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Clinical Neuroradiology
Published in: Clinical Neuroradiology 4/2016

01-12-2016 | Editorial

Intracranial Stenting in Germany

The Reimbursement Decision has been made, but the Scientific Debate Continues

Author: Bernd Eckert

Published in: Clinical Neuroradiology | Issue 4/2016

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Excerpt

The results of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) [1] and the Vitesse Stent Ischemic Therapy trial (VISSIT) [2] have changed the current clinical and reimbursement practice in the endovascular treatment of intracranial atherosclerotic disease (ICAD) for stroke prevention. After the initial clinical alert, due to the termination of the SAMMPRIS trial on 11 April 2011 the National Institute of Neurological Disorders and Stroke (NINDS) restricted reimbursement of intracranial stenting with the Wingspan stent to patients:
  • between 22 and 80 years of age,
  • who have had two or more strokes despite aggressive medical treatment, if the most recent stroke occurred more than 7 days prior to a planned Wingspan treatment,
  • who have a stenosis >70% and have shown a recovery from previous stroke (modified Rankin scale [mRS] ≤ 3).
  • Furthermore, the Wingspan Stent System should not be used for the treatment of transient ischemic attacks (TIA).
…
Literature
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Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ. Stenting and aggressive medical management for preventing recurrent stroke in Intracranial stenosis trial investigators. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014;383(9914):333–41.CrossRefPubMed
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Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Megerian JT, Lesko J, Pitzer P, Ramos J, Castonguay AC, Barnwell S, Smith WS, Gress DR, VISSIT Trial Investigators. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 2015;313(12):1240–8.CrossRefPubMed
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FDA. Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement. March 23. Silver Spring: FDA; 2012.
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Makin SD, Doubal FN, Dennis MS, Wardlaw JM, Makin SD, Doubal FN, Dennis MS, Wardlaw JM. Clinically confirmed stroke with negative diffusion-weighted imaging magnetic resonance imaging: longitudinal study of clinical outcomes, stroke recurrence, and systematic review. Stroke. 2015;46(11):3142–8.CrossRefPubMedPubMedCentral
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Maier IL, Karch A, Lipke C, Behme D, Mpotsaris A, Kabbasch C, Liebig T, Faymonville A, Reich A, Nikoubashman O, Buhk JH, von Schoenfeld P, Weber W, Mikolajczyk RT, Bähr M, Knauth M, Kallenberg K, Liman J. Transluminal angioplasty and stenting versus conservative treatment in patients with symptomatic basilar artery stenosis: Perspective for future clinical trials. Clin Neuroradiol. 2016; doi:10.​1007/​s00062-016-0528-x.PubMed
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IQWiG. Stents zur Behandlung intrakranieller arterieller Stenosen – Rapid Report. 2014, p N14–01.
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Gao HH, Gao LB. Stent implantation combined with drug therapy versus pure drug therapy for symptomatic severe stenosis of middle cerebral artery: a randomized and comparative study. J Interv Radiol (China). 2013;22(2):89–92.
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Fiehler J. Evidenzbasierte Medizin in der interventionellen Neuroradiologie. Clin Neuroradiol. 2015;25(Suppl 2):103–8.CrossRefPubMed
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Möhlenbruch MA, Pfaff J, Herweh C, Bösel J, Rizos T, Nagel S, Ringleb PA, Bendszus M, Pham M. One-pass endovascular treatment of intracranial atherosclerotic stenosis with a novel PTA balloon and self-expanding microstent. Neuroradiology. 2016;58(9):893–9.CrossRefPubMed
Metadata
Title
Intracranial Stenting in Germany
The Reimbursement Decision has been made, but the Scientific Debate Continues
Author
Bernd Eckert
Publication date
01-12-2016
Publisher
Springer Berlin Heidelberg
Published in
Clinical Neuroradiology / Issue 4/2016
Print ISSN: 1869-1439
Electronic ISSN: 1869-1447
DOI
https://doi.org/10.1007/s00062-016-0550-z

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