Current Use and Availability of Reentry Devices
Samit M. Shah, MD, PhD
Carlos Mena, MD, FACC, FSCAI
Key Points
Chronic total occlusions of the superficial femoral artery are a common presentation of peripheral arterial disease, and subintimal crossing has become a mainstay of infrainguinal intervention. However, failure to reenter the true lumen is the primary limitation to procedural success.
True lumen reentry devices have been shown in multiple trials to facilitate true lumen reentry and increase initial procedural success, but these devices are associated with increased financial cost and risk of vessel injury.
I. Chronic Total Occlusions
Chronic total occlusions (CTO) are present in nearly 50% of patients with peripheral arterial disease and most commonly affect the superficial femoral artery (SFA).1
Revascularization of CTO lesions can be technically challenging, and the presence of a CTO is associated with decreased procedural success.2 Specifically, CTO refers to occlusive lesions that have been present for greater than or equal to three months or stable lesions that completely prevent contrast opacification of the distal vessel.3,4 These lesions are composed of a proximal and distal fibrocalcific cap, mixed luminal plaque with thrombin and fibrin, and localized inflammation in the adjacent vascular wall.5
The goal of endovascular intervention for CTO is to cross the proximal cap, traverse the occluded lumen, and reenter the distal vessel to reestablish antegrade flow.6 However, the proximal cap may be heavily calcified, and lesions affecting the SFA may span over 20 cm in length.7 In many cases, crossing the true lumen may not be possible and a subintimal method can be used. This was first described by Amman Bolia in 1987 when an iatrogenic popliteal artery dissection was used to circumvent a 10 cm occlusion with recanalization of the true lumen distal to the lesion.8
The key aspects of the subintimal approach include accessing the subintimal space with a hydrophilic wire, crossing the lesion with a wire loop, and reentering the true lumen beyond the occluded segment. Angioplasty is performed in the subintimal space to create a neolumen between the intimal and adventitial layers of the vessel. The success of the subintimal approach hinges on the ability of the operator to reenter the true lumen distal to an occlusive lesion. Failure to reenter the true lumen has been cited as the primary limitation to procedural success in up to 15% of cases.9,10,11
True lumen reentry and the specialized devices that have been developed for this purpose are the focus of this chapter.
II. Pioneer Plus Catheter
First Reentry Device The first reentry device that was used in clinical practice was the CrossPoint.
TransVascular Systems (Palo Alto, CA) was subsequently purchased by Medtronic Inc. (Minneapolis, MN) in 2003, and the device was renamed the Pioneer catheter.
In 2013, the device was purchased by the Philips-Volcano Corporation (Rancho Cordova, CA) and rereleased as the Pioneer Plus catheter (Fig. 15.1A).
This dual-lumen catheter uses intravascular ultrasound (IVUS) to localize the true lumen of the vessel, and an extendable hollow 24G nitinol needle up to 7 mm long is deployed through the subintimal tissue to facilitate placement of a noncoated 0.014″ guidewire in the true lumen of the vessel.12,13 Notably, the device was recalled by Medtronic in 2011 owing to failure of the nitinol needle to retract back into the device.14
The device has an outer diameter of 6Fr and is advanced over a monorail 0.014″ guidewire into the subintimal space (Fig. 15.1B). A 20 MHz IVUS transducer at the tip of the device is used to orient the true lumen of the vessel at “12 o’clock” (Fig. 15.2) and the nitinol hypotube is then deployed to a fixed distance (from 3 to 7 mm). A second 0.014″ can then be advanced into the true lumen of the vessel, allowing for
the retraction of the needle, removal of Pioneer catheter, and subsequent angioplasty of the subintimal space. This method has been used successfully in both iliac15 and femoropopliteal lesions16 with a reported success rate greater than 95%.17,18 The length of the catheter is 120 cm which limits use of the device in infrapopliteal disease.
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