Endovascular treatment in critical ischemia: more advantages

Marc Sirvent and August Ysa.

Marc Siventangiologist and vascular surgeon, and August Ysavascular and endovascular surgeon, are the two specialists who act as co-directors of the course on the approach to critical limb ischemia (CLI). A virtual event that was held on April 7, aimed at doctors from all over the country and whose purpose was to share the latest developments and innovations in the treatment of this pathology.

In addition, Ysa presented the case ‘Approximation to complex CLI intervention through a combined strategy: discussion based on a clinical case’; and Sirvent gave a talk on Recanalization with support catheter and DCB treatment of complex lesions in distal trunks. And they talk about their knowledge about these specializations and their future in this interview with Medical Writing.

He has given a talk on recanalization with a support catheter and treatment with DCB of complex lesions in distal trunks. Which ideas of those transmitted are the ones that provide the greatest novelty?

Marc Sirvent: The objective of the presentation was, on the one hand, to present the Sergeant support catheter, whose fantastic visibility, navigability and profile facilitates the treatment of complex injuries and, on the other hand, to establish a debate on the use of impregnated balloons of paclitaxel in the infragenicular arteries (BTK) and in which clinical scenarios would they be most indicated to use them. These balloons have widely demonstrated their effectiveness in the femoro-popliteal sector, but in BTK there is much more controversy about their use. However, during the last two years, some international studies with a high level of evidence have emerged that demonstrate the efficacy of these devices in a statistically significant way also in BTK. In this direction, we comment on the BIBLIOS study, an international, multicenter study evaluating the efficacy and safety of the Luminor 14 balloon in BTK and in which our hospital actively participated. Their results are not yet published, but internal and preliminary analyzes look promising.

In late 2018, due to a meta-analysis by Katsanos et al (doi:10.1161/JAHA.118.011245), there was a lot of controversy about the safety of paclitaxel-impregnated balloons, which facilitated the emergence of sirolimus-impregnated balloons. We also wanted to address this issue during the session and it was concluded that doubts about the safety of paclitaxel seem to have largely dissipated and that sirolimus medicalized balloons have not yet reached a high level of evidence.

The session was aimed primarily at vascular surgeons and radiologists. How do both specialties share their role in innovation in the approach to CLI?

Marc Sirvent: Endovascular interventions have progressively replaced conventional surgery in the treatment of peripheral arterial disease as they are minimally invasive procedures, with low morbidity and mortality and a high success rate in most situations. These are techniques that can be performed by both vascular surgeons and interventional radiologists, and it is not uncommon to see cardiologists treating these patients in other countries.

In Spain, it is basically the vascular surgeons who treat these patients in most centers, but in others it is the interventional radiologists, working together or not with the vascular surgeons, who perform the endovascular treatment. In my opinion, vascular surgeons and interventional radiologists can come together perfectly in the approach to critical ischemia, they simply need both the necessary training in this type of technique and good cooperation. The best thing for the patient is to be operated on by the person who is best trained and who knows how to do it the best. Unfortunately, there are centers where vascular surgeons and radiologists are at odds with what, in my opinion, is a gross error that is detrimental to good care for this type of patient.

Resulting in the multidisciplinary field for the treatment of CLI, what other specialties are involved or should be involved?

Marc Sirvent: When we talk about critical ischemia, we must take into account the high percentage of diabetic patients, which exceeds 70 percent. At this point a new problem appears, which is the diabetic foot. It is not only that a foot can be ischemic, but due to long-standing and poorly controlled diabetes, there may be, for example, a motor neuropathy that causes deformities or a sensory neuropathy that prevents patients from feeling pain, predisposing factors for appearance of wounds on the feet.

In diabetic foot, the multidisciplinary approach is essential to obtain the highest success rate in the treatment of these patients and drastically reduce their amputations. And here many specialties converge, as happens in our hospital, where our Diabetic Foot Unit is an example of coordinated teamwork and a benchmark in the diagnosis and treatment of this clinical entity, training a multitude of specialists from different specialties every year.

In this way, the specialties involved, apart from vascular surgery, are: podiatry, endocrinology and nutrition, infectious medicine, plastic surgery, traumatology, diagnostic imaging (both conventional and nuclear and interventional radiology), home care, nursing, rehabilitation, primary care, social work and some other that I may have forgotten at this time. This scenario demonstrates the great complexity of the diabetic foot and the need for multidisciplinary work to treat the patient globally.


“Vascular surgeons and interventional radiologists can come together perfectly in the approach to critical ischemia, both simply need the necessary training”



What do you think will be the next steps in this field of healthcare innovation?

Marc Sirvent: Critical ischemia will grow just as diabetes does, since, as has already been said, it is a factor closely related to this disease. For this reason, and in line with what was mentioned in the previous question, I believe that one of the important points will be, precisely, that there be a multidisciplinary approach to this pathology, something that unfortunately does not occur in many centers today. This is essential to optimize the results.

On the other hand, if the focus is on endovascular therapy, it is obvious that the treatment of these patients will continue to advance with innovative therapies. For example, we are increasingly aware of the importance of preparing the vessel before using what we consider to be the definitive treatment of the artery, which is why the appearance and expansion of the use of tools for this purpose, such as the different types of scoring balloon, IVL or atherectomy systems, may provide better and longer lasting results, which implies less need for reinterventions to achieve limb salvage. In the same vein, I believe that the field of drug-impregnated technology (balloons and stents) will play a prominent role in therapeutic innovation and in the future of these patients, since different sirolimus-impregnated devices are already appearing and some are being developed. self-expanding drug-eluting stents and longer than currently available balloon-expanding drug-eluting stents.

What is the greatest advantage that the physician who has attended this conference on the treatment of critical limb ischemia (CLI) has been able to extract?

August Ysa: In recent years, endovascular treatment of critical ischemia has become the technique of choice due to its advantages (less morbidity, shorter hospital stay, lower rate of complications) compared to conventional surgery.

From a technical point of view, we must have an algorithm that allows us to maneuver through the multitude of scenarios that can arise. Among the most important steps for decision making are the selection of the target vessel, the choice of access, the choice of material, and knowledge of rescue techniques for ultra-complex scenarios. This type of training allows, based on cases, to convey to professionals these situations that arise in daily clinical practice, facilitating interaction with KOL and providing them with tools for conflict resolution.

What are the latest techniques in the treatment of CLI?

August Ysa: During the last ten years major medical companies have invested a lot of effort in developing dedicated devices for the endovascular treatment of critical ischemia, with a particular focus on the BTK (Below The Knee) sector.

CLI BTK lesions are long, diffuse, and often highly calcified. Furthermore, BTK arteries are small and therefore even minimal neointimal hyperplasia or recoil after conventional angioplasty will have a more severe adverse effect compared to larger caliber vessels. These unfavorable characteristics contribute to remarkably high restenosis rates after balloon angioplasty.

In this regard, the appearance of technology aimed at the adequate preparation of the vessel with cutting balloons (balloon scoring), atherectomy or IVL, is presented as a promising alternative in conjunction with the use of DCB, particularly in calcified or fibrotic lesions.

The development of devices with lower profiles has allowed the use of retrograde access not only to traverse lesions, but also to treat them from the distal access itself. The appearance of dedicated material can facilitate the access, crossing and treatment of these complex lesions even on an outpatient basis.

Finally, the development of new therapeutic strategies such as percutaneous venous arterialization (in which our center is a pioneer with its VAST technique), opens up new possibilities for patients defined as “without treatment options” who were traditionally indicated for a major amputation. in a primary way.


“We are facing an epidemic of ILC, and the lack of an effective long-term treatment for BTK treatment means that there is a great unmet need”



What advantages do they provide for the health professional compared to the previous ones? And for the patient?

August Ysa: We are facing an epidemic of ILC, and the lack of an effective long-term treatment for BTK treatment means that there is a huge unmet need. However, promising new technologies designed to overcome these challenges are being tested.

Balloon angioplasty for BTK continues to be the standard of care, although with unsatisfactory results. The use of non-compliant balloons can reduce the rate of early recoil, but the solution for a more lasting treatment lies fundamentally in the prevention of neointimal hyperplasia in the small BTK vessels, and in this sense, DCB therapy could become the answer .

Due to multilevel arterial disease and diffuse calcifications, endovascular procedures in patients with critical ischemia are often very challenging and complex. The possibility of improving long-term results could result in a higher rate of limb salvage and improvement in the patient’s quality of life, by reducing the need for iterative procedures.

You have presented the case ‘Approach to complex CLI intervention through a combined strategy: discussion based on a clinical case’. What challenges does the aforementioned combined strategy open up?

August Ysa: The challenge is to achieve standardization in training with dedicated and highly qualified professionals in the field of critical ischemia. Training to improve skills and training in this type of procedure is important. Adequate knowledge of the therapeutic arsenal available, and mastery of resource techniques such as retrograde access, allows us to improve our technical success rate and expand therapeutic options to complex patients or those with previous failed attempts.

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