INNOVATION SHOWCASE Innovation Showcase to feature vascular technologies of tomorrow

The CX Innovation Showcase will take place once again at this year’s symposium, with demonstrations of some of the most novel and potentially practice-changing techniques, technologies and trials in vascular surgery taking place. The session runs throughout day three in Admiral.

The session’s opening section focuses on innovation consensus—chaired by Frans Moll (Utrecht, Netherlands)—and will see speakers from across the globe offer a wide range of industry perspectives.

Later the same morning, innovations in complex abdominal aortic aneurysm (AAA) treatment and prevention will be delivered. These include custom-made fenestrated and branched endovascular aneurysm repair (EVAR) solutions, presented by Tilo Kölbel (Hamburg, Germany); and preliminary experience with a new, self-expandable stent graft in complex aortic repair, presented by Giacomo Isernia (Perugia, Italy). Additionally, a Podium First will see Andrew Holden (Auckland, New Zealand) present first-in-human experiences with the Suture-Tight device (Vesteck).

In the vascular access and renal innovation portion of the programme, novel technologies like the Holly implantable device (Nephrodite) for continuous haemodialysis, and a wearable device for non-invasive, remote monitoring and classification of access patency and flow characteristics in haemodialysis patients, will be presented by Nikhil Shah (Atlanta, United States) and John Aruny (Orangeburg, United States), respectively.

Five-year data on GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis “raise the bar” in aortoiliac occlusive disease therapy

At this year’s CX Symposium, Andrew Holden (Auckland City Hospital, Auckland, New Zealand), presented results from the longest follow-up study to date evaluating the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft; Gore) in aortoiliac occlusive disease (AIOD). Here, he details how these new data “raise the bar” for durable, robust AIOD treatments.

AIOD is an “increasingly common problem”, Holden asserts, with around a third of all peripheral arterial disease (PAD) cases involving the iliac arteries. Discussing the backdrop to the VBX FLEX Clinical Study, he notes that—with endovascular treatments growing in prevalence over the past 15 years—balloon-expandable covered stents represent a “very appealing” option for this indication, theoretically providing lower rates of serious complications as well as improvements in long-term patency outcomes.

Results from the original VBX FLEX Study appeared to bear out these benefits, with the VBX Stent Graft demonstrating high one-year rates of primary (94.5%), primary-assisted (99%) and secondary (99.5%) patency, in addition to a 98.1% rate of freedom from clinically driven target lesion revascularisation (fCD-TLR) at three years. However, in an attempt to further elucidate the durability of these positive findings, Holden led a physician-initiated follow-up in a subset of these patients out to five years.

“The concept of durable patency in aortoiliac disease is really important,” he says. “The vast majority of these patients are ‘claudicants’ [who] have a much longer life expectancy than patients with critical limb ischaemia—often living for 10 years or longer—so durability of treatment is something that has come into focus. But, until recently, we really had very little useful information on how durable these covered stents are, in particular in the iliac arteries.”

The five-year follow-up with the

Prior to the day’s lunch break, Stephen Black (London, United Kingdom) will deliver a talk titled, “Early clinical optimisation with microinfusion device and DEXTERITY study update”, as part of the venous innovation consensus session. Following this, Ramon Varcoe (Sydney, Australia) will present first-in-human experiences with a percutaneous valve for venous insufficiency. A packed afternoon session on peripheral innovations will see further updates on vascular trials—for example, the RESOLV study, set to be delivered by Marianne Brodmann (Graz, Austria). A number of presentations are also scheduled to examine the role more novel drugs like sirolimus and everolimus can play in below-the-knee treatments. Eric Secemsky (Boston, United States) will also discuss “the next frontier” in peripheral therapies: the role of micro-incisions in preparing the vessel for drug-coated balloons (DCBs).

Artificial intelligence (AI) and deep learning will be the centre of focus during the penultimate session of the day, with presentations from Guy Martin (London, United Kingdom) and Tomas Baltrunas (Vilnius, Lithuania) on robotic endovascular surgery leading the agenda. This is set to be followed by a talk from Richard Linder (Sandy, United States) on the impact of “the first global wireless network for vascular imaging and physiology”.

Chaired by Stephen Greenhalgh (London, United Kingdom), the CX Innovation Showcase will close with a Dragon’s Den-style competition. Among these innovations are a remote vascular connection technique for distal bypass surgery; the non-invasive, distant and lifelong monitoring of arteriovenous fistulas (AVFs); a prophylactic sac management system; and an electrocardiogram (ECG) “anytime, anywhere, in 60 seconds”.

VBX Stent Graft saw 59 patients enrolled from the original study’s three highest-participating centres—Holden’s own centre in Auckland, as well as Prisma Health (Greenville, USA) and Wellmont Holston Valley Medical Center (Kingsport, USA). A total of 28 patients completed the five-year follow-up and could be assessed as per the study’s primary durability endpoint of long-term primary patency. An important detail Holden highlights here is that this patient cohort was representative of the full spectrum of disease seen in AIOD patients, with about one third of patients having more complex lesions (Trans-Atlantic InterSociety Consensus [TASC] C or D).

Arriving at the crux of the study’s findings, he reports sustained long-term durability with the VBX Stent Graft, indicated by an “excellent” 84.4% primary patency rate per subject, and an 89.5% primary patency rate per lesion (n=94)—an “incredible, unrivalled performance”—at five years.

“To put that into context, there had only been one other publication reporting five-year patency—74.7% with the iCAST/Advanta V12 [Getinge] in COBEST,” Holden states, “so to really raise the bar and report a patency of 89.5% was extremely pleasing.”

He goes on to note that the persubject primary-assisted and secondary patency rates were the same (93.3%) at five years, as was the per-lesion rate (96.1%) for both. Additionally, there was a five-year, per-subject fTLR rate of 89.1%—also a “very high figure”, according to Holden—and 12 deaths (20.3%), none of which were found to have been device-related. Finally, he outlines sustained improvements in Rutherford classification scores and walking impairment, as well as on quality-of-life questionnaires.

“For these patients, we hope to provide a durable treatment, and it is very difficult to imagine any treatment for aortoiliac disease that could achieve superior patencies to this—particularly a minimally invasive therapy like an endovascular covered stent,” Holden concludes. “To be able to tell patients they are going to get a durable patency, and the vast majority will never need to have another intervention related to this treatment; those are the most compelling outcomes for me.”

The CX Symposium also saw Holden announce a “very exciting” next step in evaluating the VBX Stent Graft: a multicentre randomised controlled trial, with long-term follow-up, comparing the device to bare metal stenting in complex iliac occlusive disease.