The first session of CX 2020 LIVE also featured an Industry Symposium titled “Endovascular treatment of complex aortoiliac occlusive disease” (sponsored by Gore). Chaired by Michele Antonello (Padua, Italy), the symposium featured talks from Amer Zanabili (Oviedo, Spain) and Bella Huasen (Preston, UK), who examined the role of covered stents while reviewing the optimal endovascular management of aortoiliac occlusive disease. They questioned whether current guidelines were in need of revision to take into account the results of contemporary endovascular treatment, which goes beyond the use of bare metal stents to include the use of covered stents such as the Viabahn self-expanding and Viabahn balloon-expanding (VBX) stent grafts that offer a complete treatment solution for complex aortoiliac occlusive disease.
Endovascular therapy first-line strategy in nearly all aortoiliac lesions in Oviedo, Spain
In his talk, Zanabili discussed how Gore, with the Viabahn self-expanding and Viabahn balloon-expanding (VBX) stent grafts offered a complete treatment solution for complex aortoiliac occlusive disease. He told the online audience how his centre uses endovascular therapy as the first-line approach for “almost all” aortoiliac lesions.
Zanabili noted how aortobifemoral bypass was still the gold-standard therapy for complex aortoiliac occlusive disease—observing that the European Society of Cardiology (ESC) recommends bypass as the primary therapy with a Class II Level of evidence A recommendation. He acknowledged that surgery was associated with excellent long-term results with a primary patency rate of 85–90% at five years (and a secondary patency rate of 98%) but added that it was also associated with “considerable mortality and morbidity” (3–5% and 4–20%, respectively).
He further commented that several older studies have shown that, compared with surgery, while endovascular therapy is associated with lower primary patency, it is also associated with lower mortality and morbidity.
Zanabili went on to clarify that most of the patients in the endovascular groups of these older studies underwent treatment with bare metal stents… “at this point, we have to ask ourselves whether covered stents can improve the results achieved with the bare metal stent result. In my opinion, the answer is yes they can,” he stated.
He shared the concept of endoluminal bypass, which he explained is to “imitate the patency of open surgery, take the advantages of endovascular surgery (such as lower mortality and morbidity), and, finally, provide greater comfort for the patient”. He reported that COBEST (Covered versus balloon-expandable stent), which evaluated endoluminal bypass, showed that covered stents were associated with a lower rate of restenosis than were bare stents at 18 months (9.6% vs. 23%, respectively; p<0.02). Furthermore, long-term data from the trial showed that the advantage of covered stents continued at five years: 75% primary patency for covered stents vs. 62% for bare metal stents
His centre, Zanabili outlined, uses the self-expanding Viabahn endoprosthesis for complex and long lesions because “it is longer and more flexible than any type of balloon-expanding stent with no big with no big diameter mismatch.” In fact, he commented that they use the device “a lot” because endovascular therapy is frequently used as the first-line approach for managing aortoiliac occlusive disease. Though, he added that he and his colleagues do reserve open surgery for young patients at low surgical risk”
“In my opinion, to obtain a good long-term result that can compete with open surgery, I really think we need to use covered stents. We usually use covered stents in almost all lesions, not just in TASC C and D lesions. We also use covered stents for stenosis and occlusions of the external iliac artery, in calcified lesions, for the kissing stent technique, for intra-stent restenosis, and for obstruction of a bare metal stent,” he reported.
Discussing how his centre performs endovascular procedures, Zanabili revealed that they use computed tomography (CT) angiography before any intervention to assess “the localisation and extent of the lesion, type of lesion (stenosis, occlusion), and characteristics of lesion (calcification, thrombus etc)”. “Correct patient selection is crucial. We avoid treating claudicants who are young women, smokers or who have small arteries,” he added.
However, he said that common femoral artery disease is the “Achilles’ heel” of endovascular interventions. Therefore, his centre treated lesions in this area with femoral thromboendarterectomy or at least with patch angioplasty with the aim being to “create a healthy landing zone and improve outflow”. In particular, for iliac lesions with common femoral artery disease involvement, a hybrid approach is used with recanalisation via a guidewire before the endarterectomy and stent implantation after the patching. “We usually use the self-expanding Viabahn in external iliac artery lesions and in total iliac axis lesions. Historically, we have also used this device to treat complex lesions in the aortic bifurcation, but since the Viabahn VBX balloon expandable endoprostheses has become available, generally, it is our first choice for complex aortoiliac lesions,” he said. He concluded: “With Viabahn self-expanding and balloon-expanding stent grafts, Gore offers a global solution for the treatment of complex aortoiliac disease.”
Unique tapering makes Viabahn VBX endoprosthesis a “simple” choice
Bella Huasen (Preston, UK) reviewed how her department manages patients with aortoiliac occlusive disease in the UK. She told the CX 2020 LIVE online audience that the National Institute for Health and Care Excellence (NICE) guidance for peripheral arterial disease, which generally advises against the use of endovascular therapy for aortoiliac disease unless there is a complete occlusion, needed revising. “I would certainly say for a lot of us, the primary method of treatment is via the endovascular approach. The NICE guidance goes back to 2012. There were some revisions in 2018; however, I still think the guidance lacks the latest data and the technology changes,” She explained.
Huasen observed that where the NICE guidance does recommend stenting, for patients with critical limb ischaemia [now known as chronic limb-threatening ischaemia], it advocates the use of bare metal stents. But, she noted that covered stents—both self-expanding and balloon-expanding—were now available. “We choose balloon-expanding stents and Gore’s VBX endoprosthesis has been my primary choice for the past 24 months. The reason for choosing this stent technology is that it seems to cope very well with my patient population and the tapering it provides is unique. Not many stents, that I am aware of, allow you to taper and mould to tortuous vessels that are of various calibre and diameter. So, Viabahn VBX has proven to be simple,” she explained.
Furthermore, she said that it is interesting that this device is available in various diameters and lengths. “You can start off with 7mm diameter but post-dilate so that it becomes an 11mm diameter and all of this is [achieved] through a 7mm diameter sheath. This is a fantastic way to maintain the endovascular low sheath process and, hopefully, lower the risk of complications at the puncture site,” she commented.
According to Huasen, her “workhorse” stent was the 7mm device and she tended to use the 7Fr sheath. She outlined several complex cases in which she had used the VBX endoprosthesis, explaining that she could use it in various segments of a calcified vessel. “I may have kissing stents at the top with a single stent lower down. Basically, I reconstruct the whole inflow of the patient,” Huasen explained. Showing the post-procedure angiograms and 24-month angiograms of the cases, she said. “I have had fantastic results post-procedure and 24 months on. I have not seen any evidence of restenosis and reocclusion… the beauty of these cases is that the result is maintained.”
Huasen concluded: “Covered stents should be used in iliac disease, in particular in TASC C/D lesions. Balloon-expanding stents are proving to be successful, especially in my work. I would definitely recommend VBX for those of us who can access them; they can be used for other vessels, not just the iliacs. They have been a positive experience for me for the last 24 months. However, we are lacking data and so do need more trials and data. We also need to update our guidance.”
During the discussion that followed the two walks, Huasen said that she and Zanabili had been “chatting on social media” and had agreed that the Viabahn covered stents were “fairly amazing”. “The hard work is getting the stent through the calcium or the actual lesion. Once you are in there, it is fairly straightforward. I just ram in the VBX that I want, blow up the nominal pressure, and then mould and taper to the final size via an angioplasty balloon,” she added.
This coverage has been supported by an educational grant from Gore.