In late January 2019, the network of European HTA agencies, EUnetHTA, announced the ultimate project plan of the project OTCA20 “Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR).”
This project is being executed by the Spanish HTA body (institute Carlos III), with the co-author Slovenian Ministry of Health. The dedicated reviewers are the Italian “Sacred Heart University (Cattolica)” and the Swiss Network for Health Technology Assessment (SNHTA).
There are multiple research questions:
- To assess if the primary use of endoanchoring systems in patients with EVAR/TEVAR with high risk for endoleak type I or migration is more effective and safer (or at least as safe) than primary endovascular aortic aneurysm repair without the use of endoanchoring system
- To assess if the secondary use of endoanchoring systems (to treat complications in patients with primary EVAR/TEVAR) is more effective and safer (or at least as safe) than other endovascular aortic aneurysm repair methods without the use of anchoring system (other endovascular treatments to treat endoleaks or endograft migration) or open surgical repair
This topic is of relevance for the Spanish common services portfolio of the National Health System. The use of EVAR/TEVAR with external anchor systems in aortic aneurysm patients is increasing, and there are few systematic reviews or HTA reports about the efficacy and safety of this procedure for anchoring endografts in EVAR/TEVAR. Although this endovascular device is used in some Hospitals included in “EVAR/TEVAR procedures,” this technique is not yet in the Spanish common services portfolio of the National Health System.
The HTA Core Model Application for Rapid Relative Effectiveness Assessments (REA, v 4.2) will be followed for the selection of assessment elements. A systematic literature search will be performed for effectiveness and safety domains. The strength of evidence for all critical outcomes will be rated according to GRADE methodology. The Risk of bias (RoB) assessment of the included studies will be done according to the Cochrane Risk of bias tool on study and outcome level.
The device assessed are Aptus™ Heli-FX™ & Heli-FX™ Thoracic EndoAnchor™ Systems by Medtronic.
The final version of this rapid assessment is expected to be published at the beginning of July 2019.
See the whole plan in English here.
EUnetHTA also published the experts’ and manufacturer’s (Medtronic’s) comments, which can be found here.
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