Vascular Outcomes Program, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale New Haven Hospital, Yale School of Medicine, New Haven, Conn.
Vascular Outcomes Program, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale New Haven Hospital, Yale School of Medicine, New Haven, Conn.
J Vasc Surg. 2021 Sep;74(3):746-755. doi: 10.1016/j.jvs.2021.01.045. Epub 2021 Feb 14.
Our aim was to evaluate the efficacy and safety outcomes of the Pioneer Plus catheter (Philips, San Diego, Calif) and report the in-hospital and 30-day outcomes of lower extremity chronic total occlusion (CTO) interventions assisted by the Pioneer Plus catheter. In addition, we explored the factors associated with procedural success.
We conducted a retrospective review of 135 consecutive procedures in 116 patients from July 2011 to September 2018 performed by eight operators with various levels of experience at a high-volume center where the Pioneer Plus catheter was used for lower extremity CTO. The patient demographics, preprocedural symptoms, preprocedural testing results, procedural setting, and angiography findings were abstracted. The outcomes were divided into device-related and procedure-related outcomes. Device-related efficacy outcome included procedural success. Device-related safety outcomes included device-related complications. Procedure-related outcomes included procedure-related complications, 30-day major adverse cardiovascular events, and 30-day major adverse limb events. We conducted univariate comparisons of the provider, patient, and procedural characteristics stratified by procedural success.
Procedural success was observed in 118 procedures overall (87.4%), and success rates ≤95.8% were observed for operators with an experience level of >25 devices deployed. No device-related complications, such as pseudoaneurysm formation, vessel perforation, or arteriovenous fistula formation, were observed. The Pioneer Plus catheter was mostly often used for CTO in the superficial femoral and popliteal arteries. Overall, the procedure-related complications included access site hematoma (5.2%), major bleeding (0.7%), pseudoaneurysm formation (0.7%), distal embolization (1.5%), and acute arterial thrombosis (1.5%). The 30-day major adverse limb events included index limb unplanned amputation (0.7%), index limb reintervention (4.4%), and index limb acute limb ischemia (0.7%) and occurred in 5.9% of the procedures. The only factor associated with procedural success was operator experience (P < .0001).
The results from the present study have shown that Pioneer Plus catheter use is safe and effective when used to cross lower extremity CTO. However, further investigation is needed to identify patient- and provider-level factors to optimize patient outcomes.
评估 Pioneer Plus 导管（加利福尼亚州圣地亚哥市飞利浦公司）的疗效和安全性，并报告经 Pioneer Plus 导管辅助治疗下肢慢性完全闭塞（CTO）的住院和 30 天结果。此外，我们还探讨了与手术成功率相关的因素。
我们对 2011 年 7 月至 2018 年 9 月在一家高容量中心进行的 116 例患者 135 例连续手术进行了回顾性分析，这些手术由 8 名经验水平不同的操作人员完成，均使用了 Pioneer Plus 导管治疗下肢 CTO。提取患者人口统计学资料、术前症状、术前检查结果、手术设置和血管造影结果。结果分为器械相关和手术相关结果。器械相关疗效结果包括手术成功率。器械相关安全性结果包括器械相关并发症。手术相关结果包括手术相关并发症、30 天主要不良心血管事件和 30 天主要不良肢体事件。我们对按手术成功率分层的提供者、患者和手术特征进行了单变量比较。
总体而言，118 例手术（87.4%）获得了手术成功，经验水平≥25 例器械部署的操作人员的成功率≤95.8%。未观察到器械相关并发症，如假性动脉瘤形成、血管穿孔或动静脉瘘形成。Pioneer Plus 导管主要用于股浅动脉和腘动脉的 CTO。总体而言，手术相关并发症包括入路部位血肿（5.2%）、大出血（0.7%）、假性动脉瘤形成（0.7%）、远端栓塞（1.5%）和急性动脉血栓形成（1.5%）。30 天主要不良肢体事件包括索引肢体计划外截肢（0.7%）、索引肢体再次介入（4.4%）和索引肢体急性肢体缺血（0.7%），发生在 5.9%的手术中。唯一与手术成功率相关的因素是操作人员的经验（P<0.0001）。
本研究结果表明，Pioneer Plus 导管用于穿过下肢 CTO 是安全有效的。但是，需要进一步调查以确定患者和提供者水平的因素，以优化患者的结果。
