title: Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Department of Vascular and Endovascular Surgery, Albany Medical College, Albany, NY. Electronic address: mehtam@albanyvascular.com.
authors: Manish
authors: M
authors: Mehta
authors: Department of Vascular Surgery, Mission Health, Ashville, NC.
authors: John
authors: J
authors: Henretta
authors: Department of Vascular Surgery, Sentara Heart Hospital, Norfolk, Va.
authors: Marc
authors: M
authors: Glickman
authors: Department of Vascular Surgery, Georgetown University, Washington, D.C.
authors: David
authors: D
authors: Deaton
authors: Department of Vascular Surgery, Vanderbilt University, Nashville, Tenn.
authors: Thomas C
authors: TC
authors: Naslund
authors: Department of Vascular Surgery, Greenville Hospital System, Greenville, SC.
authors: Bruce
authors: B
authors: Gray
authors: Department of Vascular Surgery, Duke University, Durham, NC.
authors: Richard
authors: R
authors: McCann
authors: Department of Vascular Surgery, University of Alabama Birmingham, Birmingham, Ala.
authors: William
authors: W
authors: Jordan
authors: Department of Vascular Surgery and Endovascular Therapy, University of Pennsylvania, Philadelphia, Pa.
authors: Ronald
authors: R
authors: Fairman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000601:surgery; D011446:Prospective Studies; D011474:Prosthesis Design; D012086:Reoperation; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014481:United States