TY - JOUR
T1 - Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms
AU - Abdelhalim, Mohamed A.
AU - Tenorio, Emanuel R.
AU - Oderich, Gustavo S.
AU - Haulon, Stephan
AU - Warren, Gasper
AU - Adam, Donald
AU - Claridge, Martin
AU - Butt, Talha
AU - Abisi, Said
AU - Dias, Nuno V.
AU - Kölbel, Tilo
AU - Gallitto, Enrico
AU - Gargiulo, Mauro
AU - Gkoutzios, Panos
AU - Panuccio, Giuseppe
AU - Kuzniar, Marek
AU - Mani, Kevin
AU - Mees, Barend M.
AU - Schurink, Geert W.
AU - Sonesson, Björn
AU - Spath, Paolo
AU - Wanhainen, Anders
AU - Schanzer, Andres
AU - Beck, Adam W.
AU - Schneider, Darren B.
AU - Timaran, Carlos H.
AU - Eagleton, Matthew
AU - Farber, Mark A.
AU - Modarai, Bijan
AU - Multicenter International Aortic Research Group
N1 - Funding Information:
Author conflict of interest: G.O. reports consulting agreements with Cook Medical Inc, WL Gore, Centerline Biomedical, and GE Healthcare; and research grants from WL Gore and GE Healthcare. S.H. reports consulting agreements and intellectual property (IP) with Cook Medical Inc, GE Healthcare, and Bentley. D.A. reports consulting agreements with Cook Medical Inc. N.D. reports consulting agreement and IP with Cook Medical Inc. T.K. reports consulting agreements, IP, royalties, and research and travel grants with Cook Medical Inc; consulting agreements with Getinge and Philips; and IP and royalties with Terumo Aortic. G.P. reports consulting agreements with Cook Medical Inc, BD, and Philips. K.M. reports consulting agreements and research grants from Cook Medical Inc. B.M.M. reports consulting agreements with Philips, Cook, Bentley, Terumo, and Gore. G.S. reports consulting agreements and research grants from Cook Medical Inc. and Philips Medical Systems. A.S. reports consulting agreements and research grants from Cook Medical, Artivion, and Phillips Imaging. All compensation goes to the UMass Memorial Foundation. A.B. reports research support from Cook Medical, Medtronic, Philips, Terumo, and WL Gore & Associates; and consulting agreements for Artivion, Cook Medical, Medtronic, Philips, and Terumo. D.S. reports consulting agreements with Cook Medical Inc, Medtronic, Penumbra, and W.L. Gore; and research grants from Cook Medical and Philips Medical Systems. M.F. reports consulting agreements and clinical trial and research support from Cook Medical; consulting agreements and clinical trial support from WL Gore and ViTAA; and consulting agreements for Getinge. B.M. reports consulting agreements with Cook Medical Inc, Cydar Medical, and Philips.
Funding Information:
Author conflict of interest: G.O. reports consulting agreements with Cook Medical Inc, WL Gore, Centerline Biomedical, and GE Healthcare; and research grants from WL Gore and GE Healthcare . S.H. reports consulting agreements and intellectual property (IP) with Cook Medical Inc, GE Healthcare, and Bentley. D.A. reports consulting agreements with Cook Medical Inc. N.D. reports consulting agreement and IP with Cook Medical Inc. T.K. reports consulting agreements, IP, royalties, and research and travel grants with Cook Medical Inc ; consulting agreements with Getinge and Philips; and IP and royalties with Terumo Aortic. G.P. reports consulting agreements with Cook Medical Inc, BD, and Philips. K.M. reports consulting agreements and research grants from Cook Medical Inc . B.M.M. reports consulting agreements with Philips, Cook, Bentley, Terumo, and Gore. G.S. reports consulting agreements and research grants from Cook Medical Inc . and Philips Medical Systems. A.S. reports consulting agreements and research grants from Cook Medical , Artivion , and Phillips Imaging . All compensation goes to the UMass Memorial Foundation. A.B. reports research support from Cook Medical , Medtronic , Philips , Terumo , and WL Gore & Associates ; and consulting agreements for Artivion, Cook Medical, Medtronic, Philips, and Terumo. D.S. reports consulting agreements with Cook Medical Inc, Medtronic, Penumbra, and W.L. Gore; and research grants from Cook Medical and Philips Medical Systems. M.F. reports consulting agreements and clinical trial and research support from Cook Medical ; consulting agreements and clinical trial support from WL Gore and ViTAA ; and consulting agreements for Getinge. B.M. reports consulting agreements with Cook Medical Inc, Cydar Medical, and Philips.
Publisher Copyright:
© 2023 The Authors
PY - 2023/10
Y1 - 2023/10
N2 - Objective: This multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). Methods: We reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or =12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM). Results: A total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class =3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively. Conclusions: FB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.
AB - Objective: This multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). Methods: We reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or =12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM). Results: A total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class =3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively. Conclusions: FB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.
KW - Aortic dissection
KW - BEVAR
KW - Branched
KW - Fenestrated
KW - FEVAR
KW - Thoracoabdominal aortic aneurysm
U2 - 10.1016/j.jvs.2023.05.053
DO - 10.1016/j.jvs.2023.05.053
M3 - Article
C2 - 37321524
SN - 0741-5214
VL - 78
SP - 854-862.e1
JO - Journal of Vascular Surgery
JF - Journal of Vascular Surgery
IS - 4
ER -