Totally Percutaneous EVAR: Feasibility Outcomes for a Prospective, Randomized Trial Design

OBJECTIVES: Several single-center reports have been published to illustrate the feasibility and relative safety of a totally percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR). Yet, the absence of multicenter controlled trial experience leaves unanswered questions as to the technical efficacy and clinical benefit of this approach. We report our experience in the initial PEVAR feasibility phase of a new delivery system having an integrated 19Fr introducer sheath, and present the design for the first multicenter, prospective, randomized controlled trial of PEVAR.
METHODS: A feasibility evaluation of PEVAR using the IntuiTrak endovascular system (Endologix Inc., Irvine, CA) was conducted and entered into a central database. The indications, vascular characteristics, and operative experience were reviewed. A pre-specified grading system (1 to 5, 1 being best) was used by the treating physician to evaluate: the difficulty of iliac access, ease of main body deployment, inner core removal, and introducer sheath usage for delivery and deployment of accessory devices. Clinical utility measures (i.e., volume of contrast used, blood loss, total procedure time) were recorded and compared to original PMA trials.
RESULTS: Nine US institutions involving multi-specialty physician teams completed PEVAR repair using the IntuiTrak system in 25 patients. Challenging access was reported in 71% of cases. All patients received an anatomically-fixed bifurcated stent graft and extensions via the indwelling introducer sheath to achieve seal. Technical success was 100%, with no conversions to open repair. Mean device performance grades ranged from 1.2 to 1.3. Clinical utility measures were significantly reduced (P<.05) versus prior PMA trials. This and prior feasibility experience were used to develop the first randomized controlled trial to be conducted under an FDA-approved protocol. The primary composite endpoint, secondary endpoints, trial centers and protocol details will be presented.
CONCLUSIONS: This early experience supports the technical feasibility of an innovative delivery system for PEVAR. The conduct of a randomized controlled trial to objectively establish the relative safety, efficacy, and utility of this approach is clinically relevant.