This advertorial is sponsored by Cardionovum.
Cardionovum’s CE-marked Aperto drug-coated balloon (DCB) is, according to expert opinion and a growing evidence base, spearheading a revolution in the realm of vascular access maintenance for dialysis patients.
This high-pressure DCB has been specifically developed for the management of arteriovenous fistulas (AVFs), arteriovenous grafts (AVGs), and central vein stenosis (CVS), demonstrating a high level of effectiveness in protecting patency longevity.
Recent research conducted by Matteo Tozzi and colleagues at the Vascular Surgery Unit of the University of Insubria (Insubria, Italy) sheds light on the outcomes achieved with the Aperto DCB. Tozzi states that “in a randomised clinical study, the Aperto DCB had previously demonstrated its statistical superiority over a highpressure balloon. This result inspired the aim of conducting a more detailed analysis with a larger population, and today, including this experience, the Aperto DCB is backed by an extensive clinical programme, counting data from over 1,000 patients”.
Tozzi, who is professor of vascular surgery at the University of Insubria, continues: “Aperto 600 is a comprehensive study aimed at evaluating the safety and clinical efficacy of Aperto DCB angioplasty in patients undergoing haemodialysis. The research spanned seven years, from 2015 to 2022, at the ASST-Settelaghi University Hospital.”
He explains that the study followed established procedures, which included vessel preparation and DCB angioplasty. Patients were monitored every three months using colour Doppler imaging for peripheral stenosis, while clinical and haemodialysis data for CVS were collected.
The primary objective of this study, according to Tozzi, was to evaluate the patency of the vascular access circuit and the rate of restenosis in target lesions.
Tozzi and colleagues conducted angioplasties using 600 Aperto DCB, with 60.7% of the patients being male. Among the total cohort of patients, 105 patients had CVS, while the remaining 495 had stenosis in AVFs and AVGs.
Importantly, Tozzi shares, “at the one-year follow-up point, freedom from target lesion restenosis stood at 71% for AVF, 64% for AVG, and 57% for CVS, while collectively the circuit patency rate for all patients treated with the Aperto DCB reached an impressive 80%”.
Furthermore, he declares that “only 14% of cases required three or more procedures within a single year, underscoring the long-lasting impact of the Aperto DCB in preventing restenosis”.
Tozzi also emphasises that “these findings highlight the potential of the Aperto DCB in extending the survival of dialysis access. With high patency rates and a low requirement for repeated procedures, this innovative device not only offers hope to patients with AVF and AVG stenosis, but also presents an effective solution for the challenging CVS cases”.
Looking ahead, he also underlines an additional aspect of their study, mentioning that they had started a cost-benefit analysis comparing the standard care percutaneous transluminal angioplasty (PTA) versus the use of the Aperto DCB. According to Tozzi, there are clear advantages not only for patients, as it improves their quality of life through a reduced number of reinterventions and rehospitalisations due to the extended time between procedures, but also for the entire healthcare system and patient management due to the decreased costs associated with retreatments. Tozzi explains that “this economic aspect adds another layer of significance to the Aperto DCB’s impact, making it not only a medical breakthrough, but also a financially wise option for healthcare providers”.
Disclaimer: Not US Food and Drug Administration (FDA) approved