University of Groningen

Advances in complex endovascular aortic surgeryDijkstra, Martijn Leander

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chapter 1General introduction

General introduction

11

1General inTroducTion

advances in complex endovascular aortic surgery

In 1948 Dr Rudolph Nissen performed an exploratory laparotomy on one of the

most famous scientists of all time. He found that the patient suffered from an

abdominal aortic aneurysm. At the time treatment options were limited and

ligating the aorta had already been proven ineffective. He therefore ‘wrapped’

the aneurysm using cellophane hoping this would induce scar tissue formation

and reinforce the aneurysm wall. The patient, Dr Albert Einstein, recovered from

surgery and lived for several more years until 1955, when he developed severe

generalized abdominal pain and died. Autopsy confirmed a ruptured aneurysm.1

Historically, as illustrated by the first paragraph, surgical procedures for aortic

pathology were extensive and invasive. Most commonly for the abdominal aorta,

a midline incision and trans-peritoneal approach was used. Subsequent dissec-

tion of the retro-peritoneal space exposes the abdominal aorta, roughly from the

level of the renal arteries to the iliac bifurcation. Alternatively a retroperitoneal

approach can be used, which can be combined with a thoracotomy for more

proximal disease.2, 3 Until recent, this has been the mainstay of treatment for

both aneurysmal and occlusive aortic vascular disease. Needless to say, these

approaches carry considerable peri-operative morbidity and mortality rates.4

The most widely used definition for an abdominal aortic aneurysm is an abdomi-

nal aorta of more than 30 mm in diameter, measured perpendicular to the ves-

sel. The infra-renal aorta is most commonly affected, but aneurysms can extend

to (juxta-renal aneurysms) or beyond the renal arteries (supra-renal aneurysms)

in up to 15 % of cases.5, 6 Distally, concomitant common iliac aneurysms are

present in up to 20 % of the patients with an AAA.7 Pathogenesis is believed to

be multi-factorial but remains largely unclear.8, 9 Several risk factors have been

identified, including older age, male sex, Caucasian race, a family history of

aortic aneurysms, smoking and the presence of other large vessel aneurysms.5

The vast majority of AAA patients is asymptomatic and identified incidentally

upon physical examination or imaging studies. Symptomatic patients commonly

present with non-specific abdominal, back or flank pain. In case of a ruptured

aneurysm the classic presentation of severe abdominal pain radiating to the

back, hypotension and a palpable pulsatile abdominal mass is present in about

50 % of cases.5 Rupture of an aortic aneurysm is a surgical emergency and is

associated with very high morbidity and mortality rates.10 To prevent rupture

thresholds have been identified and for patients in whom the aneurysm reaches

12

Chapter 1

a certain diameter, elective treatment is the course of action. Current practice

guidelines encourage elective treatment for AAAs > 5.5 cm for men and > 5.0

cm for women, and for rapidly growing aneurysms (> 5 mm within 6 months).2, 3

If the indication for operative repair is established and the patient is deemed fit

to undergo an intervention, there are now mainly two options: open surgery or

endovascular repair. 2, 3 In 1952 Dubost et al. were the first to report an open

AAA repair and the use of a conduit to exclude the aneurysm and restore blood

flow. In this case, the thoracic aorta of a 20 year old female donor was used as a

bypass, at the time synthetic grafts were not available yet (Figure 1).11 Advances

Figure 1. Post-operative aortogram by Dubost et al.

General introduction

13

1in operative techniques and the development of synthetic bypass grafts (includ-

ing polyester (eg. Dacron) and polytetrafluoroethylene (PTFE) grafts) led to the

current open surgical treatment which has been the gold standard ever since.

The only real contra-indication for open surgical repair is extensive co-morbid

conditions with an unacceptable peri-operative mortality and morbidity risk.

Relative contra-indications include a hostile abdomen, obesity and limited life

expectancy.

In order to treat aortic disease without having to undergo major open surgery,

endovascular aortic surgery has been developed.12 In 1986 the first case of an

endovascular aneurysm repair was published by the Volodos et al.13 In the land-

mark study by Parodi et al.14 the treatment of 5 patients using an intraluminal,

stent-anchored, Dacron prosthetic graft with retrograde cannulation of the com-

mon femoral artery was described (Figures 2 and 3). Initially the technique was

utilized to treat patients deemed unfit for open surgery because of the novelty

of the procedures, lack of follow up data and unknown durability. However,

over the past two decades endovascular techniques and devices have evolved

rapidly. This has resulted in a valuable alternative to open surgery, which has

Figure 2. Schematic by Parodi et al. showing intra-luminal exclusion of an aneurysm by means of Dacron tubular grafts delivered through the transfemoral route.

14

Chapter 1

now become the mainstay of treatment for abdominal aortic aneurysms in the

United States and other parts of the Western World.15 Adverse anatomy is the

main limitation of EVAR. Ideally there should be adequate proximal and distal

landing zones without significant angulation. The exact anatomic criteria depend

on specific endograft instructions for use (IFU) as provided by the manufacturer.

If however the aneurysm extends up to, or beyond the visceral vessels, EVAR

falls short. Several more complex endovascular treatment options have been

developed to address this shortcoming, including fenestrated EVAR (FEVAR)16,

branched EVAR (BrEVAR)17, chimney EVAR (ChEVAR)18 and thoracic endovascular

aneurysm repair (TEVAR).19

One of the major issues with EVAR is the post-operative occurrence of endoleaks.

This occurs when there is persistent blood flow within the aneurysm sac after

endograft deployment. Five different types of endoleaks have been described,

depending on the origin of the leak (Table 1). Type II endoleaks are generally

considered benign, although rupture does occur in a very small proportion of

patients.20 Type I and III endoleaks do have a significant risk of aneurysm rup-

ture if left untreated.21 The correct identification of endoleaks is therefore very

important. Ideally, type I and III endoleaks should be identified peri-operatively

and treated where possible. With increasing complexity of endovascular pro-

Figure 3. Aortogram by Parodi et al. showing successful aneurysm exclusion 53 days after endograft implantation.

General introduction

15

1

cedures, conventional angiography can fall short and many centers perform a

pre-discharge CTA in these cases. The development of flat panel detectors with

cone beam CT capabilities have made it possible to obtain peri-operative CT-like

images.22 It was hypothesized this allows for accurate endoleak identification

and allow for prompt treatment. In addition, the cone beam CT images in

conjunction with a pre-operative CTA can be used for image fusion and supply

a roadmap. This in turn can facilitate target vessel cannulation and result in

decreased operative time, fluoroscopy and contrast dosage. In chapter 2 the

use of this novel technique to detect endoleaks and the possible benefits of a

roadmap were investigated.

For conventional EVAR, there are a number of commercially available endografts.

Having several device options gives the operator the advantage to choose an en-

dograft which best matches the patients’ anatomy. For FEVAR options have been

limited. The vast majority of patients have been treated using the Zenith custom-

made fenestrated endograft (Cook Medical Australia, Brisbane, Queensland,

Australia).23, 24 Alternative endografts have been launched recently, including

in 2011 the Fenestrated Anaconda (Vascutek, Renfrewshire, Scotland).25 This

custom-made endograft, based on the infrarenal Anaconda platform, has

potential advantages compared to the Zenith endograft, including the option

to reposition the endograft after initial deployment, less constraints in terms

of fenestration position and upper access for antegrade cannulation of target

vessels. In chapter 3 the initial experiences and short-term results with this new

endograft in the Netherlands are presented. In FEVAR, high-technical success

and good short-term results do not necessarily amount to a good treatment

option. Mid- and long-term complications do arise and re-intervention rates are

higher compared to open surgery.26 Longer term results will therefore ultimately

decide the performance and value of a new endograft. A follow up study was

Table 1. Endoleak classification.

Type of endoleak Origin

Type I Inadequate seal at graft ends

IA Proximal

IB Distal

IC Iliac occluder

Type II Branch vessels, e.g. lumbar or inferior mesenteric artery

Type III Disconnection of graft components

Type IV Porous graft

Type V Endotension, origin unclear

16

Chapter 1

undertaken and in chapter 4 the mid-term results of a larger cohort of patients

treated with the fenestrated Anaconda in the Netherlands are presented.

Both the Zenith and the fenestrated Anaconda endografts have extended the

applicability of EVAR. Both endografts are however custom made and typically

require 6 to 8 weeks to manufacture, which precludes their use in an acute set-

ting. This presents a problem in patients presenting with either a symptomatic or

a ruptured aneurysm that are not suitable for both conventional EVAR and open

surgery. Off-the-shelf fenestrated endografts are being developed and used in

clinical trials, but are still bound to anatomical restrictions. For these patients

other ‘bailout’ procedures have been developed. The chimney EVAR (Ch-EVAR)

procedure was initially used to treat unintentionally overstented target vessels

during FEVAR27, 28 and has successfully been used in patients with juxtarenal

aneurysms in urgent and emergency settings.29, 30 A caveat of this technique

is the occurrence of so called ‘gutters’ between the chimney graft, the main

graft and the aortic wall, resulting in endoleaks.31, 32 Combining the chimney

technique with another novel technique called endovascular aneurysm sealing

(EVAS) might resolve this. EVAS uses dual balloon-expandable stents surrounded

by polymer-filled endobags (Nellix endoprosthesis, Endologix, Irvine, California,

USA) which fill the aneurysm sac.33, 34 In chapter 5 the feasibility of the combined

use of chimney grafts and EVAS is investigated in two patients deemed unsuit-

able for FEVAR and open surgery.

As for aneurysmal disease, the gold standard for treatment of aorto-iliac oc-

clusive disease has been open surgery and carries much the same morbidity and

mortality risks.35 Parallel to the growing experience and evolving endovascular

techniques in aneurysmal disease, progress has been made for the treatment

of occlusive disease as well.36 The Inter-society Consensus for the Management

of Peripheral Arterial Disease (TASC II)37 guideline recommends endovascular

treatment for TASC A and B lesions, and open surgery for TASC C and D (if

the operative risk is acceptable). Recent studies on endovascular treatment of

aorto-iliac occlusive disease have shown high primary and secondary patency

rates (87 % and 95 %) in patients with TASC C and D lesions using the covered

endovascular repair of the aortic bifurcation (CERAB) technique.38 A prerequisite

for successful treatment is a disease free proximal landing zone. Disease extend-

ing up to, or beyond, the visceral vessels precludes endovascular treatment. In

chapter 6 the feasibility of the chimney technique combined with the CERAB to

extend the proximal landing zone was explored.

Lower morbidity and mortality rates are the main reason for pursuing and

pushing the boundaries of endovascular treatment. Overall survival benefits

General introduction

17

1are however debated. Patients often have extensive co-morbid conditions and

survival seems to be largely dependent on non-aneurysm related events, which

might warrant a conservative strategy in high risk patients.39–41 This is based on

fairly dated trials (published in 2005). Current practice has improved in terms

of advanced imaging, improved devices, increased operator experience and

patient selection, advances in peri-operative cardiopulmonary care and treat-

ment of peri-operative adverse events. It was hypothesized this led to a decrease

in peri-operative morbidity and mortality, even in high risk patients. Chapter 7

describes the outcomes of a large cohort of real-world high risk patients treated

with conventional EVAR, specifically in terms of technical success, morbidity and

30-day and 1-year mortality.

Having the opportunity to treat extensive segments of the aorta by endovascular

means does come with specific complications. Spinal cord ischemia (SCI) and

concomitant paraplegia after endovascular aneurysm repair is one of the most

dreaded complications, which is especially relevant after TEVAR.42–44 This has

been the scope of extensive research and several preventive measures have been

explored (spinal fluid drainage, avoidance of hypotension, staged repair, permis-

sive endoleak, and hypothermia) but no optimal preventive strategy has been

established. Guidelines mention some of these, but are not uniform. Chapter 8

aims to provide an overview of preventive measures used and their effectiveness

to prevent spinal cord ischemia after TEVAR and recommend an optimal preven-

tive strategy based on the available data.

Finally, the results of the studies are summarized and future perspectives dis-

cussed in Chapters 9 and 10, in English and Dutch, respectively.

18

Chapter 1

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