Proximal Abdominal EVT Supplement
Proximal Abdominal EVT Supplement
Proximal Abdominal EVT Supplement
Proximal Abdominal
Aortic Aneurysm Necks
The clinical issues and challenges that this anatomy poses for endovascular graft design.
Thrombus and Calcification and ≤ 10 mm. The rate of type IA endoleaks was signifi-
Most IFUs recommend against EVAR in the setting of cantly greater for patients with neck lengths ≤ 10 mm
significant neck thrombus and calcification. There have (11%). At follow-up, freedom from type I endoleak was
been few direct assessments of the durability of stent 97% in those with > 15 mm necks, but only 90% in those
grafts in these settings. One difficulty in analyzing this with 11- to 15-mm necks, and 89% in those with ≤ 10-mm
morphologic feature is the lack of a universally agreed- necks. No differences were observed with respect to
upon method of quantifying the degree of calcification device migration, late conversion, aneurysm rupture,
and thrombus within the proximal neck. Bastos and col- or secondary intervention. Some of the current devices
leagues directly assessed outcomes related to the pres- have adjusted their IFUs to include treatment of short-
ence of neck thrombus and demonstrated that its pres- er-necked aneurysms.
ence (in ≥ 50% of neck circumference) was associated
with endograft migration of > 10 mm (9.3% vs 2.3%) on Neck Diameter and Dilation
univariate analysis.4 Cox multivariate analysis, however, Analysis of the EUROSTAR database by Leurs et al
identified the lack of an active fixation system as the demonstrates that 32% of patients experience neck dila-
only significant factor for device migration, although tion following EVAR, with approximately 10% of these
nearly 20% of patients with neck thrombus in this series having migration associated with dilation.17 In this analy-
experienced device migration of at least 5 mm. This may sis, risk factors for neck dilation included larger device
become a significant factor, as shorter proximal necks are main body diameter and graft oversizing by at least
thought to be permissible. 20%, whereas less frequent neck dilation was observed
Wyss et al demonstrated that the presence of neck with larger baseline neck diameters and the absence of a
thrombus may have a protective effect against the devel- suprarenal bare stent. In contrast, Cao et al reported aor-
opment of long-term complications following EVAR, tic neck dilation after EVAR was associated with neck cir-
whereas the presence of calcification, particularly when cumferential thrombus, large preoperative aortic necks,
associated with neck angulation, was associated with the and large AAA diameters.18 Post-EVAR neck dilation has
development of complications.5 However, the adverse been observed at rates as high as 63% in patients who
role of neck calcification has been disputed,11 with aneu- have thrombus-lined proximal necks.4 Neck dilation,
rysm sac regression occurring in the presence of less especially in cases of thrombus-lined or large necks, may
severe aortic neck calcification.12 be representative of underrecognized diseases and dila-
tion secondary to disease progression. This process does
Angulation not occur quickly, which may explain why problems with
Proximal neck angulation has been extensively studied stent graft fixation and sealing may not become appar-
and found to be a significant factor affecting the success ent for several years after the initial EVAR procedure.19,20
of EVAR. Grisafi et al demonstrated that the presence
of an infrarenal neck angle > 45° was associated with a Hostile Neck
significantly increased risk of initial type IA endoleak.11 Specific analysis of individual factors is difficult given that
Neck angulation can be lessened, however, with device most patients without an ideal neck have multiple morpho-
placement. After successful EVAR, the degree of both logic features that create a “hostile” neck. In a single-center
suprarenal and infrarenal neck angulation decreases, with series of 552 patients, Stather and colleagues demonstrated
the angles continuing to “straighten” for up to 3 years that the presence of hostile neck anatomy (defined as diam-
postoperatively,13 which may be independent of the type eter > 28 mm, angulation > 60°, length < 15 mm, and neck
of device used.14 flare and thrombus) was not associated with alterations in
technical success, 30-day mortality, 30-day type IA endoleak
Neck Length development, or 30-day reintervention rates.21 Outcomes
Experimental modeling of proximal fixation strength after 30 days, however, demonstrate an increased rate of
in the aortic neck demonstrates that, among a variety type I endoleaks (9.5% vs 4.5%; P = .02) in those with hostile
of graft designs, pull-out forces significantly vary, and necks, but no differences with regard to device migra-
these pull-out forces can be lowered by shortening the tion, sac expansion, aneurysm rupture, or 5-year mortality.
length of the proximal seal, likely directly related to graft Patients with hostile necks, however, required significantly
design.15 Data from the EUROSTAR registry were used to more reinterventions (23% vs 11%; P < .01), as a result of the
assess outcomes for patients with short infrarenal necks.16 need to treat type IA endoleaks.
Patients were categorized into one of three groups Binary logistic regression showed that reinterventions,
according to the neck length: > 15 mm, 11 to 15 mm, technical failure, and late type I endoleak development
Figure 3. Multistage, controlled delivery of an endovascular graft is accomplished with multiple constraints. Retraction of the
delivery sheath demonstrates proximal constraints (bare stent inside cap) (A) and a distal constraining wire (B).
wise occluded) by implantation or bypass procedures. ment accuracy of the endovascular graft system has a
As such, the alternative endovascular strategy is also to significant effect on the success of the repair, specifically
move more proximal into the visceral aorta for better the ability to attain adequate proximal seal. Consider
seal and attachment in healthy vessels. Again mimick- the AAA with a 15-mm-long proximal neck. If deploy-
ing the surgical approach, endovascular devices were ment accuracy can only be expected to be within 5 mm,
developed, beginning as early as 1997, with the intent to the resulting seal zone may only be 10 mm in length, or
place the sealing component above the renal arteries and worse yet, a renal artery may be covered.
supply flow to the renal and the mesenteric vessels with Deployment accuracy is most critical when the neck
fenestrations and/or side branches.31 Continued develop- available for seal is complicated with a short length,
ment of devices targeted toward a more proximal seal angulation, calcification, and/or thrombus. Multistaged,
continues today.32-34 controlled delivery facilitates accurate placement of the
Similar to open repair, the primary design objective endograft,36,37 which in turn can maximize the amount
of AAA endovascular grafts is simply to prevent aneu- of healthy aorta available for seal (Figure 3). However, it
rysm rupture and subsequent patient death. However, is important to note that specific aortic features (eg, a
durable exclusion of the aneurysm sac from hemody- short neck, angulation, calcification, and/or thrombus)
namic pressure requires that several interrelated design that require a precise landing zone may also make accu-
functions and specific performance goals be achieved rate endograft placement more difficult and result in an
to meet this primary design objective. First, the endo- increased number of procedural complications.38
vascular graft delivery system must have the ability to
accurately deploy the graft in its intended location. Radial Force and Proximal Seal
Once placed in its intended landing site, the endovas- Once placed in a stable position, the endovascular
cular graft must provide a proximal seal and prevent graft must inhibit blood from leaking around the proxi-
its migration. Most importantly, the graft must provide mal seal (type IA endoleaks). Stents at the proximal
these functions for the life of the patient; structural end of the graft must exert adequate radial force, or
durability of the device is paramount. Herein is a dis- sealing pressure, to keep the graft against the aortic
cussion of these fundamental design features and the wall throughout the cardiac cycle and potentially other
performance criteria required to achieve these design biomechanical motions to prevent type I endoleaks.
functions. The radial force produced by stents varies based on the
extent of oversizing, and thus proper oversizing is criti-
Deployment Accuracy cal in maintaining a seal in the short- and long-term.
Achieving reliable and accurate deployment is criti- Endovascular grafts are designed and tested to maintain
cal to the long-term success of the repair. Failure of the adequate radial pressure over a specified range of over-
endovascular graft to deploy and subsequent need for sizing. These oversizing recommendations are explicitly
conversion to open repair puts the patient at high risk. defined in the IFU, and oversizing outside these bounds
Buth et al reported a perioperative mortality rate of risks complications such as endoleaks,39 continued
22% for patients who were converted to open repair aneurysm growth and/or migration,40 or endovascular
in the EUROSTAR study.35 Although the majority of graft collapse.41
the deployment failures in this study were related to The mechanical properties and long-term stability of
early device designs, they underscore the importance of the aorta in the seal zone must also be considered in
deployment reliability. In addition to reliability, deploy- selecting an appropriate seal, so that the proximal endo-
A B
Migration Resistance
In order to maintain a durable seal and exclude the
aneurysm for the life of the patient, the endovascular
graft must maintain its position relative to the aorta.
Figure 4. An endovascular graft incorporating fenestrations Endograft migration can lead to late failure of the repair,
and scallops to accommodate visceral vessels and allow seal- specifically, type I endoleak, aneurysm rupture, and
ing in the suprarenal aorta (A). Alternative designs incorpo- death. Endovascular grafts are subject to a hemodynami-
rate features such as pivoting fenestrations to allow for vari- cally challenging environment in which they must resist
ability in visceral vessel location (B). the physiologic forces associated with blood flow. Fluid
mechanics analyses show that bifurcated aortic endovas-
vascular graft design can take advantage of that sealing cular grafts are subject to cyclic forces on the order of 10 N,
zone. As previously stated, short-length seal zones, large acting to displace the graft in a caudal direction for the
neck diameters, significant angulation, the presence of life of the patient.28 As previously described, many means
thrombus, and calcification may increase the risks for of fixation have been utilized in commercially available
type I endoleaks and sac expansion. These increased risks endovascular grafts, including columnar strength, iliac fix-
may not be a result of limitations in endograft design, ation, bare stents, and active fixation (eg, hooks or barbs)
but rather limitations in the durability of aortic seal zones (Figure 2). Nonclinical studies comparing grafts with and
with these features. without active fixation have demonstrated that endo-
Architects and civil engineers have understood for vascular grafts with active fixation have higher migration
thousands of years that there are specific requirements resistance (ie, force required to displace them from the
for designing foundations so that a structure is stable aorta) than those without active fixation.42-44 These find-
and durable for centuries to come. These requirements ings have been supported by lower migration rates of
have less to do with the structural design capabilities of devices with active suprarenal fixation in clinical use.40,45-48
concrete, steel, or wood, but the ability of the earth to
be stable under the weight of a building. We are only just Fatigue Durability
beginning to understand these tradeoffs for endovascu- Finally, the endovascular graft must be durable in
lar grafts, especially in terms of how the seal zone of an order to maintain its function for the life of the patient.
endovascular graft interacts with a hostile neck. Rather Endovascular grafts must be evaluated in all modes where
than pushing the limits of infrarenal EVAR into a less- cyclic (fatigue) loads are expected. Primary cyclic loads are
than-adequate seal zone, branched and fenestrated endo- a result of pulsatile blood flow. However, the mechani-
vascular grafts were developed to take advantage of the cal loads and arterial motions from other sources, such
additional suprarenal aortic segment, effectively increas- as respiration or other bodily motions, also need to be
ing the amount of sealing zone available (Figure 4).31 considered. The aggregate effects of these loads on all
components of the endovascular graft (eg, stents, graft, conditions for endovascular aortic aneurysm repair. J Vasc Surg. 2011;54:300-306.
10. Fairman RM, Velazquez OC, Carpenter JP, et al. Midterm pivotal trial results of the Talent low profile system for repair of
sutures, etc.) need to be thoroughly evaluated. Clinical abdominal aortic aneurysm: analysis of complicated versus uncomplicated aortic necks. J Vasc Surg. 2004;40:1074-1082.
use of early endovascular grafts has elucidated many 11. Grisafi JL, Rahbar R, Nelms J, et al. Challenging neck anatomy is associated with need for intraoperative endovascular
adjuncts during endovascular aortic aneurysm repair (EVAR). Ann Vasc Surg. 2011;25:729-734.
potential failure modes. These failures provided the 12. Kaladji A, Cardon A, Abouliatim I, et al. Preoperative predictive factors of aneurysmal regression using the reporting
standards for endovascular aortic aneurysm repair. J Vasc Surg. 2012;55:1287-1295.
opportunity to develop new graft designs and, in parallel, 13. van Keulen JW, Moll FL, Arts J, et al. Aortic neck angulations decrease during and after endovascular aneurysm repair. J
new test methods to evaluate for potential failure modes. Endovasc Ther. 2010;17:594-598.
14. Hoshina K, Akai T, Takayama T, et al. Outcomes and morphologic changes after endovascular repair for abdominal aortic
The result is mature testing equipment (Figure 5) and aneurysms with severely angulated neck: a device specific analysis. Circ J. 2013;77:1996-2002.
standards for endovascular testing.49 Standards typically 15. Bosman WM, Steenhoven TJ, Suarez DR, et al. The proximal fixation strength of modern EVAR grafts in a short aneurysm
neck. An in vitro study. Eur J Vasc Endovasc Surg. 2010;39:187-192.
require testing to be completed for a 10-year equivalent 16. Leurs LJ, Kievit J, Dagnelie PC, et al. Influence of infrarenal neck length on outcome of endovascular abdominal aortic
of 400 million cycles. aneurysm repair. J Endovasc Ther. 2006;13:640-648.
17. Leurs LJ, Stultiens G, Kievit J, et al. Adverse events at the aneurysmal neck identified at follow-up after endovascular
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SUMMARY 18. Cao P, Verzini F, Parlani G, et al. Predictive factors and clinical consequences of proximal aortic neck dilatation in 230
patients undergoing abdominal aorta aneurysm repair with self-expandable stent-grafts. J Vasc Surg. 2003;37:1200-1205.
The key challenges in achieving a stable and durable 19. Verhoeven BA, Waasdorp EJ, Gorrepati ML, et al. Long-term results of Talent endografts for endovascular abdominal
proximal seal in EVAR include inadequate length of aortic aneurysm repair. J Vasc Surg. 2011;53:293-298.
20. Espinosa G, Ribeiro Alves M, Ferreira Caramalho M, et al. A 10-year single-center prospective study of endovascular
healthy aorta for sealing, large neck diameters, and the abdominal aortic aneurysm repair with the talent stent-graft. J Endovasc Ther. 2009;16:125-135.
presence of thrombus or calcification. These challenges 21. Stather PW, Sayers RD, Cheah A, et al. Outcomes of endovascular aneurysm repair in patients with hostile neck
anatomy. Eur J Vasc Endovasc Surg. 2012;44:556-561.
have become increasingly critical as EVAR is dissemi- 22. Lee JT, Ullery BW, Zarins CK, et al. EVAR deployment in anatomically challenging necks outside the IFU. Eur J Vasc
nated to more patients, especially those whose proximal Endovasc Surg. 2013;46:65-73.
23. Bachoo P, Verhoeven ELG, Larzon T. Early outcome of endovascular aneurysm repair in challenging aortic neck morphol-
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26. Stather PW, Wild JB, Sayers RD, et al. Endovascular aortic aneurysm repair in patients with hostile neck anatomy. J
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Although advancements in endovascular graft design 27. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann
Vasc Surg. 1991;5:491-499.
continue to push the indications for EVAR, it remains 28. Liffman K, Lawrence-Brown MM, Semmens JB, et al. Analytical modeling and numerical simulation of forces in an
endoluminal graft. J Endovasc Ther. 2001;8:358-371.
clear that healthy aorta is required for adequate fixation 29. Karthikesalingam A, Cobb RJ, Khoury A, et al. The morphological applicability of a novel Endovascular Aneurysm Sealing
of the endograft to prevent migration and to maintain a (EVAS) System (Nellix) in patients with abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2013;46:440-445.
30. Mehta M, Valdés FE, Nolte T et al. One-year outcomes from an international study of the Ovation abdominal stent graft
durable seal without endoleaks. n system for endovascular aneurysm repair. J Vasc Surg. 2014;59:65-73.
31. Park JH, Chung JW, Choo IW, et al. Fenestrated stent-grafts for preserving visceral arterial branches in the treatment of
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David Hartley, FIR, is a Fellow of the (Australian) 32. Greenberg RK, Sternbergh WC, Makaroun M, et al. Intermediate results of a United States multicenter trial of fenestrated
Institute of Radiography and a consultant to Cook Medical endograft repair for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2009;50:730-737.
33. Quiñones-Baldrich WJ, Holden A, Mertens R, et al. Prospective, multicenter experience with the Ventana fenestrated
in Perth, Western Australia. system for juxtarenal and pararenal aortic aneurysm endovascular repair. J Vasc Surg. 2013;58:1-9.
Matthew Eagleton, MD, is with the Department of 34. Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-Branch standard fenestrated endovascular graft for
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Vascular Surgery at the Cleveland Clinic in Cleveland, 35. Buth J, Laheij RJF; on behalf of the EUROSTAR Collaborators. Early complications and endoleaks after endovascular
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36. Chuter TA. The choice of stent-graft for endovascular repair of abdominal aortic aneurysm. J Cardiovasc Surg.
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38. Hovsepian DM, Hein AN, Pilgram TK, et al. Endovascular abdominal aortic aneurysm repair in 144 patients: correlation of
Blayne Roeder, PhD, is Director of Product Development, aneurysm size, proximal aortic neck length, and procedure-related complications. J Vasc Interv Radiol. 2001;12:1373-1382.
Aortic Intervention at Cook Medical in Bloomington, Indiana. 39. Mohan IV, Laheij RJ, Harris PL; on behalf of the EUROSTAR Collaborators. Risk factors for endoleak and the evidence for
stent-graft oversizing in patients undergoing endovascular aneurysm repair. Eur J Vasc Endovasc Surg. 2001;21:344-349.
40. Sternbergh WC, Money SR, Greenberg RK, et al; for the Zenith Investigators. Influence of endograft oversizing on device migra-
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