Examining Current and Emerging Technologies in EVAR

Panel discusses strategies and technologies used in EVAR.

By Brenda Silva

Current advances in endovascular aneurysm repair (EVAR) were the subject of a panel discussion that also looked back at its inception 25 years ago, before it became the standard for treating aortic aneurysms. Session moderator Shaun Samuels, MD, introduced the topic, and first speaker Frank Criado, MD, elaborated on the history of EVAR and what today’s registries show as its industry status.

Dr. Criado pointed out that the standard of care for EVAR as it exists today was established years ago in trials with enrollment from 1999 to 2004. During those trials, first-generation devices were used, and the trials served to establish that the biggest advantage of EVAR was a significantly lower 30-day mortality, which was 3 to 4 times lower than open surgery.

He added, “By 2010, early advantages of EVAR were lost, and it became equal in terms of mortality with open repair. What we should wonder about today is are we doing any better, and do we have devices that are really any better? There is growing evidence that that is the case, and that newer devices do offer an advantage and have contributed to improved patient outcomes.”

Speaking next, Frank J. Veith, MD, addressed strategies for improving success in ruptured EVAR. “We know EVAR is intuitively better, but EVAR for ruptured triple As is controversial. The key elements that allow good results include making a diagnosis as soon as possible; getting a CT scan on site; and carrying out all procedures in an angio suite because many patients may ultimately need an open procedure.”

He continued, “Use EVAR on all possible patients. Because of its low mortality rate, many open cases can be treated with EVAR. Also remember that randomized trials are not always the Holy Grail that they claim to be.”

Taking the podium next, Darren B. Schneider, MD, looked at branched and fenestrated EVAR. “The concept of branch incorporation is something to consider. Visceral branch devices that are patient-specific and off-the-shelf concept devices will be coming in the not-too-distant future. The US ZENITH fenestrated trial showed a 30-day mortality rate of only 1.5% with leaks rare. Fenestrated and branched endografts offer the ability to embrace the benefits of EVAR to patients with complex aortic aneurysms.”

Looking at low-profile EVAR and TEVAR devices, Dittmar Böckler, MD, pointed out that profile is currently the biggest limitation to 24Fr with EVAR, accounting for 70%.

“Since 2013, we are down to 14Fr with two devices. The potential benefit for low profile is easier delivery, and entry into tortuous vessels would be better. But we have to wonder who is asking for low profile? How many more patients can we treat if we go lower to 14? How big is the need for lower profile devices? How often do iliac arteries limit T/EVAR? How often do we experience access-related complications? What is the trade off with low profile – could lighter fabrics and the gauge of fabrics reduce visibility?”

He continued, “There are trials going on looking for low-profile devices. Low profile is already out there for T/EVAR, and over 20Fr will disappear as a forecast. Durability is at risk, but it is key for long-term success, with the most benefits expected for T/EVAR.”

Focusing on next-generation, large vessel closure devices, Eberhard Grube, MD, asserted that Prostar and ProGlide remain the standard, with a failure rate of only 9% to 10%. He suggested that there is a rapidly growing need for post-vascular closure devices and emerging devices.

“Among the emerging large vessel closing devices, there are three that are CE-marked now: MANTA, PerQseal, and InSeal, and while initial results are promising, more testing is needed in order to see if they offer more benefits in the future,” Dr. Grube said.

Finishing the discussion, Dr. Schneider returned to the podium to look at failed endografts.

“EVAR ‘failure’ is common, with reasons for failure including device failure, aortic failure, and physician failure. We should remember that late failure of EVAR occurs, and that most failures are proximal failures.”