Moonen Hanneke P F X, Koning Olivier H J, van den Haak Ronald F, Verhoeven Bart A N, Hinnen Jan Willem
Department of Vascular Surgery, Jeroen Bosch Ziekenhuis, Postbus 90153, 5200 ME, 's-Hertogenbosch, The Netherlands.
Cardiovasc Interv Ther. 2019 Jul;34(3):226-233. doi: 10.1007/s12928-018-0547-4. Epub 2018 Sep 26.
The objective is to evaluate our center's experience with the safety and efficacy of the percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR) with use of the Perclose Proglide device, in the first period after introduction in our center in 2014. We retrospectively identified all patients that underwent PEVAR or endograft extension with percutaneous approach in our center in the urgent and elective setting. Included were all procedures performed between the introduction of the technique in January 2014 and February 2016 when PEVAR had become the predominant technique in our center. Exclusion progressed from expected difficulty of the procedure as estimated by the operator to total calcification of the ventral wall of the CFA towards the end of the study period. Surgical and clinical reports were used to analyze patient characteristics, procedural success, and short-term outcome after 30 days. Follow-up imaging was used to assess mid-term access site complications at 1 and 2 years postoperatively. A univariate regression analysis was conducted to determine significant predictors of access-related complications with the Perlcose Proglide system. Of all 78 patients (mean age 74, SD: 7 years, 70 men), 68 (87.2%) underwent PEVAR and 10 (12.8%) underwent endograft extension procedures with percutaneous approach. Sixty-seven (85.9%) patients underwent an elective procedure and 11 (14.1%) patients underwent urgent PEVAR. The total number of vessels that was percutaneously accessed was 142. Direct technical success of the procedure as analyzed per vessel was 98.6% (140/142), with two cases of conversion to the femoral cut-down approach. A total of 274 Perclose Proglide devices were placed. Device failure of the Perclose device occurred in 5.8% (16/274) and was reason for conversion to cut-down procedure in one case. Mean duration of the procedure and median time of hospitalization were 100 (SD: 34) min and 2 (IQR 1, 3) days, respectively. Event-free survival per vessel after 30 days was 91.0%, with two minor access-related complication. Fifty-five individual patients (105 vessels) were eligible for inclusion in the 1-year follow-up analysis. Of these patients, 19 (34 vessels) could be included in the 2-year follow-up analysis. No additional access site complications occurred at mid-term follow-up. No significant predictors of device failure were found. The percutaneous approach to EVAR appears to be a safe and effective option with high success rate and low complication rate in a real-world setting. Based on our findings, we conclude that the technique can safely be introduced in a vascular center.
目的是评估2014年我院引入使用Perclose Proglide装置经皮途径进行血管腔内腹主动脉瘤修复术（PEVAR）后的安全性和有效性。我们回顾性确定了我院在急诊和择期情况下接受经皮途径PEVAR或血管内移植物延伸术的所有患者。纳入了2014年1月该技术引入至2016年2月PEVAR成为我院主要技术期间所进行的所有手术。排除标准从术者预估的手术预期难度，到研究期末股总动脉前壁完全钙化逐渐递进。通过手术和临床报告分析患者特征、手术成功率及术后30天的短期结果。采用随访影像学评估术后1年和2年的中期穿刺部位并发症。进行单因素回归分析以确定Perlcose Proglide系统穿刺相关并发症的显著预测因素。在所有78例患者中（平均年龄74岁，标准差：7岁，男性70例），68例（87.2%）接受了PEVAR，10例（12.8%）接受了经皮途径的血管内移植物延伸术。67例（85.9%）患者接受择期手术，11例（14.1%）患者接受急诊PEVAR。经皮穿刺的血管总数为142条。按每条血管分析，手术的直接技术成功率为98.6%（140/142），2例转为股动脉切开入路。共放置了274个Perclose Proglide装置。Perclose装置的器械失败率为5.8%（16/274），1例因器械失败转为切开手术。手术平均持续时间和住院中位时间分别为100（标准差：34）分钟和2（四分位间距1，3）天。30天后每条血管的无事件生存率为91.0%，有2例轻微穿刺相关并发症。55例个体患者（105条血管）符合1年随访分析的纳入标准。其中，19例（34条血管）可纳入2年随访分析。中期随访未出现额外的穿刺部位并发症。未发现器械失败的显著预测因素。在实际临床环境中，经皮途径EVAR似乎是一种安全有效的选择，成功率高且并发症发生率低。基于我们的研究结果，我们得出结论，该技术可在血管中心安全引入。
