Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions

Sheikh, Azfar Bilal; Llanos-Chea, Fiorella; Jelani, Qurat‐ul‐ain; Narayanan, Mahesh Anantha; Attaran, Robert R.; Schneider, Marcie; Ionescu, Cătălina; Regan, Christopher; Nagpal, Sameer; Smolderen, Kim G.; Mena‐Hurtado, Carlos

doi:10.1016/j.jvs.2021.01.045

Cited by 9 publications

(8 citation statements)

References 17 publications

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“…A factor of success with Pioneer mentioned in only one of the studies is operator familiarity. In the study by Sheikh et al (Sheikh et al, 2021 ), it was found that the operators who had used the Pioneer device over 25 times had a 95.8% success rate which dropped to 65.6% in those who had used it 5–25 times. In our experience, 10 cases is probably a reasonable number to gain confidence in the device and technique.…”

Section: Discussionmentioning

confidence: 99%

Use and effectiveness of Pioneer re-entry device for subintimal true lumen re-entry: single-centre data and a review of the literature

et al. 2021

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Introduction During subintimal angioplasty (SIA), it is not always possible to re-enter the vessel lumen due to a variety of factors. Recanalization using hydrophilic wires and catheters alone, apart from its potential technical failure, is also limited by minimal control over the re-entry point. This is frequently well beyond the point of occlusion, thus often compromising important collaterals. In order to bypass the obstruction and attain controlled re-entry into the lumen of the diseased vessel, a re-entry device (RED) may be required. This paper assesses our centre’s experience with the safety and efficacy of the Pioneer re-entry system and systematically reviews the pertinent literature. Method A single centre retrospective study of subintimal angioplasty involving the use of the Pioneer Plus intravascular guided reentry catheter was performed. Patient demographics including age, gender, risk factors, comorbidities clinical indication and complications were recorded. Lesion characteristics, including location and severity of calcification were also assessed. A systematic literature review of all reported studies where the Pioneer RED was used for iliac and lower limb revascularization was conducted by 2 of the authors using the PubMed (MEDLINE) and EMBASE databases. Results The study comprised 30 cases. Technical success was 97%. A small, quickly resolved extravasation was the only device related complication. These results are in line with the systematic review which identified 16 studies using the Pioneer RED, reporting a technical success rate of 87.4–100% (median = 100%) and complication rate of 0–25.8% (median = 0%). However, due to heterogeneity in definitions of technical success, data was not pooled.

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Section: Discussionmentioning

confidence: 99%

Use and effectiveness of Pioneer re-entry device for subintimal true lumen re-entry: single-centre data and a review of the literature

et al. 2021

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“…This technique is similar to a Pioneer Plus catheter (Philips, San Diego, CA, USA), which has both a curved needle and an IVUS transducer at the end of the catheter. 11 This technique, however, has several limitations. First, the Navifocus WR catheter is only compatible with 0.014-inch guidewires.…”

Section: Discussionmentioning

confidence: 99%

Parallel Wiring Using a Single Intravascular Ultrasound Catheter with Double Rapid Exchange Lumens Technique for Chronic Total Occlusions in Peripheral Artery Disease

et al. 2021

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Purpose: To describe a parallel wiring using a single intravascular ultrasound catheter with double rapid exchange lumens (PASSABLE) technique for peripheral CTOs. Technique: The technique is demonstrated in a 73-year-old patient with CTOs of the superficial femoral and popliteal artery. Intravascular ultrasound (IVUS) examination revealed the first guidewire was advanced to the intramedial space of the popliteal artery. Following insertion of the first guidewire into only the distal rapid exchange lumen of the IVUS catheter and a second guidewire into the proximal rapid exchange lumen, a guidewire torquer was passed over it and tightened close to an exit port of the proximal rapid exchange lumen to prevent it from exiting an entry port while advancing the IVUS catheter. The IVUS catheter was advanced to the intraplaque region using only the distal rapid exchange lumen and the second guidewire was then advanced to the intraplaque region under IVUS guidance. The IVUS-guided wiring using the second guidewire on both the distal and proximal rapid exchange lumen was continued and resulted in a successful guidewire crossing into the distal true lumen. Conclusion: This novel technique may prove beneficial in enabling operators to perform IVUS-guided parallel wiring more easily and efficiently.

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“…[25][26][27] Operators who used the Pioneer device more than 25 times had a 95.8% success rate, whereas those who had used it 5 to 25 times had a 65.6% success rate, suggesting the relevance of the learning curve in the use of this device. 28 Reported complications include self-limited focal extravasation, access site hematoma and pseudoaneurysm, and distal embolization. 25,28 In addition, the Pioneer Plus has also been described in two cases of retrograde deployment from dorsalis pedis artery access into the popliteal artery and into the SFA.…”

Section: Pioneer Plus Cathetermentioning

confidence: 99%

“…28 Reported complications include self-limited focal extravasation, access site hematoma and pseudoaneurysm, and distal embolization. 25,28 In addition, the Pioneer Plus has also been described in two cases of retrograde deployment from dorsalis pedis artery access into the popliteal artery and into the SFA. 29 The Pioneer is particularly well-suited for use in the iliac arteries, where penetration of dense plaque is of greatest importance, and precise maneuverability is not as crucial as would be needed in the distal lower extremity vessels.…”

Section: Pioneer Plus Cathetermentioning

confidence: 99%

Percutaneous Intentional Extraluminal Recanalization of Chronic Total Occlusions: A Review of Reentry Devices

Kinariwala

Taylor

Wilkins

2023

Semin intervent Radiol

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Percutaneous intentional extraluminal recanalization (PIER) is an endovascular subintimal crossing technique used to treat chronic total occlusions (CTOs) of the peripheral arteries. Intraluminal revascularization remains the standard over PIER when technically feasible; however, when intraluminal approaches fail, PIER may be preferred prior to pursuit of surgical bypass grafting. The major cause of failure of PIER is inability to reenter the true lumen after crossing the CTO. Therefore, several reentry devices and endovascular techniques have been developed to allow for the operators to safely and quickly access the true lumen distal to the occlusion. Reentry devices currently available on the market include the Pioneer Plus catheter, Outback Elite catheter, OffRoad catheter, Enteer catheter, and GoBack catheter. These devices have unique methods of use and specific advantages with regard to their technical success along with reduced procedural and fluoroscopic time. In addition, there are other endovascular techniques available that may facilitate true lumen reentry and these will also be reviewed.

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Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions

Cited by 9 publications

References 17 publications

Use and effectiveness of Pioneer re-entry device for subintimal true lumen re-entry: single-centre data and a review of the literature

Use and effectiveness of Pioneer re-entry device for subintimal true lumen re-entry: single-centre data and a review of the literature

Parallel Wiring Using a Single Intravascular Ultrasound Catheter with Double Rapid Exchange Lumens Technique for Chronic Total Occlusions in Peripheral Artery Disease

Percutaneous Intentional Extraluminal Recanalization of Chronic Total Occlusions: A Review of Reentry Devices

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