structure and a surface modification that aims to reduce thrombogenicity.

The safety and efficacy of flow diverters and their long-term clinical outcome must be investigated.

Girdhar et al., reported the thrombogenic potential of the following flow diversion devices measured experimentally in a novel human blood in-vitro pulsatile flow loop model: Pipeline™ Flex Embolization Device (Pipeline), Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline Shield), Derivo Embolization Device (Derivo), and P64 Flow Modulation Device (P64). Thrombin generation (Mean ± SD; μg/mL) was measured as: Derivo (28 ± 11), P64 (21 ± 4.5), Pipeline (21 ± 6.2), Pipeline Shield (0.6 ± 0.1) and Negative Control (1.5 ± 1.1). Platelet activation (IU/μL) was measured as: Derivo (4.9 ± 0.7), P64 (5.2 ± 0.7), Pipeline (5.5 ± 0.4), Pipeline Shield (0.3 ± 0.1), and Negative Control (0.9 ± 0.7). They found that Pipeline Shield had significantly lower platelet activation and thrombin generation than the other devices tested (p < .05) and this was comparable to the Negative Control (no device, p > .05). High resolution scanning electron microscopy performed on the intraluminal and cross-sectional surfaces of each device showed the lowest accumulation of platelets and fibrin on Pipeline Shield relative to Derivo, P64, and Pipeline. Derivo and P64 also had higher thrombus accumulation at the flared ends. Pipeline device with Phosphorylcholine surface treatment (Pipeline Shield) could mitigate device material related thromboembolic complications 1).


Kaschner et al., retrospectively analyzed all patients with ruptured dissecting and blister aneurysms treated with the Derivo between February 2016 and July 2018. Procedural details, complications, morbidity within 30 days, and angiographic aneurysm occlusion rates, initially and after six months, were assessed.

In 10 patients 11 ruptured dissecting and blister aneurysms were treated with 12 Derivos as monotherapy. No aneurysm rebleeding was observed at follow-up. One treatment-related complication occurred including a coil perforation of an additionally treated aneurysm. One patient died due to brain edema. Initial digital subtraction angiography revealed complete (O’Kelly-Marotta grading scale D) and favorable (OKM D+C) occlusion rate in three aneurysms. Six-month follow-up for digital subtraction angiography and clinical evaluation was available in 6/9 patients with complete (OKM D) occlusion in all aneurysms (6/6). Favorable (modified Rankin Scale [mRS] ≤ 2) and moderate (mRS 3) clinical outcome after a mean follow-up of 10 months was observed in six and two patients, respectively.

Endovascular treatment with the Derivo in ruptured dissecting and blister aneurysms revealed a sufficient initial division of aneurysms from the circulation without rebleeding. The Derivo is associated with high procedural and clinical short-term safety 2).


Kaschner et al., did a retrospective analysis of 32 patients with complex RIAs and UIAs treated with Derivo from Nov.2015 to Dec.2018. Clinical safety was defined as absence of death, transient attack, absence of minor and major stroke, and Derivo associated hemorrhage. Treatment efficacy was assessed angiographically (DSA) immediately after treatment and at 6 month follow-up according to the O’Kelly Marotta (OKM) grading scale (A=total filling to D=no filling; prolongation of stasis 1=arterial to 3=venous phase).

32 patients with 39 aneurysms were treated with 42 Derivos. In 5 aneurysms additional coiling was performed. Deployment was technically successful in all cases. Two patients developed a procedure related minor stroke (one transient). In 1 patient bleeding due to an inflammatory aneurysmatic wall process occurred 20 days after retreatment and in 1 patient a stroke due to instent thrombosis occurred when dual platelet inhibition (PI) was switched to permanent single PI 12 month after FD treatment. No treatment related deaths were observed. Initial DSA revealed OKMD,n=3; C,n=6; B,n=5; A,n=25. Six-month follow-up for DSA and clinical evaluation was available in 20/32 patients (62.5%), 26/39 aneurysms (66.7%) and revealed 73.1% complete and 3.8% subtotal occlusion (OKMD:19/26, OKMC3:1/26).

Treatment of complex RIAs and UIAs with the new generation Derivo appeared to be safe and effective in this single centre case series for ruptured and unruptured intracranial aneurysms. Immediate DSA revealed a significant flow modulation; and 6-month follow-up showed a high occlusion rate 3).


In a retrospective study of 59 consecutive patients (mean age: 53 years, 81% women) treated with the DED for 59 aneurysms (mean size: 8.1 mm) between November 2015 and February 2018 at 3 German tertiary care centers. Goertz et al., evaluated the rate of ischemic stroke, functional outcome, and angiographic results during a 1-year follow-up period.

Deployment of the DED was successful in all cases. Adverse events were observed in 6 procedures (10.2%), of which 2 were symptomatic (3.4%). No delayed ischemic or hemorrhagic events occurred during the 1-year follow-up and there were no deaths. Permanent morbidity due to in-stent thrombosis and consecutive ischemic stroke occurred in 1 patient (1.7%). Complete (O’Kelly-Marotta grading scale D) and favorable (O’Kelly-Marotta grading scale C+D) aneurysm occlusion was obtained in 70.5% (31/44) and 88.7% (39/44) at 6 months and 82.8% (24/29) and 100% (29/29) at 12 months, respectively.

The results demonstrated that treatment of intracranial aneurysms with the DED is associated with low rates of ischemic complications and adequate aneurysm occlusion at 1-year follow-up 4).


Between February 2016 and March 2018, 10 patients (median age 54.5 years, seven women) with 11 aneurysms were treated with the DED at three neurovascular centers. Procedural details, complications, morbidity, and aneurysm occlusion (O’Kelly-Marotta scale, OKM) were retrospectively reviewed.

Among 11 aneurysms treated, there were nine anterior circulation and two posterior circulation aneurysms. Aneurysm morphology was saccular in four cases, dissecting in three, blister-like in three, and fusiform in one. In each case, a single DED was implanted and deployment was technically successful without exception. Adjunctive coiling was performed in two aneurysms. We observed one in-stent thrombosis, presumably due to low response to clopidogrel 4 days after the procedure, which remained with a mild hemiparesis after aspiration thrombectomy. No further thromboembolic or hemorrhagic events occurred. Favorable outcome (modified Rankin scale score ≤2) at last follow-up was achieved in all patients. Among 10 aneurysms available for angiographic follow-up, complete aneurysm occlusion (OKM D) was obtained in nine cases (90.0%).

In this pilot study, endovascular treatment of ruptured intracranial aneurysms with the DED was feasible and not associated with any incidence of rebleeding 5).


In a study, the clinical outcomes of using the DED on 182 aneurysms are presented Material and Methods: In total, 146 patients with 182 aneurysms were treated with DED. The mean age of the participants was 51.5 years; among them, 46 (31.5%) presented with acute subarachnoid haemorrhage. The mean aneurysm size was 8.3 mm, and 12 aneurysms were involved the vertebrobasilar system. Ophthalmic aneurysms account for most internal carotid artery (ICA) aneurysms.

The Glasgow Coma Scale (GCS) score of 12 patients was 15. DED was associated with a mortality rate of 2.7% and permanent morbidity rate of 3.4%, and a complete aneurysm occlusion rate was achieved in 78.7% of cases after 7.02 months

The DED device is a new-generation flow diverter with excellent opening behaviour and navigational benefits. The results indicated a safe aneurysm occlusion with optimum morbidity and mortality values despite the fact that almost one-third of the patients presented with subarachnoid haemorrhage 6).


Martínez-Galdámez et al., presented the first clinical use of the largest flow diverter available, the 6×50 mm DERIVO embolization device (Acandis GmbH & Co. KG, Pforzheim, Germany), into the arterial circulation for a cervical internal carotid artery endovascular reconstruction. This is a new device for large or fusiform aneurysms requiring flow diversion, especially located in the vertebrobasilar system or extracranial segments 7).

References

1)

Girdhar G, Ubl S, Jahanbekam R, Thinamany S, Belu A, Wainwright J, Wolf MF. Thrombogenicity assessment of Pipeline, Pipeline Shield, Derivo and P64 flow diverters in an in vitro pulsatile flow human blood loop model. eNeurologicalSci. 2019 Jan 8;14:77-84. doi: 10.1016/j.ensci.2019.01.004. eCollection 2019 Mar. PubMed PMID: 30723811; PubMed Central PMCID: PMC6350389.
2)

Kaschner MG, Petridis A, Turowski B. Single-center experience with the new generation Derivo Embolization Device in ruptured dissecting and blister aneurysms. Acta Radiol. 2019 Jun 5:284185119852731. doi: 10.1177/0284185119852731. [Epub ahead of print] PubMed PMID: 31166695.
3)

Kaschner MG, Petridis A, Turowski B. Single center experience with the new generation derivo embolization device for ruptured and unruptured intracranial aneurysms. J Neurosurg Sci. 2019 May 6. doi: 10.23736/S0390-5616.19.04678-2. [Epub ahead of print] PubMed PMID: 31079436.
4)

Goertz L, Dorn F, Kraus B, Borggrefe J, Forbrig R, Schlamann M, Liebig T, Turowski B, Kabbasch C. Improved Occlusion Rate of Intracranial Aneurysms Treated with the Derivo Embolization Device: One-Year Clinical and Angiographic Follow-Up in a Multicenter Study. World Neurosurg. 2019 Mar 23. pii: S1878-8750(19)30815-0. doi: 10.1016/j.wneu.2019.03.137. [Epub ahead of print] PubMed PMID: 30910748.
5)

Goertz L, Dorn F, Kraus B, Borggrefe J, Schlamann M, Forbrig R, Turowski B, Kabbasch C. Safety and efficacy of the Derivo Embolization Device for the treatment of ruptured intracranial aneurysms. J Neurointerv Surg. 2019 Mar;11(3):290-295. doi: 10.1136/neurintsurg-2018-014166. Epub 2018 Aug 6. PubMed PMID: 30082333.
6)

Daglioglu E, Akmangit İ, Acik V, Alagoz F, Sayin B, Uckun OM, Belen AD, Arat A. The Experience of the Derivo® Embolisation Device in Intracranial Aneurysms. Turk Neurosurg. 2019 Mar 27. doi: 10.5137/1019-5149.JTN.25776-19.2. [Epub ahead of print] PubMed PMID: 31049921.
7)

Martínez-Galdámez M, Rodríguez C, Hermosín A, Crespo-Vallejo E, Monedero G, Chaviano J, Zheng B. Internal Carotid Artery Reconstruction with a “Mega Flow Diverter”: First Experience with the 6×50 mm DERIVO Embolization Device. Neurointervention. 2018 Sep;13(2):133-137. doi: 10.5469/neuroint.2018.00934. Epub 2018 Aug 31. PubMed PMID: 30196686; PubMed Central PMCID: PMC6132039.

Ceribell

Ceribell

Delirium is an acute disorder affecting up to 80% of intensive care unit (ICU) patients. It is associated with a 10-fold increase in cognitiveimpairment, triples the rate of in-hospital mortality, and costs $164 billion annually. Delirium acutely affects attention and global cognitive function with fluctuating symptoms caused by underlying organic etiologies. Early detection is crucial because the longer a patient experiences delirium the worse it becomes and the harder it is to treat. Currently, identification is through intermittent clinical assessment using standardized tools, like the Confusion Assessment Method for ICU. Such tools work well in clinical research but do not translate well into clinical practice because they are subjective, intermittent and have low sensitivity. As such, healthcare providers using these tools fail to recognize delirium symptoms as much as 80% of the time. Delirium-related biochemical derangement leads to electrical changes in electroencephalographic (EEG) patterns followed by behavioral signs and symptoms. However, continuous EEG monitoring is not feasible due to cost and need for skilled interpretation. Studies using limited-lead EEG show large differences between patients with and without delirium while discriminating delirium from other causes. The Ceribell is a limited-lead device that analyzes EEG. If it is capable of detecting delirium, it would provide an objective physiological monitor to identify delirium before symptom onset. This pilot study was designed to explore relationships between Ceribell and delirium status. Completion of this study will provide a foundation for further research regarding delirium status using the Ceribell data 1).

Brain Stethoscope Training from Ceribell on Vimeo.

1)

Mulkey MA, Hardin SR, Munro CL, Everhart DE, Kim S, Schoemann AM, Olson DM. Methods of identifying delirium: A research protocol. Res Nurs Health. 2019 May 30. doi: 10.1002/nur.21953. [Epub ahead of print] PubMed PMID: 31148216.

Consolidated Health Economic Evaluation Reporting Standards in Neurosurgery

Consolidated Health Economic Evaluation Reporting Standards

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication.


The increasing number of treatment options and the high costs associated with epilepsy have fostered the development of economic evaluations in epilepsy. It is important to examine the availability and quality of these economic evaluations and to identify potential research gaps. As well as looking at both pharmacologic (antiepileptic drugs [AEDs]) and nonpharmacologic (e.g., epilepsy surgeryketogenic dietvagus nerve stimulation) therapies, a review of Wijnen et al., examines the methodologic quality of the full economic evaluations included. Literature search was performed in MEDLINE, EMBASE, NHS Economic Evaluation Database (NHS EED), Econlit, Web of Science, and CEA Registry. In addition, Cochrane Reviews, Cochrane DARE and Cochrane Health Technology Assessment Databases were used. To identify relevant studies, predefined clinical search strategies were combined with a search filter designed to identify health economic studies. Specific search strategies were devised for the following topics: (1) AEDs, (2) patients with cognitive deficits, (3) elderly patients, (4) epilepsy surgery, (5) ketogenic diet, (6) vagus nerve stimulation, and (7) treatment of (non)convulsive status epilepticus. A total of 40 publications were included in this review, 29 (73%) of which were articles about pharmacologic interventions. Mean quality score of all articles on the Consensus Health Economic Criteria (CHEC)-extended was 81.8%, the lowest quality score being 21.05%, whereas five studies had a score of 100%. Looking at the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), the average quality score was 77.0%, the lowest being 22.7%, and four studies rated as 100%. There was a substantial difference in methodology in all included articles, which hampered the attempt to combine information meaningfully. Overall, the methodologic quality was acceptable; however, some studies performed significantly worse than others. The heterogeneity between the studies stresses the need to define a reference case (e.g., how should an economic evaluation within epilepsy be performed) and to derive consensus on what constitutes “standard optimal care” 1).


The in-hospital treatment of patients with traumatic brain injury (TBI) is considered to be expensive, especially in patients with severe traumatic brain injury. To improve future treatment decision-making, resource allocation and research initiatives, a study of van Dijck et al., from The Netherlands reviewed the in-hospital costs for patients with s-TBI and the quality of study methodology.

systematic review was performed using the following databases: PubMedMEDLINEEmbaseWeb of ScienceCochrane libraryCENTRALEmcarePsycINFOAcademic Search Premier and Google ScholarArticles published before August 2018 reporting in-hospital acute care costs for patients with s-TBI were included. Quality was assessed by using a 19-item checklist based on the CHEERS statement.

Twenty-five out of 2372 articles were included. In-hospital costs per patient were generally high and ranged from $2,130 to $401,808. Variation between study results was primarily caused by methodological heterogeneity and variable patient and treatment characteristics. The quality assessment showed variable study quality with a mean total score of 71% (range 48% – 96%). Especially items concerning cost data scored poorly (49%) because data source, cost calculation methodology and outcome reporting were regularly unmentioned or inadequately reported.

Healthcare consumption and in-hospital costs for patients with s-TBI were high and varied widely between studies. Costs were primarily driven by the length of stay and surgical intervention and increased with higher TBI severity. However, drawing firm conclusions on the actual in-hospital costs of patients sustaining s-TBI was complicated due to variation and inadequate quality of the included studies. Future economic evaluations should focus on the long-term cost-effectiveness of treatment strategies and use guideline recommendations and common data elements to improve study quality 2).

References

1)

Wijnen BFM, van Mastrigt GAPG, Evers SMAA, Gershuni O, Lambrechts DAJE, Majoie MHJM, Postulart D, Aldenkamp BAP, de Kinderen RJA. A systematic review of economic evaluations of treatments for patients with epilepsy. Epilepsia. 2017 May;58(5):706-726. doi: 10.1111/epi.13655. Epub 2017 Jan 18. Review. PubMed PMID: 28098939.
2)

van Dijck JTJM, Dijkman MD, Ophuis RH, de Ruiter GCW, Peul WC, Polinder S. In-hospital costs after severe traumatic brain injury: A systematic review and quality assessment. PLoS One. 2019 May 9;14(5):e0216743. doi: 10.1371/journal.pone.0216743. eCollection 2019. PubMed PMID: 31071199.
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