Bergonti Marco, Teruzzi Giovanni, Santagostino Giulia, Grancini Luca, Ferrari Cristina, Trabattoni Daniela, Lualdi Alessandro, Bartorelli Antonio
Department of Cardiovascular Medicine, University of Milan, Milan, Italy.
Department of Interventional Cardiology, Centro Cardiologico Monzino, Milan, Italy.
Ann Vasc Surg. 2017 Oct;44:67-76. doi: 10.1016/j.avsg.2017.03.176. Epub 2017 May 4.
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.
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).
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/cm (P = 0.020) in the overall population and 26,770 vs. 41,104 cGy/cm (P = 0.003) in complex cases. No significant difference was found for contrast volume.
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.
我们的目的是分析使用Excluder血管内支架（美国亚利桑那州弗拉格斯塔夫市W.L. Gore公司）治疗的患者进行血管内动脉瘤修复（EVAR）的结果，比较具有SIM-PULL输送系统的第二代（ExSP）和具有C3的第三代（ExC3）在术中数据和长期结果方面的差异。
在我们的单中心比较研究中，我们回顾性分析了2008年5月至2015年12月期间所有接受Excluder择期EVAR的患者。该队列首先根据所使用的血管内支架设计进行划分，然后根据国际标准确定两个复杂手术亚组。初步终点是早期和中期结果。主要终点是手术数据（即手术时间、透视时间、辐射剂量（DAP）和造影剂用量）。
该研究纳入了64例患者（24例ExSP和40例ExC3），平均随访时间为31.6±22.9个月。ExC3组患者的危险因素（既往或当前吸烟史，P = 0.019）、合并症（慢性心力衰竭和慢性肾病，P均 = 0.032）以及解剖结构更不理想（颈部成角，P = 0.035）明显更多。关于初步结果，未发现组间有显著差异。至于术中数据，手术时间明显更短：总体人群中为120分钟对151分钟（P = 0.002），复杂病例中为129分钟对173分钟（P = 0.004）。透视时间和辐射暴露也显著减少：总体人群中为24,084对32,548 cGy/cm（P = 0.020），复杂病例中为26,770对41,104 cGy/cm（P = 0.003）。造影剂用量未发现显著差异。
该研究表明，与先前的装置相比，新型C3 Excluder能够减少辐射暴露和手术时间。尽管治疗患者的合并症更多且解剖结构更复杂，但CExcluder3的结果与先前装置相当。需要进一步研究以评估该装置在长期随访中的性能。
