- Email: [email protected]
Collapsed bifurcated modular infrarenal endograft
Collapsed bifurcated modular infrarenal endograft Animesh Rathore, MD,a Peter Gloviczki, MD,b Gustavo S. Oderich, MD,b and Thomas C. Bower, MD,b Norfolk, Va; and Rochester, Minn
ABSTRACT Bilateral acute limb ischemia after endovascular aneurysm repair is extremely rare. We present the case of a 70-year-old man treated by endovascular aneurysm repair for a 7.9-cm asymptomatic infrarenal abdominal aortic aneurysm using a bifurcated modular GORE EXCLUDER endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz). The initial recovery was uneventful, but 14 days later, the patient presented with bilateral acute limb ischemia caused by collapse and thrombosis of the endograft, requiring emergency axillobifemoral bypass, fasciotomies, and subsequent endograft removal with open aneurysm repair. The patient had no other complications at 7 months of follow-up. Oversizing of a GORE EXCLUDER graft because of a conical neck, a small bird-beak configuration, and a long angulated neck with aortoiliac tortuosity were potential contributing factors to endograft infolding and collapse. (J Vasc Surg 2019;-:1-6.) Keywords: Endovascular repair; Abdominal aortic aneurysm; Endograft infolding; Endograft collapse; Acute limb ischemia
Endograft collapse after elective endovascular aneurysm repair (EVAR) is rare. Infolding was observed mostly after repair of thoracic aortic disease processes treated by first-generation less conformable thoracic endografts.1,2 Only three cases of endograft collapse occurring within 30 days after infrarenal EVAR have been reported, and none needed conversion to open repair.3-5 A handful of cases of late endograft collapse have also been reported.6-14 The patient we describe here developed endograft infolding 14 days after uneventful EVAR, requiring emergency open revascularization because of severe acute lower limb ischemia and subsequent conversion to open repair. We discuss potential causes of endograft collapse and call attention to device selection and technical details that surgeons should observe to minimize risk of this rare but severe limb- and life-threatening complication. The patient consented to publication of this report.
CASE REPORT A 70-year-old asymptomatic white man presented for general
discontinued smoking 39 years earlier. On physical examination, he was in no acute distress (blood pressure, 109/67 mm Hg; heart rate regular, 47 beats/min). He had a soft systolic murmur over the left precordium; lungs were clear. There were no carotid bruits. He had a large midabdominal nontender pulsatile mass, without bruits. Femoral and pedal pulses were normal bilaterally. His medications included atorvastatin, folic acid, metoprolol, magnesium, potassium, ezetimibe, and multivitamins. He stopped rivaroxaban 2 days before his examination. Computed tomography angiography (CTA) revealed a 79- 71-mm abdominal aortic aneurysm (AAA) that extended from the inferior mesenteric artery to the aortic bifurcation (Fig 1). Centerline imaging confirmed a long and angulated infrarenal aortic neck that measured 22 mm in diameter at the lower left renal artery, 22 mm at 15 cm and 26 mm at 19 mm distal to the renal artery, and 24 mm at the level of the inferior mesenteric artery (Fig 2). Neck angulation was 40 degrees. The patient had tortuous and aneurysmal common iliac arteries measuring 29 mm in diameter on the right and 30 mm on the left. Both open repair and EVAR were discussed in detail, including the extensive aortoiliac aneurysmal disease and tortuous iliac arteries. The patient consented to undergo EVAR.
medical examination. His medical history included intermittent
Under general anesthesia, bilateral percutaneous femoral
atrial fibrillation, four cardioversions, and a myocardial infarction
access was obtained and a bifurcated GORE EXCLUDER endo-
16 years before presentation. There was no family history of
prosthesis (W. L. Gore & Associates, Flagstaff, Ariz) was inserted
aneurysms, collagen vascular disease, or diabetes. The patient
(28.5- 14-mm main body). The repair was extended distally us-
From the Department of Surgery, Sentara Norfolk General Hospital, Norfolka;
ing a 14-cm 27-mm iliac extension limb and a 4.5-cm 32mm aortic cuff on the right and 14-cm 27-mm and 10-
and the Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester.b Author conflict of interest: none. Correspondence: Peter Gloviczki, MD, Division of Vascular and Endovascular
cm 27-mm extension limbs and a 4.5-cm 32-mm aortic cuff on the left. Landing zones and overlapping sites were dilated with 32-mm Coda balloon (Cook Medical, Bloomington,
Surgery, Mayo Clinic, Rochester, MN 55905 (e-mail: gloviczki.peter@mayo.
Ind). Completion aortography showed no attachment site endo-
edu).
leak and good graft apposition; the endograft was patent with
The editors and reviewers of this article have no relevant financial relationships to
excellent flow into the iliac arteries (Fig 3). Catheters and sheaths
disclose per the JVS policy that requires reviewers to decline review of any
were removed, and puncture sites were closed with Perclose devices (Abbott Vascular, Santa Clara, Calif). The patient awoke
manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc.
without problems, had no groin hematoma, and had excellent
https://doi.org/10.1016/j.jvs.2018.12.049
distal pulses. Overnight hospitalization was uneventful; he was 1
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Fig 1. Computed tomography angiography (CTA) shows an 79- 71-mm infrarenal abdominal aortic aneurysm (AAA) that extends from the inferior mesenteric artery to the aortic bifurcation. The aorta measured 22 mm at the renal arteries, 22 mm at 15 cm distal to the renal arteries and 26 mm at 19 mm, and 24 mm all the way to the inferior mesenteric artery. Both common iliac arteries were tortuous and aneurysmal.
anastomosis and partially removed. His hospitalization was prolonged, and he underwent closure of the fasciotomies. The patient had no other complications at 7 months of follow-up. A review of the first intraoperative completion aortogram showed a small, 1- to 2-mm bird-beak appearance at the right upper tip of the endograft (Fig 3); the distance between the uppermost stent and left renal artery was 13 mm.
DISCUSSION
Fig 2. Centerline imaging with computed tomography angiography (CTA), with length and diameter measurements. The length of the neck was 75 mm.
discharged the next day on general diet, ambulating, with palpable pedal pulses. He resumed his medications, including rivaroxaban. At 14 days, he developed bilateral sudden lower extremity pain, coolness, paresthesia, and paralysis. Emergency CTA at another tertiary care center confirmed collapsed main limb of the aortic endograft with bilateral iliac limb thromboses (Fig 4). He underwent axillobifemoral bypass and bilateral fasciotomies. During the same hospitalization, he had explantation of the collapsed endograft with open surgical repair using a bifurcated aortoiliac polyester graft. The collapsed endograft resumed normal configuration after removal; there was no stent fracture or fabric injury. The
axillobifemoral
bypass
was
disconnected
at
each
Endograft infolding 2 weeks after uneventful EVAR caused a devastating complication to this patient. There was no doubt his 7.9-cm AAA required expeditious repair because of >33% annual risk of rupture,15 with associated high mortality.16 The main questions raised after his complication concerned the choice of EVAR vs open repair and the size of the endograft we selected. EVAR is an effective, low-risk procedure and the preferred technique to repair AAAs.17 In the United States, currently >90% of patients $70 years of age undergo EVAR for nonruptured AAA.18 Results have been excellent. At our institution, 30-day mortality after 870 elective EVARs was 1.0%, with 1 death (0.2%) reported in 526 patients with low or average surgical risk.19 Until now, in >2000 aortic endovascular procedures, we had not observed a collapsed endograft after EVAR. EVAR remains our recommendation to treat select patients with an asymptomatic large AAA with adequate anatomy. Our patient had challenging anatomy for an endograft, but the neck was suitable as determined by the instructions for use (IFU) of the manufacturer: a minimum neck
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Fig 3. Steps during deployment of the endovascular graft system. A, Predeployment aortogram demonstrated slight proximal aortic neck tortuosity and reverse taper configuration. B, Deployment of the main body distal to the left (lower) renal artery. C, Molding of the proximal seal zone with the 32-mm Coda (Cook Medical) balloon. D, Completion aortogram shows successful exclusion of the aneurysm, with excellent flow into the graft. The arrow indicates small bird-beak appearance of the endograft. E, Completion aortogram shows good distal seals and no endoleak.
Fig 4. A-C, Computed tomography angiography (CTA) shows collapsed main body and thrombosed iliac limbs of the endograft at 15 days after implantation.
length of 15 mm, a proximal neck angulation #60 degrees with minimal thrombus or calcification, and an aortic neck diameter of 19 to 32 mm. The IFU recommend a 26-mm trunk-ipsilateral leg endoprosthesis for an aortic diameter of 22 to 23 mm and a 28.5-mm endoprosthesis for a neck of 24 to 26 mm. Because of a reverse-tapered neck anatomy, from 22 to 26 mm at 19 mm distal to the lowest renal artery, decreasing then to 24 mm over a length of 7.5 cm, we elected to use a 28.5-mm-dimeter main body, a 29.5% oversizing for a 22-mm neck, and a 9.6% oversizing for a 26-mm neck. The last is within recommendations of the IFU
(10%-21% oversizing). We thought this graft size would help decrease the risk of type I endoleak. Oversizing of >40% has been used for conical necks with excellent results and no graft collapse or type I endoleak at 20 months.20 However, had we used the 26-mm device, considering only the diameter of the first 15 mm of the neck, the low risk of infolding may have been even lower. With a 26-mm neck, however, a 26-mm device would have increased the risk of a type I endoleak. A conical neck was present in one patient, in addition to ours, who had collapsed GORE EXCLUDER endograft at 15 days after EVAR (Table). Reverse-tapered neck
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Table. Endograft collapse after infrarenal endovascular aneurysm repair (EVAR) First author, year
Device Neck Age, AAA Neck type Time from years, size, diameter,length, mm (size, mm) implantation mm M/F cm
Presentation
Conversion to open repair
Treatment
Outcome
Potential cause of collapse
Endograft collapse #30 days after stent graft implantation Matsagas, 2009
78 M 5.5
24
20 GORE 1 month EXCLUDER (28.5)
No symptoms
No
Asymptomatic 28-mm Talent at 1 year (Medtronic) aortic cuff with suprarenal stent
“Slight” angulation of the aortic neck
Sfyroeras, 2011
68 M 5.0
25-29
20 GORE 15 days EXCLUDER (31)
Bilateral LE ischemia
No
32-mm GORE EXCLUDER aortic cuff
Asymptomatic at 1 year
Oversized endograft in reversetapered proximal neck with 45degree angulation
van Dorp, 2017
54 M 4.2a
20
100 GORE 20 days EXCLUDER with iliac branched device (23)
Bilateral LE ischemia
No
25-mm Medtronic aortic cuff
Asymptomatic at 1 year
Tortuous iliac arteries, endograft placed 10-15 mm distal to renal arteries
Rathore, 2018
70 M 7.1
22-26
14 days 75 GORE EXCLUDER (28.5)
Bilateral LE ischemia
Yes
Axillobifemoral bypass and fasciotomies followed by open repair
Asymptomatic at 7 months
Oversized endograft in reversetapered proximal neck, small (1to 2-mm) bird beak, 40degree angulation, tortuous iliacs
Endograft collapse >30 days after stent graft implantation McCready, 2006
64 M 5.5 N/A
AneuRx 9.5 years (Medtronic)
Chronic back pain
Yes
Open repair
No Distal migration; complications type I at discharge endoleak (day 5)
Szabolcs, 2009
57 M 4.5 N/A
GORE 1 year EXCLUDER
Bilateral LE ischemia with type A aortic dissection
Yes
Open repair dissection, stenting of endograft
Asymptomatic at 2.5 years
Type A aortic dissection
van Keulen, 2009
74 M 5.4 N/A
Talent 2 years (Medtronic)
Abdominal pain, oliguria, type B aortic dissection
No
Pain resolved Balloonat discharge expandable stent and TEVAR (Relay NBS, Bolton Medical)
Type B aortic dissection
Loh, 2010
72 M 7.9
26
Endologix 6 months Powerlink (28)
Asymptomatic
No
Repeated stent Asymptomatic grafting, at 1 month Palmaz stent
Bird beaking, angulation (45-50 degrees)
Moulakakis, 2011
82 M N/A
30
Talent 6 years (Medtronic)
AAA rupture
No
Proximal endograft cuff (Medtronic Talent)
Akpinar, 2013
67 M N/A N/A
1 year Anaconda (Vascutek, Terumo)
Bilateral LE claudication
No
Type IA Aortic stent graft Stable at endoleak and stent, iliac 6 months, no endoleak stent
GORE 14 months EXCLUDER
Abdominal pain, bilateral LE ischemia
Yes
Axillobifemoral bypass
Psacharopulo,75 M 5.8 N/A 2014
Asymptomatic
Vertical graft collapse due to enlargement of proximal neck and distal migration
Type B aortic Death on dissection postoperative day 2
(Continued on next page)
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Table. Continued. Conversion to open repair
First author, year
Device Neck Age, AAA Neck type Time from years, size, diameter,length, mm (size, mm) implantation mm M/F cm
Mohapatra, 2017
75 M N/A N/A
AneuRx 4 years (Medtronic)
Bilateral LE ischemia
Yes
Axillobifemoral bypass
Itoga, 2018
59 M 4.0a N/A
GORE 4 years EXCLUDER
Type B aortic dissection, back pain, left LE ischemia
No
Asymptomatic Repair type B dissection with at 6 months endograft
Presentation
Treatment
Outcome Asymptomatic at 1 year
Potential cause of collapse Distal migration of stent graft Acute type B aortic dissection
AAA, Abdominal aortic aneurysm; LE, lower extremity; N/A, not available; TEVAR, thoracic endovascular aortic repair. a Common iliac artery aneurysm.
anatomy, always with short aortic neck, was associated with type I endoleak, but not infolding, in other series.21,22 Our review of graft infoldings after EVAR identified 13 patients with this complication, including ours (Table). Aortoiliac tortuosity was identified in all four cases with acute endograft collapse. Tortuous iliac arteries have been implicated in graft limb kink, occlusion, loss of distal seal, and type IB endoleak; increased aortoiliac tortuosity index is associated with iliac complications due to shortening of the endograft.23 The aortoiliac tortuosity, especially on the left side, was significant in our patient, but there was no calcification, thrombus, or stenosis that could have been a contraindication to EVAR according to the IFU. The aorta had only 40-degree angulation. It is possible, however, that a longer neck even with mild angulation, especially in patients with tortuous iliac arteries, exerts more tension to the main body at the lesser aortic curve, leading to poor adherence on the affected side, promoting collapse.3 It is noteworthy that three of the reported cases had an unusually long neck, 5.1 cm, 7.5 cm, and 10 cm in length, and each had an angulation of only 40 to 45 degrees. A long and even mildly tortuous aortic neck appears to be a more important risk factor of collapse than previously believed. The subtle, 1- to 2-mm bird beak that we identified only later on desktop imaging appeared clinically insignificant as there was no attachment site endoleak and no endograft kink. Based on this case, however, it seems that even minor bird beaks, if noted during EVAR, should be addressed with repeated dilation, using the Coda balloon or placement of a proximal cuff. Bird-beak configuration has not previously led to graft infolding after EVAR in our experience. However, bird beak due to oversizing or poor adherence to the wall because of plaque, thrombus, or tortuosity, a frequent risk factor for graft collapse in the thoracic aorta,2 was found in two patients after EVAR. It is possible that improved conformability of newer generation devices will minimize the risk of bird beak and stent graft collapse. Seven of 13 reported endograft collapses, and all four with acute collapse, involved the GORE EXCLUDER endograft. Device characteristics and decreased radial
force of this endograft could potentially be important in the development of collapse, especially if multiple risk factors are present. The 2018 Gore Excluder annual update includes worldwide experience of three generations of more than 297,000 devices, distributed between 1997 and 2017, with 123 in-folding events reported to the manufacturer (four between May 15, 2016 and May 15,2017) for an overall prevalence of 0.041%.24 Details about time of collapse after implantation, treatment, and outcome are not available for these patients, but infolding is not listed as a cause of conversion or device-related death. Considering that only 13 individual case reports have been published, this complication is likely to be under-reported. In two patients, the endograft was deployed 10 to 15 mm distal to the lowest renal artery. Both patients, including ours, had >7-cm necks, much more than 1.5 cm required by the IFU. Other causes included aortic dissection in four patients and inadequate proximal fixation of previous-generation endografts (AneuRx and Talent; Medtronic, Santa Rosa, Calif) in two patients. Our review of the literature indicates that this complication is considerably less frequent with EVAR using suprarenal fixation. Management of aneurysmal iliac arteries with large aortic cuffs is an effective technique outside the IFU used for more than a decade at our institution. The cuffs did not contribute to proximal graft collapse in our patient. Despite tortuosity, there was excellent graft apposition. For a 30-mm iliac artery, however, current recommendations favor using branched iliac grafts over aortic cuffs because these now have Food and Drug Administration approval.17 Patients with graft infolding usually require immediate treatment. Endovascular or a hybrid procedure with balloon thrombectomy, balloon dilation, and placement of a proximal stent or aortic cuff has been successful in most patients. Our patient, with acute infolding, and three others with delayed infolding required open revascularization with axillofemoral bypass and immediate or delayed open conversion. The only death occurred from a massive aortic dissection.
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CONCLUSIONS Collapse of a GORE EXCLUDER endograft at 14 days after implantation may have been caused by a combination of several potential factors: oversizing because of a reversetapered aortic neck, aortoiliac tortuosity with a long aortic neck, stent graft placed 10 to 15 mm distal to the lowest renal artery with a small (1- to 2-mm) bird beak after implantation, or use of a stent graft with an excellent clinical track record24 but low radial force and occasional graft infolding. Whereas none of these alone would have led to graft collapse, the unfortunate and chance combination of some or all may have led to this patient’s catastrophic complication. Careful planning and attention to these factors will help the surgeon predict and minimize the risk of infolding. Understanding characteristics of an endograft is essential. Graft oversizing for a reversetapered neck is useful to decrease type I endoleak and to ensure good fixation, but it may increase the risk of infolding in some patients. New technology, such as the Heli-FX EndoAnchor (Medtronic) system, is intended to prevent device migration and endoleak in patients with short aortic necks (<1 cm), >60-degree aortic angulation,25 and conical necks. Further long-term analysis of data of this and other such systems is needed to know whether they will help decrease the risk of infolding. Although it is not listed in the current Society for Vascular Surgery guidelines,17 predischarge CTA in our patient could have provided a clue of impending graft collapse. Re-evaluation of early postoperative imaging in select patients therefore is warranted. Finally, a primary open aortic repair in patients with complex aortic anatomy should always be considered.
REFERENCES 1. Kasirajan K, Dake MD, Lumsden A, Bavaria J, Makaroun MS. Incidence and outcomes after infolding or collapse of thoracic stent grafts. J Vasc Surg 2012;55:652-8; discussion: 658. 2. Jonker FH, Schlosser FJ, Geirsson A, Sumpio BE, Moll FL, Muhs BE. Endograft collapse after thoracic endovascular aortic repair. J Endovasc Ther 2010;17:725-34. 3. Matsagas MI, Papakostas JC, Arnaoutoglou HM, Michalis LK. Abdominal aortic endograft proximal collapse: successful repair by endovascular means. J Vasc Surg 2009;49:1316-8. 4. Sfyroeras GS, Maras D, Andrikopoulos V. Abdominal endograft collapse with acute bilateral lower limb ischemia. J Vasc Interv Radiol 2011;22:570-2. 5. van Dorp M, van Vierssen WH, Rijna H, van Boven LJ, Rijbroek A, Vermeulen EG. Treatment of abdominal aortic endograft infolding. J Vasc Endovasc Surg 2017;2:20. 6. McCready RA, Bryant MA, Divelbiss JL, Chess BA, Chitwood RW, Paget DS. Arterial infections in the new millenium: an old problem revisited. Ann Vasc Surg 2006;20: 590-5. 7. Szabolcs Z, Huttl K, Laczko A, Daroczi L, Hüttl T, Paulovich E, et al. Acute type A aortic dissection complicated by aortic stent graft collapse. Ann Thorac Surg 2009;87:1279-81. 8. van Keulen JW, Toorop RJ, de Borst GJ, Scharn DM, Prokop M, Moll FL, et al. Abdominal stent-graft collapse due to progression of a Stanford type B dissection. J Endovasc Ther 2009;16:752-4.
2019
9. Loh SA, Jacobowiz GR, Rockman CB, Veith FJ, Cayne NS. Endovascular repair of a collapsed abdominal aortic endograft due to bird-beaking. J Vasc Surg 2010;52:813-4. 10. Moulakakis KG, Dalainas I, Giannakopoulos TG, Avgerinos E, Liapis CD. Abdominal aortic endograft proximal collapse resulting in aortic aneurysm rupture. Vascular 2011;19:159-62. 11. Akpinar S, Parildar M, Alicioglu B. Post EVAR endovascular revision of late onset stent graft collapse due to type 1 endoleak in a complicated case with left limb occlusion and solitary kidney. JBR-BTR 2013;96:383-5. 12. Psacharopulo D, Ferrero E, Viazzo A, Ferri M, Ripepi M, Nessi F. Abdominal aortic endograft collapse due to false lumen radial force of an acute type B aortic dissection. Ann Vasc Surg 2014;28:1931.e9-12. 13. Mohapatra A, Magnetta MJ, Snatchko ME, Baril DT. Acute aortic occlusion secondary to aortic endograft migration and collapse. J Vasc Surg Cases Innov Tech 2017;3:183-4. 14. Itoga NK, Wu T, Dake MD, Dalman RL, Lee JT. Acute type B dissection causing collapse of EVAR endograft and iliac limb occlusion. Ann Vasc Surg 2018;46:206.e1-4. 15. Lederle FA, Johnson GR, Wilson SE, Ballard DJ, Jordan WD Jr, Blebea J, et al. Rupture rate of large abdominal aortic aneurysms in patients refusing or unfit for elective repair. JAMA 2002;287:2968-72. 16. Abdulameer H, Al Taii H, Al-Kindi SG, Milner R. Epidemiology of fatal ruptured aortic aneurysms in the United States (1999-2016). J Vasc Surg 2018;69:378-84.e2. 17. Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg 2018;67:2-77.e2. 18. Locham S, Lee R, Nejim B, Dakour Aridi H, Malas M. Mortality after endovascular versus open repair of abdominal aortic aneurysm in the elderly. J Surg Res 2017;215:153-9. 19. Gloviczki P, Huang Y, Oderich GS, Duncan AA, Kalra M, Fleming MD, et al. Clinical presentation, comorbidities, and age but not female gender predict survival after endovascular repair of abdominal aortic aneurysm. J Vasc Surg 2015;61:853-61.e2. 20. Mwipatayi BP, Picardo A, Wong J, Thomas SD, Vijayan V. Endovascular repair of abdominal aortic aneurysms with reverse taper neck anatomy using the Endurant stent-graft: analysis of stent-graft oversizing. J Endovasc Ther 2013;20: 514-22. 21. Jordan WD Jr, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, et al. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg 2015;61:1383-90.e1. 22. Pitoulias GA, Valdivia AR, Hahtapornsawan S, Torsello G, Pitoulias AG, Austermann M, et al. Conical neck is strongly associated with proximal failure in standard endovascular aneurysm repair. J Vasc Surg 2017;66:1686-95. 23. Lee K, Hossain S, Sabalbal M, Dubois L, Duncan A, DeRose G, et al. Explaining endograft shortening during endovascular repair of abdominal aortic aneurysms in severe aortoiliac tortuosity. J Vasc Surg 2017;65:1297-304. 24. GORE EXCLUDER AAA endoprosthesis. Annual clinical update. Available at: https://www.goremedical.com/annuals. Accessed March 14, 2019. 25. Goudeketting SR, van Noort K, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, et al. Influence of aortic neck characteristics on successful aortic wall penetration of EndoAnchors in therapeutic use during endovascular aneurysm repair. J Vasc Surg 2018;68:1007-16.
Submitted Oct 15, 2018; accepted Dec 2, 2018.
ABSTRACT Bilateral acute limb ischemia after endovascular aneurysm repair is extremely rare. We present the case of a 70-year-old man treated by endovascular aneurysm repair for a 7.9-cm asymptomatic infrarenal abdominal aortic aneurysm using a bifurcated modular GORE EXCLUDER endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz). The initial recovery was uneventful, but 14 days later, the patient presented with bilateral acute limb ischemia caused by collapse and thrombosis of the endograft, requiring emergency axillobifemoral bypass, fasciotomies, and subsequent endograft removal with open aneurysm repair. The patient had no other complications at 7 months of follow-up. Oversizing of a GORE EXCLUDER graft because of a conical neck, a small bird-beak configuration, and a long angulated neck with aortoiliac tortuosity were potential contributing factors to endograft infolding and collapse. (J Vasc Surg 2019;-:1-6.) Keywords: Endovascular repair; Abdominal aortic aneurysm; Endograft infolding; Endograft collapse; Acute limb ischemia
Endograft collapse after elective endovascular aneurysm repair (EVAR) is rare. Infolding was observed mostly after repair of thoracic aortic disease processes treated by first-generation less conformable thoracic endografts.1,2 Only three cases of endograft collapse occurring within 30 days after infrarenal EVAR have been reported, and none needed conversion to open repair.3-5 A handful of cases of late endograft collapse have also been reported.6-14 The patient we describe here developed endograft infolding 14 days after uneventful EVAR, requiring emergency open revascularization because of severe acute lower limb ischemia and subsequent conversion to open repair. We discuss potential causes of endograft collapse and call attention to device selection and technical details that surgeons should observe to minimize risk of this rare but severe limb- and life-threatening complication. The patient consented to publication of this report.
CASE REPORT A 70-year-old asymptomatic white man presented for general
discontinued smoking 39 years earlier. On physical examination, he was in no acute distress (blood pressure, 109/67 mm Hg; heart rate regular, 47 beats/min). He had a soft systolic murmur over the left precordium; lungs were clear. There were no carotid bruits. He had a large midabdominal nontender pulsatile mass, without bruits. Femoral and pedal pulses were normal bilaterally. His medications included atorvastatin, folic acid, metoprolol, magnesium, potassium, ezetimibe, and multivitamins. He stopped rivaroxaban 2 days before his examination. Computed tomography angiography (CTA) revealed a 79- 71-mm abdominal aortic aneurysm (AAA) that extended from the inferior mesenteric artery to the aortic bifurcation (Fig 1). Centerline imaging confirmed a long and angulated infrarenal aortic neck that measured 22 mm in diameter at the lower left renal artery, 22 mm at 15 cm and 26 mm at 19 mm distal to the renal artery, and 24 mm at the level of the inferior mesenteric artery (Fig 2). Neck angulation was 40 degrees. The patient had tortuous and aneurysmal common iliac arteries measuring 29 mm in diameter on the right and 30 mm on the left. Both open repair and EVAR were discussed in detail, including the extensive aortoiliac aneurysmal disease and tortuous iliac arteries. The patient consented to undergo EVAR.
medical examination. His medical history included intermittent
Under general anesthesia, bilateral percutaneous femoral
atrial fibrillation, four cardioversions, and a myocardial infarction
access was obtained and a bifurcated GORE EXCLUDER endo-
16 years before presentation. There was no family history of
prosthesis (W. L. Gore & Associates, Flagstaff, Ariz) was inserted
aneurysms, collagen vascular disease, or diabetes. The patient
(28.5- 14-mm main body). The repair was extended distally us-
From the Department of Surgery, Sentara Norfolk General Hospital, Norfolka;
ing a 14-cm 27-mm iliac extension limb and a 4.5-cm 32mm aortic cuff on the right and 14-cm 27-mm and 10-
and the Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester.b Author conflict of interest: none. Correspondence: Peter Gloviczki, MD, Division of Vascular and Endovascular
cm 27-mm extension limbs and a 4.5-cm 32-mm aortic cuff on the left. Landing zones and overlapping sites were dilated with 32-mm Coda balloon (Cook Medical, Bloomington,
Surgery, Mayo Clinic, Rochester, MN 55905 (e-mail: gloviczki.peter@mayo.
Ind). Completion aortography showed no attachment site endo-
edu).
leak and good graft apposition; the endograft was patent with
The editors and reviewers of this article have no relevant financial relationships to
excellent flow into the iliac arteries (Fig 3). Catheters and sheaths
disclose per the JVS policy that requires reviewers to decline review of any
were removed, and puncture sites were closed with Perclose devices (Abbott Vascular, Santa Clara, Calif). The patient awoke
manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc.
without problems, had no groin hematoma, and had excellent
https://doi.org/10.1016/j.jvs.2018.12.049
distal pulses. Overnight hospitalization was uneventful; he was 1
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Fig 1. Computed tomography angiography (CTA) shows an 79- 71-mm infrarenal abdominal aortic aneurysm (AAA) that extends from the inferior mesenteric artery to the aortic bifurcation. The aorta measured 22 mm at the renal arteries, 22 mm at 15 cm distal to the renal arteries and 26 mm at 19 mm, and 24 mm all the way to the inferior mesenteric artery. Both common iliac arteries were tortuous and aneurysmal.
anastomosis and partially removed. His hospitalization was prolonged, and he underwent closure of the fasciotomies. The patient had no other complications at 7 months of follow-up. A review of the first intraoperative completion aortogram showed a small, 1- to 2-mm bird-beak appearance at the right upper tip of the endograft (Fig 3); the distance between the uppermost stent and left renal artery was 13 mm.
DISCUSSION
Fig 2. Centerline imaging with computed tomography angiography (CTA), with length and diameter measurements. The length of the neck was 75 mm.
discharged the next day on general diet, ambulating, with palpable pedal pulses. He resumed his medications, including rivaroxaban. At 14 days, he developed bilateral sudden lower extremity pain, coolness, paresthesia, and paralysis. Emergency CTA at another tertiary care center confirmed collapsed main limb of the aortic endograft with bilateral iliac limb thromboses (Fig 4). He underwent axillobifemoral bypass and bilateral fasciotomies. During the same hospitalization, he had explantation of the collapsed endograft with open surgical repair using a bifurcated aortoiliac polyester graft. The collapsed endograft resumed normal configuration after removal; there was no stent fracture or fabric injury. The
axillobifemoral
bypass
was
disconnected
at
each
Endograft infolding 2 weeks after uneventful EVAR caused a devastating complication to this patient. There was no doubt his 7.9-cm AAA required expeditious repair because of >33% annual risk of rupture,15 with associated high mortality.16 The main questions raised after his complication concerned the choice of EVAR vs open repair and the size of the endograft we selected. EVAR is an effective, low-risk procedure and the preferred technique to repair AAAs.17 In the United States, currently >90% of patients $70 years of age undergo EVAR for nonruptured AAA.18 Results have been excellent. At our institution, 30-day mortality after 870 elective EVARs was 1.0%, with 1 death (0.2%) reported in 526 patients with low or average surgical risk.19 Until now, in >2000 aortic endovascular procedures, we had not observed a collapsed endograft after EVAR. EVAR remains our recommendation to treat select patients with an asymptomatic large AAA with adequate anatomy. Our patient had challenging anatomy for an endograft, but the neck was suitable as determined by the instructions for use (IFU) of the manufacturer: a minimum neck
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Fig 3. Steps during deployment of the endovascular graft system. A, Predeployment aortogram demonstrated slight proximal aortic neck tortuosity and reverse taper configuration. B, Deployment of the main body distal to the left (lower) renal artery. C, Molding of the proximal seal zone with the 32-mm Coda (Cook Medical) balloon. D, Completion aortogram shows successful exclusion of the aneurysm, with excellent flow into the graft. The arrow indicates small bird-beak appearance of the endograft. E, Completion aortogram shows good distal seals and no endoleak.
Fig 4. A-C, Computed tomography angiography (CTA) shows collapsed main body and thrombosed iliac limbs of the endograft at 15 days after implantation.
length of 15 mm, a proximal neck angulation #60 degrees with minimal thrombus or calcification, and an aortic neck diameter of 19 to 32 mm. The IFU recommend a 26-mm trunk-ipsilateral leg endoprosthesis for an aortic diameter of 22 to 23 mm and a 28.5-mm endoprosthesis for a neck of 24 to 26 mm. Because of a reverse-tapered neck anatomy, from 22 to 26 mm at 19 mm distal to the lowest renal artery, decreasing then to 24 mm over a length of 7.5 cm, we elected to use a 28.5-mm-dimeter main body, a 29.5% oversizing for a 22-mm neck, and a 9.6% oversizing for a 26-mm neck. The last is within recommendations of the IFU
(10%-21% oversizing). We thought this graft size would help decrease the risk of type I endoleak. Oversizing of >40% has been used for conical necks with excellent results and no graft collapse or type I endoleak at 20 months.20 However, had we used the 26-mm device, considering only the diameter of the first 15 mm of the neck, the low risk of infolding may have been even lower. With a 26-mm neck, however, a 26-mm device would have increased the risk of a type I endoleak. A conical neck was present in one patient, in addition to ours, who had collapsed GORE EXCLUDER endograft at 15 days after EVAR (Table). Reverse-tapered neck
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Table. Endograft collapse after infrarenal endovascular aneurysm repair (EVAR) First author, year
Device Neck Age, AAA Neck type Time from years, size, diameter,length, mm (size, mm) implantation mm M/F cm
Presentation
Conversion to open repair
Treatment
Outcome
Potential cause of collapse
Endograft collapse #30 days after stent graft implantation Matsagas, 2009
78 M 5.5
24
20 GORE 1 month EXCLUDER (28.5)
No symptoms
No
Asymptomatic 28-mm Talent at 1 year (Medtronic) aortic cuff with suprarenal stent
“Slight” angulation of the aortic neck
Sfyroeras, 2011
68 M 5.0
25-29
20 GORE 15 days EXCLUDER (31)
Bilateral LE ischemia
No
32-mm GORE EXCLUDER aortic cuff
Asymptomatic at 1 year
Oversized endograft in reversetapered proximal neck with 45degree angulation
van Dorp, 2017
54 M 4.2a
20
100 GORE 20 days EXCLUDER with iliac branched device (23)
Bilateral LE ischemia
No
25-mm Medtronic aortic cuff
Asymptomatic at 1 year
Tortuous iliac arteries, endograft placed 10-15 mm distal to renal arteries
Rathore, 2018
70 M 7.1
22-26
14 days 75 GORE EXCLUDER (28.5)
Bilateral LE ischemia
Yes
Axillobifemoral bypass and fasciotomies followed by open repair
Asymptomatic at 7 months
Oversized endograft in reversetapered proximal neck, small (1to 2-mm) bird beak, 40degree angulation, tortuous iliacs
Endograft collapse >30 days after stent graft implantation McCready, 2006
64 M 5.5 N/A
AneuRx 9.5 years (Medtronic)
Chronic back pain
Yes
Open repair
No Distal migration; complications type I at discharge endoleak (day 5)
Szabolcs, 2009
57 M 4.5 N/A
GORE 1 year EXCLUDER
Bilateral LE ischemia with type A aortic dissection
Yes
Open repair dissection, stenting of endograft
Asymptomatic at 2.5 years
Type A aortic dissection
van Keulen, 2009
74 M 5.4 N/A
Talent 2 years (Medtronic)
Abdominal pain, oliguria, type B aortic dissection
No
Pain resolved Balloonat discharge expandable stent and TEVAR (Relay NBS, Bolton Medical)
Type B aortic dissection
Loh, 2010
72 M 7.9
26
Endologix 6 months Powerlink (28)
Asymptomatic
No
Repeated stent Asymptomatic grafting, at 1 month Palmaz stent
Bird beaking, angulation (45-50 degrees)
Moulakakis, 2011
82 M N/A
30
Talent 6 years (Medtronic)
AAA rupture
No
Proximal endograft cuff (Medtronic Talent)
Akpinar, 2013
67 M N/A N/A
1 year Anaconda (Vascutek, Terumo)
Bilateral LE claudication
No
Type IA Aortic stent graft Stable at endoleak and stent, iliac 6 months, no endoleak stent
GORE 14 months EXCLUDER
Abdominal pain, bilateral LE ischemia
Yes
Axillobifemoral bypass
Psacharopulo,75 M 5.8 N/A 2014
Asymptomatic
Vertical graft collapse due to enlargement of proximal neck and distal migration
Type B aortic Death on dissection postoperative day 2
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Table. Continued. Conversion to open repair
First author, year
Device Neck Age, AAA Neck type Time from years, size, diameter,length, mm (size, mm) implantation mm M/F cm
Mohapatra, 2017
75 M N/A N/A
AneuRx 4 years (Medtronic)
Bilateral LE ischemia
Yes
Axillobifemoral bypass
Itoga, 2018
59 M 4.0a N/A
GORE 4 years EXCLUDER
Type B aortic dissection, back pain, left LE ischemia
No
Asymptomatic Repair type B dissection with at 6 months endograft
Presentation
Treatment
Outcome Asymptomatic at 1 year
Potential cause of collapse Distal migration of stent graft Acute type B aortic dissection
AAA, Abdominal aortic aneurysm; LE, lower extremity; N/A, not available; TEVAR, thoracic endovascular aortic repair. a Common iliac artery aneurysm.
anatomy, always with short aortic neck, was associated with type I endoleak, but not infolding, in other series.21,22 Our review of graft infoldings after EVAR identified 13 patients with this complication, including ours (Table). Aortoiliac tortuosity was identified in all four cases with acute endograft collapse. Tortuous iliac arteries have been implicated in graft limb kink, occlusion, loss of distal seal, and type IB endoleak; increased aortoiliac tortuosity index is associated with iliac complications due to shortening of the endograft.23 The aortoiliac tortuosity, especially on the left side, was significant in our patient, but there was no calcification, thrombus, or stenosis that could have been a contraindication to EVAR according to the IFU. The aorta had only 40-degree angulation. It is possible, however, that a longer neck even with mild angulation, especially in patients with tortuous iliac arteries, exerts more tension to the main body at the lesser aortic curve, leading to poor adherence on the affected side, promoting collapse.3 It is noteworthy that three of the reported cases had an unusually long neck, 5.1 cm, 7.5 cm, and 10 cm in length, and each had an angulation of only 40 to 45 degrees. A long and even mildly tortuous aortic neck appears to be a more important risk factor of collapse than previously believed. The subtle, 1- to 2-mm bird beak that we identified only later on desktop imaging appeared clinically insignificant as there was no attachment site endoleak and no endograft kink. Based on this case, however, it seems that even minor bird beaks, if noted during EVAR, should be addressed with repeated dilation, using the Coda balloon or placement of a proximal cuff. Bird-beak configuration has not previously led to graft infolding after EVAR in our experience. However, bird beak due to oversizing or poor adherence to the wall because of plaque, thrombus, or tortuosity, a frequent risk factor for graft collapse in the thoracic aorta,2 was found in two patients after EVAR. It is possible that improved conformability of newer generation devices will minimize the risk of bird beak and stent graft collapse. Seven of 13 reported endograft collapses, and all four with acute collapse, involved the GORE EXCLUDER endograft. Device characteristics and decreased radial
force of this endograft could potentially be important in the development of collapse, especially if multiple risk factors are present. The 2018 Gore Excluder annual update includes worldwide experience of three generations of more than 297,000 devices, distributed between 1997 and 2017, with 123 in-folding events reported to the manufacturer (four between May 15, 2016 and May 15,2017) for an overall prevalence of 0.041%.24 Details about time of collapse after implantation, treatment, and outcome are not available for these patients, but infolding is not listed as a cause of conversion or device-related death. Considering that only 13 individual case reports have been published, this complication is likely to be under-reported. In two patients, the endograft was deployed 10 to 15 mm distal to the lowest renal artery. Both patients, including ours, had >7-cm necks, much more than 1.5 cm required by the IFU. Other causes included aortic dissection in four patients and inadequate proximal fixation of previous-generation endografts (AneuRx and Talent; Medtronic, Santa Rosa, Calif) in two patients. Our review of the literature indicates that this complication is considerably less frequent with EVAR using suprarenal fixation. Management of aneurysmal iliac arteries with large aortic cuffs is an effective technique outside the IFU used for more than a decade at our institution. The cuffs did not contribute to proximal graft collapse in our patient. Despite tortuosity, there was excellent graft apposition. For a 30-mm iliac artery, however, current recommendations favor using branched iliac grafts over aortic cuffs because these now have Food and Drug Administration approval.17 Patients with graft infolding usually require immediate treatment. Endovascular or a hybrid procedure with balloon thrombectomy, balloon dilation, and placement of a proximal stent or aortic cuff has been successful in most patients. Our patient, with acute infolding, and three others with delayed infolding required open revascularization with axillofemoral bypass and immediate or delayed open conversion. The only death occurred from a massive aortic dissection.
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CONCLUSIONS Collapse of a GORE EXCLUDER endograft at 14 days after implantation may have been caused by a combination of several potential factors: oversizing because of a reversetapered aortic neck, aortoiliac tortuosity with a long aortic neck, stent graft placed 10 to 15 mm distal to the lowest renal artery with a small (1- to 2-mm) bird beak after implantation, or use of a stent graft with an excellent clinical track record24 but low radial force and occasional graft infolding. Whereas none of these alone would have led to graft collapse, the unfortunate and chance combination of some or all may have led to this patient’s catastrophic complication. Careful planning and attention to these factors will help the surgeon predict and minimize the risk of infolding. Understanding characteristics of an endograft is essential. Graft oversizing for a reversetapered neck is useful to decrease type I endoleak and to ensure good fixation, but it may increase the risk of infolding in some patients. New technology, such as the Heli-FX EndoAnchor (Medtronic) system, is intended to prevent device migration and endoleak in patients with short aortic necks (<1 cm), >60-degree aortic angulation,25 and conical necks. Further long-term analysis of data of this and other such systems is needed to know whether they will help decrease the risk of infolding. Although it is not listed in the current Society for Vascular Surgery guidelines,17 predischarge CTA in our patient could have provided a clue of impending graft collapse. Re-evaluation of early postoperative imaging in select patients therefore is warranted. Finally, a primary open aortic repair in patients with complex aortic anatomy should always be considered.
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9. Loh SA, Jacobowiz GR, Rockman CB, Veith FJ, Cayne NS. Endovascular repair of a collapsed abdominal aortic endograft due to bird-beaking. J Vasc Surg 2010;52:813-4. 10. Moulakakis KG, Dalainas I, Giannakopoulos TG, Avgerinos E, Liapis CD. Abdominal aortic endograft proximal collapse resulting in aortic aneurysm rupture. Vascular 2011;19:159-62. 11. Akpinar S, Parildar M, Alicioglu B. Post EVAR endovascular revision of late onset stent graft collapse due to type 1 endoleak in a complicated case with left limb occlusion and solitary kidney. JBR-BTR 2013;96:383-5. 12. Psacharopulo D, Ferrero E, Viazzo A, Ferri M, Ripepi M, Nessi F. Abdominal aortic endograft collapse due to false lumen radial force of an acute type B aortic dissection. Ann Vasc Surg 2014;28:1931.e9-12. 13. Mohapatra A, Magnetta MJ, Snatchko ME, Baril DT. Acute aortic occlusion secondary to aortic endograft migration and collapse. J Vasc Surg Cases Innov Tech 2017;3:183-4. 14. Itoga NK, Wu T, Dake MD, Dalman RL, Lee JT. Acute type B dissection causing collapse of EVAR endograft and iliac limb occlusion. Ann Vasc Surg 2018;46:206.e1-4. 15. Lederle FA, Johnson GR, Wilson SE, Ballard DJ, Jordan WD Jr, Blebea J, et al. Rupture rate of large abdominal aortic aneurysms in patients refusing or unfit for elective repair. JAMA 2002;287:2968-72. 16. Abdulameer H, Al Taii H, Al-Kindi SG, Milner R. Epidemiology of fatal ruptured aortic aneurysms in the United States (1999-2016). J Vasc Surg 2018;69:378-84.e2. 17. Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg 2018;67:2-77.e2. 18. Locham S, Lee R, Nejim B, Dakour Aridi H, Malas M. Mortality after endovascular versus open repair of abdominal aortic aneurysm in the elderly. J Surg Res 2017;215:153-9. 19. Gloviczki P, Huang Y, Oderich GS, Duncan AA, Kalra M, Fleming MD, et al. Clinical presentation, comorbidities, and age but not female gender predict survival after endovascular repair of abdominal aortic aneurysm. J Vasc Surg 2015;61:853-61.e2. 20. Mwipatayi BP, Picardo A, Wong J, Thomas SD, Vijayan V. Endovascular repair of abdominal aortic aneurysms with reverse taper neck anatomy using the Endurant stent-graft: analysis of stent-graft oversizing. J Endovasc Ther 2013;20: 514-22. 21. Jordan WD Jr, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, et al. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg 2015;61:1383-90.e1. 22. Pitoulias GA, Valdivia AR, Hahtapornsawan S, Torsello G, Pitoulias AG, Austermann M, et al. Conical neck is strongly associated with proximal failure in standard endovascular aneurysm repair. J Vasc Surg 2017;66:1686-95. 23. Lee K, Hossain S, Sabalbal M, Dubois L, Duncan A, DeRose G, et al. Explaining endograft shortening during endovascular repair of abdominal aortic aneurysms in severe aortoiliac tortuosity. J Vasc Surg 2017;65:1297-304. 24. GORE EXCLUDER AAA endoprosthesis. Annual clinical update. Available at: https://www.goremedical.com/annuals. Accessed March 14, 2019. 25. Goudeketting SR, van Noort K, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, et al. Influence of aortic neck characteristics on successful aortic wall penetration of EndoAnchors in therapeutic use during endovascular aneurysm repair. J Vasc Surg 2018;68:1007-16.
Submitted Oct 15, 2018; accepted Dec 2, 2018.