This advertorial is sponsored by Bentley.
Crossing chronic total occlusion (CTO) lesions are challenging procedures. The BeBack crossing catheter—Bentley’s first product to be available in both Europe and the USA following the company’s acquisition of Upstream Peripheral Medical Technologies’ GoBack crossing catheter in September 2022—offers a new solution in this space. Andrej Schmidt (University Hospital Leipzig, Leipzig, Germany), 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 centres 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 with regard to the success of the BeBack catheter.
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 recanalisation 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 recanalisation 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 4Fr 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 above, 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 4Fr compatible, instead of 6Fr, 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, where 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 finalise the procedure successfully.
Below the knee we mainly use the 2.9Fr BeBack device, although also the 4Fr device 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 GW passes easily intraluminally through a stenosis, but no balloon would follow due to the tightness and calcification of the lesion. In this situation, the 2.9Fr 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 finalising the procedure.
Has the BeBack changed your practice and if so, how?
For many years, we and other centres 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 recanalisation 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 finalise the procedure successfully.
During CTO recanalisations, do you think that sometimes physicians start too late to switch from one to another technique?
Not infrequently physicians try different guidewires and different catheters many times to pass a difficult CTO or to 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 increases. Complications correlate with the duration of the procedure. The retrograde approach and the BeBack catheter are our technique and technology 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 to fail 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 (2.9Fr or 4Fr), 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 2.9Fr sheath. Furthermore, it is possible to use it over a 0.014” and over a stable 0.018” guidewire, which is usually the wire of choice in more complex lesions. Due to its 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 is easy to learn.
Case images1. CTO of the left superficial femoral artery in a male patient suffering from severe claudication left calf.
2. After subintimal passage it was impossible to redirect the guidewire into the patent lumen distal to the CTO.
3. Positioning of the BeBack catheter to re-enter the guidewire. Arrow indicates an orientation-marker.
4. Marker appearing as a “C” indicates the direction of the needle, needle protruding maximally out of the BeBack catheter.
5. A 0.018” guidewire passing into the patent distal lumen.
6. Result after stenting.