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1.  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
2.  Secondary aortoesophageal fistula after thoracic aortic aneurysm endovascular repair: literature review and new insights regarding the hypothesized mechanisms 
Background: Endovascular aortic repair was first performed nearly two decades ago and has become a well-established alternative therapy for many thoracoabdominal aortic diseases. Early survival results with the endovascular aortic repair were impressive, but it also brought many complications. Aortoesophageal fistula is little-known and may be underestimated because it is an unusual complication of thoracic endovascular aortic repair. Objective: To provide a review of the general features of aortoesophageal fistula as a little-known complication after thoracic endovascular aortic repair and to present a new insight regarding the hypothesized mechanisms of this complication based on clinical experience. Methods: The new insights regarding the hypothesized mechanisms built on the literature review and clinical experience. Literature Review from PubMed and Web of Knowledge for relevant studies with English paper. Searches were performed without year, and used the combinations of the following key words: “thoracic aortic aneurysm”, “endovascular”, “aortoesophageal fistula”, “complication”. Results: The authors’ hypothesized mechanisms of aortoesophageal fistula after thoracic aortic aneurysm endovascular repair include the relatively thin vessel wall on thoracic aortic aneurysm hard to prevent the relatively rigid stent graft projecting the aortic and direct erosion into the esophagus. Conclusion: Selecting flexibility and appropriate size stent graft, avoiding the thin aortic wall, and identifying the risk factors may reduce the morbidity of complications with aortoesophageal fistula after thoracic aortic aneurysm endovascular repair.
PMCID: PMC4238538  PMID: 25419355
Thoracic aortic aneurysm; endovascular; hypothesized mechanisms; complication; aortoesophageal fistula
3.  Secondary aortoduodenal fistula following endovascular repair of inflammatory abdominal aortic aneurysm due to Streptococcus anginosus infection: A case report and literature review☆ 
Aortoenteric fistula is a rare but very serious complication of both surgical and endovascular abdominal aortic reconstruction. Since the advent of endovascular abdominal aortic aneurysm repair (EVAR), 20 cases of aortoduodenal fistula associated with aortic stent grafts have been reported.1 However, only a handful has been reported following inflammatory abdominal aortic aneurysm repair. It most commonly presents with bleeding, usually from the upper gastro-intestinal tract. With recent advances in the screening, diagnosis and management of abdominal aortic aneurysms either surgically or through an endovascular approach, the diagnosis of an aortoduodenal fistula in patients with gastro-intestinal bleeding must be suspected and excluded.
We describe a case of secondary aortoduodenal fistula that occurred two and a half years following endovascular stent graft repair of an inflammatory abdominal aortic aneurysm. We also outline the emergency correction plan and the attempts at repair.
This case defies the general concept that patients with inflammatory abdominal aortic aneurysms are relatively immune to rupture. Although the presence of a peri-aneurysm thick inflammatory membrane decreases the possibility of rupture, these patients are more susceptible to other related complications such as aorto-enteric and aorto-caval fistulas.2 This case also demonstrates the peculiar presence of Streptococcus anginosus as the pathological organism leading to graft infection and subsequent fistula, as opposed to enterococci which are often found in endograft infection.
Aorto-enteric fistulas are associated with a grave prognosis. Early diagnosis is crucial and extra vigilance should be taken in cases of inflammatory AAA.
PMCID: PMC4189064  PMID: 25201477
4.  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
5.  Midterm results with thoracic endovascular aortic repair for chronic type B aortic dissection with associated aneurysm 
Thoracic endovascular aortic repair for chronic type B aortic dissection with associated descending thoracic aneurysm remains controversial. Concerns include potential ischemic complications due to branch vessel origin from the chronic false lumen and continued retrograde false lumen/aneurysm sac pressurization via fenestrations distal to implanted endografts. The present study examines midterm results with thoracic endovascular aortic repair for chronic (>2 weeks) type B aortic dissection with associated aneurysm to better understand the potential role of thoracic endovascular aortic repair for this condition.
Between March 2005 and December 2009, 51 thoracic endovascular aortic repair procedures were performed at a single institution for management of chronic type B dissection. The indication for thoracic endovascular aortic repair was aneurysm in all cases. A subset of 7 patients (14%) underwent placement of the EndoSure wireless pressure measurement system (CardioMEMS, Inc, Atlanta, Ga) in the false lumen adjacent to the primary tear for monitoring aneurysm sac/false lumen pulse pressure after thoracic endovascular aortic repair.
Mean patient age was 57 ± 12 years (range, 30–82 years); 14 patients (28%) were female. Mean aortic diameter was 6.2 ± 1.4 cm. There were no in-hospital/30-day deaths, strokes, or permanent paraplegia/paresis. There were no complications related to compromise of downstream branch vessels arising from the false lumen. Two patients (3.9%) who had preexisting ascending aortic dilation had retrograde acute type A aortic dissection; both were repaired successfully. Median postoperative length of stay was 4 days. Mean follow-up is 27.0 ± 16.5 months (range, 2–60 months). Actuarial overall survival is 77.7%at 60 months with an actuarial aorta-specific survival of 98%over this same time period. Actuarial freedom from reintervention is 77.3%at 60 months. All patients with the EndoSure wireless pressure measurement system exhibited a decrease in aneurysm sac/false lumen pulse pressure indicating a depressurized false lumen. The aneurysm sac/false lumen pulse pressure ratio decreased from 52% ± 27% at the predischarge measurement to 14% ± 5% at the latest follow-up reading (P = .029).
Thoracic endovascular aortic repair for chronic type B dissection with associated aneurysm is safe and effective at midterm follow-up. Aneurysm sac/false lumen pulse pressure measurements demonstrate a significant reduction in false lumen endotension, thus ruling out clinically significant persistent retrograde false lumen perfusion and provide proof of concept for a thoracic endovascular aortic repair-based approach. Longer-term follow-up is needed to determine the durability of thoracic endovascular aortic repair for this aortic pathology.
PMCID: PMC3688644  PMID: 21241855
6.  Aortoesophageal fistula as a complication of thoracic aorta aneurism stent grafting – a case report and literature review 
Polish Journal of Radiology  2012;77(4):77-80.
Endovascular stent grafting is performed in patients with aneurysms of aorta or other major vessels. The procedure is considered to be generally safe, with a low risk of complications, the most common of which include endoleaks, stenosis or thrombosis at the stagraft and itsmigration.
Very rare complications include aortoesophageal and aortobronchial fistulas (0.5–1.7% cases).
Case Report:
A 64-year-old patient was admitted to our hospital with suspected aortoesophageal fistula. Two years prior, the patient had undergone a stent graft repair of the thoracic aorta at the local vascular surgery clinic. Both laboratory results and CT angiography revealed aortoesophageal fistula, which was also detected in endoscopic examination.
Despite intensive treatment and preparation for surgery, the patient died 6 days after admission.
Aortoesophageal and aortobronchial fistulas are among the most dangerous and difficult-to-treat complications in the treatment of thoracic aortic aneurysms by endovascular stent-grafting. This clearly indicates that preventive care and regular medical examinations are important to prevent their occurrence.
PMCID: PMC3529719  PMID: 23269943
aortoesophageal fistula; thoracic aortic aneurysm; stent graft
7.  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
8.  Practice Patterns for Thoracic Aneurysms in the Stent Graft Era: Health Care System Implications 
The Annals of thoracic surgery  2010;90(6):1833-1839.
The FDA approved the first thoracic aneurysm endograft in 2005. However because the United States lacks a thoracic aneurysm endovascular repair registry, implications of FDA endograft approval on surgical management of thoracic aneurysms in clinical practice are unknown.
Retrospective review of thoracic aneurysm repair rates for 2000–07 and analysis of patient characteristics and complications for 2006 and 2007 cohorts uses the National Inpatient Sample. ICD-9 codes were used to identify unruptured descending thoracic aneurysm cases undergoing either thoracic endovascular aortic repair (39.73) or Open Repair (38.45).
Thoracic aneurysm Open Repair averaged 3.3 per million from 2000–2002 and increased to 5.6 per million in 2003 with introduction of 16 slice CT scanners. In 2005 endovascular repair was 1.2 repairs per million, which increased dramatically to 6.1 repairs per million in 2006. In 2007, endovascular repair decreased to 4.8 repairs per million while Open Repair rate was 3.1 repairs per million. The 2006 and 2007 Open Repair cohorts had more favorable baseline characteristics compared to the endovascular cohort. Open Repair mortality was significantly greater than endovascular mortality in 2006 (estimated relative risk=8.48, 95% CI 3.03–23.75), but not in 2007 (estimated relative risk=0.71, 95% CI 0.12–4.24). Length of stay was greater for Open Repair in 2006 and 2007.
Thoracic endovascular aortic repair has been rapidly adopted in the United States resulting in increased treatment of thoracic aortic aneurysms. Despite older age and comorbidities, endovascular repair had better outcomes and shorter hospital stays.
PMCID: PMC3976178  PMID: 21095320
Aneurysm (descending); Endovascular Stents
9.  Treatment of Acute Visceral Aortic Pathology with Fenestrated-Branched Endovascular Repair in High Surgical Risk Patients 
Journal of vascular surgery  2013;58(1):56-65.e1.
The safety and feasibility of fenestrated/branched endovascular repair of acute visceral aortic disease in high risk patients is unknown. The purpose of this report is to describe our experience with surgeon-modified endografts(sm-EVAR) for the urgent or emergent treatment of pathology involving the branched segment of the aorta in patients deemed to have prohibitively high medical and/or anatomic risk for open repair.
A retrospective review was performed on all patients treated with sm-EVAR for acute indications. Planning was based on 3D-CTA reconstructions and graft configurations included various combinations of branch, fenestration, or scallop modifications.
Sixteen patients [mean age(±SD)68±10 years; 88% male] deemed high risk for open repair underwent urgent or emergent repair using sm-EVAR. Indications included: degenerative suprarenal or thoracoabdominal aneurysm (6), presumed or known mycotic aneurysm(4), anastomotic pseudoaneurysm (3), false lumen rupture of type B dissection(2), and penetrating aortic ulceration(1). Nine (56%) had previous aortic surgery and all patients were either ASA class IV(N=9) or IV-E(N=7). A total of 40 visceral vessels (celiac=10, SMA=10, RRA=10, LRA=10) were revascularized with a combination of fenestrations (33), directional graft branches (6), and graft scallops (1). Technical success was 94% (N=15/16), with one open conversion. Median contrast use was 126mL (range 41–245) and fluoroscopy time was 70 minutes(range 18–200). Endoleaks were identified intra-operatively in 4 patients [type II(N=3); IV(N=1)] but none have required remediation. Mean LOS was 12±15 days (median 5.5; range 3–59).
Single complications occurred in 5(31%) patients: brachial sheath hematoma (1), stroke(1), ileus(1), respiratory failure(1), and renal failure(1). An additional patient experienced multiple complications including spinal cord ischemia(1) and multi-organ failure resulting in death(N=1;in-hospital mortality 6.3%). The majority of patients were discharged to home (63%;N=10) or short term rehabilitation units (25%;N=4) while one patient required admission to a long-term acute care (LTAC) setting. There were no re-interventions at a median follow-up of 6.2(range 1–16.1) months. Postoperative CTA was available for all patients and demonstrated 100% branch vessel patency, with 1 type III endoleak pending intervention. There were two late deaths at 1.4 and 13.4 months due to non-aortic related pathology.
Urgent or emergent treatment of acute pathology involving the visceral aortic segment with fenestrated/branched endograft repair is feasible and safe in selected high-risk patients; however the durability of these repairs is yet to be determined.
PMCID: PMC4183351  PMID: 23706619
10.  In Situ Reconstruction with Cryopreserved Arterial Allografts for Management of Mycotic Aneurysms or Aortic Prosthetic Graft Infections 
Texas Heart Institute Journal  2006;33(1):14-18.
We designed this study to evaluate a multi-institutional experience regarding the efficacy of cryopreserved aortic allografts in the treatment of infected aortic prosthetic grafts or mycotic aneurysms. We reviewed clinical data of all patients from 4 institutions who underwent in situ aortic reconstruction with cryopreserved allografts for either infected aortic prosthetic graft or mycotic aneurysms from during a 6-year period. Relevant clinical variables and treatment outcomes were analyzed.
A total of 42 patients (37 men; overall mean age 63 ± 13 years, range 41–74 years) were identified during this study period. Treatment indications included 34 primary aortic graft infections (81%), 6 mycotic aneurysms (22%), and 2 aortoenteric erosions (5%). Transabdominal and thoracoabdominal approaches were used in 38 (90%) and 4 patients (10%), respectively. Staphylococcus aureus was the most commonly identified organism (n=27, 64%). Although there was no intraoperative death, the 30-day operative mortality was 17% (n=7). There were 21 (50%) nonfatal complications, including local wound infection (n=8), lower-extremity deep venous thrombosis (n=5), amputation (n=6), and renal failure requiring hemodialysis (n=2). The average length of hospital stay was 16.4 ± 7 days. During a mean follow-up period of 12.5 months, reoperation for allograft revision was necessary in 1 patient due to graft thrombosis (6%). The overall treatment mortality rate was 21% (n=9).
In situ aortic reconstruction with cryopreserved allografts is an acceptable treatment method in patients with infected aortic prosthetic graft or mycotic aneurysms. Our study showed that mid-term graft-related complications such as reinfection or aneurysmal degeneration were uncommon.
PMCID: PMC1413601  PMID: 16572862
Aneurysm, infected/surgery; bacterial infections/complications/surgery; arteries/transplantation; blood vessel prosthesis/adverse effects; cryopreservation; prosthesis-related infections/ surgery; staphylococcal infections/surgery; surgical wound infection/surgery; reoperation; transplantation, homologous
11.  Aorto-enteric fistula development secondary to mycotic abdominal aortic aneurysm following intravesical bacillus Calmette–Guerin (BCG) treatment for transitional cell carcinoma of the bladder 
Intravesical BCG-instillation for bladder cancer is considered safe but is not without risk. While most side-effects are localised and self-limiting, the development of secondary vascular pathology is a rare but significant complication.
A 77-year-old male presented with a mycotic abdominal aortic aneurysm and associated aorto-enteric fistula 18 months after receiving intravesical BCG-instillations for early stage transitional cell carcinoma.
Response rates to intravesical BCG for early stage transitional cell carcinoma are high. The procedure produces a localised inflammatory response in the bladder but the exact mechanism of action is unclear. The treatment is generally well tolerated but BCG-sepsis and secondary vascular complications have been documented.
Mycotic abdominal aortic aneurysm with associated aorto-enteric fistula secondary to BCG is very rare. Few examples have been documented internationally and the extent of corresponding research and associated management proposals is limited.
Surgical options include in situ repair with prosthetic graft, debridement with extra-anatomical bypass and, occasionally, endovascular stent grafting. Recommended medical therapy for systemic BCG infection is Isoniazid, Rifampicin and Ethambutol.
Current screening methods must be updated with clarification regarding duration of anti-tuberculous therapy and impact of concomitant anti-tuberculous medication on the therapeutic action of intravesical BCG. Long-term outcomes for patients post graft repair for mycotic aneurysm are unknown and more research is required regarding the susceptibility of vascular grafts to mycobacterial infection.
Recognition of the risks associated with BCG-instillations, even in immunocompetent subjects, is paramount and must be considered even several months or years after receiving the therapy.
PMCID: PMC3537938  PMID: 23127864
BCG; Aortic aneurysm; Aorto-enteric fistula; Bladder carcinoma
12.  Safety of elective management of synchronous aortic disease with simultaneous thoracic and aortic stent graft placement 
Journal of vascular surgery  2012;56(4):957-64.e1.
Simultaneous treatment of multilevel aortic disease is controversial due to the theoretic increase in morbidity. This study was conducted to define the outcomes in patients treated electively with simultaneous thoracic endovascular aortic aneurysm repair (TEVAR) and abdominal aortic endovascular endografting for synchronous aortic pathology.
Patients treated with simultaneous TEVAR and endovascular aneurysm repair (T&E) at the University of Florida were identified from a prospectively maintained endovascular aortic registry and compared with those treated with TEVAR alone (TA). The study excluded patients with urgent or emergency indications, thoracoabdominal or mycotic aneurysm, and those requiring chimney stents, fenestrations, or visceral debranching procedures. Demographics, anatomic characteristics, operative details, and periprocedural morbidity were recorded. Mortality and reintervention were estimated using life-table analysis.
From 2001 to 2011, 595 patients underwent TEVAR, of whom 457 had elective repair. Twenty-two (18 men, 82%) were identified who were treated electively with simultaneous T&E. Mean ± standard deviation age was 66 ± 9 years, and median follow-up was 8.8 months (range, 1–34 months). Operative indications for the procedure included dissection-related pathology in 10 (45%) and various combinations of degenerative etiologies in 12 (55%). Compared with TA, T&E patients had significantly higher blood loss (P < .0001), contrast exposure (P < .0001), fluoroscopy time (P < .0001), and operative time (P < .0001). The temporary spinal cord ischemia rate was 13.6% (n = 3) for the T&E group and 6.0% for TA (P = .15); however, the permanent spinal cord ischemia rate was 4% for both groups (P = .96). The 30-day mortality for T&E was 4.5% (n = 1) compared with 2.1% (n = 10) for TA. Temporary renal injury (defined by a 25% increase over baseline creatinine) occurred in two T&E patients (9.1%), with none requiring permanent hemodialysis; no significant difference was noted between the two groups (P = .14). One-year mortality and freedom from reintervention in the T&E patients were 81% and 91%, respectively.
Acceptable short-term morbidity and mortality can be achieved with T&E compared with TA, despite longer operative times, greater blood loss, and higher contrast exposure. There was a trend toward higher rates of renal and spinal cord injury, so implementation of strategies to reduce the potential of these complications or consideration of staged repair is recommended. Short-term reintervention rates are low, but longer follow-up and greater patient numbers are needed to determine procedural durability and applicability.
PMCID: PMC3766713  PMID: 22743020
13.  Endovascular treatment of descending thoracic aneurysms 
Current strategies for repair of descending thoracic aortic aneurysms consist of open repair with surgical graft replacement or thoracic endovascular aortic repair. We review and update our overall experience in aortic thoracic diseases and specifically analyzed our outcomes with thoracic endovascular aortic repair in patients with descending thoracic aortic aneurysms.
From 1993 to present a total of 1144 patients were treated in our Center for pathology involving the thoracic aorta. Since 1998, 322 patients underwent thoracic endovascular aortic repair, and among this group, in 188 cases the descending aorta was involved. In 74% of patients treated for a descending thoracic aortic lesion, a degenerative aneurysm was observed.
In patients with descending thoracic aortic aneurysms receiving thoracic endovascular aortic repair, our technical success rate, i.e. deployment of endograft with complete exclusion of the lesion/minimal endoleak, was 99.5% (one case required emergent open conversion) with a perioperative mortality of 2.6% (five patients). The rate of spinal cord ischemia, manifesting either as paraplegia or paraparesis, was 4.7%. Delayed onset spinal cord ischemia ameliorated with adequate arterial pressure and cerebrospinal fluid drainage.
Our experience of selected patients undergoing thoracic endovascular aortic repair of descending thoracic aorta aneurysms is satisfactory with very low mortality and morbidity. A large use of thoracic endovascular aortic repair is foreseen in the next future.
PMCID: PMC3484596  PMID: 23439690
thoracic aortic aneurysm; endovascular aortic repair; aortic endoprostheses; thoracic aortic aneurysms; type B aortic dissection
14.  Mycotic aneurysm in a turtle hunter: brief review and a case report 
Salmonella-associated mycotic aneurysm is a rare, but dreaded, complication of salmonellosis. Immunocompromised and elderly populations are more susceptible to develop this extra-intestinal complication. Salmonella is spread via fecal–oral and vehicle-borne routes. Reptiles, especially small pet turtles, have been linked with an increased risk of Salmonella infection. Diagnosis of mycotic aneurysm is a challenge due to atypical presentations. Recently, widespread use of CT scan imaging to evaluate for unexplained abdominal pain and sepsis has led to early identification of mycotic aneurysms. Antibiotic therapy and surgical intervention are the cornerstones of management. Open surgery has been the gold standard of treatment but is associated with increased morbidity and mortality. A relatively new alternative to open surgery is endovascular aneurysm repair (EVAR). It is comparatively less invasive and is associated with reduced early morbidity and mortality in the setting of mycotic aneurysm. However, there is a risk of late infection. Here, we present a patient with Salmonella mycotic aneurysm initially treated conservatively with antibiotic therapy who later underwent successful interval EVAR with no complications to date. Also included is a brief review of Salmonella-associated mycotic aneurysms.
PMCID: PMC4475255  PMID: 26091653
Salmonella; mycotic aneurysm; review
15.  Thoracic Aortic Endograft Collapse after Endovascular Treatment of a Traumatic Pseudoaneurysm 
Aortic endograft placement is evolving into the standard of care for treatment of patients with anatomically suitable thoracic aortic aneurysms. Application of this technique and these devices in other thoracic aortic pathology, such as traumatic pseudoaneurysms, symptomatic type B aortic dissections, penetrating ulcers, and even mycotic aneurysms, appears to be promising. We report a case in which a stent graft was used to treat a post-traumatic pseudoaneurysm of the thoracic aorta. The case was complicated by delayed collapse of the endograft, which led to hypoperfusion of the extremities, kidneys, and intestines. Reestablishment of endograft patency and distal reperfusion was achieved by placement of two balloon-expandable stents within the endograft. Potential factors leading to the development of this complication are discussed.
PMCID: PMC3036329  PMID: 21326469
Thoracic aorta; trauma; endograft; collapse
16.  Combined Endovascular and Surgical Treatment of Primary Aortoesophageal Fistula 
Texas Heart Institute Journal  2010;37(6):722-724.
Primary aortoesophageal fistula is a rare cause of massive upper gastrointestinal bleeding. Conservative treatment of aortoesophageal fistula results in a 60% in-hospital mortality rate with no late survival, and conventional surgical treatment has a reported in-hospital mortality rate that approaches 40%.
Thoracic endovascular aortic repair is an innovative and less invasive technique for the treatment of aortoesophageal fistula. It enables the rapid control of aortic bleeding and prevents fatal early exsanguination. However, the technique does not repair the esophagus, and there remains a substantial risk of mediastinitis and infection of the stent-graft. Herein, we report the cases of 2 patients in whom we used a combined treatment: thoracic endovascular aortic repair and delayed surgical repair of the esophagus. The esophageal repair involved direct suture of the esophageal wall and reinforcement with an intercostal muscle flap. Early follow-up evaluations suggest that our treatment of both patients was successful. We discuss the advantages and limitations of our technical choices and briefly review the pertinent medical literature.
PMCID: PMC3014136  PMID: 21224956
Aorta, thoracic/surgery; aortic diseases/diagnosis/etiology/surgery; esophageal fistula/diagnosis/etiology/therapy; stents; surgical flaps; treatment outcome
17.  Surgical approach for the treatment of aortoesophageal fistula combined with dual aortic aneurysms: a case report 
Aortoesophageal fistula is a rare disease with a high mortality rate. The disease is with high mortality due to aneurysm rupture, and thus successfully managed cases are rarely reported. Here, we report a case of aortoesophageal fistula caused by a huge descending aneurysm and another smaller aneurysm found in the aortic arch. Such case was relatively rare in the cardiovascular field. Due to the limited experience, it was difficult to determine the proper therapeutic strategy. For this case, for the dual aneurysm, we surgically inserted an aortic endovascular stent-graft to exclusive the aneurysm and simultaneously repair the other aortic arch aneurysm. The patient had an uneventful recovery and was discharged after 1 month antibiotics therapy for the palliative treatment of the esophageal fistula. She survived for 8 months at home before dying of massive hematemesis. Here, we present the operative method and our therapeutic experience for this extremely rare case.
PMCID: PMC4228427  PMID: 24180498
Aortoesophageal fistula (AEF); Thoracic aortic aneurysm; Stent graft
18.  Surgical Treatment of Aortobronchial and Aortoesophageal Fistulae due to Thoracic Aortic Aneurysm 
We present a review of our single-institution experience, over 19 years, with aortobronchial and aortoesophageal fistulae due to descending thoracic aortic aneurysm.
We conducted a retrospective chart review of 10 cases involving surgery for aortobronchial and aortoesophageal fistulae in our clinic from February 1985 through October 2004. Pathologic or predisposing conditions associated with aortobronchial fistula were descending thoracic aortic aneurysm (n = 8), previous aortic surgery (n = 1), and concomitant aortoesophageal fistula (n = 1). Three patients presented emergently with aortobronchial fistula (n = 2) and aortoesophageal fistula (n = 1). Ages of the 10 patients ranged from 42 to 74 years (median, 63 years). The median cross-clamp time was 34 minutes (range, 27–41 min). Repairs, in 9 patients, involved an inlay of prosthetic tube graft using the clamp-and-sew technique, and in 1 patient repair involved patch aortoplasty.
The operative mortality rate was 20%: 1 patient had acute concomitant aortoesophageal and aortobronchial fistulae, and another had chronic aortobronchial fistula. There was no embolic stroke or paraplegia. During follow-up (median, 2.5 years), there were no deaths or postoperative morbidity.
We conclude that repair of aortobronchial and aortoesophageal fistulae using the clamp-and-sew technique can be performed with acceptable operative mortality and long-term results. However, the mortality rate continues to be highly significant in patients with acute bleeding aortobronchial fistula or with aortoesophageal fistula, despite rapid surgical intervention.
PMCID: PMC1351823  PMID: 16429896
Aortic aneurysm/surgery; bronchial fistula/etiology/surgery; esophageal fistula/etiology/surgery; hemoptysis/diagnosis
19.  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
20.  Hybrid Endovascular Repair in Aortic Arch Pathologies: A Retrospective Study 
The aortic arch presents specific challenges to endovascular repair. Hybrid repair is increasingly evolving as an alternative option for selected patients, and promising initial results have been reported. The aim of this study was to introduce our experiences and evaluate mid-term results of supra aortic transpositions for extended endovascular repair of aortic arch pathologies. From December 2002 to January 2008, 25 patients with thoracic aortic aneurysms and dissections involving the aortic arch were treated with hybrid endovascular treatment in our center. Of the 25 cases, 14 were atherosclerotic thoracic aortic aneurysms and 11 were thoracic aortic dissection. The hybrid repair method included total-arch transpositions (15 cases) or hemi-arch transpositions (10 cases), and endovascular procedures. All hybrid endovascular procedures were completed successfully. Three early residual type-I endoleaks and one type-II endoleak were observed. Stroke occurred in three patients (8%) during the in-hospital stage. The perioperative mortality rate was 4%; one patients died post-operatively from catheter related complications. The average follow-up period was 15 ± 5.8 months (range, 1–41 months). The overall crude survival rate at 15 months was 92% (23/25). During follow-up, new late endoleaks and stent-raft related complications were not observed. One case (4%) developed a unilateral lower limb deficit at 17 days and was readmitted to hospital. In conclusion, the results are encouraging for endovascular aortic arch repair in combination with supra-aortic transposition in high risk cases. Aortic endografting offers good mid-term results. Mid-term results of the hybrid approach in elderly patients with aortic arch pathologies are satisfying.
PMCID: PMC3000108  PMID: 21151464
aortic arch; endovascular repair; aneurysm; dissection
21.  Current management and outcome of chronic type B aortic dissection: results with open and endovascular repair since the advent of thoracic endografting 
Annals of Cardiothoracic Surgery  2014;3(3):264-274.
Thoracic endovascular aortic repair (TEVAR) has become the preferred treatment for chronic type B aortic dissection (CTBAD) at our institution. However, it remains incapable of treating all patients with CTBAD. The present study aims to review our contemporary results with open and endovascular CTBAD repairs since the advent of thoracic endografting.
The records of all patients undergoing index repair of CTBAD (chronic DeBakey type IIIA, IIIB and repaired type I) at our institution between June 2005 and December 2013, were retrospectively reviewed.
A total of 107 patients underwent CTBAD repair, of whom 70% (n=75) underwent endovascular-based procedures [44 TEVAR, 27 hybrid arch and four hybrid thoracoabdominal aortic aneurysm (TAAA) repair] and 30% (n=32) underwent open procedures (nine open descending and 23 open TAAA). Connective tissue disease (CTD), prior aortic surgery and DeBakey dissection type were strongly associated with the choice of operation. The rates of stroke, paraplegia and operative mortality following endovascular-based repairs were 0%, 0% and 4% (n=3), respectively. Adverse neurologic events were higher following open repair, and rates of stroke, paraplegia, and operative mortality were 16% (n=5), 9% (n=3), and 6% (n=2), respectively. However, 1- and 5-year survival rates were similar for endovascular-based repairs (86% and 65%, respectively), and open repairs (88% and 79%, respectively). Over a median follow-up interval of 34 months, the rate of descending aortic reintervention was 24% (n=18) following endovascular-based repairs and 0% following open repairs (P=0.001). Forty-four percent (n=8) of descending aortic reinterventions were required to treat stent graft complications (five endoleak, two stent graft collapse and one stent graft-induced new entry tear) and the remainder were required to treat metachronous pathology (n=2) or progressive aneurysmal disease related to persistent distal fenestrations (n=8).
Endovascular repair of CTBAD was associated with excellent procedural and survival outcomes, but at the expense of further reinterventions. Open repair remains relevant for patients who are not candidates for endovascular repair and was associated with higher procedural morbidity but similar overall survival and fewer reinterventions.
PMCID: PMC4052409  PMID: 24967165
Aortic dissection; aortic surgery; outcomes
22.  Aneurysm formation at both ends of an endograft associated with maladaptive aortic changes after endovascular aortic repair in a healthy patient 
We report a case in which saccular aneurysms formed at both ends of an endograft that exhibited maladaptive aortic changes after endovascular aortic repair in a patient without significant evidence of connective tissue disease. A 66-year old male underwent thoracic endovascular aortic repair (TEVAR) for a distal aortic arch aneurysm. A follow-up computed tomography (CT) scan performed at 6 months after the TEVAR detected a small saccular aneurysm at the distal edge of the endograft. At 10 months after the TEVAR, a new large aneurysm appeared at the proximal edge of the endograft. To prevent the latter aneurysm rupturing, total arch replacement with endograft fixation was performed. A CT scan obtained at 18 months after the TEVAR demonstrated that the aneurysm at the distal edge of the endograft had progressed and so we considered reintervention. Unfortunately, the patient died of intracranial haemorrhaging before the second procedure could be carried out. A histopathological examination of the aneurysm wall did not detect any significant background factors, such as connective tissue disease, inflammation or infection. The present case involved unexpected late complications, which might have been caused by changes in the form of the aorta after TEVAR.
PMCID: PMC3805213  PMID: 23906964
Thoracic endovascular aortic repair; Thoracic aorta
23.  Endovascular Treatment of Infrarenal Abdominal Aortic Aneurysm with Short and Angulated Neck in High-Risk Patient 
Endovascular treatment of abdominal aortic aneurysms (AAA) is an established alternative to open repair. However lifelong surveillance is still required to monitor endograft function and signal the need for secondary interventions (Hobo and Buth 2006). Aortic morphology, especially related to the proximal neck, often complicates the procedure or increases the risk for late device-related complications (Hobo et al. 2007 and Chisci et al. 2009). The definition of a short and angulated neck is based on length (<15 mm), and angulation (>60°) (Hobo et al. 2007 and Chisci et al. 2009). A challenging neck also offers difficulties during open repairs (OR), necessitating extensive dissection with juxta- or suprarenal aortic cross-clamping. Patients with extensive aneurysmal disease typically have more comorbidities and may not tolerate extensive surgical trauma (Sarac et al. 2002). It is, therefore, unclear whether aneurysms with a challenging proximal neck should be offered EVAR or OR (Cox et al. 2006, Choke et al. 2006, Robbins et al. 2005, Sternbergh III et al. 2002, Dillavou et al. 2003, and Greenberg et al. 2003). In our case the insertion of a thoracic endograft followed by the placement of a bifurcated aortic endograft for the treatment of a very short and severely angulated neck proved to be feasible offering acceptable duration of aneurysm exclusion. This adds up to our armamentarium in the treatment of high-risk patients, and it should be considered in emergency cases when the fenestrated and branched endografts are not available.
PMCID: PMC3713317  PMID: 23936726
24.  Double Primary Aortoenteric Fistulae: A Case Report of Two Simultaneous Primary Aortoenteric Fistulae in One Patient 
Aortoenteric fistula is a rare but potentially fatal condition causing massive gastrointestinal bleeding. In particular, double primary aortoenteric fistulae are vanishingly rare. We encountered a 75-year-old male patient suffering from abdominal pain, hematochezia, hematemesis, and hypotension. His computed tomography images showed abdominal aortic aneurysm and suspected aortoenteric fistulae. During surgery, we found two primary aortoenteric fistulae. The one fistula was detected between the abdominal aorta and the third portion of the duodenum, and the other fistula was detected between the abdominal aorta and the sigmoid colon. We conducted the closure of the fistulae, the exclusion of the aneurysm, and axillo-bifemoral bypass with a polytetrafluoroethylene graft. The patient was discharged with no complications on the 21st postoperative day.
PMCID: PMC3487019  PMID: 23130309
Aneurysm; Aorta; Fistula
25.  Clinical outcomes of hybrid repair for thoracoabdominal aortic aneurysms 
Annals of Cardiothoracic Surgery  2012;1(3):293-303.
Thoracoabdominal aortic aneurysm (TAAA) hybrid repair consists of aortic visceral branch rerouting followed by TAAA endograft exclusion. This technique has been shown to represent a technically feasible strategy in selected patients.
We analyzed 52 high-risk patients who underwent hybrid TAAA repair between 2001 and 2012 in our centre with a variety of visceral rerouting configurations and of commercially available thoracic endografts. Thirty-seven simultaneous (71.2%) and 15 staged procedures (21.8%) were performed with a four-vessel revascularization in 18 cases (34.6%), a three-vessel revascularization in 11 cases (21.2%) and a two-vessel revascularization in 23 cases (44.2%).
No intraoperative deaths were observed. We recorded a perioperative mortality rate of 13.5% (n=7), including deaths from multiorgan failure (n=2), myocardial infarction (n=2), coagulopathy (n=1), pancreatitis (n=1) and bowel infarction (n=1). Perioperative morbidity rate was 28.8% (n=15), including 2 cases of transient paraparesis and 1 case of permanent paraplegia. Renal failure (n=5), pancreatitis (n=3), respiratory failure (n=3) and dysphagia (n=1) were also observed. At median follow-up of 23.9 months procedure-related mortality rate was 9.6%: two patients died from visceral graft occlusion and three from aortic rupture. There were three endoleaks and one endograft migration, none of which resulted in death. Five patients (9.6%) died as a consequence of unrelated events.
Typical complications of conventional TAAA open surgery have not been eliminated by hybrid repair, and significant mortality and morbidity rates have been recorded. Fate of visceral bypasses and incidence of endoleak and other endograft-related complications needs to be carefully assessed. Hybrid TAAA repair should currently be limited to high-risk surgical patients with unfit anatomy for endovascular repair.
PMCID: PMC3741770  PMID: 23977511
Thoracoabdominal; aorta; aneurysm; hybrid; endovascular

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