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 ... -  《-》

Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms.

This study evaluated the 2-year safety and effectiveness of the European First-in-Human INNOVATION trial for the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. From March 2010 to June 2011, the INNOVATION prospective multicenter trial involving six centers in Europe enrolled and treated 60 asymptomatic patients (95% male; mean age, 74.4 ± 6.9 years) with the INCRAFT System. Main inclusion criteria included proximal aortic neck length of 15 mm or more with a diameter up to 27 mm; distal iliac landing zones with a length greater than 10 mm and a diameter between 9 and 18 mm; and aortic bifurcation >18 mm in diameter and access vessels large enough to accept the 14F outer diameter of the delivery system. The primary end point was technical success at 1 month; 2-year safety end points included the absence of device- or procedure-related major adverse events, absence of type I or III endoleaks, and maintenance of device integrity through 2 years of follow-up. Study oversight was provided by a Data Safety Monitoring Board with event adjudication by a Clinical Events Committee and imaging analysis by an independent core laboratory. Of 60 successfully treated patients, two did not come back for their 1-month evaluation but remained enrolled in the study; 56 were evaluated at 1 year and 52 at 2 years. Of the 58 patients, 56 met the 1-month primary safety and effectiveness end point (97%; 95% confidence interval, 88%-100%). All patients were free from aneurysm enlargement through 2 years. There were no type I or III endoleaks at the 2-year time point. All-cause mortality at 2 years was 11.5%, and no death was device or procedure related. In total, three patients required a postprocedure intervention, two to repair a type I endoleak and one for limb occlusion. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration and stent fractures in all patients. The INCRAFT AAA Stent Graft System provides a durable solution for patients with abdominal aortic aneurysms, with a low frequency of device-related events through 2 years of follow-up.

Torsello G ，Scheinert D ，Brunkwall JS ，Chiesa R ，Coppi G ，Pratesi C ... -  《-》

Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system.

Endovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif). This prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States. A total of 155 patients were enrolled in the trial (mean age, 73 ± 8 years; male, 93.5%; mean AAA diameter, 53.6 ± 7.9 mm). The Aptus endograft is a two-component system: a multilumen, modular endograft with two docking limbs (Aptus Endograft System) and the Heli-FX Aortic Securement System comprising an electronically controlled applier (Heli-FX Applier) with helical EndoAnchors provided in a cassette and a deflectable sheath (Heli-FX Guide) designed for delivery of the applier to the target location for EndoAnchor implantation. The main eligibility criteria included proximal neck length of ≥12 mm, diameter of 19 to 29 mm, and infrarenal angulation of ≤60 degrees. The primary safety end point was freedom from major adverse events at 30 days, and the primary effectiveness end point was successful aneurysm treatment at 12 months. Thrombus-related events (TRE) were defined as limb occlusion or thromboembolism from the endograft. Subjects were observed for a median of 4.2 years, with imaging end points analyzed by a core laboratory and adverse events adjudicated by a clinical events committee. Among 155 enrolled subjects, 153 (98.7%) underwent successful implantation of the Aptus endograft and a median of five EndoAnchors; two subjects were converted to open surgical repair during the initial procedure. Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with one postdischarge cardiac death 18 days after implantation. There were no AAA ruptures. There were no fractures of stents or EndoAnchors. There was one type I endoleak and one type III endoleak. Stent graft migration was noted in five subjects, none associated with sac enlargement, type I endoleak, or EndoAnchor dislocation from the endograft. AAA sac shrinkage of ≥5 mm at 1, 2, and 3 years was observed in 60.3%, 72.9%, and 81.7%, respectively. Sixty-one subjects (39.4%) experienced 113 TRE, associated with 80 reinterventions (in 58 subjects) unassociated with limb loss or death. A root cause analysis of TRE identified small, out-of-specification docking limbs with graft infolding and high local shear, resulting in thrombus formation within the endograft with subsequent distal embolization in some cases. Early results of the Aptus endograft trial met its safety and effectiveness end points; however, a high rate of TRE was observed because of manufacturing discrepancies. The findings confirm a low rate of type I and type III endoleaks, migration, and non-TRE reintervention with a high rate of aneurysm sac regression during midterm follow-up.

Mehta M ，Henretta J ，Glickman M ，Deaton D ，Naslund TC ，Gray B ，McCann R ，Jordan W ，Fairman R ... -  《-》

Results of endovascular repair of infrarenal aortic aneurysms using the Endurant stent graft.

Recent reports showed that the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, Calif) is safe and effective for endovascular repair of abdominal aortic aneurysms (AAAs). However, due to its relatively recent introduction, only short-term follow-up data are available. This study presents the 4-year results using this device. All clinical data, including detailed anatomic information of the first 100 consecutive patients treated with the Endurant stent graft for an infrarenal AAA in three Dutch high-volume hospitals, were prospectively collected. Computed tomography angiography was routinely performed before the procedure, ≤ 1 month, and at 1 year post-endovascular aneurysm repair. Thereafter, the imaging modality during yearly follow-up was individualized (duplex ultrasound imaging or computed tomography angiography). Patients were classified as within or outside the instructions for use (IFU) for analysis. Study end points were primary clinical success, overall and AAA-related mortality, and sac morphology changes and endoleak during follow-up. Estimates were obtained using Kaplan-Meier plots. The study included 100 consecutive patients (88 men) with a median age of 74 years (interquartile range [IQR], 67-79 years) and median AAA diameter of 58 mm (IQR, 55-65 mm), between December 2007 and March 2009. Twenty patients (20%) were treated outside the IFU (18, outside proximal neck IFU, one outside iliac IFU, and one outside both IFUs). Median follow-up was 48 months (IQR, 36-53 months), and no patients were lost. One contained rupture was observed after 1.5 months due to graft infection. No patients had graft migration. Two type Ia endoleaks, 5 type Ib endoleaks, and 15 type II endoleaks were found. Primary clinical success was 97%, 90%, 84% and 77% at 1, 2, 3, and 4 years, respectively. Primary clinical success was comparable for patients treated within or outside IFU (P = .20), although both patients outside iliac IFU needed a secondary iliac intervention. Over time, maximum aneurysm diameter decreased ≥ 5 mm, remained stable, and increased ≥ 5 mm in 58%, 32%, and 10% of the patients, respectively. All-cause mortality was 20% at 4 years, with a 3% AAA-related mortality. The 4-year follow-up data of the Endurant stent graft for AAA treatment shows its use results in a low AAA-related mortality with adequate prevention of rupture or aneurysm growth. Although patients with very challenging anatomy were treated in our series, primary clinical success rates were comparable for patients treated within and outside the IFU. However, both patients outside the iliac IFU needed a secondary iliac intervention. The knowledge of the present results may aid in improving outcomes in the future.

Zandvoort HJ ，Gonçalves FB ，Verhagen HJ ，Werson DA ，Moll FL ，de Vries JP ，van Herwaarden JA ... -  《-》

One year outcomes of the United States regulatory trial of the Endurant Stent Graft System.

To report the 1-year outcomes of the United States (US) regulatory trial of the Endurant Stent Graft System (Medtronic Vascular), a new device for the treatment of abdominal aortic aneurysms (AAA). This was a prospective, single arm, multicenter trial conducted at 26 sites in the US. From April 2008 to May 2009, 150 patients with AAA were treated with the Endurant bifurcated stent graft. The main inclusion criteria were an AAA diameter >5 cm, proximal neck length ≥ 10 mm, bilateral iliac fixation length ≥ 15 mm, and a neck angulation of ≤ 60 degrees. A clinical events committee (CEC) adjudicated all adverse events except blood loss, and a core laboratory reviewed all imaging. The primary safety endpoint was freedom from major adverse events at 30 days, and the primary effectiveness endpoint was successful aneurysm treatment at 12 months. One hundred forty-nine patients (99.3%) had a successful stent graft implant, 83.3% under general anesthesia. One failure was due to inability to cannulate the contralateral gate. One patient developed a neck rupture during the procedure, but was still treated successfully. Patients were predominantly male (91.3%), elderly (mean age, 73.1 years) with significant comorbidities. Mean estimated blood loss was 185 mL (range, 0-1450 mL), with blood transfusion required in one patient. Average hospital stay was 2.1 days. At 1 month, the major adverse events rate was only 4% with no operative mortality. Serious adverse events were recorded in 43 of 150 (28.7%) patients. Cardiac (8.7%), fever (6%), urological (4.7%), pulmonary (4%), and vascular events (4%) were the most frequent. Through 12 months of follow up, there were no migrations, ruptures, or conversions. No type I or III endoleaks were identified during the first year. Fifteen of 129 patients (11.6%) had endoleaks at 6 months and 13 of 130 (10%) at 1 year, all type II except for one indeterminate endoleak. One Type II endoleak proved to be a Type IB on later angiography. Ten aneurysm related reinterventions were performed during the first year of follow up, mostly for limb thrombosis or stenosis (5) or for type II endoleak (2). Four of the procedures were endovascular. Aneurysm sac diameter decreased >5 mm at 1 year in 47% of patients and remained stable in 53%. No sac showed an increase of >5 mm. None of seven late deaths (range, 90-458 days post-implant) was adjudicated to be aneurysm related. Early results of the Endurant pivotal trial are quite encouraging and suggest a safe and effective new device for the treatment of abdominal aortic aneurysms.

Makaroun MS ，Tuchek M ，Massop D ，Henretta J ，Rhee R ，Buckley C ，Mehta M ，Ellozy S ，Endurant US Pivotal Trial Investigators ... -  《-》