Thrombectomy for patients with ischemic stroke

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Research area: High tech medicine

Duration: May 2015 – March 2016
Publication: Decision Support Document No. 95: https://eprints.aihta.at/1084/

Language: German and English

Background:

Acute ischemic stroke is a common and serious disease in which the blood supply to the brain is interrupted. Since in many cases the cause is an arterial occlusion induced by a blood clot, a promising treatment approach is dissolving the blood clot with medication. Intravenous (systemic) administration, as well as catheter-based (local) intra-arterial injection of lysing agents is currently in use at specialized centers (stroke units) shortly after stroke.

Stroke care has been in the center of attention lately, because in addition to the conventional lysis treatment, endovascular interventions (so-called. thrombectomies) with different technologies are increasingly being used. They are also used in acute care in a narrow time window, but are not suitable – just like the lysis - for every stroke patient and also require an interdisciplinary infrastructure. For the evidence-based provision of health services and for structural planning, it is important to have information about the effectiveness of endovascular interventions in different patient groups and about the structural needs.

Objective:

It is the objective of the project,

  • to report the status quo of the technical developments for the different thrombectomy-devices
  • to analyse infrastructure and process requirements as well as suitable patient groups (diagnostic criteria)  for thrombectomy (and/or thrombolysis)
  • to provide information (based on the EUnetHTA WP5b project) on the safety and efficacy of the different thrombectomy-devices

Research questions:

  1. Which trombectomy-devices are currently in use?
    Which of these devices are CE certified/ FDA approved? Which are the major product specific properties and differences? Furthermore are there any relevant consequences (for patients, infrastructure, the process, etc.) caused by product differences? What are the future developments in the field of thrombectomy technique?
  2. In which patients has the benefit of thrombectomy been tested during clinical trials? Which patients were excluded from clinical trials (possible contraindications)?
    Which objectified diagnostic criteria determined the indication for thrombectomy (and/or thrombolysis)? Which systemic requirements/settings for thrombectomy were defined in clinical trials?
  3. How effective and safe is thrombectomy compared to conventional interventions (systemic and local lysis, conservative treatment; specification of thePICO- questions according to EUnetHTA WP5b)?

Methods:

  • Scoping: contact with national and international members from the EUnetHTA thrombectomy expert team, the Austrian stroke association (ÖGSF), the ministry of health (BMG) – (medical quality management register), the association Gesundheit Österreich GmbH – (ischemic stroke register), and, if applicable, thrombectomy-device manufacturers
  • Selective (web-) search for CE certified/ FDA approved thrombectomy-devices. Data extraction based on the information provided by the manufacturers of
    thrombectomy systems, systemic requirements/ implications for practice, and patient populations. Search for future developments in thrombectomy-devices in the databases of the American/British Horizon Scanning programs
  • Data extraction of in-/exclusion criteria, characteristics of included patients and surrounding conditions from publications of thrombectomy studies
  • Preparing a national report based on EUnetHTA´s WP5b (06-12/2015) systemic review to the efficacy and safety of thrombectomy in ischemic stroke


Schedule / milestones:

05-06/2015:

  • Scoping
  • Searching for CE certified/ FDA approved thrombectomy-devices, data extraction of the information provided by the manufacturers, searching within the American/ British Horizon Scanning Systems

07-08/ 2015:

  • Data extraction of in-/exclusion criteria and patients´ characteristics (diagnostic criteria) from publications. if applicable, further manual search/ expert contacts for diagnostic criteria

07-10/2015:

  • Dedicated reviewer for the systemic review of EUnetHTA 

11-12/2015:

  • Preparing the national report based on the EUnetHTA REA review

References:

LBI-HTA: Mechanical percutaneous transluminal procedures for the removal of intracerebral blood clots in acute ischemic stroke. DSD 46, 2011. https://eprints.aihta.at/920

EUnetHTA: Thrombectomy – ongoing (start 06 - end 12/2015)

ESO. Consensus statement on mechanical thrombectomy in acute ischemic stroke – ESO-Karolinska Stroke Update 2014 in collaboration with ESMINT and ESNR, download:  http://2014.strokeupdate.org/consensus-statement-mechanical-thrombectomy-acute-ischemic-stroke