TY - JOUR
T1 - Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts
AU - U.S. Fenestrated and Branched Aortic Research Consortium Investigators
AU - Tenorio, Emanuel R.
AU - Oderich, Gustavo S.
AU - Farber, Mark A.
AU - Schneider, Darren B.
AU - Timaran, Carlos H.
AU - Schanzer, Andres
AU - Beck, Adam W.
AU - Motta, Fernando
AU - Sweet, Matthew P.
N1 - Funding Information:
Author conflict of interest: G.S.O. has received consulting fees and grants from Cook Medical, W. L. Gore, and GE Healthcare (all paid to Mayo Clinic with no personal income). M.A.F.: Cook: research support, consultant, and clinical trials; W. L. Gore, Medtronic, and Endologix: consultant and clinical trials. D.B.S.: contracted research: Cook, Endologix, W. L. Gore; consultant: Medtronic, W. L. Gore. C.H.T.: contracted research: Cook Medical and W. L. Gore; consulting/proctoring: Cook Medical. A.S.: consultant: Cook Medical. A.W.B.: consultant for Cook Medical, Endologix, Medtronic, Terumo Aortic; funded researcher for Cook Medical, Medtronic Terumo Aortic, W. L. Gore & Associates; all proceeds to the University of Alabama at Birmingham.
Funding Information:
Conception and design: ET, MF, DS, CT, AS, AB, MS Analysis and interpretation: ET, GO Data collection: ET, GO, FM Writing the article: ET Critical revision of the article: ET, GO, MF, DS, CT, AS, AB, FM, MS Final approval of the article: ET, GO, MF, DS, CT, AS, AB, FM, MS Statistical analysis: ET Obtained funding: Not applicable Overall responsibility: GO Appendix (online only) Video (online only) Description of the use of fusion mask to identify the septum between the true and false lumens and creation of a new fenestration to address a vessel. (Reproduced by permission by permission of Mayo Foundation for Medical Education and Research. All rights reserved.) Appendix Additional material for this article may be found online at www.jvascsurg.org .
Publisher Copyright:
© 2019 Society for Vascular Surgery
PY - 2020/9
Y1 - 2020/9
N2 - Objective: The objective of this study was to analyze outcomes of fenestrated-branched endovascular aneurysm repair (F/BEVAR) for treatment of postdissection and degenerative thoracoabdominal aortic aneurysms (TAAAs). Methods: We reviewed the clinical data of 240 patients with extent I to extent III TAAAs enrolled in seven prospective physician-sponsored investigational device exemption studies from 2014 to 2017. All patients had manufactured off-the-shelf or patient-specific fenestrated-branched stent grafts used to target 888 renal-mesenteric arteries with a mean of 3.7 vessels per patient. End points included mortality, major adverse events (any-cause mortality, stroke, paralysis, dialysis, myocardial infarction, respiratory failure, bowel ischemia, and estimated blood loss >1 L), technical success, target artery patency, target artery instability, occlusion or stenosis, endoleak, rupture or death, reintervention, and renal function deterioration. Results: There were 50 patients (21%) treated for postdissection TAAAs and 190 (79%) who had degenerative TAAAs. Postdissection TAAA patients were significantly younger (67 ± 9 years vs 74 ± 8 years; P <.001), were more often male (76% vs 52%; P =.002), and had more prior aortic repairs (84% vs 67%; P =.02) and larger renal (6.4 ± 1.2 mm vs 5.8 ± 0.9 mm; P <.001) and mesenteric (8.9 ± 1.7 mm vs 7.8 ± 1.4 mm; P <.001) target artery diameters. There was no difference in aneurysm diameter (66 ± 13 mm vs 67 ± 11 mm; P =.50), extent I or extent II TAAA classification (64% vs 56%; P =.33), and length of supraceliac coverage (22 ± 9.5 cm vs 20 ± 10 cm; P =.38) between postdissection and degenerative patients, respectively. Preloaded guidewire systems (66% vs 43%; P =.003) and fenestrations as opposed to directional branches (58% vs 24%; P <.001) were used more frequently to treat postdissection patients. Technical success was 100% for postdissection TAAAs and 99% for degenerative TAAAs (P =.14). At 30 days, there was no difference in mortality (2% postdissection, 3% degenerative), major adverse events (24% postdissection, 26% degenerative; P =.73), spinal cord injury (6% postdissection, 12% degenerative; P =.25), paraplegia (2% postdissection, 7% degenerative; P =.19), and dialysis (0% postdissection, 5% degenerative; P =.24). Mean follow-up was 14 ± 12 months. Endoleaks were significantly more frequent in patients with postdissection TAAAs (76%) compared with degenerative TAAAs (43%; P <.001). At 2 years, there was no difference in patient survival (84% ± 7% vs 72% ± 4%; P =.13), freedom from aorta-related death (98% ± 2% vs 94% ± 2%; P =.45), primary (95% ± 2% vs 97% ± 1%; P =.93) and secondary target artery patency (99% ± 1% vs 98% ± 1%; P =.48), target artery instability (89% ± 3% vs 91% ± 1%; P =.17), and freedom from reintervention (58% ± 10% vs 67% ± 5%; P =.23) for postdissection and degenerative TAAAs, respectively. Conclusions: Despite minor differences in demographics, anatomic factors, and stent graft design, F/BEVAR was safe and effective with nearly identical outcomes in patients with postdissection and degenerative TAAAs. Larger clinical experience and longer follow-up are needed to better evaluate differences in mortality, spinal cord injury, target artery instability, and reintervention.
AB - Objective: The objective of this study was to analyze outcomes of fenestrated-branched endovascular aneurysm repair (F/BEVAR) for treatment of postdissection and degenerative thoracoabdominal aortic aneurysms (TAAAs). Methods: We reviewed the clinical data of 240 patients with extent I to extent III TAAAs enrolled in seven prospective physician-sponsored investigational device exemption studies from 2014 to 2017. All patients had manufactured off-the-shelf or patient-specific fenestrated-branched stent grafts used to target 888 renal-mesenteric arteries with a mean of 3.7 vessels per patient. End points included mortality, major adverse events (any-cause mortality, stroke, paralysis, dialysis, myocardial infarction, respiratory failure, bowel ischemia, and estimated blood loss >1 L), technical success, target artery patency, target artery instability, occlusion or stenosis, endoleak, rupture or death, reintervention, and renal function deterioration. Results: There were 50 patients (21%) treated for postdissection TAAAs and 190 (79%) who had degenerative TAAAs. Postdissection TAAA patients were significantly younger (67 ± 9 years vs 74 ± 8 years; P <.001), were more often male (76% vs 52%; P =.002), and had more prior aortic repairs (84% vs 67%; P =.02) and larger renal (6.4 ± 1.2 mm vs 5.8 ± 0.9 mm; P <.001) and mesenteric (8.9 ± 1.7 mm vs 7.8 ± 1.4 mm; P <.001) target artery diameters. There was no difference in aneurysm diameter (66 ± 13 mm vs 67 ± 11 mm; P =.50), extent I or extent II TAAA classification (64% vs 56%; P =.33), and length of supraceliac coverage (22 ± 9.5 cm vs 20 ± 10 cm; P =.38) between postdissection and degenerative patients, respectively. Preloaded guidewire systems (66% vs 43%; P =.003) and fenestrations as opposed to directional branches (58% vs 24%; P <.001) were used more frequently to treat postdissection patients. Technical success was 100% for postdissection TAAAs and 99% for degenerative TAAAs (P =.14). At 30 days, there was no difference in mortality (2% postdissection, 3% degenerative), major adverse events (24% postdissection, 26% degenerative; P =.73), spinal cord injury (6% postdissection, 12% degenerative; P =.25), paraplegia (2% postdissection, 7% degenerative; P =.19), and dialysis (0% postdissection, 5% degenerative; P =.24). Mean follow-up was 14 ± 12 months. Endoleaks were significantly more frequent in patients with postdissection TAAAs (76%) compared with degenerative TAAAs (43%; P <.001). At 2 years, there was no difference in patient survival (84% ± 7% vs 72% ± 4%; P =.13), freedom from aorta-related death (98% ± 2% vs 94% ± 2%; P =.45), primary (95% ± 2% vs 97% ± 1%; P =.93) and secondary target artery patency (99% ± 1% vs 98% ± 1%; P =.48), target artery instability (89% ± 3% vs 91% ± 1%; P =.17), and freedom from reintervention (58% ± 10% vs 67% ± 5%; P =.23) for postdissection and degenerative TAAAs, respectively. Conclusions: Despite minor differences in demographics, anatomic factors, and stent graft design, F/BEVAR was safe and effective with nearly identical outcomes in patients with postdissection and degenerative TAAAs. Larger clinical experience and longer follow-up are needed to better evaluate differences in mortality, spinal cord injury, target artery instability, and reintervention.
KW - Fenestrated and branched endovascular aneurysm repair
KW - Postdissection thoracoabdominal aneurysm
KW - Thoracoabdominal aneurysm
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U2 - 10.1016/j.jvs.2019.10.091
DO - 10.1016/j.jvs.2019.10.091
M3 - Article
C2 - 31882309
AN - SCOPUS:85076845476
SN - 0741-5214
VL - 72
SP - 822-836.e9
JO - Journal of Vascular Surgery
JF - Journal of Vascular Surgery
IS - 3
ER -