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Further…the future ain’t what it used to be.

April 6, 2007

Fixation dilemma: stretched and extended or hooked on barbs

Are the mechanical properties of stent­grafts really designed for

permanent AAA repair? What design features might minimize stent­graft
migration? Why can the migration in dilating aortic necks not be
prevented? What are the consequences of aortic neck enlargement and
the loss of friction seal in regards to stent­graft device integrity?

Some representatives of the stent­graft industry recently hypothesized that

recent designs with columnar strength, and modular extension of stent­
grafts to the iliac­hypogastric bifurcation might slow down migration;
however there seems to be little evidence in the literature in support of
such a statement. Many stent­grafts design alterations have been
unsuccessfully applied to deal with the migration and loss of seal issues.
Neither the addition of barbs and/or hooks to the proximal stent­graft nor
the over expansion of the stent­graft in the neck of the aneurysm has
eliminated or significantly decreased the displacement leading to
migration.

Picture: examples of proximal design characteristics of stent­grafts: (A) was taken of the market, (B)
relies on hooks and radial expansion, (C) relies on radial extension, (D) not available in the USA,
also relying on radial extension.
So what exactly does not work with the current design of stent­grafts? In
current designs the pressure mode of fixation to the aortic wall can be
divided into active and passive fixation devices. The active fixation is
defined by using barbs or hooks for attachment to the aortic wall. Passive
fixation stent­grafts use only radial force for attachment. It is obvious that
passive fixation devices are even more prone to distal migration than
active fixation devices. The reports on changes in aortic neck dilation
have been conflicting. It makes sense that excessive oversizing exposes
the aneurysm neck to pressure coming from the larger diameter stent­
graft. The constant pressure of the outward radial forces seems to exhaust
the elasticity of an already disease aortic and it may cause the neck of
an AAA to steadily enlarge. From that point on it is a matter of time when
the stent­graft outward extension approaches its maximal designed
diameter and ultimately a reduction in outward pressure sets in – the
stent­graft looses its grip and seal to the aortic wall.

The loss of friction forces and seal between stent­graft and aortic neck
seems to be a huge challenge for the durability of the device, especially
since not much is known about the underlying reasons for the natural
phenomenon of aneurysm neck dilation and lengthening. The result:
complications such as endograft migration, and separation of modular
stent­graft components. The consequence is a “secondary intervention” –
the AAA patient needs to undergo yet another procedure resulting from
the mismatch in compliancy between the stent­graft and the arterial wall.

Currently there are ongoing investigations about a number of different

endograft designs that vary in method of attachment, composition, and
modular component structure from the current stent­graft designs. In
simulations with dynamic fluid models a graft limb diameter equal to
approximately 0.7 of the main modular component at the bifurcation
proofed to be the least susceptible to migration. In addition, new graft
design and fixation methods with more prosthesis flexibility, has shown to
minimize the shear stress rates and therefore minimalizes the possibility of
distal migration.

This good news comes at a critical time for endovascular surgery. With
recent reports of mid­ to long­term failures of the current stent­graft design
many questions have been raised by patients and physicians alike
regarding stent­graft durability. The need for new fixation techniques and
new endograft design is striking.

K.T.

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