Early outcomes of the t-Branch off-the-shelf multi-branched stent graft in 542 patients for elective and urgent aortic pathologies - a retrospective observational study
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Early outcomes of the t-Branch off-the-shelf multi-branched stent graft in 542 patients for elective and urgent aortic pathologies - a retrospective observational study. / Kölbel, Tilo; Spanos, Konstantinos; Jama, Katarzyna; Behrendt, Christian-Alexander; Panuccio, Giuseppe; Eleshra, Ahmed; Rohlffs, Fiona; Jakimowicz, Tomasz.
In: J VASC SURG, Vol. 74, No. 6, 12.2021, p. 1817-1824.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Early outcomes of the t-Branch off-the-shelf multi-branched stent graft in 542 patients for elective and urgent aortic pathologies - a retrospective observational study
AU - Kölbel, Tilo
AU - Spanos, Konstantinos
AU - Jama, Katarzyna
AU - Behrendt, Christian-Alexander
AU - Panuccio, Giuseppe
AU - Eleshra, Ahmed
AU - Rohlffs, Fiona
AU - Jakimowicz, Tomasz
N1 - Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
PY - 2021/12
Y1 - 2021/12
N2 - OBJECTIVE: The t-Branch, a standardized off-the-shelf multi-branched stent graft has been used for the treatment of elective and urgent cases in aortic disease. The aim of this study was to assess the early outcomes in terms of technical success, mortality, and morbidity in >500 patients being treated with the t-Branch device.METHODS: A two-center retrospective observational study was undertaken including patients treated using the t-Branch (Cook Medical, Bloomington, IN) in elective or urgent settings for complex abdominal aortic aneurysm and thoraco-abdominal aortic aneurysm between 2014 and 2019 (early experience 2014-2016; late experience 2017-2019). Primary endpoints were technical success and early (30-day) mortality, and secondary endpoints were early morbidity, endoleak, and target vessel patency rates. Multivariable regression models were used to determine the independent association of risk factors with (1) mortality and (2) spinal cord ischemia.RESULTS: A total of 542 patients (mean age, 70.5 ± 8.5 years; 388 men [72%]; mean aneurysm diameter, 7.5 ± 2.5 cm) were included (63% elective; 90% thoraco-abdominal aortic aneurysm). The technical success rate was 97% (526/542) (elective, 96.7% [328/339] vs urgent, 97.6% [208/213]). The total 30-day mortality rate was 12.3% (8.5% in elective, 15% in symptomatic, and 30% in contained rupture). After multivariate regression analysis, the mortality rate was associated with older age (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.03-1.11; P < .001) and with lower baseline glomerular filtration rate (OR, 0.98; 95% CI, 0.98-0.99; P < .001). In elective cases, the mortality rate was associated with a history of coronary artery disease (OR, 0.26; 95% CI, 0.09-0.73; P < .011) and higher body mass index (OR, 0.87; 95% CI, 0.77-0.98; P < .027). In urgent cases, the mortality rate was associated with older age, (OR, 1.07; 95% CI, 1.02-1.13; P < .010) and lower baseline glomerular filtration rate (OR, 0.97; 95% CI, 0.95-0.99; P < .001). The spinal cord ischemia rate was 10.5% (6.5% temporary, 4% permanent) and was associated with the early study period (OR, 2.01; 95% CI, 1.03-3.89; P < .038). The renal impairment rate was 13%, the stroke rate was 2.5%, and the myocardial infarction rate was 1.8%, whereas the access complications rate was 7.7%. On early computed tomography angiography, the primary patency rate for the right renal artery was 99.6%, for the left renal artery was 100%, for the superior mesenteric artery was 99.4%, and for the coeliac trunk was 99.8%. The endoleak I and III rates were 2.7% (15/542) and 2.7% (15/542), respectively.CONCLUSIONS: Elective and urgent use of the t-Branch multi-branched off-the shelf stent graft showed high technical success and early target vessel patency rates. Early mortality and morbidity rates were acceptable.
AB - OBJECTIVE: The t-Branch, a standardized off-the-shelf multi-branched stent graft has been used for the treatment of elective and urgent cases in aortic disease. The aim of this study was to assess the early outcomes in terms of technical success, mortality, and morbidity in >500 patients being treated with the t-Branch device.METHODS: A two-center retrospective observational study was undertaken including patients treated using the t-Branch (Cook Medical, Bloomington, IN) in elective or urgent settings for complex abdominal aortic aneurysm and thoraco-abdominal aortic aneurysm between 2014 and 2019 (early experience 2014-2016; late experience 2017-2019). Primary endpoints were technical success and early (30-day) mortality, and secondary endpoints were early morbidity, endoleak, and target vessel patency rates. Multivariable regression models were used to determine the independent association of risk factors with (1) mortality and (2) spinal cord ischemia.RESULTS: A total of 542 patients (mean age, 70.5 ± 8.5 years; 388 men [72%]; mean aneurysm diameter, 7.5 ± 2.5 cm) were included (63% elective; 90% thoraco-abdominal aortic aneurysm). The technical success rate was 97% (526/542) (elective, 96.7% [328/339] vs urgent, 97.6% [208/213]). The total 30-day mortality rate was 12.3% (8.5% in elective, 15% in symptomatic, and 30% in contained rupture). After multivariate regression analysis, the mortality rate was associated with older age (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.03-1.11; P < .001) and with lower baseline glomerular filtration rate (OR, 0.98; 95% CI, 0.98-0.99; P < .001). In elective cases, the mortality rate was associated with a history of coronary artery disease (OR, 0.26; 95% CI, 0.09-0.73; P < .011) and higher body mass index (OR, 0.87; 95% CI, 0.77-0.98; P < .027). In urgent cases, the mortality rate was associated with older age, (OR, 1.07; 95% CI, 1.02-1.13; P < .010) and lower baseline glomerular filtration rate (OR, 0.97; 95% CI, 0.95-0.99; P < .001). The spinal cord ischemia rate was 10.5% (6.5% temporary, 4% permanent) and was associated with the early study period (OR, 2.01; 95% CI, 1.03-3.89; P < .038). The renal impairment rate was 13%, the stroke rate was 2.5%, and the myocardial infarction rate was 1.8%, whereas the access complications rate was 7.7%. On early computed tomography angiography, the primary patency rate for the right renal artery was 99.6%, for the left renal artery was 100%, for the superior mesenteric artery was 99.4%, and for the coeliac trunk was 99.8%. The endoleak I and III rates were 2.7% (15/542) and 2.7% (15/542), respectively.CONCLUSIONS: Elective and urgent use of the t-Branch multi-branched off-the shelf stent graft showed high technical success and early target vessel patency rates. Early mortality and morbidity rates were acceptable.
U2 - 10.1016/j.jvs.2021.05.041
DO - 10.1016/j.jvs.2021.05.041
M3 - SCORING: Journal article
C2 - 34171424
VL - 74
SP - 1817
EP - 1824
JO - J VASC SURG
JF - J VASC SURG
SN - 0741-5214
IS - 6
ER -
