Polymer based endografts have improved rates of proximal aortic neck dilatation and migration.

Proximal aortic neck dilatation (PND) affects a considerable proportion of patients undergoing endovascular aneurysm repair (EVAR) and is associated with increased rates of type I endoleak (EL1), migration, and reinterventions. Although there are numerous studies investigating PND following the placement of endografts that utilize self-expanding stent (SES) technology, there are few reports for patients treated with endografts that utilize polymer-filled rings. The purpose of this study is to examine PND and graft migration after EVAR with the Ovation stent graft. The study comprised patients who underwent EVAR as part of the prospective, international, multicenter Ovation stent graft trial. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Neck diameter was measured at the level of the lowest renal artery. PND was defined as neck enlargement of 3 mm or more. Graft migration was defined as distal movement >10 mm or movement ≤10 mm when resulting in secondary intervention. A total of 238 patients received this device during the study period. Patients were predominantly male (81%), with a mean age of 73 ± 8 years. Median follow-up was 58 months (IQR 36-60). Almost half the patients (110 patients, 46%) had challenging anatomy; defined as outside the instructions for use (IFU) with other commercially available stent grafts. 41 patients (17.2%) had a proximal neck length <10 mm and 93 (39%) had a minimum access vessel diameter <6 mm. The technical success rate was 100%. The 1-, 3- and 5-year overall survival rates were 96.6%, 86.2% and 74.9%, respectively. The immediate postoperative proximal neck diameter ranged from 16 mm to 31 mm with a mean of 22.4 ± 3 mm. During follow-up, ten patients (4.2%) developed PND. Freedom from PND estimates at 1, 3 and 5 years were 97.7%, 96%, and 93.6%, respectively. None of the patients developed endograft migration. The use of the Ovation stent graft was associated with low rates of PND despite challenging neck anatomy in 17% of patients. No graft migration was observed. The design of this endograft may explain its superiority to SES in preventing neck dilatation and migration even in patients with challenging neck anatomy. This is important, as we continue to see significant late failures of EVAR due to proximal neck degeneration.

Mathlouthi A ，Yei K ，Barleben A ，Al-Nouri O ，Malas MB ... -  《-》

Absence of proximal neck dilatation and graft migration after endovascular aneurysm repair with balloon-expandable stent-based endografts.

Malas MB ，Ohki T ，Veith FJ ，Chen T ，Lipsitz EC ，Shah AR ，Timaran C ，Suggs W ，Gargiulo NJ 3rd ，Parodi JC ... -  《JOURNAL OF VASCULAR SURGERY》

One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair.

This study evaluated 1-year safety and effectiveness outcomes of the United States regulatory trial for the Ovation Abdominal Stent Graft System (TriVascular Inc, Santa Rosa, Calif) for endovascular repair of abdominal aortic aneurysms (AAAs). This prospective, multicenter, single-arm trial was conducted at 36 sites in the United States, Germany, and Chile to evaluate the safety and effectiveness of the Ovation stent graft. From November 2009 to May 2011, 161 patients (88% males; mean age, 73 ± 8 years) with AAAs (mean diameter, 54 ± 9 mm) were treated with the Ovation stent graft. The main body is a modular two-docking limb device with a 14F outer diameter delivery system, active suprarenal fixation, and polymer-filled proximal rings that accommodate the aortic neck for seal. Main inclusion criteria included proximal aortic neck length ≥ 7 mm, inner neck diameter between 16 and 30 mm, distal iliac landing zones length ≥ 10 mm, and diameter between 8 and 20 mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30 days, 6 months, and annually through 5 years. A Clinical Events Committee adjudicated adverse events, an independent imaging core laboratory analyzed imaging, and a Data Safety and Monitoring Board provided study oversight. Complete 1-year follow-up data were available for this report. The Ovation stent graft was implanted successfully in 161 patients (100%), including 69 (42.9%) by percutaneous access. General anesthesia was used in 106 patients (65.8%). Technical success was 100%, and mean procedure time was 110 minutes. Median procedural blood loss was 150 mL, and median hospital stay was 1 day. The 30-day major adverse event rate was 2.5%. At 1 year, AAA-related and all-cause mortality were 0.6% and 2.5%, respectively. Major adverse event and serious adverse event rates through 1 year were 6.2% and 38.5%, respectively. The 1-year treatment success rate was 99.3%. The imaging core laboratory reported no stent graft migration or type I, III, or IV endoleaks. At 1 year, type II endoleaks were identified in 34% of patients, and AAA enlargement was identified in one patient (0.7%). No AAA rupture or conversion to open surgery was reported. AAA-related secondary procedures were performed in 10 patients (6.2%) for 12 findings, including endoleak (six), aortic main body stenosis (three), and iliac limb stenosis or occlusion (three). The 1-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in treatment of patients with AAAs, particularly in patients with challenging anatomic characteristics, including short aortic necks and narrow iliac arteries. Longer-term follow-up is needed.

Mehta M ，Valdés FE ，Nolte T ，Mishkel GJ ，Jordan WD ，Gray B ，Eskandari MK ，Botti C ，A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation Abdominal Stent Graft System Investigators ... -  《-》

The correlation of aortic neck length to late outcomes following EVAR with the Ovation stent graft.

Endovascular aneurysm repair (EVAR) performed outside manufacturers' instructions for use due to short aortic neck for the treatment of abdominal aortic aneurysm (AAA) is associated with unfavorable outcomes. Newer endografts now have an indication for shorter neck aneurysms that previous endografts do not, but this cohort has yet to be evaluated individually. The aim of this study is to evaluate 5-year outcomes after EVAR in patients with short aortic necks (<10 mm) using the Ovation stent graft. The study comprised 238 patients who underwent EVAR as part of the prospective international multicenter Ovation stent graft trials. The main inclusion criteria were AAA diameter ≥ 5 cm, proximal parallel neck length ≥7 mm, neck angulation ≤60°, and bilateral iliac fixation length ≥10 mm. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Patients were divided into short neck (<10 mm) and standard neck (≥10 mm) groups. End points included long-term survival, freedom from aneurysm-related mortality (ARM), freedom from type Ia endoleak, and freedom from reintervention. Patients were predominantly male (81%) with a mean age of 73 ± 8 years. Median follow-up time was 58 months (interquartile range, 36-60 months). Of 238 patients, 41 (17.2%) had a proximal neck length <10 mm and would be considered outside the instructions for use with other stent grafts. Baseline characteristics were relatively similar between the two groups. The 5-year overall survival estimates were 77.8% for the standard neck group compared with 59.5% for the short neck group (P = .03). There were no differences in the 5-year freedom from ARM (99.2% vs 100%; P = .7), freedom from type Ia endoleak (96.3% vs 96.3%; P = .8), and freedom from reintervention (77.9% vs 79.7%; P = .7) between the standard and short neck groups, respectively. After adjusting for age and other potential confounders, short proximal neck was associated with a two-fold increase in 5-year all-cause mortality (adjusted hazard ratio, 2; 95% confidence interval, 1.02-3.8; P = .04]. The Ovation endograft performed well in short AAA neck with no difference in 5-year type Ia endoleak, reintervention, and ARM rates. However, short proximal neck was independently associated with a two-fold increase in the risk of all-cause mortality at 5 years. These findings confirm the prior literature on the association of hostile neck anatomy with late mortality following EVAR.

Mathlouthi A ，Khan MA ，Al-Nouri O ，Barleben A ，Aburahma A ，Malas MB ... -  《-》

Long-term outcomes of the Ovation Stent Graft System investigational device exemption trial for endovascular abdominal aortic aneurysm repair.

Barleben A ，Mathlouthi A ，Mehta M ，Nolte T ，Valdes F ，Malas MB ，Ovation trial investigators ... -  《-》