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Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use

2017; SAGE Publishing; Volume: 24; Issue: 2 Linguagem: Inglês

10.1177/1526602816685581

1545-1550

Gianmarco de Donato, Francesco Setacci, Luciano Bresadola, Patrizio Castelli, Roberto Chiesa, Nicola Mangialardi, Giovanni Nano, Carlo Setacci, Carlo Setacci, Gianmarco de Donato, Carmelo Ricci, Daniele Gasparini, Gianluca Piccoli, Roberto Chiesa, Andrea Kahlberg, Giovanni Nano, Silvia Stegher, Patrizio Castelli, Gianpaolo Carrafiello, Nicola Rivolta, Claudio Novali, Carlo Rivellini, Massimo Lenti, Giacomo Isernia, Nicola Mangialardi, Sonia Ronkey, Rocco Giudice, Francesco Speziale, Giovanni Nano, Luciano Bresadola, Giustino Marcucci, Federico Accrocca, Pietro Volpe, Francesco Talarico, Gaetano La Barbera,

Vascular Procedures and Complications

To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long.A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24-50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or 2 mm).At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was -0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group.Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.