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1. Long-term chimney/snorkel endovascular aortic aneurysm repair experience for complex abdominal aortic pathologies within the PERICLES registry.

Author

Taneva GT, Lee JT, Tran K, Dalman R, Torsello G, Fazzini S, Veith FJ, and Donas KP

Subjects
Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Blood Vessel Prosthesis, Female, Humans, Male, Middle Aged, Postoperative Complications mortality, Postoperative Complications surgery, Registries, Reoperation, Retrospective Studies, Risk Factors, Stents, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Endovascular Procedures mortality
Abstract

Objective: The early and short-term efficacy of the snorkel/chimney technique for endovascular aortic aneurysm repair (ch-EVAR) have been previously reported. However, long-term ch-EVAR performance, vessel patency, and patient survival remain unknown. Our study evaluated the late outcomes to identify possible predictors of failure within the PERICLES (performance of the chimney technique for the treatment of complex aortic pathologies) registry., Methods: Clinical and radiographic data from patients who had undergone ch-EVAR from 2008 to 2014 in the PERICLES registry were updated with an extension of the follow-up. Regression models were used to evaluate the relevant anatomic and operative characteristics as factors influencing the late results. We focused on patients with ≥30 months of follow-up (mean, 46.6 months; range, 30-120 months)., Results: A total of 517 patients from the initial PERICLES registry were included in the present analysis, from which the mean follow-up was updated from 17.1 months to 28.2 months (range, 1-120 months). All-cause mortality at the latest follow-up was 25.5% (n = 132), with an estimated patient survival of 87.6%, 74.4%, and 66.1% at 1, 3, and 5 years, respectively. A subgroup of 244 patients with 387 chimney grafts placed (335 renal arteries, 42 superior mesenteric arteries, 10 celiac arteries) and follow-up for ≥30 months was used to analyze specific anatomic and device predictors of adverse events. In the subgroup, the technical success was 88.9%, and the primary patency was 94%, 92.8%, 92%, and 90.5% at 2.5, 3, 4, and 5 years, respectively. The mean aneurysm sac regression was 7.8 ± 11.4 mm (P < .0001). Chimney graft occlusion had occurred in 24 target vessels (6.2%). Late open conversion was required in 5 patients for endograft infection in 2, persistent type Ia endoleak in 2, and endotension in 1 patient. The absence of an infrarenal neck (odds ratio, 2.86; 95% confidence interval, 1.32-6.19; P = .007) was significantly associated with long-term device-related complications. A sealing zone diameter >30 mm was significantly associated with persistent or late type Ia endoleak (odds ratio, 4.86; 95% confidence interval, 1.42-16.59; P = .012)., Conclusions: The present analysis of the PERICLES registry has provided the missing long-term experience for the ch-EVAR technique, showing favorable results with more than one half of the patients surviving for >5 years and a chimney graft branch vessel patency of 92%. The absence of an infrarenal neck and treatment with a sealing zone diameter >30 mm were the main anatomic long-term limits of the technique, requiring adequate preoperative planning and determination of the appropriate indication., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Published
2021
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2. Snorkel/chimney and fenestrated endografts for complex abdominal aortic aneurysms.

Author

Ullery BW, Lee JT, and Dalman RL

Subjects
Aortic Aneurysm, Abdominal diagnostic imaging, Aortography, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Humans, Prosthesis Design, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
Abstract

Complex endovascular aneurysm repair (EVAR) involves extension of the proximal aortic seal zone with preservation of branch vessel patency, thereby expanding the applicability of endografting from the infrarenal to the suprarenal aorta. Snorkel/chimney (Sn-EVAR) and fenestrated EVAR (f-EVAR) serve as the two most commonly utilized advanced endovascular techniques to combat hostile proximal neck anatomy. The purpose of this article is to describe the principles and evolution of these advanced endovascular strategies, technical considerations, and results of sn- and f-EVAR in the management of challenging neck anatomy in abdominal aortic aneurysm disease.

Published
2015

3. EVAR deployment in anatomically challenging necks outside the IFU.

Author

Lee JT, Ullery BW, Zarins CK, Olcott C 4th, Harris EJ Jr, and Dalman RL

Subjects
Aged, Aged, 80 and over, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation methods, Female, Follow-Up Studies, Humans, Male, Middle Aged, Retrospective Studies, Aortic Aneurysm, Abdominal pathology, Aortic Aneurysm, Abdominal surgery, Endovascular Procedures standards
Abstract

Objective: Treatment of abdominal aortic aneurysms with high-risk anatomy (neck length <10-15 mm, neck angle >60°) using commercially available devices has become increasingly common with expanding institutional experience. We examined whether placement of approved devices in short angled necks provides acceptable durability at early and intermediate time points., Methods: A total of 218 patients (197 men, 21 women) at a single academic center underwent endovascular aneurysm repair (EVAR) with a commercially available device between January 2004 and December 2007. Available medical records, pre- and postoperative imaging, and clinical follow-up were retrospectively reviewed. Patients were divided into those with suitable anatomy (instructions for use, IFU) for EVAR and those with high-risk anatomic aneurysm characteristics (non-IFU)., Results: IFU (n = 143) patients underwent repair with Excluder (40%), AneuRx (34%), and Zenith (26%) devices, whereas non-IFU (n = 75) were preferentially treated with Zenith (57%) over Excluder (25%) and AneuRx (17%). Demographics and medical comorbidities between the groups were similar. Operative mortality was 1.4% (2.1% IFU, 0% non-IFU) with mean follow-up of 35 months (range 12-72). Non-IFU patients tended to have larger sac diameters (46.7% ≥60 mm) with shorter (30.7% ≤10 mm), conical (49.3%), and more angled (68% >60°) necks (all p < .05 compared with IFU patients). Operative characteristics revealed that the non-IFU patients were more likely to be treated utilizing suprarenal fixation devices, to require placement of proximal cuffs (13.3% vs. 2.1%, p = .003), and needed increased fluoroscopy time (31 vs. 25 minutes, p = .02). Contrast dose was similar between groups (IFU = 118 mL, non-IFU = 119 mL, p = .95). There were no early or late surgical conversions. Rates of migration, endoleak, need for reintervention, sac regression, and freedom from aneurysm-related death were similar between the groups (p > .05)., Conclusions: EVAR may be performed safely in high-risk patients with unfavorable neck anatomy using particular commercially available endografts. In our experience, the preferential use of active suprarenal fixation and aggressive use of proximal cuffs is associated with optimal results in these settings. Mid-term outcomes are comparable with those achieved in patients with suitable anatomy using a similar range of EVAR devices. Careful and mandatory long-term follow-up will be necessary to confirm the benefit of treating these high-risk anatomic patients., (Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Published
2013
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4. Collected World Experience About the Performance of the Snorkel/Chimney Endovascular Technique in the Treatment of Complex Aortic Pathologies

Author

Donas, K. P., Lee, J. T., Lachat, M., Torsello, G., Veith, F. J., Dalman, R. L., Tran, K., Pecoraro, F., Bisdas, T., Seifert, S., Esche, M., Gasparini, D., Frigatti, P., Adovasio, R., Mucelli, F. P., Damrauer, S. M., Woo, E. Y., Beck, A., Scali, S., Minion, D., Salenius, J., Suominen, V., Mangialardi, N., Ronchey, S., Fazzini, S., Mestres, G., Riambau, V., Mosquera, N. J., Donas, K., Lee, J., Lachat, M., Torsello, G., Veith, F., Dalman, R., Tran, K., and Pecoraro, F.

Subjects
Registrie, Male, medicine.medical_treatment, Kaplan-Meier Estimate, Global Health, Settore MED/22 - Chirurgia Vascolare, Severity of Illness Index, Endovascular aneurysm repair, Aortic aneurysm, Retrospective Studie, Stent, Registries, Abdominal aortic aneurysm, Endovascular, Fenestrated, Thoracoabdominal, Vascular, Aortic Aneurysm, Abdominal, Aortography, Blood Vessel Prosthesis Implantation, Endovascular Procedures, Europe, Female, Follow-Up Studies, Humans, Prosthesis Design, Prosthesis Failure, Retrospective Studies, Risk Assessment, Stents, Survival Rate, Treatment Outcome, United States, Blood Vessel Prosthesis, medicine.diagnostic_test, Medicine (all), Aortic Aneurysm, Blood Vessel Prosthesi, Human, United State, medicine.medical_specialty, Follow-Up Studie, Blood vessel prosthesis, medicine, Abdominal, Survival rate, Endovascular Procedure, business.industry, Retrospective cohort study, medicine.disease, Surgery, business, Abdominal surgery
Abstract

OBJECTIVES: We sought to analyze the collected worldwide experience with use of snorkel/chimney endovascular aneurysm repair (EVAR) for complex abdominal aneurysm treatment. BACKGROUND: EVAR has largely replaced open surgery worldwide for anatomically suitable aortic aneurysms. Lack of availability of fenestrated and branched devices has encouraged an alternative strategy utilizing parallel or snorkel/chimney grafts (ch-EVAR). METHODS: Clinical and radiographic information was retrospectively reviewed and analyzed on 517 patients treated by ch-EVAR from 2008 from 2014 by prearranged defined and documented protocols. RESULTS: A total of 119 patients in US centers and 398 in European centers were treated during the study period. US centers preferentially used Zenith stent-grafts (54.2%) and European centers Endurant stent-grafts (62.2%) for the main body component. Overall 898 chimney grafts (49.2% balloon expandable, 39.6% self-expanding covered stents, and 11.2% balloon expandable bare metal stents) were placed in 692 renal arteries, 156 superior mesenteric arteries (SMA), and 50 celiac arteries. At a mean follow-up of 17.1 months (range: 1-70 months), primary patency was 94%, with secondary patency of 95.3%. Overall survival of patients in this high-risk cohort for open repair at latest follow-up was 79%. CONCLUSIONS: This global experience represents the largest series in the ch-EVAR literature and demonstrates comparable outcomes to those in published reports of branched/fenestrated devices, suggesting the appropriateness of broader applicability and the need for continued careful surveillance. These results support ch-EVAR as a valid off-the-shelf and immediately available alternative in the treatment of complex abdominal EVAR and provide impetus for the standardization of these techniques in the future.

Published
2015
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5. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years

Author

Powell, JT, Sweeting, MJ, Ulug, P, Blankensteijn, JD, Lederle, FA, Becquemin, J-P, Greenhalgh, RM, Beard, JD, Buxton, MJ, Brown, LC, Harris, PL, Rose, JDG, Russell, IT, Sculpher, MJ, Thompson, SG, Lilford, RJ, Bell, PRF, Whitaker, SC, Poole-Wilson, PA, Ruckley, CV, Campbell, WB, Dean, MRE, Ruttley, MST, Coles, EC, Halliday, A, Gibbs, SJ, Epstein, D, Hannon, RJ, Johnston, L, Bradbury, AW, Henderson, MJ, Parvin, SD, Shepherd, DFC, Mitchell, AW, Edwards, PR, Abbott, GT, Higman, DJ, Vohra, A, Ashley, S, Robottom, C, Wyatt, MG, Byrne, D, Edwards, R, Leiberman, DP, McCarter, DH, Taylor, PR, Reidy, JF, Wilkinson, AR, Ettles, DF, Clason, AE, Leen, GLS, Wilson, NV, Downes, M, Walker, SR, Lavelle, JM, Gough, MJ, McPherson, S, Scott, DJA, Kessell, DO, Naylor, R, Sayers, R, Fishwick, NG, Gould, DA, Walker, MG, Chalmers, NC, Garnham, A, Collins, MA, Gaines, PA, Ashour, MY, Uberoi, R, Braithwaite, B, Davies, JN, Travis, S, Hamilton, G, Platts, A, Shandall, A, Sullivan, BA, Sobeh, M, Matson, M, Fox, AD, Orme, R, Yusef, W, Doyle, T, Horrocks, M, Hardman, J, Blair, PHB, Ellis, PK, Morris, G, Odurny, A, Vohra, R, Duddy, M, Thompson, M, Loosemore, TML, Belli, AM, Morgan, R, Adiseshiah, M, Brookes, JAS, McCollum, CN, Ashleigh, R, Aukett, M, Baker, S, Barbe, E, Batson, N, Bell, J, Blundell, J, Boardley, D, Boyes, S, Brown, O, Bryce, J, Carmichael, M, Chance, T, Coleman, J, Cosgrove, C, Curran, G, Dennison, T, Devine, C, Dewhirst, N, Errington, B, Farrell, H, Fisher, C, Fulford, P, Gough, M, Graham, C, Hooper, R, Horne, G, Horrocks, L, Hughes, B, Hutchings, T, Ireland, M, Judge, C, Kelly, L, Kemp, J, Kite, A, Kivela, M, Lapworth, M, Lee, C, Linekar, L, Mahmood, A, March, L, Martin, J, Matharu, N, McGuigen, K, Morris-Vincent, P, Murray, S, Murtagh, A, Owen, G, Ramoutar, V, Rippin, C, Rowley, J, Sinclair, J, Spencer, S, Taylor, V, Tomlinson, C, Ward, S, Wealleans, V, West, J, White, K, Williams, J, Wilson, L, Grobbee, DE, Bak, AAA, Buth, J, Pattynama, PM, Verhoeven, ELG, van Voorthuisen, AE, Balm, R, Cuypers, PWM, Prinssen, M, van Sambeek, MRHM, Baas, AF, Hunink, MG, van Engelshoven, JM, Jacobs, MJHM, de Mol, BAJM, van Bockel, JH, Reekers, J, Tielbeek, X, Wisselink, W, Boekema, N, Heuveling, LM, Sikking, I, de Bruin, JL, Buskens, E, Tielbeek, AV, Reekers, JA, Pattynama, P, Prins, T, van der Ham, AC, van der Velden, JJIM, van Sterkenburg, SMM, ten Haken, GB, Bruijninckx, CMA, van Overhagen, H, Tutein Nolthenius, RP, Hendriksz, TR, Teijink, JAW, Odink, HF, de Smet, AAEA, Vroegindeweij, D, van Loenhout, RMM, Rutten, MJ, Hamming, JF, Lampmann, LEH, Bender, MHM, Pasmans, H, Vahl, AC, de Vries, C, Mackaay, AJC, van Dortmont, LMC, van der Vliet, AJ, Schultze Kool, LJ, Boomsma, JHB, van Dop, HR, de Mol van Otterloo, JCA, de Rooij, TPW, Smits, TM, Yilmaz, EN, van den Berg, FG, Visser, MJT, van der Linden, E, Schurink, GWH, de Haan, M, Smeets, HJ, Stabel, P, van Elst, F, Poniewierski, J, Vermassen, FEG, Freischlag, JA, Kohler, TR, Latts, E, Matsumura, J, Padberg, FT, Kyriakides, TC, Swanson, KM, Guarino, P, Peduzzi, P, Antonelli, M, Cushing, C, Davis, E, Durant, L, Joyner, S, Kossack, A, LeGwin, M, McBride, V, O'Connor, T, Poulton, J, Stratton, S, Zellner, S, Snodgrass, AJ, Thornton, J, Haakenson, CM, Stroupe, KT, Jonk, Y, Hallett, JW, Hertzer, N, Towne, J, Katz, DA, Karrison, T, Matts, JP, Marottoli, R, Kasl, S, Mehta, R, Feldman, R, Farrell, W, Allore, H, Perry, E, Niederman, J, Randall, F, Zeman, M, Beckwith, D, O'Leary, TJ, Huang, GD, Bader, M, Ketteler, ER, Kingsley, DD, Marek, JM, Massen, RJ, Matteson, BD, Pitcher, JD, Langsfeld, M, Corson, JD, Goff, JM, Kasirajan, K, Paap, C, Robertson, DC, Salam, A, Veeraswamy, R, Milner, R, Guidot, J, Lal, BK, Busuttil, SJ, Lilly, MP, Braganza, M, Ellis, K, Patterson, MA, Jordan, WD, Whitley, D, Taylor, S, Passman, M, Kerns, D, Inman, C, Poirier, J, Ebaugh, J, Raffetto, J, Chew, D, Lathi, S, Owens, C, Hickson, K, Dosluoglu, HH, Eschberger, K, Kibbe, MR, Baraniewski, HM, Endo, M, Busman, A, Meadows, W, Evans, M, Giglia, JS, El Sayed, H, Reed, AB, Ruf, M, Ross, S, Jean-Claude, JM, Pinault, G, Kang, P, White, N, Eiseman, M, Jones, R, Timaran, CH, Modrall, JG, Welborn, MB, Lopez, J, Nguyen, T, Chacko, JKY, Granke, K, Vouyouka, AG, Olgren, E, Chand, P, Allende, B, Ranella, M, Yales, C, Whitehill, TA, Krupski, WC, Nehler, MR, Johnson, SP, Jones, DN, Strecker, P, Bhola, MA, Shortell, CK, Gray, JL, Lawson, JH, McCann, R, Sebastian, MW, Kistler Tetterton, J, Blackwell, C, Prinzo, PA, Lee, N, Cerveira, JJ, Zickler, RW, Hauck, KA, Berceli, SA, Lee, WA, Ozaki, CK, Nelson, PR, Irwin, AS, Baum, R, Aulivola, B, Rodriguez, H, Littooy, FN, Greisler, H, O'Sullivan, MT, Kougias, P, Lin, PH, Bush, RL, Guinn, G, Bechara, C, Cagiannos, C, Pisimisis, G, Barshes, N, Pillack, S, Guillory, B, Cikrit, D, Lalka, SG, Lemmon, G, Nachreiner, R, Rusomaroff, M, O'Brien, E, Cullen, JJ, Hoballah, J, Sharp, WJ, McCandless, JL, Beach, V, Minion, D, Schwarcz, TH, Kimbrough, J, Ashe, L, Rockich, A, Warner-Carpenter, J, Moursi, M, Eidt, JF, Brock, S, Bianchi, C, Bishop, V, Gordon, IL, Fujitani, R, Kubaska, SM, Behdad, M, Azadegan, R, Ma Agas, C, Zalecki, K, Hoch, JR, Carr, SC, Acher, C, Schwarze, M, Tefera, G, Mell, M, Dunlap, B, Rieder, J, Stuart, JM, Weiman, DS, Abul-Khoudoud, O, Garrett, HE, Walsh, SM, Wilson, KL, Seabrook, GR, Cambria, RA, Brown, KR, Lewis, BD, Framberg, S, Kallio, C, Barke, RA, Santilli, SM, d'Audiffret, AC, Oberle, N, Proebstle, C, Johnson, LL, Jacobowitz, GR, Cayne, N, Rockman, C, Adelman, M, Gagne, P, Nalbandian, M, Caropolo, LJ, Pipinos, II, Johanning, J, Lynch, T, DeSpiegelaere, H, Purviance, G, Zhou, W, Dalman, R, Lee, JT, Safadi, B, Coogan, SM, Wren, SM, Bahmani, DD, Maples, D, Thunen, S, Golden, MA, Mitchell, ME, Fairman, R, Reinhardt, S, Wilson, MA, Tzeng, E, Muluk, S, Peterson, NM, Foster, M, Edwards, J, Moneta, GL, Landry, G, Taylor, L, Yeager, R, Cannady, E, Treiman, G, Hatton-Ward, S, Salabsky, B, Kansal, N, Owens, E, Estes, M, Forbes, BA, Sobotta, C, Rapp, JH, Reilly, LM, Perez, SL, Yan, K, Sarkar, R, Dwyer, SS, Perez, S, Chong, K, Hatsukami, TS, Glickerman, DG, Sobel, M, Burdick, TS, Pedersen, K, Cleary, P, Back, M, Bandyk, D, Johnson, B, Shames, M, Reinhard, RL, Thomas, SC, Hunter, GC, Leon, LR, Westerband, A, Guerra, RJ, Riveros, M, Mills, JL, Hughes, JD, Escalante, AM, Psalms, SB, Day, NN, Macsata, R, Sidawy, A, Weiswasser, J, Arora, S, Jasper, BJ, Dardik, A, Gahtan, V, Muhs, BE, Sumpio, BE, Gusberg, RJ, Spector, M, Pollak, J, Aruny, J, Kelly, EL, Wong, J, Vasilas, P, Joncas, C, Gelabert, HA, DeVirgillio, C, Rigberg, DA, Cole, L, Marzelle, J, Sapoval, M, Favre, J-P, Watelet, J, Lermusiaux, P, Lepage, E, Hemery, F, Dolbeau, G, Hawajry, N, Cunin, P, Harris, P, Stockx, L, Chatellier, G, Mialhe, C, Fiessinger, J-N, Pagny, L, Kobeiter, H, Boissier, C, Lacroix, P, Ledru, F, Pinot, J-J, Deux, J-F, Tzvetkov, B, Duvaldestin, P, Jourdain, C, David, V, Enouf, D, Ady, N, Krimi, A, Boudjema, N, Jousset, Y, Enon, B, Blin, V, Picquet, J, L'Hoste, P, Thouveny, F, Borie, H, Kowarski, S, Pernes, J-M, Auguste, M, Desgranges, P, Allaire, E, Meaulle, P-Y, Chaix, D, Juliae, P, Fabiani, JN, Chevalier, P, Combes, M, Seguin, A, Belhomme, D, Baque, J, Pellerin, O, Favre, JP, Barral, X, Veyret, C, Peillon, C, Plissonier, D, Thomas, P, Clavier, E, Martinez, R, Bleuet, F, C, D, Verhoye, JP, Langanay, T, Heautot, JF, Koussa, M, Haulon, S, Halna, P, Destrieux, L, Lions, C, Wiloteaux, S, Beregi, JP, Bergeron, P, Patra, P, Costargent, A, Chaillou, P, D'Alicourt, A, Goueffic, Y, Cheysson, E, Parrot, A, Garance, P, Demon, A, Tyazi, A, Pillet, J-C, Lescalie, F, Tilly, G, Steinmetz, E, Favier, C, Brenot, R, Krause, D, Cercueil, JP, Vahdat, O, Sauer, M, Soula, P, Querian, A, Garcia, O, Levade, M, Colombier, D, Cardon, J-M, Joyeux, A, Borrelly, P, Dogas, G, Magnan, P-É, Branchereau, A, Bartoli, J-M, Hassen-Khodja, R, Batt, M, Planchard, P-F, Bouillanne, P-J, Haudebourg, P, Bayne, J, Gouny, P, Badra, A, Braesco, J, Nonent, M, Lucas, A, Cardon, A, Kerdiles, Y, Rolland, Y, Kassab, M, Brillu, C, Goubault, F, Tailboux, L, Darrieux, H, Briand, O, Maillard, J-C, Varty, K, Cousins, C, EVAR-1, DREAM, OVER and ACE Trialists, Surgery, ICaR - Ischemia and repair, ACS - Microcirculation, ACS - Atherosclerosis & ischemic syndromes, Halliday, A, Sweeting, Michael [0000-0003-0980-8965], Apollo - University of Cambridge Repository, and National Institute for Health Research

Subjects
Male, medicine.medical_treatment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 030204 cardiovascular system & hematology, Endovascular aneurysm repair, Medical and Health Sciences, law.invention, Aortic aneurysm, 0302 clinical medicine, Randomized controlled trial, DESIGN, law, Models, 80 and over, Multicenter Studies as Topic, 030212 general & internal medicine, Randomized Controlled Trials as Topic, RISK, Aged, 80 and over, Hazard ratio, Endovascular Procedures, DREAM, 11 Medical And Health Sciences, Statistical, Middle Aged, Corrigenda, Abdominal aortic aneurysm, Aortic Aneurysm, Treatment Outcome, CARDIOVASCULAR-DISEASE, Elective Surgical Procedures, Female, Reoperation, medicine.medical_specialty, and over, 03 medical and health sciences, Aneurysm, medicine, Journal Article, MANAGEMENT, Humans, Comparative Study, Abdominal, OVER and ACE Trialists, Aged, Models, Statistical, business.industry, MORTALITY, Odds ratio, medicine.disease, Surgery, Vascular Grafting, business, Abdominal surgery, Meta-Analysis, EVAR-1, Aortic Aneurysm, Abdominal
Abstract

Background The erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation. Methods An individual-patient data meta-analysis of four multicentre randomized trials of EVARversus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention. Results The analysis included 2783 patients, with 14 245 person-years of follow-up (median 5·5 years). Early (0–6 months after randomization) mortality was lower in the EVAR groups (46 of 1393 versus 73 of 1390 deaths; pooled hazard ratio 0·61, 95 per cent c.i. 0·42 to 0·89; P = 0·010), primarily because 30-day operative mortality was lower in the EVAR groups (16 deaths versus 40 for open repair; pooled odds ratio 0·40, 95 per cent c.i. 0·22 to 0·74). Later (within 3 years) the survival curves converged, remaining converged to 8 years. Beyond 3 years, aneurysm-related mortality was significantly higher in the EVAR groups (19 deaths versus 3 for open repair; pooled hazard ratio 5·16, 1·49 to 17·89; P = 0·010). Patients with moderate renal dysfunction or previous coronary artery disease had no early survival advantage under EVAR. Those with peripheral artery disease had lower mortality under open repair (39 deaths versus 62 for EVAR; P = 0·022) in the period from 6 months to 4 years after randomization. Conclusion The early survival advantage in the EVAR group, and its subsequent erosion, were confirmed. Over 5 years, patients of marginal fitness had no early survival advantage from EVAR compared with open repair. Aneurysm-related mortality and patients with low ankle : brachial pressure index contributed to the erosion of the early survival advantage for the EVAR group. Trial registration numbers: EVAR-1, ISRCTN55703451; DREAM (Dutch Randomized Endovascular Aneurysm Management), NCT00421330; ACE (Anévrysme de l'aorte abdominale, Chirurgie versus Endoprothèse), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575.

Published
2017
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