Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms With the Endurant Device Konstantinos Papazoglou,1 Alexandros Mallios,2 Fatemeh Rafati,3 Neophytos Zambas,1 and Christos Karkos,1 Thessaloniki, Greece; Paris, France; and Staffordshire, United Kingdom
Background: Endovascular treatment of ruptured aortic aneurysms is performed in many centers around the world. New endovascular stent-grafts may prove to improve results. We report our experience with the Endurant device. Methods: From June 2010 to November 2010, we treated five male patients (mean age: 75.8 years) suffering from ruptured abdominal aortic aneurysm with the Endurant device. The mean aneurysm diameter was 90.2 mm; the mean neck length was 13 mm; the mean proximal neck diameter was 27 mm; and the mean proximal angulation was 64 . Results: Technical success rate was 100%. In one patient, a proximal leak was diagnosed intraoperatively, and a proximal extension was successfully deployed. No secondary procedures were necessary and no open conversions required during the first admission. One patient required a proximal extension at 3 months for a type I endoleak. The 30-day mortality was 20%, and no further deaths occurred during the follow-up (mean duration: 15 months). Conclusion: New stent-grafts may ameliorate the prognosis of ruptured abdominal aortic aneurysms. Our experience with the Endurant device has shown promising results. To our knowledge, this is the first report of endovascular treatment of ruptured aortic aneurysms with this stent-graft.
INTRODUCTION The prognosis of ruptured aortic aneurysms is often dismal, with up to 40% of patients not surviving the journey into the hospital.1 The mortality of open repair remains significant, with figures of up to 50%.2 Endovascular repair has demonstrated encouraging results in several publications with
1 Fifth Surgical Department, Hippokratio Hospital, Thessaloniki, Greece. 2 Department of Vascular Surgery, Institut Mutualiste Montsouris, Paris, France. 3 Department of Vascular Surgery, University Hospital of North Staffordshire, Staffordshire, UK.
Correspondence to: Alexandros Mallios, MD, Department of Vascular Surgery, Institut Mutualiste Montsouris, 20 Bd Edgar Quinet, 75014 Paris, France; E-mail:
[email protected] Ann Vasc Surg 2013; 27: 162–167 http://dx.doi.org/10.1016/j.avsg.2012.04.013 Ó 2013 Elsevier Inc. All rights reserved. Manuscript received: October 11, 2011; manuscript accepted: April 11, 2012; published online: September 13, 2012.
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reduced 30-day mortality rates. According to a recent publication analyzing the Medicare database, similar encouraging results have been shown over a follow-up period of 4 years.3 However, in other prospective trials, there was no statistical difference in mortality between open and endovascular repair. Difficult anatomical characteristics, common in ruptured aneurysms,4 can also reduce the application of endovascular treatment. New devices, like the Endurant stent-graft (Medtronic Cardiovascular, Santa Rosa, CA), seem to expand the indications for using such a method, giving the option of successful endovascular treatment in more challenging aneurysms.5 To our knowledge, this is the first report of endovascular treatment of ruptured aortic aneurysms (rEVAR) with this particular stent-graft.
PATIENTS AND METHODS Between June 2010 and November 2010, we treated five patients suffering from an acute aortic
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Table I. Patient and AAA characteristics (Fig. 1)
reoperation during the initial admission. The need for perioperative blood transfusion was, on average, 1,350 mL/patient. The 30-day mortality was 20%, with the death of patient 4 on postoperative day 2 from cardiac arrest during placement of a nasogastric tube. This patient also had a large hematoma postoperatively and an intra-abdominal pressure of 20 mm Hg. No patient required mechanical ventilation or intensive care unit treatment. Average hospital stay for the four patients who survived was 6.25 days. Patients took, on average, 3 days to mobilize fully after their operation. Oral alimentation was permitted on the second or third day in all patients (Table II). One patient developed a large hematoma extending into the retroperitoneum. On postoperative day 10, after being discharged, he re-presented with a right iliofemoral vein thrombosis. This was treated successfully with anticoagulation. One patient developed macroscopic hematuria, requiring longterm catheterization. Otherwise, the postoperative course of the four surviving patients was uneventful. Immediate postoperative imaging showed no signs of an endoleak. Aneurysms remained stable through the period of computed tomographic follow-up at 1 month, 6 months, and yearly intervals, with a mean duration of 15 months. All patients reported a good functional level. One patient presented with a proximal type I endoleak 3 months postoperatively, due to extreme neck angulation. Reoperation with proximal cuff deployment under local anesthesia resulted in a favorable outcome (Figs. 2 and 3).
Patient
Age
AAA diameter (mm)
1 2 3 4 5 Mean
72 64 82 82 79 75.8
87 100 70 107 87 90.2
Neck length (mm)
Neck diameter (mm)
Neck angulation ( )
15 15 15 15 5 13
25 26 29 32 23 27
30 80 60 70 80 64
AAA, abdominal aortic aneurysm.
aneurysm rupture using the Endurant device. All patients were male, and mean age was 75.8 years (range: 64e82 years). Patient age and aneurysm characteristics are presented in Table I. Clinical presentation was of acute abdominal and lumbar pain in the past 24 hours with signs of hemodynamic instability before hospital admission. Arterial pressure on presentation in all patients was 100 mm Hg. In two of five patients with no history of renal impairment, their respective hypovolemic states caused preoperative creatinine levels to rise by 2 mg/dL. Three of the five patients also presented with metabolic acidosis. One of the five patients had an aorto-uni-iliac stent-graft. This patient had a long-standing asymptomatic iliac occlusion and so we proceeded without a femorofemoral bypass to avoid additional trauma. All other cases were treated with an Endurant aortobiiliac stent-graft. In one of the five patients, a proximal type I endoleak necessitated the use of a proximal extension cuff. One patient had distal extensions placed at the level of the common iliac arteries to seal the aneurysm distally, whereas in another patient, extensions were placed in both external iliac arteries. All cases were carried out under local anesthesia, with surgical exposure of both femoral arteries in four of five cases and percutaneous access in the fifth. However, after graft deployment, a femoral cutdown was performed to close the femoral arteriotomies. An aortic occlusion balloon was used during graft deployment in one patient owing to significant intraoperative hemodynamic instability.
RESULTS Technical success rate was 100%. All aneurysms were excluded and bleeding controlled during the first intervention. In one case, a proximal type I leak necessitated a proximal extension cuff. However, this was achieved on completion of the first intervention, and no patient required
DISCUSSION Thus, rEVAR appears to be superior to open repair, and it has been proposed in the literature as the gold standard of management in eligible cases.1,3,6e8 Conversely, the only randomized trial available has failed to demonstrate a mortality reduction in the endovascular group.9 Three randomized trials are currently in progress, and they may finally offer more conclusive data on this topic.10e12 The Endurant device, the latest stent-graft on the market from this company, appears to have some significant improvements on various technical features, and several publications have demonstrated encouraging results during conventional endovascular aneurysm repair.5,13,14 This is the first publication, to our knowledge, reporting rEVAR with this particular device. The mortality was 20% in this small series, with one
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Fig. 1. The anatomy in most cases was challenging, as seen in this patient with angulated proximal neck and the rupture just below.
Table II. Results Patient
ICU stay days
Hospitalization days
Mobilization
Oral alimentation
Follow-up leak
Death (30 d)
Death (12 mo)
1 2 3 4 5 Mean
0 0 0 0 0 0
7 5 2edeath 7 6 6.25a
2 2 e 5 4 3a
2 2 e 3 2 6
e 1 NA e e 25.00%a
e e 1 e e 20.00%
e e 1 e e 20.00%
Complication (not leak related)
NA 1 25.00%a
ICU, intensive care unit; NA, not applicable. a Patient who died is not included in the calculations.
patient of five dying on postoperative day 2. This was after a technically successful operation. Most publications that report good results after rEVAR indicate a mortality rate of approximately 10% to 25%.3,7,8 In our previous experience of rEVAR with the use of various endografts, the mortality was 39%.15 We believe that this significant improvement may be attributed to our increased experience but also to the improved features of this new device. In this series, the patient who died had an aneurysm of 70-mm diameter with a 15-mm neck but significant angulation. Postoperatively, there were no signs of an endoleak and Haematocrit remained stable. A large retroperitoneal hematoma and intra-abdominal pressure of 20 mm Hg were our main concerns, although the patient
maintained adequate diuresis. We did not perform a laparotomy, as there were no clinical signs of abdominal compartment syndrome. Cause of death was cardiac arrest, likely secondary to placement of a nasogastric tube. Although a minimally invasive procedure, it appears that in the context of overall systemic stress, this was adequate to initiate an unfortunate cascade of events, which could not be reversed after 20 minutes of cardiopulmonary resuscitation. In all cases except onedwhere the left iliac artery was already occludeddwe achieved sealing of the aneurysm with the use of bifurcated devices. This seems to be encouraging because many rEVAR enthusiasts tend to use an aortouni-iliac device. This is to avoid the time lost during limb
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Fig. 2. One patient required the placement of a proximal extension for type I endoleak 3 months after endovascular treatment of ruptured aortic aneurysm. (A) Before proximal extension. (B) After the placement of the extension.
Fig. 3. Patient 5 computed tomographic scan of controldno sign of endoleak. (A) No endoleak at the level of the body of the stent-graft, (B) the limb of the graft
crossing overd‘‘ballerina’’ position, (C) threedimensional reconstruction where we can see the ‘‘ballerina’’ position of the stent-graft.
catheterization.6 All cases were undertaken with local anesthesia, and we consider this an important factor in the success of this technique. Avoidance of hemodynamic deterioration due to general anesthesia in an already unstable patient may improve the results of rEVAR, and this has been described in the literature.16 Furthermore, in our last case, we performed endovascular aneurysm repair percutaneously to shorten sealing time and reduce postprocedural pain. We carried out the groin incision and arterial exposure at the end of the operation for safe closure of the femoral arteries. This
percutaneous approach may also hasten control of bleeding and, when possible, should be the initial method for placement of an occlusion balloon or the device itself.16,17 The proximal neck in all these cases was challenging but within the limits of a typical ruptured aneurysm. The accurate delivery system with good radiopaque marking allowed us precise positioning and deployment with no evidence of a proximal endoleak on completion arteriography (Fig. 4). Extension to the external iliac artery without embolization of the internal iliac was performed in
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Fig. 4. A good radiopaque marking and a precise delivery system permit accurate deployment just below the renal arteries. (A) Angiography before releasing the tip of the device. (B) After complete deployment.
two patients. This did not cause a type II endoleak or continual bleeding. It has been described as safe practice, and we believe that in an emergency setting of a ruptured aneurysm, this is a strategy that can be followed.18,19 Another important issue that seems to be better addressed with the Endurant device is one of graft porosity, which in the case of ruptured aneurysms may be crucial because of the coagulopathy that exist in most patients. As communication between the sac and the abdominal cavity exists through the rupture, increased porosity may lead to continuous transmission of high arterial pressures with or without extravasation.20 This may contribute to the creation of abdominal compartment syndrome, which can increase susceptibility to multiorgan failure and death. The only patient who died in our series had an intra-abdominal pressure at 20 mm Hg. This factor might have participated in the unfortunate result.
CONCLUSION In summary, rEVAR is feasible in the majority of cases and offers promising results compared with open surgery when performed in experienced centers. New stent-grafts may improve mortality and morbidity rates, as technical features address previously noted disadvantages of the method. The Endurant device has many desirable characteristics that may lead to optimum results, in keeping with our limited experience with this graft. To our knowledge, this is the first report of rEVAR with this particular stent-graft.
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