over
the past three decades as a less invasive method compared to open surgical
repair and has become more popular in many international centres because of its
improved early survival and shorter hospital stays (3, 4). However,
this tempting modality is not without complications, such as vascular access
problems, endoleaks, stent kinking, and thrombosis (5, 6). In this
study, we investigated all the records for patients who underwent EVAR in our
unit over the past 4-year period.
METHODS
We retrospectively reviewed all the charts of the
patients who underwent elective EVAR for infra-renal AAA between January 2015 and
December 2019. The Institutional Review Board approved the study protocol for
the Royal Medical Services. Emergency EVAR, ruptured AAA, and dissected
aneurysms were excluded from our study cohort.
Patients’ relevant demographics, comorbidities, and
risk factors were collected (Table I), as well as important anatomical features,
including aneurysmal location and maximum dimension, size, and proximal length,
all of which we assessed carefully during our EVAR planning (Table II).
Patients with sizable AAA were
offered EVAR if they had a significant risk profile for undergoing open
surgical repair or upon the patient’s wishes and if they had favourable
aneurysmal anatomy. All patients had baseline angiographic computed tomography
(CT) to delineate the details of the AAA and plan the proper sizing. All
procedures were performed under local anaesthesia utilizing a percutaneous
approach, unless the open groin approach was needed. The Medtronic Endurant II
bifurcated stent graft (Medtronic International Ltd, Nasaco Tech Centre,
Singapore) was used in all the cases.
Outcomes during and early in the
post-procedure period were recorded, including early mortality, vascular access
complications, stent graft thrombosis or kinking, and type II endoleaks.
Table I: Baseline demographics and
comorbidities of the included patients
Baseline
patient characteristics
(n) (%)
|
EVAR (137)
|
Age,
Mean (SD)
|
71.6 (7.1)
|
Male
Sex
|
125 (91.2)
|
Smoking
|
106 (77.4)
|
Diabetes
Mellitus
|
58 (42)
|
Systemic
Hypertension
|
112 (81.2)
|
Kidney
Dysfunction (Creatinine > 2.0 dl/l)
|
5 (3.7)
|
Ischemic
Heart Disease
|
87 (63.5)
|
Chronic
Obstructive Pulmonary Disease
|
45 (32.9)
|
Dyslipidemia
|
65 (47.5)
|
Abbreviations: EVAR:
endovascular aortic repair, SD: standard deviation
RESULTS
During our study period, 137 patients had EVAR and
fulfilled our inclusion criteria. Two (1.5%) had early mortality after the
procedure: One patient had fatal acute myocardial infarction, and the other was
related to acute respiratory failure. Eight patients (5.8%) had femoral artery Pseudoaneurysms;
all of them were treated surgically by simple femoral arterial reconstruction. Eight
patients (5.8%) had early type II endoleaks, all of which were treated
conservatively; however, four of them needed late re-intervention after a 1-year
period. Four (2.9%) patients had early stent graft thrombosis. The average
hospital stay period was 2.1 days. All the outcomes are summarized in Table
III.
Table III. Early Outcomes after EVAR
Outcome
|
EVAR (137)
|
Early Mortality
|
2 (1.5)
|
Vascular Access Pseudoaneurysm
|
8 (5.8)
|
Endograft Thrombosis
|
4 (2.9)
|
Endoleak Type II
|
8 (5.8)
|
Length of Stay days, Mean, SD
|
2.1
|
Myocardial Infarction
|
1 (0.7)
|
Kidney Dysfunction
|
4 (1.5)
|
Abbreviations: EVAR:
endovascular aortic repair, SD: standard deviation
DISCUSSION
Since it was introduced in 1991 as a
treatment option for AAA, EVAR has been more widely utilized in the United
States (4). This
increasing tendency does not reflect a replacement of open surgical repair by
EVAR, but rather a complementary management for those patients with a higher
risk profile for undergoing open surgical repair. Early mortality was reported
in two cases (1.5%) in our cohort. Those patients had multiple comorbidities:
One had ischemic heart disease and chronic obstructive airway disease and
suffered from myocardial infarction early after the procedure, and the other
had acute respiratory failure and needed prolonged ventilation.
Our results in terms of early mortality are comparable
to those of other larger trials from multi-institutional reports, such as the
OVER trial (7-9). The reported
improved early survival in EVAR could be due to the less-invasive insertion
methods, such as the percutaneous technique utilizing local anaesthesia, and
the improved physiological profiles for the devices used, or it may be due to
the avoidance of aortic clamping, which is used in open surgical repair.
Endoleaks
are the most common troublesome outcome after EVAR, which may happen in up to
50% of patients in certain series (10). Type II
endoleaks are the most common variety to occur, and there are debates
surrounding the best management strategy amongst interventional radiologists
and vascular surgeons (11).
Recommendations by the Society of Vascular Surgeons indicated that conservative
treatment is acceptable, but intervention is needed if the sac expands by more
than 10 mm (12). Eight patients
developed early endoleaks, and all of them were managed conservatively initially;
however, re-interventions were needed in four patients via endovascular methods
later after a 1-year period.
Vascular
access complications such as iliofemoral dissection or even rupture and intimal
plaque disruption are well known and reported in association with the EVAR
procedure (13). Factors
that may predispose to this untoward outcome include heavy arterial
calcifications and tortuous, small-diameter femoral and iliac arteries (14). Our
series demonstrated eight cases of vascular injuries; all of them were managed
promptly by simple femoral artery reconstruction with the help of our vascular surgery
colleagues, and none of the patients had negative impacts on survival related
to this complication. Our planning and anticipation of such complications in
vulnerable patients and improving the skills amongst our team may lead to the
improvement in this outcome.
Graft thrombosis or graft limb
occlusion has been reported by many authors in the literature as a possible
negative outcome leading to re-interventions; factors related to graft
thrombosis include poor deployment of the distal limb of the endograft or stent
kinking (15). Luckily, only four (2.9%) patients
had early graft limb thrombosis in our cohort which comparable or even better
than reported in other studies (16), but to be fair, in our reporting,
long-term follow-up is needed to accurately assess this outcome, since many of
these cases of stent thrombosis have EVAR thrombosis during long-term follow-up.
We did
not include quality of life as an endpoint in our study. Patients who have
undergone open surgical repair can accept minor functional disabilities and
discomfort related to surgery, while patients who have had the EVAR procedure
expect themselves to recover quickly, so they cannot accept any deviation from
the norm. Thus, interpretation of this endpoint may be subject to patient
subjective reporting bias.
Our study
has some limitations that are worth mentioning. Being retrospective in nature meant
that some important patient data were missed. In addition, our data gathering was
limited to the index admission period without the important post-dismissal
relevant outcomes, which we think are crucial in assessing the functional
ability of the endograft over long-term follow up. Nevertheless, this study demonstrated several
valued strengths, which were derived from the referral hospital sample size,
absence of biased selection of the patients, and standardized methods of management
strategies.
CONCLUSION
Our experience with EVAR in the
treatment of AAA is encouraging. Early outcomes, including early mortality,
vascular access complications, and endoleaks, are comparable to what has been
reported in other trials and registries. We would like to stress the importance
of a national EVAR registry that includes long-term follow-up to demonstrate
the implant device’s function over a long period.
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