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Early type III endoleak with an Endurant endograft
Early type III endoleak with an Endurant endograft Issam Abouliatim, MD,a Djelloul Gouicem, MD,a Hicham Kobeiter, MD,b Marek Majeski, MD,a and Jean-Pierre Becquemin, MD,a Créteil, France We report the case of an 81-year-old man who presented with an intraoperative type III endoleak after treatment with an Endurant endograft for a 60-mm abdominal aortic aneurysm. To our knowledge, this is the first case of a type III endoleak reported with this new device. It was most likely due to a tear in the polyester graft, the cause of which remains speculative. The tear was demonstrated by postoperative angiography, which was more informative than computed tomography. The endoleak was successfully treated by relining with an aorto-uni-iliac device. ( J Vasc Surg 2010;52: 1665-7.)
Endovascular aortic repair (EVAR) of abdominal aortic aneurysms offers a short-term benefit over open repair in terms of perioperative morbidity and mortality.1 Device technology is continually improving and is aimed at treating patients who were previously not suitable for EVAR for anatomic reasons.2 Most notably, a low-profile introducer sheath and greater flexibility of the devices allow passage of the stent graft through a narrowed, diseased, or tortuous iliac artery. Endurant (Medtronic Cardiovascular, Santa Rosa, Calif) is a new-generation endograft with a low-profile and flexible stent graft. Preliminary results with this stent graft are encouraging and, so far, no adverse events have been reported; however, studies are limited and follow-up is very short. We report a case of type III endoleak due to tearing of the polyester graft during the procedure and discuss the mechanisms of occurrence and methods of diagnosis. CASE REPORT An 81-year-old man presented with a 60-mm asymptomatic abdominal aortic aneurysm. His medical history included rhythmic cardiopathy and a pulmonary embolism treated with anti-vitamin K. He had previously been treated with saphenous vein bypasses in the legs for bilateral popliteal aneurysms. A computed tomography (CT) scan showed an infrarenal aortic aneurysm 60 mm in diameter. The proximal neck was 22 mm in length and 28 mm in diameter with an angulation of 90°. Both common iliac arteries were 25 mm in diameter. The aorto-iliac angulation was 90° and the internal iliac arteries were patent (Fig 1, A). Given the morphology and angulation of the proximal neck, an Endurant endograft (Medtronic Cardiovascular) was chosen. It was considered that the low profile and flexibility of this particular graft was From the Department of Vascular Surgery,a and the Radiology Department,b Hopital Henri-Mondor, APHP, University Paris 12, Créteil, France. Competition of interest: none. Reprint requests: Issam Abouliatim, MD, 51, av du Maréchal de Tassigny, 94 Créteil, France (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest. 0741-5214/$36.00 Copyright © 2010 by the Society for Vascular Surgery. doi:10.1016/j.jvs.2010.07.020
appropriate to fit the angulation of the neck and the tortuosity of the iliac arteries. The common femoral arteries were surgically exposed and a 32-mm main body Endurant bifurcated endograft was positioned and prolonged bilaterally with 28-mm limbs. The internal iliac arteries were left open. The procedure was uneventful. Final completion angiography revealed a faint type I proximal endoleak. Repeated inflations with a compliant aortic occlusion balloon (Coda Balloon Catheters, Bloomington, Ind) in the proximal neck failed to close the leak, but the proximal sealing zone seemed adequate. Because there was no obvious explanation for the leak, it was decided to stop the operation and assess the leak with a postoperative CT scan. The CT scan performed on day 2 showed satisfactory infrarenal positioning of the graft. The metallic frame seemed to be intact (Fig 1, B). Given the good stent graft apposition, a type I endoleak was considered to be unlikely (Fig 1, C and D). On day 4, a new angiography was performed via a brachial puncture. The pigtail was placed proximally in the main body of the graft and injection of contrast medium showed a large opacification of the aneurysmal sac (Fig 2, A). A 90-cm-long 5F introducer was placed at the bifurcation of the stent graft close to the controlateral leg, on the left and confirmed the leak (Fig 2, B). During the endovascular maneuvers, the aneurysmal sac was catheterized directly through the endograft with the guidewire and introducer sheath, confirming the presence of a hole in the polyester fabric (Fig 2, C). To locate the defect precisely, an angiography catheter was placed at the proximal part of the left leg but showed no endoleak (Fig 2, C). The catheter was then moved forward with concomitant contrast medium injection and a huge opacification of the aneurysm seemed to be in front of the proximal part of the controlateral leg (Fig 2, D). To close the endoleak, the patient finally underwent relining with insertion of an aorto-uni-iliac endograft (Zenith Renu), left-to-right femoro-femoral bypass, and occlusion of the right common iliac artery. The latter procedure was successful and no endoleak was seen on final angiography (Fig 3, A, B). The patient was discharged 10 days later after a CT scan confirmed exclusion of the aneurysm sac.
DISCUSSION Type III endoleaks after EVAR occur late during follow-up and are mainly caused by modular disconnection or a fabric defect.3 They were not infrequent with 1665
1666 Abouliatim et al
JOURNAL OF VASCULAR SURGERY December 2010
Fig 1. A computed tomography (CT) scan. A, A CT scan 3D reconstruction shows the anatomic configuration of the infrarenal aortic aneurysm. B, A CT scan 3D reconstruction shows the correct positioning of the stent graft and the leak in the aneurysmal sac. C, A transverse CT scan shows the good deployment of the infrarenal stent graft. D, A transverse CT scan shows the leakage.
Fig 2. An angiographic exam. A, A pigtail in the main body of the stent graft showed a large leakage. B, A straight 5F angiography catheter was placed at the bifurcation near the controlateral leg and confirmed the leakage. C, A 0.035 guidewire easily catheterized the aneurysmal sac through the endograft. D, The catheter was moved forward showing a large opacification of the aneurysm in front of the proximal part of the controlateral leg.
first-generation grafts4-6 but seem less common with new-generation grafts. To our knowledge, this is the first case of a type III endoleak reported with an Endurant endograft. The Endurant graft was recently CE (Conformité Européenne) marked in Europe, is under approval submission in France, and is currently undergoing clinical trials in the United States. Preliminary results are encouraging, even in short neck and high-angulated anatomies.7 The low profile and excellent flexibility are designed to overcome two challenges: hostile neck anatomies and safe access and tracking through small iliac arteries. The cause of the defect in our case was not obvious. Due to the lack of gross pathologic examination of the graft, the explanation can only be speculative. There are four hypotheses to explain the damage to the fabric: (i) excessive endovascular manipulation; (ii) excessive pressure of ballooning; (iii) damage to the fabric by the acute tip of a stent displaced by severe neck angulations; and (iv) manufacturing defect.
In our patient, hypotheses (i) and (ii) are improbable. There was no adverse event or excessive endovascular manipulation during the procedure that may have contributed to fabric damage. The landing zones and graft overlaps were modeled with a low-pressure balloon. The involvement of excessive pressure due to balloon inflation has already been advocated as a cause of fabric tear in a Zenith endograft.8 On the contrary, hypothesis (iii) is relevant. The neck was severely angulated, which may have caused the damage. This hypothesis is more plausible because the defect was close to the angulation. Finally, a defect during manufacturing may be possible despite thorough quality control established by the company. Medtronic was informed of the case and provided no explanation nor was aware of a similar case. The difficulty in diagnosing this rare event must be underlined. It was not possible to establish the origin of the endoleak intraoperatively. An easy way to determine whether it was a type I or type III endoleak would have been to inflate a compliant balloon in the neck intraopera-
JOURNAL OF VASCULAR SURGERY Volume 52, Number 6
Abouliatim et al 1667
In summary, early type III endoleaks may occur even with the newest stent graft technology. Due to the potential health risks, type III endoleaks should be looked for in cases of persistent sac opacification during EVAR. The present case also illustrates the diagnostic difficulty in identifying the exact location of an early endoleak. REFERENCES
Fig 3. A, Computed tomography (CT) scan showing elimination of the endoleak after Renu endograft (Zenith Renu, 32/115 mm). B, Abdominal CT maximum-intensity projections image of the final revision.
tively and inject from below. Unfortunately, we did not consider this procedure and preferred to perform a CT scan, which was not helpful. Angiography combined with a search using wires and a catheter was the most useful procedure to localize the endoleak, as reported previously by others.5,9 Type III endoleaks should be treated promptly because direct endoleaks are associated with considerable risk of aneurysm rupture.10-12 Treatment, which can be endovascular or open, is chosen according to anatomic features. In our case, treatment with an aorto-uni-iliac device (Zenith Renu; 32/115 mm) was chosen because it was felt that this was the easiest way to solve the problem. In addition, angiography showed that the tear location was in front of the proximal part of the controlateral leg at the level of the distal part of the main body. A single proximal cuff would have been less safe due to the short length of the additional graft, with the risk of not treating the defect.
1. EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomized controlled trial. Lancet 2005;365:2179-86. 2. Albertini JN, Perdikides T, Soong CV, Hinchliffe RJ, Trojanowska M, Yusuf SW. Endovascular repair of abdominal aortic aneurysms in patients with severe angulation of the proximal neck using a flexible stent-graft: European Multicenter Experience. J Cardiovasc Surg (Torino) 2006;47:245-50. 3. Teruya TH, Ayerdi J, Solis MM, Abou-Zamzam AM, Ballard JL, McLafferty RB, et al. Treatment of type III endoleak with an aortouniiliac stent graft. Ann Vasc Surg 2003;17:123-8. 4. Becquemin JP, Poussier B, Allaire E, Kobeiter H, Desgranges P. Endograft fabric disintegration simulating a type II endoleak. J Endovasc Ther 2002;9:203-7. 5. Lee WA, Huber TS, Seeger JM. Late type III endoleak from graft erosion of an Excluder stent graft: a case report. J Vasc Surg 2006;44: 183-5. 6. Wanhainen A, Nyman R, Eriksson MO, Björck M. First report of a late type III endoleak from fabric tears of a Zenith stent graft. J Vasc Surg 2008;48:723-6. 7. Verhagen HJ, Torsello G, De Vries JP, Cuypers PH, Van Herwaarden JA, Florek HJ, et al. Endurant stent-graft system: preliminary report on an innovative treatment for challenging abdominal aortic aneurysm. J Cardiovasc Surg (Torino) 2009;50:153-8. 8. van der Vliet JA, Blankensteijn JD, Kool LJ. Type III endoleak caused by fabric tear of a Zenith endograft after low-pressure balloon modeling. J Vasc Interv Radiol 2005;16:1042-4. 9. Juszkat R, Staniszewski R, Zarzecka A, Majewski W. Diagnosis of type III endoleak and endovascular treatment with aortouniiliac stent-graft. J Vasc Interv Radiol 2009;20:125-9. 10. Zarins CK, White RA, Fogarty TJ. Aneurysm rupture after endovascular repair using the AneuRx stent graft. J Vasc Surg 2000;31:960-70. 11. Politz JK, Newman VS, Stewart MT. Late abdominal aortic aneurysm rupture after AneuRx repair: a report of three cases. J Vasc Surg 2000;31:599-606. 12. Teutelink A, van der Laan MJ, Milner R, Blankensteijn JD. Fabric tears as a new cause of type III endoleak with Ancure endograft. J Vasc Surg 2003;38:843-6. Erratum in: J Vasc Surg 2003;38:1449. Submitted Apr 21, 2010; accepted Jul 14, 2010.
Endovascular aortic repair (EVAR) of abdominal aortic aneurysms offers a short-term benefit over open repair in terms of perioperative morbidity and mortality.1 Device technology is continually improving and is aimed at treating patients who were previously not suitable for EVAR for anatomic reasons.2 Most notably, a low-profile introducer sheath and greater flexibility of the devices allow passage of the stent graft through a narrowed, diseased, or tortuous iliac artery. Endurant (Medtronic Cardiovascular, Santa Rosa, Calif) is a new-generation endograft with a low-profile and flexible stent graft. Preliminary results with this stent graft are encouraging and, so far, no adverse events have been reported; however, studies are limited and follow-up is very short. We report a case of type III endoleak due to tearing of the polyester graft during the procedure and discuss the mechanisms of occurrence and methods of diagnosis. CASE REPORT An 81-year-old man presented with a 60-mm asymptomatic abdominal aortic aneurysm. His medical history included rhythmic cardiopathy and a pulmonary embolism treated with anti-vitamin K. He had previously been treated with saphenous vein bypasses in the legs for bilateral popliteal aneurysms. A computed tomography (CT) scan showed an infrarenal aortic aneurysm 60 mm in diameter. The proximal neck was 22 mm in length and 28 mm in diameter with an angulation of 90°. Both common iliac arteries were 25 mm in diameter. The aorto-iliac angulation was 90° and the internal iliac arteries were patent (Fig 1, A). Given the morphology and angulation of the proximal neck, an Endurant endograft (Medtronic Cardiovascular) was chosen. It was considered that the low profile and flexibility of this particular graft was From the Department of Vascular Surgery,a and the Radiology Department,b Hopital Henri-Mondor, APHP, University Paris 12, Créteil, France. Competition of interest: none. Reprint requests: Issam Abouliatim, MD, 51, av du Maréchal de Tassigny, 94 Créteil, France (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest. 0741-5214/$36.00 Copyright © 2010 by the Society for Vascular Surgery. doi:10.1016/j.jvs.2010.07.020
appropriate to fit the angulation of the neck and the tortuosity of the iliac arteries. The common femoral arteries were surgically exposed and a 32-mm main body Endurant bifurcated endograft was positioned and prolonged bilaterally with 28-mm limbs. The internal iliac arteries were left open. The procedure was uneventful. Final completion angiography revealed a faint type I proximal endoleak. Repeated inflations with a compliant aortic occlusion balloon (Coda Balloon Catheters, Bloomington, Ind) in the proximal neck failed to close the leak, but the proximal sealing zone seemed adequate. Because there was no obvious explanation for the leak, it was decided to stop the operation and assess the leak with a postoperative CT scan. The CT scan performed on day 2 showed satisfactory infrarenal positioning of the graft. The metallic frame seemed to be intact (Fig 1, B). Given the good stent graft apposition, a type I endoleak was considered to be unlikely (Fig 1, C and D). On day 4, a new angiography was performed via a brachial puncture. The pigtail was placed proximally in the main body of the graft and injection of contrast medium showed a large opacification of the aneurysmal sac (Fig 2, A). A 90-cm-long 5F introducer was placed at the bifurcation of the stent graft close to the controlateral leg, on the left and confirmed the leak (Fig 2, B). During the endovascular maneuvers, the aneurysmal sac was catheterized directly through the endograft with the guidewire and introducer sheath, confirming the presence of a hole in the polyester fabric (Fig 2, C). To locate the defect precisely, an angiography catheter was placed at the proximal part of the left leg but showed no endoleak (Fig 2, C). The catheter was then moved forward with concomitant contrast medium injection and a huge opacification of the aneurysm seemed to be in front of the proximal part of the controlateral leg (Fig 2, D). To close the endoleak, the patient finally underwent relining with insertion of an aorto-uni-iliac endograft (Zenith Renu), left-to-right femoro-femoral bypass, and occlusion of the right common iliac artery. The latter procedure was successful and no endoleak was seen on final angiography (Fig 3, A, B). The patient was discharged 10 days later after a CT scan confirmed exclusion of the aneurysm sac.
DISCUSSION Type III endoleaks after EVAR occur late during follow-up and are mainly caused by modular disconnection or a fabric defect.3 They were not infrequent with 1665
1666 Abouliatim et al
JOURNAL OF VASCULAR SURGERY December 2010
Fig 1. A computed tomography (CT) scan. A, A CT scan 3D reconstruction shows the anatomic configuration of the infrarenal aortic aneurysm. B, A CT scan 3D reconstruction shows the correct positioning of the stent graft and the leak in the aneurysmal sac. C, A transverse CT scan shows the good deployment of the infrarenal stent graft. D, A transverse CT scan shows the leakage.
Fig 2. An angiographic exam. A, A pigtail in the main body of the stent graft showed a large leakage. B, A straight 5F angiography catheter was placed at the bifurcation near the controlateral leg and confirmed the leakage. C, A 0.035 guidewire easily catheterized the aneurysmal sac through the endograft. D, The catheter was moved forward showing a large opacification of the aneurysm in front of the proximal part of the controlateral leg.
first-generation grafts4-6 but seem less common with new-generation grafts. To our knowledge, this is the first case of a type III endoleak reported with an Endurant endograft. The Endurant graft was recently CE (Conformité Européenne) marked in Europe, is under approval submission in France, and is currently undergoing clinical trials in the United States. Preliminary results are encouraging, even in short neck and high-angulated anatomies.7 The low profile and excellent flexibility are designed to overcome two challenges: hostile neck anatomies and safe access and tracking through small iliac arteries. The cause of the defect in our case was not obvious. Due to the lack of gross pathologic examination of the graft, the explanation can only be speculative. There are four hypotheses to explain the damage to the fabric: (i) excessive endovascular manipulation; (ii) excessive pressure of ballooning; (iii) damage to the fabric by the acute tip of a stent displaced by severe neck angulations; and (iv) manufacturing defect.
In our patient, hypotheses (i) and (ii) are improbable. There was no adverse event or excessive endovascular manipulation during the procedure that may have contributed to fabric damage. The landing zones and graft overlaps were modeled with a low-pressure balloon. The involvement of excessive pressure due to balloon inflation has already been advocated as a cause of fabric tear in a Zenith endograft.8 On the contrary, hypothesis (iii) is relevant. The neck was severely angulated, which may have caused the damage. This hypothesis is more plausible because the defect was close to the angulation. Finally, a defect during manufacturing may be possible despite thorough quality control established by the company. Medtronic was informed of the case and provided no explanation nor was aware of a similar case. The difficulty in diagnosing this rare event must be underlined. It was not possible to establish the origin of the endoleak intraoperatively. An easy way to determine whether it was a type I or type III endoleak would have been to inflate a compliant balloon in the neck intraopera-
JOURNAL OF VASCULAR SURGERY Volume 52, Number 6
Abouliatim et al 1667
In summary, early type III endoleaks may occur even with the newest stent graft technology. Due to the potential health risks, type III endoleaks should be looked for in cases of persistent sac opacification during EVAR. The present case also illustrates the diagnostic difficulty in identifying the exact location of an early endoleak. REFERENCES
Fig 3. A, Computed tomography (CT) scan showing elimination of the endoleak after Renu endograft (Zenith Renu, 32/115 mm). B, Abdominal CT maximum-intensity projections image of the final revision.
tively and inject from below. Unfortunately, we did not consider this procedure and preferred to perform a CT scan, which was not helpful. Angiography combined with a search using wires and a catheter was the most useful procedure to localize the endoleak, as reported previously by others.5,9 Type III endoleaks should be treated promptly because direct endoleaks are associated with considerable risk of aneurysm rupture.10-12 Treatment, which can be endovascular or open, is chosen according to anatomic features. In our case, treatment with an aorto-uni-iliac device (Zenith Renu; 32/115 mm) was chosen because it was felt that this was the easiest way to solve the problem. In addition, angiography showed that the tear location was in front of the proximal part of the controlateral leg at the level of the distal part of the main body. A single proximal cuff would have been less safe due to the short length of the additional graft, with the risk of not treating the defect.
1. EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomized controlled trial. Lancet 2005;365:2179-86. 2. Albertini JN, Perdikides T, Soong CV, Hinchliffe RJ, Trojanowska M, Yusuf SW. Endovascular repair of abdominal aortic aneurysms in patients with severe angulation of the proximal neck using a flexible stent-graft: European Multicenter Experience. J Cardiovasc Surg (Torino) 2006;47:245-50. 3. Teruya TH, Ayerdi J, Solis MM, Abou-Zamzam AM, Ballard JL, McLafferty RB, et al. Treatment of type III endoleak with an aortouniiliac stent graft. Ann Vasc Surg 2003;17:123-8. 4. Becquemin JP, Poussier B, Allaire E, Kobeiter H, Desgranges P. Endograft fabric disintegration simulating a type II endoleak. J Endovasc Ther 2002;9:203-7. 5. Lee WA, Huber TS, Seeger JM. Late type III endoleak from graft erosion of an Excluder stent graft: a case report. J Vasc Surg 2006;44: 183-5. 6. Wanhainen A, Nyman R, Eriksson MO, Björck M. First report of a late type III endoleak from fabric tears of a Zenith stent graft. J Vasc Surg 2008;48:723-6. 7. Verhagen HJ, Torsello G, De Vries JP, Cuypers PH, Van Herwaarden JA, Florek HJ, et al. Endurant stent-graft system: preliminary report on an innovative treatment for challenging abdominal aortic aneurysm. J Cardiovasc Surg (Torino) 2009;50:153-8. 8. van der Vliet JA, Blankensteijn JD, Kool LJ. Type III endoleak caused by fabric tear of a Zenith endograft after low-pressure balloon modeling. J Vasc Interv Radiol 2005;16:1042-4. 9. Juszkat R, Staniszewski R, Zarzecka A, Majewski W. Diagnosis of type III endoleak and endovascular treatment with aortouniiliac stent-graft. J Vasc Interv Radiol 2009;20:125-9. 10. Zarins CK, White RA, Fogarty TJ. Aneurysm rupture after endovascular repair using the AneuRx stent graft. J Vasc Surg 2000;31:960-70. 11. Politz JK, Newman VS, Stewart MT. Late abdominal aortic aneurysm rupture after AneuRx repair: a report of three cases. J Vasc Surg 2000;31:599-606. 12. Teutelink A, van der Laan MJ, Milner R, Blankensteijn JD. Fabric tears as a new cause of type III endoleak with Ancure endograft. J Vasc Surg 2003;38:843-6. Erratum in: J Vasc Surg 2003;38:1449. Submitted Apr 21, 2010; accepted Jul 14, 2010.