PracticeUpdate Neurology June 2019

ISC 2019 21

SCENT Trial Reveals High Success RatesWith Surpass Flow Diverter in Challenging Aneurysms The findings represent an important step forward in the use of flow diversion.

O utcomes with the Surpass flow diverter for the treatment of hard-to-treat intracranial aneu- rysms were so positive in the pivotal SCENT trial as to expand the indications for flow diversion, according to a presentation made at the ISC 2019. “Surpass is a single-layer chromium stent, like the Pipeline device, but fundamentally very different. It has a different number of wires used to make the mesh, and this number increases as it goes from smaller to bigger diameters,” study co-author Alex- ander Coon, MD, of the Johns Hopkins Hospital in Baltimore told Elsevier’s PracticeUpdate . “This allows you to maintain a consistent pore density across the neck of the aneurysm, which gives you a more consistent amount of flow diversion, which promotes healing.” Unlike other flow diverters, the Surpass is preloaded on a catheter. “It’s an over-the-wire delivery system versus an empty catheter system,” explained Dr. Coon. “Historically, that’s been considered a limita- tion, but nowadays, with modern access techniques and catheters that are available to deliver these sys- tems, it actually provides a tremendous amount of control and safety.” The SCENT trial data were presented to the US Food and Drug Administration for approval of Surpass, which occurred in July of 2018. For this international, multicenter, prospective, non-randomized trial, the outcomes of treating wide-neck (≥4 mm), large or giant intracranial aneurysms ≥10 mm in size using the Surpass flow diverter were compared with those of historical controls. SCENT was supported by Stryker, manufacturer of Surpass. From 2012 to 2015, 180 patients were treated with the Surpass flow diverter at 26 sites. Their mean age was 61.0 years and 91.7% were female. The aneurysms were most frequently located in the carotid-ophthalmic segment (33.3%), followed by the cavernous segment (28.9%), posterior commu- nicating artery (21.1%), supraclinoid carotid artery (11.1%), superior hypophyseal artery (3.3%), and the petrous segment (2.2%). The mean aneurysm dimen- sion included a dome height of 13.4 ± 5.7 mm. Mean neck width was 6.7 mm. Overall, technical success was achieved in 97.8% of patients, and the mean number of Surpass devices used was 1.1 per procedure, with 86.7% of aneurysms treated with a single flow diverter. The primary effectiveness endpoint was the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (≤50% stenosis) of the parent artery, and any retreatment of the tar- get aneurysm at 12 months. The rate of this outcome was 62.8% (95% confidence interval 55.3–69.9). The 12-month major ipsilateral stroke or neurological death rate of 10.6% (95% CI 55.3–69.9).

“In America, the SCENT trial allowed for expansion of flow diverter indications,” explained Dr. Coon, “[because] it… was going for more difficult, more distal, and more dangerous aneurysms in addition to the aneurysms [included] in the PUFS trial, [the pivotal trial using the Pipeline device], … particularly large and giant [posterior communicating] aneu- rysms, which are very difficult to eradicate.” Because of the location of the aneurysms treated in SCENT, the Surpass device often had to be placed in the middle cerebral artery, which was rare in the PUFS trial.” “I largely see this as a step forward in the field, expanding the indication for [intracranial] aneurysms all the way to the [internal carotid artery] terminus,” continued Dr. Coon. “Also, 1.1 devices on average were used [in SCENT], compared with the PUFS, which was more like 3.1.” The primary reason is that the Surpass is available in longer lengths and wider diameters than the Pipeline. The need for fewer devices has obvious economic advantages. “It’s an expansion and improvement of flow diver- sion,” concluded Dr. Coon. “It’s more sophisticated flow diversion because of the innovative design. … We’ve done over 80 cases in the first month, and they have all been perfect. We are really looking to raise the bar with these data.” Dr. Coon has been a proctor and consultant for Stryker, Medtronic, MicroVention, Sequent Medical, and Inneuroco. www.practiceupdate.com/c/79804 Go to PracticeUpdate.com for your conference news At PracticeUpdate.com, we aim to provide you with coverage of the most important meetings, including pre-meeting recommendations from experts, news coverage during the conference, and videos and expert analyses of studies relevant to your patients. Next up: • American Academy of Neurology (AAN) 71st Annual Meeting, 4–10 May 2019

Dr. Alexander Coon

" I largely see this as a step forward in the

field, expanding the indication for [intracranial] aneurysms all the way to the [internal carotid artery] terminus. "

Go to PracticeUpdate.com for your AAN 2019 news.

VOL. 4 • NO. 2 • 2019