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.

Pipeline embolization device for posterior circulation aneurysm

Pipeline embolization device for posterior circulation aneurysm

The use of the pipeline embolization device (PED) for posterior circulation aneurysms remains controversial. In a meta-analysis, Liang et al., from the Beijing Tiantan Hospital and Beijing Tsinghua Changgung Hospital, aimed to explore the safety and efficacy of PED for these aneurysms. Meta regression was used to identify predictors for incomplete aneurysm occlusion and procedure-related complications.

PubMedWeb of Science, and OVID databases were searched to identify all published references evaluating the treatment effect of PED for posterior circulation aneurysms. Only studies written in English, reporting original data, and including more than 10 cases were considered for inclusion. Patient demographics, aneurysm characteristics, angiographic, and clinical outcomes were extracted. A random effects model was adopted to pool the obliteration rates and complications rates across selected studies. Finally, they conducted meta-regression analysis to identify the predictors of the angiographic outcomes.

12 studies, including 358 patients with 365 aneurysms were included. The pooled complete aneurysm obliteration rate was 82% (95% confidence interval [CI], 73%-90%) and the pooled procedure-related complication rate was 18% (95% CI, 14%-22%). Increasing age predicted incomplete obliteration of aneurysms after PED treatment in these patients (P=0.01).

PED is an alternative to treat intracranial aneurysms of the posterior circulation, achieving high complete occlusion rates, but less effective in senile patients. However, the risk of procedure-related complications is not negligible. Further larger and long-term follow-up studies are needed before definitive conclusions might be drawn 1).


From November 2015 to November 2016, 35 patients with 38 posterior circulation aneurysms were treated with the PED in this retrospective study. We evaluated the angiographic and clinical outcomes of these aneurysms at last follow-up, and made a comparison between anterior (n = 163) and posterior circulation (n = 38) aneurysms regarding the technical nuances, occlusion rate, complications rate, and time to occlusion to explore whether we should rationalize the use of the PED for these aneurysms.

With a median follow-up time of 5.5 months, complete occlusion was achieved in 33 aneurysms (91.7%). Aneurysms with stenosis parent artery tended to have lower occlusion rate (P = 0.064; odds ratio, 0.074; 90% confidence interval, 0.001-1.781), and V4 segment aneurysms tended to occlude themselves much faster than vertebrobasilar junction aneurysms (median, 148 vs. 246 days, respectively; P = 0.076). The periprocedural complication rate was 10.8%, and no major adverse events occurred. Compared with anterior circulation aneurysms, shorter procedure time (116.0 vs. 135.4 minutes, P = 0.012) and higher occlusion rate (91.4% vs. 72.8%, P = 0.023) were achieved for posterior circulation aneurysms. Besides, technical event rate (8.1% vs. 14.1%, P = 0.424) and complication rate (10.8% vs. 18.4%, P = 0.338) tended to be lower. Survival analysis indicated a shorter interval to complete occlusion for V4 segment aneurysms compared with anterior circulation (148 vs. 191 days, respectively; P = 0.047).

PED has a favorable performance at posterior circulation, and it is rational to expand the indication to include these aneurysms. However, a case-control study is still needed to further expatiate whether the PED has advantages over traditional endovascular treatment 2).


In 2018, a retrospective review of prospectively maintained databases at 8 academic institutions was performed for the years 2009 to 2016 to identify patients with posterior circulation aneurysms treated with PED placement.

A total of 129 consecutive patients underwent 129 procedures to treat 131 aneurysms; 29 dissecting, 53 fusiform, and 49 saccular lesions were included. At a median follow-up of 11 months, complete and near-complete occlusion was recorded in 78.1%. Dissecting aneurysms had the highest occlusion rate and fusiform the lowest. Major complications were most frequent in fusiform aneurysms, whereas minor complications occurred most commonly in saccular aneurysms. In patients with saccular aneurysms, clopidogrel responders had a lower complication rate than did clopidogrel nonresponders. The majority of dissecting aneurysms were treated in the immediate or acute phase following subarachnoid hemorrhage, a circumstance that contributed to the highest mortality rate in those aneurysms.

In the largest series till 2018, fusiform aneurysms were found to have the lowest occlusion rate and the highest frequency of major complications. Dissecting aneurysms, frequently treated in the setting of subarachnoid hemorrhage, occluded most often and had a low complication rate. Saccular aneurysms were associated with predominantly minor complications, particularly in clopidogrel nonresponders 3).


In 2015, a case series publication of Albuquerque et al. stated that patient selection is essential for safe and effective PED treatment of posterior circulation aneurysms. The PED is equally effective in achieving aneurysm obliteration with an acceptable risk profile as it is in the anterior circulation. Dolichoectatic aneurysms were not included in this treatment cohort. PED may be a preferable alternative to open surgical treatment of posterior circulation aneurysms 4).

References

1)

Liang F, Zhang Y, Yan P, Ma C, Liang S, Jiang C. Outcomes and complications after the use of the pipeline embolization device in the treatment of intracranial aneurysms of the posterior circulation: A systematic review and meta-analysis. World Neurosurg. 2019 Apr 5. pii: S1878-8750(19)30972-6. doi: 10.1016/j.wneu.2019.03.291. [Epub ahead of print] PubMed PMID: 30959253.
2)

Liang F, Zhang Y, Guo F, Zhang Y, Yan P, Liang S, Jiang Y, Jiang P, Jiang C. Use of Pipeline Embolization Device for Posterior Circulation Aneurysms: Single-Center Experiences with Comparison with Anterior Circulation Aneurysms. World Neurosurg. 2018 Apr;112:e683-e690. doi: 10.1016/j.wneu.2018.01.129. Epub 2018 Feb 2. PubMed PMID: 29410337.
3)

Griessenauer CJ, Ogilvy CS, Adeeb N, Dmytriw AA, Foreman PM, Shallwani H, Limbucci N, Mangiafico S, Kumar A, Michelozzi C, Krings T, Pereira VM, Matouk CC, Harrigan MR, Shakir HJ, Siddiqui AH, Levy EI, Renieri L, Marotta TR, Cognard C, Thomas AJ. Pipeline embolization of posterior circulation aneurysms: a multicenter study of 131 aneurysms. J Neurosurg. 2018 Apr 1:1-13. doi: 10.3171/2017.9.JNS171376. [Epub ahead of print] PubMed PMID: 29726768.
4)

Albuquerque FC, Park MS, Abla AA, Crowley RW, Ducruet AF, McDougall CG. A reappraisal of the Pipeline embolization device for the treatment of posterior circulation aneurysms. J Neurointerv Surg. 2015 Sep;7(9):641-5. doi: 10.1136/neurintsurg-2014-011340. Epub 2014 Aug 4. PubMed PMID: 25092926.

Intrathecal Drug Delivery Device Infection

Intrathecal Drug Delivery Device Infection

A major complication of Intrathecal Drug Delivery Device (IDDD) implantationis infection.

Morgalla et al., assessed IDD-related complications in 51 patients who had IDD systems implanted for the treatment of chronic pain or spasticity.

Twelve patients (23.5%) presented a total of 22 complications. The main type of complication was catheter-related (50%), followed by pump failure, infection, and inappropriate refilling 1).


Device-related and surgical wound infection occurred in 12 patients (3%), and nine were regarded as severe in the series of Taira et al., 2).

Risk Factors

Patients with extremely low muscle bulk, visceral pumps may be impractical or impossible, with increased risks of dehiscence and infection 3).


Periodic refills of intrathecal implanted pumps do not seem to be a risk factor for infection if standard sterile refill procedures are performed. In a study, it was clear that comorbid infections from other parts of the body do not present as a risk for device contamination 4).

Prevention

Follett et al., concluded from the available data that the most effective antiinfection measures consist of adherence to published guidelines and recommendations that apply to surgical site infections (SSIs) in general 5).


The use of vancomycin powder in patients with implants in the series of is series of Ghobrial et al., did not reduce infection rates compared to published historical controls, and was elevated compared to institutional controls 6).


The combination of local neomycin/polymyxin with systemic antibiotic therapy can lead to a significantly lower rate of postoperative infection than when systemic antibiotics are used alone 7).


The subfascial implantation technique was associated with a reduced rate of local wound and pump infections and provided optimal cosmetic results as compared with that observed in retrospective cases 8).

Treatment

The current standard of care in the treatment of IDDD infection necessitates that the pump be explanted and the infection treated prior to implantation of a new IDDD. This process leads to long hospital stays, interruptions in optimal medical management, and a high risk for dangerous drug withdrawals.


Infections can be treated with repetitive local application of gentamicin-impregnated collagen fleece 9).


Leibold et al., describe a technique that allows for the explantation of the infected pump and implantation of a new pump concurrently, which they have named the “Turner Switch” technique in honor of its inventor.

The authors conducted a retrospective analysis of cases of infected IDDDs in which patients underwent simultaneous explantation of the infected pump and implantation of a new pump. Demographics and clinical data were collected.

Data from a total of 17 patients (11 male, 6 female) who underwent simultaneous IDDD explantation and implantation to treat infections were analyzed from a 3-year period. No patients experienced infection of the newly implanted pump or catheter. Of the 17 patients, 14 (82.4%) had baclofen pumps to treat spasticity and 3 (17.6%) had fentanyl pumps to treat chronic pain. The median hospital stay was 7 days, with 16 of 17 (94.1%) patients able to be discharged home or to a facility with a level of care similar to their preoperative care. All patients ultimately experienced complete resolution of their initial infections. Five patients (29.4%) required a return to the operating room within the next 5 months (for repair of a CSF leak in 2 cases, for treatment of infection at the old pump site in 2 cases, and for treatment of a CSF leak compounded with infection in 1 case). No patient experienced infection of the newly implanted pump or catheter.

IDDD infections represent a large portion of morbidity associated with these devices. The current standard of care for deep pump infections requires pump explantation and a course of antibiotics prior to reimplantation of the IDDD. The authors demonstrate the effectiveness of a procedure involving simultaneous explantation of an infected pump and implantation of a new pump on the contralateral side in the treatment of IDDD infections 10).


Ingale et al., suggested that consideration should be given to selective dorsal rhizotomy (SDR) as an alternative in patients previously implanted with Intrathecal Drug Delivery systems complicated by infection or nearing end of battery life 11).

Case reports

A patient with pump-site infection and Escherichia coli meningitis secondary to transcolonic perforation of an intrathecal baclofen pump catheter. While this is rare, we review the intraoperative precautions and best practices that should be taken to prevent and manage this unusual complication 12).


Intrathecal drug delivery device infection with Mycobacterium fortuitum was not been reported previously. Aliabadi et al., reported a case of an implanted baclofen pump infection and associated mycobacterium meningitis due to Mycobacterium fortuitum. The entire pump system was removed and the patient was treated successfully with a prolonged regimen of antibiotics 13).


In a case neurological complaints were pain and dysaesthesiae in the lower back and thigh, as well as paresis of the ileopsoas muscle. MRI of the lumbar spine showed an intradural-extramedullary mass at the level of L1 homogeneously enhancing with gadolinium. This mass was situated at the tip of an intrathecal catheter implanted 11 years before for a morphine trial infusion as therapy for phantom pain after amputation of the right arm. Now, removal of the catheter was performed. Cultures of lumbar CSF and the catheter tip demonstrated coagulase negative staphylococcus. Antibiotic medication with cephalosporines was given for 6 weeks. After removal of the catheter, the patient was free of pain and he progressively regained full neurological function. Although most catheter-associated granulomas reported so far were sterile in nature, bacterial infection should still be considered even years after catheter placement 14).


A patient who experienced a prolonged course of intrathecal baclofen withdrawal syndrome after removal of an implantable baclofen pump for treatment of pump infection and meningitis. The current literature outlines management options for the acute management of this syndrome. In this report the authors discuss the long-term presentation of this syndrome and suggest a treatment strategy for management of the syndrome. A 37-year-old man who presented with a baclofen pump infection and meningitis experienced acute onset of intrathecal baclofen withdrawal syndrome 12 hours after the pump had been surgically removed. The patient’s symptoms evolved into a severe, treatment-refractory withdrawal syndrome lasting longer than 1 month. Oral baclofen replacement with adjunctive administration of parenteral gamma-aminobutyric acid agonists only served to stabilize the patient’s critical condition throughout his hospital course. Replacement of the baclofen pump and restoration of intrathecal delivery of the medication was necessary to trigger the patient’s dramatic recovery and complete reversal of the withdrawal syndrome within approximately 48 hours. These findings indicate that a more direct method of treating infected baclofen pumps than immediate surgical removal is necessary to prevent the onset of intrathecal baclofen withdrawal syndrome. Various options for preventing the onset of the syndrome while simultaneously treating the infection are discussed 15).

References

1)

Morgalla M, Fortunato M, Azam A, Tatagiba M, Lepski G. High-Resolution Three-Dimensional Computed Tomography for Assessing Complications Related to Intrathecal Drug Delivery. Pain Physician. 2016 Jul;19(5):E775-80. PubMed PMID: 27389121.
2)

Taira T, Ueta T, Katayama Y, Kimizuka M, Nemoto A, Mizusawa H, Liu M, Koito M, Hiro Y, Tanabe H. Rate of complications among the recipients of intrathecal baclofen pump in Japan: a multicenter study. Neuromodulation. 2013 May-Jun;16(3):266-72; discussion 272. doi: 10.1111/ner.12010. Epub 2012 Dec 14. PubMed PMID: 23240625.
3)

Waqar M, Ellenbogen JR, Kumar R, Sneade C, Zebian B, Williams D, Pettorini BL. Indwelling intrathecal catheter with subcutaneous abdominal reservoir: a viable baclofen delivery system in severely cachectic patients. J Neurosurg Pediatr. 2014 Oct;14(4):409-13. doi: 10.3171/2014.6.PEDS13686. Epub 2014 Aug 1. PubMed PMID: 25084089.
4)

Dario A, Scamoni C, Picano M, Fortini G, Cuffari S, Tomei G. The infection risk of intrathecal drug infusion pumps after multiple refill procedures. Neuromodulation. 2005 Jan;8(1):36-9. doi: 10.1111/j.1094-7159.2005.05218.x. PubMed PMID: 22151381.
5)

Follett KA, Boortz-Marx RL, Drake JM, DuPen S, Schneider SJ, Turner MS, Coffey RJ. Prevention and management of intrathecal drug delivery and spinal cord stimulation system infections. Anesthesiology. 2004 Jun;100(6):1582-94. Review. PubMed PMID: 15166581.
6)

Ghobrial GM, Thakkar V, Singhal S, Oppenlander ME, Maulucci CM, Harrop JS, Jallo J, Prasad S, Saulino M, Sharan AD. Efficacy of intraoperative vancomycin powder use in intrathecal baclofen pump implantation procedures: single institutional series in a high risk population. J Clin Neurosci. 2014 Oct;21(10):1786-9. doi: 10.1016/j.jocn.2014.04.007. Epub 2014 Jun 14. PubMed PMID: 24938386.
7)

Miller JP, Acar F, Burchiel KJ. Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application. J Neurosurg. 2009 Feb;110(2):247-50. PubMed PMID: 19263587.
8)

Kopell BH, Sala D, Doyle WK, Feldman DS, Wisoff JH, Weiner HL. Subfascial implantation of intrathecal baclofen pumps in children: technical note. Neurosurgery. 2001 Sep;49(3):753-6; discussion 756-7. PubMed PMID: 11523691.
9)

Peerdeman SM, de Groot V, Feller RE. In situ treatment of an infected intrathecal baclofen pump implant with gentamicin-impregnated collagen fleece. J Neurosurg. 2010 Jun;112(6):1308-10. doi: 10.3171/2009.8.JNS081692. PubMed PMID: 19731988.
10)

Leibold AT, Weyhenmeyer J, Lee A. Simultaneous explantation and implantation of intrathecal pumps: a case series. J Neurosurg. 2019 Apr 12:1-7. doi: 10.3171/2019.1.JNS18919. [Epub ahead of print] PubMed PMID: 30978693.
11)

Ingale H, Ughratdar I, Muquit S, Moussa AA, Vloeberghs MH. Selective dorsal rhizotomy as an alternative to intrathecal baclofen pump replacement in GMFCS grades 4 and 5 children. Childs Nerv Syst. 2016 Feb;32(2):321-5. doi: 10.1007/s00381-015-2950-9. Epub 2015 Nov 9. PubMed PMID: 26552383.
12)

Devine OP, Harborne AC, Lo WB, Price R. Colonic perforation by an intrathecal baclofen pump catheter causing delayed Escherichia coli meningitis. BMJ Case Rep. 2017 Dec 20;2017. pii: bcr-2017-222539. doi: 10.1136/bcr-2017-222539. PubMed PMID: 29269368.
13)

Aliabadi H, Osenbach RK. Intrathecal Drug Delivery Device Infection and Meningitis due to Mycobacterium Fortuitum: A Case Report. Neuromodulation. 2008 Oct;11(4):311-4. do 10: i: 10.1111/j.1525-1403.2008.00181.x. PubMed PMID: 22151146.
14)

Lehmberg J, Scheiwe C, Spreer J, van Velthoven V. Late bacterial granuloma at an intrathecal drug delivery catheter. Acta Neurochir (Wien). 2006 Aug;148(8):899-901; discussion 901. Epub 2006 Jun 23. PubMed PMID: 16791432.
15)

Douglas AF, Weiner HL, Schwartz DR. Prolonged intrathecal baclofen withdrawal syndrome. Case report and discussion of current therapeutic management. J Neurosurg. 2005 Jun;102(6):1133-6. Review. PubMed PMID: 16028775.
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