University of Groningen

Endovascular approaches to complex aortic aneurysmsde Niet, Arne

DOI:10.33612/diss.111895510

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CHAPTER

General introduction

1

Chap

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8

1General introduction 9

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

Chap

ter

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10

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

Figure 2: The first description of using an interposition graft by Dr. Charles Dubost in 1951.12

1General introduction 11

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

Chap

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12

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

the first introduced fenestrated endograft and contains circular stainless steel Z-stents and

1General introduction 13

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

Chap

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1

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

1General introduction 15

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

Chap

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