Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair
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Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair. / Tsilimparis, Nikolaos; Gouveia E Melo, Ryan; Schanzer, Andres; Sobocinski, Jonathan; Austermann, Martin; Chiesa, Roberto; Resch, Timothy; Gargiulo, Mauro; Timaran, Carlos; Maurel, Blandine; Adam, Donald; Dias, Nuno; Oderich, Gustavo S; Kölbel, Tilo; Gomez Palones, Francisco; Simonte, Gioele; Giudice, Rocco; Mesnard, Thomas; Loschi, Diletta; Leone, Nicola; Gallito, Enrico; Spath, Paolo; Porras Cólon, Jesus; Elboushi, Amro; Wachtmeister, Melker; Sonesson, Bjorn; Tenorio, Emanuel; Panuccio, Giuseppe; Isernia, Giacomo; Bertoglio, Luca.
In: J VASC SURG, Vol. 78, No. 4, 10.2023, p. 863-873.e3.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair
AU - Tsilimparis, Nikolaos
AU - Gouveia E Melo, Ryan
AU - Schanzer, Andres
AU - Sobocinski, Jonathan
AU - Austermann, Martin
AU - Chiesa, Roberto
AU - Resch, Timothy
AU - Gargiulo, Mauro
AU - Timaran, Carlos
AU - Maurel, Blandine
AU - Adam, Donald
AU - Dias, Nuno
AU - Oderich, Gustavo S
AU - Kölbel, Tilo
AU - Gomez Palones, Francisco
AU - Simonte, Gioele
AU - Giudice, Rocco
AU - Mesnard, Thomas
AU - Loschi, Diletta
AU - Leone, Nicola
AU - Gallito, Enrico
AU - Spath, Paolo
AU - Porras Cólon, Jesus
AU - Elboushi, Amro
AU - Wachtmeister, Melker
AU - Sonesson, Bjorn
AU - Tenorio, Emanuel
AU - Panuccio, Giuseppe
AU - Isernia, Giacomo
AU - Bertoglio, Luca
N1 - Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
PY - 2023/10
Y1 - 2023/10
N2 - OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters.METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter.RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively.CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.
AB - OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters.METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter.RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively.CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Blood Vessel Prosthesis
KW - Blood Vessel Prosthesis Implantation
KW - Endovascular Aneurysm Repair
KW - Aortic Aneurysm, Abdominal/diagnostic imaging
KW - Aortic Aneurysm, Thoracic/diagnostic imaging
KW - Retrospective Studies
KW - Cohort Studies
KW - Endovascular Procedures
KW - Treatment Outcome
KW - Time Factors
KW - Aortic Aneurysm, Thoracoabdominal
KW - Prosthesis Design
U2 - 10.1016/j.jvs.2023.05.043
DO - 10.1016/j.jvs.2023.05.043
M3 - SCORING: Journal article
C2 - 37330705
VL - 78
SP - 863-873.e3
JO - J VASC SURG
JF - J VASC SURG
SN - 0741-5214
IS - 4
ER -
