Clinical outcomes of endurant II stent-graft for infrarenal aortic aneurysm repair: Comparison of on-label versus off-label use

Corte, G.; Dinoto, E.; Badalamenti, G.; Bruno, S.

Risultato della ricerca: Article

4 Citazioni (Scopus)

Abstract

PURPOSE We aimed to compare the outcomes of the Endurant II (Medtronic) stent-graft used under instructions for use versus off-label in high-risk patients considered unfit for conventional surgery. METHODS Data from patients treated with the Endurant II stent-graft between December 2012 and March 2015 were retrospectively analyzed. Sixty-four patients were included. Patients were assigned to group A if treated under instructions for use (n=34, 53%) and to group B if treated off-label (n=30, 47%). Outcome measures included perioperative mortality and morbidity, survival, freedom from reintervention, endoleak incidence, in-hospital length of stay, and mean stent-graft component used. Mean follow-up was 22.61±12 months (median, 21.06 months; range, 0–43 months). RESULTS One perioperative mortality (1.6%) and one perioperative complication (1.6%) occurred in group B. At two months follow-up, one iliac limb occlusion (1.6%) occurred in group A. No type I/III endoleaks were recorded. A type II endoleak was identified in three cases (4.7%). Overall survival at three years was 89% (97% for group A, 82% for group B; P = 0.428). Reintervention-free survival at three years was 97% for both groups (P = 0.991). A longer in-hospital stay was observed in group B (P = 0.012). CONCLUSION The Endurant II (Medtronic) new generation device was safe in off-label setting at mid-term follow-up. The off-label use of the Endurant II (Medtronic) is justified in patients considered unfit for conventional surgery. Larger studies are required in this subgroup of patients.
Lingua originaleEnglish
pagine (da-a)450-454
Numero di pagine5
RivistaDiagnostic and Interventional Radiology
Volume22
Stato di pubblicazionePublished - 2016

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Off-Label Use
Aortic Aneurysm
Stents
Transplants
Endoleak
Length of Stay
Survival
Mortality
Extremities
Outcome Assessment (Health Care)
Morbidity
Equipment and Supplies
Incidence

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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Clinical outcomes of endurant II stent-graft for infrarenal aortic aneurysm repair: Comparison of on-label versus off-label use. / Corte, G.; Dinoto, E.; Badalamenti, G.; Bruno, S.

In: Diagnostic and Interventional Radiology, Vol. 22, 2016, pag. 450-454.

Risultato della ricerca: Article

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title = "Clinical outcomes of endurant II stent-graft for infrarenal aortic aneurysm repair: Comparison of on-label versus off-label use",
abstract = "PURPOSE We aimed to compare the outcomes of the Endurant II (Medtronic) stent-graft used under instructions for use versus off-label in high-risk patients considered unfit for conventional surgery. METHODS Data from patients treated with the Endurant II stent-graft between December 2012 and March 2015 were retrospectively analyzed. Sixty-four patients were included. Patients were assigned to group A if treated under instructions for use (n=34, 53{\%}) and to group B if treated off-label (n=30, 47{\%}). Outcome measures included perioperative mortality and morbidity, survival, freedom from reintervention, endoleak incidence, in-hospital length of stay, and mean stent-graft component used. Mean follow-up was 22.61±12 months (median, 21.06 months; range, 0–43 months). RESULTS One perioperative mortality (1.6{\%}) and one perioperative complication (1.6{\%}) occurred in group B. At two months follow-up, one iliac limb occlusion (1.6{\%}) occurred in group A. No type I/III endoleaks were recorded. A type II endoleak was identified in three cases (4.7{\%}). Overall survival at three years was 89{\%} (97{\%} for group A, 82{\%} for group B; P = 0.428). Reintervention-free survival at three years was 97{\%} for both groups (P = 0.991). A longer in-hospital stay was observed in group B (P = 0.012). CONCLUSION The Endurant II (Medtronic) new generation device was safe in off-label setting at mid-term follow-up. The off-label use of the Endurant II (Medtronic) is justified in patients considered unfit for conventional surgery. Larger studies are required in this subgroup of patients.",
keywords = "Radiology, Nuclear Medicine and Imaging; Cardiology and Cardiovascular Medicine",
author = "{Corte, G.; Dinoto, E.; Badalamenti, G.; Bruno, S.} and Guido Bajardi and Felice Pecoraro",
year = "2016",
language = "English",
volume = "22",
pages = "450--454",
journal = "Diagnostic and Interventional Radiology",
issn = "1305-3825",
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T1 - Clinical outcomes of endurant II stent-graft for infrarenal aortic aneurysm repair: Comparison of on-label versus off-label use

AU - Corte, G.; Dinoto, E.; Badalamenti, G.; Bruno, S.

AU - Bajardi, Guido

AU - Pecoraro, Felice

PY - 2016

Y1 - 2016

N2 - PURPOSE We aimed to compare the outcomes of the Endurant II (Medtronic) stent-graft used under instructions for use versus off-label in high-risk patients considered unfit for conventional surgery. METHODS Data from patients treated with the Endurant II stent-graft between December 2012 and March 2015 were retrospectively analyzed. Sixty-four patients were included. Patients were assigned to group A if treated under instructions for use (n=34, 53%) and to group B if treated off-label (n=30, 47%). Outcome measures included perioperative mortality and morbidity, survival, freedom from reintervention, endoleak incidence, in-hospital length of stay, and mean stent-graft component used. Mean follow-up was 22.61±12 months (median, 21.06 months; range, 0–43 months). RESULTS One perioperative mortality (1.6%) and one perioperative complication (1.6%) occurred in group B. At two months follow-up, one iliac limb occlusion (1.6%) occurred in group A. No type I/III endoleaks were recorded. A type II endoleak was identified in three cases (4.7%). Overall survival at three years was 89% (97% for group A, 82% for group B; P = 0.428). Reintervention-free survival at three years was 97% for both groups (P = 0.991). A longer in-hospital stay was observed in group B (P = 0.012). CONCLUSION The Endurant II (Medtronic) new generation device was safe in off-label setting at mid-term follow-up. The off-label use of the Endurant II (Medtronic) is justified in patients considered unfit for conventional surgery. Larger studies are required in this subgroup of patients.

AB - PURPOSE We aimed to compare the outcomes of the Endurant II (Medtronic) stent-graft used under instructions for use versus off-label in high-risk patients considered unfit for conventional surgery. METHODS Data from patients treated with the Endurant II stent-graft between December 2012 and March 2015 were retrospectively analyzed. Sixty-four patients were included. Patients were assigned to group A if treated under instructions for use (n=34, 53%) and to group B if treated off-label (n=30, 47%). Outcome measures included perioperative mortality and morbidity, survival, freedom from reintervention, endoleak incidence, in-hospital length of stay, and mean stent-graft component used. Mean follow-up was 22.61±12 months (median, 21.06 months; range, 0–43 months). RESULTS One perioperative mortality (1.6%) and one perioperative complication (1.6%) occurred in group B. At two months follow-up, one iliac limb occlusion (1.6%) occurred in group A. No type I/III endoleaks were recorded. A type II endoleak was identified in three cases (4.7%). Overall survival at three years was 89% (97% for group A, 82% for group B; P = 0.428). Reintervention-free survival at three years was 97% for both groups (P = 0.991). A longer in-hospital stay was observed in group B (P = 0.012). CONCLUSION The Endurant II (Medtronic) new generation device was safe in off-label setting at mid-term follow-up. The off-label use of the Endurant II (Medtronic) is justified in patients considered unfit for conventional surgery. Larger studies are required in this subgroup of patients.

KW - Radiology, Nuclear Medicine and Imaging; Cardiology and Cardiovascular Medicine

UR - http://hdl.handle.net/10447/201314

UR - http://www.dirjournal.org/sayilar/85/buyuk/450%E2%80%93454.p

M3 - Article

VL - 22

SP - 450

EP - 454

JO - Diagnostic and Interventional Radiology

JF - Diagnostic and Interventional Radiology

SN - 1305-3825

ER -