Back to Search
Start Over
Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions.
- Source :
-
Journal of vascular surgery [J Vasc Surg] 2021 Sep; Vol. 74 (3), pp. 746-755. Date of Electronic Publication: 2021 Feb 14. - Publication Year :
- 2021
-
Abstract
- Objective: 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.<br />Methods: 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.<br />Results: 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).<br />Conclusions: 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.<br /> (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Catheterization, Peripheral adverse effects
Chronic Disease
Endovascular Procedures adverse effects
Equipment Design
Female
Humans
Male
Middle Aged
Peripheral Arterial Disease diagnostic imaging
Peripheral Arterial Disease physiopathology
Retrospective Studies
Time Factors
Treatment Outcome
Ultrasonography, Interventional adverse effects
Vascular Patency
Catheterization, Peripheral instrumentation
Endovascular Procedures instrumentation
Lower Extremity blood supply
Peripheral Arterial Disease therapy
Ultrasonography, Interventional instrumentation
Vascular Access Devices
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6809
- Volume :
- 74
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of vascular surgery
- Publication Type :
- Academic Journal
- Accession number :
- 33592298
- Full Text :
- https://doi.org/10.1016/j.jvs.2021.01.045