The original publication is available at http://www,cvja.co.za/Includes bibliography.Background: Endovascular aneurysm repair (EVAR)
(using an Federal Drug Association-approved AneuRx®
device) compared to conventional surgical repair of
abdom inal aortic aneurysm (AAA) previously rendered
favourable outcomes regarding post-operative pain,
avoidence of laparotomy, and rapid rehabilitation and
hospital discharge in high-risk patients, including octagenarians.
Objectives: To assess the safety, reduction in aneurysmrelated
deaths, and interim survival data up to 72
months after AAA exclusion by endoluminal endografts
(EVAR).
Design: We carried out an open, controlled, prospective,
multidisciplinary EVAR study for the period 1998 to
2003 (six years). In the earlier part of the study, EVAR
was compared with previously published results of
conventional open aneurysmectomy surgery.
Setting: Heart Unit, Panorama Medi-Clinic, Parow,
South Africa.
Participants: We recruited adult male and female patients presenting with AAA and fulfilling the inclusion criteria
for endovascular repair, as recommended by the consensus
2003 meeting of the Vascular Association of South
Africa (VASSA). All patients were offered open surgery
as an alternative and were entered into the VASSA
EVAR trial registry. Pre-operatively, AAA anatomy was
assessed by spiral-computed tomography (CT), and
selectively with conventional angiography and intravascular
ultrasound (IVUS). Informed consent was obtained
in accordance with the recommendations of the Senate
of Surgery Paper 2, Ethical Guidelines, Great Britain
and Ireland. Patients underwent EVAR by a multidisciplinary
interventional team.
Interventions: Two hundred and seven adult patients
with AAA were assessed. Forty-four of the 207 (21.2%)
were excluded from EVAR because of irreversible comorbid
factors and complex aneurysm morphology. One
hundred and sixty-three patients (78%), with a mean
age of 70.7 years (range 60−91 years), underwent EVAR
(1998−2003). Five patients were lost to follow-up (3%).
Median AAA diameter was 56.9 mm and ASA ratings
were I, 1.2%; II, 15.9%; III, 57%; IV, 22.6%; and
V, 2.4%. EVAR was performed in high- and low-risk
categories of both sexes. Most patients were in ASA
groups III and IV.
Devices deployed: EVAR was performed using a selection
of endografts over 72 months − AneuRx® (Medtronic)
47; Talent® (Medtronic) 49; Vanguard® three; Zenith®
(Cook) one; Powerlink® (Endologix) 62; and other, one.
Results: Thirty-day outcome: successful deployment
99%, primary stent patency 97%, surgical conversion
0.6%, procedural or intra-operative mortality 1.2%,
30-day mortality 4.3%, endoleaks 1.84%, and secondary
intraprocedural endovascular interventions 24.5%. Perioperative
mortality was 3.1% (one aneurysm related).
One patient had suspected endograft infection. Late
mortality was 21.4% (35 patients due to co-morbidities,
and one was aneurysm related). Follow-up was a median
of 28.3 months (range 1−69 months). In 163 patients, two
persisting endoleaks (1.2%) were detected. Endotension
was detected in 3/163 (1.8%) with average sac increase of 0.8 cm. Conversion to open surgery was needed in one
patient (0.6%). Co-morbidities that contributed to late
mortality included multi-organ failure, ischaemic heart
disease (IHD), cardiomyopathy, renal failure, stroke and
cancer. One procedural rupture was fatal (0.6%). Two
late ruptures occurred; one was successfully endostented
and the other patient died after a failed surgical intervention
(0.6%).
Endovascular repair of AAA is more expensive than
conventional surgery. Introduction of the Endologix stent
has reduced operative time from 120 to 60 minutes in
un complicated patients. Newer-generation aortic stents
allow better control of negative remodeling and stent
migration.
Conclusion: A multidisciplinary team can safely perform
EVAR, with a low 30-day mortality rate in selected
patients graded ASA II−IV and with favourable aortic
aneurysm morphology. About 22% of patients with
AAA are not suited for EVAR. Persisting late endoleaks
occurred in 1.2% of the cohort study and were not device
specific. Life-long follow-up post EVAR is a prerequisite
to detect late device failure, endoleaks and aneurysm-sac
enlargement, and to assure the durability of these midterm
results. Short-term aneurysm rupture prevention
is a predictable outcome in high-risk groups.Publishers' versio
