Third- versus Second-Generation Stent Graft for Endovascular Aneurysm Repair: A Device-Specific Analysis.

PURPOSE: Our purpose is to analyze the outcomes of endovascular aneurysm repair (EVAR) in patients treated with Excluder endograft (W.L. Gore and Associate, Flagstaff, AZ), comparing second generation, featuring SIM-PULL delivery system (ExSP) and third generation, featuring C3 (ExC3), concerning intraprocedural data and long-term outcomes.

METHODS

In our single-center, comparative study, we retrospectively analyzed all patients undergoing elective EVAR with Excluder from May 2008 to December 2015. This cohort was firstly divided according to the design of the endograft used, and then, two subgroups of complex procedures were identified according to International Standards. Preliminary end points were early- and mid-term outcomes. Primary end point was procedural data (i.e., procedural and fluoroscopy time, radiation dose (DAP), and contrast medium amount).

RESULTS

The study included 64 patients (24 ExSP and 40 ExC3) with a mean follow-up of 31.6 ± 22.9 months. Patients in ExC3 group had significantly more risk factors (past or present history of smoking, P = 0.019), comorbidities (chronic heart failure and chronic kidney disease, both P = 0.032), as well as a more unfavorable anatomy (neck angulation, P = 0.035). Concerning preliminary outcome, no significant between-group difference was noted. As for intraoperative data, procedure duration was significantly shorter: 120 vs. 151 min (P = 0.002) in the overall population and 129 vs. 173 min (P = 0.004) in complex cases. A significant reduction was also found in fluoroscopy time and radiation exposure: 24,084 vs. 32,548 cGy/cm2 (P = 0.020) in the overall population and 26,770 vs. 41,104 cGy/cm2 (P = 0.003) in complex cases. No significant difference was found for contrast volume.

CONCLUSIONS

The study shows that new C3 excluder enables to reduce radiation exposure and procedural time compared to the previous device. C3 excluder results are comparable to those of the previous device in spite of more comorbidities and complex anatomy of the treated patients. Further studies are needed to assess device performance on longer-term follow-up.