This advertorial is sponsored by Bentley.
Crossing chronic total occlusion (CTO) lesions is a challenging procedure. The BeBack crossing catheter—Bentley’s first product to be available in both Europe and the United States following the company’s acquisition of Upstream Peripheral Medical Technologies’ GoBack catheter in September 2022—offers a new solution in this space. In this interview, Andrej Schmidt, MD, a senior interventionalist at University Hospital Leipzig in Leipzig, Germany, who was one of the first to use the catheter, shares his clinical experience with the BeBack, noting how it has been a “game-changer” in his endovascular peripheral arterial disease (PAD) practice.
What does your PAD practice look like, and what do you think are the most difficult aspects to overcome when treating CTO lesions?
The University Hospital Leipzig is one of the larger centers in Germany for the endovascular therapy of peripheral arterial occlusive disease, and we receive a lot of very complex cases—many of them failed in other hospitals. These are very often patients with severely calcified infrainguinal disease, but also complex iliac total occlusions.
Could you talk us through your first experience with the BeBack catheter?
We were struggling with a CTO of the common iliac artery in an abdominal aneurysm patient, and failed to get through the CTO coming from retrograde, cross-over and antegrade using an arm-access. Nothing worked until, eventually, we used the BeBack catheter via the retrograde approach. With this, device passage through the CTO back into the aorta succeeded immediately. This experience was an eye-opener for us.
Can the BeBack also be used as a support catheter?
In addition to its main purpose as a crossing catheter for complex, calcified CTOs, the BeBack indeed can be used as a support catheter, since it is quite stable and stiff. This feature is very helpful in difficult total occlusions. It also can be used as a re-entry catheter—for example during a recanalization of a CTO of the femoropopliteal segment. In the typical situation of being stuck subintimally, unable to pass the guidewire back into the true lumen distal to the CTO, the BeBack reliably helps to re-enter the distal patent segment of the artery.
How is the BeBack part of your recanalization strategy?
This depends on the type of lesion and the problem encountered during the intervention. For example, a typical femoropopliteal CTO is usually approached from antegrade. In case of inability to penetrate the guidewire into the CTO, either due to dense fibrosis of the proximal cap or severe calcification, the BeBack catheter is used as a crossing device by pushing the adjustable needle just a little bit out of the tip of the 4F catheter. More frequent, however, is the situation that the guidewire passes the CTO subintimally, and reconnection to the patent lumen, distal to the CTO, fails. As mentioned, the BeBack catheter is then used as a re-entry-device by protruding the curved inner needle further out of the tip of the catheter. Different to other re-entry devices is that the BeBack is 4F compatible, instead of 6F, and introduction into calcified, tight lesions may be easier. Yet, it can be used over a 0.018” guidewire, which is often the guidewire of choice in difficult CTOs, improving stability and success compared to 0.014” guidewires.
Another situation in which the BeBack is our device of choice is a reocclusion of the femoropopliteal segment with previous spot-stenting. Usually, the guidewire passes subintimally, and entering into the occluded lumen of a stent within a longer CTO is not possible. In this situation, the BeBack—indeed reliably and fast—allows the guidewire to enter into the proximal end of the occluded stent and to finalize the procedure successfully.
Below the knee, we mainly use the 2.9F BeBack device, although the 4F device also is used in the proximal third of the calf for penetrating through calcific CTOs, or for re-entering after subintimal guidewire passage. In some cases of severely calcified infrapopliteal lesions, it can happen that the guidewire passes easily intraluminally through a stenosis, but no balloon would follow due to the tightness and calcification of the lesion. In this situation, the 2.9F BeBack is inserted over the guidewire and, with the needle slightly protruded from the tip of the catheter, it is drilled into the problematic plaque. This technique, mimicking the Japanese technique of transcutaneous plaque-piercing, is very successful in facilitating introduction of balloons into the lesion and finalizing the procedure.
Has the BeBack changed your practice, and, if so, how?
For many years, we and other centers have helped to develop techniques to improve the success rate in difficult peripheral CTOs. The retrograde and bidirectional approach became standard in case of inability to pass a CTO from antegrade. However, in some cases it can be anticipated that establishing a retrograde access will be cumbersome or time consuming. In these cases, we now prefer the BeBack to keep the intervention simple. Furthermore, a bidirectional recanalization can be time consuming and may even fail. In this situation, the BeBack helps to speed up, and may even be the only way to finalize the procedure successfully.
During CTO recanalizations, do you think that sometimes physicians start to switch from one technique to another too late?
Not infrequently, physicians try different guidewires and different catheters many times in order to pass a difficult CTO, or re-enter back into the patent distal lumen. This increases the risk of protruding the dissection distal to the CTO, destroying healthy segments, which sometimes worsens the clinical situation. Furthermore, radiation dose and the amount of contrast medium increase. Complications correlate with the duration of the procedure. The retrograde approach and the BeBack catheter together are our technique and technology of choice in order to shorten the procedure time.
How much time—or how many attempts—would you give yourself with conventional techniques before using the BeBack crossing catheter?
It depends on the complexity of the lesion. If we see a chance to be successful using an antegrade approach, we may proceed for some minutes. In very complex lesions, where it can be anticipated that a conventional approach has a high risk of failure or may take time, we switch to the BeBack catheter within a minute.
If a colleague were to ask you about the BeBack, how would you describe it?
The BeBack is a reliable crossing and re-entry device. It is very slim (2.9F or 4F), yet very stable and can easily be used not only in larger diameter arteries like iliacs, but also in small arteries—even via a retrograde pedal access through a 2.9F sheath. Furthermore, it is possible to use the catheter over 0.014” and stable 0.018” guidewires, the latter of which is usually the wire of choice in more complex lesions. Due to the BeBack’s straightforward design, it is easy to position and reposition the device, and control the depth and direction of the 360-degree adjustable needle from the tip of the catheter. It is helpful in quite a large variety of difficult situations, and handling the BeBack is easy to learn.