Heli-FX™ EndoAnchor™ in endovascular aneurysm repair of abdominal and thoracic aorta: Italian regional report available

Introduction
The abdominal aorta is the most common site of aneurysms with an estimated prevalence of about 5-7% of the population over the age of 60 (in the USA). The annual incidence of new diagnoses is about 0.4-0.67% in Western populations. Data referred to the thoracic aorta are limited since the condition is asymptomatic: some studies report prevalence ranging from 0.16% to 0.34% and incidence estimates between 5.6 and 10.4 cases/100,000 patients per year.

The Heli-FX™ EndoAnchor™ system is manufactured by Medtronic and proposed for those patients that, due to specific anatomical characteristics, may experience issues with the optimal positioning of the endograft, endoleak, and graft migration.

The system consists of metallic helical anchors (EndoAnchor™) that are inserted into the aortic wall with an applicator (Heli-FX™ applier) introduced through a guide catheter (Heli-FX™ guide). The average unit price for the Heli-FX™ EndoAnchor™ system in Italy (during 2016–2017) was between 5,238 and 7,729 EUR for EVAR and 5,929 EUR for TEVAR. The authors estimated that, in Emilia-Romagna, the maximum number of patients eligible to use this system would be 140 per year (110 for EVAR and 30 for TEVAR).

Methods
The assessment was developed around the following elements:

• Population: patients with difficult anatomy undergoing to EVAR/TEVAR for the first time or patients already treated with EVAR/TEVAR who have experienced endoleak and/or endograft migration;
• Intervention: EVAR/TEVAR performed with the Heli-FX™ EndoAnchor™ system;
• Comparator: standard EVAR/TEVAR;
• Outcomes: Effectiveness: rate of patients free from endoleak and/or endograft migration, rate of re-interventions related to treatment of the aneurysm, cause-specific mortality;
  Safety: adverse events related to the device (e.g. rupture, displacement, non-insertion), adverse events related to the procedure, procedural mortality, peri-procedural mortality, other adverse events; Technical performance: success of the procedure (rate of patients in which the device is correctly implanted), total procedural time, fluoroscopy time, deployment time.
• Time of follow-up: ≥ 12 months;
• Study design: Secondary studies (HTA reports and systematic reviews); Primary studies (RCTs and controlled observational studies with ≥ 10 patients; case reports, case series with < 10 patients and data from device surveillance databases considered only for safety outcomes).

Results
Sixteen studies were included for effectiveness evaluation and a case report was included only for safety assessment. The studies enrolled a total of 2,359 patients, including 2,204 (93.4%) with abdominal aortic aneurysm (14/16 studies). However, the vast majority was a series of uncontrolled cases, some of which published only as conference abstracts. The only case-control study available was based on the analysis of 229 patients enrolled in the ANCHOR register (NCT01534819). The study compared 99 propensity-matched pairs and found no differences in terms of endoleak and graft migration. No ongoing RCTs or other controlled studies were identified.

See the full report in Italian here.

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