carotid stenting

A CX debate between two prominent carotid interventionists— Peter Schneider (San Francisco, United States) and Domenico Valenti (London, United Kingdom)—yesterday revealed that the vascular community is currently divided over the benefits of transcarotid artery revascularisation (TCAR), as compared to percutaneous carotid artery stenting (CAS).

SCHNEIDER KICKED OFF the debate by arguing in favour of TCAR, initially outlining some of the limitations of percutaneous CAS that prior studies have demonstrated—for example, unwanted events relating to manipulation of the aortic arch as well as incomplete particulate capture. He went on to query if there is a “better way” to treat carotid artery disease, positing that TCAR may offer a solution that overcomes these limitations. Once again referring to the current literature in this space, he noted that TCAR can enable greater neuroprotective capabilities; improved safety in symptomatic patients and octogenarians; and carries a more efficient learning curve, versus percutaneous stenting.

After reiterating the “unresolved challenges” CAS faces, including those relating to the aortic arch and particulate capture, Schneider concluded that prospective TCAR studies and his own experiences have shown both safety and efficacy with the procedure, demonstrating outcomes that are “competitive” with carotid endarterectomy (CEA) and “substantially better” than with percutaneous stenting.

Offering a riposte to these assertions, Valenti stated that TCAR—in essence, at least—has been around for many years, and is therefore not the “disruptive technology” within carotid interventions it is sometimes presented as, also claiming that his opponent and other TCAR advocates have been “mesmerised” by the existing data. Homing in on said data, Valenti challenged positive conclusions drawn from the results of the ROADSTER 2 trial, noting its non-randomised nature, low proportion of symptomatic patients and, “more importantly”, lack of stratified data on delay to treatment. Additionally, he told attendees that findings from the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative (VQI) are also limited by selection biases, gaps in the data, and the fact they come from a nonrandomised trial. Finally, Valenti noted that CAS has been subject to far more “intense scrutiny” than TCAR to date—for example, in the CREST, ICSS and SPACE randomised controlled trials (RCTs). And, while he commented that TCAR may yet prove useful in certain patients, they are yet to be identified, and the lack of RCT-derived evidence supporting it means the “death” of percutaneous stenting is not imminent. A subsequent audience poll produced a very close result, but ultimately saw more CX attendees concur with Valenti’s closing gambit that “TCAR is not about to send CAS to oblivion”, as 52% voted against the statement that ‘TCAR is better than percutaneous carotid stenting’.

Following his Podium First presentation ‘Statin treatment after aortic repair’ during the abdominal aortic session on Wednesday morning, Kevin Mani (Uppsala, Sweden) joined Janet Powell (London, United Kingdom) at the new CX Vascular Live studio to discuss the new data, its implications and potential further research in the space. Powell had also given a presentation during the same session, speaking on a core outcome set for abdominal aortic aneurysm (AAA) repair.

“Statin treatment did not affect perioperative mortality, but it did significantly affect improved long-term survival,” Mani stated in the studio, sharing one of the key findings from his presentation on a national study of patients undergoing aortic repair. However, he stressed that the dose of statin “did not affect mortality in-andof itself”.

Hence Verhagen

Endurant stent graft proves efficacious and durable in ENGAGE 10-year data

Yesterday’s Podium First presentation from Hence Verhagen (Rotterdam, Netherlands) saw him present unique 10-year data from the ENGAGE OUS registry on the Endurant abdominal aortic aneurysm (AAA) stent graft (Medtronic). “Ever since we started doing endovascular aneurysm repair (EVAR) about 30 years ago, there have been concerns about durability,” Verhagen stated at the opening of the talk. “What we have revealed is that the survival between open and endovascular patients is the same in the long term.”

VERHAGEN DIRECTED HIS AUDIENCE’S attention to previous randomised controlled trials such as EVAR1 and DREAM, which “raise[d] concern” around durability. The latter in particular showed patients in its EVAR group had “many more secondary interventions after about four years”. He also said that, though there were some other studies with long-term data (≥10 years), many of these have “strict limitations”, leading to a “paucity of long-term data” with a large stenting sample size. The reason, he said, was the high mortality in such trials— meaning that, after 10 years, “there are not that many patients left […] You need a very large group to start off with to have survival and results after 10 years.”

Setting out some details of the registry, Verhagen detailed it included 1,260 patients from 79 sites in 30 countries. The patients initially enrolled only consented to five-year follow-up, however, which

Hands-on aortic course opens up new options in physician-modified F/BEVAR

Wednesday’s aortic course gave attendees the opportunity for hands-on learning on physician-modified grafts for fenestrated and branched endovascular aneurysm repair (F/BEVAR).

Course director Alexander Zimmermann (Zürich, Switzerland) guided participants through a series of interactive sessions in which they were instructed on key objectives including measurement and modification of modified grafts.

“For thoracoabdominal aneurysms you have branched, offthe-shelf stent grafts, and for infrarenal aneurysms you have standard devices that you can use in emergency or urgent situations,” Zimmermann tells CX Daily News, outlining the rationale for the course. “For aneurysms that are at the level of the renal visceral arteries, there is a lack of off-the-shelf devices to treat emergency or ruptured cases.”

Having the option to use a physician modified graft in these cases offers a route outside of open surgery or parallel grafts, Zimmermann explains, closing the gap between the thoracoabdominal and infrarenal emergent cases.

The CX aortic course is unique as many physicians will not have had the opportunity for instructor-led education on this subject to date, says Zimmermann. “To lower the fear for using this kind of device and to do something hands on and to experience how easy it can be done will help to widen the indication in emergency cases,” he says.

“The goal is that when they leave this course, they are capable of doing these physician modifications by themselves and with the next emergency that they experience in their hospital, they have another option besides parallel grafts or open surgery.” required a reconsent process for 10-year followup—with only 49 of the initial 79 centres agreeing. This, combined with patient refusals, reduced the total cohort for long-term results to around 390 patients. “Not surprisingly, these patients were a little younger than the original and had generally fewer comorbidities,” Verhagen added.

All-cause mortality up to 10 years was analysed, revealing a survival rate of about 42%. There was no steep decline after five years, something which also held for aneurysm-related mortality (around 5% of patients). Reinterventions, “the Achilles’ heel of EVAR,” were also not found to accelerate after five years’ follow-up, with around 70% of patients free from secondary interventions. Stratified into groups undergoing reintervention at 0–5 years and at 6–10 years, Verhagen and colleagues found “very, very few” type 3 endoleaks “in the first seven years or so”, he stated, “with a slight increase at 10 years”.

Patients with a type 1a endoleak, Verhagen noted, increased in number by 4.1% at 10 years. Of those, however, 40% “started off with well-known risk factors”. Clinical events were also examined, with aneurysm rupture—“the ultimate failure”—occurring “very, very little”, increasing at a rate of 1.5% at 10 years.

Setting out a few limitations, Verhagen reminded his audience of the loss of patients during the reconsenting process, leaving a healthier cohort, as well as the fact that it was a single-arm observational registry. The take-home message, Verhagen stated, was that these were “probably unique data” up to 10 years, and that they “confirm the long-term efficacy and the durability of the Endurant stent graft with these numbers of aneurysms and mortality”. There was “no big decline” in patient outcomes at this longer follow-up point, with consistent 60% sac regression. Reviewing the most frequent causes of late adverse events, he put forward that initial hostile anatomy was a particularly influential factor. Finally, he said that “lifelong surveillance is critical for EVAR patients”.

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