Journal of Vascular Surgery
Volume 50, Issue 1 , Pages 8-14, July 2009

Reporting mid- and long-term results of endovascular grafting for abdominal aortic aneurysms using the aortomonoiliac configuration

1st Department of Surgery, Aristotle University of Thessaloniki, and Papageorgiou General Hospital, Thessaloniki, Greece

Received 22 October 2008; accepted 19 December 2008.

Article Outline

Purpose

This study evaluated the feasibility, efficacy, and durability of a specific aortomonoiliac endograft for the treatment of abdominal aortic aneurysm (AAA) during a midterm follow-up.

Methods

From January 2002 until November 2008, 106 patients (6 women; mean age, 73.37 ± 7.39 years) were treated for an AAA using an EndoFit aortomonoiliac graft (LeMaitre Vascular, Burlington, Mass). All procedures were elective.

Results

Mean follow-up was 34.9 months (SD, 20.08; range, 2-81 months). Long-term data (follow-up >60 months) were available for nine patients, none of which reported any vascular or procedure related complications. Three of the 106 patients (2.83%) died during early follow-up (<30 days); eight died during late follow-up (7.54%). Endograft infection developed in two patients (1.88%), and an aortoduodenal fistula developed in two (1.88%). Also observed were 15 type II (14.15%) and three type I (2.83%) endoleaks. Femorofemoral bypass thrombosis was detected in two patients (1.88%).

Conclusion

In this retrospective analysis, the aortomonoiliac configuration for elective AAA repair was proven to be safe and efficacious. Midterm and long-term follow-up results in this series compare well with previously reported results for AAA endografting using both bifurcated and aortomonoiliac endoprostheses.

 

Endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs) is feasible, efficacious, and has considerable short-term benefits compared with conventional open surgery, including shorter duration of operation, reduced blood loss, shorter length of hospital and intensive care unit stay, improved quality of life, and lower 30-day mortality and morbidity rates. Midterm results of EVAR are sufficiently encouraging to justify the choice of the procedure1, 2, 3, 4, 5, 6, 7, 8; however, the long-term verdict is still unclear.9, 10, 11, 12, 13, 14, 15

Endografting with a bifurcated endoprosthesis is contraindicated in certain patients due to various anatomic restrictions. In those patients, the deployment of an aortomonoiliac endograft, followed by a femorofemoral crossover bypass, could overcome the anatomic limitations and successfully exclude the aortic pathology, therefore avoiding open surgical repair.16, 17, 18, 19, 20, 21, 22, 23, 24 Several reports have proved that the aortomonoiliac configuration is both feasible and efficacious.16, 17, 18, 19, 20, 21, 22, 23, 24 The short-term results are comparable to those that have been reported for bifurcated endoprostheses, and the patency of the unavoidable extra-anatomical femorofemoral bypass is as high as 99%.16, 17, 18, 19, 20, 21, 22, 23, 24 Most series, however, do not provide long-term data and do not exclude patients treated for a ruptured AAA. In addition, most reports include patients treated with a variety of aortomonoiliac endografts, which further affects the ability to reach a definite conclusion.

This retrospective report analyses the results of elective endovascular grafting for the exclusion of AAAs using a specific endoprosthesis during a mean follow-up of 35 months. Long-term data for follow-up >60 months were available in nine patients.

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Methods 

Patient selection 

The clinical database of our department, located in a tertiary hospital, was retrospectively interrogated to identify all patients who had undergone elective endovascular aneurysm repair (EVAR) of an AAA between January 2002 and November 2008 using the EndoFit aortomonoiliac endoprosthesis (LeMaitre Vascular, Burlington, Mass), followed by a femorofemoral crossover bypass. The primary indication for EVAR was an AAA transverse diameter ≥5 cm or a rapidly increasing sac if ≤5 cm. Any symptomatic AAA was also eligible for EVAR. Ruptured AAAs were not included in this series.

The primary indications for EVAR with the aortomonoiliac configuration were the following:

1.narrow terminal aorta, defined as a transverse diameter <15 mm;

2.contralateral common iliac artery angle >90° from the longitudinal axis of the aneurysm;

3.obstructed contralateral common iliac artery;

4.concomitant ecstatic or frankly aneurysmal bilateral common iliac arteries, unless the patient had indispensable internal iliac arteries;

5.Conversion to the aortomonoiliac configuration while deploying a bifurcated endograft due to impossible contralateral limb catheterization.

Relative indications for EVAR with the aortomonoiliac configuration were a heavily calcified contralateral external iliac artery or a narrow contralateral common iliac artery (diameter <5 mm), with or without previous transluminal angioplasty.

The contraindications for aortomonoiliac graft implantation were the following:

1.proximal neck <10 mm in length (device-dependent);

2.proximal neck >32 mm in diameter (device-dependent);

3.proximal neck thrombus >30% of the perimeter;

4.bilateral common iliac arteries >18 mm in diameter with indispensable internal iliac arteries (device-dependent), defined as nonpatent superior mesenteric artery or nonpatent Haller's tripod;

5.excessive bilateral iliac artery tortuosity >90°;

6.excessive bilateral iliac artery calcification; and

7.indispensable inferior mesenteric artery.

General contraindications for every endovascular procedure were age <18, allergy to contrast medium, coagulopathy, pregnancy or lactation, creatinine level >1.7 mg/dL, groin infection and connective tissue disease.

Whenever a bifurcated endograft could be implanted, the aortomonoiliac configuration was avoided because it involves an extra-anatomic bypass.

Device specifications 

The EndoFit self-expanding stent graft consists of an endoskeleton made of nitinol stents. The graft has a conical shape (proximal diameter is larger than the distal diameter). A nitinol bare proximal stent situated at the top of the endograft enhances proximal fixation. The first covered stent is doubled to further increase radial force and sealing. The fabric is made of two layers of expanded polytetrafluoroethylene that are affixed to the stent skeleton with a thermal process to avoid the need for fixation sutures. As a result, there is no interface of the metallic stent with blood, aortic wall, or incoming wires.

The endograft is inserted through a flexible 18F to 22F hydrophilic sheath for maximal trackability through tortuous or calcified iliac arteries. The graft comes preloaded on a sheath or in a separate cartridge from which it can be loaded on the pre-positioned sheath during the operation.

The proximal diameter of the stent graft is 20 to 36 mm, and the distal diameter is 12 to 26 mm. The EndoFit is available in lengths of 10 to 20 cm. The EndoFit Occluder kit was available in sizes of 18 to 34 mm in diameter and 3.5 cm in length; this allows the operator to occlude contralateral aneurysmal iliac arteries of up to 30 mm in diameter (transverse).

Preoperative assessment 

Preoperative assessment included helical contrast-enhanced computed tomography angiography (CTA) acquired at 3- or 5-mm intervals with 2- or 3-dimensional reconstruction in all cases. In patients with impaired renal function, a preoperative magnetic resonance angiography (MRA) scan was obtained instead of contrast-enhanced CTA. The exact dimensions of the proximal and distal landing zones (diameter and length), aortic and iliac artery tortuosity, and the inner diameters of the access vessels were determined in all patients preoperatively. Digital subtraction angiography (DSA) was used before EVAR in 19 patients (17.92%) to evaluate intermittent claudication or peripheral arterial disease, or both. Patient comorbidities at admission are summarized in Table I. Anatomic characteristics are summarized in Table II.

Table I. Comorbidities upon admission
ComorbiditiesPatients, No (%)
Coronary disease53(50)
Acute myocardial infarction31(29.25)
Diabetes mellitus11(10.30)
Arterial hypertension69(65.09)
Hyperlipidemia43(40.57)
Smokers and ex-smokers87(82.08)
Chronic renal insufficiency6(5.66)
Stroke3(2.83)
Chronic obstructive pulmonary disease18(16.98)
Hostile abdomen11(10.38)

COPD, Chronic obstructive pulmonary disease.

Table II. Anatomic characteristics at admission
Anatomic characteristicsMean (range)No. (%)
Maximal aneurysmal diameter, cm6.1(5-12)
Maximal CIA diameter, cm14(11-70)
Proximal neck diameter, cm26(20-30)
Neck length, cm15(10-25)
Neck angulation, degrees25(5-72)
Diameter of terminal aorta, cm24(4-60)
Excessive contralateral CIA angulation 68(64)
Contralateral iliac stenosis(<6 mm) 24(23)
Occluded contralateral iliac artery 2(1.9)
Excessive iliac calcification 41(39)
Bilateral aneurysmal iliac arteries 8(7.5)
Neck thrombus 3(3)
Narrow terminal aorta 26(25)
Inability to cannulate a bifurcated graft 1(0.9)

CIA, Common iliac artery.

Implantation procedure 

All procedures were performed in a fully equipped operating room with the patient under regional or general anesthesia and fluoroscopic control using a mobile C-arm (Siremobil 2000; Siemens, Erlangen, Germany) and iopromide (Ultravist 300, Bayer Schering Pharma AG, Berlin, Germany), a nonionic contrast agent. Standard patient monitoring included electrocardiography and arterial pressure. All procedures were performed by the same team, including two resident vascular surgeons and an attending vascular surgeon. The implantation procedure is described thoroughly elsewhere.24

In accordance with our department's standard protocol for patients undergoing EVAR,25 aspirin and clopidogrel were administered the day of the procedure. Aspirin was discontinued on postoperative day 30, and clopidogrel was continued as a life-long treatment. The patients ambulated on postoperative day 2. A plain abdominal radiograph was used to document graft integrity and position. The patient was usually released on postoperative day 4.

Follow-up 

All patients were followed up according to our department's standard EVAR protocol, which included plain abdominal radiography (anteroposterior and lateral views) and a contrast-enhanced CTA at 1, 6, and 12 months, and annually thereafter. Assessment focused primarily on device migration, proximal neck and aneurysm sac diameters, and the presence of endoleaks. A full clinical examination was performed at every follow-up visit. Angiography was reserved for investigation of suspected endoleak or graft occlusion.

Definitions 

Technical success was defined as endoprosthesis deployment to exclude the aneurysm and achieve a patent graft without need for a secondary intervention. Major deployment-related and implant-related complications, technical success, and all events occurring during follow-up were analyzed and defined according to Chaikof et al.26 Endoleaks were classified according to the White-May definitions27; type II endoleaks were not considered as major deployment-related complications.26 Postimplant syndrome was defined as postoperative fever combined with leukocytosis; it was not considered as a major complication.26

Statistical analysis 

All continuous variables were tested for normality using the Kolmogorov-Smirnov test. Normally distributed continuous variables are expressed as mean ± standard deviation (SD) or range, where appropriate. Life-table survival analysis was performed for major complications and death secondary to the procedure (defined as death ≤30 days after the procedure), the implant or major cardiac complications, or both, including all perioperative, early (<30 days), and late (>30 days) follow-up events. Also examined were cumulative rates (life-table analysis) for major complications and death secondary to the procedure (defined as death ≤30 days after the procedure) as well as implant or major cardiac complications, or both. All analyses were performed using the SPSS 13.0 software (SPSS Inc, Chicago, Ill).

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Results 

Procedural results 

Between January 2002 and November 2008, 106 patients (6 women; mean age, 73.37 ± 7.39 years) were treated with the EndoFit (LeMaitre Vascular, Burlington, Mass) aortomonoiliac device. Contraindications resulted in the exclusion of 14 patients from treatment with an aortomonoiliac device. During the same period, 297 patients were treated for an AAA using a bifurcated endoprosthesis. A tubular stent graft was used in 55 patients, and 126 patients were offered open repair. The stent graft was successfully deployed in all patients (100% technical success). EndoFit extensions were used in 19 of 106 patients (17.92%), either for landing in the external iliac artery or when the length of the main graft body was inadequate to reach the distal landing zone. The ipsilateral internal iliac artery was intentionally occluded in 11 patients (10.37%) to accomplish safe distal attachment and sealing (the common iliac artery was aneurysmal in all of those patients).

Regional anesthesia was used in 103 procedures and general anesthesia was used in three. According to American Society of Anesthesiologists (ASA) classification,23 49 (46.2%) were at class 3 or higher and were thus considered as being at high surgical risk. There were no perioperative deaths.

The mean operative time was 114 minutes (range, 82-243 minutes), and the mean fluoroscopy time was 14 minutes (range, 9-48 minutes). The mean amount of contrast medium used was 160 mL (range, 80-280 mL). Perioperative blood transfusion was required in 18 patients (16.98%), but none required >2 U of blood.

The mean length of hospital stay was 6 days (range, 4-11 days). All patients were monitored in the intensive care unit (ICU) postoperatively for at least 2 hours, with a mean ICU stay of 4 hours (range, 2-72 hours), before being transferred to the surgical ward.

Early follow-up (≤30 days) 

Three deaths (2.83%) occurred during early follow-up. An 88-year-old man with chronic renal failure and cardiac insufficiency died on postoperative day 2 of acute myocardial infarction. Two other men, 78 and 80 years old, respectively, died of acute myocardial infarction after discharge from hospital and ≤30 days after the operation. One patient (0.94%) had a nonfatal acute myocardial infarction on postoperative day 2.

A 68-year-old-man (0.94%) treated for an anastomotic AAA was diagnosed with an aortoduodenal fistula 18 days after the grafting procedure. A blood culture was also found positive for Bacteroides fragilis. The patient was offered emergency laparotomy. Cultures from the extracted graft revealed Stenotrophomonas maltophilia. The patient was admitted to the ICU, where he remained hospitalized for 9 days. The patient fully recovered and was in good condition 4 years after the procedure.

Two endoleaks were observed during early follow-up. A proximal type I endoleak (0.94%) was identified at 1 month and was treated with a proximal cuff. A type II endoleak (0.94%) was discovered on postoperative day 30, but no further action was taken. The patient remained under surveillance and has reported no further complications related to the procedure.

Femorofemoral graft thrombosis occurred in one patient (0.94%) during early follow-up due to insufficient inflow caused by a residual stenosis of the endograft. The deficit was treated immediately with thrombectomy of the PTFE graft and balloon dilatation of the EndoFit graft.

A wound hematoma occurred in 10 patients and was treated conventionally. Superficial infection and lymphorrhea were identified in eight patients (7.54%) and were treated conventionally. All patients with clinical evidence of a superficial infection or wound hematoma, or both, had an indium white blood cells scan to exclude further infection of the endoluminal devices. The results of all scans were negative. No further infection-related sequelae were noted in these patients during follow-up. Postimplant syndrome developed in 14 patients (13.2%) and was treated conventionally with nonsteroidal anti-inflammatory drugs. No graft migration, paraplegia, distal embolization, or any other serious complications were observed during early follow-up.

Late follow-up (>30 days) 

Mean follow-up was 34.94 months (SD, 20.08; range, 2-81 months). Fourteen patients were lost to late follow-up. Long-term follow-up data ≥60 months were available for nine patients, none of whom was lost to follow-up. One patient died 2 years after the operation of causes not related to the procedure; however, no vascular or procedure related complications were observed after postoperative day 30 within this patient group. Eight deaths (7.54%) have occurred during late follow-up: 1 patient (0.94%) died of lower gastrointestinal bleeding 20 months after aortomonoiliac graft implantation and 14 months after he had been treated for a secondary aortoduodenal fistula, 3 (3.77%) died of acute myocardial infarction (classified as major cardiac complication), 2 (1.88%) died of unknown causes (classified as indeterminate death), and 2 (1.88%) died of cancer.

A 60-year-old man (0.94%) was diagnosed with an aortoduodenal fistula and graft infection at postoperative month 6. No evident defects were noted in the explanted graft. The patient recovered, but eventually died 14 months later after being admitted to another institution because of lower gastrointestinal bleeding. The two patients with aortoduodenal fistulas and graft infection are being discussed analytically elsewhere.28

A distal type I endoleak was observed at postoperative month 12 in one patient and was treated with an EndoFit extension graft; no further complications have occurred in this patient. Another distal type I endoleak was detected in another patient at the 12-month follow-up abdominal CT scan and was treated with a balloon-expanding (Parodi type) extension; the patient has remained under surveillance ever since, and no further procedure related complications have been reported. One patient was admitted at postoperative month 6 reporting intermittent claudication, and the subsequent imaging investigation disclosed a thrombosis of the femorofemoral bypass. The deficit was treated with thrombectomy of the PTFE graft; the patient has not reported further vascular complications.

A stenosis of the femorofemoral bypass graft was observed in one patient at postoperative month 12; the patient was treated conservatively, and no further vascular complications have been observed.

Type II endoleaks were observed in 14 patients (13.2%) during late follow-up (>30 days), but none underwent reoperations; they all remained under normal follow-up surveillance. Four patients (3.77%) sustained a nonfatal acute myocardial infarction. The cumulative rates at 81 months were 12% for procedure related death (Fig 1) and 29% for major complications (Fig 2). Late follow-up outcomes are summarized in Table III. Changes in AAA volume and AAA diameter during follow-up could not be reported because we lacked postoperative CT scans that included 1-mm slices.

  • View full-size image.
  • Fig 1. 

    Life-table analysis is shown for freedom from death related to the procedure or the implant, or both, or death secondary to a major cardiac complication throughout follow-up.

Table III. Outcome for late follow-up (>30 days)
EventPatients, No. (%)
Death8(7.54)
Endoleak type I2(1.88)
Endoleak type II14(13.20)
Aortoduodenal fistula + infection1(0.94)
Acute myocardial infarction4(3.77)
Bypass thrombosis or stenosis2(1.88)

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Discussion 

This report provides evidence that the midterm and long-term results of endovascular grafting using the aortomonoiliac EndoFit stent graft compare well with the results that have been reported so far for various aortomonoiliac and bifurcated endoprostheses or open surgical repair. Our initial results with the specific aortomonoiliac graft were reported 3 years ago and included 39 patients. The median follow-up was 14 months.24

The aortomonoiliac configuration was initially reported by May et al,14 Parodi et al,22 and Marin et al23 using a balloon-expandable stent graft (proximal graft affixation) and a distal surgical anastomosis of the graft to the ipsilateral iliac or common femoral artery. Since then, several authors have been reluctant about—or even opposed to—the specific configuration, claiming poor femorofemoral bypass patency rates, basing their assertion is based on various reports citing 5-year patency rates of 35% to 92%.29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 However, aortomonoiliac endografting, followed by a femorofemoral crossover bypass, is applied in patients with aneurysmal disease who typically do not present with obstructive peripheral arterial disease.

Moreover, most registries relative to patency rates of femorofemoral crossover bypass as an adjunct to aortomonoiliac endografting have reported high patency rates of up to 91% at 3 years40 and 99% at 4 years.41 In this series, the overall patency rate of the femorofemoral bypass was 98.11%. These results are well comparable with iliac leg thrombosis rates for bifurcated modular endoprostheses.42 The primary patency rate was 97.5%, and the secondary patency rate was 100% in our initial report.24 In this series, thrombosis of the femorofemoral bypass developed in two of 106 patients (1.88%). Our technical success rate was 100%, which compares favorably with the reported rates of 94% to 99% for various other endografts.42, 43, 44, 45, 46, 47, 48, 49, 50, 51

An interesting observation during follow-up >60 months is that no procedure related complication developed after postoperative day 30 in any of the patients for whom long-term data were available. Endoleak from the site of the occluded iliac artery may also theoretically occur when an aortomonoiliac graft is used; however, this complication was not documented in our patient group.

Recognized advantages of the aortomonoiliac configuration include the ease of device deployment as well as the absence of modular interface requirements and their potential pitfalls. The aortomonoiliac configuration is particularly favored in patients who present with ruptured aneurysms because the rapid exclusion of the aneurysm sac is of major importance to avoid a fatal outcome. The aortomonoiliac graft is deployed in considerably less time because contralateral stump cannulation and deployment of a contralateral leg is not needed.

In some AAAs, implantation of a bifurcated endoprosthesis may not be feasible due to anatomic restrictions such as a narrow terminal aorta and a tortuous, narrow, or obstructed contralateral iliac artery.49 In this series, the aortomonoiliac configuration was reserved for relatively unfavorable aortic anatomies, such as aneurysm neck angulation, narrow terminal aorta or complex iliac artery anatomy, or both, as well as for patients who were unfit for open surgical repair. One would, therefore, expect a potential increase in early and late complication rates, which has not been documented. The aortomonoiliac configuration in our department has been applied (elective EVAR) to about 18% of the patients who eventually underwent elective EVAR for an AAA. This is mainly due to the anatomic limitations that we often encounter in patients who are being considered for EVAR, possibly attributable to our department being situated in a tertiary hospital.

A major complication seen twice in this series was the development of an aortoduodenal fistula; however, no defects were noted in the extracted graft. Both patients have been discussed thoroughly elsewhere.28 One of the patients was treated for an anastomotic aneurysm diagnosed after he had undergone open infrarenal AAA repair with an aortoaortic Dacron graft. We assume that the aortomonoiliac graft infection could be attributed to preexisting infection of the Dacron graft that was underestimated at the time of endovascular repair.

The limitations of this report include its retrospective nature and that 14 patients were lost to follow-up. However, the relatively large number of patients involved (106), given that the aortouniiliac configuration is usually reserved for aneurysm rupture and not elective AAA repair, and the duration of the follow-up, enable for relatively safe conclusions to be made.

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Conclusions 

This report provides evidence that the aortomonoiliac configuration using the specific endoprosthesis is a safe procedure over the midterm and long-term and compares well with the results of repair with bifurcated endoprostheses that have been published.4, 9, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51 In any case, the technique incorporates an extra-anatomic bypass and should be reserved for unfavorable anatomies and patients unfit for open repair.

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Author contributions 


Conception and design: JL, NS

Analysis and interpretation: AS, NM, KS

Data collection: AS, NM, JL, KS

Writing the article: AS, NM

Critical revision of the article: JL, NM, AS, NS

Final approval of the article: NS, DK, NM, AS, JL

Statistical analysis: AS

Obtained funding: NS, DK

Overall responsibility: NS

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 Competition of interest: none.

PII: S0741-5214(08)02293-3

doi:10.1016/j.jvs.2008.12.054

Journal of Vascular Surgery
Volume 50, Issue 1 , Pages 8-14, July 2009

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