Cited by 29Neuroscience and Neural EngineeringVagus Nerve Stimulation ResearchCardiac pacing and defibrillation studies

The DOI matches its Crossref record; the references it cites are not checked yet.

Endovascular Neuromodulation: Safety Profile and Future Directions

Open access

Abstract

Endovascular neuromodulation is an emerging technology that represents a synthesis between interventional neurology and neural engineering. The prototypical endovascular neural interface is the StentrodeTM, a stent-electrode array which can be implanted into the superior sagittal sinus via percutaneous catheter venography, and transmits signals through a transvenous lead to a receiver located subcutaneously in the chest. Whilst the StentrodeTM has been conceptually validated in ovine models, questions remain about the long-term viability and safety of this device in human recipients. Although technical precedence for venous sinus stenting already exists in the setting of idiopathic intracranial hypertension, long-term implantation of a lead within the intracranial veins has never been previously achieved. Contrastingly, transvenous leads have been successfully employed for decades in the setting of implantable cardiac pacemakers and defibrillators. In the current absence of human data on the StentrodeTM, the literature on these structurally comparable devices provides valuable lessons that can be translated to the setting of endovascular neuromodulation. This review will explore this literature in order to understand the potential risks of the StentrodeTM and define avenues where further research and development are necessary in order to optimise this device for human application.

Overview

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.3389/fneur.2020.00351

Cites

Statistics

Verification

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The Stentrode is designed for a 10-year lifespan, avoids invasive battery replacements through wireless power using near-field RF, with a transmission depth of ≈30 mm and 2% efficiency.

    “Another example of a battery-free implant is the Stentrode, designed for a 10-year lifespan, avoids invasive battery replacements through wireless power using near-field RF, with a transmission depth of ≈30 mm and 2% efficiency, connected to an Inductively Powered Internal Telemetry Unit (ITU) for power and Bluetooth signal transmission (Aldaoud et al., 2018; Oxley et al., 2020; Raza et al., 2020)”

    From Comparative analysis of energy transfer mechanisms for neural implants (2024) · cites this paper as Raza et al., 2020

    The Introduction identifies the Stentrode and describes its permanent transvenous lead, but does not give the claimed power specifications. In “Lead Failure,” the 10-year life expectancy refers to cardiac leads, not a Stentrode design target. The paper does not substantiate battery-free near-field RF power, a 30 mm transmission depth, or 2% efficiency; its “Lead Safety” section says current endovascular electrode arrays rely on a lead rather than wireless signal transmission. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Citations

The citation lists haven’t been fetched yet

References 81 · Cited by 29

Research works printed but not linked: 79

  1. Nagahama, 2018, Intracranial eEG for seizure focus localization: evolving techniques, outcomes, complications, and utility of combining surface and depth electrodes, J Neurosurg., 2018, 1, 10.3171/2018.1.JNS171808 · DOI
  2. Cook, 2013, Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: a first-in-man study, Lancet Neurol., 12, 563, 10.1016/S1474-4422(13)70075-9 · DOI
  3. Deuschl, 2006, A randomized trial of deep-brain stimulation for parkinson's disease, N Engl J Med., 355, 896, 10.1056/NEJMoa060281 · DOI
  4. Vansteensel, 2016, Fully implanted brain-computer interface in a locked-in patient with aLS, N Engl J Med., 375, 2060, 10.1056/NEJMoa1608085 · DOI · Paper page
  5. Anumanchipalli, 2019, Speech synthesis from neural decoding of spoken sentences, Nature., 568, 493, 10.1038/s41586-019-1119-1 · DOI · Paper page
  6. Akbari, 2019, Towards reconstructing intelligible speech from the human auditory cortex, Sci Rep., 9, 874, 10.1038/s41598-018-37359-z · DOI · Paper page
  7. Hamer, 2002, Complications of invasive video-EEG monitoring with subdural grid electrodes, Neurology., 58, 97, 10.1212/WNL.58.1.97 · DOI
  8. Ben-Haim, 2009, Risk factors for hemorrhage during microelectrode-guided deep brain stimulation and the introduction of an improved microelectrode design, Neurosurgery., 64, 754, 10.1227/01.NEU.0000339173.77240.34 · DOI
  9. Cardinale, 2013, Stereoelectroencephalography: surgical methodology, safety, and stereotactic application accuracy in 500 procedures, Neurosurgery., 72, 353, 10.1227/NEU.0b013e31827d1161 · DOI
  10. Boviatsis, 2010, Surgical and hardware complications of deep brain stimulation. A seven-year experience and review of the literature, Acta Neurochir (Wien)., 152, 2053, 10.1007/s00701-010-0749-8 · DOI
  11. Polikov, 2005, Response of brain tissue to chronically implanted neural electrodes, J Neurosci Methods., 148, 1, 10.1016/j.jneumeth.2005.08.015 · DOI · Paper page
  12. Satzer, 2014, Variation in deep brain stimulation electrode impedance over years following electrode implantation, Stereotact Funct Neurosurg., 92, 94, 10.1159/000358014 · DOI
  13. Oxley, 2016, Minimally invasive endovascular stent-electrode array for high-fidelity, chronic recordings of cortical neural activity, Nat Biotechnol., 34, 320, 10.1038/nbt.3428 · DOI
  14. Opie, 2018, Focal stimulation of the sheep motor cortex with a chronically implanted minimally invasive electrode array mounted on an endovascular stent, Nat Biomed Eng., 2, 907, 10.1038/s41551-018-0321-z · DOI
  15. Teplitzky, 2014, Computational modeling of an endovascular approach to deep brain stimulation, J Neural Eng., 11, 026011, 10.1088/1741-2560/11/2/026011 · DOI
  16. Sefcik, 2016, The evolution of endovascular electroencephalography: historical perspective and future applications, Neurosurg Focus., 40, E7, 10.3171/2016.3.FOCUS15635 · DOI
  17. Penn, 1973, Intravascular intracranial eEG recording, Technical note. J Neurosurg., 38, 239, 10.3171/jns.1973.38.2.0239 · DOI
  18. Mikuni, 1997, Frontopolar ictal epileptiform discharges on scalp electroencephalogram in temporal lobe epilepsy, J Clin Neurophysiol., 14, 507, 10.1097/00004691-199711000-00007 · DOI
  19. Kunieda, 2000, Use of cavernous sinus eEG in the detection of seizure onset and spread in mesial temporal lobe epilepsy, Epilepsia., 41, 1411, 10.1111/j.1528-1157.2000.tb00116.x · DOI
  20. Thömke, 1998, Endovascular electroencephalography during an intracarotid amobarbital test with simultaneous recordings from 16 electrodes, J Neurol Neurosurg Psychiatry., 64, 565, 10.1136/jnnp.64.4.565 · DOI
  21. Bower, 2013, Intravenous recording of intracranial, broadband eEG, J Neurosci Methods., 214, 21, 10.1016/j.jneumeth.2012.12.027 · DOI
  22. John, 2018, Signal quality of simultaneously recorded endovascular, subdural and epidural signals are comparable, Sci Rep., 8, 8427, 10.1038/s41598-018-36257-8 · DOI
  23. Puffer, 2013, Venous sinus stenting for idiopathic intracranial hypertension: a review of the literature, J Neurointerv Surg., 5, 483, 10.1136/neurintsurg-2012-010468 · DOI
  24. Lai, 2014, Visual outcomes and headache following interventions for idiopathic intracranial hypertension, J Clin Neurosci., 21, 1670, 10.1016/j.jocn.2014.02.025 · DOI
  25. Teleb, 2013, Idiopathic intracranial hypertension. A systematic analysis of transverse sinus stenting, Interv Neurol., 2, 132, 10.1159/000357503 · DOI
  26. Satti, 2015, Meta-Analysis of cSF diversion procedures and dural venous sinus stenting in the setting of medically refractory idiopathic intracranial hypertension, AJNR Am J Neuroradiol., 36, 1899, 10.3174/ajnr.A4377 · DOI
  27. Starke, 2015, Endovascular treatment of venous sinus stenosis in idiopathic intracranial hypertension: complications, neurological outcomes, and radiographic results, Sci World J., 2015, 140408, 10.1155/2015/140408 · DOI
  28. Nicholson, 2019, Venous sinus stenting for idiopathic intracranial hypertension: a systematic review and meta-analysis, J Neurointerv Surg., 11, 380, 10.1136/neurintsurg-2018-014172 · DOI
  29. Raper, 2017, Patency of the vein of labbé after venous stenting of the transverse and sigmoid sinuses, J Neurointerv Surg., 9, 587, 10.1136/neurintsurg-2016-012903 · DOI
  30. Levitt, 2016, Venous sinus stenting for idiopathic intracranial hypertension is not associated with cortical venous occlusion, J Neurointerv Surg., 8, 594, 10.1136/neurintsurg-2015-011692 · DOI
  31. Korkeila, 2007, Venous obstruction after pacemaker implantation, Pacing Clin Electrophysiol., 30, 199, 10.1111/j.1540-8159.2007.00650.x · DOI
  32. Oginosawa, 2002, The incidence and risk factors for venous obstruction after implantation of transvenous pacing leads, Pacing Clin Electrophysiol., 25, 1605, 10.1046/j.1460-9592.2002.01605.x · DOI
  33. Abu-El-Haija, 2015, Venous stenosis after transvenous lead placement: a Study of outcomes and risk factors in 212 consecutive patients, J Am Heart Assoc., 4, e001878, 10.1161/JAHA.115.001878 · DOI
  34. Sticherling, 2001, Prevalence of central venous occlusion in patients with chronic defibrillator leads, Am Heart J., 141, 813, 10.1067/mhj.2001.114195 · DOI
  35. Lickfett, 2004, Incidence of venous obstruction following insertion of an implantable cardioverter defibrillator. A study of systematic contrast venography on patients presenting for their first elective ICD generator replacement, Europace., 6, 25, 10.1016/j.eupc.2003.09.001 · DOI
  36. Oxley, 2018, An ovine model of cerebral catheter venography for implantation of an endovascular neural interface, J Neurosurg., 128, 1020, 10.3171/2016.11.JNS161754 · DOI
  37. Opie, 2016, Feasibility of a chronic, minimally invasive endovascular neural interface, Conf Proc IEEE Eng Med Biol Soc., 2016, 4455, 10.1109/EMBC.2016.7591716 · DOI
  38. Opie, 2017, Micro-CT and histological evaluation of an neural interface implanted within a blood vessel, IEEE Trans Biomed Eng., 64, 928, 10.1109/TBME.2016.2552226 · DOI
  39. Stoney, 1976, The incidence of venous thrombosis following long-term transvenous pacing, Ann Thorac Surg., 22, 166, 10.1016/S0003-4975(10)63980-X · DOI
  40. Sheth, 2018, Venous collateral drainage patterns predict clinical worsening in dural venous sinus thrombosis, J Neurointerv Surg., 10, 171, 10.1136/neurintsurg-2016-012941 · DOI
  41. Raper, 2018, A pilot study and novel angiographic classification for superior sagittal sinus stenting in patients with non-thrombotic intracranial venous occlusive disease, J Neurointerv Surg., 10, 74, 10.1136/neurintsurg-2016-012906 · DOI
  42. Matsumoto, 2016, A case of stenting for acute cerebral venous sinus thrombosis in the superior sagittal sinus, Interv Neuroradiol., 22, 709, 10.1177/1591019916663093 · DOI
  43. Adachi, 2015, Stenting for acute cerebral venous sinus thrombosis in the superior sagittal sinus, Interv Neuroradiol., 21, 719, 10.1177/1591019915609120 · DOI
  44. Ohara, 2012, Superior sagittal sinus dural arteriovenous fistulas treated by stent placement for an occluded sinus and transarterial embolization. A case report, Interv Neuroradiol., 18, 333, 10.1177/159101991201800314 · DOI
  45. Entezami, 2019, Endovascular stenting of the superior sagittal sinus to alleviate venous compression caused by a parasagittal meningioma, BMJ Case Rep., 12, 4, 10.1136/bcr-2018-227935 · DOI
  46. Ganesan, 2008, Stent placement for management of a small parasagittal meningioma, Technical note. J Neurosurg., 108, 377, 10.3171/JNS/2008/108/2/0377 · DOI
  47. Finn, 2007, Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization, Circulation., 115, 2435, 10.1161/CIRCULATIONAHA.107.693739 · DOI
  48. Donnelly, 2018, Venous obstruction in cardiac rhythm device therapy, Curr Treat Options Cardiovasc Med., 20, 64, 10.1007/s11936-018-0664-5 · DOI
  49. Sanjeev, 2006, Superior vena cava and innominate vein dimensions in growing children : an aid for interventional devices and transvenous leads, Pediatr Cardiol., 27, 414, 10.1007/s00246-006-1133-6 · DOI
  50. Bharmanee, 2015, Comparative chronic valve and venous effects of lumenless versus stylet-Delivered pacing leads in patients with and without congenital heart, Pacing Clin Electrophysiol., 38, 1343, 10.1111/pace.12728 · DOI
  51. Figa, 1997, Risk factors for venous obstruction in children with transvenous pacing leads, Pacing Clin Electrophysiol., 20, 1902, 10.1111/j.1540-8159.1997.tb03594.x · DOI
  52. Andrews, 1989, Microsurgical anatomy of the venous drainage into the superior sagittal sinus, Neurosurgery., 24, 514, 10.1227/00006123-198904000-00005 · DOI
  53. Da Costa, 2002, Incidence and risk factors of upper extremity deep vein lesions after permanent transvenous pacemaker implant: a 6-month follow-up prospective study, Pacing Clin Electrophysiol., 25, 1301, 10.1046/j.1460-9592.2002.01301.x · DOI
  54. Costa, 2009, Prevention of venous thrombosis by warfarin after permanent transvenous leads implantation in high-risk patients, Pacing Clin Electrophysiol., 32, S247, 10.1111/j.1540-8159.2008.02295.x · DOI
  55. Goto, 1998, Long-term thrombosis after transvenous permanent pacemaker implantation, Pacing Clin Electrophysiol., 21, 1192, 10.1111/j.1540-8159.1998.tb00177.x · DOI
  56. Di Cori, 2010, Transvenous extraction performance of expanded polytetrafluoroethylene covered iCD leads in comparison to traditional iCD leads in humans, Pacing Clin Electrophysiol., 33, 1376, 10.1111/j.1540-8159.2010.02879.x · DOI
  57. Wilkoff, 2005, Improved extraction of ePTFE and medical adhesive modified defibrillation leads from the coronary sinus and great cardiac vein, Pacing Clin Electrophysiol., 28, 205, 10.1111/j.1540-8159.2005.40029.x · DOI
  58. Klug, 2007, Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study, Circulation., 116, 1349, 10.1161/CIRCULATIONAHA.106.678664 · DOI
  59. Rahman, 2016, Infection and readmission rate of cardiac implantable electronic device insertions: an observational single center study, Am J Infect Control., 44, 278, 10.1016/j.ajic.2015.10.006 · DOI
  60. Polyzos, 2015, Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis, Europace., 17, 767, 10.1093/europace/euv053 · DOI
  61. Prutkin, 2014, Rates of and factors associated with infection in 200 909 medicare implantable cardioverter-defibrillator implants: results from the national cardiovascular data registry, Circulation., 130, 1037, 10.1161/CIRCULATIONAHA.114.009081 · DOI
  62. Arnold, 2018, Cardiovascular implantable electronic device infections, Infect Dis Clin North Am., 32, 811, 10.1016/j.idc.2018.06.004 · DOI
  63. Da Costa, 1998, Role of the preaxillary flora in pacemaker infections: a prospective study, Circulation., 97, 1791, 10.1161/01.CIR.97.18.1791 · DOI
  64. Özcan, 2017, Infective endocarditis and risk of death after cardiac implantable electronic device implantation: a nationwide cohort study, Europace., 19, 1007, 10.1093/europace/euw404 · DOI
  65. Korantzopoulos, 2016, Infection control in implantation of cardiac implantable electronic devices: current evidence, controversial points, and unresolved issues, Europace., 18, 473, 10.1093/europace/euv260 · DOI
  66. Le, 2011, Clinical predictors of cardiovascular implantable electronic device-related infective endocarditis, Pacing Clin Electrophysiol., 34, 450, 10.1111/j.1540-8159.2010.02991.x · DOI
  67. Baddour, 2010, Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the american heart association, Circulation., 121, 458, 10.1161/CIRCULATIONAHA.109.192665 · DOI · Paper page
  68. Lekkerkerker, 2009, Risk factors and time delay associated with cardiac device infections: leiden device registry, Heart., 95, 715, 10.1136/hrt.2008.151985 · DOI
  69. Romeyer-Bouchard, 2010, Prevalence and risk factors related to infections of cardiac resynchronization therapy devices, Eur Heart J., 31, 203, 10.1093/eurheartj/ehp421 · DOI
  70. Lloyd, 2015, Competition for space during bacterial colonization of a surface, J R Soc Interface., 12, 0608, 10.1098/rsif.2015.0608 · DOI
  71. Kondo, 2016, New horizon for infection prevention technology and implantable device, J Arrhythm., 32, 297, 10.1016/j.joa.2016.02.007 · DOI
  72. Lau, 2018, Leads and electrodes for cardiac implantable electronic devices
  73. Swerdlow, 2016, Implantable cardiac defibrillator lead failure and management, J Am Coll Cardiol., 67, 1358, 10.1016/j.jacc.2015.12.067 · DOI
  74. Birnie, 2012, Clinical predictors of fidelis lead failure: report from the canadian heart rhythm society device committee, Circulation., 125, 1217, 10.1161/CIRCULATIONAHA.111.053744 · DOI
  75. Zeitler, 2015, Cable externalization and electrical failure of the riata family of implantable cardioverter-defibrillator leads: a systematic review and meta-analysis, Heart Rhythm., 12, 1233, 10.1016/j.hrthm.2015.03.005 · DOI
  76. Goyal, 2015, Randomized assessment of rapid endovascular treatment of ischemic stroke, N Engl J Med., 372, 1019, 10.1056/NEJMoa1414905 · DOI
  77. Martínez-Galdámez, 2019, Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up, J Neurointerv Surg., 11, 396, 10.1136/neurintsurg-2018-014204 · DOI
  78. Kawamata, 1996, Morphometric anatomy of superficial cerebral veins and cerebral sulci, Showa Univ J Med Sci., 8, 103, 10.15369/sujms1989.8.103 · DOI
  79. Bousser, 2007, Cerebral venous thrombosis: an update, Lancet Neurol., 6, 162, 10.1016/S1474-4422(07)70029-7 · DOI

Metadata

Authors
Raza, S. A., Opie, N. L., Morokoff, A., Sharma, R. P., Mitchell, P. J., & Oxley, T. J.
Affiliations
  • The Royal Melbourne Hospital (AU)
  • The University of Melbourne (AU)
  • Stanford Health Care (US)
Corresponding author
Raza, Samad A.
Venue
Frontiers in Neurology
Published
2020-04-24
Volume
11
Pages
351-351
ISSN
1664-2295 (ISSN-L)
OpenAlex
W3020541237
Cited by
29
References
81
Citations by year
2026: 7 · 2025: 5 · 2024: 4 · 2023: 6 · 2022: 4 · 2021: 3
FWCI
0.45
Type
journal article
Language
en
Open access
Locations
  • Frontiers in Neurology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Minerva Access (University of Melbourne) (submittedVersion, cc-by)
Topics
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
  • Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
Keywords
neural interfaces, superior sagittal sinus, transvenous leads, device safety, long-term implantation, venous sinus stenting, idiopathic intracranial hypertension, implantable pacemaker, defibrillators

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review