A Proposed Update To The Endoleak Classif ication System In The Era Of Fenestrated And

Branched Endografts

CHARALABIDIS, Peter1, DELANEY, Chris2

1. Vascular Surgery Department, The Alfred Hospital, Victoria, Australia

2. Vascular Surgery Department, Flinders Medical Center, South Australia

A ims

The development of stent grafting techniques for the repair of Abdominal

Aortic Aneurysms was accompanied by a new lexicon and ultimately the

creation of a contemporary Endoleak Classification System to report on stent

graft related complications (Table 1). With the natural evolution of the

technology to Fenestrated EndoVascular Aneurysm Repair (FEVAR) and

Branched EndoVascular Aneurysm Repair (Branched EVAR), we propose

that an update of the Classification System is required to make it

contemporaneous. A systematic review of the literature is utilised to highlight

the importance of this update.

Table 1: Current Classification Scheme for Endoleaks

Journal Articles Used for the Analysis:1. The endovascular treatment of juxta-renal abdominal aortic aneurysm using fenestrated endograft: early and mid-term results.Gallitto E, Gargiulo M, Freyrie A, Mascoli C, Massoni Bianchini C, Ancetti S, Faggioli G, Stella A. J Cardiovasc Surg (Torino). 2015 Sep 292. Early Results of Physician Modified Fenestrated Stent Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms.Cochennec F, Kobeiter H, Gohel M, Leopardi M, Raux M, Majewski M, Desgranges P, Allaire E, Becquemin JP. Eur J Vasc Endovasc Surg. 2015 Aug 73. Outcomes of surgeon-modified fenestrated-branched endograft repair for acute aortic pathology.Scali ST, Neal D, Sollanek V, Martin T, Sablik J, Huber TS, Beck AW. J Vasc Surg. 2015 Nov;62(5):1148-11594. Endovascular treatment options for complex abdominal aortic aneurysms.Ronchey S, Serrao E, Kasemi H, Pecoraro F, Fazzini S, Alberti V, Mangialardi N. J Vasc Interv Radiol. 2015 Jun;26(6):842-545. Twelve-year results of fenestrated endografts for juxtarenal and group IV thoracoabdominal aneurysms.Mastracci TM, Eagleton MJ, Kuramochi Y, Bathurst S, Wolski K. J Vasc Surg. 2015 Feb;61(2):355-646. Geometry and respiratory-induced deformation of abdominal branch vessels and stents after complex endovascular aneurysm repair.Ullery BW, Suh GY, Lee JT, Liu B, Stineman R, Dalman RL, Cheng CP. J Vasc Surg. 2015 Apr;61(4):875-847. Type Ia endoleaks after fenestrated and branched endografts may lead to component instability and increased aortic mortality.O'Callaghan A, Greenberg RK, Eagleton MJ, Bena J, Mastracci TM. J Vasc Surg. 2015 Apr;61(4):908-148. Results of the United States multicenter prospective study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominalaortic aneurysms.Oderich GS, Greenberg RK, Farber M, Lyden S, Sanchez L, Fairman R, Jia F, Bharadwaj P; Zenith Fenestrated Study Investigators. J Vasc Surg. 2014Dec;60(6):1420-89. Postapproval outcomes of juxtarenal aortic aneurysms treated with the Zenith fenestrated endovascular graft.Vemuri C, Oderich GS, Lee JT, Farber MA, Fajardo A, Woo EY, Cayne N, Sanchez LA. J Vasc Surg. 2014 Aug;60(2):295-30010. Dutch experience with the fenestrated Anaconda endograft for short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair.Dijkstra ML, Tielliu IF, Meerwaldt R, Pierie M, van Brussel J, Schurink GW, Lardenoye JW, Zeebregts CJ. J Vasc Surg. 2014 Aug;60(2):301-711. Fenestrated endovascular repair of complex aortic aneurysms.Canning C, Martin Z, Colgan MP, Abdulrahim O, McCafferty M, Fitzpatrick J, Haider SN, Madhavan P, O'Neill S. Ir J Med Sci. 2015 Mar;184(1):249-5512. Endovascular repair of complex aortic aneurysms.Silverberg D, Glauber V, Rimon U, Yakubovitch D, Reinitz ER, Sheick-Yousif B, Khaitovich B, Schneiderman J, Halak M. Isr Med Assoc J. 2014 Jan;16(1):5-1013. Comparison of fenestrated endovascular aneurysm repair and chimney graft techniques for pararenal aortic aneurysm.Banno H, Cochennec F, Marzelle J, Becquemin JP. J Vasc Surg. 2014 Jul;60(1):31-914. Early Australasian experience with branched endovascular thoracoabdominal aortic aneurysm repair.Jamieson RW, Huilgol RL. ANZ J Surg. 2013 Nov;83(11):808-1315. Experience with a novel custom-made fenestrated stent graft in the repair of juxtarenal and type IV thoracoabdominal aneurysms.Rolls AE, Jenkins M, Bicknell CD, Riga CV, Cheshire NJ, Burfitt N, Hamady M. J Vasc Surg. 2014 Mar;59(3):615-2216. Early experience with fenestrated stent grafts for treatment of juxtarenal aortic aneurysm.Unno N, Yamamoto N, Higashiura W, Suzuki M, Mano Y, Sano M, Saito T, Sugisawa R, Konno H. Ann Vasc Dis. 2013;6(3):642-5017. Outcomes of fenestrated endovascular repair of juxtarenal aortic aneurysm.Kristmundsson T, Sonesson B, Dias N, Törnqvist P, Malina M, Resch T. J Vasc Surg. 2014 Jan;59(1):115-2018. Fenestrated and chimney endografts for juxtarenal aneurysms: early and midterm results.Suominen V, Pimenoff G, Salenius J. Scand J Surg. 2013;102(3):182-8

Of the 3168 grafts reported on, there were 90 (3%) Type Ia endoleaks

(Figure 1). Long-term management and outcomes were reported for 66 (73%)

of these. Of the reported cases, fifty percent (50% or 33 Type Ia endoleaks)

were managed expectantly, with resolution in time of only 13 (39%) of these.

Of the other 33 endoleaks: 9 (14%) were embolised, 2 (3%) were corrected

with open procedures, and 22 (33%) were re-stented or had an extension of

the previous stents.

Furthermore, 137 (4%) Type IIIa endoleaks were identified (Figure 2). Long-

term management and outcomes were reported for 55 (40%) of these. This

included 13 (24%) that were observed, with resolution in 9 (69%). A further 38

(69%) were stented [of which 4 (11%) persisted], while 1 (2%) was embolised

and 3 (5%) were treated with open procedures.

Figure 2

Methods

To identify papers reporting on stent graft complications following FEVAR,

Branched EVAR or both, an electronic search of the literature was performed

using MEDLINE (PubMed), Scopus, Cochrane Central Register of Controlled

Trials and The Cochrane Library from inception through to January 2016.

Search terms included abdominal aortic aneurysm, endovascular aneurysm

repair, fenestrated, branched and endoleak. Reference lists of review articles

and primary studies were also examined.

Results

A total of 38 suitable papers were identified from 2006 to 2015 and included

in the review. These included a range of devices, cohort sizes and experience

of proceduralists from around the globe. Follow-up duration ranged from a

median of 6 months to 8 years.

Discussion

In our review, while the incidence of Type I endoleaks was similar to other

reports (3% vs 3.5% at 1 year in Eurostar) there was a noticeably higher

incidence of Type III endoleaks (4% vs <1% in Eurostar). Of greater

significance was that more of both types of endoleaks were managed

conservatively, with ongoing observation for 50% of Type I endoleaks and 24%

of Type III endoleaks. This represents a huge paradigm shift from

“There is a general agreement on the need to expeditiously treat patients with Type I or Type III endoleaks” (Baum et al, 2003). While 39% of these Type I

and 69% of these Type III endoleaks resolved, the ultimate outcome of the

persisting endoleaks, plus observation of the resolved endoleaks

‘sealed’ by clot, is imperative for assessing the long-term feasibility of these

procedures.

Conclusions

As more vascular services adopt the use of FEVAR and Branched EVAR, we

believe that there exists a need to separate these Type I and Type III events

from the cohort of similar complications in standard EVAR, given that their

management and rates of persistence vary from traditional EVAR outcomes.

We therefore propose that the Endoleak Classification System should now

include'Type Id Endoleak: Proximal Endoleak in the setting of either a Fenestrated or Branched Endograft' and'Type IIId Endoleak: Endoleak at fenestration, branch, target vessel stent, or between stent graft segments in the setting of either Fenestrated or Branched Endograft' .

Whilst these Type Id and Type III endoleaks may seem inevitable in some

anatomical circumstances, it is imperative that we start collecting this

information with an updated Endoleak Classification System for both literature

reporting and audit practices.

19. Treatment of acute visceral aortic pathology with fenestrated/branched endovascular repair in high-surgical-risk patients.Scali ST, Waterman A, Feezor RJ, Martin TD, Hess PJ Jr, Huber TS, Beck AW. J Vasc Surg. 2013 Jul;58(1):56-6520. Prospective, multicenter experience with the Ventana Fenestrated System for juxtarenal and pararenal aortic aneurysm endovascular repair.Quiñones-Baldrich WJ, Holden A, Mertens R, Thompson MM, Sawchuk AP, Becquemin JP, Eagleton M, Clair DG. J Vasc Surg. 2013 Jul;58(1):1-921. Fenestrated endovascular aortic repair for juxtarenal abdominal aortic aneurysm.Guo W, Zhang HP, Liu XP, Jia X, Xiong J, Ma XH. Chin Med J (Engl). 2013 Feb;126(3):409-1422. Comparison of short- and mid-term follow-up between standard and fenestrated endografts.Perot C, Sobocinski J, Maurel B, Millet G, Guillou M, d'Elia P, Amiot S, Wattez H, Bohnert A, Azzaoui R, Haulon S. Ann Vasc Surg. 2013 Jul;27(5):562-7023. Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms.Starnes BW. J Vasc Surg. 2012 Sep;56(3):601-724. Management of perioperative endoleaks during endovascular treatment of juxta-renal aneurysms.Coscas R, Becquemin JP, Majewski M, Mayer J, Marzelle J, Allaire E, You K, Desgranges P, Kobeiter H. Ann Vasc Surg. 2012 Feb;26(2):175-8425. Initial experience with a new fenestrated stent graft.Bungay PM, Burfitt N, Sritharan K, Muir L, Khan SL, De Nunzio MC, Lingam K, Huw Davies A. J Vasc Surg. 2011 Dec;54(6):1832-826. Secondary procedures after aortic aneurysm repair with fenestrated and branched endografts.Troisi N, Donas KP, Austermann M, Tessarek J, Umscheid T, Torsello G. J Endovasc Ther. 2011 Apr;18(2):146-5327. Early outcome following endovascular repair of pararenal aortic aneurysms: triple- versus double- or single-fenestrated stent-grafts.Manning BJ, Agu O, Richards T, Ivancev K, Harris PL. J Endovasc Ther. 2011 Feb;18(1):98-10528. Preloaded fenestrated stent-grafts for the treatment of juxtarenal aortic aneurysms.Manning BJ, Harris PL, Hartley DE, Ivancev K. J Endovasc Ther. 2010 Aug;17(4):449-5529. Fenestrated endovascular grafting: the French multicentre experience.Amiot S, Haulon S, Becquemin JP, Magnan PE, Lermusiaux P, Goueffic Y, Jean-Baptiste E, Cochennec F, Favre JP; Association Universitaire de Rechercheen Chirurgie Vasculaire. Eur J Vasc Endovasc Surg. 2010 May;39(5):537-4430. Endovascular repair of thoracoabdominal aortic aneurysms.Haulon S, D'Elia P, O'Brien N, Sobocinski J, Perrot C, Lerussi G, Koussa M, Azzaoui R. Eur J Vasc Endovasc Surg. 2010 Feb;39(2):171-831. Outcomes of fenestrated endografts in the treatment of abdominal aortic aneurysm in Western Australia (1997-2004).Semmens JB, Lawrence-Brown MM, Hartley DE, Allen YB, Green R, Nadkarni S. J Endovasc Ther. 2006 Jun;13(3):320-9.32. A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes.O'Neill S, Greenberg RK, Haddad F, Resch T, Sereika J, Katz E. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):115-2333. Temporary aneurysm sac perfusion as an adjunct for prevention of spinal cord ischemia after branched endovascular repair of thoracoabdominal aneurysms. Kasprzak PM, Gallis K, Cucuruz B, Pfister K, Janotta M, Kopp R. Eur J Vasc Endovasc Surg. 2014 Sep;48(3):258-6534. Results of complex aortic stent grafting of abdominal aortic aneurysms stratified according to the proximal landing zone using the Society for Vascular Surgery classification.Patel SD, Constantinou J, Simring D, Ramirez M, Agu O, Hamilton H, Ivancev K. J Vasc Surg. 2015 Aug;62(2):319-2535. Fenestrated Endografting for Aortic Aneurysm Repair: A 7-Year Experience.Ziegler P, Avgerinos ED, Umscheid T, Perdikides,T, Stelter,WJ. J Endovasc Ther 2007; 14:609-61836. Fenetrated Endovascular Repair for Juxtarenal Aortic Aneurysm.Scurr JR, Brennan JA, Gilling-Smith GL, Harris PL, Vallabhaneni SR, McWilliams RG. Br Journal of Surgery 2008; 95:326-33237. Fenestrated Stent Grafting for Short-necked and Juxtarenal Abdominal Aortic Aneurysm: An 8-year Single-centre Experience.Verhoeven EL, Vourliotakis G, Bos WT, Tielliu IF, Zeebregts CJ, Prins TR, Bracale UM, Van Den Dungen JJ. Ur J Vasc Endovasc Surg 2010; 39:529-536.38. Fenestrated Aortic Endografts for Juxtarenal Aortic Aneurysm: Medium Term Outcomes.Tambyraja AL, Fishwick NG, Bown MJ, Nasim A, McCarthy MJ, Sayers RD. Eur J Vasc Endovasc Surg 2011; 42:54-58

3168 Reported Grafts

90 (3%) Reported Type Ia Endoleaks

66 (73%) Available Management Outcomes

33 (50%) Managed Expectantly

13 (39%) Resolved

20 (61%) Persisted

33 (50%)Treated: - 9 (14%) Embolised

- 2 (3%) Open Surgery

- 22 (33%) Stent Extension

3168 Reported Grafts

137 (4%) Reported Type IIIa Endoleaks

55 (40%) Available Management

Outcomes

13 (24%) Observed

9 (69%) Resolved

4 (31%) Persisted

38 (69%) Stented

34 (89%) Resolved

4 (11%) Persisted

1 (2%) Embolised

3 (5%) Open Surgery

Figure 1