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1.  Novel Treatment of an Enlarging Internal Iliac Artery Aneurysm in Association with a Type 2 Endoleak via Percutaneous Embolisation of the Superior Gluteal Artery through a Posterior Approach 
Internal iliac artery (IIA) aneurysms, while rare, carry a significant risk of mortality if they rupture. Endovascular intervention is now the preferred method of treatment for IIAs; however, due to technical considerations, this is not always feasible. We report a case of a patient who developed an enlarging IIA aneurysm in association with a type 2 endoleak supplied by multiple feeding arteries where conventional endovascular treatment was not possible. A novel method of effectively treating the IIA aneurysm with a posterior approach via image-guided puncture of the superior gluteal artery was employed. Five arteries supplying the superior gluteal from the contralateral internal iliac artery were selectively catheterised and coiled before the aneurysmal sac was embolised. The patient made an uneventful recovery, and follow-up imaging demonstrated resolution of the endoleak and decompression of the aneurysmal sac. This case demonstrates that the posterior approach is a safe and viable method of treating internal iliac artery aneurysm when traditional endovascular approaches are technically possible.
PMCID: PMC3694376  PMID: 23841015
2.  Endovascular Repair of Descending Thoracic Aortic Aneurysm 
Executive Summary
To conduct an assessment on endovascular repair of descending thoracic aortic aneurysm (TAA).
Clinical Need
Aneurysm is the most common condition of the thoracic aorta requiring surgery. Aortic aneurysm is defined as a localized dilatation of the aorta. Most aneurysms of the thoracic aorta are asymptomatic and incidentally discovered. However, TAA tends to enlarge progressively and compress surrounding structures causing symptoms such as chest or back pain, dysphagia (difficulty swallowing), dyspnea (shortness of breath), cough, stridor (a harsh, high-pitched breath sound), and hoarseness. Significant aortic regurgitation causes symptoms of congestive heart failure. Embolization of the thrombus to the distal arterial circulation may occur and cause related symptoms. The aneurysm may eventually rupture and create a life-threatening condition.
The overall incidence rate of TAA is about 10 per 100,000 person-years. The descending aorta is involved in about 30% to 40% of these cases.
The prognosis of large untreated TAAs is poor, with a 3-year survival rate as low as 25%. Intervention is strongly recommended for any symptomatic TAA or any TAA that exceeds twice the diameter of a normal aorta or is 6 cm or larger. Open surgical treatment of TAA involves left thoracotomy and aortic graft replacement. Surgical treatment has been found to improve survival when compared with medical therapy. However, despite dramatic advances in surgical techniques for performing such complex operations, operative mortality from centres of excellence are between 8% and 20% for elective cases, and up to 50% in patients requiring emergency operations. In addition, survivors of open surgical repair of TAAs may suffer from severe complications. Postoperative or postprocedural complications of descending TAA repair include paraplegia, myocardial infarction, stroke, respiratory failure, renal failure, and intestinal ischemia.
The Technology
Endovascular aortic aneurysm repair (EVAR) using a stent graft, a procedure called endovascular stent-graft (ESG) placement, is a new alternative to the traditional surgical approach. It is less invasive, and initial results from several studies suggest that it may reduce mortality and morbidity associated with the repair of descending TAAs.
The goal in endovascular repair is to exclude the aneurysm from the systemic circulation and prevent it from rupturing, which is life-threatening. The endovascular placement of a stent graft eliminates the systemic pressure acting on the weakened wall of the aneurysm that may lead to the rupture. However, ESG placement has some specific complications, including endovascular leak (endoleak), graft migration, stent fracture, and mechanical damage to the access artery and aortic wall.
The Talent stent graft (manufactured by Medtronic Inc., Minneapolis, MN) is licensed in Canada for the treatment of patients with TAA (Class 4; licence 36552). The design of this device has evolved since its clinical introduction. The current version has a more flexible delivery catheter than did the original system. The prosthesis is composed of nitinol stents between thin layers of polyester graft material. Each stent is secured with oversewn sutures to prevent migration.
Review Strategy
To compare the effectiveness and cost-effectiveness of ESG placement in the treatment of TAAs with a conventional surgical approach
To summarize the safety profile and effectiveness of ESG placement in the treatment of descending TAAs
Measures of Effectiveness
Primary Outcome
Mortality rates (30-day and longer term)
Secondary Outcomes
Technical success rate of introducing a stent graft and exclusion of the aneurysm sac from systemic circulation
Rate of reintervention (through surgical or endovascular approach)
Measures of Safety
Complications were categorized into 2 classes:
Those specific to the ESG procedure, including rates of aneurysm rupture, endoleak, graft migration, stent fracture, and kinking; and
Those due to the intervention, either surgical or endovascular. These include paraplegia, stroke, cardiovascular events, respiratory failure, real insufficiency, and intestinal ischemia.
Inclusion Criteria
Studies comparing the clinical outcomes of ESG treatment with surgical approaches
Studies reporting on the safety and effectiveness of the ESG procedure for the treatment of descending TAAs
Exclusion Criteria
Studies investigating the clinical effectiveness of ESG placement for other conditions such as aortic dissection, aortic ulcer, and traumatic injuries of the thoracic aorta
Studies investigating the aneurysms of the ascending and the arch of the aorta
Studies using custom-made grafts
Literature Search
The Medical Advisory Secretariat searched The International Network of Agencies for Health Technology Assessment and the Cochrane Database of Systematic Reviews for health technology assessments. It also searched MEDLINE, EMBASE, Medline In-Process & Other Non-Indexed Citations, and Cochrane CENTRAL from January 1, 2000 to July 11, 2005 for studies on ESG procedures. The search was limited to English-language articles and human studies.
One health technology assessment from the United Kingdom was identified. This systematic review included all pathologies of the thoracic aorta; therefore, it did not match the inclusion criteria. The search yielded 435 citations; of these, 9 studies met inclusion criteria.
Summary of Findings
The results of a comparative study found that in-hospital mortality was not significantly different between ESG placement and surgery patients (2 [4.8%] for ESG vs. 6 [11.3%] for surgery).
Pooled data from case series with a mean follow-up ranging from 12 to 38 months showed a 30-day mortality and late mortality rate of 3.9% and 5.5%, respectively. These rates are lower than are those reported in the literature for surgical repair of TAA.
Case series showed that the most common cause of early death in patients undergoing endovascular repair is aortic rupture, and the most common causes of late death are cardiac events and aortoesophageal or aortobronchial fistula.
Technical Success Rate
Technical success rates reported by case series are 55% to 100% (100% and 94.4% in 2 studies with all elective cases, 89% in a study with 5% emergent cases, and 55% in a study with 42% emergent cases).
Surgical Reintervention
In the comparative study, 3 (7.1%) patients in the ESG group and 14 (26.5%) patients in the surgery group required surgical reintervention. In the ESG group, the reasons for surgical intervention were postoperative bleeding at the access site, paraplegia, and type 1 endoleak. In the surgical group, the reasons for surgery were duodenal perforation, persistent thoracic duct leakage, false aneurysm, and 11 cases of postoperative bleeding.
Pooled data from case series show that 9 (2.6%) patients required surgical intervention. The reasons for surgical intervention were endoleak (3 cases), aneurysm enlargement and suspected infection (1 case), aortic dissection (1 case), pseudoaneurysm of common femoral artery (1 case), evacuation of hematoma (1 case), graft migration (1 case), and injury to the access site (1 case).
Endovascular Revision
In the comparative study, 3 (7.1%) patients required endovascular revision due to persistent endoleak.
Pooled data from case series show that 19 (5.3%) patients required endovascular revision due to persistent endoleak.
Graft Migration
Two case series reported graft migration. In one study, 3 proximal and 4 component migrations were noted at 2-year follow-up (total of 5%). Another study reported 1 (3.7%) case of graft migration. Overall, the incidence of graft migration was 2.6%.
Aortic Rupture
In the comparative study, aortic rupture due to bare stent occurred in 1 case (2%). The pooled incidence of aortic rupture or dissection reported by case series was 1.4%.
Postprocedural Complications
In the comparative study, there were no statistically significant differences between the ESG and surgery groups in postprocedural complications, except for pneumonia. The rate of pneumonia was 9% for those who received an ESG and 28% for those who had surgery (P = .02). There were no cases of paraplegia in either group. The rate of other complications for ESG and surgery including stroke, cardiac, respiratory, and intestinal ischemia were all 5.1% for ESG placement and 10% for surgery. The rate for mild renal failure was 16% in the ESG group and 30% in the surgery group. The rate for severe renal failure was 11% for ESG placement and 10% for surgery.
Pooled data from case series show the following postprocedural complication rates in the ESG placement group: paraplegia (2.2%), stroke (3.9%), cardiac (2.9%), respiratory (8.7%), renal failure (2.8%), and intestinal ischemia (1%).
Time-Related Outcomes
The results of the comparative study show statistically significant differences between the ESG and surgery group for mean operative time (ESG, 2.7 hours; surgery, 5 hours), mean duration of intensive care unit stay (ESG, 11 days; surgery, 14 days), and mean length of hospital stay (ESG, 10 days; surgery, 30 days).
The mean duration of intensive care unit stay and hospital stay derived from case series is 1.6 and 7.8 days, respectively.
Ontario-Based Economic Analysis
In Ontario, the annual treatment figures for fiscal year 2004 include 17 cases of descending TAA repair procedures (source: Provincial Health Planning Database). Fourteen of these have been identified as “not ruptured” with a mean hospital length of stay of 9.23 days, and 3 cases have been identified as “ruptured,” with a mean hospital length of stay of 28 days. However, because one Canadian Classification of Health Interventions code was used for both procedures, it is not possible to determine how many were repaired with an EVAR procedure or with an open surgical procedure.
Hospitalization Costs
The current fiscal year forecast of in-hospital direct treatment costs for all in-province procedures of repair of descending TAAs is about $560,000 (Cdn). The forecast in-hospital total cost per year for in-province procedures is about $720,000 (Cdn). These costs include the device cost when the procedure is EVAR (source: Ontario Case Costing Initiative).
Professional (Ontario Health Insurance Plan) Costs
Professional costs per treated patient were calculated and include 2 preoperative thoracic surgery or EVAR consultations.
The professional costs of an EVAR include the fees paid to the surgeons, anesthetist, and surgical assistant (source: fee service codes). The procedure was calculated to take about 150 minutes.
The professional costs of an open surgical repair include the fees of the surgeon, anesthetist, and surgical assistant. Open surgical repair was estimated to take about 300 minutes.
Services provided by professionals in intensive care units were also taken into consideration, as were the costs of 2 postoperative consultations that the patients receive on average once they are discharged from the hospital. Therefore, total Ontario Health Insurance Plan costs per treated patient treated with EVAR are on average $2,956 (ruptured or not ruptured), as opposed to $5,824 for open surgical repair and $6,157 for open surgical repair when the aneurysm is ruptured.
Endovascular stent graft placement is a less invasive procedure for repair of TAA than is open surgical repair.
There is no high-quality evidence with long-term follow-up data to support the use of EVAR as the first choice of treatment for patients with TAA that are suitable candidates for surgical intervention.
However, short- and medium-term outcomes of ESG placement reported by several studies are satisfactory and comparable to surgical intervention; therefore, for patients at high risk of surgery, it is a practical option to consider. Short- and medium-term results show that the benefit of ESG placement over the surgical approach is a lower 30-day mortality and paraplegia rate; and shorter operative time, ICU stay, and hospital stay.
PMCID: PMC3382300  PMID: 23074469
3.  Endovascular aneurysm repair in emergent ruptured abdominal aortic aneurysm with a ‘real’ hostile neck and severely tortuous iliac artery of an elderly patient 
BMC Surgery  2014;14:11.
Endovascular aneurysm repair (EVAR) has been a revolutionary development in the treatment of abdominal aortic aneurysms (AAAs). Meanwhile, unfavorable anatomy of the aneurysm has always been a challenge to vascular surgeons, and the application of EVAR in emergent and elderly patients are still in dispute.
Case presentation
A 79-year-old woman presented as an emergency of abdominal pain with acute hypotension, heart rate elevation and a rapid decrease of hemoglobin. Emergent computed tomographic angiography (CTA) showed a ruptured AAA (rAAA) extending from below the opening of bilateral renal arteries down to the celiac artery and elongated to both common iliac arteries. The hostile neck and severely tortuous iliac artery made the following procedure a great challenge. An emergent endovascular approach was performed in which an excluder aortic main body was deployed below the origin of the bilateral renal arteries covering the ruptured aortic segment. Two iliac legs were placed superior to the opening of the right hypogastric respectively. In order to avoid the type Ib endoleak, we tried to deploy another cuff above the bifurcation of the iliac artery. However, the severely tortuous right iliac artery made this procedure extremely difficult, and a balloon-assisted technique was used in order to keep the stiff wire stable. Another iliac leg was placed above the bifurcation of the left iliac artery. The following angiography showed a severe Ia endoleak in the proximal neck and therefore, a cuff was deployed distal to opening of the left renal artery with off-the-shelf solution. The patient had an uneventful recovery with a resolution of the rAAA. She is well and symptom-free 6 months later.
Endovascular aneurysm repair (EVAR) in emergent elderly rAAA with hostile neck and severe tortuous iliac artery is extremely challenging, and endovascular management with integrated technique is feasible and may achieve a satisfactory early result.
PMCID: PMC4016293  PMID: 24597740
Endovascular aneurysm repair (EVAR); Ruptured abdominal aortic aneurysm (rAAA); Hostile anatomy; Elderly patient
4.  Endovascular management of the patent inferior mesenteric artery in two cases of uncontrolled type II endoleak after endovascular aneurysm repair 
Endovascular aneurysm repair (EVAR) has well documented advantages over traditional open repair and has been widely adopted as the alternative treatment modality for abdominal aortic aneurysm. However, endoleaks specifically type II can be a significant problem with this technique leading to aortic sac expansion and potential rupture. A large number of type II endoleaks are caused by persistent inferior mesenteric artery (IMA) retrograde bleeding. Various methods to try to manage this complication have been previously described. IMA embolization via the marginal artery of Drummond, however, has not been adequately popularized as an alternative less invasive approach to the treatment of type II endoleak.
Case Report:
Two men, ages 77 and 81, underwent uneventful EVAR for 5.5 and 5.0 cm infrarenal abdominal aortic aneurysms, respectively, using Zenith Cook® bifurcated stent grafts. Computed tomography angiography at 1 and 6 months postoperatively demonstrated small type II endoleaks in both cases which were followed clinically. Subsequent follow-up tomography scan at 12 months revealed persistent type II endoleaks related to retrograde filling from the IMA with significant enlargement of the aneurysm sacs. Both patients underwent successful IMA coil embolization via the marginal artery of Drummond.
Percutaneous IMA embolization using standard endovascular techniques to access the marginal artery of Drummond is an alternative, and in our opinion, preferred technique for controlling type II endoleaks caused by a persistently patent IMA.
PMCID: PMC3234148  PMID: 22171248
Endoleak; marginal artery; drummond; coil embolization
5.  Endovascular Repair of Abdominal Aortic Aneurysm 
The Medical Advisory Secretariat conducted a systematic review of the evidence on the effectiveness and cost-effectiveness of endovascular repair of abdominal aortic aneurysm in comparison to open surgical repair. An abdominal aortic aneurysm [AAA] is the enlargement and weakening of the aorta (major blood artery) that may rupture and result in stroke and death. Endovascular abdominal aortic aneurysm repair [EVAR] is a procedure for repairing abdominal aortic aneurysms from within the blood vessel without open surgery. In this procedure, an aneurysm is excluded from blood circulation by an endograft (a device) delivered to the site of the aneurysm via a catheter inserted into an artery in the groin. The Medical Advisory Secretariat conducted a review of the evidence on the effectiveness and cost-effectiveness of this technology. The review included 44 eligible articles out of 489 citations identified through a systematic literature search. Most of the research evidence is based on non-randomized comparative studies and case series. In the short-term, EVAR appears to be safe and comparable to open surgical repair in terms of survival. It is associated with less severe hemodynamic changes, less blood transfusion and shorter stay in the intensive care and hospital. However, there is concern about a high incidence of endoleak, requiring secondary interventions, and in some cases, conversion to open surgical repair. Current evidence does not support the use of EVAR in all patients. EVAR might benefit individuals who are not fit for surgical repair of abdominal aortic aneurysm and whose risk of rupture of the aneurysm outweighs the risk of death from EVAR. The long-term effectiveness and cost-effectiveness of EVAR cannot be determined at this time. Further evaluation of this technology is required.
The objective of this health technology policy assessment was to determine the effectiveness and cost-effectiveness of endovascular repair of abdominal aortic aneurysms (EVAR) in comparison to open surgical repair (OSR).
Clinical Need
An abdominal aortic aneurysm (AAA) is a localized, abnormal dilatation of the aorta greater than 3 cm or 50% of the aortic diameter at the diaphragm. (1) A true AAA involves all 3 layers of the vessel wall. If left untreated, the continuing extension and thinning of the vessel wall may eventually result in rupture of the AAA. The risk of death from ruptured AAA is 80% to 90%. (61) Heller et al. (44) analyzed information from a national hospital database in the United States. They found no significant change in the incidence rate of elective AAA repair or ruptured AAA presented to the nation’s hospitals. The investigators concluded that technologic and treatment advances over the past 19 years have not affected the outcomes of patients with AAAs, and the ability to identify and to treat patients with AAAs has not improved.
Classification of Abdominal Aortic Aneurysms
At least 90% of the AAAs are affected by atherosclerosis, and most of these aneurysms are below the level of the renal arteries.(1)
An abdominal aortic aneurysm may be symptomatic or asymptomatic. An AAA may be classified according to their sizes:(7)
Small aneurysms: less than 5 cm in diameter.
Medium aneurysms: 5-7cm.
Large aneurysms: more than 7 cm in diameter.
Small aneurysms account for approximately 50% of all clinically recognized aneurysms.(7)
Aortic aneurysms may be classified according to their gross appearance as follows (1):
Fusiform aneurysms affect the entire circumference of a vessel, resulting in a diffusely dilated lesion
Saccular aneurysms involve only a portion of the circumference, resulting in an outpouching (protrusion) in the vessel wall.
Prevalence of Abdominal Aortic Aneurysms
In community surveys, the prevalence of AAA is reported to be between 1% and 5.4%. (61) The prevalence is related to age and vascular risk factors. It is more common in men and in those with a positive family history.
In Canada, Abdominal aortic aneurysms are the 10th leading cause of death in men 65 years of age or older. (60) Naylor (60) reported that the rate of AAA repair in Ontario has increased from 38 per 100,000 population in 1981/1982 to 54 per 100,000 population in 1991/1992. For the period of 1989/90 to 1991/92, the rate of AAA repair in Ontarians age 45 years and over was 53 per 100,000. (60) In the United States, about 200,000 new cases are diagnosed each year, and 50,000 to 60,000 surgical AAA repairs are performed. (2) Ruptured AAAs are responsible for about 15,000 deaths in the United States annually. One in 10 men older than 80 years has some aneurysmal change in his aorta. (2)
Symptoms of Abdominal Aortic Aneurysms
AAAs usually do not produce symptoms. However, as they expand, they may become painful. Compression or erosion of adjacent tissue by aneurysms also may cause symptoms. The formation of mural thrombi, a type of blood clots, within the aneurysm may predispose people to peripheral embolization, where blood vessels become blocked. Occasionally, an aneurysm may leak into the vessel wall and the periadventitial area, causing pain and local tenderness. More often, acute rupture occurs without any prior warning, causing acute pain and hypotension. This complication is always life-threatening and requires an emergency operation.
Diagnosis of Abdominal Aortic Aneurysms
An AAA is usually detected on routine examination as a palpable, pulsatile, and non-tender mass. (1)
Abdominal radiography may show the calcified outline of the aneurysms; however, about 25% of aneurysms are not calcified and cannot be visualized by plain x-ray. (1) An abdominal ultrasound provides more accurate detection, can delineate the traverse and longitudinal dimensions of the aneurysm, and is useful for serial documentation of aneurysm size. Computed tomography and magnetic resonance have also been used for follow-up of aortic aneurysms. These technologies, particularly contrast-enhanced computer tomography, provide higher resolution than ultrasound.
Abdominal aortography remains the gold standard to evaluate patients with aneurysms for surgery. This technique helps document the extent of the aneurysms, especially their upper and lower limits. It also helps show the extent of associated athereosclerotic vascular disease. However, the procedure carries a small risk of complications, such as bleeding, allergic reactions, and atheroembolism. (1)
Prognosis of Abdominal Aortic Aneurysms
The risk of rupture of an untreated AAA is a continuous function of aneurysm size as represented by the maximal diameter of the AAA. The annual rupture rate is near zero for aneurysms less than 4 cm in diameter. The risk is about 1% per year for aneurysms 4 to 4.9 cm, 11% per year for aneurysms 5 to 5.9 cm, and 25% per year or more for aneurysms greater than 6 cm. (7)
The 1-year mortality rate of patients with AAAs who do not undergo surgical treatment is about 25% if the aneurysms are 4 to 6 cm in diameter. This increases to 50% for aneurysms exceeding 6 cm. Other major causes of mortality for people with AAAs include coronary heart disease and stroke.
Treatment of Abdominal Aortic Aneurysms
Treatment of an aneurysm is indicated under any one of the following conditions:
The AAA is greater than 6 cm in diameter.
The patient is symptomatic.
The AAA is rapidly expanding irrespective of the absolute diameter.
Open surgical repair of AAA is still the gold standard. It is a major operation involving the excision of dilated area and placement of a sutured woven graft. The surgery may be performed under emergent situation following the rupture of an AAA, or it may be performed electively.
Elective OSR is generally considered appropriate for healthy patients with aneurysms 5 to 6 cm in diameter. (7) Coronary artery disease is the major underlying illness contributing to morbidity and mortality in OSR. Other medical comorbidities, such as chronic renal failure, chronic lung disease, and liver cirrhosis with portal hypertension, may double or triple the usual risk of OSR.
Serial noninvasive follow-up of small aneurysms (less than 5 cm) is an alternative to immediate surgery.
Endovascular repair of AAA is the third treatment option and is the topic of this review.
PMCID: PMC3387737  PMID: 23074438
6.  Fenestrated Endovascular Grafts for the Repair of Juxtarenal Aortic Aneurysms 
Executive Summary
Endovascular repair of abdominal aortic aneurysm (AAA) allows the exclusion of the dilated aneurismal segment of the aorta from the systematic circulation. The procedure requires, however, that the endograft extends to the healthy parts of the aorta above and below the aneurysm, yet the neck of a juxtarenal aortic aneurysm (JRA) is too short for a standard endovascular repair. Fenestrated endovascular aortic repair (f—EVAR) provides a solution to overcome this problem by enabling the continuation of blood flow to the renal and visceral arteries through holes or ‘fenestrations’ in the graft. These fenestrations are designed to match the ostial diameter of the renal and visceral arteries.
There are three varieties fenestration, small, large, and scallop, and their location needs to be customized to fit the anatomy of the patient. If the device is not properly designed, if the alignment is inaccurate, or if the catheterization of the visceral arteries is not possible, the procedure may fail. In such cases, conversion to open surgery may become the only option as fenestrated endografts are not retrievable.
It is recommended that a stent be placed within each small fenestration to the target artery to prevent shuttering of the artery or occlusion. Many authors have noted an increased risk of vessel occlusion in unstented fenestrations and scallops.
Once placed in a patient, life-long follow-up at regular intervals is necessary to ensure the graft remains in its intended location, and that the components have adequate overlap. Should the need arise, routine follow-up allows the performance of timely and appropriate intervention through detection of events that could impact the long-term outcomes.
Alternative Technology
The technique of fenestrated endovascular grafting is still in evolution and few studies have been with published mid-term outcome data. As the technique become more common in vascular surgery practices, it will be important to determine if it can provide better outcomes than open surgical repair (OSR).
In an OSR approach, aortic clamping above one or both renal arteries, or above the visceral arteries, is required. The higher the level of aortic clamping, the greater the risk of cardiac stress and renal or visceral ischemia. During suprarenal or supraceliac aortic clamping, strain-induced myocardial ischemia may also occur due to concomitant rise in cardiac afterload and a decrease in cardiac output. Reports indicate that 6% of patients undergoing surgical repair develop myocardial infarction. The ideal level of clamp location remains controversial with conflicting views having been reported.
A search of electronic databases (OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library, and the International Agency for Health Technology Assessment [INAHTA] database was undertaken to identify evidence published from January 1, 2004 to December 19, 2008. The search was limited to English-language articles and human studies. The automatic search alerts were received and reviewed up to March 23, 2009.
The literature search and automatic search update identified 320 citations, of which 13 met inclusion/exclusion criteria. One comparative study presented at an international seminar, five single-arm studies on f—EVAR, and 7 studies on OSR (one prospective and six retrospective) were considered for this analysis.
To grade the strength of the body of evidence, the grading system formulated by the GRADE working group and adopted by MAS, was applied. The GRADE system classifies evidence quality as high (Grade A), moderate (Grade B), or low (Grade C) according to four key elements: study design, study quality, consistency across studies, and directness.
A summary of the characteristics of the f—EVAR and OSR studies found through the literature search is shown in Table ES-1.
Patient Characteristics: f–EVAR Studies versus OSR Studies
JRA, Juxtarenal aortic aneurysm; SRA, Suprarenal aortic aneurysm; TAA, Thoracic aortic aneurysm
Mortality Outcomes
The pooled estimate for 30-day mortality was 1.8% among the f—EVAR studies and 3.1% among the OSR studies that reported data for the repair of JRA separately. The pooled estimate for late mortality was 12.8% among the f—EVAR studies and 23.7% among the OSR studies that reported data for JRA separately.
Visceral Artery Events Reported in f—EVAR Studies
Renal Events during f-EVAR
A total of three main renal arteries and two accessory renal arteries became occluded during the procedure. These were all due to technical issues, except one accessory renal artery in which the artery was intentionally covered. One patient required open surgery following the procedure.
Renal Events During the follow-up
A total of 12 renal arteries (12 patients) were found to be occluded during follow-up. In two patients, the same side accessory renal artery was also occluded. Four (1.5%) patients lost one kidney and five (2.3%) patients underwent dialysis, three (1.4%) of which became permanent.
A total of 16 cases of renal artery stenosis (16 patients) occurred during follow-up. Eight of these were treated and eight were observed. Segmental renal infarcts were found in six patients but renal function was not impaired.
Mesenteric Events during f-EVAR
Three mesenteric events occurred during the f—EVAR procedures resulting in two deaths. One patient developed bowel ischemia due to embolization of the superior mesenteric artery (SMA); this patient died 13 days after the procedure from multiorgan failure. One patient died eights days after the procedure from mesenteric ischemia and bowel perforation. The third SMA event occurred during surgery with subsequent occlusion in early follow-up.
Mesenteric Events during Follow-up
During follow-up, five (1.8%) SMA occlusions/partial occlusions and one SMA stenosis were noted. Three of the five patients with SMA occlusion/partial occlusion remained asymptomatic and no further intervention was necessary. One patient underwent SMA bypass surgery and in two patients, the problem solved by SMA stenting. A summary of the outcomes reported in the f—EVAR and OSR studies is shown in Table ES-2.
Summary of Outcomes: Fenestrated Endovascular Graft Versus Open Surgical Repair for Treatment of Juxtarenal Aortic Aneurysm
Short- and medium-term results (up to 2 years) of f—EVAR for the repair of JRA showed that outcomes in f—EVAR series compare favourably with the figures for the OSR series; however, uncertainty remains regarding the long-term results. The following observations are based on low quality evidence.
F—EVAR has lower 30-day mortality than OSR (1.8% vs. 3.1%) and a lower late-mortality over the period of time that patients have been followed (12.8% vs. 23.7%).
There is a potential for the loss of target vessels during or after f—EVAR procedures. Loss of a target vessel may lead to loss of its respective end organ. The risk associated with this technique is mainly due to branch vessel ischemia or occlusion (primarily among the renal arteries and SMA). Ischemia or occlusion of these arteries can occur during surgery due to technical failure and/or embolization or it may occur during follow-up due to graft complications such as graft migration, component separation, or arterial thrombosis. The risk of kidney loss in this series of f—EVAR studies was 1.5% and the risk of mesenteric ischemia was 3.3%. In the OSR studies, the risk of developing renal insufficiency was 14.4% and the risk of mesenteric ischemia was 2.9%.
F—EVAR has a lower rate of postoperative cardiac and pulmonary complications.
Endoleak occurs in 22.5% of patients undergoing f—EVAR (all types) and about 8% of these require treatment. Most of the interventions performed to treat such endoleaks conducted using a minimally invasive approach.
Due to the complexity of the technique, patients must be appropriately selected for f—EVAR, the procedure performed by highly experienced operators, and in centers with advanced, high-resolution imaging systems to minimize the risk of complications.
Graft fenestrations have to be custom designed for each patient to fit and match the anatomy of their visceral arteries. Planning and sizing thus requires scrutiny of the target vessels with a high degree precision. This is important not only to prevent end organ ischemia and infarction, but to avoid prolonging procedures and subsequent adverse outcomes.
Assuming the average cost range of FEVAR procedure is $24,395-$30,070 as per hospital data and assuming the maximum number of annual cases in Ontario is 116, the average estimated cost impact range to the province for FEVAR procedures is $2.83M-$3.49M annually.
PMCID: PMC3377528  PMID: 23074534
7.  A Comparative Study of Bell-Bottom Technique versus Hypogastric Exclusion for the Treatment of Aneurysmal Extension to the Iliac Bifurcation 
Journal of Vascular Surgery  2012;55(4):956-962.
A significant proportion of patients undergoing endovascular aneurysm repair (EVAR) have common iliac artery aneurysms (CIAA). Aneurysmal involvement at the iliac bifurcation potentially undermines long-term durability.
Patients who underwent EVAR with CIAA were identified in two teaching hospitals. Bell-bottom technique (iliac limb ≥ 20mm) (BBT) or internal iliac artery embolization and limb extension to the external iliac artery (IIE+EE) were used. Outcome between these two approaches are compared.
One hundred and eighty five patients were identified. . Indication for EVAR included asymptomatic AAA (n=157), symptomatic or ruptured aneurysm (n=19), and common iliac artery aneurysm (n=9). Mean AAA diameter was 59 mm. A total of 260 large CIAAs were treated. One hundred and sixty six CIAA limbs were treated with BBT, 94 limbs underwent IIE+EE. Total reintervention rates were similar for BBT (n=19, 11%) and IIE+EE (n=18, 19.1%) (p=0.149). Similar rates of reintervention for type 1b or 3 endoleak are reported, BBT (n=7, 4%) versus IIE+EE (n=4, 4%) (p=1.0). There was no significant difference in limb patency rates. Thirty-day mortality was 1%. Median follow-up was 22 months. While there was no significant difference in complications between the two groups the combined incidence of perioperative complications and reinterventions was higher in the IIE+EE group (49% versus 22%, p-0.002).
The combined incidence of perioperative complications and reinterventions is significantly higher in the IIE+EE when compared with the BB technique. Therefore, when feasible, BB is desirable..
PMCID: PMC3319281  PMID: 22226182
8.  Technical tips and procedural steps in endovascular aortic aneurysm repair with concomitant recanalization of iliac artery occlusions 
SpringerPlus  2013;2:605.
The goal of this paper is to describe our technical strategy and procedural steps for endovascular aneurysm repair (EVAR) when performed with concomitant recanalization of the iliac artery occlusion.
Materials and methods
Three octogenarians having abdominal aortic aneurysm (AAA)/common iliac artery aneurysms (CIAA) with unilateral external iliac artery (EIA) occlusion underwent EVAR with recanalization of the occluded iliac arteries. Crossing the iliac artery occlusions was attempted in a retrograde approach using a 0.035 inch-hydrophilic guidewire. After passage of a guidewire, predilation was performed using 6mm balloon. Then a 12-Fr sheath was advanced via the occluded EIA for contralateral iliac limb delivery. Internal iliac artery embolization was subsequently performed as needed. A self-expanding stent was then placed in the occluded EIA after EVAR.
Recanalization of the EIA occlusion, followed by stentgraft delivery through the occlusion and EVAR, was successfully performed in all three patients. Penetration of the occluded EIA was successfully achieved only by retrograde approach in two patients, and by bidirectional approach in the other patient. No perioperative complication or death occurred. Postoperative CT showed no type I or III endoleaks in the aneurysms and patent iliac arteries in all patients.
Total endovascular repairs were successfully performed for three patients with AAA and concomitant unilateral EIA occlusions. The proposed steps described in this report might reduce the complication rate and enhance the technical success rate associated with this procedure.
PMCID: PMC3837076  PMID: 24294549
Abdominal aortic aneurysm; Endovascular aneurysm repair; Iliac artery occlusion; Peripheral arterial disease; Stent placement
9.  Successful treatment of type I endoleak of common iliac artery with balloon expandable stent (Palmaz XL stent) during endovascular aneurysm repair 
Type 1 endoleak of common iliac artery (type Ib endoleak) should be treated during endovascular aneurysm repair (EVAR). An 86-year-old female was diagnosed with abdominal aortic aneurysm measuring 6.6 cm in diameter and right internal iliac artery aneurysm measuring 4.0 cm in diameter. She underwent EVAR after right internal iliac artery embolization. There was type Ib endoleak, which was repaired by balloon-expandable stent, Palmaz XL stent (Cordis). We report successful treatment of type Ib endoleak with Palmaz XL stent, which may be considered as an alternative option for type Ib endoleak after EVAR.
PMCID: PMC3268146  PMID: 22324049
Abdominal aortic aneurysm; Endovascular procedure; Endoleak
10.  External aortic wrap for repair of type 1 endoleak☆ 
Type 1 endoleak is a rare complication after endovascular abdominal aortic aneurysm repair (EVAR) with a reported frequency up to 2.88%. It is a major risk factor for aneurysmal enlargement and rupture.
We present a case of a 68 year old gentleman who was found to have a proximal type 1 endoleak with loss of graft wall apposition on routine surveillance imaging post-EVAR. An initial attempt at endovascular repair was unsuccessful. Given the patient's multiple medical co-morbidities, which precluded the possibility of conventional graft explantation and open repair, we performed a novel surgical technique which did not require aortic cross-clamping. A double-layered Dacron wrap was secured around the infra-renal aorta with Prolene sutures, effectively hoisting the posterior bulge to allow wall to graft apposition and excluding the endoleak. Post-operative CT angiogram showed resolution of the endoleak and a stable sac size.
Several anatomical factors need to be considered when this technique is proposed including aortic neck angulation, position of lumbar arteries and peri-aortic venous anatomy. While an external wrap technique has been investigated sporadically for vascular aneurysms, to our knowledge there is only one similar case in the literature.
Provided certain anatomical features are present, an external aortic wrap is a useful and successful option to manage type 1 endoleak in high-risk patients who are unsuitable for aortic clamping.
PMCID: PMC4189073  PMID: 25217878
Endoleak; EVAR; AAA; Dacron graft
11.  Coil Embolization for Intracranial Aneurysms 
Executive Summary
To determine the effectiveness and cost-effectiveness of coil embolization compared with surgical clipping to treat intracranial aneurysms.
The Technology
Endovascular coil embolization is a percutaneous approach to treat an intracranial aneurysm from within the blood vessel without the need of a craniotomy. In this procedure, a microcatheter is inserted into the femoral artery near the groin and navigated to the site of the aneurysm. Small helical platinum coils are deployed through the microcatheter to fill the aneurysm, and prevent it from further expansion and rupture. Health Canada has approved numerous types of coils and coil delivery systems to treat intracranial aneurysms. The most favoured are controlled detachable coils. Coil embolization may be used with other adjunct endovascular devices such as stents and balloons.
Intracranial Aneurysms
Intracranial aneurysms are the dilation or ballooning of part of a blood vessel in the brain. Intracranial aneurysms range in size from small (<12 mm in diameter) to large (12–25 mm), and to giant (>25 mm). There are 3 main types of aneurysms. Fusiform aneurysms involve the entire circumference of the artery; saccular aneurysms have outpouchings; and dissecting aneurysms have tears in the arterial wall. Berry aneurysms are saccular aneurysms with well-defined necks.
Intracranial aneurysms may occur in any blood vessel of the brain; however, they are most commonly found at the branch points of large arteries that form the circle of Willis at the base of the brain. In 85% to 95% of patients, they are found in the anterior circulation. Aneurysms in the posterior circulation are less frequent, and are more difficult to treat surgically due to inaccessibility.
Most intracranial aneurysms are small and asymptomatic. Large aneurysms may have a mass effect, causing compression on the brain and cranial nerves and neurological deficits. When an intracranial aneurysm ruptures and bleeds, resulting in a subarachnoid hemorrhage (SAH), the mortality rate can be 40% to 50%, with severe morbidity of 10% to 20%. The reported overall risk of rupture is 1.9% per year and is higher for women, cigarette smokers, and cocaine users, and in aneurysms that are symptomatic, greater than 10 mm in diameter, or located in the posterior circulation. If left untreated, there is a considerable risk of repeat hemorrhage in a ruptured aneurysm that results in increased mortality.
In Ontario, intracranial aneurysms occur in about 1% to 4% of the population, and the annual incidence of SAH is about 10 cases per 100,000 people. In 2004-2005, about 660 intracranial aneurysm repairs were performed in Ontario.
Treatment of Intracranial Aneurysms
Treatment of an unruptured aneurysm attempts to prevent the aneurysm from rupturing. The treatment of a ruptured intracranial aneurysm aims to prevent further hemorrhage. There are 3 approaches to treating an intracranial aneurysm.
Small, asymptomatic aneurysms less than 10 mm in diameter may be monitored without any intervention other than treatment for underlying risk factors such as hypertension.
Open surgical clipping, involves craniotomy, brain retraction, and placement of a silver clip across the neck of the aneurysm while a patient is under general anesthesia. This procedure is associated with surgical risks and neurological deficits.
Endovascular coil embolization, introduced in the 1990s, is the health technology under review.
Literature Review
The Medical Advisory Secretariat searched the International Health Technology Assessment (INAHTA) Database and the Cochrane Database of Systematic Reviews to identify relevant systematic reviews. OVID Medline, Medline In-Process and Other Non-Indexed Citations, and Embase were searched for English-language journal articles that reported primary data on the effectiveness or cost-effectiveness of treatments for intracranial aneurysms, obtained in a clinical setting or analyses of primary data maintained in registers or institutional databases. Internet searches of Medscape and manufacturers’ databases were conducted to identify product information and recent reports on trials that were unpublished but that were presented at international conferences. Four systematic reviews, 3 reports on 2 randomized controlled trials comparing coil embolization with surgical clipping of ruptured aneurysms, 30 observational studies, and 3 economic analysis reports were included in this review.
Safety and Effectiveness
Coil embolization appears to be a safe procedure. Complications associated with coil embolization ranged from 8.6% to 18.6% with a median of about 10.6%. Observational studies showed that coil embolization is associated with lower complication rates than surgical clipping (permanent complication 3-7% versus 10.9%; overall 23% versus 46% respectively, p=0.009). Common complications of coil embolization are thrombo-embolic events (2.5%–14.5%), perforation of aneurysm (2.3%–4.7%), parent artery obstruction (2%–3%), collapsed coils (8%), coil malposition (14.6%), and coil migration (0.5%–3%).
Randomized controlled trials showed that for ruptured intracranial aneurysms with SAH, suitable for both coil embolization and surgical clipping (mostly saccular aneurysms <10 mm in diameter located in the anterior circulation) in people with good clinical condition:Coil embolization resulted in a statistically significant 23.9% relative risk reduction and 7% absolute risk reduction in the composite rate of death and dependency compared to surgical clipping (modified Rankin score 3–6) at 1-year.
The advantage of coil embolization over surgical clipping varies widely with aneurysm location, but endovascular treatment seems beneficial for all sites.
There were less deaths in the first 7 years following coil embolization compared to surgical clipping (10.8% vs 13.7%). This survival benefit seemed to be consistent over time, and was statistically significant (log-rank p= 0.03).
Coil embolization is associated with less frequent MRI-detected superficial brain deficits and ischemic lesions at 1-year.
The 1- year rebleeding rate was 2.4% after coil embolization and 1% for surgical clipping. Confirmed rebleeding from the repaired aneurysm after the first year and up to year eight was low and not significantly different between coil embolization and surgical clipping (7 patients for coil embolization vs 2 patients for surgical clipping, log-rank p=0.22).
Observational studies showed that patients with SAH and good clinical grade had better 6-month outcomes and lower risk of symptomatic cerebral vasospasm after coil embolization compared to surgical clipping.
For unruptured intracranial aneurysms, there were no randomized controlled trials that compared coil embolization to surgical clipping. Large observational studies showed that:
The risk of rupture in unruptured aneurysms less than 10 mm in diameter is about 0.05% per year for patients with no pervious history of SAH from another aneurysm. The risk of rupture increases with history of SAH and as the diameter of the aneurysm reaches 10 mm or more.
Coil embolization reduced the composite rate of in hospital deaths and discharge to long-term or short-term care facilities compared to surgical clipping (Odds Ratio 2.2, 95% CI 1.6–3.1, p<0.001). The improvement in discharge disposition was highest in people older than 65 years.
In-hospital mortality rate following treatment of intracranial aneurysm ranged from 0.5% to 1.7% for coil embolization and from 2.1% to 3.5% for surgical clipping. The overall 1-year mortality rate was 3.1% for coil embolization and 2.3% for surgical clipping. One-year morbidity rate was 6.4% for coil embolization and 9.8% for surgical clipping. It is not clear whether these differences were statistically significant.
Coil embolization is associated with shorter hospital stay compared to surgical clipping.
For both ruptured and unruptured aneurysms, the outcome of coil embolization does not appear to be dependent on age, whereas surgical clipping has been shown to yield worse outcome for patients older than 64 years.
Angiographic Efficiency and Recurrences
The main drawback of coil embolization is its low angiographic efficiency. The percentage of complete aneurysm occlusion after coil embolization (27%–79%, median 55%) remains lower than that achieved with surgical clipping (82%–100%). However, about 90% of coiled aneurysms achieve near total occlusion or better. Incompletely coiled aneurysms have been shown to have higher aneurysm recurrence rates ranging from 7% to 39% for coil embolization compared to 2.9% for surgical clipping. Recurrence is defined as refilling of the neck, sac, or dome of a successfully treated aneurysm as shown on an angiogram. The long-term clinical significance of incomplete occlusion following coil embolization is unknown, but in one case series, 20% of patients had major recurrences, and 50% of these required further treatment.
Long-Term Outcomes
A large international randomized trial reported that the survival benefit from coil embolization was sustained for at least 7 years. The rebleeding rate between year 2 and year 8 following coil embolization was low and not significantly different from that of surgical clipping. However, high quality long-term angiographic evidence is lacking. Accordingly, there is uncertainty about long-term occlusion status, coil durability, and recurrence rates. While surgical clipping is associated with higher immediate procedural risks, its long-term effectiveness has been established.
Indications and Contraindications
Coil embolization offers treatment for people at increased risk for craniotomy, such as those over 65 years of age, with poor clinical status, or with comorbid conditions. The technology also makes it possible to treat surgical high-risk aneurysms.
Not all aneurysms are suitable for coil embolization. Suitability depends on the size, anatomy, and location of the aneurysm. Aneurysms more than 10 mm in diameter or with an aneurysm neck greater than or equal to 4 mm are less likely to achieve total occlusion. They are also more prone to aneurysm recurrences and to complications such as coil compaction or parent vessel occlusion. Aneurysms with a dome to neck ratio of less than 1 have been shown to have lower obliteration rates and poorer outcome following coil embolization. Furthermore, aneurysms in the middle cerebral artery bifurcation are less suitable for coil embolization. For some aneurysms, treatment may require the use of both coil embolization and surgical clipping or adjunctive technologies, such as stents and balloons, to obtain optimal results.
Information from 3 countries indicates that coil embolization is a rapidly diffusing technology. For example, it accounted for about 40% of aneurysm treatments in the United Kingdom.
In Ontario, coil embolization is an insured health service, with the same fee code and fee schedule as open surgical repair requiring craniotomy. Other costs associated with coil embolization are covered under hospitals’ global budgets. Utilization data showed that in 2004-2005, coil embolization accounted for about 38% (251 cases) of all intracranial aneurysm repairs in the province. With the 2005 publication of the positive long-term survival data from the International Subarachnoid Aneursym Trial, the pressure for diffusion will likely increase.
Economic Analysis
Recent economic studies show that treatment of unruptured intracranial aneurysms smaller than 10 mm in diameter in people with no previous history of SAH, either by coil embolization or surgical clipping, would not be effective or cost-effective. However, in patients with aneurysms that are greater than or equal to 10 mm or symptomatic, or in patients with a history of SAH, treatment appears to be cost-effective.
In Ontario, the average device cost of coil embolization per case was estimated to be about $7,500 higher than surgical clipping. Assuming that the total number of intracranial aneurysm repairs in Ontario increases to 750 in the fiscal year of 2007, and assuming that up to 60% (450 cases) of these will be repaired by coil embolization, the difference in device costs for the 450 cases (including a 15% recurrence rate) would be approximately $3.8 million. This figure does not include capital costs (e.g. $3 million for an angiosuite), additional human resources required, or costs of follow-up. The increase in expenditures associated with coil embolization may be offset partially, by shorter operating room times and hospitalization stays for endovascular repair of unruptured aneurysms; however, the impact of these cost savings is probably not likely to be greater than 25% of the total outlay since the majority of cases involve ruptured aneurysms. Furthermore, the recent growth in aneurysm repair has predominantly been in the area of coil embolization presumably for patients for whom surgical clipping would not be advised; therefore, no offset of surgical clipping costs could be applied in such cases. For ruptured aneurysms, downstream cost savings from endovascular repair are likely to be minimal even though the savings for individual cases may be substantial due to lower perioperative complications for endovascular aneurysm repair.
The two Guidance documents issued by the National Institute of Clinical Excellence (UK) in 2005 support the use of coil embolization for both unruptured and ruptured (SAH) intracranial aneurysms, provided that procedures are in place for informed consent, audit, and clinical governance, and that the procedure is performed in specialist units with expertise in the endovascular treatment of intracranial aneurysms.
For people in good clinical condition following subarachnoid hemorrhage from an acute ruptured intracranial aneurysm suitable for either surgical clipping or endovascular repair, coil embolization results in improved independent survival in the first year and improved survival for up to seven years compared to surgical clipping. The rebleeding rate is low and not significantly different between the two procedures after the first year. However, there is uncertainty regarding the long-term occlusion status, durability of the stent graft, and long-term complications.
For people with unruptured aneurysms, level 4 evidence suggests that coil embolization may be associated with comparable or less mortality and morbidity, shorter hospital stay, and less need for discharge to short-term rehabilitation facilities. The greatest benefit was observed in people over 65 years of age. In these patients, the decision regarding treatment needs to be based on the assessment of the risk of rupture against the risk of the procedure, as well as the morphology of the aneurysm.
In people who require treatment for intracranial aneurysm, but for whom surgical clipping is too risky or not feasible, coil embolization provides survival benefits over surgical clipping, even though the outcomes may not be as favourable as in people in good clinical condition and with small aneurysms. The procedure may be considered under the following circumstances provided that the aneurysm is suitable for coil embolization:
Patients in poor/unstable clinical or neurological state
Patients at high risk for surgical repair (e.g. people>age 65 or with comorbidity), or
Aneurysm(s) with poor accessibility or visibility for surgical treatment due to their location (e.g. ophthalmic or basilar tip aneurysms)
Compared to small aneurysms with a narrow neck in the anterior circulation, large aneurysms (> 10 mm in diameter), aneurysms with a wide neck (>4mm in diameter), and aneurysms in the posterior circulation have lower occlusion rates and higher rate of hemorrhage when treated with coil embolization.
The extent of aneurysm obliteration after coil embolization remains lower than that achieved with surgical clipping. Aneurysm recurrences after successful coiling may require repeat treatment with endovascular or surgical procedures. Experts caution that long-term angiographic outcomes of coil embolization are unknown at this time. Informed consent for and long-term follow-up after coil embolization are recommended.
The decision to treat an intracranial aneurysm with surgical clipping or coil embolization needs to be made jointly by the neurosurgeon and neuro-intervention specialist, based on the clinical status of the patient, the size and morphology of the aneurysm, and the preference of the patient.
The performance of endovascular coil embolization should take place in centres with expertise in both neurosurgery and endovascular neuro-interventions, with adequate treatment volumes to maintain good outcomes. Distribution of the technology should also take into account that patients with SAH should be treated as soon as possible with minimal disruption.
PMCID: PMC3379525  PMID: 23074479
12.  The highs and lows of endovascular aneurysm repair: the first two years of the Eurostar Registry. 
The Eurostar Registry was established in 1996 to collate information, from centres across Europe, on the outcome from endovascular grafting of aortic aneurysms. At the end of the first year of the project, data on 430 patients had been entered onto the database. In 420 patients (97.7%), the endografts were deployed without major complications. The 30-day mortality rate was low at 3.4% and deaths were confined mostly to 'high risk' patients with major co-morbidity. Endoleaks, which were present on discharge from hospital in 15.7% of patients, were associated with a significantly increased incidence of continued expansion of the aneurysm sac postoperatively (P < 0.01). Thus the early results confirmed the feasibility and low complication rate of endovascular repair of aneurysms, but a higher than expected incidence of endoleaks. At 2 years, 895 patients had been registered. The rate of early endoleaks remained significantly unchanged but another 18% of patients had developed new endoleaks during the first year of follow-up. Six delayed ruptures had been reported, 3 fatal. There were indications that 'self sealed' endoleaks continued to pressurise the aneurysm sac. Severe distortion of the grafts with kinking and other structural changes associated with postoperative longitudinal shrinking of the aneurysm sac was observed in 69% of patients at 1 year. Clinical complications associated with these changes included late endoleak and graft limb occlusion. Early unrealistic optimism about endovascular aneurysm repair has been replaced with a more realistic understanding of its benefits and limitations as a result of the Eurostar project and other registries. Randomised studies are now required to establish the most appropriate role for this approach, alongside established therapies.
PMCID: PMC2503164  PMID: 10364946
13.  Aneurysmal degeneration and type Ib endoleak with proximal aneurysm rupture: A case report, review of literature and technical suggestions 
Despite the reduction in mortality incidences of AAA in proportion to increased use of EVAR, the natural history of aneurysms with the presence of an endoleak post EVAR remains unclear. With a cumulative AAA rupture incidence of 2% at six years post EVAR, the lack of an immediate endoleak is not an indicator of success.
Case report
We present a case of an 80-year-old man who presented to the emergency department with generalised abdominal pain and hypotension. Four years earlier he had underwent an EVAR for a 6 cm infra-renal AAA. The computed tomography angiogram (CTA) illustrated aneurysmal dilatation of the left common iliac artery with extensive retroperitoneal haemorrhage. The patient was transferred to the operating room for an endovascular repair but due to significant episodes of haemodynamic instability, an emergency exploratory laparotomy was performed. To our surprise, there was a left-sided infra-renal anterolateral rupture of the aneurysm sac. The stent was explanted with difficulty from its fixed proximal aortic section down to left-sided common iliac artery. The fixed bare portion of the stent in the proximal aorta and in the right common iliac artery was left in-situ and the rest was integrated to a trouser graft with an end-to-end technique.
On detection of an endoleak, the aim should focus on their endovascular management, as open conversions are associated with high mortality and morbidity. Conclusion: If open conversion is indicated, all technical aspects of the repair including partial stent extraction should be considered for best outcome.
PMCID: PMC4268475  PMID: 25568785
Abdominal aortic aneurysm (AAA); Endovascular aneurysm repair (EVAR); Endoleak; Technical suggestion; Explantation of endograft
14.  Occlusion of the common and internal iliac arteries for aortoiliac aneurysm repair: experience with the Amplatzer vascular plug 
Canadian Journal of Surgery  2009;52(6):E276-E280.
We sought to evaluate and describe our centre’s experience with the Amplatzer vascular plug (AVP) for the occlusion of common and internal iliac arteries (CIA; IIA) during endovascular aortic aneurysm repair (EVAR).
We performed a retrospective analysis of 20 consecutive patients between October 2006 and December 2007, who underwent occlusion of the CIA or IIA before or during EVAR to prevent endoleak.
Among these 20 patients, 21 occlusion procedures occurred and 20 were successful. In the only unsuccessful case, the patient had EVAR, but occlusion with an AVP was not possible because of severe narrowing at the origin of the vessel. Of the successfully treated patients, 2 presented with ruptured aneurysms, whereas the others had elective procedures. Eleven patients received aortouni-iliac grafts and femoral–femoral bypass, and 9 patients received a bifurcated stent graft. In 5 patients, the AVP occlusion and EVAR procedures were staged; in these cases occlusion occurred first, followed by EVAR on average 29 (standard deviation [SD] 23) days later. We deployed 7 AVPs in the CIA, whereas 13 were deployed in the IIA. The average diameter of the vessels occluded was 10 (SD 1) mm and the average size of the device used was 13 (SD 1) mm, representing a device diameter 28% (SD 2%) greater than the vessel diameter. We used a single device in 18 patients, whereas 2 devices were deployed in the same artery in 2 patients. Four patients underwent concomitant coil embolization. On follow-up computed tomography (CT) scans, all occlusion procedures were clinically successful. At the 14-month (SD 1 mo) follow-up, 4 patients had a small type-II endoleak unrelated to the occlusion procedure and 1 had a type-I endoleak that required graft limb extension. Four patients had buttock claudication but none had changes in sexual function, ischemic complications or device dislodgement on CT scans.
The AVP is a safe and effective method to occlude the CIA and IIA in patients undergoing EVAR.
PMCID: PMC2792393  PMID: 20011164
15.  Transradial approach for the endovascular treatment of type I endoleak after aortic aneurysm repair: a case report 
BMC Surgery  2013;13(Suppl 2):S47.
Endovascular repair of aortic aneurysms (EVAR) is obtained through the positioning of an aortic stent-graft, which excludes the aneurysmatic dilation. Type I endoleak is the most common complication, and it is caused by an incompetent proximal or distal attachment site, causing the separation between the stent-graft and the native arterial wall, and in turn creating direct communication between the aneurysm sac and the systemic arterial circulation. Endoleak occurrence is associated with high intrasac pressures, and requires a quick repair to prevent abdominal aortic aneurysm rupture.
Case presentation
We report the first case of a 80-year-old man undergoing percutaneous closure of a peri-graft endoleak (type I) by transcatheter embolization through radial arterial access.
The transradial approach has been shown to be a safe and effective alternative to the traditional transfemoral approach. A decrease in vascular complications and improved patient comfort are the primary benefits of this technique in patients with previous EVAR.
PMCID: PMC3851154  PMID: 24267381
16.  CT- and Fluoroscopy-Guided Percutaneous Transabdominal Embolization of Type II Endoleak 
The Eurasian Journal of Medicine  2013;45(2):132-134.
We report a case of a 79-year-old male patient who was treated 3 years previously at another hospital for an abdominal aortic aneurysm with a maximal diameter of 80 mm. After the treatment control period, computed tomography imaging revealed a type II endoleak and no progression in the size of the aneurysm sac. Selective injection of the superior mesenteric artery revealed that the endoleak was filled by the inferior mesenteric artery via the marginal artery. However, it was not possible to access using retrograde catheterization. We decided to treat the type II endoleak percutaneously. Embolization was performed at the tomography table using fluoroscopy with a mobile C-arm, and the puncture was performed transabdominally because there was no access to the sac via a translumbar approach. Under fluoroscopic guidance, various diameter/length coils were deployed. Follow-up computed tomography scans confirmed the collapsed aneurysm sac. When other conventional endovascular methods have failed, percutaneous transabdominal treatment of a type II endoleak with sac enlargement offers an alternative treatment method.
PMCID: PMC4261490  PMID: 25610266
Abdominal aortic aneurysm; embolization; type II endoleak
17.  Internal Iliac Artery Embolization during an Endovascular Aneurysm Repair with Detachable Interlock Microcoils 
Korean Journal of Radiology  2014;15(5):613-621.
The purpose of this study was to evaluate the effectiveness of detachable interlock microcoils for an embolization of the internal iliac artery during an endovascular aneurysm repair (EVAR).
Materials and Methods
A retrospective review was conducted on 40 patients with aortic aneurysms, who had undergone an EVAR between January 2010 and March 2012. Among them, 16 patients were referred for embolization of the internal iliac artery for the prevention of type II endoleaks. Among 16 patients, 13 patients underwent embolization using detachable interlock microcoils during an EVAR. Computed tomographic angiographies and clinical examinations were performed during the follow-up period. Technical success, clinical outcome, and complications were reviewed.
Internal iliac artery embolizations using detachable interlock microcoils were technically successful in all 13 patients, with no occurrence of procedure-related complications. Follow-up imaging was accomplished in the 13 cases. In all cases, type II endoleak was not observed with computed tomographic angiography during the median follow-up of 3 months (range, 1-27 months) and the median clinical follow-up of 12 months (range, 1-27 months). Two of 13 (15%) patients had symptoms of buttock pain, and one patient died due to underlying stomach cancer. No significant clinical symptoms such as bowel ischemia were observed.
Internal iliac artery embolization during an EVAR using detachable interlock microcoils to prevent type II endoleaks appears safe and effective, although this should be further proven in a larger population.
PMCID: PMC4170162  PMID: 25246822
Detachable interlock microcoil; Endovascular aneurysm repair; Internal iliac artery embolization
18.  Clinical significance of type I endoleak on completion angiography 
Type I endoleak is known to be associated with sac enlargement and occasional rupture, therefore, the treatment of type I endoleak is recommended at the time of diagnosis. The aim of this study was to identify the significance of early type I endoleak found on completion angiography.
Between January 2000 and December 2012, a total of 86 patients underwent endovascular abdominal aortic aneurysm repair (EVAR) and 10 patients (11.6%) were diagnosed with type Ia endoleak on completion angiography. Clinical and radiologic data were reviewed retrospectively.
Of the 10 patients, two underwent EVAR with custom-made stent-grafts in the initial stage and both of them needed immediate treatment: one case involved open repair while the other involved insertion of an additional stent-graft. In 8 patients, the amount of leakage decreased after repeated balloon molding. They were managed conservatively and followed up with computed tomography angiography within 2 weeks after EVAR. In 7 of the 8 cases, type Ia endoleaks disappeared. In one patient with a persistent endoleak and a folded posterior wall of the stent-graft, coil embolization was performed 1 week after EVAR. With a median follow-up of 12 months (range, 1-61 months), no patients showed recurrence of type I endoleak or sac expansion.
Type I endoleaks diagnosed on completion angiography sealed spontaneously in 7 of 10 patients (70.0%). In cases of decreased amounts of leakage after balloon molding, simple observation may be an alternative to repetitive procedures. The long-term follow-up of patients with self-sealed type I endoleaks is mandatory.
PMCID: PMC3994602  PMID: 24761415
Endovascular aneurysm repair; Abdominal aortic aneurysm; Endoleak
19.  Role of multidetector computed tomography in evaluating complications following endovascular repair of aortic aneurysm 
To study the role of multidetector computed tomography (MDCT) in evaluating various complications following endovascular stenting of aortic aneurysms.
Materials and Methods:
Over a period of 2 years (June 2005 to June 2007), 50 patients with aortic aneurysm on computed tomography (CT) angiogram were prospectively studied. Images were acquired on a 64 slice multidetector row CT scanner (GE—LightSpeed VCT) after intravenous administration of nonionic iodinated contrast. Nineteen patients underwent endovascular stent-graft repair based on their medical and surgical risk factors. Stent-graft related complications were recorded by CT angiography and analyzed using descriptive statistics.
Most common complication related to the endovascular stent-graft placement was endoleak (44.4%), followed by puncture site hematoma (27.8%), thrombotic occlusion of a limb of the bifurcated stent graft, kinking of the stent-graft, and difficult catheterization with intimal tear in the common iliac artery were 5.6% each. Poststent diameter of the aneurysm was an important predictor of endoleaks. All the patients with either increase or no change in the aneurysm size had endoleaks.
MDCT angiography is an important modality in identifying, describing, and following up the various complications following endovascular repair of aortic aneurysms, endoleaks being the most common complication. Decrease in the poststent diameter of the aneurysm suggested a good outcome.
PMCID: PMC2982200  PMID: 21187866
Aneurysm; endoleaks; multidetector computed tomography; stents
20.  Complex Common and Internal Iliac or Aortoiliac Aneurysms and Current Approach: Individualised Open-Endovascular or Combined Procedures 
Objective. Bilateral internal iliac artery aneurysms constitute the utmost configuration of infrarenal aortoiliac disease. We detail characteristic aortoiliac disease patterns and reconstructive techniques we have used, along with a visualized decision-making chart and a short review of the literature. Material and Methods. A retrospective, observational study of twelve clinical cases of patients with aortoiliac disease are described. Two patients had a common iliac artery aneurysm and were managed by the application of inversed stent-grafts; another case was repaired by the insertion of a standard bifurcated stent-graft flared in the right common iliac artery and with an iliac branched device in the left iliac arterial axis. Open approach was used in 5 cases and in 4 cases a combination of aortouniliac stent-grafting with femoral-femoral bypass was applied. Results. Technical success was 100%. One endoleak type Ib in a flared iliac limb was observed and corrected by internal iliac embolism and use of an iliac limb stent-graft extension. We report 100% patency rate during 26.3 months of followup. Conclusion. Individualized techniques for the management of isolated iliac or aortoiliac aneurismal desease with special concern in maintaining internal iliac artery perfusion lead to elimination of perioperative complications and long-term durability and patency rates.
PMCID: PMC4195433  PMID: 25328706
21.  Endovascular Treatment of Isolated Iliac Artery Aneurysms with Anaconda Stent Graft Limb 
Isolated aneurysms of the iliac arteries are relatively rare conditions that traditionally have been treated by surgical reconstruction. We report our experience with endovascular treatment of iliac artery aneurysms (IAAs) with Anaconda stent graft limb. Two male patients were found to have 4.5 and 3.6 cm isolated common IAAs, respectively. The endograft was successfully advanced and deployed precisely to the intended position in both cases. In one case the internal iliac artery was embolized. No type I or II endoleak was observed immediately after the procedure. In one patient postimplantation fever (>38°C) and gluteal claudication occurred. After 2 years followup both iliac endovascular stent grafts are patent and without endoleak. Endovascular treatment with Anaconda limb stent graft seems to be a safe and feasible alternative to open surgery.
PMCID: PMC3703722  PMID: 23862094
22.  Canadian experience with percutaneous endovascular aneurysm repair: short-term outcomes 
Canadian Journal of Surgery  2009;52(5):E156-E160.
To decrease the morbidity associated with cut-downs during endovascular aneurysm repair, some authors have suggested the totally percutaneous endovascular repair (PEVAR). The goal of this report is to evaluate and describe our centre’s experience with the total percutaneous endovascular aneurysm repair (PEVAR) for aortic abdominal aneurysm (AAA).
We performed a retrospective analysis of 15 consecutive patients with AAA, including 1 with right common iliac artery aneurysm.
There were 12 men and 3 women with a mean age of 74 (standard deviation [SD] 2) years who underwent PEVAR with a Perclose ProGlide suture-mediated closure system between July 2007 and July 2008. All surgeries were elective. Forty percent of patients had a history of smoking, 73% were hypertensive, 33% were diabetic, 20% had chronic obstructive pulmonary disease and 40% had coronary artery disease. Fourteen patients had bilateral deployment for bifurcated devices (7 bifurcated Gore Excluder, 7 bifurcated Cook Zenith grafts), and 1 patient had unilateral deployment for a Cook Zenith device. The outer diameter of the sheaths used for puncture sites was on average 18.1-Fr (SD 0.6), with main bodies being 21.1-Fr (SD 0.3) and contralateral sides 15-Fr (SD 0.3). Procedural success was 93%, with 1 patient requiring a femoral artery cut-down because of failure of the Perclose device to deploy in the groin. Another patient had persistent venous bleeding in 1 puncture site that stopped with skin suturing. Endovascular aneurysm repair was 100% with no conversion to open surgery and no type-I endoleaks. The mean length of stay in hospital was 2.2 (SD 0.4) days. There were no long-term groin complications at 6 (SD 1) months’ follow-up.
To our knowledge, this is the first Canadian report of experience with PEVAR using the Perclose device. The technique is safe, reliable and allows discharge of patients soon after surgery.
PMCID: PMC2769107  PMID: 19865546
23.  Evaluation and Treatment of Suspected Type II Endoleaks in Patients with Enlarging Abdominal Aortic Aneurysms 
To evaluate angiographic diagnosis and embolotherapy of patients with enlarging abdominal aortic aneurysms and computed tomographic (CT) diagnosis of type II endoleak.
Materials and Methods
A retrospective review was performed of all patients referred to a single vascular and interventional radiology section from January 1, 2003, to June 1, 2011, with a diagnosis of enlarging aneurysm and type II endoleak. Twenty-five patients underwent 40 procedures between 12 and 82 months after endograft insertion (mean, 48 mo) for diagnosis and/or treatment of endoleaks.
Type II endoleaks were treated with cyanoacrylate, coils, and ethylene vinyl alcohol copolymer in 16 patients. Technical success rate was 88% (14 of 16 patients) and clinical success rate was 100% (16 of 16 patients). Aneurysm growth was arrested in all cases over a mean follow-up of 27.5 months (range, 6 – 88 mo). Endoleaks in nine patients were misclassified on CT; two had type I endoleaks and seven had type III endoleaks. Four of the nine patients (two type I endoleaks and two type III endoleaks) were correctly classified after initial angiography. The other five type III endoleaks were correctly classified on CT after coil embolization of the inferior mesenteric artery. Direct embolization was performed via sac puncture with ethylene vinyl alcohol copolymer in two of the latter five patients and eliminated endoleaks in both.
Aneurysm growth caused by type II endoleaks was arrested by embolization. CT misclassification occurred relatively commonly; type III endoleaks purported to be type II endoleaks were found in 28% of patients (seven of 25).
PMCID: PMC3506247  PMID: 22609291
24.  Outcome of Renal Stenting for Renal Artery Coverage During Endovascular Aortic Aneurysm Repair 
Journal of Vascular Surgery  2009;49(5):1100-1106.
To determine the outcome of adjunctive renal artery stenting for renal artery coverage at the time of endovascular abdominal aortic aneurysm repair (EVAR).
Between 8/2000 to 8/2008, 29 patients underwent elective EVAR using bifurcated Zenith stent-grafts and simultaneous renal artery stenting. Renal artery stenting during EVAR was performed with endograft “encroachment” on the renal artery ostium (n = 23) or placement of a renal stent parallel to the main body of the endograft (“snorkel”, n = 8). Follow-up included routine contrast-enhanced computed tomography (CT), multi-view abdominal x-rays, and creatinine measurement at 1, 6, and 12 months, and then yearly thereafter.
31 renal arteries were stented successfully in 29 patients. All patients with planned renal artery stent placement (n=18) had a proximal neck length < 15mm. Mean proximal neck length was shorter in patients who underwent the “snorkel” technique (6.9 ± 3.1 mm) compared to those with planned endograft encroachment (9.9 ± 2.6 mm). None of the patients with unplanned endograft encroachment had neck lengths < 15mm (mean length: 26.3±10.2 mm). Mean proximal neck angulation was 42.8 ± 24.0 degrees and did not differ between the groups. One patient had a type I endoleak on completion angiography, and 2 additional patients had a type I endoleak on the first postoperative CT scan. All type I endoleaks resolved by the one-month postoperative CT scan. Primary-assisted patency of renal artery stents was 100% at a median follow-up of 12.5 months (range 2 days to 77.4 months). One patient had near occlusion of a renal artery stent noted on follow-up CT scan at 9 months; patency was restored by placement of an additional stent. One patient required dialysis following sustained hypotension from a right external iliac artery injury which resulted in prolonged post-operative bleeding. Mean creatinine at baseline was 1.1 ± 0.3 mg/dl, 1.2 ± 0.5 mg/dl at 1 month follow-up, and 1.2 ± 0.5 mg/dl at 2 years of follow-up. There were no cases of late type I endoleaks (>one month postoperatively) or stent-graft migration.
Adjunctive renal artery stenting during endovascular AAA repair using the “encroachment” and “snorkel” techniques is safe and effective. Short and medium term primary patency rates are excellent, but careful follow-up is needed to determine the durability of these techniques.
PMCID: PMC3276369  PMID: 19233597
25.  Static sac size with a type II endoleak post-endovascular abdominal aortic aneurysm repair: surveillance or embolization? 
A best evidence topic was written according to a structured protocol. The question addressed was whether embolization is superior to surveillance for a type II endoleak associated with a static sac size post-endovascular abdominal aortic aneurysm repair (EVAR). Four hundred and sixty-one papers were identified, of which 10 papers presented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group studied, study type, and relevant outcomes and results are tabulated. A review of the available literature suggests that most type II endoleaks are innocuous and will seal spontaneously during the long-term follow-up, even when they persist for more than 6 months. An analysis of the large European Collaborators on Stent-Graft Techniques for Aortic Aneurysm Repair (EUROSTAR) registry that includes prospective data on 2463 patients from 87 European hospitals showed that type II endoleaks were not associated with an increased risk of rupture; this correlates well with the large single-centre studies included in this review. Based on the available evidence, we conclude that the management of most isolated type II endoleaks should be conservative—with close radiological follow-up—even when persistent, with intervention restricted to theoese associated with sac enlargement >5 mm over a 6-month period or >10 mm when compared with pre-EVAR diameter.
PMCID: PMC3422929  PMID: 22617500
Abdominal aortic aneurysm; Endovascular repair; Endoleak; Conservative management

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