Results of Endovascular Abdominal Aortic Aneurysm Repair with the Zenith stent-graft

Article Outline

• Abstract
• Introduction
• Materials and Methods
  • Patients
  • Work-up
  • Procedure
  • Follow-up
  • Definitions and statistics
• Results
  • Technical success, in-hospital mortality and morbidity
  • Follow-up
  • Late mortality
  • Endoleaks, device migrations, and graft limb occlusions
  • Re-interventions
• Discussion
• References
• Copyright

Abstract 

Objective

To evaluate single center results of the Zenith stent-graft for elective abdominal aortic aneurysm repair.

Methods

Data from all patients treated with a Zenith graft between March 1999 and December 2006 were retrospectively analyzed from a prospective database. Outcome measures were technical success, all-cause and aneurysm related mortality, late complications, and re-interventions.

Results

A total of 234 patients were included, of which 216 were male. Mean age was 72.1±6.9 years. Mean diameter of the aneurysm was 60.9±10mm. Technical success rate was 98.3%. Thirty day mortality was 1.7%. Median follow-up was 26.9 months (range, 1–104). Overall survival was 92.2±1.8% at 1 year, 87.2±2.3% at 2 years, and 69.9±4.6% at 5 years. During follow-up, one aneurysm ruptured due to limb disconnection, which was treated by bridging stent-grafting. Re-interventions were performed in 9.2% of the patients, with 79% by endovascular means. There was no mortality related to re-intervention.

Conclusions

Endovascular abdominal aortic aneurysm repair with the Zenith device provides excellent results with a low risk for aneurysm-related death and rupture, and a low re-intervention rate in the mid-term.

Keywords: Abdominal aneurysm, Endovascular, Zenith, Mid-term, Re-interventions

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Introduction 

Although early benefits of endovascular abdominal aortic aneurysm repair (EVAR) have been demonstrated in two randomized trials, the number of late complications and re-interventions remains an issue of debate.¹, ² First generation devices were associated with high rates of late complications.¹, ³ Later, the rate of secondary interventions seemed to decline, which was readily attributed to improved stent-graft design and better patient selection.⁴, ⁵

The Zenith (Cook Inc, Bloomington, IN, USA) stent-graft is a third generation device that underwent very few changes over the years. It is available both in a custom-made two-part bifurcated device and in a standard three-part (aortic bifurcation+two iliac limbs) device. Although it has been used in more than 15 000 patients worldwide, there are still only few reports regarding the mid- and long-term follow-up.

The aim of this study was to report our single centre experience with the Zenith stent-graft.

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Materials and Methods 

The EVAR programme in our University Medical Center started in 1996. In the first years devices were mainly chosen based upon availability. From 1999 onwards several devices were commercially available allowing us to tailor device selection according to anatomical features of the aneurysm (e.g. Talent [Medtronic World Medical, Sunrise, FL, USA] for proximal necks with a large diameter, Excluder [W.L. Gore and Associates, Flagstaff, AZ, USA] for narrow and angulated iliac arteries because of the flexibility of the device, Zenith [Cook Inc, Bloomington, IN, USA] for short proximal necks in view of the suprarenal fixation of the bare stent with hooks and barbs). Since 2001 we have the availability of a full range of Zenith devices in stock. This, together with the versatility of the device in terms of distal diameter (10–24mm) and lengths, is the reason why many patients were treated with a Zenith device.⁶, ⁷

Patients 

Between March 1999 and December 2006, a total of 379 patients underwent elective EVAR. The Zenith graft was selected in 234 patients. The device incorporates self-expanding stainless-steel Z stents attached to a polyester graft material. Features of the device are the suprarenal fixation and a controlled release mechanism of the bare top stent.⁷, ⁸

Work-up 

Pre-operative work-up consisted of a multi-slice computed tomography (CT) scan to evaluate the anatomy of the proximal and distal landing zones and the access through the femoral arteries. In selected cases, an additional angiography was performed. Evaluation of the indications for surgery and selection of the device was done by a team of senior staff members including an interventional radiologist.

Procedure 

All procedures were performed in an operating theatre using a mobile image intensifier. Access to the femoral arteries was usually performed through surgical dissection, preferably under local anaesthesia. A description of the technique has been reported elsewhere.⁹ Embolization of an internal iliac artery (IIA), if needed, was routinely performed during the same procedure. Patients received antibiotic prophylaxis (cefazoline 1g) and heparin (5000IU) intravenously.

Follow-up 

From 1996 to January 1999, duplex ultrasound scanning, CTA (or MRA for suitable devices) and multiplanar abdominal radiography were performed before discharge of the patient. Follow-up included CTA or MRA, duplex ultrasound, and abdominal X-ray at 1, 3, 6, 12, 18, and 24 months, and yearly thereafter. From 1999 on, based on our clinical experience and emerging literature, but also due to logistical and stochastic burden for the patient, the protocol was simplified: duplex ultrasound scanning and multiplanar abdominal radiography were done before discharge. At 1 month, a contrast-enhanced CT-scan was performed. Routine follow-up thereafter consisted of duplex ultrasound scanning and multiplanar abdominal radiography at 6 months, 1 year and annually thereafter. CT-scan (or angiography) was only done on indication (endoleak, growth of aneurysm, migration>5mm, kinking). All patients treated with the Zenith device were followed with the new protocol.¹⁰, ¹¹, ¹² All patients were put on antiplatelet therapy after the procedure.

Definitions and statistics 

Data were collected prospectively on intention-to-treat basis but analysed in a retrospective manner with SPSS 12.0 (SPSS, Chicago, IL, USA). Reporting standards for endovascular aortic aneurysm repair were used for definitions and analysis of endpoints.¹³ Primary endpoints were technical success, all-cause and aneurysm related mortality and aneurysm rupture. The cause of death was determined by assessment of patient charts and by contacting the general practitioners and patients' relatives if necessary. Aneurysm related mortality was defined as death resulting from aneurysm rupture (as proven by autopsy, surgery or CT scan) or any death occurring within 30 days after the original procedure or a re-intervention. In case an autopsy was not available, we classified the death as probably unrelated if the clinical picture was consistent and documented with reliable observations during the terminal illness. When these criteria could not be met, the cause of death was considered indeterminate. Secondary endpoints were late complications including migration (>5mm), endoleak, aneurysm sac diameter changes and re-intervention.

Primary technical success was defined as a successful introduction and deployment of the device in the absence of conversion or intra-operative mortality, type I or III endoleaks, or graft limb occlusion. When unplanned endovascular or surgical procedures were necessitated during the procedure or within 24h, the terms assisted primary or secondary technical success, respectively, were used. Re-intervention was defined as any endovascular (transfemoral) or open surgical intervention (transfemoral or transabdominal) performed after the initial EVAR in order to maintain or restore the function of the endograft. When more than one re-intervention was necessary during follow-up, the classification of primary, secondary and tertiary re-intervention was used.¹⁰ Variables were expressed as mean±standard deviation or median (range) by skewed data. Time-to-event variables were studied with Kaplan–Meier survival analysis.

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Results 

A total of 234 patients underwent elective EVAR with the Zenith stent-graft. There were 216 male patients. Mean age was 72.1±6.9 years. Indications for surgery and co-morbidities are summarized in Table 1. Mean diameter of the aneurysm sac was 60.9±10mm (range 45–150mm). Two aneurysms were smaller than 50mm; the first was 45mm (anastomotic aneurysm after tube-graft with rapid growth) the second 47mm but with growth of 1cm in 6 months. Forty-nine aneurysms had a diameter between 50 and 55mm. Median neck length was 22.5mm (range 10–100). One hundred and three patients (44%) had a neck length between 10 and 20mm.

Table 1. Patient co-morbidity and indication for surgery

	N	%
ASA classification
ASA II	96	41.0
ASA III	128	54.7
ASA IV	10	4.3
Co morbidity
Hypertension	134	57.3
Chronic obstructive pulmonary disease	68	29.1
Coronary artery disease	114	48.7
Congestive heart failure	14	6.0
Arrhythmia	32	13.7
Diabetes mellitus	34	14.5
Hypercholesterolemia	82	35.0
Renal insufficiency (creat>150μmol/l)	17	7.3
Prior abdominal surgery (laparotomy)	46	19.7
Indications for surgery
Infrarenal aneurysm	212	90.6
Aorto-iliac aneurysm	14	6.0
Anastomotic aneurysm	4	1.7
Inflammatory aneurysm	4	1.7

Different types of the Zenith device were used. A bifurcated graft was used in 220 patients (94%) including 156 patients with a Tri-Fab (three-part) prosthesis and 64 patients with a Custom-Made (two-part) prosthesis. Ten patients were treated with an aorto-uni-iliac device with a femoral–femoral cross-over bypass and three patients with a tube-graft. One patient did not receive an endograft (see below). Procedural details are shown in Table 2. In 13 patients a combination of a Cook body with Excluder limb(s) was used.

Table 2. Perioperative data

Operating time (min)	116.4±29.5
Fluoroscopy time (min)	9.0±8.6
Amount of contrast (mL)	153.8±55.1
Blood loss (mL)	156.7±107
Local anaesthesia (no. of patients)	175
Regional anaesthesia (no. of patients)	36
General anaesthesia (no. of patients)	23
Length of stay (days)	4.6±3.9

In 23 (10%) patients, planned additional intra-operative endovascular manoeuvres were performed. In 14 patients embolization of side branches was performed (13 IIA and one IMA). In five patients a self-expandable stent (Wallstent, Boston Scientific, Natick, MA, USA) was positioned inside a limb to correct kinking in order to avoid occlusion. Four patients underwent percutaneous transluminal angioplasty (PTA) intra-operatively (three iliac arteries and one renal artery).

Technical success, in-hospital mortality and morbidity 

Primary technical success rate was 95.3% (223/234 patients). The primary assisted technical success rate was 97.4% (228/234 patients). Five patients required unplanned additional stent-graft components: Three patients had a type I endoleak at the completion angiography which was corrected with a proximal extension, and two patients received a bridging stent-graft to correct insufficient overlap zones. Secondary technical success rate was 98.3%(230/234 patients): One patient underwent a re-intervention within 24h to correct a graft limb thrombosis; in the second patient a femoral artery graft interposition (for femoral artery aneurysm) occluded at day 1, which required immediate revision. In four patients (1.7%) the procedure was technically unsuccessful. In one patient the delivery system could not be introduced through the narrow and calcified iliac arteries. The patient was judged inoperable for an open procedure due to inoperable coronary disease. He died 1 year later due to myocardial infarction. In three patients a type I endoleak was seen at completion angiogram. Two patients had a proximal endoleak, which was treated with re-ballooning. After ballooning, a small endoleak persisted which was initially accepted. The third patient had a small distal endoleak. The IIA on the opposite side being already occluded, it was decided not to occlude the second IIA by overstenting it. In all three cases the endoleaks disappeared within 1 month.

Overall 30 day mortality was 1.7% (four patients). Two patients died of myocardial infarct at 1 and 7 days, respectively. Another patient died at day 8 due to cerebral haemorrhage in a metastasis. The fourth patient died at home at day 15 after an uneventful procedure, most likely to myocardial infarction. According to reporting standards for endovascular aortic aneurysm repair, there were five severe, six moderate, and 28 mild surgical complications in 39 patients (16.7%).¹³ Details of these complications are shown in Table 3.

Table 3. Early complications

There were three re-interventions within the hospital stay. Two occurred within 24h as mentioned above. In the third patient, who underwent a percutaneous approach (closure with a Prostar, Abbott Vascular, Redwood City, CA, USA) a false aneurysm was surgically repaired on the sixth postoperative day. All reinterventions are listed in Table 4.

Table 4. Indication and procedures for re-intervention

CM, custom made; TF, Tri-Fab; A/E, acute/elective; CFA, common femoral artery; AAA, aneurysm abdominal aorta; IMA/IIA/EIA, inferior mesenteric artery/internal iliac artery/external iliac artery.

Follow-up 

Initial follow-up was available in all 229 surviving treated patients (four deaths, one aborted treatment). Median follow-up was 26.9 months (range, 1–104). However, 26 patients were lost to follow-up between 12 and 35 months. Reasons were co-morbidity in combination of advanced age in 22 patients, and moving away to other area in four patients.

Late mortality 

During follow-up, 43 (18.8%) patients died between 2 and 96 months (median 23 months). Autopsy findings confirmed that death was unrelated in six patients. In 33 patients, death was classified as probably unrelated in view of consistent clinical findings: malignancy (15), cardiac (5), pulmonary disease (5), stroke (5), bleeding gastric ulcer (2), and ischemic bowel (1). Finally four patients died without known cause and were classified as indeterminate aneurysm related deaths. Overall survival was 92.2±1.8% at 1 year, 87.2±2.3% at 2 years, 81.1±3% at 3 years and 69.9±4.6% at 5 years (Fig. 1).

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• Figure 1 

  Overall patient survival over mid-term follow-up.

Endoleaks, device migrations, and graft limb occlusions 

During follow-up endoleaks of any type were diagnosed in 50 patients (21.8%). There were seven high-pressure endoleaks (type I or type III).

Type I endoleaks were seen in five patients (2.2%). A proximal type I endoleak occurred in two patients. In the first patient, the graft did not seal sufficiently in an angulated proximal neck. In the second patient, a complete disconnection between the bare stent and the graft occurred and was diagnosed at 5-years follow-up. Both required treatment as discussed below. A distal type I endoleak occurred in three patients. In two patients, this was due to extension of disease in dilated common iliac arteries. In the third patient, a limb was initially not positioned far enough inside the common iliac artery. All three cases required endovascular re-intervention, two of them in the acute setting.

Type III endoleaks were seen in two patients (0.9%). Both were disconnections of the contra-lateral limb, one in a 10cm large aneurysm. Both were repaired by endovascular means, one in the acute setting, and the other in the elective setting.

Type II endoleaks were diagnosed in 43 patients (18.8%). In 24 (56%) patients spontaneous resolution occurred, mainly during the first 6 months. In 11 patients the type II endoleak persisted but no treatment was initiated until now. In eight patients with a type II endoleak, five in conjunction with a growing aneurysm, a re-intervention was performed. No patient with a type II endoleak ruptured. Aneurysm sac growth>5mm was seen in 7 (3.1%) patients (five with type II endoleak, two without evidence of endoleak). Overall, mean AAA sac diameter decreased from 60.6±10.3 to 49.0±12mm.

Proximal migration of more than 5mm without endoleak occurred in three (1.3%) patients. None of these three patients required treatment. This is without including the mentioned patient with the disconnection of the bare stent.

Four (1.7%) patients experienced graft limb occlusions, including the occlusion on day 1. Three patients required treatment as mentioned below. The last patient experienced mild claudication only and was not treated.

Re-interventions 

Twenty-nine re-interventions were performed in 21 (9.2%) patients, including the three in-hospital re-interventions.

Six patients underwent acute re-intervention. Three patients of which one was in shock were admitted with sudden onset of pain. Investigation showed a distal type I endoleak in two cases (one ruptured, one non-ruptured) and one non-ruptured type III endoleak. All three cases were treated by endovascular means. Recovery was uneventful. The other three acute re-interventions were done for graft limb occlusions. Details are shown in Table 4.

One semi-acute reintervention was required for a possibly infected stent-graft. The patient presented with general malaise, fever and diffuse abdominal and lower back pain 10 months after the EVAR procedure. CT-scan showed fluid collections behind the proximal part of the endovascular graft and dorsal to the aorta. CT-guided translumbar needle aspiration of these collections yielded growth with Listeria monocytogenes. Radiological drainage and prolonged antibiotic treatment resulted in favourable outcome at midterm follow-up (25 months) with preservation of the endograft.¹⁴ At present, the patient is symptom free, with normal CT-scan findings and infection parameters.

Details of all re-interventions are shown in Table 4. In total there were 23 (79%) transfemoral and six (21%) transabdominal re-interventions. The transabdominal procedures included one ileofemoral cross-over bypass for graft limb occlusion, and five laparotomies to ligate lumbar arteries (type II endoleak with growing aneurysm). In one of these cases it proved impossible to control the bleeding and it was decided to perform a conversion. The patient's recovery was uneventful. The primary re-intervention was successful in 15 (71.4%) patients. However, in six patients, new complications occurred and resulted in secondary and tertiary re-interventions. There was no mortality related to re-intervention. The cumulative intervention-free survival is shown in Fig. 2.

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• Figure 2 

  Cumulative intervention free survival rates.

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Discussion 

This cohort study is the largest published single center study with the Zenith stent-graft in Europe. Its use appears to be safe with a secondary technical success rate of 98.3% and 1.7% surgical mortality in the whole cohort (i.e. including low- and high-risk patients). The durability of the device, measured by the late related mortality and re-intervention rate at mid-term follow-up, is excellent. In this series, re-intervention rate was 9.2% including three early re-interventions. Late re-interventions were required in 18 (7.9%) patients for a re-intervention free survival rate of 95.9±1.3% at 1 year, 93.4±1.8% at 2 years and 85.8±3.5% at 5 years follow-up. This is a significant improvement compared to earlier results of EVAR, with reported late re-intervention rates between 11 and 18%.¹, ³ Several other more recent reports on the Zenith graft confirm our findings with re-intervention rates ranging between 6.8 and 12.5% (Table 5).⁵, ¹⁵, ¹⁶, ¹⁷, ¹⁸, ¹⁹, ²⁰ Although better patient selection and increased experience with EVAR probably play a role, graft design is also contributing to durability and longevity of the procedure.²¹ The Zenith graft provides a secure proximal fixation by combining transrenal fixation with hooks and a high radial force. Proximal migration carried a low incidence (1.7%) during follow-up in this series. Three grafts migrated between 5 and 10mm but are now stable with still sufficient sealing in a longer neck (18, 21, and 24mm). In a fourth patient with an older type of attachment of the bare stent with the graft material, the bare stent disconnected completely which required a bridging cuff. This problem was solved by the manufacturer by strengthening the attachment between the bare stent and the stent-graft. The low incidence of proximal migration was confirmed by other series.¹⁷, ¹⁸

Table 5. Literature overview of reports on the Zenith graft, used in over 50 patients, published from 2001 on

SC/MC: single-center or multi-center study.

nm: Not mentioned.

An advantage of the Tri-Fab system is versatility with regard to length and diameter issues distally. It makes exact positioning at the distal landing zone possible, because the required iliac leg extensions can be measured and selected after insertion of the main body. Obviously this necessitates the immediate availability of back-up devices. Over time, we have learned to take advantage of this option.

A theoretical disadvantage in a three-part modular device is the higher risk of disconnection and subsequent type III endoleak.⁷, ¹⁷ In our series we saw only two disconnections (0.9%), both in the contra lateral limb, but never in an ipsilateral limb which is usually positioned with a two-to-three stent overlap. This urged us to consider a one-and-a-half stent overlap for the contra lateral limb. Since then no more disconnections were seen. In retrospect, both disconnections were predictable from the X-rays made during routine follow-up, since these showed initial minor migration. Unfortunately this was missed both times, which stresses the importance of a thorough review of follow-up examinations. With earlier diagnosis, i.e. before full disconnection, endovascular repair with a bridging stent-graft would have been much easier. After disconnection, catheterization can sometimes prove tedious in view of misalignment.

The limbs of the Zenith prosthesis are prone to kinking in tortuous and narrow iliac arteries, due to their interrupted stent design.¹⁵, ¹⁷, ²², ²³ In our study, we encountered only four (1.7 %) graft-limb occlusions. This relatively low rate can be explained by a meticulous choice of stent-graft and the tactical approach in each patient. In patients at risk for iliac limb occlusion (tortuous and/or narrow vessels) a self-expandable stent positioned inside the Zenith graft limb should avoid kinking and subsequent occlusion.²³ We applied this with success in five patients. Another option in case of a longer proximal neck (in our opinion>20mm) is to use a device with infrarenal fixation but with more flexible iliac limbs (e.g. Gore Excluder). As mentioned above, in case of aneurysms with a short neck and tortuous iliac arteries, we did not hesitate to use a combination of a Cook Zenith Tri-Fab body with Gore Excluder limbs. The Gore Excluder limbs with their proximal diameter of 16mm do seal well inside the gates of the Zenith Tri-Fab body. For completeness, we report that none of these 13 patients required re-intervention.

In our series, re-intervention rate was low, and importantly, not associated with mortality. It is known that trans-abdominal and extra-anatomic procedures to treat complications after EVAR do carry a higher risk of mortality and morbidity.⁴ In our series 79% of re-interventions were performed by transfemoral approach. This is certainly one explanation for the 0% mortality. Other possible explanations are diagnosis and treatment of complications at an early stage, in order to carry out the procedure in an elective setting.

In conclusion, the Zenith device is a safe and durable third-generation device, with a low re-intervention rate. Over the years, the Zenith graft gradually became our first choice, not only in short necks, in view of the excellent results and the grafts' versatility.

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