NeuroNews issue 44 - EU

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January 2022 | Issue 44

Featured in this issue:

www.neuronewsinternational.com

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Michael Chen Improving stroke triage and transport

Profile Salim Hayek page 14

The Diversion-p64 study—the largest prospective study using the p64 flow modulation device (phenox) to date—has demonstrated that the device has a high level of efficacy and carries a low rate of mortality and permanent morbidity. This is the conclusion of a report published in the Journal of NeuroInterventional Surgery by Alain Bonafe (Department of Neuroradiology, Hôpital Gui De Chauliac, Montpellier, France) and colleagues.

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at an average of 375±73 days, and available for 343 patients (81.7%)—complete aneurysm occlusion and residual neck were seen in 83.7% and 2.3% of cases, respectively, resulting in an 86% (n=295) rate of adequate occlusion. Safety data were available for 413 patients (98.3%) at the first follow-up and showed a composite morbidity/ mortality rate of 2.42% (n=10). In these patients, the major procedure-related stroke rate was 1.9% (n=8), with all of these being due to thromboembolic complications, and the mortality rate was 0.97% (n=4), with two of these deaths relating to a major stroke within the territory of the implanted device. No further episodes of major stroke or death occurred between the first and second follow-up, with data available for 372 patients, the authors add. After highlighting the main limitations of the Diversion-p64 study—its non-randomised nature and lack of a control arm—Bonafe and colleagues conclude that the trial met its primary efficacy and safety endpoints. “The results of Diversion-p64 demonstrate one of the lowest rates of morbidity/ mortality seen in any prospective study on flow diversion,” they add. “It can be concluded that the device has a high efficacy and excellent safety profile that is comparable to other devices.”

The results of Diversion-p64 demonstrate one of the lowest rates of morbidity/ mortality seen in any prospective study on flow diversion.”

Patient access to spinal cord stimulation page 20

Global study demonstrates high efficacy and low mortality rates with p64 flow diverter

n an effort to build on existing evidence in treating intracranial aneurysms with the p64, researchers initiated the Diversion-p64 study—a single-arm, international, multicentre, prospective trial to assess the safety and efficacy of the device. Between December 2015 and January 2019, a total of 420 patients (mean age=55±12 years; 86.2% female) met the eligibility criteria and were enrolled at 26 centres across 10 countries. In this patient population, a total of 445 devices were implanted, resulting in a mean number of 1.06±0.47 devices per patient. Adjunctive coiling was performed in 14% of cases (n=59). The primary efficacy endpoint in Diversion-64 was complete intracranial aneurysm occlusion (Raymond-Roy Occlusion Classification=one) on follow-up angiography, and the study’s primary safety endpoint was the incidence of major, treatment-related stroke (National Institutes of Health Stroke Scale [NIHSS] score increase=four points) or neurologic death at three–six months, with a secondary safety endpoint at seven–12 months after treatment. Relaying the study’s results, the authors state that angiographic follow-up data were available for 357 patients (85%) at the first follow-up—performed at an average of 145±43 days. At this point, complete occlusion and residual neck were reported in 71.7% and 4.5% of cases, respectively, leading to 76.2% (n=272) of cases demonstrating adequate occlusion. At the second Bonafe et al angiographic follow-up—performed

Neuromodulation:

Alain Bonafe

Novel stimulation technique could be “gamechanger” in treatment-resistant depression Stanford accelerated intelligent neuromodulation therapy (SAINT)— a novel, high-dose intermittent theta-burst stimulation (iTBS)— was found to be safe and more effective than sham stimulation in a recent randomised controlled trial (RCT). And, according to Nolan Williams, assistant professor within the Department of Psychiatry and Behavioral Sciences at Stanford University Medical Center in Stanford, USA, this technology has the potential to be a “gamechanger” for patients with major, treatmentresistant depression. “THE CLINICAL RESULTS FROM our study were significant and rapid,” Williams, who also founded the Stanford Brain Stimulation Lab and, as such, played a key role in developing SAINT, told NeuroNews. “After five days of treatment, 79% of people experienced remission, meaning they were no longer experiencing symptoms of depression or suicidal ideation. Some patients found the treatment to be life-changing. “Conventional treatments for intractable depression take weeks or even months to begin working, and provide remission Continued on page 2


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