TY - JOUR
T1 - Outcomes of a novel upper extremity preloaded delivery system for fenestrated-branched endovascular repair of thoracoabdominal aneurysms
AU - Mirza, Aleem K.
AU - Tenorio, Emanuel R.
AU - Kärkkäinen, Jussi M.
AU - Pather, Keouna
AU - Kratzberg, Jarin
AU - Mendes, Bernardo C.
AU - DeMartino, Randall R.
AU - Oderich, Gustavo S.
N1 - Publisher Copyright:
© 2019 Society for Vascular Surgery
PY - 2020/8
Y1 - 2020/8
N2 - Objective: The aim of this study was to evaluate the feasibility and outcomes of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) using a novel low profile (LP) device with upper extremity preloaded guidewire system (PGS) and compare procedural metrics and outcomes with a standard multibranch stent graft (t-Branch; Cook Medical, Bloomington, Ind). Methods: We reviewed the clinical data of 232 consecutive patients treated by fenestrated-branched endovascular aortic repair for TAAA and enrolled in a prospective nonrandomized trial between 2014 and 2017. Patients who had repair using t-Branch or patient-specific TAAA devices using upper extremity LP-PGS were included. End points were technical success, operative and fluoroscopic time, patient radiation exposure, time from arterial access to complete device deployment, total contrast volume, and 30-day rates of major adverse events (MAEs) and mortality. Results: There were 54 patients, including 33 males (67%) and 21 females (33%), with a mean age of 73 ± 9 years old. Forty-nine patients (91%) had extent I-III and five patients (9%) had extent IV TAAAs. Device design was t-Branch in 24 patients (44%) and LP-PGS in 30 patients (56%). A total of 206 renal-mesenteric arteries were incorporated with no difference between groups (mean, 3.8 ± 0.6 target vessels/patient; P =.92). Patients treated by t-Branch device had larger mean aneurysm diameter (79 ± 16 vs 66 ± 10 mm; P =.0006). All patients had transbrachial approach. Technical success was achieved in all patients in both groups. Patients treated by LP-PGS devices had lower radiation dose (1250 ± 849 vs 3154 ± 2421 mGy; P =.003) and shorter operating time for complete device deployment (105 ± 42 vs 123 ± 34 minutes; P =.043). There was no difference in mean operative time (252 ± 69 vs 273 ± 56 minutes; P =.23), fluoroscopy time (82 ± 29 vs 96 ± 35 minutes; P =.08) or contrast volume (163 ± 59 vs 197 ± 75 mL; P =.07) comparing LP-PGS and t-Branch respectively. There was no 30-day or in-hospital mortality. There were no differences in MAEs, which occurred in 18 patients (33%) in both groups (P >.05). Conclusions: Endovascular TAAA repair using the standard or LP-PGS multibranch stent graft was associated with high technical success, no mortality, and a low rate of MAEs in this study. Patients treated by upper extremity LP-PGS had shorter time to complete device deployment, suggesting decreased technical demand with preloaded systems.
AB - Objective: The aim of this study was to evaluate the feasibility and outcomes of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) using a novel low profile (LP) device with upper extremity preloaded guidewire system (PGS) and compare procedural metrics and outcomes with a standard multibranch stent graft (t-Branch; Cook Medical, Bloomington, Ind). Methods: We reviewed the clinical data of 232 consecutive patients treated by fenestrated-branched endovascular aortic repair for TAAA and enrolled in a prospective nonrandomized trial between 2014 and 2017. Patients who had repair using t-Branch or patient-specific TAAA devices using upper extremity LP-PGS were included. End points were technical success, operative and fluoroscopic time, patient radiation exposure, time from arterial access to complete device deployment, total contrast volume, and 30-day rates of major adverse events (MAEs) and mortality. Results: There were 54 patients, including 33 males (67%) and 21 females (33%), with a mean age of 73 ± 9 years old. Forty-nine patients (91%) had extent I-III and five patients (9%) had extent IV TAAAs. Device design was t-Branch in 24 patients (44%) and LP-PGS in 30 patients (56%). A total of 206 renal-mesenteric arteries were incorporated with no difference between groups (mean, 3.8 ± 0.6 target vessels/patient; P =.92). Patients treated by t-Branch device had larger mean aneurysm diameter (79 ± 16 vs 66 ± 10 mm; P =.0006). All patients had transbrachial approach. Technical success was achieved in all patients in both groups. Patients treated by LP-PGS devices had lower radiation dose (1250 ± 849 vs 3154 ± 2421 mGy; P =.003) and shorter operating time for complete device deployment (105 ± 42 vs 123 ± 34 minutes; P =.043). There was no difference in mean operative time (252 ± 69 vs 273 ± 56 minutes; P =.23), fluoroscopy time (82 ± 29 vs 96 ± 35 minutes; P =.08) or contrast volume (163 ± 59 vs 197 ± 75 mL; P =.07) comparing LP-PGS and t-Branch respectively. There was no 30-day or in-hospital mortality. There were no differences in MAEs, which occurred in 18 patients (33%) in both groups (P >.05). Conclusions: Endovascular TAAA repair using the standard or LP-PGS multibranch stent graft was associated with high technical success, no mortality, and a low rate of MAEs in this study. Patients treated by upper extremity LP-PGS had shorter time to complete device deployment, suggesting decreased technical demand with preloaded systems.
KW - Fenestrated and branched endovascular aortic repair
KW - Low profile
KW - Preloaded guidewire system
KW - Upper extremity
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U2 - 10.1016/j.jvs.2019.09.058
DO - 10.1016/j.jvs.2019.09.058
M3 - Article
C2 - 31987669
AN - SCOPUS:85078249274
SN - 0741-5214
VL - 72
SP - 470
EP - 479
JO - Journal of vascular surgery
JF - Journal of vascular surgery
IS - 2
ER -