Midterm Results of Proximal Sealing With Ovation Stent Graft According to the Instruction for Use vs Off-Label Condition
Abstract
Publication Date:
2016
abstract:
Objectives
With a core laboratory analysis of morphologic changes, this study evaluated midterm results of proximal sealing in patients treated with the Ovation stent graft according to requirement of neck length by the device-specific instructions for use (IFU) at time of implantation vs those treated in an off-label (Off-L) situation.
Methods
This was a multicenter registry of all patients undergoing EVAR with a TriVascular Ovation endograft, with a minimum computed tomography (CT) follow-up of 24 months. Patients operated on according to the minimum neck length requirement of 7 mm (IFU group) were compared with those with a proximal neck <7 mm (Off-L group) to evaluate estimated 4-year survival, freedom from any device-related reinterventions, freedom from neck enlargement (>2 mm), freedom from type I endoleak, and freedom from migration (>3 mm).
Results
Inclusion criteria were met in 89 patients (IFU group, n = 57; Off-L group, n = 32). Mean follow-up was 32 months (range, 24-50 months). At 4 years, there were no differences in survival (85.9 IFU vs 87.7% Off-L; P = .3), freedom from any device-related reintervention (94.7% IFU vs 93.3% Off-L; P = .6), freedom from neck enlargement (100% IFU vs 100% Off-L; P = 1), freedom from type I endoleak (99.2% IFU vs 98.5% Off-L; P = .8), or freedom from migration (100% IFU vs 100% Off-L; P = 1).
Conclusions
Use of Ovation stent graft in the absence of a suitable neck length of 7 mm was not associated with poor outcomes in the midterm period. These data show that the use of Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, as confirmed by the recent FDA-approved changes to the indication statement.
With a core laboratory analysis of morphologic changes, this study evaluated midterm results of proximal sealing in patients treated with the Ovation stent graft according to requirement of neck length by the device-specific instructions for use (IFU) at time of implantation vs those treated in an off-label (Off-L) situation.
Methods
This was a multicenter registry of all patients undergoing EVAR with a TriVascular Ovation endograft, with a minimum computed tomography (CT) follow-up of 24 months. Patients operated on according to the minimum neck length requirement of 7 mm (IFU group) were compared with those with a proximal neck <7 mm (Off-L group) to evaluate estimated 4-year survival, freedom from any device-related reinterventions, freedom from neck enlargement (>2 mm), freedom from type I endoleak, and freedom from migration (>3 mm).
Results
Inclusion criteria were met in 89 patients (IFU group, n = 57; Off-L group, n = 32). Mean follow-up was 32 months (range, 24-50 months). At 4 years, there were no differences in survival (85.9 IFU vs 87.7% Off-L; P = .3), freedom from any device-related reintervention (94.7% IFU vs 93.3% Off-L; P = .6), freedom from neck enlargement (100% IFU vs 100% Off-L; P = 1), freedom from type I endoleak (99.2% IFU vs 98.5% Off-L; P = .8), or freedom from migration (100% IFU vs 100% Off-L; P = 1).
Conclusions
Use of Ovation stent graft in the absence of a suitable neck length of 7 mm was not associated with poor outcomes in the midterm period. These data show that the use of Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, as confirmed by the recent FDA-approved changes to the indication statement.
Iris type:
Abstract (in Rivista)
List of contributors:
de Donato, G; Bresadola, L; Castelli, Patrizio; Chiesa, R; Mangialardi, N; Nano, G; Setacci, F; Setacci, C.
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