University of Groningen
Endovascular approaches to complex aortic aneurysms
de Niet, Arne
DOI:
10.33612/diss.111895510
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COMPLEX AORTIC ANEURYSMS
Arne de Niet
“Endovascular approaches to complex aortic aneurysms”
PhD thesis, University Medical Center Groningen, with a summary in Dutch
ISBN 978-94-034-2172-8
Copyright © A. de Niet, 2019 Groningen
All rights are reserved. No part of this book may be reproduced or transmitted in any form or by any means, without prior written permission of the author.
Cover design Annikki de Niet
Lay-out Arne de Niet
Printed by Ridderprint
This thesis was financially supported by Het Wetenschapsfonds Deventer Ziekenhuis, Vakgroep Chirurgie Deventer Ziekenhuis, Angiocare, Noord Negentig, GDM B.V., LeMaitre Vascular Inc., ABN AMRO.
Endovascular approaches to complex aortic
aneurysms
PhD Thesis
to obtain the degree of PhD at the University of Groningen
on the authority of the Rector Magnificus Prof. C. Wijmenga
and in accordance with the decision by the College of Deans. This thesis will be defended in public on
Wednesday 8 January at 12:45 hours
by
Arne de Niet
born on 6 March 1988Supervisors
Prof. C.J.A.M. Zeebregts Prof. M.M.P.J. Reijnen
Assessment committee
Prof. J.P.P.M de Vries Prof. L.J. Schultze Kool Prof. G.W.H. Schurink
Chapter 1 – General introduction 7 Chapter 2 – Mid- and long-term outcome of currently available endografts for the
treatment of infrarenal abdominal aortic aneurysm 19
Chapter 3 – Fenestrated endografts for complex abdominal aortic aneurysm repair 41 Chapter 4 – Outcome of fenestrated endovascular aneurysm repair in octogenarians; a
retrospective multicentre analysis 63
Chapter 5 – Endograft conformability in fenestrated endovascular aneurysm repair for
complex abdominal aortic aneurysm 79
Chapter 6 – The Fenestrated Anaconda™ for the treatment of complex abdominal aortic
aneurysm repair 97
Chapter 7 – Outcomes after treatment of complex aortic abdominal aneurysms with the
Fenestrated Anaconda™ endograft 111
Chapter 8 – Early results with the custom-made Fenestrated Anaconda aortic cuff in the
treatment of complex abdominal aortic aneurysm 135
Chapter 9 – Geometric changes over time in bridging stents after branched and
fenestrated endovascular repair for thoracoabdominal aneurysm 153
Chapter 10 – Summary and future perspectives 171 Chapter 11 – Dutch Summary Nederlandse samenvatting 183 Appendices 195
– Co-authors 197
– The Fenestrated Anaconda™ Study Group 198
– List of publications 200
– Acknowledgements 202 – About the author 209
CHAPTER
General
Ch
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1
An increased diameter of the abdominal aorta usually develops undetected. Once the abdominal aorta is aneurysmatic, the risk of rupture increases. A fast growing, saccular
shaped, mycotic, or large diameter aneurysm correlates with the risk of rupture.1-3 Rupture of
an abdominal aortic aneurysm (AAA) was observed on average in a Scandinavian population
in 6 per 100,000 persons, and once ruptured out of hospital death is around 85%.4 A small
amount of people reaches the hospital in time and if left untreated virtually all patients die from the ruptured AAA (rAAA). In treated rAAA cases, a 30-43% mortality risk still exists
in current practice.5,6 Most of these AAAs are found by chance during imaging for another
medical issue, but mortality risk once ruptured mandates active surveillance or planned surgical treatment of the intact AAA once discovered.
Possibly the first known description of a ‘tumor of the vessels’ dates back to 1550 BC in ancient Egypt, on the Ebers Papyrus. Although mostly regarded to pseudoaneurysms, it was the first
known description of aneurysmatic vascular disease.7 Almost two millennia later, in the 2nd
century AD, a more thorough description of an aortic aneurysm was recorded: ‘There are two kinds of aneurysms: in the first the artery is locally dilated, in the second the artery has
been torn and has disgorged blood into the surrounding flesh.’8 This description by Antyllus
was followed by a description of opening the aneurysm, evacuating its content, removing the dilation and tying both sides of the artery together. It was until 1817 when Sir Astley Cooper described the treatment of an iliac artery rupture by ligating the aorta. The acute bleeding was treated, but the patient died 48 hours post-operatively. In this case the active problem was probably treated, but the patient did not seem to benefit.
AAA treatment similar like we currently know it was founded by Dr. Rudolph Matas in 1888
by describing the concept of endoaneurysmorrhaphy.7,9 The aneurysm was opened, clamping
was done by ‘pressure over the exposed artery by the finger of an assistant’ and the aortic wall was folded and sutured to the abdominal wall to treat the aneurysm while preserving aortic
lumen (Figure 1).10 This technique seemed more successful, because his patient survived 18
months finally succumbing of pulmonary tuberculosis. The aorta, however, still consisted of
a weakened aneurysmatic wall.7 The use of a foreign body for the treatment of an AAA was
introduced in the 1940s, and the most famous case was the use of cellophane wrapped within the aorta of Albert Einstein. After treatment he survived another five years, ultimately dying
from a rAAA.11 It was questionable if the wrapping prolonged survival, and in the early 1950s,
Dr Charles Dubost described the first procedure as we still perform it today. Through an open left thoraco-abdominal approach, the abdominal aorta was resected and a human aortic graft
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was implanted (Figure 2).12
Since then the open abdominal surgical procedure has been refined with the use of a synthetic tube or bi-iliac graft and this remained unchanged for the last few decades. In these open procedures current 30 day post-operative mortality
rate is 3-5% with a complication risk of 13-47%.13,14
To prevent complications related to major open surgical repair an endovascular approach was introduced in the former Soviet Union by Dr. Nikolay Volodos. In 1987 a self-fixating synthetic endograft was introduced from the femoral artery into the thoracic aorta for a post-traumatic false aneurysm. The patient survived over 18 years, finally
succumbing from a myocardial infarction.15 Subsequently,
the procedure was described more thoroughly by Parodi et
al. in the early 90s (Figure 3).16
Figure 1: The concept of endoaneurysmarrhaphy described by Dr. Rudolph Matas first performed in 1888. The aortic lumen is preserved by opening the aneurysm, folding the wall of aneurysm and suturing it to the abdominal wall. 10
1
Figure 3: The introduction of an endograft through the femoral artery. The endograft consists of a metal stent covered by fabric and is held within a sheath during introduction. After deployment the endograft seals the abdominal aneurysm.16
15-30% with a high incidence of conversion to open repair. The endografts and delivery systems were made by the surgeons themselves, and most complications were related to
malposition and improper release of the endograft.17 In the sequential years the design and
manufacturing shifted towards dedicated industries and surgeons gained more experience.18
Newer generations endografts had a more flexible design and with a lower profile making
optimal deployment easier.19 Different endograft designs were introduced into the market
by different manufactures and the preferred endograft can be chosen for specific anatomic features. The 30-day post-operative complication rates improved towards 5%, with a lower
mortality rate up to 2% in EVAR versus 5% in open surgical repair.20-22 Over the recent years
these devices have been developed further, but the long-term outcome of the latest generations endografts is not yet clear. In Chapter 2 the available studies with at least three years follow-up of these currently available devices are reviewed.
The endograft is tied within a sheath and introduced from the femoral arteries. Once deployed it can seal the AAA preventing the necessity of an open surgical procedure. Those endografts are usually designed with a metal stent for support, covered by a fabric sealing of the aneurysmal sac from blood pressure. By placing the endograft just below the renal arteries vascularization is maintained to the visceral arteries, and depending on design, blood flow is maintained to one or both iliac arteries.
The initial results of this endovascular aneurysm repair (EVAR) had a 30-day post-operative complication rate of
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The use of these infrarenal EVAR endografts is limited in complex AAAs with certain anatomical features. Once the aortic neck becomes too short (<10mm), too angulated (>60°),
is calcified or has a non-parallel configuration, the classic endograft cannot seal properly.23
Consequently, there is an increased risk of migration of the endograft or a type Ia endoleak.24,25
A more proximal deployment of the endograft in patients with such anatomical features, would cover the renal arteries (RA), superior mesenteric artery (SMA) or even the celiac axis (CA). By fenestrating the endograft at the location of those visceral arteries, the vas-cularization is maintained, and a more proximal placement of the endograft is only limited
to sheath size (Figure 4).26,27 The fenestrations are stented with balloon expandable covered
stents to maintain vascularization. These stents have an acceptable patency rate both at early
and long-term follow-up.28 Furthermore, these stents seem to prevent rotation and migration
of the main endograft.29
The development of the fenestrated endovascular aneurysm repair (FEVAR) started with fe-nestrating the infrarenal endograft just before procedure and adding markers to the
fenestra-tions (Figure 4).26,27,30 Currently, the fenestrated endografts are designed using dedicated
software and are customized according to individual patient anatomy. The differences and results in current literature of commercially available custom-made endografts are reviewed in Chapter 3.
An AAA is considered an age related disease. Life expectancy in the Western population increases and more elderly will be in need for elective AAA treatment. Elderly often have
more comorbidities and consequently they are at higher risk for surgical repair.31 With an
already shorter life expectancy in an increasing age, treatment of an AAA might not be beneficial regarding to survival and reintervention-free survival. Especially in complex AAA
cases outcome of FEVAR is not fully clear in the elderly.32,33 Chapter 4 compares the outcome
of FEVAR in octogenarians versus non-octogenarians for survival and reintervention-free survival.
As described in Chapter 3, the various available fenestrated endografts consist of different materials and the design is also slightly different. Consequently, the endografts can have a different influence on the patient’s native anatomy. Furthermore, an inadequate endograft conformability to the patient’s anatomy can lead to complications, ultimately necessitate
rein-terventions.34 The Zenith® Fenestrated endograft (Cook Medical, Bloomington, Indiana) was
1
Bungay. Since its introduction more experience has been gained with this specific design and current literature is reviewed in more detail in Chapter 6. Apart from a few studies, literature on the Fenestrated Anaconda™ for primary complex AAAs was limited. One of these studies
reported a 10% incidence of a specific procedural endoleak.35 In these cases, blood still flows
along the top of the endograft into the aneurysmal sac. Consequently, pressure remains in the aneurysmal sac, and the risk of rupture is still present. There are up to five different endoleaks,
but this specific endoleak is called a type Ia endoleak (Figure 5).36 During the procedure type I
and type III endoleaks are considered important criteria for technical success, because mainly those keep pressure in the aneurysmal sac. The question remains if these procedural endoleaks influence clinical outcome and the 10% incidence of a procedural type Ia endoleak was not seen in all studies. Therefore, in Chapter 7 a global analysis of the Fenestrated Anaconda™ is
Figure 4: Proximal part of an endograft with an enforced puncture hole (fenestration) for a more proximal placement of the endograft while maintaining vascularization of the target vessel. 27
after releasing repositioning is possible with the diameter-reducing ties. The Fenestrated Anaconda™ endograft (Terumo Aortic, Inchinnan, Scotland, UK) was introduced a few years later and contains circular nitinol stents with a stent free zone for fenestrations. After deployment it is fully collapsed, repositioned and redeployed. Chapter 5 focuses on the difference in anatomical change in treated patients by either the Zenith® Fenestrated or the Fenestrated Anaconda™.
One of the newer fenestrated endografts is the Fenestrated Anaconda™, and was first described in 2011 by Dr. Peter
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14
carried out, particularly focusing on the incidence and clinical relevance of these procedural endoleaks.
As discussed in this introduction, after treatment of an (r)AAA a complicated course can necessitate a reintervention. In some cases open redo surgery can be unfavorable due to patient comorbidities, anatomical features of the AAA, previous AAA repair or partial involvement of the thoracic aorta (a thoraco-abdominal aortic aneurysm, TAAA). Especially in patients with open redo surgery after previous EVAR, the procedural mortality can be as
high as 14%.37 In cases with a type Ia endoleak after EVAR, a migrated infrarenal endograft,
a TAAA involving the visceral arteries, a para-anastomotic AAA after prior open surgical repair or a complex AAA with a normal distal aorta, a proximal cuff can be used. Placement of this aortic cuff towards to the thoracoabdominal transition will results in devascularization of the visceral arteries. A fenestrated aortic cuff may be a proper alternative and can be used in such cases. The use of a Zenith® Fenestrated aortic cuff had a technical success 92% and
a one year survival rate of 94%.38 In recent years 57 cases were treated with the Fenestrated
Anaconda™ aortic cuff globally. The results from 29 of these cases were gathered and are described in Chapter 8.
Figure 5: Description of endoleaks in fenestrated endografts. The type I and III endoleaks are considered to maintain pressure in the aneurysmal sac, consequently leading to aneurysm sac expansion and eventual rupture.36
1
In case the aneurysm extends to the visceral arteries, there will be too much distance between the fenestration and the target vessel and a fenestrated endograft will not be sufficient. By attaching a branch to the folded endograft (Branched EVAR, BEVAR), a bridge can be formed between the placed endograft and the origin of the target vessel. After deployment of the main endograft, with the attached branch, an additional stent will be placed within the branch to close the gap between the branch and the target vessel. The technique was introduced in 1994
and described in 1997 by Inoue et al. for the left subclavian artery.39 Shortly thereafter, in 1995,
they introduced the similar design for an aneurysm in the descending aorta with a branch to
the celiac axis (Figure 6).40
Once a TAAA is present, 26% of patients die within two years, while open surgical repair has
an in-hospital post-operative mortality up to 22%.41,42 A branched, or combined branched and
fenestrated, EVAR (b/f EVAR) can be used to seal a TAAA or pararenal AAA. Current reported technical success of this design ranges between 87 and 100%, but the long-term results of the
b/f EVAR are still unknown.43,44 To bridge the gap between the branch or fenestration and
the target vessel covered stents are used. The durability of these stents have been proven, but
the change in geometrical configuration over time has not yet been described before.45 The
peri-operative experience and long term follow-up after treatment with BEVAR is described in Chapter 9. Furthermore, this chapter focuses on the geometrical changes of bridging stents over time in both branches and fenestrations.
In both Chapter 10 (English) and Chapter 11 (Dutch) these studies are summarized and the future perspective are discussed.
Figure 6: By attaching a branch to the main endograft, a bridge can be formed between the endograft and the target vessel. The endograft and attached branch are deployed and a covered stent is placed to close the gap between the branch and the target vessel.40
Ch
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1.Grant SW, Hickey GL, Grayson AD, Mitchell DC, McCollum CN. National risk prediction model for elective abdominal aortic aneurysm repair. Br J Surg. 2013;100:645-53.
2.Parkinson F, Ferguson S, Lewis P, Williams IM, Twine CP, South East Wales Vascular Network. Rupture rates of untreated large abdominal aortic aneurysms in patients unfit for elective repair. J Vasc Surg. 2015;61:1606-12. 3.Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018;67:2-77.
4.Bengtsson H, Bergqvist D. Ruptured abdominal aortic aneurysm: a population-based study. J Vasc Surg. 1993;18:74-80.
5.Gupta AK, Dakour-Aridi H, Locham S, Nejim B, Veith FJ, Malas MB. Real-world evidence of superiority of endovascular repair in treating ruptured abdominal aortic aneurysm. J Vasc Surg. 2018;68:74-81.
6.Briggs CS, Sibille JA, Yammine H, Ballast JK, Anderson W, Nussbaum T, et al. Short-term and midterm survival of ruptured abdominal aortic aneurysms in the contemporary endovascular era. J Vasc Surg. 2018;68:408,414.e1.
7.Bobadilla JL. From Ebers to EVARs: A Historical Perspective on Aortic Surgery. Aorta (Stamford). 2013;1:89-95.
8.Prioreschi P. A history of Medicine: Roman medicine. 2nd ed. Horatius Press; 1996.
9.Livesay JJ, Messner GN, Vaughn WK. Milestones in the treatment of aortic aneurysm: Denton A. Cooley, MD, and the Texas Heart Institute. Tex Heart Inst J. 2005;32:130-4.
10.Matas R. I. An Operation for the Radical Cure of Aneurism based upon Arteriorrhaphy. Ann Surg. 1903;37:161-96.
11.Cohen JR, Graver LM. The ruptured abdominal aortic aneurysm of Albert Einstein. Surg Gynecol Obstet. 1990;170:455-8.
12.Dubost C, Allary M, Oeconomos N. Resection of an aneurysm of the abdominal aorta: reestablishment of the continuity by a preserved human arterial graft, with result after five months. AMA Arch Surg. 1951;44:848-51.
13.Conrad MF, Crawford RS, Pedraza JD, Brewster DC, Lamuraglia GM, Corey M, et al. Long-term durability of open abdominal aortic aneurysm repair. J Vasc Surg.
2007;46:669-75.
14.Landry GJ, Liem TK, Abraham CZ, Jung E, Moneta GL. Predictors of perioperative morbidity and mortality in open abdominal aortic aneurysm repair. Am J Surg. 2019.
15.Volodos NL. The 30th Anniversary of the First Clinical Application of Endovascular Stent-grafting. Eur J Vasc Endovasc Surg. 2015;49:495-7.
16.Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg. 1991;5:491-9.
17.Chuter TA, Risberg B, Hopkinson BR, Wendt G, Scott RA, Walker PJ, et al. Clinical experience with a bifurcated endovascular graft for abdominal aortic aneurysm repair. J Vasc Surg. 1996;24:655-66.
18.Tadros RO, Sher A, Kang M, Vouyouka A, Ting W, Han D, et al. Outcomes of using endovascular aneurysm repair with active fixation in complex aneurysm morphology. J Vasc Surg. 2018.
19.Maudet A, Daoudal A, Cardon A, Clochard E, Lucas A, Verhoye JP, et al. Endovascular Treatment of Infrarenal Aneurysms: Comparison of the Results of Second- and Third-Generation Stent Grafts. Ann Vasc Surg. 2016;34:95-105.
20.Prinssen M, Verhoeven EL, Buth J C, P.W., van Sambeek M.R., Balm R, Buskens E, et al. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004;351:1607-18.
21.Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG, EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004;364:843-8.
22.Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT,Jr, Matsumura JS, Kohler TR, et al. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA. 2009;302:1535-42.
23.Chisci E, Kristmundsson T, de Donato G, Resch T, Setacci F, Sonesson B, et al. The AAA with a challenging neck: outcome of open versus endovascular repair with standard and fenestrated stent-grafts. J Endovasc Ther. 2009;16:137-46.
24.Sternbergh WC,3rd, Carter G, York JW, Yoselevitz M, Money SR. Aortic neck angulation predicts adverse outcome with endovascular abdominal aortic aneurysm repair. J Vasc Surg. 2002;35:482-6.
1
25.Sampaio SM, Panneton JM, Mozes GI, Andrews JC, Bower TC, Karla M, et al. Proximal type I endoleak after endovascular abdominal aortic aneurysm repair: predictive factors. Ann Vasc Surg. 2004;18:621-8. 26.Park JH, Chung JW, Choo IW, Kim SJ, Lee JY, Han MH. Fenestrated stent-grafts for preserving visceral arterial branches in the treatment of abdominal aortic aneurysms: preliminary experience. J Vasc Interv Radiol. 1996;7:819-23.
27.Browne TF, Hartley D, Purchas S, Rosenberg M, Van Schie G, Lawrence-Brown M. A fenestrated covered suprarenal aortic stent. Eur J Vasc Endovasc Surg. 1999;18:445-9.
28.Grimme FA, Zeebregts CJ, Verhoeven EL, Bekkema F, Reijnen MM, Tielliu IF. Visceral stent patency in fenestrated stent grafting for abdominal aortic aneurysm repair. J Vasc Surg. 2014;59:298-306.
29.England A, García-Fiñana M, Fisher RK, Naik JB, Vallabhaneni SR, Brennan JA, et al. Migration of fenestrated aortic stent grafts. J Vasc Surg. 2013;57:1543-52.
30.Uflacker R, Robison JD, Schonholz C, Ivancev K. Clinical experience with a customized fenestrated endograft for juxtarenal abdominal aortic aneurysm repair. J Vasc Interv Radiol. 2006;17:1935-42.
31.Lange C, Leurs LJ, Buth J, Myhre HO, EUROSTAR collaborators. Endovascular repair of abdominal aortic aneurysm in octogenarians: an analysis based on EUROSTAR data. J Vasc Surg. 2005;42:624-30.
32.Hertault A, Sobocinski J, Kristmundsson T, Maurel B, Dias NV, Azzaoui R, et al. Results of F-EVAR in octogenarians. Ann Vasc Surg. 2014;28:1396-401. 33.Roy IN, Millen AM, Jones SM, Vallabhaneni SR, Scurr JR, McWilliams RG, et al. Long-term follow-up of fenestrated endovascular repair for juxtarenal aortic aneurysm. Br J Surg. 2017;104:1020-7.
34.Schuurmann RCL, van Noort K, Overeem SP, van Veen R, Ouriel K, Jordan WD,Jr, et al. Determination of Endograft Apposition, Position, and Expansion in the Aortic Neck Predicts Type Ia Endoleak and Migration After Endovascular Aneurysm Repair. J Endovasc Ther. 2018:1526602818764616.
35.Dijkstra ML, Tielliu IF, Meerwaldt R, Pierie M, van Brussel J, Schurink GW, et al. Dutch experience with the fenestrated Anaconda endograft for short-neck
infrarenal and juxtarenal abdominal aortic aneurysm repair. J Vasc Surg. 2014;60:301-7.
36.Jain AK, Oderich GS, Tenorio ER, Karkkainen JM, Mendes BC, Macedo TA, et al. Natural history of target vessel endoleaks after fenestrated-branched endovascular aortic repair. J Vasc Surg. 2018;67:e53-4. 37.Locati P, Socrate AM, Costantini E. Paraanastomotic aneurysms of the abdominal aorta: a 15-year experience review. Cardiovasc Surg. 2000;8:274-9.
38.Katsargyris A, Yazar O, Oikonomou K, Bekkema F, Tielliu I, Verhoeven EL. Fenestrated stent-grafts for salvage of prior endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2013;46:49-56. 39.Inoue K, Iwase T, Sato M, Yoshida Y, Tanaka T, Kubota Y, et al. Clinical application of transluminal endovascular graft placement for aortic aneurysms. Ann Thorac Surg. 1997;63:522-8.
40.Inoue K, Iwase T, Sato M, Yoshida Y, Ueno K, Tamaki S, et al. Transluminal endovascular branched graft placement for a pseudoaneurysm: reconstruction of the descending thoracic aorta including the celiac axis. J Thorac Cardiovasc Surg. 1997;114:859-61.
41.Hansen PA, Richards JM, Tambyraja AL, Khan LR, Chalmers RT. Natural history of thoraco-abdominal aneurysm in high-risk patients. Eur J Vasc Endovasc Surg. 2010;39:266-70.
42.Cowan JA,Jr, Dimick JB, Henke PK, Huber TS, Stanley JC, Upchurch GR,Jr. Surgical treatment of intact thoracoabdominal aortic aneurysms in the United States: hospital and surgeon volume-related outcomes. J Vasc Surg. 2003;37:1169-74.
43.Gallitto E, Gargiulo M, Freyrie A, Massoni CB, Pini R, Mascoli C, et al. Endovascular Repair of Thoracoabdominal Aortic Aneurysm in High-Surgical Risk Patients: Fenestrated and Branched Endografts. Ann Vasc Surg. 2017;40:170-7.
44.Baba T, Ohki T, Kanaoka Y, Maeda K, Ohta H, Fukushima S, et al. Clinical Outcomes of Spinal Cord Ischemia after Fenestrated and Branched Endovascular Stent Grafting during Total Endovascular Aortic Repair for Thoracoabdominal Aortic Aneurysms. Ann Vasc Surg. 2017;44:146-57.
45.Mastracci TM, Greenberg RK, Eagleton MJ, Hernandez AV. Durability of branches in branched and fenestrated endografts. J Vasc Surg. 2013;57:926-33.
CHAPTER
Mid- and long-term
outcome of currently
available endografts
for the treatment of
infrarenal abdominal
aortic aneurysm
Leonie T. Jonker Arne de Niet Michel M.P.J. Reijnen Ignace F.J. Tielliu Clark J. Zeebregts Surgical Technology International, 2018;33:239-250Ch
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Abstract
Currently, there is a wide range of commercially available endografts for infrarenal abdominal aortic aneurysm (AAA) repair. Results of long-term follow up after endovascular aneurysm repair (EVAR) are limited. Thereby, the durability of these endografts and the difference between manufacturers is not fully clear.
In this review, studies with mid- and long-term results, with a minimum median follow up of 36 months per endograft, were included describing results with Cook Zenith® Flex® endograft (Cook Medical Inc., Bloomington, Indiana) (n=6), Cordis Corporate INCRAFT® (Cordis Corporation, Freemont, California) (n=1), Gore® EXCLUDER® (W.L. Gore & Associates Inc., Flagstaff, Arizona) (n=3), Medtronic Endurant™ (Medtronic plc, Santa Rosa, California) (n= 6), and Vascutek Anaconda™ (Vascutek Ltd., Inchinnan, Scotland) (n=2).
The assisted technical success varied between 83% and 100%, and the perioperative mortality, early reintervention, and early conversion rates were comparable for the studied endografts. At three-year follow up, the freedom from AAA-rupture and AAA-related death varied between 98% and 100%. The results demonstrated an increasing complication and reintervention rate over time. When adhering to the instruction for use, minor differences were seen during follow up between the endografts.
Latest generation endografts continue to have good postoperative results; the reinterventi-on-rate of 10–20% over time mandates an ongoing close patient follow up. The choice of a specific design depends on native patient anatomy and the experience of the implanting surgeon.
2
Introduction
Since Parodi et al.1 reported the concept of endovascular aneurysm repair (EVAR) in 1991,
EVAR increasingly became the preferred option for treatment of abdominal aortic aneurysm
(AAA). Currently, nearly 80% of all AAAs are treated by EVAR in the United States.2,3 EVAR
is associated with a lower perioperative mortality and morbidity and a shorter hospital stay
compared to open aneurysm repair (OAR).4-6 However, long-term survival rates seem to be
better for OAR, this is mainly attributed to secondary AAA rupture.7 Furthermore, EVAR
has been associated with a higher rate of secondary interventions and a significantly higher
in-hospital cost of care compared to OAR.8-10
Over time, technological advances have improved the capacity of endografts to treat aortic AAAs. Improved fabrics, better scaffolding designs and materials, low-profile delivery systems, more precise deployment mechanisms, enhanced fixation, greater conformability, and diverse
modular components were developed and applied to newer generation endografts.11 Most
manufacturers of EVAR devices now produce their third-generation commercially available
endograft.12 These technological improvements, combined with increased surgical experience
and selection of patients within the specified instructions for use (IFU), led to higher
reinter-vention-free survival and higher freedom from aneurysm-related death after EVAR.11,13
Results of long-term follow up after EVAR are limited and the durability of endografts remains unclear. In this review, we describe mid- and long-term results of the latest-genera-tion endografts currently commercially available for treatment of infrarenal AAAs. Primary outcome parameters were overall survival, freedom from AAA-rupture, and AAA-related death, while a secondary outcome measure was freedom from reintervention.
Ch
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22
Materials and methods
A PubMed search was performed with Medical Subject Headings (MeSH) terms including “Aortic Aneurysm, Abdominal/surgery” combined with “Aortic Aneurysm, Abdominal/ therapy” or “abdominal aneurysm” and “endovascular procedures” or endovascular”, “EVAR” and “follow-up”. All 1519 articles published in the English literature over a 10-year period (until January 2018) were screened for title and abstract. Additional searches were done adding for terms of the specific endografts and by cross-referencing. Reports of results of elective EVAR performed within the IFU, and with a currently available endograft, were eligible for inclusion. Studies with a minimum median follow up of 36 months were eligible for comparative analysis between endografts. If early results of the endograft were published previously, relevant data were obtained from that earlier report.
To review the applicability of the different endografts, primary and secondary outcome measures were compared according to the reporting standards of Chaikof et al. Primary technical success requires a successful introduction and deployment of the device in the absence of surgical conversion, mortality, type I or III endoleaks, or graft limb obstruction. It can include the use of planned additional modular components, angioplasty, and adjunctive surgical procedures. If unplanned endovascular procedures are necessitated, the term assisted
primary technical success is used.14
Pooled analysis was done for primary and primary-assisted technical success, freedom from reintervention, overall-survival, freedom from AAArupture, and AAA-related death. Ka-plan-Meier analysis was used for survival analysis, but when not available, survival or freedom from events at median follow up was presented. Separately, adverse events during median follow up were collected, including endograft patency, limb occlusion, endograft migration, kinking, stentbody fracture, disconnection, endoleak, and freedom from reintervention. In most selected articles, conversion from EVAR to open surgical repair was reported as early
2
Results
The inclusion criteria were met in 122 studies. Mid- and long-term results with a minimum median follow up of 36 months per endograft were reported in 18 studies—Cook Zenith® Flex® endograft (Cook Medical Inc., Bloomington, Indiana) (n=6), Cordis Corporate INCRAFT® (Cordis Corporation, Freemont, California) (n=1), Gore® EXCLUDER® (W. L. Gore & Associates Inc., Flagstaff, Arizona) (n=3), Medtronic Endurant™ (Medtronic plc, Santa Rosa, California) (n= 6) and Vascutek Anaconda™ (Vascutek Ltd., Inchinnan, Scotland) (n=2), all of which are discussed in detail below.
TABLE I: INSTRUCTION FOR USE FOR DISCUSSED ENDOGRAFTS Endograft Cook Zenith® SP
Flex® Cordis Corp INCRAFT® EXCLUDER®GORE® Endurant™ IIMedtronic Anaconda™Vascutek Prox LZ diam (mm) 18–32 20–27 19–32 19–32 17.5–31 Prox LZ length (mm) ≥15 ≥15 ≥15 10 15 Max LZ angle 60 NA ≤60⁰ ≤60⁰ ≤90⁰ Iliac LZ diam (mm) 7.5–20 9–18 8–25 8–25 8.5–21 Iliac LZ length (mm) ≥10 ≥10 ≥10 ≥15 ≥20 Fixation Suprarenal hooks Infra- and
transrenal hooks Infrarenal hooks Suprarenal hooks Infrarenal hooks Device Bifurcated with
iliac, 2x iliac extension Bifurcated with iliac, 2x iliac extension Bifurcated with iliac, 1x iliac extension Bifurcated with iliac, 2x iliac extension, proximal cuff extension Bifurcated short, 2x iliac extension Delivery system Flexor Flexible
Ultra-Low Profile INCRAFT®
C3 Endurant II Anaconda Delivery system OD
(Fr) 18–22 14 12–18 14–20 20–23 Main body sheath
size OD (Fr) 18–22 14–16 16–18 18–20 20–23 Limb sheath size OD
(Fr) 12–16 12–13 12–15 14–16 18 Fabric Fabric (polyester
woven) sewed into stent Fabric (low-porosity woven polyester) over stent Fabric in stent, Low-permeable ePTFE and FEP
Fabric in stent, multifilament
polyester
Fabric in stent Stent Stainless steel
Cook-Z Nitinol Nitinol Nitinol M-shaped Nitinol Fr=French size, OD=outer diameter, LZ=landing zone, Diam=diameter, ePTFE=expanded, polytetrafluoroethyle-ne, FEP=fluorinated ethylene propylene.
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Zenith® Flex® AAA Endovascular Graft
The Cook Zenith® Flex® endograft is a three-part system consisting of a bifurcated aortic main-body and two iliac extensions (Figure 1a and b). The stainless-steel Z-stents are hand-sutured to a woven polyester graft material. The uncovered proximal stent has hooks to provide active suprarenal fixation. The design of the Zenith® Flex® graft has virtually remained unchanged since its introduction in 1997. The gaps of fabric between the stents were made wider to improve flexibility. The Zenith® Flex® promotes resistance to graft migration by proximal anchoring hooks and selfexpanding Z-stents which provide radial force and columnar strength by a long main-body design with stability and flexibility. IFU are shown
in Table I. Long-term results of EVAR with Zenith® Flex® were reported in six papers.12,15-19
Figure 1a: The Cook Zenith® Flex® endograft.
2
30-day postoperative outcome
Only a few studies reported numbers for primary technical success (Table II). In the study by Greenberg et al., three of the 739 implantations of the Zenith® Flex® AAA endograft were aborted due to iliac artery morphology not appreciated before the procedure of which two were successfully treated by open repair and the third patient decided to have no further
intervention.15 Thirty-day mortality was 1–3%, mostly non-AAA-related. In the report by
Verzini et al., one of five perioperative deaths was due to AAA rupture.12 Freedom from
rein-tervention at 30 days was 93.4%.15,19
Mid- and long-term outcomes
Overall survival in all six papers was estimated by Kaplan-Meier analysis (Table II). Pooled
analysis estimated an overall survival at eight years of 51.8%.12,18,19 Table III shows freedom
from AAA-rupture, AAA-related death, and reintervention. At 10-year follow up, Verzini et al. found an estimated overall survival of 37.8%, freedom from AAA rupture of 98.1%, freedom from AAA-related death of 97.3%, and freedom from late reintervention and conversion of
75.5%.12 Adverse events related to EVAR during follow up are listed in Table IV.
The INCRAFT® AAA Stent Graft is a three-piece modular bifurcated system (Figure 2a and b).
Figure 1b: The Cook Zenith® Flex® endograft after implantation on CT-angiography
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Incraft® AAA stent graft
The graft is composed of nitinol circular Z-stents, with a low-porosity polyester graft covering the stents. The main-body has a short infrarenal sealing endoskeleton. For active suprarenal fixation, the endograft has eight to 10 proximal barbs. It has an ultra-low-profile delivery system (14 French outer diameter) to facilitate navigation in complex access anatomies such as tortuous and/or calcified iliac access vessels. The graft has the unique capability of in situ length adjustment up to 2–3cm bilaterally and an active locking mechanism between the main-body and limbs to minimize type III endoleaks. The INCRAFT® system comes with a limited number of device sizes and lengths but, because of its adjustable design, allows for treatment of a wide variety of anatomic variations. The INNOVATION trial is the first clinical, multicenter, prospective, nonrandomized study of the INCRAFT® system that included 60
patients.20-22 The IFU during the INNOVATION trial are shown in Table I.
30-day postoperative outcome
Primary technical success was 90%. At the end of the procedure, 55 of 60 patients (92%) had absence of type I or III endoleak. One patient required a proximal aortic cuff for correction of a type Ia endoleak intraoperatively. Mortality at 30 days was 0% and freedom from reinterventi-on at 30 days was 100%.
Mid- and long-term outcomes
Overall survival at one and two year follow up is shown in Table II. With a median follow up of 48 months, a total of 9/60 patients died in four years, and no death was AAA or device related.22 Adverse events during follow up are shown in Table IV.
2
Figure 2b: The INCRAFT® AAA stent graft after implantation on CT-angiography.
Gore® EXCLUDER® AAA Endoprosthesis
The Gore® EXCLUDER® is a twomodular system consisting of a bifurcated endograft with a standard ipsilateral and a separate contralateral iliac extension (Figure 3a and b). Presently, the endograft consists of low permeability expanded polytetrafluoroethylene (ePTFE) and fluorinated ethylene propylene (FEP). The endograft is externally supported by nitinol stents to which it is attached by a bonding film rather than through sutures. Active infrarenal fixation is accomplis-hed by circumferential nitinol anchors and a proximal sealing cuff without suprarenal fixation. The new C3 delivery system, in use since 2010, made it possible to reposition the endograft after deployment by a constrai-ning wire at the top of the endograft. The low permeabi-lity Gore® EXCLUDER® differs from the original Gore® EXCLUDER® Endoprosthesis by the addition of film
layers that decrease the overall permeability of the graft. The IFU are shown in Table I. The results of the Gore® EXCLUDER®, with a median follow up over 36 months, were described in three papers.
30-day postoperative outcome
Pooled analysis shows a primary technical success of 95.9%.23-26 In the series described by Bos
et al., two patients had a type Ia endoleak at completion angiography. One was successfully corrected with a proximal extension. In the second patient, a small proximal endoleak was accepted after ballooning in a 50mm long neck and it spontaneously resolved at one-month
follow up.25 Bastos Goncalves et al. needed to convert to open repair in 1/144 patients due to
inadvertently low deployment. Additional intraoperative endovascular procedures (including ballooning) were necessary in 22/144 patients: for a type Ia endoleak (n=17), type Ib endoleak (n=2), and for partial occlusion of a renal artery (n=4). The exact mechanism of partial renal occlusion was not specified.26 Mortality at 30 days was 0–1.4% and freedom from
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Mid- and long-term outcomes
Overall survival is shown in Table II.24-26 Bos
et al. reported six out of 20 deaths, classified as indeterminate AAArelated, but no AAA rupture was diagnosed in five years of follow
up.25 Bastos Goncalves et al. estimated a freedom
from AAA-related mortality of 96.6%.26 At 10
years follow up, Pratesi et al. had an overall survival of 62.5% and an estimated freedom from AAA-related mortality of 97.2%.24 Freedom from reintervention is shown in Table III. Open reinter-vention was necessary in 2.7% of the cases. Addi-tionally, Pratesi et al. found a freedom from rein-tervention at five, seven, and 10 years of 87.7%, 82.4%, and 80.6, respectively. Table IV shows the main reasons for reintervention during follow up.
Figure 3b: The Gore® EXCLUDER® after implantation on CT-angiography.
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The Endurant™ Stent graft
The Endurant™ II consists of a three-piece modular system with M-shaped nitinol stents secured to high density polyester (Figure 4a and b). Suprarenal fixation hooks were designed to compensate for the decreased columnar strength. The second-generation device (Endurant™ II stent graft) was improved with a lower-profile delivery system and longer limb lengths to accommodate a wider range of anatomical variations. Better delivery system visualization was accomplished by adding radio opaque markers to the endograft. IFU are shown in Table I. Mid- and long-term results of the Medtronic Endurant™ were reported in six articles with a
minimum median follow up of 36 months.27-32 Out of 897 patients included in the articles, 99
patients were treated outside the IFU. 30-day postoperative outcome
Pooled primary and primary-assisted technical success were 96.3% and 99.2%, respectively. Two additional stent placements in a renal artery were required and one unplanned aorto-iliac
device was placed. There were no primary type I or III endoleaks or conversions.27,33 The
device could not be implanted in one patient due to stenotic iliac vessels, and the procedure
was terminated.28 The single technical device failure in the series described by Singh et al.
was due to an inability to cannulate a contralateral gate that was collapsed in a narrowed distal aorta and, essentially, this created a monoiliac device
which was completed by a femoro-femoral crossover
bypass.30 In addition to procedures to resolve endoleaks,
9.2% of the patients in Mannetje et al.’s report required an iliac artery intervention, either to allow device implantation
or to optimize the end result on completion angiography.31
One failure was secondary to unintentional coverage of both renal arteries leading to renal artery occlusion and, in another, the Endurant™ endograft was not inserted due to
unsuitable anatomy at the time of the index procedure.32
Pooled 30-day-mortality was 1.6%. One patient rejected further treatment after an unsuccessful embolectomy of an
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iliac obstruction and died within 30 days. Another patient died within 30 days because of gastro-intes-tinal bleeding during heparin therapy for an arterial
occlusion of the leg.27,33 Freedom from reintervention
within 30 days was 96.9%. Mid- and long-term outcomes
Reported overall survival is shown in Table II. Table III shows the freedom from AAA-rupture and AAA-related death estimated by three studies. Zandvoort et al. reported three (3%) AAArelated deaths, all in the first year of follow up. Survival rates for patients treated within IFU were comparable to
survival rates for those treated outside IFU.27 Bisdas et
al. had an overall mortality of 29% at median follow up of 42 months, with a known cause of death in 68/78
Figure 4b: The Endurant™ II after implantation on CT-angiography
patients.28 One death was AAA related. In Oliveira et al.’s report, late AAA rupture occurred in
two patients (3.1%), and this resulted in the death of one patient.29 Freedom from
reinterven-tion and the main reasons for reintervenreinterven-tions are menreinterven-tioned in Tables III and IV. The Anaconda™ AAA stent graft system
The Anaconda™ is a three-piece modular graft system (Figure 5a and b). The graft material is made of woven polyester. The main-body consists of two proximal nitinol rings for proximal seal, with four pairs of proximal hooks for infrarenal fixation. The body below these rings is unsupported by stents allowing them to be placed in a more angulated infrarenal aorta. The limbs have an independent ring design and cannulation of the contralateral limb is facilitated by the ONE-LOK™ (Sigma Corporation, Kawasaki, Japan) magnet system. The delivery system has the ability to reposition the proximal main-body. IFU are shown in Table I. Mid- and long-term results of EVAR with Vascutek Anaconda™ were reported in two papers with a follow up of 36 and 40 months.
2
30-day postoperative outcome
Rödel et al. achieved a technical success of 83% in patients with
a mean proximal AAA neck angulation of 82˚.34 In one patient,
conversion to open repositioning was necessary because of an improperly released main-body below the aortic neck angulation due to an aortic rim. Because of unsuccessful contralateral iliac leg deployment in an already-deployed Anaconda™ mainbody, one patient needed a femorofemoral crossover bypass additional to an aortouni-iliac endovascular graft . Furthermore, there were four (6.7%) cases with a type Ia and Ib endoleak at fi nal angiography. Freyrie et al. compared the midterm results of 65 patients with severe neck angulation (Group A, GA: ≥60˚) with
737 patients with nonangulated necks (Group B, GB: <45˚).35
Th e endograft main-body was repositioned in 35% and 20.7% of cases, respectively, but this did not result in a diff erence in type Ia endoleaks occurrence (GA 1.5% vs. GB 1.3%) or conversion to open repair (GA 3% vs. 0.6%). Mortality at 30 days was 0–1.5%, and freedom from reintervention at 30 days was 97–99.7%.
Mid- and long-term outcomes
In the report of Freyrie et al., a follow up of 36 months was achieved in 14 patients in GA and
in 120 patients in GB.35 Overall survival at three
years showed no statistically signifi cant diff erence in survival between treatment of angulated versus non-angulated necks (Table III). None of the deaths were AAA related. In total, 18/838 (2.1%) patients needed open AAA repair during follow up. Complications of endovascular treatment of AAA during follow up are mentioned in Table IV.
Figure 5a: Th e Anaconda™ AAA stent graft .
Figure 5b: Th e Anaconda™ AAA stent graft aft er implantation on CT-angiography.
Ch ap ter 2 32 TAB LE II THIR TY -D AY POS TO PER ATIVE O UT C O ME P ER END O GR AFT . Ea rly o pen co nv er sio n (%) 0.3 0.3 0.3 0.0 - 0.0 0.5 0.0 0.0 0.4 0.0 0.7 - 0.6 0.0 0.0 0.0 3.3 - 0.0 0.9 - b3 0.6 c Po ole d a na lysi s o f t he p os to pera tiv e r es ul ts p er en dog ra ft, minim al f ol lo w u p o f 36 m on th s. S om e o f t he e ar ly r es ul ts w er e o bt ain ed f ro m e ar lier p ub lic at io ns o f t he s tudies. 20-23,33,49,50 - D at a n ot a va ila ble , a P rim ar y t ec hnic al s ucces s o f 872 p at ien ts r ep or te d b y t he e ar ly s tud y r es ul ts in P ra tesi , 2014. 23 b Of a t ot al o f 65 p at ien ts w ith m edi an f ol lo w u p <36 m on th s. c Of a t ot al o f 737 p at ien ts w ith a m edi an f ol lo w u p <36 m on th s. GA: G ro up A n ec k a ngu la tio n ≥60˚, GB: g ro up B n ec k a ngu la tio n <45˚ Fr ee do m f ro m rein ter ven tio n 30 da ys (%) 93.4 97.1 - - - 94 - 100.0 100.0 97.9 98.9 97.2 - 96.9 - 96 - 98.7 96.8 97 99.1 98.3 b97 99.6 c 30-d ay M or ta lit y (%) 1.6 0.8 3.0 0.9 - 1.4 0.8 0.0 0.0 0.9 0.0 1.4 - 1.6 2.0 - 3.1 0.0 1.5 2.2 1.0 0.0 1.5 b 1.3 c A ssi ste d p rim ar y te chnic al s ucces s (%) 99.9 99.5 - - - 100.0 - 92.0 92.0 99.1 98.9 99.3 - 99.2 100.0 99.7 100.0 99.3 97.7 98.9 83.0 83.0 - -Pr im ar y t ec hnic al succes s (%) 99.8 - - 99.7 100.0 - - 90.0 90.0 95.9 97.8 89.6 97.5 a 96.3 98.0 - 98.5 - 93.8 - 83.0 83.0 - -N o. o f pa tien ts 68.5 60 54 51.6 66.4 40 99.2 48 48 79.6 36 60 94.4 44.9 48 42 52 42 59.2 37 36.2 40 36 36 N o. o f pa tien ts 1737 105 279 318 143 282 610 60 60 697 92 144 461 897 100 273 65 150 131 178 170 36 14 120 Pu blic at io n ye ar 2008 2009 2010 2011 2012 2017 2017 2009 2012 2018 2014 2014 2015 2016 2017 2017 2014 2014 2014 Fir st a ut ho r C oo k Z eni th® S P Flex® Gr ee nb erg 15 D ias 16 Fo rb es 17 M er ten s 18 Vä är äm äk i 19 Verzini 12 C or di s C or p IN CR AFT® Pra tesi 20-22 GO RE® EX CL UD ER® Bos 25 Ba stos G on ca lv es 26 Pra tesi 23,24 M ed tro nic En dura nt™ Za nd vo or t 27,33 Bis das 28 O liv eira 29, 49 Si ng h 30,50 M ann et je 31 D eer y 32 Va sc ut ek A naco nd a™ Rö del 34 Fr ey rie 35 (GA≥60˚) Fr ey rie 35 (GB<45˚)
2
TAB LE III: AND L O N G-TERM O UT C O MES P ER END O GR AFT . O vera ll S ur vi va l Fr ee do m f ro m AAA -r up tur e Fr ee do m f ro m AAA -r el at ed dea th Fr ee do m f ro m r e-in ter ven tio n Fir st a ut ho r N o. o f pa tien ts M edi an FU (m) 1 y ea r (%) 3 y ea r (%) 5 y ea r (%) 1 y ea r (%) 3 y ea r (%) 5 y ea r (%) 1 y ea r (%) 3 y ea r (%) 5 y ea r (%) 1 y ea r (%) 3 y ea r (%) 5 y ea r (%) C oo k Z eni th® S P Flex 1737 68,5 93.1 80.8 70.0 99.9 99.7 99.2 98.5 97.9 97.6 94.5 84.4 82.6 Gr ee nb erg 4 2008 105 60 94.5 81.6 77.6 99.9 99.9 99.9 98.1 97.5 97.5 90.2 82.5 79.3 D ias 16 2009 279 54 92 80 67 100* 99.3* -97 96 96 92 84 77 Fo rb es 17 2010 318 51,6 94 85 76 100* 100* 100* -M er ten s 18 2011 143 66.4 93.6 81.5 72.1 100 100 98.1 -90.7 83.5 77.1 Vä är äm äk i 19 2012 282 40 93 74 62 -93 86 81 Verzini1 3 2017 610 99.2 92.8 81.8 70.1 99.8 99.6 99.4 99.2 98.8 98.4 98 -87.7 C or di s C or p IN CR AFT® 60 48 98.2* 88.3* 100* 100* . 100* 100* Pra tesi 20-22 2017 60 48 98.2* 88.3* -100* 100* -100* 100* -GO RE® EX CL UD ER® 697 79,6 95.4 84.6 73.5 99.5* 99.2* 97.6 97.6 97.4 91.9 87.6 Bos 25 2009 92 36 95.2 83.9 70.2 100* 100* 100* -95 87 87 Ba stos G on ca lv es 26 2012 144 60 93 79 62 -97.6 -97.6 -73* Pra tesi 23,24 2018 461 94.4 96.2 86.5 77.7 99.4* 99* 99* -97.9 92.9 87.7 M ed tro nic En dura nt™ 897 44,9 93.0 81.4 72.5 100 99.6 99.2 99.1 99.0 98.5 94.5 91.8 84.8 Za nd vo or t 27,33 2014 100 48 88 82 -98 85 -Bis das 28 2014 273 42 90 77 67 -95.2 93 87 O liv eira 29, 49 2015 65 52 -83.1* -66.2* Si ng h 30,50 2016 150 42 96 89.1 82.3 100 99.2 99.2 100 99.2 99.2 95.3 91.6 89 t M ann et je 31 2017 131 59,2 93 -72.7 -98.4 -97.6 89.3 -75.2 D eer y 32 2017 178 37 98 87* -100 100 -98.9 98.9 -94* 93.8 -Va sc ut ek A naco nd a™ 36 36,2 97.0* 94.8 . 100* 98.4* 100* 100* 89.0* 80.0* Rö del 34 2014 36 40 97.0* 91.7* -100* 100* -89.0* 80.0* -Fr ey rie 35 (GA≥60˚) 2014 14 36 -95.4 -100* 85* -100* -Fr ey rie 35 (GB<45˚) 2014 120 36 -94.7 -100* 100* -100* -Po ole d a na lysi s p er en dog ra ft f ro m K ap la n-M eier s ur vi va l a na lysi s d at a. * S ur vi va l o r f re edo m f ro m e ven t a t m edi an f ol lo w u p o f t he s tud y (a s r ep or te d in t he f our th co lumn).- D at a n ot a va ila ble . GA: G ro up A n ec k a ngu la tio n ≥60˚, GB: g ro up B n ec k an gu la tio n <45˚Ch ap ter 2 34 TAB LE IV : T O TAL AD VERS E E VENT S P ER END O GR AFT D URIN G MED IAN FO LL O W -UP Lat e co nv er sio n (%) 0.02* 1.4 0.6 3.5 0.4 1.8 0.0 3.3 4.9 2.0 0.0 0.7 0.0 0.0 - 0.0 11.0 7.1 0.8 Po ole d d at a o f t ot al ad ver se e ven ts d ur in g m edi an f ol lo w u p p er a rt ic le. G re en ber g et a l. wa s t he o nl y s tud y c alc ul at in g t he f re edo m f ro m a n ad ver se e ven t a t e ac h y ea r o f f ol lo w up u sin g K ap la n-M eier a na lysi s. Th er ef or e, t he r es ul ts a re r ep or te d in t he t ab le b ut n ot in clude d in t he p oo le d a na lysi s. * K ap la n M eier s ur vi va l a na lysi s. GA: G ro up A n ec k an gu la tio n ≥60˚, GB: g ro up B n ec k a ngu la tio n <45˚ rAAA (%) 1.4 0.1* 1.4 0.0 4.2 0.7 1.1 0.0 0.0 2.7 0.0 0.7 0.6 0.3 0.0 0.4 3.1 0.7 0.8 0.0 3.5 2.8 7.1 0.0 En do le ak typ e III (%) 1.2 0.0* - 0.0 2.8 0.4 2.5 0.0 0.0 0.5 0.0 0.0 - 0.6 0.0 0.3 0.0 0.0 2.4 0.0 1.2 0.0 0.0 0.8 En do le ak typ e I (%) 1.5 0.0* - 2.5 12.6 5.0 9.4 0.0 6.7 0.0 3.3 12.0 - 0.4 7.0 2.0 16.9 2.0 7.1 1.1 0.6 11.1 0.0 1.6 Di sco nn ec tio ns (%) 7.2 0.1* - 0.0 2.1 0.0 - 6.7 0.0 8.5 0.0 1.4 0.0 4.2 - 0.0 0.0 0.0 0.8 0.0 3.5 0.0 0.0 0.0 St en t b od y frac tur es (%) 0.4 0.03* - 0.0 4.2 0.0 - 0.0 1.7 0.3 0.0 0.0 0.0 0.1 - 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Kin kin g (%) 0.8 - - - - 0.7 - 1.7 0.0 0.0 0.0 0.0 0.0 0.0 - 0.0 0.0 0.7 0.0 0.6 0.0 5.6 0.0 0.0 M ig ra tio n (%) 1.0 0.07* - 0.0 - 1.1 1.1 0.0 0.0 0.0 2.2 0.0 0.9 0.3 - 1.0 0.0 0.0 0.0 0.0 1.2 2.8 0.0 0.0 Lim b occ lu sio n (%) 0.8 0.03* - 0.6 5.6 2.8 3.4 0.0 5.0 0.9 0.0 14 1.3 0.3 4.0 4.0 10.8 3.3 5.6 3.4 0.6 14.0 0.0 0.8 M edi an FU (m) 2.8 60 54 51.6 66.4 40 99.2 5.0 48 1.2 36 60 94.4 4.5 48 42 52 42 59.2 37 3.5 40 36 36 n= 69 105 279 318 143 282 610 48 60 79.6 92 144 461 44.9 100 273 65 150 131 178 36.2 36 14 120 Pu blic at io n ye ar 1632 2008 2009 2010 2011 2012 2017 60 2017 697 2009 2012 2018 897 2014 2014 2015 2016 2017 2017 170 2014 2014 2014 Fir st a ut ho r, y ea r C oo k Z eni th® S P Flex Gr ee nb erg 4 D ias 16 Fo rb es 17 M er ten s 18 Vä är äm äk i 19 Verzini 13 C or di s C or p IN CR AFT® Pra tesi 20-22 GO RE® EX CL UD ER® Bos 25 Ba stos G on ca lv es 26 Pra tesi 23,24 M ed tro nic En dura nt™ Za nd vo or t 27,33 Bis das 28 O liv eira 29, 49 Si ng h 30,50 t M ann et je 31 D eer y 32 Va sc ut ek A naco nd a™ Rö del 34 Fr ey rie 35 (GA≥60˚) Fr ey rie 35 (GB<45˚)
2
Discussion
This review describes the results of the latest generation of currently available endografts for EVAR after a mid- and long-term outcome of 36 months of follow up.
The latest generation endografts are more flexible and low-profile.36 There have also been
improvements for more controlled deployment and easier catheterization.37 The IFU are
different for every specific type of endografts and help the clinician to choose the best available endograft for the treatment of a patient with an infrarenal AAA.
The current analysis showed comparable results between the endografts. The periopera-tive mortality, early reintervention, and early conversion rates were very low in all studied endografts, while the primary-assisted technical success varied between 83% and 100%. The latter appears to be lower in the Anaconda™ graft, potentially related to a higher incidence of type Ia endoleaks due to the stent design that needs more time to fully expand. Adhering to the IFU has led to good mid- and long-term clinical outcomes in all endografts. At three-year follow up, the freedom from AAA rupture and AAA-related death varied between 98% and 100%. The results, however, still demonstrate a significant complication and reinterven-tion rate after EVAR, mainly occurring during the first three years after initial treatment. Although newer generation endografts are used, this reintervention rate of 10–20% indicated
the ongoing need for long-term follow up.38-40
Long-term results of follow up of the current endografts with the newest adjustments are still awaited. Because the design and delivery system of the Zenith® Flex®, Gore® EXCLUDER®, and the Medtronic Endurant™ II endografts have been virtually left unchanged, we chose to present longterm results of the latest available version.
The reviewed studies did not all specify the specific type of Zenith® Flex® endograft. Mertens et al. included the use of the older custom-made two-part design of Zenith® Flex®, which they used for the first two years of the study. The remaining studies described the Standard Profile, which is currently called Zenith® Flex® The Z-track introduction system, which was approved by the Food and Drug Administration (FDA) in 2008, was not specifically mentioned in the studies included in this review. The recently approved Cook Zenith® Low-Profile (Cook Medical Inc., Bloomington, Indiana) has similar outcomes to the Zenith® Standard-Profile (SP) (Cook Medical Inc., Bloomington, Indiana) endograft, despite being used to treat more
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particular modification available.
In 2004, the Gore® EXCLUDER® with low permeability (LP) was introduced. Bos et al. used LP endografts in 38/92 (41%) and Bastos Goncalves in 83/144 (58%) of the patients. Pratesi et al. did not specify the permeability of the used endografts. Multiple studies have demon-strated a greater shrinkage rate of the AAA sac in using LP grafts compared to the older
design with original permeability (OP).26,42-44 Additionally, in 2010, the C3 delivery system
was introduced. The reviewed studies did not use the C3 delivery system, which included the possibility for repositioning. In one study, with a large patient cohort of 200 cases, technical success was achieved in 196 cases (98%) where endograft repositioning was used in 45%, mostly for adjustment to the renal artery. Adverse events related to repositioning were noticed in three cases, but they were repaired by endovascular means. Overall, survival at one and three years was 97.2% and 89.6%, respectively. No migration, type I/III endoleaks, or limb occlusion were detected during median follow up of 17.8 months. Estimated freedom from
reintervention was 92.4 at one year and 89.9 at three years.45
Not included in this review are the results of The Global Registry for Endovascular Aortic Treatment (GREAT). This is a prospective observational multicenter cohort registry that enrolled 3166 patients receiving a Gore® EXCLUDER® endograft for treatment of an infrarenal
AAA from January 2011 to January 2017.46 The five-year follow-up results were only published
in May 2018, which was outside the searching criteria for selecting studies for this review. Howard et al. reported a technical success in 99.9% of cases. Freedom from reintervention was 93.7% at one year and 83.2% at five years. Five-year survival was 64.4% in the group with a large proximal aortic neck (≥25mm) and 76.5% in the group with a normal baseline
proximal aortic neck (<25mm).47
In 2012, the FDA approved the Medtronic Endurant™ II. Compared to the older Medtronic Endurant™ I design, it includes a lower-profile delivery system, longer limb lengths, and better delivery system visualization. No longterm follow-up study has been published yet, but good short-term results seem to reflect the changes in design.
Comparing the results of the INCRAFT® and Vascutek Anaconda™ with the other endografts is difficult because of the few published studies with a median follow up over 36 months. During the first years, there was a tendency to perform EVAR in higher risk patients. Although, for this study, only articles were selected that were published in the past 10 years,
2
studies are prospective nonrandomized controlled design studies or retrospective analyses of prospective databases. Each clinician has its own preferences and experience, consequently influencing the choice to use a specific endograft. When interpreting outcomes from retros-pective data, this selection bias might influence the results. When strictly adhering to IFU, this bias can be minimized, but a randomized control trial with long-term follow up would show the true difference between available endografts for infrarenal AAA repair.
Conclusion
Currently, there is a wide range of commercially available endografts for infrarenal abdominal aortic AAA repair. The long-term results of these devices are not fully clear but have possibly improved with the introduction of newer generation endografts for infrarenal AAA repair. Nevertheless, given the differences in stent and graft design, each endograft will need to prove its own long-term efficacy. This review provides an overview of long-term results and the implications of choosing one of these latest generation endografts.
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