The Aperto® drug-coated balloon: A “first-line” treatment for arteriovenous fistula lesions


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Matteo Tozzi

In 2023, there are a number of different options available for treating the vascular access complications of thrombosis and stenosis, Matteo Tozzi (University of Insubria, Varese, Italy) tells Vascular News. He highlights that perhaps the most useful option of all—with “fantastic outcomes” for patients—is the Aperto drug-coated balloon (DCB; Cardionovum), and considers this to be a “first-line” treatment for intimal hyperplasia in patients with an arteriovenous fistula (AVF).

The CE-marked Aperto DCB, Cardionovum claims, offers a prolonged dialysis access survival. The company details that the device is a high-pressure DCB intended for the treatment of shunt stenosis. Specifically, Cardionovum notes, it is designed to protect AVFs and shunt grafts from early restenosis and to prevent and successfully dilate intimal hyperplasia.

Tozzi and colleagues in the Vascular Surgery Unit at the University of Insubria recently prepared an analysis of over 600 AVF patients who they have treated with the Aperto DCB in their centre. The analysis includes the team’s experience from 2014 to 2023 with the device. “The outcomes are better [with the Aperto DCB] compared to standard balloon angioplasty,” Tozzi reports, adding that, “for haemodialysis patients with stenosis in their vascular access, I think DCB is the better option for treatment”.

Within the patient cohort included in the analysis, Tozzi highlights that there were a large number of central vein stenosis (CVS) lesions. The associate professor of vascular surgery notes that the central vein is a very challenging location for treatment of a stenosis and that there are likely many patients suffering with this hard-to-treat complication. In Tozzi’s opinion, the best first approach in these patients is DCB treatment. “In our cohort of patients, we treated more than 100 CVS lesions with the Aperto DCB and the results are better [than with standard balloon angioplasty],” he communicates.

Tozzi continues that around half of the patients he treats with CVS lesions undergo only one procedure within a year, elaborating that it is possible with a DCB alone to prolong the life of a patient’s access circuit and the functionality of their AVF in this period. After two years, however, he states that 40% of these patients go on to receive a stent graft, which he describes as the “second step” in the treatment of a CVS lesion when there are two or three instances of restenosis in the same time period.

He reiterates that the DCB should be viewed as a “first-line” treatment in CVS lesions, adding the caveat that in cases of “very fast” restenosis it is possible to treat these patients with a stent graft after treatment with a DCB. However, he notes that DCB treatment is often used again in the treatment pathway. Following treatment with a stent graft, he explains, it is sometimes necessary to perform a DCB angioplasty to treat aged stenosis.

Looking ahead, Tozzi believes that in the future the use of DCBs in de novo lesions will become more prevalent. In this type of lesion, he explains, cell replication is higher and so a DCB and the paclitaxel drug “run very well”.

In addition, Tozzi points to the importance of including DCBs in the guidelines for AVF treatment in the near future. This, he believes, would increase the possibility for patients who suffer with a stenosed vascular access to be treated with this “perfect device”.

Disclaimer: Not FDA approved


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