Aperto® drug-coated balloon technology shows promise in dialysis access patients

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Aperto
Michael Lichtenberg at CIRSE 2022

The Aperto drug-coated balloon (DCB) technology (Cardionovum) is “one of the very promising new technologies” for treating central vein stenosis and restenosis in dialysis access patients, Michael Lichtenberg (Arnsberg Vascular Center, Arnsberg, Germany) tells Vascular News.

Shunt stenosis and restenosis represent common threats to the function of arteriovenous fistulas (AVFs) and shunt grafts in patients on haemodialysis. Patients often develop a consecutive neointimal hyperplasia in haemodialysis access vessels as well as along the needle puncture site.

The new Aperto paclitaxel-releasing, high-pressure DCB dilatation catheter provides a dual shunt treatment quality for the prevention and dilatation of intimal hyperplasia. The device can treat AVF or polytetrafluoroethylene (PTFE) shunt graft venous outflow lesions successfully, leading to a substantial reduction of haemodialysis shunt stenosis and restenosis, for a prolonged dialysis access survival. The benefits of Aperto have also been demonstrated in the literature.1

Lichtenberg, who is director of the Angiology Department at the Arnsberg Vascular Center, has some clinical experience with the Aperto DCB technology, and shared his thoughts on the technology with Vascular News at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meeting (10–14 September, Barcelona, Spain). He spoke about some of the major difficulties associated with treating patients with central vein stenosis and restenosis, the latest treatments available, and some key insights from the APERTO CVS trial assessing the Aperto DCB technology.

What are some of the major difficulties associated with treating central vein stenosis and restenosis?

“Patients who are on chronic dialysis really depend on arteriovenous access for their dialysis treatment. Unfortunately, we know that arteriovenous access could have a lot of issues with stenosis and restenosis, which also counts for central veins, and if the central veins are blocked—i.e. they are stenotic or restenotic— it could mean that these patients lose their arteriovenous access for dialysis.”

What are the latest state-of-the-art treatments for this patient population?

“Unfortunately, standard balloon angioplasty is the most commonly used therapy option at the moment for restenosis or stenotic AVFs and central vein stenosis. There are new technologies like scoring devices and drug-eluting balloon angioplasties, which are now coming into focus, because we have learned that these new technologies have much better patency rates and freedom from loss of patency than standard balloon angioplasty. It has become clear that we need these new concepts to maintain patency.”

As a physician, what do you look for in a DCB in terms of features?

“You cannot use every DCB in stenotic and restenotic lesions, and the reason for this relates to device diameters. For central vein stenosis, you need DCBs with large diameters, for example 10mm or 12mm. That means you need dedicated products, dedicated DCBs for these indications. Therefore, I am really looking forward to having these new devices available, because they will expand treatment options.”

Can you tell us about the APERTO CVS trial?

“The Aperto DCB is one of the very promising new technologies for stenotic and restenotic lesions, and especially for central vein stenosis. The Aperto is available with large diameters and so with this device it is possible to treat central vein stenosis. The APERTO CVS trial prospectively analyses the efficacy and safety of this DCB technology for central vein stenosis. We have already recruited a couple of patients and the interim data are very promising.”

References

  1. Y Yin, Y Shi, T Cui, et al. Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicentre randomised controlled trial. American Journal of Kidney Diseases 2021; 71(1): 19–27.

DISCLAIMER: Not approved in the USA


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