Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy

ABSTRACT

Introduction

The Ovation ALTO is the next generation aortic stent graft from Endologix for the treatment of infra-renal abdominal aortic aneurysms. The device uses polymer-injected rings to create a proximal seal at the aneurysm neck.

Areas Covered

Results from the first clinical study of the ALTO graft are analyzed and the potential benefits of the graft in minimizing post-treatment aneurysmal neck dilation discussed. The implications of the ALTO’s Instructions-For-Use (IFU) and low-profile delivery system are also reviewed.

Expert Opinion

The re-positioning of the sealing rings higher on the graft and an integrated compliant balloon are the most significant improvements on the Ovation iX, facilitating accurate placement of the proximal sealing ring and prompt balloon dilation of the polymer rings. The expansion the IFU to include neck lengths of ≥7 mm will mean more patients are eligible for infra-renal EVAR within IFU with the ALTO device. The published data on the device to date is limited. With over 1000 implants worldwide we would hope for more published data to become available. If this demonstrates similar mid-term results to that seen with the Ovation iX in arguably more hostile neck anatomy, then the Ovation ALTO is likely to be more widely used.

KEYWORDS:

• Abdominal aortic aneurysm
• ALTO
• aortic neck
• endovascular
• EVAR
• Ovation
• stent graft

Funding

This paper was not funded.

Article highlights

• The Ovation ALTO represents a next generation endograft from Endologix, utilising polymer-injected Customseal^TM technology to provide a proximal seal between the endograft and the aneurysm neck. The sealing rings of the ALTO stent graft have the ability to conform to the aneurysm neck and exert minimal radial force in contrast to other self-expanding stent grafts currently available on the market.

• The sealing rings have been placed higher on the ALTO graft, with the midportion of the first sealing ring at 7mm compared to the Ovation iX where it is at 13mm. ALTO therefore offers an endovascular treatment option in patients with infra-renal aortic aneurysms with a neck length as short as 7mm. The device maintains the low-profile system associated with the Ovation iX graft. The ALTO therefore has the potential to increase the number of patients who are eligible for on-label infra-renal EVAR treatment.

• The ALTO graft may confer further benefits for female patients, who have more challenging anatomy when compared with male patients, as demonstrated in the data from the LUCY study examining the Ovation iX 43].

• Limited initial data suggests high technical success and encouraging short term results. We await long term data. Longer-term data is available for the Ovation iX graft which demonstrates favourable mid-term durability at 5 years, but we cannot presume that these favourable results will also be seen with the ALTO graft.

• Cases of polymer leak and anaphylactic reaction were reported with the Ovation iX graft. Endologix have undertaken rigorous testing of both grafts which has led to modification of the polymer rings with the next generation ALTO device. No cases of polymer leak have been reported for the 1,000+ cases performed to date.

• This paper reviews the current state of the market and provides an overview of the device, as well as an opinion on the ALTO’s potential.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.