Long-Term Results of Large Stent Grafts to Treat Abdominal Aortic Aneurysms Adrien Kaladji,1,2,3 Eric Steintmetz,4 Yann Gou€effic,5 Michel Bartoli,6 and Alain Cardon,1 for the Academic Association for Surgical Research (AURC), Rennes, Dijon, Nantes, and Marseille, France
Background: Open surgery and endovascular treatment are currently the 2 methods of treatment for abdominal aortic aneurysms (AAAs). Although in open surgery, the proximal diameter of the implanted prostheses seldom exceeds 24 mm, endovascular aneurysm repair (EVAR) makes it possible to use stent grafts up to 36 mm in diameter. The aim of this study was to compare the long-term results of these large stent grafts compared with the others. Methods: A total of 908 patients operated between 1998 and 2012 for a nonruptured AAA with an infrarenal stent graft were enrolled in this multicentric retrospective study. The patients in whom the proximal diameter of the principal component of the stent graft was above 32 mm belonged to group 1 (n ¼ 170) and the others belonged to group 2 (n ¼ 738). The qualitative and quantitative data were compared with the chi-squared test and the t-test, respectively. The long-term data were analyzed with the log-rank test and KaplaneMeier curves. Results: Mean age of the patients was 75 ± 8.3 years, and the average follow-up duration was 38 ± 28.2 months. There was no difference between the 2 groups regarding demographic data, risk factors except chronic renal insufficiency (30.6% in group 1 vs. 21.2%, P ¼ 0.011), and the proportion of obese patients (26.2% vs. 17.7%, P ¼ 0.02). Concerning the preoperative anatomic features, there was a significant difference between the groups concerning the length of the neck (25.5 ± 10.1 vs. 28.3 ± 12.6 mm, P ¼ 0.008), the maximum diameter of the AAA (58 ± 10.1 vs. 56.1 ± 10.1 mm, P ¼ 0.027), and the oversizing (18.1 ± 8.3% in group 1 vs. 16.8 ± 7.4% in group 2, P ¼ 0.043). There was no difference of the postoperative rates of complications, technical failure, endoleaks, and death. In the long run, analyses of survival showed that the rates of proximal endoleaks (13% vs. 3.9%, P < 0.0001) and of reintervention (24.1% vs. 14.7%, P ¼ 0.009) were higher in group 1. There was no significant difference between the 2 groups regarding the evolution of the aneurysmal sac, the long-term rate of death from all causes or in relation to the aneurysm. Conclusions: Our results suggest that large stent grafts are more at the risk of proximal endoleak and reintervention in the long run. However, there were no differences observed in mortality or evolution of the aneurysmal sac in the patients treated by EVAR with wide neck during the period of follow-up.
1 Service de Chirurgie Cardiothoracique et Vasculaire, CHU de Rennes, Rennes, France. 2
INSERM, U1099, Rennes, France.
3
Laboratoire de Traitement du Signal et de l’Image (LTSI), Universite de Rennes 1, Rennes, France. 4
Service de Chirurgie Cardiovasculaire, Centre Hospitalier Universitaire Le Bocage, CHU Le Bocage, Dijon, France. 5 Service de Chirurgie Vasculaire, l’Institut du Thorax, CHU Nantes, Nantes, France.
1416
6 Service de Chirurgie Vasculaire, APHM, H^opital de la Timone, Universite d’Aix-Marseille, Marseille, France.
Correspondence to: Adrien Kaladji, MD, Service de Chirurgie Cardiothoracique et Vasculaire, CHU de Rennes, Rennes 35033, France; E-mail: [email protected]
Ann Vasc Surg 2015; 29: 1416–1425 http://dx.doi.org/10.1016/j.avsg.2015.04.088 Ó 2015 Elsevier Inc. All rights reserved. Manuscript received: October 16, 2014; manuscript accepted: April 8, 2015; published online: July 10, 2015.
Vol. 29, No. 7, October 2015
INTRODUCTION During the surgical treatment of abdominal aortic aneurysms (AAAs), it is rare to implant prostheses above 24 mm in diameter. Endovascular aneurysm repair (EVAR) makes it possible to implant stent grafts up to 36 mm in diameter at the level of the proximal neck and up to 28 mm in diameter at the level of the distal neck, which correspond to potentially pathologic zones of anchoring. Several publications1e7 studied these wide necks, and most reported the occurrence of more endoleaks during the follow-up. With conventional aortic surgery, the diameter of the prostheses would not make it possible to treat such wide necks. As a matter of fact, in open surgery, the neck will adapt to the surgical sutures, whereas in EVAR, the surgeon must imperatively comply with the rules of sizing to avoid an endoleak. However, when implanting a stent graft measuring 36 mm in diameter, it is likely to face an advanced mechanism of destruction of the wall of the aneurysmal neck,8 which does nothing but delay the appearance of a juxtarenal aneurysm. Few publications were interested specifically in the results of wide stent grafts. The aim of this study was to compare the preoperative data and the immediate and long-term results between stent grafts with a proximal principal component > or 28 mm were strongly associated with the risk of growth of the sac, in connection with proximal endoleaks. Taking into account the results of EVAR for AAAs with wider necks, one could suggest treating these aneurysms like juxtarenal aneurysms that is with fenestrated stent grafts. It would be interesting to study the theoretical cost of using fenestrated stent grafts in all the patients requiring a stent graft larger than 32 mm compared with the cost of a standard stent graft and a reintervention for proximal endoleak based on a 13% risk as shown in our study. Such a study would obviously comprise many biases because fenestrated stent grafts are also exposed to the risk of reintervention. Zayed et al.17 already reported the results
Vol. 29, No. 7, October 2015
Large stent grafts to treat abdominal aortic aneurysms 1421
Fig. 3. Cumulative proportion of patients without reintervention in each group.
of large stent grafts with good results. However, the follow-up in this study was shorter (median of 6 months). However, the results must be balanced. Different evolutions were observed during the period of treatment of the patients. First, several generations of stent grafts were used. However, the results of the last generations of stent grafts have really improved.18 Suprarenal anchoring and the hooks made it possible to decrease the rates of stent-graft migration and of endoleak.19 The rate of regression of the sac was also better with the last generations of stent grafts.18,20e22 The design of the stent grafts and their radial force are probably at the origin of the improvement of these results including for large stent grafts. The preoperative sizing of the stent grafts also evolved considerably. Currently, the measurement of the diameters according to the central line is regarded as the gold standard.20e22 The
tools allowing this technique of measurement were not widely available and were not used at the beginning of the use of stent grafts. Even if the subgroup analyses appear to show the absence of difference over the time concerning oversizing, errors of measurement of the diameter contributed to the choice of stent grafts, which would not have been chosen with the currently available tools. We could not analyze all the preoperative CT scans on a sizing station and retrospectively evaluate if the choice of the stent graft would have been the same at the time when the patient was operated. Sobocinski et al.23 showed that the use of a 3-dimensional work station with central lines made it possible to decrease the rate of endoleak. In their study, the rate of proximal endoleak was almost 4 times higher in the patients treated before the use of this work station, which underlines the direct impact of preoperative measurements on the long-term
1422 Kaladji et al.
Annals of Vascular Surgery
Fig. 4. Cumulative proportion of surviving patients in each group.
complications of stent grafts. The subgroup analysis between the first and last 200 patients of the cohort confirms these results. We observed a reduction in the rate of proximal endoleak between the 2 periods, in favor of an improvement of the results linked to the learning curve, the diffusion and the more frequent use of the sizing tools, and the last generations of stent grafts. In spite of these factors, the reduction of the rate of endoleak is much lower for the group of the large stent grafts, which confirms a higher risk of endoleak. Many articles compared the methods of measurement because they could influence the choice of the device. Currently, the method of measurement according to the central line is practically not questioned, except possibly for the measures of length of the thoracic aorta.24 On the other hand, on a given cross section, the question of the choice of the minimal and/or maximum diameter or intern and/or extern can be posed. Most of the studies measure the diameters from adventitia to adventitia6,7,22,23 and the choice of the maximum
diameter was retained in the study of Sobocinski et al.,23 which was not always the case in former studies.25 The choice of the oversizing was also discussed. It was observed that a 30% oversizing exposed to the risk of migration25 and that a 20% oversizing of exposed to a risk of dilation of the proximal neck.26 Taking into account these observations, an oversizing between 15% and 20% for the rectilinear necks must be respected. On the other hand for the tapered necks, the question still remains discussed. In spite of these limits, other studies confirm our results indirectly. One meta-analysis5 reported a risk to develop a proximal endoleak 4 times higher in the presence of hostile necks, the latter being defined by nonrespect of the instructions for use given by the manufacturers.27,28 Most of the studies1,7,29,30 fixed the ‘‘hostile’’ neck according to a number of criteria including a proximal neck diameter above 28 mm. However, starting from 28 mm, the manufacturers propose compatible stent grafts respecting an oversizing of 20%, which poses the problem of the
Vol. 29, No. 7, October 2015
Large stent grafts to treat abdominal aortic aneurysms 1423
Fig. 5. Cumulative proportion of patients not presenting a proximal endoleak according to the oversizing.
Fig. 6. Cumulative proportion of patients without a proximal endoleak according to the centers.
definition of a hostile neck. In the study of Schanzer et al.,16 the threshold of 28 mm was found as a risk factor of proximal endoleak. Regarding the length of the neck, the literature is exhaustive. In the lastquoted study, the length of the neck was not a risk factor of aneurysmal growth. Other studies showed that necks between 10 and 15 mm in length had an acceptable risk of proximal endoleak.31 On the other hand, below this threshold, the risk seems important32 and chimney techniques or fenestrated stent grafts seem more secure.
CONCLUSIONS In this study, the use of a stent graft with a proximal diameter of at least 32 mm increased the risk of medium-term proximal endoleak and reintervention and should make discuss open surgery in the patients with a low or intermediate operative risk. However, no difference of mortality or evolution of the aneurysmal sac was observed for the patients treated by EVAR with a wide neck during the period of follow-up.
1424 Kaladji et al.
Annals of Vascular Surgery
Fig. 7. Cumulative proportion of patients without a proximal endoleak according to the length of the proximal neck.
REFERENCES 1. Aburahma AF, Campbell JE, Mousa AY, et al. Clinical outcomes for hostile versus favorable aortic neck anatomy in endovascular aortic aneurysm repair using modular devices. J Vasc Surg 2011;54:13e21. 2. Fairman RM, Velazquez OC, Carpenter JP, et al. Midterm pivotal trial results of the Talent Low Profile System for repair of abdominal aortic aneurysm: analysis of complicated versus uncomplicated aortic necks. J Vasc Surg 2004;40: 1074e82. 3. Fulton JJ, Farber MA, Sanchez LA, et al. Effect of challenging neck anatomy on mid-term migration rates in AneuRx endografts. J Vasc Surg 2006;44:932e7. discussion 937. 4. Georgiadis GS, Trellopoulos G, Antoniou GA, et al. Early results of the Endurant endograft system in patients with friendly and hostile infrarenal abdominal aortic aneurysm anatomy. J Vasc Surg 2011;54:616e27. 5. Antoniou GA, Georgiadis GS, Antoniou SA, et al. A metaanalysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg 2013;57:527e38. 6. Stather PW, Sayers RD, Cheah A, et al. Outcomes of endovascular aneurysm repair in patients with hostile neck anatomy. Eur J Vasc Endovasc Surg 2012;44: 556e61. 7. Stather PW, Wild JB, Sayers RD, et al. Endovascular aortic aneurysm repair in patients with hostile neck anatomy. J Endovasc Ther 2013;20:623e37. 8. Diehm N, Di Santo S, Schaffner T, et al. Severe structural damage of the seemingly non-diseased infrarenal aortic aneurysm neck. J Vasc Surg 2008;48:425e34. 9. Sonesson B, L€ anne T, Hansen F, et al. Infrarenal aortic diameter in the healthy person. Eur J Vasc Surg 1994;8:89e95. 10. Liddington MI, Heather BP. The relationship between aortic diameter and body habitus. Eur J Vasc Surg 1992;6:89e92. 11. Badran MF, Gould DA, Raza I, et al. Aneurysm neck diameter after endovascular repair of abdominal aortic aneurysms. J Vasc Interv Radiol 2002;13(9 Pt 1): 887e92. 12. Napoli V, Sardella SG, Bargellini I, et al. Evaluation of the proximal aortic neck enlargement following endovascular
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
repair of abdominal aortic aneurysm: 3-years experience. Eur Radiol 2003;13:1962e71. Rodway AD, Powell JT, Brown LC, et al. Do abdominal aortic aneurysm necks increase in size faster after endovascular than open repair? Eur J Vasc Endovasc Surg 2008;35: 685e93. Soberon AB, de Garcia MM, Moll GG, et al. Follow-up of aneurysm neck diameter after endovascular repair of abdominal aortic aneurysms. Ann Vasc Surg 2008;22: 559e63. Kaladji A, Cardon A, Laviolle B, et al. Evolution of the upper and lower landing site after endovascular aortic aneurysm repair. J Vasc Surg 2012;55:24e32. Schanzer A, Greenberg RK, Hevelone N, et al. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation 2011;123:2848e55. Zayed HA, Bell RE, Clough RE, et al. Results of endovascular repair of abdominal aortic aneurysms with an unfavorable proximal neck using large stent-grafts. Cardiovasc Intervent Radiol 2009;32:1161e4. Cieri E, De Rango P, Isernia G, et al. Effect of stentgraft model on aneurysm shrinkage in 1,450 endovascular aortic repairs. Eur J Vasc Endovasc Surg 2013;46:192e200. Pintoux D, Chaillou P, Azema L, et al. Long-term influence of suprarenal or infrarenal fixation on proximal neck dilatation and stentgraft migration after EVAR. Ann Vasc Surg 2011;25:1012e9. Aziz I, Lee J, Lee JT, et al. Accuracy of three-dimensional simulation in the sizing of aortic endoluminal devices. Ann Vasc Surg 2003;17:129e36. Isokangas JM, Hietala R, Perala J, et al. Accuracy of computer-aided measurements in endovascular stent-graft planning: an experimental study with two phantoms. Invest Radiol 2003;38:164e70. Kaladji A, Lucas A, Kervio G, et al. Sizing for endovascular aneurysm repair: clinical evaluation of a new automated three-dimensional software. Ann Vasc Surg 2010;24: 912e20. Sobocinski J, Chenorhokian H, Maurel B, et al. The benefits of EVAR planning using a 3D workstation. Eur J Vasc Endovasc Surg 2013;46:418e23. Kaladji A, Spear R, Hertault A, et al. Centerline is not as accurate as outer curvature length to estimate thoracic endograft length. Eur J Vasc Endovasc Surg 2013;46:82e6.
Vol. 29, No. 7, October 2015
25. Sternbergh WC 3rd, Money SR, Greenberg RK, et al., for the Zenith Investigators. Influence of endograft oversizing on device migration, endoleak, aneurysm shrinkage, and aortic neck dilation: results from the Zenith multicenter trial. J Vasc Surg 2005;29:20e6. 26. Conners MS III, Sternbergh WC 3rd, Carter G, et al. Endograft migration 1-4 years after endovascular AAA repair with the AneuRx device: a cautionary note. J Vasc Surg 2002;36: 476e84. 27. Abbruzzese TA, Kwolek CJ, Brewster DC, et al. Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis. J Vasc Surg 2008;48:19e28. 28. Torsello G, Troisi N, Donas KP, et al. Evaluation of the Endurant stent graft under instructions for use vs off-label conditions for endovascular aortic aneurysm repair. J Vasc Surg 2011;54:300e6.
Large stent grafts to treat abdominal aortic aneurysms 1425
29. Choke E, Munneke G, Morgan R, et al. Outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile neck anatomy. Cardiovasc Intervent Radiol 2006;29:975e80. 30. Hoshina K, Kato M, Hosaka A, et al. Middle-term results of endovascular aneurysm repair in Japan: does intraoperative endovascular management against the hostile aneurysmal neck prevent the proximal type I endoleak? Int Angiol 2011;30:467e73. 31. AbuRahma AF, Campbell J, Stone PA, et al. The correlation of aortic neck length to early and late outcomes in endovascular aneurysm repair patients. J Vasc Surg 2009;50: 738e48. 32. Bastos Goncalves F, Hoeks SE, Teijink JA, et al. Risk factors for proximal neck complications after endovascular aneurysm repair using the endurant stentgraft. Eur J Vasc Endovasc Surg 2015;49:156e62.
Background: Open surgery and endovascular treatment are currently the 2 methods of treatment for abdominal aortic aneurysms (AAAs). Although in open surgery, the proximal diameter of the implanted prostheses seldom exceeds 24 mm, endovascular aneurysm repair (EVAR) makes it possible to use stent grafts up to 36 mm in diameter. The aim of this study was to compare the long-term results of these large stent grafts compared with the others. Methods: A total of 908 patients operated between 1998 and 2012 for a nonruptured AAA with an infrarenal stent graft were enrolled in this multicentric retrospective study. The patients in whom the proximal diameter of the principal component of the stent graft was above 32 mm belonged to group 1 (n ¼ 170) and the others belonged to group 2 (n ¼ 738). The qualitative and quantitative data were compared with the chi-squared test and the t-test, respectively. The long-term data were analyzed with the log-rank test and KaplaneMeier curves. Results: Mean age of the patients was 75 ± 8.3 years, and the average follow-up duration was 38 ± 28.2 months. There was no difference between the 2 groups regarding demographic data, risk factors except chronic renal insufficiency (30.6% in group 1 vs. 21.2%, P ¼ 0.011), and the proportion of obese patients (26.2% vs. 17.7%, P ¼ 0.02). Concerning the preoperative anatomic features, there was a significant difference between the groups concerning the length of the neck (25.5 ± 10.1 vs. 28.3 ± 12.6 mm, P ¼ 0.008), the maximum diameter of the AAA (58 ± 10.1 vs. 56.1 ± 10.1 mm, P ¼ 0.027), and the oversizing (18.1 ± 8.3% in group 1 vs. 16.8 ± 7.4% in group 2, P ¼ 0.043). There was no difference of the postoperative rates of complications, technical failure, endoleaks, and death. In the long run, analyses of survival showed that the rates of proximal endoleaks (13% vs. 3.9%, P < 0.0001) and of reintervention (24.1% vs. 14.7%, P ¼ 0.009) were higher in group 1. There was no significant difference between the 2 groups regarding the evolution of the aneurysmal sac, the long-term rate of death from all causes or in relation to the aneurysm. Conclusions: Our results suggest that large stent grafts are more at the risk of proximal endoleak and reintervention in the long run. However, there were no differences observed in mortality or evolution of the aneurysmal sac in the patients treated by EVAR with wide neck during the period of follow-up.
1 Service de Chirurgie Cardiothoracique et Vasculaire, CHU de Rennes, Rennes, France. 2
INSERM, U1099, Rennes, France.
3
Laboratoire de Traitement du Signal et de l’Image (LTSI), Universite de Rennes 1, Rennes, France. 4
Service de Chirurgie Cardiovasculaire, Centre Hospitalier Universitaire Le Bocage, CHU Le Bocage, Dijon, France. 5 Service de Chirurgie Vasculaire, l’Institut du Thorax, CHU Nantes, Nantes, France.
1416
6 Service de Chirurgie Vasculaire, APHM, H^opital de la Timone, Universite d’Aix-Marseille, Marseille, France.
Correspondence to: Adrien Kaladji, MD, Service de Chirurgie Cardiothoracique et Vasculaire, CHU de Rennes, Rennes 35033, France; E-mail: [email protected]
Ann Vasc Surg 2015; 29: 1416–1425 http://dx.doi.org/10.1016/j.avsg.2015.04.088 Ó 2015 Elsevier Inc. All rights reserved. Manuscript received: October 16, 2014; manuscript accepted: April 8, 2015; published online: July 10, 2015.
Vol. 29, No. 7, October 2015
INTRODUCTION During the surgical treatment of abdominal aortic aneurysms (AAAs), it is rare to implant prostheses above 24 mm in diameter. Endovascular aneurysm repair (EVAR) makes it possible to implant stent grafts up to 36 mm in diameter at the level of the proximal neck and up to 28 mm in diameter at the level of the distal neck, which correspond to potentially pathologic zones of anchoring. Several publications1e7 studied these wide necks, and most reported the occurrence of more endoleaks during the follow-up. With conventional aortic surgery, the diameter of the prostheses would not make it possible to treat such wide necks. As a matter of fact, in open surgery, the neck will adapt to the surgical sutures, whereas in EVAR, the surgeon must imperatively comply with the rules of sizing to avoid an endoleak. However, when implanting a stent graft measuring 36 mm in diameter, it is likely to face an advanced mechanism of destruction of the wall of the aneurysmal neck,8 which does nothing but delay the appearance of a juxtarenal aneurysm. Few publications were interested specifically in the results of wide stent grafts. The aim of this study was to compare the preoperative data and the immediate and long-term results between stent grafts with a proximal principal component > or 28 mm were strongly associated with the risk of growth of the sac, in connection with proximal endoleaks. Taking into account the results of EVAR for AAAs with wider necks, one could suggest treating these aneurysms like juxtarenal aneurysms that is with fenestrated stent grafts. It would be interesting to study the theoretical cost of using fenestrated stent grafts in all the patients requiring a stent graft larger than 32 mm compared with the cost of a standard stent graft and a reintervention for proximal endoleak based on a 13% risk as shown in our study. Such a study would obviously comprise many biases because fenestrated stent grafts are also exposed to the risk of reintervention. Zayed et al.17 already reported the results
Vol. 29, No. 7, October 2015
Large stent grafts to treat abdominal aortic aneurysms 1421
Fig. 3. Cumulative proportion of patients without reintervention in each group.
of large stent grafts with good results. However, the follow-up in this study was shorter (median of 6 months). However, the results must be balanced. Different evolutions were observed during the period of treatment of the patients. First, several generations of stent grafts were used. However, the results of the last generations of stent grafts have really improved.18 Suprarenal anchoring and the hooks made it possible to decrease the rates of stent-graft migration and of endoleak.19 The rate of regression of the sac was also better with the last generations of stent grafts.18,20e22 The design of the stent grafts and their radial force are probably at the origin of the improvement of these results including for large stent grafts. The preoperative sizing of the stent grafts also evolved considerably. Currently, the measurement of the diameters according to the central line is regarded as the gold standard.20e22 The
tools allowing this technique of measurement were not widely available and were not used at the beginning of the use of stent grafts. Even if the subgroup analyses appear to show the absence of difference over the time concerning oversizing, errors of measurement of the diameter contributed to the choice of stent grafts, which would not have been chosen with the currently available tools. We could not analyze all the preoperative CT scans on a sizing station and retrospectively evaluate if the choice of the stent graft would have been the same at the time when the patient was operated. Sobocinski et al.23 showed that the use of a 3-dimensional work station with central lines made it possible to decrease the rate of endoleak. In their study, the rate of proximal endoleak was almost 4 times higher in the patients treated before the use of this work station, which underlines the direct impact of preoperative measurements on the long-term
1422 Kaladji et al.
Annals of Vascular Surgery
Fig. 4. Cumulative proportion of surviving patients in each group.
complications of stent grafts. The subgroup analysis between the first and last 200 patients of the cohort confirms these results. We observed a reduction in the rate of proximal endoleak between the 2 periods, in favor of an improvement of the results linked to the learning curve, the diffusion and the more frequent use of the sizing tools, and the last generations of stent grafts. In spite of these factors, the reduction of the rate of endoleak is much lower for the group of the large stent grafts, which confirms a higher risk of endoleak. Many articles compared the methods of measurement because they could influence the choice of the device. Currently, the method of measurement according to the central line is practically not questioned, except possibly for the measures of length of the thoracic aorta.24 On the other hand, on a given cross section, the question of the choice of the minimal and/or maximum diameter or intern and/or extern can be posed. Most of the studies measure the diameters from adventitia to adventitia6,7,22,23 and the choice of the maximum
diameter was retained in the study of Sobocinski et al.,23 which was not always the case in former studies.25 The choice of the oversizing was also discussed. It was observed that a 30% oversizing exposed to the risk of migration25 and that a 20% oversizing of exposed to a risk of dilation of the proximal neck.26 Taking into account these observations, an oversizing between 15% and 20% for the rectilinear necks must be respected. On the other hand for the tapered necks, the question still remains discussed. In spite of these limits, other studies confirm our results indirectly. One meta-analysis5 reported a risk to develop a proximal endoleak 4 times higher in the presence of hostile necks, the latter being defined by nonrespect of the instructions for use given by the manufacturers.27,28 Most of the studies1,7,29,30 fixed the ‘‘hostile’’ neck according to a number of criteria including a proximal neck diameter above 28 mm. However, starting from 28 mm, the manufacturers propose compatible stent grafts respecting an oversizing of 20%, which poses the problem of the
Vol. 29, No. 7, October 2015
Large stent grafts to treat abdominal aortic aneurysms 1423
Fig. 5. Cumulative proportion of patients not presenting a proximal endoleak according to the oversizing.
Fig. 6. Cumulative proportion of patients without a proximal endoleak according to the centers.
definition of a hostile neck. In the study of Schanzer et al.,16 the threshold of 28 mm was found as a risk factor of proximal endoleak. Regarding the length of the neck, the literature is exhaustive. In the lastquoted study, the length of the neck was not a risk factor of aneurysmal growth. Other studies showed that necks between 10 and 15 mm in length had an acceptable risk of proximal endoleak.31 On the other hand, below this threshold, the risk seems important32 and chimney techniques or fenestrated stent grafts seem more secure.
CONCLUSIONS In this study, the use of a stent graft with a proximal diameter of at least 32 mm increased the risk of medium-term proximal endoleak and reintervention and should make discuss open surgery in the patients with a low or intermediate operative risk. However, no difference of mortality or evolution of the aneurysmal sac was observed for the patients treated by EVAR with a wide neck during the period of follow-up.
1424 Kaladji et al.
Annals of Vascular Surgery
Fig. 7. Cumulative proportion of patients without a proximal endoleak according to the length of the proximal neck.
REFERENCES 1. Aburahma AF, Campbell JE, Mousa AY, et al. Clinical outcomes for hostile versus favorable aortic neck anatomy in endovascular aortic aneurysm repair using modular devices. J Vasc Surg 2011;54:13e21. 2. Fairman RM, Velazquez OC, Carpenter JP, et al. Midterm pivotal trial results of the Talent Low Profile System for repair of abdominal aortic aneurysm: analysis of complicated versus uncomplicated aortic necks. J Vasc Surg 2004;40: 1074e82. 3. Fulton JJ, Farber MA, Sanchez LA, et al. Effect of challenging neck anatomy on mid-term migration rates in AneuRx endografts. J Vasc Surg 2006;44:932e7. discussion 937. 4. Georgiadis GS, Trellopoulos G, Antoniou GA, et al. Early results of the Endurant endograft system in patients with friendly and hostile infrarenal abdominal aortic aneurysm anatomy. J Vasc Surg 2011;54:616e27. 5. Antoniou GA, Georgiadis GS, Antoniou SA, et al. A metaanalysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg 2013;57:527e38. 6. Stather PW, Sayers RD, Cheah A, et al. Outcomes of endovascular aneurysm repair in patients with hostile neck anatomy. Eur J Vasc Endovasc Surg 2012;44: 556e61. 7. Stather PW, Wild JB, Sayers RD, et al. Endovascular aortic aneurysm repair in patients with hostile neck anatomy. J Endovasc Ther 2013;20:623e37. 8. Diehm N, Di Santo S, Schaffner T, et al. Severe structural damage of the seemingly non-diseased infrarenal aortic aneurysm neck. J Vasc Surg 2008;48:425e34. 9. Sonesson B, L€ anne T, Hansen F, et al. Infrarenal aortic diameter in the healthy person. Eur J Vasc Surg 1994;8:89e95. 10. Liddington MI, Heather BP. The relationship between aortic diameter and body habitus. Eur J Vasc Surg 1992;6:89e92. 11. Badran MF, Gould DA, Raza I, et al. Aneurysm neck diameter after endovascular repair of abdominal aortic aneurysms. J Vasc Interv Radiol 2002;13(9 Pt 1): 887e92. 12. Napoli V, Sardella SG, Bargellini I, et al. Evaluation of the proximal aortic neck enlargement following endovascular
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
repair of abdominal aortic aneurysm: 3-years experience. Eur Radiol 2003;13:1962e71. Rodway AD, Powell JT, Brown LC, et al. Do abdominal aortic aneurysm necks increase in size faster after endovascular than open repair? Eur J Vasc Endovasc Surg 2008;35: 685e93. Soberon AB, de Garcia MM, Moll GG, et al. Follow-up of aneurysm neck diameter after endovascular repair of abdominal aortic aneurysms. Ann Vasc Surg 2008;22: 559e63. Kaladji A, Cardon A, Laviolle B, et al. Evolution of the upper and lower landing site after endovascular aortic aneurysm repair. J Vasc Surg 2012;55:24e32. Schanzer A, Greenberg RK, Hevelone N, et al. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation 2011;123:2848e55. Zayed HA, Bell RE, Clough RE, et al. Results of endovascular repair of abdominal aortic aneurysms with an unfavorable proximal neck using large stent-grafts. Cardiovasc Intervent Radiol 2009;32:1161e4. Cieri E, De Rango P, Isernia G, et al. Effect of stentgraft model on aneurysm shrinkage in 1,450 endovascular aortic repairs. Eur J Vasc Endovasc Surg 2013;46:192e200. Pintoux D, Chaillou P, Azema L, et al. Long-term influence of suprarenal or infrarenal fixation on proximal neck dilatation and stentgraft migration after EVAR. Ann Vasc Surg 2011;25:1012e9. Aziz I, Lee J, Lee JT, et al. Accuracy of three-dimensional simulation in the sizing of aortic endoluminal devices. Ann Vasc Surg 2003;17:129e36. Isokangas JM, Hietala R, Perala J, et al. Accuracy of computer-aided measurements in endovascular stent-graft planning: an experimental study with two phantoms. Invest Radiol 2003;38:164e70. Kaladji A, Lucas A, Kervio G, et al. Sizing for endovascular aneurysm repair: clinical evaluation of a new automated three-dimensional software. Ann Vasc Surg 2010;24: 912e20. Sobocinski J, Chenorhokian H, Maurel B, et al. The benefits of EVAR planning using a 3D workstation. Eur J Vasc Endovasc Surg 2013;46:418e23. Kaladji A, Spear R, Hertault A, et al. Centerline is not as accurate as outer curvature length to estimate thoracic endograft length. Eur J Vasc Endovasc Surg 2013;46:82e6.
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25. Sternbergh WC 3rd, Money SR, Greenberg RK, et al., for the Zenith Investigators. Influence of endograft oversizing on device migration, endoleak, aneurysm shrinkage, and aortic neck dilation: results from the Zenith multicenter trial. J Vasc Surg 2005;29:20e6. 26. Conners MS III, Sternbergh WC 3rd, Carter G, et al. Endograft migration 1-4 years after endovascular AAA repair with the AneuRx device: a cautionary note. J Vasc Surg 2002;36: 476e84. 27. Abbruzzese TA, Kwolek CJ, Brewster DC, et al. Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis. J Vasc Surg 2008;48:19e28. 28. Torsello G, Troisi N, Donas KP, et al. Evaluation of the Endurant stent graft under instructions for use vs off-label conditions for endovascular aortic aneurysm repair. J Vasc Surg 2011;54:300e6.
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29. Choke E, Munneke G, Morgan R, et al. Outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile neck anatomy. Cardiovasc Intervent Radiol 2006;29:975e80. 30. Hoshina K, Kato M, Hosaka A, et al. Middle-term results of endovascular aneurysm repair in Japan: does intraoperative endovascular management against the hostile aneurysmal neck prevent the proximal type I endoleak? Int Angiol 2011;30:467e73. 31. AbuRahma AF, Campbell J, Stone PA, et al. The correlation of aortic neck length to early and late outcomes in endovascular aneurysm repair patients. J Vasc Surg 2009;50: 738e48. 32. Bastos Goncalves F, Hoeks SE, Teijink JA, et al. Risk factors for proximal neck complications after endovascular aneurysm repair using the endurant stentgraft. Eur J Vasc Endovasc Surg 2015;49:156e62.
