Transatlantic multicenter study on the use ...
Document type :
Article dans une revue scientifique: Article original
PMID :
Permalink :
Title :
Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.
Author(s) :
Tsilimparis, Nikolaos [Auteur]
Gouveia E Melo, Ryan [Auteur]
Schanzer, Andres [Auteur]
Sobocinski, Jonathan [Auteur]
Advanced Drug Delivery Systems (ADDS) - U1008
Austermann, Martin [Auteur]
Chiesa, Roberto [Auteur]
Resch, Timothy [Auteur]
Gargiulo, Mauro [Auteur]
Timaran, Carlos [Auteur]
Maurel, Blandine [Auteur]
Institut du Thorax [Nantes]
Adam, Donald [Auteur]
Dias, Nuno [Auteur]
Oderich, Gustavo S. [Auteur]
Kölbel, T. [Auteur]
Gomez Palones, F. [Auteur]
Simonte, Gioele [Auteur]
Giudice, Rocco [Auteur]
Mesnard, Thomas [Auteur]
Advanced Drug Delivery Systems (ADDS) - U1008
Institut Coeur Poumon [CHU Lille]
Loschi, Diletta [Auteur]
Leone, Nicola [Auteur]
Gallito, Enrico [Auteur]
Spath, Paolo [Auteur]
Porras Cólon, Jesus [Auteur]
Elboushi, Amro [Auteur]
Wachtmeister, Melker [Auteur]
Sonesson, Bjorn [Auteur]
Tenorio, Emanuel [Auteur]
Panuccio, Giuseppe [Auteur]
Isernia, Giacomo [Auteur]
Bertoglio, Luca [Auteur]
Gouveia E Melo, Ryan [Auteur]
Schanzer, Andres [Auteur]
Sobocinski, Jonathan [Auteur]
Advanced Drug Delivery Systems (ADDS) - U1008
Austermann, Martin [Auteur]
Chiesa, Roberto [Auteur]
Resch, Timothy [Auteur]
Gargiulo, Mauro [Auteur]
Timaran, Carlos [Auteur]
Maurel, Blandine [Auteur]
Institut du Thorax [Nantes]
Adam, Donald [Auteur]
Dias, Nuno [Auteur]
Oderich, Gustavo S. [Auteur]
Kölbel, T. [Auteur]
Gomez Palones, F. [Auteur]
Simonte, Gioele [Auteur]
Giudice, Rocco [Auteur]
Mesnard, Thomas [Auteur]
Advanced Drug Delivery Systems (ADDS) - U1008
Institut Coeur Poumon [CHU Lille]
Loschi, Diletta [Auteur]
Leone, Nicola [Auteur]
Gallito, Enrico [Auteur]
Spath, Paolo [Auteur]
Porras Cólon, Jesus [Auteur]
Elboushi, Amro [Auteur]
Wachtmeister, Melker [Auteur]
Sonesson, Bjorn [Auteur]
Tenorio, Emanuel [Auteur]
Panuccio, Giuseppe [Auteur]
Isernia, Giacomo [Auteur]
Bertoglio, Luca [Auteur]
Journal title :
Journal of Vascular Surgery
Abbreviated title :
J Vasc Surg
Volume number :
78
Pages :
863-873
Publication date :
2023-06-25
ISSN :
1097-6809
English keyword(s) :
Fenestrated aortic repair
Preloaded
Modified delivery system
FEVAR
Aortic aneurysm
Preloaded
Modified delivery system
FEVAR
Aortic aneurysm
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
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 ...
Show more >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.Show less >
Show more >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.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Collections :
Submission date :
2023-12-15T05:14:01Z
2024-02-26T10:47:23Z
2024-02-26T10:47:23Z