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EUnetHTA published an assessment of prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR)
In mid-November 2019, the report of the project OTCA20, titled “Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR)” was published on the website of the European Network for HTA (EUnetHTA).
The project was executed by the Spanish Health Technology Assessment Agency (AETS-ISCIII) together with the Catholic University of the Sacred Heart (UCSC Gemelli), Italy and Swiss Network for Health Technology Assessment (SNHTA).
The Heli-FX ™ EndoAnchor ™ system (Medtronic, Minneapolis, MN, USA) consists of the Heli-FX ™ applicator with the EndoAnchor ™ cassette and the Heli-FX ™ guide catheter with an obturator. The comparators consist of commercially available endografts including newly introduced ones (debranching, chimneys, fenestrations and branches).
Their use is indicated in patients whose anatomical features may predispose them to suboptimal positioning of the endoprosthesis and consequent endovascular losses (endoleaks) and/or migration of the endoprosthesis itself (unfavorable anatomy or hostile neck-related issues). The Heli-FX ™ EndoAnchor ™ can be used at the time of the initial positioning of the endoprosthesis or during subsequent procedures (i.e., a repair). The device has been proposed as an anchoring system in addition to the standard endoprostheses used in EVAR or TEVAR for abdominal, thoracoabdominal aortic aneurysm repair as a means of increasing adhesion and fixation of the vascular endoprosthesis to the aortic wall, recreating the durability of anastomosis sutures.
Reimbursement policies are variable throughout the EU. Whereas some countries have specific reimbursement for the device, other countries do not provide separate and/or distinct reimbursement plans for the Heli-FX ™ EndoAnchor ™ (covered as part of the procedure or a more general grouping).
The selection of assessment elements is based on the HTA Core Model Application for Rapid REA Assessments (4.2). For Effectiveness (EFF) and Safety (SAF) domains, we performed a systematic literature search in the following bibliographic databases: PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database for Systematic Reviews, according to a predefined search strategy. Furthermore, a search of the clinical trials registries ClinicalTrials.gov, EU Clinical Trials Registry and the International Clinical Trials Registry Platform (ICTRP) was carried out for those studies still ongoing. In addition to these electronic searches, a hand search (reference lists of the relevant studies), as well as an internet search, including HTA agency websites, was performed. Moreover, a search of regulatory documents was also carried out at the U.S. Food and Drug Administration (FDA) website
Results - clinical effectiveness:
- Mortality: one patient in the prophylaxis subgroup (4 studies, 392 patients) (1/392) (0.25%±0.32 weighted by sample size) died of aneurysm-related causes within 30 days. In the studies containing data on secondary interventions (2 studies, 88 patients), no deaths were attributed to the aneurysm. In the retrospective series, 2 patients of 51 died (3.9%, 1 study). For thoracic aneurysms, the aneurysm related mortality rate at 30 days was 2/54, 3.7% of the retrospective cohort (Ongstad SB et al., 2016). Aneurysm-related mortality at one year (abdominal aneurysm) was 0.26%±0.32 (1 patient from a sample of 379 prophylactic patients from 3 studies, weighted by sample size) (Deaton DH et al., 2009, Mehta M et al., 2014, Jordan Jr WD et al., 2015). No deaths related to aneurysm were recorded in cases requiring a secondary intervention (2 studies, 88 patients) (Avci M et al., 2012, De Vries JPPM et al., 2014). In the retrospective series, primary interventions (including prophylaxis, immediate type I endoleaks and maldeployment) in a series of 51 patients revealed a mortality rate of 5.88% (Goudeketting SR et al., 2019). Aneurysm-related mortality in thoracic aneurysm at one year was 9.3% (5 patients in a retrospective series of 54)
- Morbidity: the aneurysm rupture rate for thoracic aneurysms was 1.9% (1/54) in the only study available. Of the 392 patients included, 38 underwent a reintervention (9.7%±7), weighted according to sample size (Deaton DH et al., 2009, Perdikides T et al., 2012, Mehta M et al., 2014, Jordan Jr WD et al., 2015). A retrospective case series found that 25.5% of the patients needed a reintervention (13/51; these 13 patients required a total of 17 reinterventions) with a mean follow-up period of 23.9 months (IQR 13.4, 35.6 months) (Goudeketting SR et al., 2019). The reintervention rate for thoracic aneurysm, reported in a retrospective cohort study of 54 patients, was 16.7% (9/54). In the retrospective series, the rate of occurrence or recurrence of complications (abdominal aneurysm) was 17.64% (9/51), and for thoracic aneurysm 9.3% (5 of 54 patients from a retrospective study). The only study containing comparative data involving EVAR without Heli-FX ™ EndoAnchor ™ reported a recurrence of complications (abdominal aneurysms) with a rate of 2% in the intervention group and 4% in the control group, over 2 years, with no significant differences in the Kaplan-Meier analysis (Muhs BE et al., 2012)
- Safety: a weighted mean of 0.2% ± 0.13% (1/517) from five observational studies at 30 days after the EVAR procedure was determined (Deaton DH et al., 2009, Avci M et al., 2012, Perdikides T et al., 2012, De Vries JPPM et al., 2014, Mehta M et al., 2014). In the case of thoracic aneurysm repair, the procedure-related mortality rate at 30 days was 3.7% (2/54); this was based on one retrospective study of patients who had undergone a TEVAR procedure (Ongstad SB et al., 2016)
- The use of Heli-FX ™ EndoAnchor ™ in EVAR patients (prophylactically or as part of endograft migration or type I endoleak treatment) would be safe in the midterm follow-up for those presenting unfavorable neck anatomy and probably safe over long-term follow-up for those with friendly neck anatomies. However, comparative data on standard endovascular therapy is not currently available. Therefore any conclusions regarding the safety of Heli-FX ™ EndoAnchor ™ in TEVAR patients cannot be formed
- The information compiled on critical outcomes (rate of type I endoleaks or migration, rate of reintervention, rate of aneurysm rupture or rate of aneurysm-related mortality), although of very low quality, would suggest the effectiveness of the device. Nonetheless, evidence from high-quality comparative studies remains lacking. Results should be compared with treatment regimens without the Heli-FX ™ EndoAnchor™ system in randomized controlled trials for most of the critical and important outcomes
The full details in English can be found here.
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