Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study

Roberto Silingardi, Pasqualino Sirignano, Francesco Andreoli, Wassim Mansour, Mattia Migliari, Francesco Speziale, LIVE Study Collaborators, Giancarlo Accarino, Dimitri Apostolou, Guido Bajardi, Stefano Bartoli, Filippo Benedetto, Franco Briolini, Stefano Camparini, Emidio Costantini, Giovanni Credi, Ruggiero Curci, Raffaello Dallatana, Gianmarco de Donato, Carlo Dionisi, Vittorio Dorrucci, Leonardo Ercolini, Gianfranco Fadda, Mauro Ferrari, Loris Flora, Andrea Gaggiano, Roberto Gattuso, Franco Grego, Sabrina Grimaldi, Giovanni Impedovo, Arnaldo Ippoliti, Antonio Jannello, Sergio Losa, Nicola Mangialardi, Isaac Martinez, Javier Martinez, Stefano Michelagnoli, Giancarlo Palasciano, Vincenzo Palazzo, Domenico Palombo, Raffaele Pulli, Sonia Ronchey, Giovanni Rossi, Antonino Scolaro, Gianantonio Simoni, Francesco Spinelli, Francesco Talarico, Maurizio Taurino, Marco Trogolo, Nicola Tusini, Gianfranco Veraldi, Pier Francesco Veroux, Gennaro Vigliotti, Pietro Volpe, Roberto Silingardi, Pasqualino Sirignano, Francesco Andreoli, Wassim Mansour, Mattia Migliari, Francesco Speziale, LIVE Study Collaborators, Giancarlo Accarino, Dimitri Apostolou, Guido Bajardi, Stefano Bartoli, Filippo Benedetto, Franco Briolini, Stefano Camparini, Emidio Costantini, Giovanni Credi, Ruggiero Curci, Raffaello Dallatana, Gianmarco de Donato, Carlo Dionisi, Vittorio Dorrucci, Leonardo Ercolini, Gianfranco Fadda, Mauro Ferrari, Loris Flora, Andrea Gaggiano, Roberto Gattuso, Franco Grego, Sabrina Grimaldi, Giovanni Impedovo, Arnaldo Ippoliti, Antonio Jannello, Sergio Losa, Nicola Mangialardi, Isaac Martinez, Javier Martinez, Stefano Michelagnoli, Giancarlo Palasciano, Vincenzo Palazzo, Domenico Palombo, Raffaele Pulli, Sonia Ronchey, Giovanni Rossi, Antonino Scolaro, Gianantonio Simoni, Francesco Spinelli, Francesco Talarico, Maurizio Taurino, Marco Trogolo, Nicola Tusini, Gianfranco Veraldi, Pier Francesco Veroux, Gennaro Vigliotti, Pietro Volpe

Abstract

Background: Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations.

Objective: The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients.

Methods: All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500.

Results: The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients' baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025.

Conclusions: This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval.

International registered report identifier (irrid): PRR1-10.2196/16959.

Keywords: AFX 2; abdominal aortic aneurysm; aortic aneurysm; endovascular aortic repair; endovascular repair; long-term results.

Conflict of interest statement

Conflicts of Interest: None declared.

©Roberto Silingardi, Pasqualino Sirignano, Francesco Andreoli, Wassim Mansour, Mattia Migliari, Francesco Speziale, LIVE Study Collaborators. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.04.2020.

References

    1. Coppi G, Silingardi R, Tasselli S, Gennai S, Saitta G, Veraldi GF. Endovascular treatment of abdominal aortic aneurysms with the Powerlink Endograft System: influence of placement on the bifurcation and use of a proximal extension on early and late outcomes. J Vasc Surg. 2008 Oct;48(4):795–801. doi: 10.1016/j.jvs.2008.05.011.
    1. Wang GJ, Carpenter JP, Endologix Investigators The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008 Sep;48(3):535–45. doi: 10.1016/j.jvs.2008.04.031.
    1. Albertini J, Lahlou Z, Magnan P, Branchereau A, French Powerlink Multicenter Trial Investigators Endovascular repair of abdominal aortic aneurysms with a unibody stent-graft: 3-year results of the French Powerlink Multicenter Trial. J Endovasc Ther. 2005 Dec;12(6):629–37. doi: 10.1583/05-1629R.1.
    1. Qu L, Raithel D. From clinical trials to clinical practice: 612 cases treated with the Powerlink stent-graft for endovascular repair of AAA. J Cardiovasc Surg (Torino) 2009 Apr;50(2):131–7.
    1. Diethrich EB. Novel sealing concept in the Endologix AFX unibody stent-graft. J Cardiovasc Surg (Torino) 2014 Feb;55(1):93–102.
    1. Carpenter JP, Garcia MJ, Harlin SA, Jordan WD, Jung MT, Krajcer Z, Rodriguez-Lopez JA. Contemporary results of endovascular repair of abdominal aortic aneurysms: effect of anatomical fixation on outcomes. J Endovasc Ther. 2010 Apr;17(2):153–62. doi: 10.1583/09-2977.1.
    1. Silingardi R, Azzoni I, Giuliani E, Saitta G, Gennai S, Coppi G. Unibody endografts for abdominal aortic aneurysm repair reduce radiation and nephrotoxic exposure compared with modular endografts. Ann Vasc Surg. 2015;29(4):751–7. doi: 10.1016/j.avsg.2014.11.011.
    1. Setacci F, Sirignano P, Cappelli A, Setacci C. The wonders of a newly available post-analysis CT software in the hands of vascular surgeons. Eur J Vasc Endovasc Surg. 2012 Apr;43(4):404–6. doi: 10.1016/j.ejvs.2011.11.027.
    1. Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, Matsumura JS, May J, Veith FJ, Fillinger MF, Rutherford RB, Kent KC, Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1048–60. doi: 10.1067/mva.2002.123763.
    1. Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kölbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee. de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Björck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein H-H, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco J-B, Verhagen H. Editor's choice - European Society for Vascular Surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8–93. doi: 10.1016/j.ejvs.2018.09.020.
    1. Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2–77.e2. doi: 10.1016/j.jvs.2017.10.044.
    1. Greenhalgh RM, Brown LC, Kwong GPS, Powell JT, Thompson SG, EVAR trial participants Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004;364(9437):843–8. doi: 10.1016/S0140-6736(04)16979-1.
    1. Prinssen M, Verhoeven ELG, Buth J, Cuypers PWM, van Sambeek MRHM, Balm R, Buskens E, Grobbee DE, Blankensteijn JD, Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607–18. doi: 10.1056/NEJMoa042002.
    1. EVAR trial participants Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005;365(9478):2179–86. doi: 10.1016/S0140-6736(05)66627-5.
    1. Blankensteijn JD, de Jong SECA, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SMM, Verhagen HJM, Buskens E, Grobbee DE, Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2005 Jun 09;352(23):2398–405. doi: 10.1056/NEJMoa051255.
    1. Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT, Matsumura JS, Kohler TR, Lin PH, Jean-Claude JM, Cikrit DF, Swanson KM, Peduzzi PN, Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA. 2009 Oct 14;302(14):1535–42. doi: 10.1001/jama.2009.1426.
    1. Becquemin J, Pillet J, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P, Steinmetz E, Marzelle J, trialists ACE. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011 May;53(5):1167–1173.e1. doi: 10.1016/j.jvs.2010.10.124.
    1. Giles KA, Landon BE, Cotterill P, O'Malley AJ, Pomposelli FB, Schermerhorn ML. Thirty-day mortality and late survival with reinterventions and readmissions after open and endovascular aortic aneurysm repair in Medicare beneficiaries. J Vasc Surg. 2011 Jan;53(1):6–12,13.e1. doi: 10.1016/j.jvs.2010.08.051.
    1. Patel R, Sweeting MJ, Powell JT, Greenhalgh RM, EVAR Trial Investigators Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial. Lancet. 2016 Nov 12;388(10058):2366–2374. doi: 10.1016/S0140-6736(16)31135-7.
    1. Lederle FA, Kyriakides TC, Stroupe KT, Freischlag JA, Padberg FT, Matsumura JS, Huo Z, Johnson GR, OVER Veterans Affairs Cooperative Study Group Open versus endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2019 May 30;380(22):2126–2135. doi: 10.1056/NEJMoa1715955.

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