In Barcelona, INS president Marc Russo (Newcastle, Australia) demonstrated what he believes is a “true breakthrough” in pain management—a novel spinal cord stimulation (SCS) technique centred around the dorsal horn dendrite.
Following the first endovascular implantation of Synchron’s Stentrode brain-computer interface (BCI) device in the USA, physicians have highlighted the wider significance of this breakthrough case—not only in progressing a technology that stands to fulfil an unmet need for patients with severe paralysis, but also by illuminating new frontiers that may be on the horizon for neurointerventional surgery.
First Stentrode implant heralds new field in neurointervention incredibly of
COMMAND, a prospective, open-label, single-arm, early feasibility study, is being conducted under what Synchron claims is the first investigational device exemption (IDE) awarded by the US Food and Drug Administration (FDA) to a company assessing a permanently implanted BCI. It is intended to assess the safety and efficacy of the company’s motor BCI technology platform, including the Stentrode device, in patients with severe paralysis—with the goal of utilising patient brain data to enable them to control digital devices hands-free and, ultimately, achieve improvements in functional independence.“Wearebeyond excited to get to work with our patient, guiding them through the training process as they learn to use this device to live more independently and, most importantly, communicate with their family and friends,” said COMMAND
principal investigator David Putrino (Mount Sinai Health System, New York, USA).
Detailing the Stentrode implantation, Majidi said right internal jugular venous access was obtained to reach the ‘point of interest’ in the superior sagittal sinus. Once visual markers had been established on imaging, a 6Fr guide Late-breaking studies lead 2022 congressINS THIS EDITION OF NEURONEWS homes in on this year’s International Neuromodulation Society (INS) congress (21–26 May 2022, Barcelona, Spain), featuring three latebreaking presentations from the event.
on page
Featured in this issue: www.neuronewsinternational.com August 2022 | Issue 47 HBOT: Future standard of care in stroke? page 10 8 ParisLINNCfromHighlights Profile Isil pageSaatci16
exciting milestone for the field, because
Synchron recently announced the successful completion of the first implant in its US COMMAND study, with lead clinical investigator Shahram Majidi (Mount Sinai Health System, New York, USA) delivering a detailed presentation of this case for the first time at the Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada).“Thisis an incredibly exciting milestone for the field, because of its implications and huge potential,” said Majidi, who performed this novel procedure at Mount Sinai. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery.”
First COMMAND patient Majidi began his presentation of this milestone procedure at SNIS 2022 by noting that more than five million people in the USA alone suffer from severe paralysis, with the majority being completely dependent on caregivers to fulfil their basic daily needs. The COMMAND study was set up to assess the Stentrode’s potential in improving functional independence for these patients by restoring neural signal transmission from the cerebral cortex and executing digital commands—with a total planned enrolment of six quadriparesis patients.
This is an
New data on the safety of deep brain stimulation (DBS) in Huntington’s disease patients and occipital nerve stimulation (ONS) for chronic cluster headache were delivered by Jan Vesper (Düsseldorf, Germany) and Frank Huygen (Rotterdam, The Netherlands), respectively. In addition to further clinical studies and the latest industry news, this issue also features insights on female representation in the brain stimulation field, with a progress update from several members of the Women in Neuromodulation (WiN) group, and highlights the eight phaseone winners for the US$9.8 million Neuromod Prize.
“Our first patient is a 67-year-old gentleman with severe quadriplegia from ALS [amyotrophic lateral sclerosis] on a ventilator,” Majidi reported, stating that pre-implant imaging included a magnetic resonance cerebral venogram and structural magnetic resonance imaging (MRI). He further noted that MRI markers were later co-registered into a live angiography and provided a “roadmap to ascertain accurate deployment of the device”.
its implications and huge potential.”
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To read about these breakthroughs and insights, and much more from the world of neuromodulation, turn to
US
Shahram Majidi Continued 2
page 21.
“At this point, we pulled the guide catheter back to the proximal segment of the superior sagittal sinus, and carefully unsheathed the device while maintaining close visualisation of the target markers for precise deployment of the stent right next to the motor cortex,” Majidi told the SNIS audience. Postoperative three-dimensional digital subtraction angiography (3D-DSA) was then obtained to confirm patency of the superior sagittal sinus and the device’s position.
SERVICE: After recently(NHS)HealthNationalServiceEnglandmissed its 2022 target of making thrombectomies available to all patients who may benefit, the Stroke Association has called on the UK government to prioritise improved access to this “miracle treatment”.
European Society for Minimally Invasive Neurological Therapy (ESMINT) president Jens Fiehler also spoke to NeuroNews to offer perspectives on this potentially “historic” study. “The Stentrode technology represents a major hope for patients with severe paralysis and potentially a huge leap forward in treating this condition,” he said. “Unlike other options, the unique, minimally invasive approach for implanting this type of permanent BCI uses well-established vascular routes—which will make BCI technology accessible for more patients and allow a higher scale of usage, at an earlier time, to be achieved.
n SILK VISTA BABY SAFE AND EFFECTIVE IN PICA ANEURYSM TREATMENT: The Silk Vista Baby flow diversion device (Balt) has been shown to be both safe and effective in the treatment of complex posterior inferior cerebellar artery (PICA) aneurysms, as per a retrospective database review published in Neurosurgery by Ricardo and(Jacksonville,HanelUSA)colleagues.
n HIGHER STROKE RATES WITH EARLY TCAR VERSUS ENDARTERECTOMY: Data presented at the Vascular Annual Meeting (VAM) by Adham Elmously (New York, USA) have indicated higher ipsilateral postoperative stroke rates with transcarotid artery revascularisation (TCAR) compared to carotid endarterectomy (CEA), particularly when the former is performed within 48 hours of a neurologic event.
n UK STROKE ASSOCIATION CALLS FOR THROMBECTOMY24/7
For more on this story go to page 18
Bruce Campbell (University of Melbourne, Melbourne, Australia), who earlier this year presented long-term safety data from four patients in the SWITCH trial at the American Academy of Neurology (AAN) annual meeting (2–7 April, Seattle, USA), echoed that this first US case is an “exciting step” towards restoring functionality for paralysis patients, also noting that the Stentrode’s minimally invasive implantation method represents a key advantage and is “unique” in the BCI “Synchron’sspace.
“The fusion of neuromodulation and neurointervention using Stentrode is an extremely exciting new field that is combining two of the most rapidly growing and successful minimally invasive techniques in the neurosciences,” Timo Krings (University of Toronto, Toronto, Canada) said, speaking to NeuroNews. “Not only does this technique—as Thomas Oxley [Synchron founder and CEO] so elegantly showed in his first publication—help us to record brain activity and thus act as a BCI, but it may also allow for less invasive neuromodulation in the future. While there are still challenges to this approach, the landmark work of Dr Majidi and the technology developed by Dr Oxley [make them] true trailblazers in the newly developed field of functional endovascular neurosurgery.”
Continued from page 1
“The next step is to use AI [artificial intelligence] to obtain the electrocorticography signals from predefined attempted limb movements, and convert them to certain digital command outputs, so that the patient can have the freedom of controlling digital devices,” he concluded.
ongoing COMMAND trial, and subsequent first patient procedure at Mount Sinai, were made possible through encouraging safety results from the SWITCH trial—which demonstrated that the Stentrode was safe in humans, stayed in place, and did not lead to blockage of the blood vessel in which the device was implanted,” Campbell told NeuroNews. “These crucial early safety findings open the door to more trials and further enrolment.”
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For more on this story go to page 7
A subclavicular, subcutaneous pocket for implantation of an internal telemetry unit was created, and this unit was inserted and connected to an external device before intraoperative neuronal data were collected from the patient. A postoperative X-ray confirmed proper placement of the telemetry unit. “The patient [tolerated the procedure well], and was discharged within 48 hours and placed on DAPT [dual antiplatelet therapy] for three months,” Majidi added.
“The latest announcement from Synchron created significant excitement at the SNIS annual meeting and across the field of neurointerventional surgery,” SNIS past president William Mack (University of Southern California, Los Angeles, USA) told NeuroNews. “Enrolment of the first patient in the US COMMAND trial is an important step towards implementation of one of the most exciting advances our field has seen in decades. If this technology continues to progress, it could profoundly affect the lives of many of our patients and transform the field of neurointerventional surgery.”
vasculature,” he continued. “Endovascular implantation of the Stentrode signifies an initial fusion of neurointerventional surgery and functional/restorative neuroscience—an important concept that could guide our field for years to come.”
“The US COMMAND study will be a starting point for new treatment options the neurointerventional community can offer. We do not need to think very hard to come up with many more applications for a multitude of conditions. I am looking forward to getting this kind of technology in the hands of European neurointerventionists, making it available for European patients and—hopefully—starting an EU COMMAND study.”
Global physician reactions
First US Stentrode implant heralds new field in neurointervention catheter and then a 4Fr preloaded delivery catheter carrying the Stentrode were advanced to the superior sagittal sinus next to the motor cortex.
For more on this story go to page 13
Jens Fiehler William Mack Bruce Campbell Timo Krings
According to Mack—who disclosed that he is chair of COMMAND’s data safety monitoring board—it is also “very significant” that this BCI technology can be implanted via endovascular surgery, as minimally invasive access routes remove the need for direct implantation via craniotomy. “This is a breakthrough for the neurointerventional space; it indicates that we have only scratched the surface in terms of the types of procedures that can be performed through the cerebral
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“We hope this research persuades state governments to take a close look at their stroke care protocols and implement changes to improve triage andLiketransport.”trauma, stroke is timesensitive—and previous studies have shown that, when patients are taken to a slightly more distant facility that is better equipped to treat them (a Level 1 stroke centre), rather than simply going to the closest facility, they have been found to undergo the appropriate care more quickly and have less disability at 90 days after their stroke. The researchers believe this new study confirms the previous results and shows just how critical changing EMS protocols are to a patient’s survival.
4 August 2022 | Issue47New Frontiers SNIS ROUND-UP
Mahesh Jayaraman presenting at SNIS 2022
For patients, this could mean safer and more efficient surgeries, better outcomes and an overall seamless experience. This type of technology would be applicable to neurovascular procedures requiring navigation through small, tortuous, delicate vessels.
Study researchers tested this robotic technology through mock trials and found the prototype was
“Endovascular thrombectomy for acute ischaemic stroke is one of the most effective therapies in medicine and its efficacy is critically dependent on time,” said lead author Jason Tarpley (Pacific Stroke and Aneurysm Center, Santa Monica, USA). “Simply put, the faster we act, the better our stroke patients’ outcomes will be. Our results represent an advance that has the potential to speed up the identification of LVO stroke during the triage process at the hospital.”
Robotics breaks new ground Stroke surgery and other neuroendovascular procedures could be made safer and easier through robotics, according to another research presentation at SNIS 2022. As per recent findings, a new multi-articulated, self-steering microcatheter for neuroendovascular surgery has the potential to increase technical precision, reduce procedural time and radiation exposure, and enable semi-automation of catheter navigation.
Beyond stroke, these pathologies include brain aneurysms, arteriovenous malformations (AVMs) and fistulas (AVFs), and others.
“There is still so much we need to learn about COVID-19, especially its impact on younger patients,” said lead author Pascal Jabbour (Thomas continueandCOVID-19onUSA).University,JeffersonPhiladelphia,“Stroke’simpactindividualswithisalarmingonewemusttoresearchand remedy.”
Pascal Jabbour Jason TarpleyRohan Chitale
androboticsCOVID-19,artificial intelligence programme.featuringartificialconcerningneurointerventionin(25–29Surgery’sTheprominentlyfeatureSocietyofNeuroInterventional(SNIS)19thannualmeetingJuly,Toronto,Canada)homedonanumberofkeydisruptorsinthefield,withresearchCOVID-19,roboticsandintelligence(AI)technologiesacrosstheevent’sfive-day
THESE FINDINGS, WHICH are now also published online in the Journal of NeuroInterventional Surgery, show that US states using field-based stroke severity triage as part of their Emergency Medical Systems (EMS) transport protocols give severe stroke patients more rapid access to specially trained neuroendovascular care teams and lifesaving thrombectomy procedures. In the study, “Long-term effect of field triage on times to endovascular treatment for emergent large vessel occlusion”, researchers compared stroke patients between two adjacent states over a 5.5year span. Both states were served by a single Level 1 (comprehensive) stroke centre.After matching the patients from the two regions based on distance to the Level 1 centre, the researchers found that time to treatment decreased by 55 minutes following implementation of severity-based triage. In contrast, there was no change in time to treatment in the adjacent region with traditional EMS protocols over 5.5 years, despite extensive efforts to improve workflow at referring hospitals. As a result, clinical outcomes at 90 days were significantly better in those patients who resided in the state with severitybased triage, compared with traditional EMS“Theprotocols.timelost in transfer from the nearest hospital to the best-equipped facility clearly jeopardises a patient’s chance of recovery,” said Mahesh Jayaraman (Brown University/Rhode Island Hospital, Providence, USA), lead author of the study, who also presented these findings at SNIS 2022.
Another new study delivered at SNIS 2022 indicated that AI can identify when a patient is having a stroke caused by emergent LVO— therefore making them a mechanical thrombectomy candidate.
The study used AI algorithms to detect gaze deviation from a noncontrast computed tomography (NCCT) scan. These scans can predict if a patient is having an LVO stroke and, as such, will benefit from a timely, minimally invasive thrombectomy, potentially reducing or preventing long-term disability/damage to their brain.
Researchers found that COVID-19 patients are also over 2.5 times more likely to have an unfavourable outcome and face a difficult recovery post-stroke. Their study reviewed data for 575 patients with acute large vessel occlusion (LVO)—including 194 who had COVID-19 and 381 who did not. These patients spanned nearly 50 thrombectomy-capable comprehensive stroke centres across Europe and North America. The control group was composed of patients who presented with LVO and received a thrombectomy from January 2018 to December 2020. In the study, researchers compared which patients had successful revascularisations following a thrombectomy procedure and left the hospital with little-to-no disabilities, and found that patients with COVID-19 (who were younger and had fewer risk factors) were less likely to achieve successful revascularisation. In addition, the thrombectomy was prolonged in the COVID-19 group, as was the length of hospital stay. Mortality rates were more than twice as high in the COVID-19 group compared to controls and, overall, COVID-19 was a predictor of poorer outcomes, despite many of the patients being younger, healthier and even having mild symptoms of the virus before the onset of stroke, the researchers concluded.
“The creation of this technology is a first step toward semi-autonomous navigation for neuroendovascular procedures,” said lead author Rohan Chitale (Vanderbilt University Medical Center, Nashville, USA). “We hope that developing robotic catheters that can bend on command and sense their surroundings will allow these complex, risky procedures to be performed more simply and safely.”
Direct triage to Level 1 stroke centres reduces time to treatment and improves patient outcomes
AI in stroke detection
able to autonomously navigate through a minimally invasive surgery simulation.
Implementing severity-based field triage leads to faster treatment and less disability for stroke patients, according to late-breaking research presented recently at the Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada).
In the study, an AI algorithm was trained using 200 scans to identify gaze direction. It then identified clinical symptoms of ipsiversive gaze deviation in 116 LVO stroke patients treated with thrombectomy. It correctly identified 79% of proximal occlusions with ipsiversive gaze deviation, but was not as successful in identifying cases with less severe symptoms.
ONE OF THESE PRESENTATIONS indicated that stroke patients with COVID-19 face worse outcomes, and are often younger and healthier, as compared to ‘typical’ stroke patient populations.
Late-breaking research presented at the recent Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada) has shown that thrombectomy procedures can achieve positive outcomes for patients experiencing strokes caused by a basilar artery occlusion (BAO)—despite typically being reserved for the treatment of large vessel occlusion (LVO) stroke. These findings were delivered by lead author Fawaz Al-Mufti (Westchester Medical Center/ New York Medical College, New York, USA), who said: “Patients who receive thrombectomy increase their life expectancy by five years compared to patients who do not. For every 10 minutes saved in getting a thrombectomy, patients experience an additional month of life free from disability. Furthermore, BAO stroke is associated with 40% mortality and, of the survivors, 80% have severe deficits. This is especially true for BAO stroke patients with high NIHSS [National Institutes of Health Stroke Scale], where endovascular thrombectomy portends a mortality and disability benefit.”Al-Mufti detailed that this research, dubbed the BArONIS study, sought to build on recent breakthroughs achieved in the ATTENTION and BAOCHE studies in China, and assess whether the positive outcomes seen in BAO stroke patients who underwent mechanical thrombectomy procedures in these randomised controlled trials are likely to translate to Western populations.BArONIS involved conducting a retrospective analysis of the US National Inpatient Sample database and included non-elective admissions of BAO patients with an NIHSS score >9 who received thrombectomy between 2015 and 2019. The study’s primary clinical endpoint was a favourable outcome, measured via ‘routine discharge’ of the patient to their home or acute rehabilitation, while safety endpoints included mortality and symptomatic intracranial haemorrhage. Across nearly 4,000 patients, this analysis found that BAO stroke patients who underwent thrombectomy were younger, and were more likely to be female, as well as having a slightly higher NIHSS score and rate of atrial fibrillation, on average, than those who did not undergo thrombectomy. At SNIS 2022, Al-Mufti also detailed that BAO patients treated via thrombectomy were more likely to experience a favourable outcome, and there was no difference in the rates of mortality or symptomatic intracranial haemorrhage between the two groups. In addition, a subgroup analysis revealed that BAO patients with an NIHSS score >20 experienced a statistically significant benefit in terms of mortality rates, as well as favourable outcome benefits, after undergoing thrombectomy.“Wefeelthat this is a real-world corroboration of the clinical findings demonstrated in both ATTENTION and BAOCHE,” Al-Mufti said. “There are limitations to our study—we lack granularity, and we do not know about time from ‘last known normal’, but hopefully the overall size of the study will dilute the effects of these issues.”
We feel that this is a real-world corroboration of the clinical findings demonstrated in both and BAOCHE.” Fawaz Al-Mufti
Arthur began by noting that the study enrolled 150 patients with wide-neck cerebral aneurysms across 26 global sites, and its primary endpoints were originally assessed at one year, but researchers did “everything they could” to follow patients out to five years. He also said follow-up in a five-year study is “difficult”, adding that “COVID-19 has affected our practice and this study a fair amount”, and noting that the pandemic was responsible for some missing imagingDiscussingdata.
Arthur concluded by noting that the intrasaccular segment presents a new strategy that he finds “extremely promising”. “I think the WEB device has now been shown, in a long-term cohort—which is important—to be both safe and effective,” he added. “It is fantastic that none of these patients experienced the endpoint that we most wanted to avoid, which was haemorrhage of the aneurysm.”
Late-breaking data bolster evidence thrombectomysupportingforBAO stroke
safety findings, Arthur said: “It is really exciting to see that, in a trial of 150 patients, 148 of whom got the device, not one of the treated aneurysms has experienced a rupture—the ruptured aneurysms did not re-rupture and the unruptured aneurysms did not rupture.” Arthur also reported seven deaths and five subarachnoid haemorrhages, two of which were deemed to have been related to the device.
THE SOCIETY OF NEUROINTERVENTIONAL Surgery’s (SNIS) 19th annual meeting (25–29 July 2022, Toronto, Canada) saw research involving the Woven EndoBridge (WEB; Microvention/ Terumo) device disclosed for the first time, with co-principal investigator Adam Arthur (University of Tennessee Health Sciences Center and SemmesMurphey Clinic, Memphis, USA) delivering a late-breaking presentation of five-year data from the WEB-IT trial.
ATTENTION
Moving on to detail effectiveness data, he stated: “In looking at occlusion status shifts, there are more patients with progressive occlusion than with worsening of occlusion status. And, using last observation carried forward methodology, we see a stable and high number of complete occlusions and adequate occlusions.”
Drawing comparisons between these recent findings and one-year WEB-IT data, Arthur reported an increased complete occlusion rate, from 57.9% at one year to 58.1% at five years, and a marginal decrease in terms of adequate occlusion rate, from 87.9% to 87.2%.
COMPLETEocclusionrate 57.9% 58.1% AT ONE YEAR AT FIVE YEARS ADEQUATEocclusionrate 87.2%AT87.9%ONEYEAR AT FIVE YEARS Adam Arthur
5Issue47 | August 2022 Image_credit New Frontiers
Arthur went on to add that, in WEB-IT’s US cohort, a retreatment rate of 15.5% (23 of 148 patients) was observed over the five years, and all retreatments were completed safely. He noted that “absolutely no aneurysm bleeds” occurred in the study, but said there were two significant, aneurysm-related adverse events following retreatment with a flow diverter—one of which involved a stroke, and one of which resulted in patient death following an “Aneurysmangioplasty.locationis interesting,” Arthur continued. “Obviously, these are point estimates, and there is not enough statistical power to really say something meaningful, but I do find it intriguing that, at the MCA [middle cerebral artery] location, there is some suggestion of a higher retreatment risk. I think a larger cohort may tell us something interesting here.”
WEB flow diverter shown to be safe and effective in long-term cohort
The speaker further claimed that, while WEB-IT saw a retreatment rate of 15.5%, retreatments of WEB are “quite easy and quite safe”, although he followed this by noting there is a need to be “careful” when it comes to subsequent interventions after the first retreatment due to the dangers they pose.
Elsewhere at SNIS, a second study— presented by lead author Ali Alawieh (Emory School of Medicine, Atlanta, USA)—indicated another area that thrombectomy treatments could yet expand into: distal vessel occlusion (DVO) stroke. In this multicentre study, researchers analysed outcomes in nearly 7,500 patients undergoing thrombectomy for different types of strokes across 32 US centres. They found that, while this is another space in which thrombectomies are not typically deployed, postthrombectomy clinical outcomes for DVOs were comparable to those seen in patients experiencing LVO stroke. “Thrombectomy has changed the way medical professionals care for patients with stroke,” said Alawieh. “If more stroke patients can experience this lifesaving treatment, we want to ensure that happens.”
6 August 2022 | Issue47
“We did not imagine this genotype would affect the outcome of endovascular therapy so substantially,” Ihara further stated. “Information on the genotype will be useful for people who receive endovascular therapy (hopefully before the procedure) because individuals who are of East Asian descent and have the genetic variant need to be more strictly monitored than usual for reocclusion during and after endovascular treatment.”Thenumber of people found to have the genetic variant was too small to determine which clot-removal devices or medicines may be better at preventing reocclusion—but the researchers are now initiating a larger multicentre study to answer these questions, and to examine the long-term outcome of variant carriers following EVT.
While people with the genetic variant were just as likely as non-carriers to initially have success with re-establishing blood flow to at least half of the brain tissue that had been deprived of blood during the stroke, study outcomes also revealed that those with the genetic variant were far more likely (70%) than non-carriers (5.6%) to have the treated artery become re-blocked before the procedure was complete, known as ‘instant reocclusion’. Carries of the variant were also far more likely (60%) than non-carriers (0.4%) to have the treated artery become re-blocked within two weeks of an initially successful endovascular procedure, referred to as ‘early reocclusion’.
Rare disease variant specific to East Asian patients increases postreocclusionthrombectomyrisk
We did not imagine this genotype would affect the outcome of endovascular therapy so substantially.”
Thrombectomy
Moyamoya is a rare, progressive disorder caused by blocked arteries at the base of the brain that can result in a stroke or other neurological symptoms, such as motor or sensory impairment, headache or vertigo.
Researchers analysed the outcomes of 277 East Asian adults (46.2% women, median age of 76 years) who received EVT for an ischaemic stroke at the National Cerebral and Cardiovascular Center between 2011 and 2021.
The researchers compared 10 patients found to carry the RNF213 p.R4810K variant to 267 patients without the variant on several short-term outcome measures. Their results were adjusted for the age of the patients.
“In the field of acute stroke, genetic testing has not been considered important,” said senior study author Masafumi Ihara (National Cerebral and Cardiovascular Center, Osaka, Japan).
And, because moyamoya is diagnosed by conventional brain angiography or magnetic resonance angiography (MRA), and symptoms are varied and stroke-related, many people may not know they have the disease before experiencing a stroke.
All of the patients had an acute anterior-circulation LVO—a stroke in which a clot blocks one of the large arteries responsible for supplying blood to the forebrain. The type of endovascular procedure performed was determined by the medical team and was unrelated to whether the patient had the aforementioned genetic variant.
Mechanical
“It is important to note, however, that genotyping is currently only available in a research setting, for participants in a clinical trial such as ours,” Ihara added.According to the researchers, results from this study involving an East Asian population may not be generalised to other people with different genetic backgrounds.“However, additional genetic variants may affect the outcome of endovascular therapy in different ethnic populations, which needs further investigation,” Ihara concluded.
“However, since our study found that a specific genetic variant substantially affects the outcome of endovascular therapy [EVT], physicians involved in acute stroke medicine, especially in East Asian countries and in western countries where many East Asian descendants are living, need to know theseThefindings.”geneticvariant studied, called RNF213 p. R4810K, is present in one in 50 people of East Asian descent, and in 80–90% of people with the genetic disorder moyamoya disease.
Among people who received endovascular mechanical thrombectomy to remove a large vessel occlusion (LVO), those with a rare genetic disease variant found primarily in people of East Asian descent were more likely to have the vessel reclog during, or shortly after, the procedure. This is according to a study published in Stroke: Vascular and Interventional Neurology
THIS YEAR, NHS ENGLAND MISSED ITS original target of making thrombectomy available to all patients for whom it could provide benefit, only delivering the procedure to 28% of all suitable patients by December 2021, as per a Stroke Association press release. In light of this, the Stroke Association’s ‘Saving Brains’ report has called for a 24/7 thrombectomy service. While this service could cost up to £400 million, the charity claims that treating all suitable strokes with thrombectomy would save the NHS £73 million per year. Stroke professionals quoted in the report cite insufficient bi-plane suites, containing radiology equipment, as a barrier to a 24/7 service being established.Despitemechanical thrombectomy having been shown to reduce disability and length of hospital stay in suitable stroke patients, rates of these endovascular procedures vary across the UK. Almost 8% of stroke patients receive a thrombectomy in London, compared to 0–3% in other parts of the country, the release notes. And, despite the unpredictability of stroke occurrences and criticality of timely treatments, just 25% of thrombectomy-capable centres operate 24/7 services, and close to half (42%) only operate Monday to Friday, during office hours.
Stroke Association calls for 24/7 thrombectomy service across the UK
the neurovascular replicator Asist stroke system (Mentice) prior to this first case. It demonstrated excellent trackability and ease of use in the Mentice replicator— even when deployed in a variety of very challenging vascular anatomies. The Emboguard device performed similarly well in my first clinical cases. My preclinical and initial clinical impression indicates that Emboguard certainly belongs in the league of these markedly improved, next-generation balloon guide catheters. What is your experience of using the device to date— from your perspective as a physician, what are the advantages it offers? My experience using the device has been positive in terms of ease of use, trackability and overall performance thus far.
Could you briefly describe the recent first thrombectomy procedure(s) with the Emboguard balloon guide catheter?
David Fiorella is the director of the Cerebrovascular and Vascular Centers, co-director of the Comprehensive Stroke Center, and a professor in the Department of Neurosurgery, in the Renaissance School of Medicine at Stony Brook University in New York, USA.
“Thrombectomy really is a game-changing treatment, yet the number of people receiving [it] in the UK remains much lower than elsewhere in Europe, and has been only slowly increasing over recent years,” said Martin James (Royal Devon and Exeter Hospital, Exeter, UK). “At this rate, it will not be available to all those who could benefit for many years to come. We need to ensure thrombectomy is available to people with stroke wherever and whenever they need it, and that will require a big investment in people and equipment for the NHS.”
treatment that pulls patients back from near-death and alleviates the worst effects of stroke,” said Stroke Association chief executive Juliet Bouverie. “It is shocking that so many patients are missing out and being saddled with unnecessary disability. Plus, the lack of understanding from government, the NHS and local health leaders about the brain-saving potential of thrombectomy is putting lives at risk. There are hard-working clinicians across the stroke pathway facing an uphill struggle to provide this treatment and it is time they got the support they need to make this happen.
DISCLOSURES: Fiorella is a consultant of Cerenovus, part of Johnson & Johnson MedTech.
Having been launched earlier this year, the Emboguard balloon guide catheter (Cerenovus) was recently used in mechanical thrombectomy procedures for the first time. David Fiorella (Stony Brook University Hospital, New York, USA), who performed these milestone stroke treatments, speaks to NeuroNews to discuss the device and the wider implications it may hold for the neurovascular space.
“It really is simple—thrombectomy saves brains, saves money and changes lives; now is the time for real action, so that nobody has to live with avoidable disability ever again. There is an unacceptable postcode lottery of stroke treatment, at a time when tackling health inequalities is a key priority for the government and NHS. Rates are rising gradually due to sustained efforts from national and local stroke teams, but progress is far slower than it needs to be.”
7Issue47 | August 2022 Mechanical Thrombectomy
My experience with the Emboguard balloon guide catheter has been positive. I will continue to integrate these nextgeneration balloon guide catheters into my clinical practice, as appropriate, in ischaemic stroke and endovascular intervention cases. I am a strong believer in the benefits of balloon guide catheters like Emboguard to optimise patient outcomes, so I anticipate we will see more physicians beginning to use this device now that it is available as a part of Cerenovus’ stroke solutions portfolio.
What benefits does it offer for the patient? While a randomised controlled trial of balloon guide versus no balloon guide would provide definitive clinical evidence, the available data give a strong signal to indicate that the use of a balloon guide catheter likely improves first-pass recanalisation and patient outcomes in thrombectomy. The Emboguard device is in the category of next-generation balloon guide catheters, which are substantially more navigable and stable than their predecessors. I believe that this new catheter technology will represent a substantial advance for interventional stroke therapy.
Emboguard and others is to improve patient outcomes and treatment during cases. As stated, the existing evidence points to a substantial benefit for the use of balloon guide catheters and the industry has continued to advance these devices—and overall innovation in the neurovascular space—in the interest of improving patient care. What does the future hold for this device?
As the first physician to use the Emboguard balloon guide catheter during a thrombectomy to treat an ischaemic stroke, I was impressed by the device trackability and how easily it integrated into my setup. We were able to get first-pass mTICI [modified thrombolysis in cerebral infarction] 3, in combination with other devices, and the patient recovered well. Overall, I have been pleased with the device performance during and since this first case.
A new report released by the UK Stroke Association warns that, if mechanical thrombectomy rates remain at 2020/21 levels, a total of 47,112 stroke patients in England would miss out on this “game-changing” treatment over the length of the newly revised National Health Service (NHS) Long Term Plan. As such, the charity has called on the UK government to prioritise a 24/7 thrombectomy service and improve nationwide access to this “miracle treatment” moving forward.
First Emboguard experiences reveal “excellent trackability and ease of use” in thrombectomy
Why did you select the Emboguard specifically for this first case? I had extensively tested Emboguard in
As per its recent report, the UK Stroke Association is calling for: The UK Treasury to provide urgent funding for thrombectomy in the 2022 autumn budget, including infrastructure, equipment, workforce training and support, targeting both thrombectomy centres and referring stroke units The UK Department of Health and Social Care (DHSC) to develop a sustainable workforce plan to fill the gaps in qualified staff NHS England to address challenges in transfer to and between hospitals in its upcoming Urgent and Emergency Care Plan Innovation—such as artificial intelligence (AI) imaging software and video triage in ambulances—to be put into practice Local systems to act on their Thrombectomy Quality Reviews and solve pathway issues that are currently holding back thrombectomy rate improvements The public to sign an open letter calling on the UK government to act on the recommendations in its Saving Brains report and provide a 24/7 thrombectomy “Thrombectomyserviceisamiracle
The Saving Brains report highlights staffing shortages and estimates that achieving a universal 24/7 service would require doubling the number of interventional neuroradiologists (INRs) in the workforce, as well as the fact there are only 106 professionals who can perform thrombectomy in England—roughly four per centre. The report indicates that low thrombectomy rates are caused by prolonged ambulance response times, lengthy handovers and delayed inter-hospital transfers.
Do you think it holds the potential to be used in other case and procedure types in the future? The Emboguard balloon guide catheter is currently indicated for use in angiographic procedures, including acute ischaemic stroke as well as carotid and venous stenting. What impact do you think technologies like Emboguard are having, or will have, on the space?neurovascular The benefit of new technologies like
At the outset of his talk, Caroff noted that decisions regarding antithrombotic medications are “easier” to make for those in the cardiology space, owing to the presence of clear guidelines in both Europe and the USA. However, the relatively small number of studies—and lack of randomised controlled trials (RCTs)—on these medicines in cerebral aneurysms and acute ischaemic stroke means current practice varies, and is often based on teaching or the views of key opinion leaders, Caroff claimed. To this end, he highlighted the results of a comprehensive national survey conducted across France in 2021 and published in the Journal of NeuroInterventional Surgery earlier this year. This survey was carried out within the JENI (Jeunes en Neuroradiologie Interventionnelle) group—a network of young French physicians working in interventional neuroradiology that is “very well-coordinated and reactive”, according to Caroff. Summarising the survey’s findings, Caroff reported that there was a defined protocol for antithrombotic medications in 58% of centres, meaning there is no available protocol in close to half of the centres surveyed and antithrombotic strategies are based primarily on operator discretion. “I think this reflects the fact that, due to uncertainties, the best strategy could not be determined or formalised, but it could also mean that different physicians within a centre may not act the same way,” he asserted.
LINNC
Rice stated that, owing to the nine sensors on the device, arranged into three rows, it is also capable of identifying clots that have a ‘mixed’ composition—which may have substantial amounts of red blood cells, fibrin and platelets in their makeup— with this being signified by different impedance readings between the different groups of sensors.
“We have to define topics, and I think we also have to be ready to face a high number of patients,” he posited, noting that more than 18,000 patients were included in the RCT that was used to prove ticagrelor’s superiority over clopidogrel in the cardiology space. Finally, Caroff asserted that there is a need for global neurointerventional societies to collaborate here, and restated the importance of more definitive protocols and recommendations. “This is going to be difficult without [further] evidence,” he conceded, “and, clearly, people with years of practice will not change what they are doing based on recommendations.” He also noted, however, that renewed protocols may be more beneficial in helping to guide younger, less experienced physicians.
Moving on to discuss the Clotild technology, Rice noted its unique, “very clever” microsensor, which is 2mm in size and performs impedance measurements that are transmitted to the Cloviz tablet device via a Bluetooth transmitter, providing real-time insight on what the clot looks like, and the length of the occlusion. This translates to the sensor delivering higher impedance measurements in red blood cell-rich clots, and lower impedance measurements for fibrin-rich clots, he added, reporting a “really good differentiation” between the two.
THE PRESENTER STARTED BY noting that the first-pass effect is “very important” in this space, increasing the likelihood of a thrombolysis in cerebral infarction (TICI) 3 score and a “great clinical outcome” for the patient.
The world of interventional neuroradiology will likely need to follow the cardiology field and conduct large-scale prospective studies in order to move away from ‘eminencebased medicine’, and gain a better understanding of antithrombotic medication outcomes.
“Finally, there is a need for harmonisation because—if we want to gain credibility as a field— we clearly need to change our practice,” Caroff concluded. In a subsequent discussion, Guilherme Dabus (Miami Neuroscience Institute, South Miami, USA) supported many of Caroff’s points, noting that “in a lot of the things we do, we really are still an eminence-based field”, and stating that further data collection and prospective studies on these medications are warranted. Responding to Caroff’s point on the need for societies to get involved in wide-scale antithrombotic medication research, J Mocco (Mount Sinai Health System, New York, USA) said that multi-thousand-patient analyses are feasible through existing, ongoing registries— such as those supported by the Society of NeuroInterventional Surgery (SNIS) and the Society of Vascular and Interventional Neurology (SVIN)—but this will require “every one of us taking time out of our day to put the data in, which is not easy.”.
AI-poweredNeuroradiologydevice delivers
Large-scale prospective studies required to elucidate antithrombotic medication outcomes
thrombi, for example, are more susceptible to distal embolisation, while fibrin-rich and platelet-rich thrombi may be harder to remove but also have less chance of embolising distally.
those in attendance (98%) believe interventional neuroradiology guidelines on the use of antiplatelet therapy and heparin are required. He proceeded to echo this message himself, noting that “very efficient” protocols are needed. The speaker also highlighted the importance of further evaluation in this space, adding: “I think there is room for prospective, controlled registries to help us improve our understanding. There is clearly a need for randomisation too—but this is going to be very tricky.”
Rice noted that recent studies have also confirmed that clot composition has a significant bearing on patient outcomes too. Red blood cell-rich
8 August 2022 | Issue47Interventional
The Clotild smart guidewire system (Sensome), which uses artificial intelligence (AI) to provide real-time insights on clot composition, is showing early promise in the first-inhuman CLOT OUT study, according to Hal Rice (Gold Coast University Hospital, Southport, Australia). Rice discussed this novel technology and the potential it offers in endovascular thrombectomy procedures using electrical impedance spectroscopy at LINNC Paris 2022 (30 May–1 June, Paris, France).
“amazing physiologic information” to guide thrombectomy treatments
Caroff moved on to state that discrepancies in aspirin dosages and choices of P2Y12 inhibitors (ticagrelor, clopidogrel and prasugrel) for unruptured aneurysms were observed, and the survey also found “major variability” in heparin bolus dosages. In addition, the speaker noted his surprise that close to 25% of all centres were using postoperative heparinisation. He then highlighted uncertainties and further variation in ruptured aneurysm treatment strategies—specifically in heparin bolus injection approaches and emergent stenting, for which there was “no consensus”. “We still have many uncertainties in acute ischaemic stroke as well, but we are beginning to get more answers, and I think this should inspire us regarding aneurysm treatments,” Caroff continued. Here, he highlighted the fact that, for mothership patients, 15% of comprehensive stroke centres in the survey reported a switch from alteplase to tenecteplase as a first-line fibrinolytic and that, in spite of the increased risk of symptomatic intracranial haemorrhage observed in the MR CLEAN-MED trial, 28% of centres occasionally administered an intravenous bolus of heparin at the beginning of a mechanical thrombectomy procedure.Caroffthen revealed the results of an online survey conducted among LINNC attendees during his talk, indicating that an overwhelming majority of
“I think we can do better,” Jildaz Caroff (Bicêtre Hospital, Le KremlinBicêtre, France) told attendees at LINNC Paris 2022 (30 May–1 June, Paris, France), emphasising the need to move from eminence- to evidence-based practice.
He then detailed that the Clotild device uses a database centred around clots with a known composition. This database has been used to train a machine-learning model capable of recognising different compositions, which is then able to predict composition in unknown clots, Rice reported.Healso claimed that this use of electrical impedance spectroscopy presents a novel means for characterising occlusions in stroke, with data having shown continued coherence through ex vivo, animal and early inhuman research thus far. The next part of Rice’s presentation homed in on the CLOT OUT trial, which is the first in-human study
Jildaz Caroff Hal Rice
Following this presentation, Vitor Pereira (St Michael’s Hospital, Toronto, Canada) highlighted the fact that future advances may also open up the possibility of treating cases such as this with medications.AdamArthur (University of Tennessee, Knoxville, USA) noted these types of hybrid approaches can be “very useful” in difficult cases and said it was interesting to see a case in which “a surgeon caused your problem, but you then used a surgeon to solve thatLINNCproblem”.course director Jacques Moret (Bicêtre University Hospital, Paris, France) claimed this was a “spectacular” case backed by good understanding, management and results. At the close of the session, Saraf was presented with the 2022 Best Case Award and was joined on stage by many of the LINNC faculty members who had voted for her to receive this prize. evaluating the safety of the Clotild smart guidewire system. Training and validating the aforementioned prediction model via a database is also a key objective of CLOT OUT, he noted.The single-arm, multicentre study began in late 2021, is taking place across Australia and Europe, and intends to enrol roughly 100 patients with an M1-origin acute ischaemic stroke in order to collect a total of 60 clots. Providing a status update on CLOT OUT, Rice said the trial has enrolled 11 patients to date, with no devicerelated complications being observed in these completed cases, and the first Data Safety Monitoring Board meeting recently recommended continuation of theConcludingstudy. his talk, Rice said this “exciting” technology is akin to other stroke care innovations like robotics and administering thrombolytics postthrombectomy.“Aswellaswhat we see on an angiogram or feel in terms of resistance during a procedure, this wire means we are now getting amazing physiologic information too,” he continued. “It also integrates very well into our current mechanical thrombectomy workflows, with very little delay to these timecriticalHere,procedures.”hereported that deployment of the Clotild device adds fewer than five minutes to the overall thrombectomy workflow. Rice also alluded briefly to future applications beyond clot composition and length, such as in vessel wall analysis to elucidate other key occlusion characterises like smooth muscle content and cholesterol— possibly identifying clots that are actually intracranial atherosclerosis (ICAS) lesions, not thromboembolic occlusions.“Theseparameters can really help to guide the mechanical thrombectomy procedure and potentially increase the first-pass effect going forward,” he stated. “It is early days, with 11 patients out of 100 enrolled, but the technology is definitely very promising.”
Rashmi Saraf on stage with LINNC faculty members “Spectacular” unilateral proptosis treatment receives LINNC Paris Best Case Award
9Issue47 | August 2022 Interventional Neuroradiology
RASHMI SARAF (KING EDWARD Memorial [KEM] Hospital, Mumbai, India) delivered the case in question, detailing that a 14-year-old girl presented at her hospital with severe, unilateral proptosis and virtually no vision in one eye. She noted that an initial angiogram showed the girl had previously undergone an ECA and superior ophthalmic vein (SOV) ligation at another centre, and a digital subtraction angiography revealed two discreet intraosseous arteriovenous fistulas (AVFs) in the greater wing of sphenoid bone—both of which had eventual common drainage. Saraf detailed that, owing to the previous access being closed, her team attempted to use the collaterals from the deep cervical artery but got “nowhere near” the fistulas, and could not even reach the occipital artery. After discussing alternatives with her hospital’s cardiovascular and thoracic surgeon, Saraf said the decision was taken to “re-explore the neck” with a direct ECA puncture distal to the ligation. This procedure also proved “very difficult” for the surgeon, according to Saraf, as the ligation was so high up (almost at C2 level) and distal. A surgical neck resection was performed, with direct puncture being done in the ECA distal to ligation, and access was achieved. A balloon was kept in the right internal carotid artery (ICA) to protect the vessel. The liquid embolic used (Onyx, Medtronic) started penetrating “after some time” following injection into the distal internal maxillary artery (IMAX).
A final, post-embolisation angiogram revealed “complete obliteration” of the targeted fistula. Saraf asserted the importance of packing the intraosseous pouches, as the fistulas can reoccur otherwise. She also reported that the patient’s proptosis gradually decreased over the following six weeks and she is now doing “quite well”. Saraf then detailed that further investigations after the procedure revealed a diagnosis of cerebrofacial arteriovenous metameric syndrome (CAMS)—at the age of four years—with a slowly proliferating intraosseous lesion in the right sphenoid bone that, over the course of a decade, progressed to intraosseous AVF draining into the SOV with venous congestion and carotid cavernous fistula (CCF)-likeDiscussingsymptoms.themanagement of this case, Saraf added that it was a “technical challenge” because prior arterial and venous surgical ligation had “taken away all of our endovascular accesses”.
An “interesting case” of unilateral proptosis in a 14-year-old girl, treated using a hybrid approach via direct external carotid artery (ECA) puncture, was presented during a roundtable session at this year’s LINNC Paris Course (30 May–1 June, Paris, France) and was subsequently recognised with the LINNC faculty’s Best Case Award.
In a subsequent discussion, Jacques Moret (Bicêtre University Hospital, Paris, France) praised this “fascinating” use of high technology, and Vitor Pereira (St Michael’s Hospital, Toronto, Canada) noted that it has the potential to improve first-pass recanalisation rates by “bringing personalised medicine to the thrombectomy world”.
Saraf closed her presentation with multiple takehome messages—the first of these being that regular follow-up is necessary in childhood facial haemangioma cases with bony enhancement, and this is especially true in female patients, as hormonal changes during puberty may lead to lesions progressing into more obvious fistulas, even if they have previously remained stable for a long period.
In addition, the speaker told the LINNC audience that proper diagnoses and assessment of imaging can prevent catastrophic surgeries like the one this patient had to undergo. “There is always a way out,” she concluded. “When there is no endovascular access, or no ultrasound guidance, surgeons can be of great help—and direct surgical exposure may be considered if access is not available.”
It is early days, with 11 patients out of 100 enrolled, but the technology is definitely promising.”very
E very year, more than 800,000 people in the USA have a stroke. Stroke remains the secondleading cause of death and the thirdleading cause of death and disability combined. Many advances have been made with regards to acute management of stroke but, unfortunately, nearly 75% of stroke victims suffer from chronic dysfunction and 15–30% of stroke survivors have a severe disability. Within the last decade, HBOT has been studied and utilised as a therapeutic modality for chronic stroke survivors. HBOT utilises 100% oxygen in an environmental pressure higher than one absolute atmospheres (ATA) to enhance the amount of oxygen dissolved in the body’s tissues. In the chronic stroke stage, HBOT induces oxygenation, which improves energy metabolism in the border zones of focal cerebral ischaemia. Often, a stroke will cause cell death, but there tends to be an area surrounding the stroke that is collaterally injured, called the penumbra. The penumbra is the target for healing and regeneration by HBOT. In addition, HBOT can decrease the post-ischaemic inflammatory response and restore mitochondrial function. Lastly, and most interestingly, providing a unique protocol with repeated intermittent hyperoxic exposures has been shown to induce physiological regenerative effects, which normally occur during hypoxia, including the creation and repair of neurons (neurogenesis), stem cell proliferation and generation of new blood vessels (angiogenesis).
Amir Hadanny is chief researcher and head of International Clinical Operations at Aviv Clinics. He is also a certified neurosurgeon, hyperbaric physician and chief medical research officer at the Sagol Center for Hyperbaric Medicine and Research in Be’er Ya’akov, Israel.
Comment & Analysis Aviv Clinics’ hyperbaric suite
Mohammed Elamir is an Aviv Clinics physician, based in The Villages, USA, with more than eight years of experience in internal medicine. He is also a fellow of the American Board of Internal Medicine.
Case study Here, we detail a case study involving a patient referred to as ‘Mr Jones’.
3. Boussi-Gross R, Golan H, Volkov O, et al Improvement of memory impairments in poststroke patients by hyperbaric oxygen therapy. Neuropsychology. 2015; 29(4): 610–21.
In the end, the results speak for themselves, and it will be a matter of when, not if, HBOT will be the standard of care for treating poststroke patients.”
Mohammed Elamir & Amir Hadanny
Current literature Clinically, the literature suggests evidence of significant improvement in both neurological and physiological deficits, quality of life, activities of daily life and cognitive function. As proven by Efrati et al in a randomised controlled trial, HBOT leads to significant neurological improvements in post-stroke patients, even at chronic late stages, following a two-month programme.1 BoussiGross et al analysed the data of more than 90 chronic stroke patients and demonstrated a significant memory improvement.2 Recently, Hadanny et al showed all cognitive domains are improved in 162 patients, regardless of stroke type or location.3 It was once thought that new nerve fibres could not be regenerated in the brain, but that is no longer true. Tal et al showed HBOT can improve both white and grey microstructures indicating regeneration of nerve fibres. These microstructural changes correlate with neurocognitive improvements.4Whenassessing who may be a suitable candidate for the treatment, patients should undergo a comprehensive evaluation of their physical, emotional and cognitive deficits. Next, patients should have both brain metabolic imaging and anatomical imaging (diffusion tensor imaging [DTI]). Ideal patients for the treatment are those with considerable metabolic defects with a mismatch between function and anatomical findings i.e. salvageable tissue. The correlation between the deficits and the salvageable areas are evaluated to determine outcomes and suitability for HBOT. Eligible patients go through a full programme that includes the unique intermittent exposures of two hours a day at pressure of 2.0 ATA while breathing 100% oxygen, five days a week, for a total of 60 treatments. When combined with other conventional treatments like physical, cognitive, and occupational therapies, a significant amplification can be achieved. At the end of the programme, the patient repeats physical, cognitive and imaging assessments to quantify objective changes and measure improvements on the Quality-of-Life Scale (QOLS).
ClinicsAviv
Mohammed Elamir (The Villages, USA) and Amir Hadanny (Be’er Ya’akov, Israel) marked this year’s Stroke Awareness Month by discussing hyperbaric oxygen therapy (HBOT)—an emerging approach that they believe could break new ground in post-stroke recovery.
Mr Jones was treated at Aviv Clinics eight years after suffering an ischaemic stroke that caused left-side hemiparesis. He needed full assistance from his wife to stand and complete activities of daily living, and his main mode of mobilisation was a wheelchair. Mr Jones underwent a full assessment, including cognitive, physical and brain imaging—as is standard with the Aviv Clinics assessment. During this assessment period, Mr Jones walked 30 feet in one minute and 37 seconds (1.04 multiple errands test score [METS]). His desired treatment outcome was to regain independence and no longer be a burden on his wife. Mr Jones underwent 12 weeks of HBOT treatments, composed of 60 sessions, as well as concomitant physical therapy, occupational therapy, neuropsychological training and coaching from a dietitian. Post-treatment assessment, his single-photon emission computed tomography (SPECT) scan showed 20% improvement in the metabolic function of the penumbra. His cognitive scores increased by one standard deviation in memory, executive function, and attention. His physical performance improved tremendously, increasing his ability to walk without assistance up to 86 feet in two minutes (>2 METS). He regained his independence, no longer needed his wheelchair, and he and his wife were elated with his improvements.
Treating chronic-stage stroke with hyperbaric oxygen therapy
4. Tal S, Hadanny A, Sasson E, et al. Hyperbaric Oxygen Therapy Can Induce Angiogenesis and Regeneration of Nerve Fibers in Traumatic Brain Injury Patients. Front Hum Neurosci. 2017; 11: 508.
DISCLOSURES: The authors both disclosed that they are affiliated with Aviv Clinics.
References: 1. Efrati S, Fishlev G, Bechor Y, et al. Hyperbaric Oxygen Induces Late Neuroplasticity in Post Stroke Patients – Randomized, Prospective Trial. PLOS ONE. 2013; 8(1): e53716.
Angiogenesis is induced mainly in brain regions signalling ischaemia or metabolic dysfunction.
2. Hadanny A, Rittblat M, Bitterman M, et al. Hyperbaric oxygen therapy improves neurocognitive functions of post-stroke patients – a retrospective analysis. Restor Neurol Neurosci. 2020; 38(1): 93–107.
Clinical application This is an exciting time for the treatment of chronic-stage stroke. The research is convincing and clinics around the world, like Aviv Clinics, are implementing this new HBOT protocol to help post-stroke patients achieve cognitive and physical improvements.Today,thepriority for the Aviv clinical team is to educate the poststroke community on new treatment methods that can increase independence and regain physical and cognitive functions. Unfortunately, not all HBOT programmes are the same, and ensuring false claims with inferior methods is important. In the end, the results speak for themselves, and it will be a matter of when, not if, HBOT will be the standard of care for treating post-stroke patients.
10 August 2022 | Issue47Hyperbaric Oxygen Therapy
Currently, the majority of acute stroke research uses the terms sex and gender interchangeably. The statement suggests that studies examining biological and hormonal factors related to stroke should consider analysis by sex, while research assessing the impact of stroke on quality of life and other social factors may analysisfindby gender to be relevant.moreThere is currently a large overlap between sex and gender in this population, the statement says. However, while the number of transgender individuals in the USA is estimated to be rather low (0.3–0.8%), selfidentified gender diversity in people with stroke is expected to increase in the future. Age at EVT treatment also varies. While stroke incidence increases with age, women tend to be 4–5 years older than men when a stroke occurs (average age at first stroke is about 68 years in men and 72 years in women), which is linked to poorer outcomes.
“As a healthcare system that is responsible for and tracks patients after they are discharged from the hospital, the VA is well-suited to conduct this type of analysis and do the follow-up indicated—for example, helping patients control blood pressure after a stroke or ministroke,” said Bravata. “Given the widespread phenomena that people received less healthcare during the pandemic, we would expect the same decrease in primary care visits in non-VA settings. As patients return to primary care, post-stroke checkups and blood pressure control hopefully can be prioritised.”
COVID-19 “did not affect stroke care quality or outcomes” in largest healthcareUSsystem
RESEARCHERS FROM THE US Department of Veterans Affairs (VA), and the Regenstrief Institute in Indianapolis, USA and Monash University in Melbourne, Australia, assessed patients with strokes or ministrokes (transient ischaemic attacks [TIAs]) in 128 hospitals across the USA within the VA’s health system—which claims to be the nation’s largest integrated healthcare system. As with non-COVID-19other
In one of the first studies to investigate the overall quality of care and outcomes of stroke care for non-COVID-19 hospitalised patients during the pandemic from a US perspective, researchers have reported no decline in overall quality of care nor outcomes, after risk adjustment, when comparing patients with stroke and ministrokes from prior to the pandemic (March to September 2019) to the same months during the pandemic (March to September 2020).
11Issue47 | August 2022 Stroke Care
LINKED INOUTCOMESPOORERTOWOMEN
Dawn Bravata
conditions, the number of hospitalisations for strokes and ministrokes was lower during the pandemic than before COVID-19; approximately 30% lower for ministrokes and 19% lower for strokes. The researchers used seven standardised measures to determine that overall quality of care for stroke and ministroke did not diminish in VA facilities during the pandemic. They found that the use of statin medications continued to increase during 2020, especially among patients with stroke—a trend that had been evident for several years prior to the pandemic. However, patients with stroke or ministroke had far fewer primary care visits, delaying or deferring care during the pandemic.
However, because EVT was only recently established as a standard of care for ischaemic stroke, there are limited data about the physiological differences in treatment and outcomes between men and women, the AHA statement details. It provides a list of suggestions to assess sex- and genderrelated differences in EVT research, and a guide for clinicians to improve care for people who have undergone EVT by addressing sex- and gender-specific factors.Thestatement clarifies that sex refers to biological factors, is categorised as male or female, and is static (i.e. does not change over a person’s lifetime), while gender is defined in terms of individual social roles, behaviours and expressions. Gender identity differs from sex in that it is neither binary nor static; it exists along a continuum and may change over time, and—due to limitations of data available—the statement addresses only binary gender.
AHA statement highlights need for more data on sex differences in stroke treatments
The statement refers mostly to sex differences on the basis of the data that were captured in most EVT studies, and the use of ‘male and female’ or ‘men and women’ refers to sex—with the acknowledgement, however, that some of the addressed sex differences may truly be related to gender rather than sex.
As patients return to primary care, post-stroke checkups and blood pressure control hopefully can be prioritised.”
THE NEW SCIENTIFIC statement, entitled “Toward a better understanding of sex- and genderrelated differences in endovascular stroke treatment”, is published in the journal Stroke. This follows a 2019 update to the AHA stroke treatment guidelines that recommended mechanical clot removal—also known as endovascular therapy (EVT)—for select stroke patients to improve the likelihood of functional recovery.
A new American Heart Association (AHA) scientific statement has highlighted the need for more data about sex differences in the use of and response to mechanical thrombectomy for acute ischaemic stroke, and suggests the need for a clear differentiation between sex and gender in future research.
With few exceptions, stroke and ministroke patient characteristics were similar between 2019 (prepandemic) and 2020. The researchers found that, during the pandemic, a slightly greater proportion of patients came to the hospital as a result of a stroke, rather than due to a ministroke (69% vs 66%). Bravata noted that individuals with transient symptoms of ministrokes may have hesitated to seek medical attention during the pandemic. The study evaluated care for patients with stroke or ministroke from typical causes, and did not include patients who were admitted to the hospital for COVID-19 and then had a stroke or ministroke. Fewer than 2% (72 individuals) of those admitted to the 128 VA hospitals with stroke or ministroke from March to September 2020 concurrently had or subsequently developed COVID-19. These findings are published in the Journal of Stroke and Cerebrovascular Diseases by Bravata and her colleagues.
Moving researchersforward,needto be aware of the profound impact of sex on stroke incidence, treatment and prognosis, such as noting sex-related differences in research data, the AHA statement notes. In addition, clinicians need to understand the importance of sex- andbiasesgender-relatedintheir daily practice to meet the specific needs peopleof who receive EVT.Itadds that the (AAN)NeurologyAcademyAmericanofaffirms the value of this statement as an educational tool for neurologists, and the statement is endorsed by the American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) too.
OCCURRENCESTROKEAGEAVERAGEATFIRST 68 72years old men yearswomenold
During the pandemic, about 40% of stroke patients did not have a blood pressure measurement, while only 10% of stroke patients did not have a blood pressure measurement pre-pandemic. Missing blood pressure checks was associated with a six-fold increase in short-term mortality and a three-fold increase in longterm mortality, according to Dawn Bravata (Indiana University School of Medicine, Indianapolis, USA), who led the study. She noted that a robust relationship between increasing blood pressure and stroke risk has long been known to exist. The researchers found that blood pressure, when measured during the pandemic, was not as well-controlled as it had been during the pre-pandemic period. The study also found that death rates of stroke or ministroke patients in VA hospitals were not statistically different after risk adjustment during the prepandemic and pandemic time periods.
The majority of cases the CorPath GRX Neurovascular Robotic System (Siemens Healthineers) has been deployed in to date are cerebral aneurysm treatments— primarily neurovascular coiling and stenting procedures, as per the indications currently approved in Europe. Siemens Healthineers is now working towards expanding into additional markets and, according to Raymond Turner IV, endovascular neurosurgeon at PRISMA Health and Siemens Healthineers chief medical officer (Neurovascular), the company has high hopes for expanding this technology even further across neurointerventions moving forward.
Importance of imaging
“We are 100% dependent on imaging and image quality as neurosurgeons—we are not looking at the brain with our own eyes,” he continues. “So, we need to be able to trust that what we are seeing on the screens is what is really happening. It is very much like imaging is the surgeon’s eyes and robotics is the surgeon’s hands. Bringing the two together is key.”
“One benefit we are seeing with the robot today is its ability to give you millimetre accuracy and precision,” says Turner.
In addition, Zeleňák states that future remote capabilities offer “fascinating” potential, such as the possibility for multiple physicians in different hospitals to collaborate on the same case—if they have a robotic system at their centres. He goes on to cite the fact that, in addition, robotic systems may enable more experienced physicians to operate remotely, meaning their time is used more effectively and leading to additional cost-effectiveness benefits.
Again, Turner alludes to subsequently improved patient outcomes, as this could make manoeuvres more efficient and precise. He adds that imaging has a critical role to play here as well, by linking what the physician sees on the screen to what the robot is doing. “In 2022, image quality is phenomenal— compared to even 10 years ago—and it is only going to get better,” he states.
The fact that robotics can reduce radiation exposure for the interventionalist by enabling them to operate from a radiation-shielded location is also a key advantage, he adds. And, in cardiology, reduced radiation exposure has been seen in patients too.
Zeleňák also believes that, as with artificial intelligence (AI), physicians may worry that robotic technologies are designed to ‘replace’ them, but asserts that this is not the case. “I am convinced that this is the only way we can manage the healthcare system in the future as the number of cases and procedures increases over time,” he concludes.
The inevitable growth of neurovascular robotics: Improved precision today, potential remote capabilities in the future
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“There are several advantages to such a system,” he claims. “Firstly, procedures can be performed from a different room to the patient—which is especially relevant in the COVID era. And, potentially, in the future, procedures can be performed from another hospital, another country or even another continent, with the only real limitation being internet speed.” Here, Zeleňák also corroborates Turner’s view that significant reductions in radiation exposure and a level of precision that is difficult to achieve in manual procedures are among robotics’ other key benefits. He goes on to note that, initially, his centre used the device for diagnostic cases, before expanding into the treatment of intracranial aneurysms across a range of locations via stenting and stent-assisted coiling procedures. Drawing on the 27 in-human cases he has deployed the robot in thus far, Zeleňák says it can “perfectly simulate” every step of a more traditional, manual procedure and, as such, experienced operators should have little difficulty transitioning to using the roboticZeleňáksystem.also attempts to allay fears physicians may have about not being able to feel devices or materials in their own hands, and being more likely to make a mistake as a result, by reiterating that the system is simple and easy to use. Further, he highlights the robot’s built-in ability to help protect patient safety and stop the procedure if it detects too much force being exerted through the system.
According to Turner, another “huge benefit” offered by robotics is control. In addition to removing the issues of physiological tremor and physician fatigue that must be factored into manual procedures, he notes that—because the operator sits at a console, and is closer to the screen than they would be during a non-robotic procedure—this technology enables ergonomic advantages with increased levels of comfort and visibility as well.
“For any procedure, there is a learning curve, and this has been confirmed by previous publications but, if you know what to do already, my view is that the learning curve with robotics is not very big,” Zeleňák adds, in addition to recommending that initial training via in vitro models is a good way to familiarise oneself with the technology. What does the future hold? As the robot was only introduced in his centre relatively recently, Zeleňák notes that it is not currently deployed in every one of his neurovascular cases, but says that—beyond additional costs associated with such a new technology—there are no other major limitations preventing its use in almost every case further down the line. “I am 100% sure that, in the very near future, we will be using it in normal, daily practice,” he adds.
“When you are treating aneurysms that might be 3mm or 4mm in size, millimetres matter, and being able to move a device by 1mm at a time, if required, is important. And it is not just that it can be more precise than a human—it is more precise every single time.”
“It is important that we see this through,” Turner says. “It takes time, and there is a maturation process while we build up more evidence, but I do not think this is any different from the maturation process we saw when going from open surgery to endovascular techniques. Now, we are moving into robotics. It will happen in our lifetimes, so it is up to us—the physician community—to really help identify opportunities that will help our patients and drive the technology forwards.”
Turner also urges physicians and hospitals to “get on board now and be an early mover”, rather than “sitting on the side-lines”—citing not only the more immediate benefits regarding precision and radiation exposure, but also long-term considerations over implementing robotics at their centres. “We are very much in the infancy of this, but I think [healthcare systems] need to be realistic about where things are going to go in the next three, five, even 10 years, with robotics. It is about making sure that everything is positioned so that, as the technology advances, you advance with it rather than lagging behind and letting the opportunity to improve patient outcomes slip by.”
Disclaimer: CorPath GRX for use in neurovascular interventions is available in select markets. It is not available for sale in the USA. Consult your local sales representative to confirm availability. Future availability in all markets cannot be guaranteed. Remote capabilities are currently under development; it is not for sale. Its future availability cannot be guaranteed.
12 Advertorial August 2022 | Issue47
Raymond Turner Zeleňák(below);IVKamilusing the GRXCorPathSystem (right)
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According to Turner, other fields are moving in a similar direction right now, with the CorPath GRX System having already been approved for cardiovascular and peripheral vascular cases in both the USA and around the globe—and its continued progress both in and out of neurointervention is near-inevitable. He believes robotics will eventually be capable of performing “the vast majority” of neurovascular procedures, with more urgent cases within the stroke care space on the horizon.
“I think all of these advantages of the robot should ultimately increase safety—not only by allowing operators to place devices precisely, therefore optimising the treatment, but also by improving the safety profile for the patient,” Turner notes. “Both of those things should drive better outcomes.”
User experience Having introduced the CorPath GRX System at his centre in an effort to reduce COVID-19 infection risks, before using the device for the first time in February 2022, Kamil Zeleňák— head of the Department of Radiology in Comenius University’s Jessenius Faculty of Medicine (Martin, Slovakia)— is currently among the most experienced surgeons in Europe when it comes to robotic-assisted neurovascular procedures.
“When you look at the 30-day follow-up, the majority of these lesions disappear,” Motaganahalli then detailed, adding that lesions persisted in only 5.8% of the patients assessed at this timepoint. The mean volume of the lesions at this point was 0.21cc, which were again predominantly located in the territory of the middle cerebral artery. No incidences of stroke or neurological death, the study’s secondary endpoints, were seen.
“These lesions are very small and—when followed up—the majority of those procedures are resolved,” Motaganahalli added. The results of the study should serve as a benchmark, and point to the detection of new white lesions as a surrogate marker for future carotid revascularisation clinical trials, he concluded. These lesions are very small and— when followed up —the majority of those procedures are resolved.” Motaganahalli
Raghu
Low rate of new white lesions detected after TCAR using diffusion-weighted MRI New white lesions are not a common occurrence in patients who have undergone transcarotid artery revascularisation (TCAR), a study in which patients were assessed post-procedurally using diffusion-weighted magnetic resonance imaging (DW-MRI), has found.
SPEAKING ON BEHALF OF senior author Danielle Bajakian (Columbia University Medical Center, New York, USA) and colleagues, Elmously concluded that TCAR within 14 days of a neurologic event results in higher ipsilateral postoperative stroke rates when compared to CEA, especially when performed within 48 hours.Elmously and colleagues state that carotid revascularisation within 14 days of a neurologic event is recommended by society guidelines. They note that TCAR carries the lowest overall stroke rate for any carotid artery stenting technique, but stress that “outcomes of TCAR within 14 days of a neurologic event have not been studied or directly compared to CEA”. The research team compared in-hospital outcomes of symptomatic patients undergoing TCAR and CEA within 14 days of stroke or transient ischaemic attack (TIA) from January 2016 to February 2020 using the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) carotid artery stenting and CEA databases. They note that propensity score matching was used to adjust for patient risk factors, and that the primary outcome was a composite of postoperative ipsilateral stroke, death and myocardial infarction (MI). The researchers detail that 1,281 symptomatic patients underwent TCAR and that 13,429 patients underwent CEA within 14 days of a neurologic event. After 1:1 propensity matching, they add, 728 matched pairs were included for analysis. At VAM, Elmously communicated that the primary composite outcome of stroke, death or MI was more frequent in the TCAR group (4.7% vs 2.6%, p=0.04). The presenter informed delegates that this was driven by a higher rate of postoperative ipsilateral stroke in the TCAR group (3.8% vs 1.8%, p=0.005). In addition, he reported that there was no difference between TCAR and CEA in terms of death (0.7% vs 0.8%, p=0.8) or MI (0.8% vs 1%, minutes,range(69proceduresAlthoughp=0.7).TCARwereshorterminutes,interquartile53–85vs120IQR93–150,p<0.001) and postoperative length of stay was similar (two days, p=0.3) compared to CEA, TCAR patients were more likely to be discharged to a facility other than home (26% vs 18.9%, p<0.01), Elmously detailed. He also said that performing TCAR within 48 hours of a stroke was an independent predictor of postoperative stroke or TIA (odds ratio [OR] 5.4, 95% confidence interval [CI] 1.8–16).
Further insights on post-carotid revascularisation stroke rates were presented elsewhere at VAM, with Pasqualino Sirignano (University of Rome, Rome, Italy) delivering a retrospective study that compared symptomatic carotid artery stenting (CAS) and CEA patients treated within one month of symptom onset. The study’s findings support female sex being considered as an independent risk factor for new stroke occurrence after carotid revascularisation in symptomatic patients, he reported.
Adham Elmously (New York Presbyterian Hospital, New York, USA) presented outcomes of early transcarotid artery revascularisation (TCAR) versus carotid endarterectomy (CEA) after acute neurologic events during the opening day of the Vascular Annual Meeting (VAM; 15–18 June, Boston, USA).
13Issue47 | August 2022 TCAR
Early TCAR results in higher ipsilateral postoperative stroke rates when compared to carotid endarterectomy
For the study, a total of 55 patients were enrolled across five centres from the USA, as well as centres in Madrid, Spain, and Munich, Germany. Each patient underwent three MRI scans, one within the 72 hours preceding the TCAR procedure, another before their discharge from hospital, and a third at 30-dayRelatingfollow-up.tothestudy’s primary endpoint, detection of new white lesions from the DW-MRI scan, Motaganahalli detailed that new white lesions were seen in 14.5% of patients prior to the TCAR procedure, with a mean volume of 0.11cc. New white lesions were then seen in 21.8% of the study population in scans taking place between 12–60 hours post-procedure, with a mean volume of 0.03cc. Predominantly, these were distributed in the territory of the middle cerebral artery, Motaganahalli said.
“Patients who underwent TCAR and DW-MRI post-procedurally had a low incidence of new white lesions,” the presenter told attendees of the plenary session. Of these, he added, the majority were in the ipsilateral hemisphere, and located in the middle cerebral artery territory and distribution.
ElmouslyAdham VAM
THIS WAS THE FINDING DELIVERED BY Raghu Motaganahalli (Indiana University School of Medicine, Indianapolis, USA), who presented data from a multicentre, single-arm, open-label study evaluating the incidence and volume of new white lesions occurring within 30 days after TCAR. Motaganahalli told attendees of a plenary session at the 2022 Vascular Annual Meeting (VAM; 15–18 June, Boston, USA) that the outcomes of the analysis should serve as the benchmark for future comparisons evaluating carotid revascularisation strategies on cerebral new white lesions. DWI has high sensitivity and specificity for the early detection of ischaemic lesions, Motaganahalli detailed in his presentation, noting that, on DWMRI, early ischaemic lesions appear as new white lesions. Data from previous studies suggest that there is around a 17% chance of patients developing new white lesions following a TCAR procedure, Motaganahalli said, adding that the study presented at VAM 2022 is the first in the USA to evaluate the occurrence of new white lesions using DW-MRI.
Primary outcomecompositeofstroke,deathorMI 4.7% 2.6% groupTCAR groupCEA
Alzheimer’s patients’ brains have a “quantifiably smaller” hippocampus, says Weinkauf. “We found the same thing in patients with severe carotid stenosis [defined as >70% stenosis] compared to well-matched controls with <50% carotid stenosis bilaterally,” he adds. “It is something you can quantify to see if something is changing. The project started by asking these kinds of questions. We want to try to quantify the brain: volumes, structural connectivity, functional connectivity and other relevant findings associated with neurodegeneration. We did not have these tools 20 years ago, or even five years ago in some cases, so even if someone had thought of this then they would not have necessarily had the tools to investigate. We are lucky to have surgical treatments for this problem. We will also be able to follow that population to see if they have key structural and functional brain changes that improve with intervention.”
Research indicates low stroke risk and benefit of medication alone in asymptomatic carotid stenosis
“This strategy gets at a key deficit in how we currently approach carotid disease management: there is minimal patient selection for defining carotid disease subpopulations that may benefit most from treatment,” Weinkauf adds.
interventions:Carotid A new pathway for preventing dementia?
“T he question of how to best treat patients with narrowing of the carotid artery without symptoms has been a longstanding research priority,” said Robert Chang (The Permanente Medical Group, Oakland, USA).
The study, published in The Journal of the American Medical Association (JAMA), is believed to be the largest and most current assessment of long-term stroke risk in this population, according to KaiserRandomisedPermanente.clinical trials conducted prior to 2010 concluded that surgery to remove carotid artery blockages was the best option for reducing stroke risk in patients with severe stenosis. But, as medical treatments for reducing stroke risk have improved, physicians have questioned whether surgery should remain the preferred treatment for asymptomatic patients, a Kaiser Permanente press release states.
Craig Weinkauf (University of Arizona, Tucson, USA) is leading a trial looking into a connection between Alzheimer’s disease and carotid stenosis. “We want to try to quantify the brain: volumes, structural connectivity, functional connectivity and other relevant findings associated neurodegeneration,”withhesays.
To answer that question, Chang and his colleagues identified 3,737 Kaiser Permanente members in Northern California who had been diagnosed with severe asymptomatic carotid stenosis (70–99% blockage) between 2008 and 2012. None of these patients had previously had surgery.
Related questions are being asked in various ways by other groups as well, including the CREST-H (haemodynamics) part of the CREST-2 trial. “It is clear that these types of questions are in the air and hopefully, as a field, we will be able to improve care for our vascular patients by better understanding the connection between carotid artery stenosis and brain health,” Weinkauf says, also noting that some carotid patients have told him that, following a procedure for carotid disease, their vision, hearing and thinking all improved. “I think there is more overlap between these two large patient populations, those with carotid and those at risk for Alzheimer’s, than is currently appreciated,” he adds.
14 August 2022 | Issue47Carotid Interventions
The risk of having a future stroke caused by asymptomatic carotid stenosis is “so low” that most patients with this condition could potentially be treated with the newest medications and may not require surgery. That is according to new research from Kaiser Permanente.
The study’s senior author, Mai Nguyen-Huynh (The Permanente Medical Group, Oakland, USA), said the findings did not surprise her. “We suspected that we may find a low risk of stroke in these patients because there are now better stroke-prevention treatments, including medications to control blood pressure, prevent blood clots, and reduce cholesterol, than when the original randomised trials were done,” she noted. “I think our study will make many patients and their doctors think twice about surgery if they can instead be on an effective, aggressive medical management programme to lower their stroke risk from asymptomatic carotid disease.”
Chang and Nguyen-Huynh currently lead a team at the Kaiser Permanente Division of Research affiliated with a national, randomised clinical trial, called CREST-2, that is enrolling patients in a study comparing surgery or stenting to medical management in patients with asymptomatic severe carotid stenosis. “This head-to-head comparison of carotid surgery versus medical management in a clinical trial is what we need to help us determine the appropriate approach,” Nguyen-Huynh added.
Carotid disease causes 10–20% of strokes, but Weinkauf believes physicians might not consider it a major problem if one or two vessels are occluded, because the brain still has so much collateral blood flow. The point of the study, he says, is to ask: ‘What if this thinking is wrong?’
“We decided to take a step back and begin our study by asking how likely it is that these patients will actually have a stroke related to their severe stenosis. Our analyses showed that this risk is so low that it appears that, for most patients, surgery may not be necessary.”
CAROTID
WEINKAUF ENROLLED THE first patient just a few months ago in a National Institutes of Health (NIH) study to determine the impact of carotid disease on cognitive impairment and Alzheimer’s disease. Alzheimer’s, the most common type of dementia, affects an estimated 5.8 million Americans and is the fifth-leading cause of death among those aged 65 years and older. Carotid disease can be slowed or reduced though lifestyle management, medication and surgical intervention. Because it is modifiable, finding a connection between carotid disease and Alzheimer’s could provide a new pathway for decreasing dementia risk, Weinkauf states. He is leading the study, funded by a US$4.9 million NIH grant, working with many other experts in neuroimaging, magnetic resonance imaging, vascular disease, Alzheimer’s and neurocognitive function.
“Risk-stratification of this population will be integral for honing and improving our vascular care and obtaining important objectives like personalisation of carotid vascular care. We hope our study can help us better understand brain health in our patients and define key, quantifiable markers that help guide our surgical care.”
Researchers started in March and will continue over the next five years to recruit roughly 240 patients, primarily in Arizona. With advanced imaging, neurocognitive testing, and other specialised tests, they will investigate which pathological changes specific to Alzheimer’s are associated with carotid disease; how (and if) carotid disease leads to those changes; and which carotid disease treatments are effective against acognitivestartneurodegeneration.Alzheimer’s-associatedTheteamwillbydeterminingpatients’baselinefunction,andwhatconstitutesnormaldeclinecausedbyageing.Thistrialcontinuesresearchfroman
Craig Weinkauf
The research team first looked to see how the stenosis had been treated. Reviewing the patients’ medical records showed that 1,423 patients had had surgery to treat the stenosis, and 2,314 had not. The team also tracked which patients were taking a statin to help lower cholesterol in the blood or medication to reduce high blood pressure. Next, the team looked to see how many patients had a carotid-related stroke on the same side as the severe carotid stenosis. They followed the patients through 2019. Overall, 133 strokes were diagnosed in 129 patients during the follow-up period. Statistical analyses showed that the patients who did not have surgery had a 4.7% cumulative risk of having a stroke within five years of their carotid stenosis diagnosis.
The researchers hope to determine if baseline factors can identify people at increased risk for Alzheimer’s and/ or other forms of cognitive impairment and dementia. In a similar fashion, they will be looking to determine which baseline factors may help define who benefits from intervention.
“We are looking into this question: does carotid disease infer specific risk for Alzheimer’s disease beyond that of baseline cardiovascular risk factors?” Weinkauf continues. “We are looking beyond stroke, beyond general cardiovascular risk factors, at how blockages in the arteries that lead to your brain affect your brain health.”
earlier project in which Weinkauf and close collaborators sought to quantify cognitive function and brain changes. They quantified various aspects of cognition and brain structure, including brain volumes of the hippocampus, the portion of the brain that supports memory, learning, navigation and space perception, and potentially also plays a role in Alzheimer’s disease.
Writing in EJVES, Ku, Taslimi et al communicate that a total of 47,411 patients were included in 11 studies, with 14,345 (30.2%) receiving DAPT and 33,066 (69.7%) receiving aspirin only. They report no significant difference in the rates of perioperative stroke (odds ratio [OR], 0.87; 95% confidence interval [CI], 0.72–1.05) and TIA (OR, 0.78; 95% CI, 0.52–1.17) despite a significant reduction in TCDmeasured micro-emboli (OR, 0.19; 95% CI, 0.1–0.35) with DAPT versus the aspirin-only group. In addition, they relay that subgroup analysis did not reveal any significant difference in ischaemic stroke risk between patients with asymptomatic and symptomatic carotid artery stenosis, and that DAPT was associated with an increased risk of neck haematoma (OR, 2.79; 95% CI, 1.87–4.18) and reoperation for bleeding (OR, 1.98; 95% CI, 1.77–2.23) versus aspirin. Finally, they highlight that haemorrhagic stroke was an underreported outcome in the literature. Despite the present analysis representing what the authors claim to be the largest conducted on the topic to date, Ku, Taslimi et al also acknowledge some limitations of the study. For example, they write that this review was limited by the studies available in the literature, as is the case in meta-analyses. “Most were retrospective reviews and other observational trials, with only two RCTs [randomised controlled trials],” they elaborate, adding that additional subgroup analyses could not be performed as a result of the heterogeneity in reporting.”
The guideline document, authored by chairperson Ross Naylor (Leicester Vascular Institute, Leicester, UK), co-chairperson Barbara Rantner (Ludwig Maximilian University of Munich, Munich, Germany) and colleagues, has been published in the European Journal of Vascular and Endovascular Surgery
“These involved scenarios where there were either no data, or conflicting evidence that did not allow recommendations to be made,” they elaborate. The current guidelines have addressed some of these questions, which include: Is there a validated algorithm for identifying ‘higher risk for stroke’ ACS [asymptomatic carotid stenosis] patients? Does ACS cause cognitive decline and can this be reversed or prevented by CEA or CAS? And which recently symptomatic patients with <50% stenosis might benefit from urgent CEA or CAS?
THE EUROPEAN SOCIETY FOR Vascular Surgery (ESVS) has released 2023 clinical practice guidelines on the management of atherosclerotic carotid and vertebral artery disease.
“The risks of performing CEA on DAPT outweigh the benefits, even in symptomatic carotid stenosis patients,” Ku, Taslimi et al conclude. They note, however, that the overall quality of studies was low, and suggest “improved reporting of CEA outcomes in the literature is necessary”.
ESVS publishes 2023 guidelines on management of atherosclerotic carotid and vertebral artery disease
The authors’ objective was to conduct a systematic review and metaanalysis of the perioperative outcomes of CEA on DAPT versus aspirin monotherapy in order to determine optimal perioperative management with these antiplatelet agents. What sets their study apart in the literature, according to Ku, Taslimi et al, is the addition of newly published articles, the subgroup analysis for symptomatic carotid stenosis, which had yet to be explored previously, and use of improved statistical methodology over previous meta-analyses of SAPT versus DAPT for CEA. The investigators note that they searched the Web of Science, PubMed, and Embase databases from inception to July 2021. The main outcomes included ischaemic complications (stroke, transient ischaemic attack [TIA], and transcranial Doppler [TCD]measured micro-emboli), haemorrhagic complications (haemorrhagic stroke, neck haematoma, and reoperation for bleeding), and composite outcomes.
This ambiguity is reflected in surgeons’ practice. “Surveys of surgeons who perform CEA have shown significant variations in perioperative antiplatelet prescribing patterns,” the authors communicate. “Although the vast majority would not stop aspirin prior to CEA, 43% and 55% of surgeons would stop clopidogrel prior to CEA for asymptomatic and symptomatic patients, respectively.”
The document contains 133 recommendations, including 38 that are new and 11 that have been ‘regraded’ since 2017, which is when the last ESVS guidelines on this topic were published. The manuscript contains 629 references, 289 of which are new (i.e. published between 2017 and 2022). Thirtynine of the references are from randomised controlled trials, 71 are systematic reviews and/or meta-analyses, and the references also include data from 50 vascular registries or quality programmes.initiativeInthedocument, the authors first address what is new in the 2023 guidelines. They write that each section has been revised or rewritten and that five new sections have been added, including management of free-floating thrombus; management of carotid webs; management of symptomatic patients with an ipsilateral 50–99% carotid stenosis and atrial fibrillation; planning carotid interventions in anticoagulated patients; and timing of carotid interventions in patients with acute ischaemic stroke undergoing thrombolysis.
Naylor, Rantner and colleagues add that the new guidelines highlight similarities and discrepancies with the 2021 American Heart Association (AHA) guidelines on the management of stroke/transient ischaemic attack (TIA), the 2021 European Stroke Organisation (ESO) guidelines on carotid endarterectomy (CEA) and carotid artery stenting (CAS), the 2021 German-Austrian guidelines on the management of carotid disease, and the 2021 Society for Vascular Surgery (SVS) guidelines on the management of patients with carotid and vertebral artery disease. In addition, the authors note that a series of unanswered questions in the 2017 guidelines were highlighted as being priorities for future research.
“Consensus medical management guidelines recommend aspirin monotherapy for asymptomatic atherosclerotic carotid artery disease and DAPT with aspirin and the addition of clopidogrel or dipyridamole for symptomatic carotid artery disease,” they write. However, they stress that “it remains unclear whether the second antiplatelet agent should be withheld preoperatively and resumed after surgery to reduce bleeding risk or continued throughout the perioperative period to reduce the ischaemic complication risk in patients with symptomatic carotid stenosis.”
15Issue47 | August 2022 Carotid Interventions
At the time of carotid endarterectomy (CEA), surgeons should consider single antiplatelet therapy (SAPT) rather than dual antiplatelet therapy (DAPT). This is the conclusion of a new meta-analysis—reportedly the largest conducted on the topic to date—published in the European Journal of Vascular and Endovascular Surgery (EJVES).
Another limitation the authors highlight relates to the drawbacks of the information available within the literature. “Reporting of ischaemic stroke outcomes for asymptomatic versus symptomatic carotid artery stenosis was lacking in many studies,” they note, stating that this limited the number of studies available for this subgroup analysis. In addition, they state that information on the timing of CEA in symptomatic patients and ischaemic events that occurred while waiting for surgery was also lacking. The reporting of haemorrhagic stroke was also limited in the literature.
“AT THE TIME OF CEA IN symptomatic or asymptomatic patients with carotid stenosis, perioperative DAPT has no effect on the occurrence of the ischaemic CEA complications versus perioperative aspirin SAPT,” authors Jerry Ku (University of Toronto, Toronto, Canada) and Shervin Taslimi (Kingston General Hospital, Kingston, USA) et al write. “However,” they note, “DAPT does result in an increase of haemorrhagic CEA complications.” These are the key findings behind the investigators’ recommendation of SAPT over DAPT at the time of CEA, although Ku, Taslimi et al acknowledge the poor overall quality of available evidence. The authors begin by highlighting a lack of granularity in the available guidelines on this topic.
The risks of performing endarterectomycarotidon dual inthetherapyantiplateletoutweighbenefits,evenpatientswith symptomatic carotid stenosis.”
Barbara Rantner Ross Naylor
Perioperative outcomes of carotid endarterectomy not improved on dual versus single antiplatelet therapy
Why did you set up WLNC—and how has it progressed over the past decade? This year, we had the 10th anniversary of WLNC. It started with six people—Cekirge, Islak, Kocer and myself from Turkey, Demetrius Lopes from the USA and Pedro Lylyk from Argentina—as the founders.
How would you say the neurointervention space in Turkey compares to other places across the world? Almost everyone in Turkey is covered by some sort of insurance system and, because neurointervention procedures are very expensive, more than 90% of people would not be able to afford their treatments otherwise. Ever since Professor Cekirge and I started very early on alongside our beloved friends and Turkish WLNC partners Civan Islak and Naci Kocer developing new neurointervention techniques, the Turkish neurointervention space has been taking an increasingly leading role. Because of this role since the late 1990s, we have had a chance to work with the newest endovascular technologies to develop advanced techniques. This has been our most important advantage—but, our main challenge has been the economic fluctuations that sometimes mean we struggle to treat our patients with necessary devices.
alisonlang.com
Three years ago, the organising committee expanded to include Ricardo Hanel and Adnan Siddiqui from the USA, Charbel Mounayer from France and Jian Min Liu from China. The target of WLNC has been establishing the world’s largest and most global live neurointervention educational platform. The idea has been to show the ‘real-life’ experience, with live transmissions of advanced neurointervention procedures as opposed to recorded/edited cases. We want to demonstrate that real-life experience with no editing, as if one were actually in the angio lab witnessing all that goes on—including challenges faced and how they were overcome—to much larger groups from different institutions all over the world. There is an open discussion during the transmission, meaning anyone can ask any question, at any time. With this unfiltered interaction, everybody learns, including us. WLNC is a rotating meeting too; we have held it in the USA three times, in China twice, and in Argentina, Japan, Spain and Turkey. There were also online versions during the pandemic and WLNC 2023 will be in Brazil. We move all around the world so people from more remote countries, or people who may not be able to travel otherwise, can attend. Moreover, to increase accessibility, WLNC founded the idea of educational grants in 2013, providing grants to over a hundred physicians each year—something that has been followed by many other meetings since.
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What do you feel has been the most important development in interventional neuroradiology during your career? I consider myself lucky to have been in this field almost from the very beginning. I got to witness a lot of important changes—detachable coiling, balloon assistance, stent usage and more—but I would say flow diverters have made the biggest impact in terms of our understanding, and also in providing a solution for many difficult cases in aneurysm treatment. Stenting had been in use in interventional radiology/cardiology, and balloons were already being used in other parts of the body, but flow diversion represents a different avenue that started specifically in neurointervention. That is why I think these devices are the most important advance we have seen in aneurysm treatment. In brain AVM management, it is of course
Isil Saatci
Every member of my immediate family were doctors— my mother, my father, and my brother. My brother was still a medical student when I was deciding, but my mother and father were already physicians, so I did not know any other profession! Although my favourite subject was mathematics, I still went to medical school. In the very first year, I was not sure if it was for me, but after that I began to enjoy it a lot more. I selected radiology because I was so intrigued by the idea that you could instantly diagnose the patient. At that time, interventional radiology had already started—although its applications in the brain were very limited. I very much enjoyed neuro subjects at university, and I did my fellowship in neuroradiology, as neurointervention only existed in a few select places back then. I had limited exposure to neurointervention procedures during my residency, but the speciality did not really exist in my country and was only just getting started elsewhere in the world. Even so, I loved neuro, and I wanted to go into neurointervention, because it was very challenging, but the fact you could find a solution without ‘opening up’ the patient was exciting.
Who have your mentors been and how have they impacted your career? Undoubtedly, my first mentor was my chairman at Hacettepe University, Aytekin Besim, who was so inspiring and motivating with his ever-open mind. He was a radiologist and interventionist, and he always supported the idea of minimally invasive treatments over open surgery. I went to Jacques Moret’s lab and spent some time there early on, and he was very inspiring too. I was not one of his own pupils, but he was so eager to teach everybody who came to his lab, and I would say he was my first mentor in neurointervention. After we had established ACINR, our first live neurointervention course, I had a chance to work professionally with him when we organised our joint LINNC-ACINR courses. I also learned a lot from Michel Mawad and Alejandro Berenstein in terms of philosophies, and as senior interventional neuroradiologists as well.
Isil Saatci has been practising interventional neuroradiology (INR) in Ankara, Turkey for almost the entirety of her career—initially at Hacettepe University, where she also attended medical school, and currently at Koru Hospitals. Saatci was also the first woman to specifically practise INR in her country and played a significant role, not only in establishing this speciality in Turkey, but also in advancing this field across the whole world as one of the pioneers of contemporary INR. Since 1992, she has dedicated herself—with her partner Saruhan Cekirge—to developing and improving advanced endovascular techniques for the treatment of cerebral aneurysms and brain arteriovenous malformations (AVMs), while also focusing on training neurointerventionists worldwide in these advanced techniques since the early 2000s—either in her own institutions with international workshops, or via proctoring and performing cases globally, from North America to Japan. Over the course of almost three decades in INR, another of Saatci’s major accomplishments involved founding and organising the World Live Neurovascular Conference (WLNC). And, as she tells NeuroNews, she has perhaps been the only woman to perform live neurointervention cases and help train INRs in front of hundreds since 2006, first in the Anatolian Course of Interventional Neuroradiology (ACINR), then in LINNC-ACINR joint meetings, and now in WLNC.
PROFILE
What initially attracted you to medicine, and the field of interventional neuroradiology specifically?
1987–1992: Residency, Radiology Department, Hacettepe University School of Medicine (Ankara, Turkey)
sectionNeurointerventionaleditor, Neuroradiology Associate editor, Journal SurgeryNeuroInterventionalof(JNIS)
What is the most significant unmet need in the field right now?
1991–1992: Neuroradiology,Fellowship,Georgetown University (Washington DC, USA)
Eventually, after a certain accumulation of knowledge and experience, with their self-confidence and insight, they will have their unique practice. What are your interests outside of the field of medicine?
Until the past few years, almost my entire time besides working was dedicated to my two wonderful daughters—because my speciality and my career were already demanding, and I was very content to devote my spare time to them. Otherwise, I like to travel very much. What I enjoy most while travelling is meeting with local people. I enjoy the sincerity of it and forming those close relationships, even with people I am meeting for the first time. Different cultures and remote places are always exciting. In terms of particular places—of course, I appreciate every place I visit—but I really like to spend time in Mediterranean countries. I also like dancing and, in particular, Latin dancing. I enjoy watching dancing too, as it puts me in a cheerful mood. I like to cook; I am certainly not a ‘chef’, but cooking for my loved ones is good enough for me!
To me, it is probably surface modification of flow diverters because, if we can eliminate the need for antiaggregation, that would be a great step forward. Resorbable devices may also prove to be a major addition. Research is currently underway in these areas, and I think the refinement of flow diverters—to exclude the risks associated with having a device permanently implanted in the head, or a device that requires additional medication with its own potential risks—could enable tremendous change in our space.
Country representative and subspeciality committee member of interventional neuroradiology, European Society of Neuroradiology (ESNR)
Education: 1981–1987: Medical school, Hacettepe University School of Medicine (Ankara, Turkey)
Current appointments: Professor of Neuroradiology and neurointerventionist at Koru Hospitals (Ankara, Turkey)
17Interview Fact file Issue47 | August 2022
More than 140 international academic publications Pioneering leader of the interventional neuroradiology field since 1992 the introduction of Onyx (Medtronic). The intranidal injection of a liquid embolic has been improved further thanks to additional transvenous and transarterial techniques like the ‘pressure cooker’ approach (Rene Chapot) and multiplug flow control (Cekirge), both of which have revolutionised the treatment, in my opinion.
What advice would you give to people embarking on a career in neurointervention? They need to have good background training in either neuroradiology, neurosurgery or neurology, followed by a good fellowship programme in a well-established and busy centre where they can have intense exposure to a wide variety of cases. They have to feel comfortable with their anatomical knowledge. They would benefit from trying to travel, and spending time in different angio labs, to witness different philosophies and techniques with an open mind. As in other areas of medicine, they have to follow the literature all the time.
Honours (selected): Co-founder and organiser of the World Live Neurovascular Conference (WLNC)
located distally (40%). The mean neck size was 3mm (standard deviation [SD] 1.35, range 2.5–5mm), whereas the mean PICA diameter was 1.6mm (SD 0.26, range 1.5–1.7mm). The mean length of follow-up was six months (SD 8.28, range 4.5–16 months), Hanel and colleagues also state. Treatment-related adverse events observed in the review included one case of transient hypoaesthesia. Two additional events were reported but—according to the authors—were adjudicated as having been unrelated to the procedure. Complete occlusion, measured as Raymond-Roy class I, was achieved in all cases, leading Hanel and colleagues to conclude in their Neurosurgery report that the Silk Vista Baby device was safely and effectively used in the treatment of PICA aneurysms overall. Ricardo Hanel
Hanel and colleagues detail that databases from different centres were retrospectively reviewed for PICA aneurysms treated with the device, with demographic information, clinical presentation, radiographic characteristics, procedural complications, and immediate postprocedural outcomes, all being obtained.Theyreport that 14 patients harbouring 15 true PICA aneurysms were treated between January 2019 and June 2021. Nine were female (64.2%), and the mean age was 51±14.9 years. Most patients had previously ruptured aneurysms, treated by another endovascular technique, the authors note. Six aneurysms were
“These findings confirm previous studies indicating that—in addition to blood pressure control—smoking cessation and aggressive treatment of Type 2 diabetes may also help reduce the risk of aneurysm rupture,” Huang added.
The body’s RAAS includes hormones that affect blood pressure regulation, and dysregulation of the RAAS can lead to the development of high blood pressure. Two components of RAAS have been shown to be involved in the development of intracranial aneurysms, and previous research has found that dysregulation of RAAS may also contribute to aneurysm rupture. Medications that block the effects of the RAAS, known as RAAS inhibitors, are often used to treat high blood
Silk Vista Baby demonstrates safety and effectiveness in PICA aneurysm treatment
Owing to the fact the Silk Vista Baby flow diverter was designed for ease of use in vessels with a smaller diameter, in distal lesions, and with 0.017inch microcatheter delivery systems, they set out to report outcomes associated with the device in the treatment of PICA aneurysms.
18 August 2022 | Issue47Aneurysm Treatments
Using a multivariable model, the researchers calculated that women’s risk of aneurysm rupture was 1.8 times higher than men’s risk, and that the following factors increased the risk of aneurysm rupture: uncontrolled hypertension; exposure to second-hand smoke; and untreated Type 2 diabetes.
A multicentre study of more than 3,000 people with high blood pressure and brain aneurysms found that the use of reninangiotensin-aldosterone system (RAAS) inhibitors—a class of blood pressure-lowering medications—reduced the risk of an aneurysm rupture by 18%. These findings have been published in the journal Hypertension
distally:locatedSix 40% 3mmsize:neckMean 1.6mmdiameter:PICAMean
Participants’ hypertension status was categorised as controlled (normal blood pressure with the use of antihypertensive medications) or uncontrolled (high blood pressure, defined as 140/90mmHg or above, with the use of antihypertensive medications), and was determined by blood pressure measurements taken at one point in time—three months before they were hospitalised for aneurysm.
participants who took RAAS inhibitors experienced an intracranial aneurysm rupture, compared to 67% of those who used non-RAAS inhibitors.
“Based on these data, we estimate that nearly 18% of ruptured aneurysms may be prevented if all patients with high blood pressure and intracranial aneurysms were prescribed with RAAS inhibitors. Due to the strong potential benefit and high safety of RAAS inhibitors, these findings may also help clinicians to optimise treatment to help people with high blood pressure prevent aneurysm rupture.”
15 PICA aneurysms in 14 patients
The analysis found that 32% of
FOLLOWING A RETROSPECTIVE REVIEW of databases from multiple different centres, researchers have reported the safe and effective use of the Silk Vista Baby (Balt) flow diversion device in the treatment of complex posterior inferior cerebellar artery (PICA) aneurysms. Writing in the journal Neurosurgery, Ricardo Hanel (Baptist Neurological Institute, Jacksonville, USA) and colleagues also state that, based on their findings, “the smaller delivery system profile reduces the risk of procedure complications and creates new treatment options for distal lesions”.
“APPROXIMATELY HALF OF [all] patients with intracranial aneurysms have high blood pressure, which can cause vascular inflammation and increase the risk of aneurysm rupture,” said the study’s senior author Qinghai Huang (Changhai Hospital Affiliated To Second Military Medical University, Shanghai, China). “Given that one third of patients with ruptured aneurysms die and another third remain dependent for daily life activities, there is a need to identify modifiable risk factors to prevent aneurysm rupture.”
RAAS inhibitors shown to reduce risk of intracranial aneurysm rupture in hypertensive patients
Huangpressure.andcolleagues’
“However, more research is needed to understand how RAAS inhibitors are involved in the prevention of intracranial aneurysm rupture in adults with high bloodThepressure.”authorsnoted that limitations of their study included its retrospective nature, the existence of potential confounders, the fact that hypertension was defined as a blood pressure of 140/90mmHg (rather than of 130/80mmHg), the exact value of participants’ blood pressure not being taken, and the duration and dose of RAAS inhibitors not being recorded in theNonetheless,database.
Huang and colleagues conclude their Hypertension paper by stating that “the use of RAAS inhibitors was significantly associated with a decreased rupture risk independent of blood pressure control among hypertensive patients with intracranial aneurysms”.
The authors begin by noting that the treatment of small-calibre vessel lesions using flow diverters “remains challenging” because of the vasculature’s narrow luminal diameter and tortuosity—which, in turn, makes navigation and delivery of conventional devices with standard microcatheters more difficult.
Based on these data, we estimate that nearly 18% of ruptured aneurysms may be prevented if all patients with high blood pressure and intracranial aneurysms were prescribed with RAAS inhibitors.”
study analysed data collected from 2016 to 2021 at 20 medical centres in different regions across China, both pre- and postrupture, to evaluate the impact of the use of RAAS inhibitors and other blood pressure medications, including betablockers and diuretics, on the risk of aneurysm rupture. More than 3,000 adults with high blood pressure and intracranial aneurysms were included. The study sample was one-third men and two-thirds women, with an average age of 61 years.
“We were surprised to find that, even among people with controlled hypertension, those who took RAAS inhibitors still had a significantly lower rupture risk than individuals who used non-RAAS inhibitors,” Huang continued. “Our study highlights that using the proper antihypertensive medications to achieve normalisation of blood pressure may remarkably decrease the risk of a ruptured aneurysm.
I think we have proved that the HPC technology works really well with the p64 MW, and—compared to the pEGASUS HPC stent—uncoated flow diverter devices have a much higher thrombogenicity, because they have a lot of wires and the device has a far greater surface area. So, if the coating is strong enough to allow implantation of a flow diverter alongside SAPT, it would make sense for it to easily enable implantation of pEGASUS HPC with SAPT.
References: 1. Hellstern, V; Aguilar Pérez, M; Henkes, E et al. Use of a p64 MW Flow Diverter with Hydrophilic Polymer Coating (HPC) and Prasugrel Single Antiplatelet Therapy for the Treatment of Unruptured Anterior Circulation Aneurysms: Safety Data and Short-term Occlusion Rates. Cardiovasc Intervent Radiol. 2022. https://doi.org/10.1007/s00270-022-03153-8.
Victoria Hellstern
p64 MW HPC flow diverterpEGASUSand HPC stent
What is the unmet need that the HPC technology could resolve for physicians and their patients?
After analysing periprocedural and postprocedural complication rates, we concluded that flow diversion with SAPT has a solid safety profile—for example, our periprocedural complications were mostly technical and had no clinical consequences for the patients. It is also really important to highlight the fact we had no ischaemic or haemorrhagic complications at all during the procedures, even though they were performed under SAPT. We performed magnetic resonance imaging (MRI) too, using diffusion-weighted imaging (DWI) lesions as safety markers of flow diverter implantation, and basically found that three quarters of the patients had zero or very minimal pathological signals. These data indicate that p64 implantation with prasugrel is at least as safe as uncoated flow diverter implantation withWeDAPT.alsolooked at short- and mid-term occlusion rates, and overall efficacy of these treatments, and these were pretty impressive as well. We observed occlusion rates of 70% at up to three months, and nearly 85% after nine months. In some locations, such as internal carotid artery (ICA) aneurysms, we had even higher occlusion rates at 73% and 88%, respectively. These rates are exceedingly high. As such, we feel that the coated p64 MW with a SAPT strategy results in faster and higher aneurysm occlusion rates. The ongoing COATING trial, led by Laurent Pierot (University Hospital of Reims, Reims, France), is also currently investigating this—and we hope and expect that they will confirm our findings, and raise the bar in surface modification in the process.
Disclaimer: The p64 MW (HPC) Flow Modulation Device and pEGASUS (HPC) Stent System have received the CE Mark. They are not approved for sale nor are they available for sale or use in the United States.
Following the publication of a study assessing the use of Hydrophilic Polymer Coating (HPC) technology with the p64 MW flow modulation device (phenox) at her centre earlier this year, Victoria Hellstern (Klinikum Stuttgart, Stuttgart, Germany) discusses the significance held by this unique surface modification product in the neurointervention space—and offers her thoughts on further avenues it could move into in the future.
Phenox is now in the process of launching its HPC technology for stent-assisted coiling too—why is this a significant development? The benefits offered by surface modification in stent-assisted coiling are similar to those outlined previously in flow diverter devices, in terms of removing the need for DAPT and, in turn, reducing ischaemic and haemorrhagic complications. However, the antithrombotic coating of an open-cell stent like the pEGASUS HPC device (phenox) is something we have never had before in neurointervention. And, in the future, it could even be deployed in the treatment of stroke or intracranial stenosis as well as aneurysms, so I think the use indications will continue to spread even more widely and more rapidly. The application of flow diverters in middle cerebral artery (MCA) bifurcation aneurysms remains highly controversial in the field, and many operators prefer to stick with stent-assisted coiling rather than flow diversion. I think phenox’s coated stent will meet the needs of those people, and allow them to also use SAPT in the future, increasing the safety profile of the procedure as well as simplifying patient care afterwards. The most beneficial cases will probably be those bifurcation aneurysms, and posterior-circulation aneurysms, because they are associated with higher rates of ischaemic complications when treated with a flow diverter. These cases now stand to benefit from reduced complications with stent-assisted coiling and SAPT as well.
I would not expect there to be any problems; if anything, coating the p64 MW was the trickier part, and shifting to stent-assisted coiling is even more likely to be successful. You can also start to think about implanting these devices with aspirin only. We do not have the data to back this up yet, but it is a possibility that would work—and that would be extremely beneficial, because aspirin is so easy to use and safe.
Finally, how would you assess the potential offered by this coating technology—in neurointervention, but also in other spaces as well?
I think the most essential benefit in neurointervention will be that it allows us to really change and simplify our management protocols for the patient. I also told one of my colleagues in cardiology about this coating recently, and he said he would love to have that in his practice—because they have many of the same DAPT-related problems with coronary stents. The feedback from the trauma surgeons in our centre is great as well. They are really happy with the coated flow diverters, as they can operate under SAPT with fewer worries. You could also begin to think about coating microcatheters or guidewires—in fact, pretty much anything we use in neurointervention—to reduce the risk of thromboembolic complications. Really, I think that the future applications in our space could be limitless.
Is it likely the coating will be just as successful in safely reducing the need for DAPT once it moves to stents, and are there any key differences compared to flow diverters?
Please could you outline the design, objectives and findings from your recent study published in CardioVascular and Interventional Radiology? In the paper, we summarised our daily clinical experiences with the HPC-coated version of the p64 MW flow diverter.1 It reports a retrospective, singlecentre study of 102 patients with 132 aneurysms, which is a very large cohort in the neurointervention field, from March 2020 to December 2021. All patients underwent treatment of their unruptured, anterior-circulation, saccular aneurysms with the p64 MW device and SAPT (prasugrel). We compared safety and effectiveness outcomes in our study against another paper published by our group, involving the uncoated p64 MW device with DAPT, as well as other historical flow diversion literature.
Why does this study provide particularly positive and durable evidence that coating works in flow diversion?
It is the first study that has been done in elective cases with such a high number of patients. A lot of other studies have involved acute subarachnoid haemorrhage (SAH) patients with really small numbers, whereas we used elective patients throughout our daily clinical practice. The biggest advantage of this technology will probably be seen in those acute SAHs, because it will change treatment options for those patients dramatically, but we were able to show that an even wider group of less urgent aneurysm cases could also benefit from reduced thromboembolic complications with a coated flow diverter plus SAPT.
19AdvertorialIssue47 | August 2022 THIS ADVERTORIAL IS SPONSORED BY PHENOX
Flow diverting, stenting and beyond— HPC technology offers “limitless” potential in neurointervention
The introduction of flow diverters to the neurointervention field about 10–12 years ago changed treatment options for intracranial aneurysms dramatically. Formerly untreatable aneurysms have become treatable and, for other aneurysms, the treatment has become much easier. However, one of the major drawbacks for flow diverter implantation has always been the need for dual antiplatelet therapy (DAPT), as this increases the risks for a range of ischaemic and haemorrhagic complications. There are also compliance problems, as the patient needs to take two medications daily rather than just one, as well as the fact that patients who are on DAPT are more likely to experience bleeding complications if they undergo further surgeries in the future. These are the exact issues that phenox’s HPC-coated p64 MW device is seeking to address—as the only commercially available flow diverter with instructions for use (IFU) explicitly stating that it should be used alongside single antiplatelet therapy (SAPT) right now. With other surface-modified flow diverters, the decision to use SAPT can be made if appropriate in a given situation, but their IFU will still recommend DAPT, whereas we can use the coated p64 MW with SAPT in routine clinical practice.
Victoria Hellstern is a leading consultant for Interventional Neuroradiology in the Department of Diagnostic and Interventional Neuroradiology at Klinikum Stuttgart in Stuttgart, Germany. She also holds the European Diploma in Neuroradiology (EDiNR), and her research interests include surfacemodified flow diverters.
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Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Product available in the European Economic Area (EEA) only. Please check availability with your local sales representative or customer service. The list of physicians in the e-tool is not exhaustive nor exclusive, you may reach out to any physician of your choice. This e-tool does not offer a medical advice rather information that you may validate independently with your physician. This material is not intended for use in France. 2022 © Boston Scientific Corporation or its affiliates. All rights reserved. Date of prep May 2022. NM-1275503-AA
Giving you confidence in referring your patients to the right specialists to find a solution for their chronic pain
Marc Russo
A group of researchers, led by Gustavo Deco (Pompeu Fabra University, Barcelona, Spain), were able to overcome these limitations with the help of computational modelling and simulation. In a study published in Cerebral Cortex, Deco and colleagues used neuroimaging data from 620 healthy adults, collected during previous research. Half of the patients included were older than 65 years of age, while the other half were younger than 65. The team looked for key differences between the brain states of the two groups, and identified a brain state similar to the so-called ‘rich club’ region—a network of 12 brain hubs well-connected with each other.
HUMAN BRAIN PROJECT (HBP)
Dorsal horn dendrite stimulation offers “true breakthrough” in pain management field
“We found that older participants had reduced capacity to access a brain state overlapping with the brain’s rich club organisation,” said Anira Escrichs (Pompeu Fabra University, Barcelona, Spain), first author of the study. “This state is key for the efficient transmission of information within the brain. We successfully simulated the brain states detected in the older group in a wholebrain computational model. We then applied artificial stimulations in all brain regions of the model, looking for a way to induce a brain state similar to the one observed in the younger participants.”
researchers have used whole-brain virtual models to simulate what happens when neurostimulation is applied to ageing human brains, providing novel insights into how the dynamics of a healthy brain change as it grows older. The researchers believe that, crucially, this could help identify new targets and strategies for therapeutic neurostimulation.
“We believe that these findings could have important implications for designing neurostimulation interventions and reversing the effects of ageing on the functionality of the brain,” Escrichs added.
toSimulationstimulation:
Continued on page 22
As the brain ages, its neurodynamics and the connections between neurons change dramatically—often resulting in decreased cognitive function. But, while non-invasive brain stimulation techniques have emerged in recent times as possible treatments for neurological and degenerative disorders, contrasting and mitigating the effects of ageing, large-scale studies involving healthy human brains are hampered by ethical hurdles.
Speaking to NeuroNews, Russo provided insight on the backdrop to these findings. “For 55 years—as long as I have been alive—we have been using SCS to stimulate the back of the spinal cord and activate a circuit that then interacts with the transmitting pain pathway to ultimately block or mitigate pain signals to the brain,” he said. “It works, and we have been refining it for the last 55 years, but we are slowly reaching a point of saturation whereby our gains are getting smaller and smaller each decade—and, still, chunks of patients are left in pain despite this therapy.”
The team found that some brain areas were optimal to force the transition from the older to the middle-aged regime, and they identified the precuneus—a prominent region of the rich club—as the best target. In addition to providing new information about how the brain reacts differently to external stimulation depending on age, this study could also lay the groundwork for new therapeutic approaches.
Russo, who is also the current INS president, noted that these limitations around established SCS approaches led him to ask: “What if we did the opposite, in all aspects, to what we have been doing for 50-plus years?” He and a small team therefore devised a means to administer stimulation in a way that pertains directly to the pain pathway by targeting a different part of the nerve in the spinal cord. Specifically, he said, this meant stimulating the dorsal horn dendrites at the other end of the neurone
A novel approach to spinal cord stimulation (SCS), which involves targeting the dorsal horn dendrite—in contrast with more traditional ‘axonal’ SCS techniques—has been labelled as a “true breakthrough” in the field of pain management. That is according to Marc Russo (Hunter Pain Specialists, Newcastle, Australia), who presented data from a clinical trial assessing this new modality at the recent International Neuromodulation Society (INS) congress (21–26 May 2022, Barcelona, Spain).
Researchers use virtual brain models to identify key therapeutic targets
21Issue47 | August 2022
“It is a true breakthrough in our field, and will likely lead to new discoveries and new ways of doing things,” Russo told NeuroNews, “and it all came from a single night around a restaurant table asking some ‘what if’ questions, to which we knew no answers, but had a desire to explore in the hope of realising something better.”
Jan Vesper
And, in addition to outlining high clinician ratings and treatment satisfaction levels across all follow-up timepoints, he concluded by reporting adverse events observed during the trial—including nine minor lead migrations and seven implantable pulse generator (IPG)-related events (all of which were resolved), as well as three major lead migrations, three pain flares and one surgery-related event.
In the trial, surgery was performed under general anaesthesia, including bilateral stereotactic insertion of quadripolar electrodes (3387, Medtronic) into the globus pallidus as well as stimulator implantation (Activa PC, Medtronic) for chronic stimulation. A 1:1 randomisation process followed this procedure, Vesper detailed, and differences in Unified Huntington’s disease rating scale total motor scores (UHDRS-TMS) at 12 weeks—the primary endpoint—were evaluated postoperatively versus baseline and compared between the two groups.
Discussing efficacy outcomes, and the trial’s primary endpoint, Vesper reported no significant differences between the two groups. He said that certain factors may have biased these results, including microlesion effects, the fact investigators were blinded, and a lack of complete data at six months, but concluded that DBS does not appear to be superior to any conservative medical treatment—based on these Vesperfindings.alsoclaimed that, while no specific predictors have been identified to date, DBS may hold benefits in some Huntington’s patients, and further evaluations are ongoing, such as independent video ratings of clinical results as per one of the trial’s secondary endpoints.
This much pain relief transforms [patient] lives back to some form of normality.”
four dropouts. According to Vesper, extensive clinical evaluations regarding motor function, cognition, psychiatry/ emotion and quality of life were performed at baseline, and at three- and six-month postoperative follow-up visits. Data were also balanced at baseline to remove selection bias risks.
“I treated one patient and their pain disappeared,” Russo told NeuroNews “I treated a second and theirs disappeared as well. I treated a third and their pain decreased by 75%. I was gobsmacked—I just could not believe it!” These positive early findings led Russo and his colleagues to set up an investigator-initiated clinical trial in which 27 patients (mean age=58.4 years; 48% females) had their chronic non-specific low back pain (CNLBP) treated with Subwave. The primary endpoint of the trial was pain score on the Visual Analogue ScaleReporting(VAS).six-month results from this trial at INS 2022, he said that mean VAS scores decreased from 72.48 at baseline to 27.37 at six weeks, 31.04 at 10 weeks, 32.37 at 14 weeks and, finally—in the 26 patients available for follow-up—21.47 at 26 weeks.
In addition, Russo noted a median pain relief of 76.4% at 26 weeks, while 77% of patients were deemed ‘remitters’ (VAS ≤30) at the same timepoint. “This much pain relief transforms their lives back to some form of normality,” he added. Further analysis revealed that 63% of patients were ‘responders’ and 37% were ‘high responders’ at six weeks post-activation of Subwave. These rates shifted to 70% and 30%, respectively, at 10 weeks, 63% and 26% at 14 weeks, and 77% and 46% at 26 weeks. Russo also relayed secondary endpoint data, including reductions in mean brief pain inventory (BPI) scores, improved quality-of-life outcomes, and positive findings as per the short form health survey (SF-36), at 26 weeks compared to baseline.
Russo ended his INS 2022 presentation by claiming that this novel approach, stimulating dorsal horn dendrites, represents a promising treatment strategy for NLBP patients and is deliverable via any and all of the SCS systems that are currently commercially available. He also noted that he and his team opted not to patent Subwave, instead providing it as a “gift” to industry, physicians and patients alike that carries no additional cost or fresh regulatory burden. Russo went on to state that the results achieved are better than or equal to those seen in the latest clinical trials of any of the current cutting-edge techniques developed by neurostimulation companies to treat pain conditions.
IN WHAT VESPER CLAIMED IS the first prospective, multicentre, doubleblinded, sham-controlled randomised controlled trial (RCT) assessing DBS in chorea-dominant Huntington’s patients, researchers assessed procedural safety of pallidal stimulation, with a follow-up totalling 12 weeks. Vesper noted that prior case reports have suggested DBS as a treatment option in this patient population—but the exact target for stimulation is subject to debate. A previous pilot trial showed the equality of internal versus external pallidal stimulation as well as a potential benefit of DBS for improving chorea. As such, Vesper and his team conducted a multicentre RCT intended to prove the efficacy and safety of pallidal DBS for Huntington’s, and to show superiority of DBS in improving motor function in the stimulation group compared to a ‘stimulation-off’ group.
22 August 2022 | Issue47 to the axon, which has been the primary target of SCS therapies for several decades. He presented the INS audience with an overview of the novel ‘Subwave’ waveform for preferential dorsal horn dendrite stimulation, detailing a stimulation frequency of 100Hz, a pulse width of 1,000 microseconds with the epidural leads in the typical midline position, and a bipole at T9/10 level.
Late-breaking research indicates safety of deep brain stimulation in Huntington’s patients
Vesper informed INS 2022 attendees that all adverse events resolved without sequelae in the trial. In addition, no unanticipated adverse events or serious adverse events occurred, and no instances of intracerebral haemorrhage (ICH) were observed either. One patient died during open phase (after 12 weeks), he noted, and this event was determined as unrelated to surgery. One infection occurred at 12 weeks after surgery too.
Eight European sites participated, with a total of 44 patients being randomised and 40 being deemed eligible for final analysis—owing to
72.48 27.37 21.47 MeanscoresVAS
Deep brain stimulation (DBS) offers a safe therapy option for reducing chorea in patients with Huntington’s disease, but it remains to be seen whether it is superior to any conservative medical treatments in this space. This was the concluding message from Jan Vesper (Heinrich Heine University, Düsseldorf, Germany) in his presentation of late-breaking clinical trial research at the International Neuromodulation Society (INS) congress (21–26 May 2022, Barcelona, Spain).
Dorsal horn dendrite stimulation offers “true breakthrough” in pain management field from page 21 at baseline at six weeks at 26 weeks
Continued
FerrariMichelHuygenFrank
The study’s primary endpoint was mean attack frequency per week in the final four weeks of the blinded period (week 21 to week 24) compared with baseline across all patients, as well as showing a groupwise difference if a decrease was seen, Huygen said. He also detailed several secondary endpoints including mean attack intensity on a 0–10 numeric rating scale, patient satisfaction and quality of life, (serious) adverse events, and economic outcomes.
After outlining the characteristics and epidemiology of chronic cluster headaches, including the fact that 15% of patients with this condition are refractory or intolerant to preventative medications, he briefly detailed what ONS is and how it works. Huygen told the INS audience that the approach involves subcutaneously implanting two stimulation leads with four electrodes in the occipital region, which are then connected to an implantable pulse generator in the patient’s abdominal or gluteal region.
The five-point Likert Scale was used to assess patient satisfaction. At 24 weeks, 90.8% of patients said they would recommend ONS, with 74% saying they would strongly recommend it, and this figure climbed to 96.8% (73% strongly) at 48 weeks. One third of patients in the trial experienced a serious adverse event, which—according to Huygen— is similar to rates seen in other ONS studies. He also noted that, in the open-label study phase, 34 events were observed across 30 patients (23% of the total patient population). In the masked study phase, the number of serious adverse events in the high-intensity stimulation group was greater, at 17 (in 23% of patients), versus eight (in 11% of patients) in the low-intensity group. Huygen detailed that two thirds of these events were battery replacements or dislocated/ fractured leads, and said that the rate of non-serious adverse events was also similar to those reported in other ONS studies.
It would have been even more convincing if we would have shown a doseresponse relation, but there are more than enough arguments to suggest that we are looking at a real effect and not a placebo.”
Huygen then delivered mean attack intensity data, noting a similarly significant and clinically relevant reduction across the total study population, from 7.58 at baseline to 5.57 at 21–24 weeks. Again, however, there was no difference between the 100% and 30% stimulation groups. He also noted that 44.6% of patients were ≥50% responders, and 55.4% of patients were ≥30% responders, at 21–24 weeks.
Occipital nerve stimulation shows clinical benefit and safety in chronic cluster headache
Wider significance Speaking to NeuroNews following the INS congress, Huygen alluded to the importance these data may hold for patients who suffer from persistent chronic cluster headaches. “Of course, it would have been even more convincing if we would have shown a dose-response relation, but there are more than enough arguments to suggest that we are looking at a real effect and not a placebo,” he said. “And, if the treatment has effect, it is a real life-changer. Patients regain their lives, participate in work and social life again, and sleep normally once more (attacks often occur at night).
T hese findings were presented by Frank Huygen (Erasmus University Medical Center, Rotterdam, The Netherlands), who—on behalf of Michel Ferrari (Leiden University Medical Center, Leiden, The Netherlands) and the other ICON study researchers—also reported that ONS proved to be safe and well-tolerated across more than 100 patients.
In terms of quality-of-life measures, mean sum scores for both mental and physical health as per the 36-item Short Form Health Survey (SF-36) increased at 24 weeks compared to baseline—across the entire study population—and then rose again at 48 weeks.
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New data Relaying the results from ICON, Huygen said that a statistically significant and clinically relevant reduction in attack frequency was seen in both groups, but there were no noteworthy differences between the two groups. Across the total study population, mean attack frequency decreased by roughly 50%—from 15.75 at baseline to 7.38 during the 21–24-week period. This represented a reduction compared to the mean attack frequency at 1–4 weeks (9.62), although this rate rose slightly to 7.62 through the 45–48-week period.
Discussing wider, potentially ‘real-world’ use of this approach moving forward, Huygen added: “I presume this depends mainly on the different healthcare compensation systems worldwide. In The Netherlands, based on the study results, the treatment is included in the regular package of the healthcare insurance companies and is reimbursed. The analyses of a cost-effectiveness study have yet to be completed, but the impression is that, despite high initial costs, ONS in cluster headache appears to be costeffective. We also have to keep in mind that—especially for the studied group of patients—there is no alternative treatment available.”
Huygen highlighted prior literature on the effect of ONS—reporting that early, published case series were positive, but included small numbers of patients and constituted a “very low” quality of evidence. There had also previously been no controlled studies of the approach, he noted.
Finally, Huygen reported that, based on patient and neurologist responses at 24 weeks regarding which stimulation intensity they thought they had received/ administered, blinding was deemed to have been successful. Briefly touching on long-term follow-up results in the ICON study, he told the INS audience that 35/64 patients (55%) were ≥50% responders, and 84% said they would recommend ONS, at three years, increasing to 22/31 (71%) and a rate of 90% at five years.Discussing these findings, the speaker said that about 50% of patients experienced a 50% reduction in the frequency of their cluster headache attacks within a matter of weeks—following a stable, 12-week baseline period—and “all other endpoints” also showed significant differences in time as well. After reiterating the lack of difference between the two study groups, Huygen dispelled the idea that the aforementioned reductions could have been powered by the placebo effect, as an “abrupt and long-lasting strong effect” was seen in a severely chronically affected population, and personal attention and interaction was also equal across both groups. Huygen noted that, in addition to the reduction in attack frequency and intensity it appeared to achieve, ONS was found to be well-tolerated. Low-intensity stimulation (30%) was also found to be effective, he added, claiming that future research should now focus on optimal stimulation parameters. The speaker concluded his presentation by noting that earlier data from ICON, which was conducted at four sites across The Netherlands, Belgium, Hungary and Germany, were published in The Lancet Neurology last year.
A randomised controlled trial (RCT) presented at the International Neuromodulation Society (INS) congress (21–26 May 2022, Barcelona, Spain) has demonstrated significant and clinically relevant reductions in the frequency of medically intractable chronic cluster headache attacks following occipital nerve stimulation (ONS) therapy.
ICON study Moving on to the ICON study, the speaker said the aim was to assess the preventive effectiveness and tolerance of ONS in medically intractable chronic cluster headache. Inclusion criteria included, but were not limited to, adult patients (≥18 years) on the International Classification of Headache Disorders-II (ICHD-2) criteria for chronic cluster headache who were deemed ‘medically intractable’. After a 12-week baseline observation period, eligible patients were randomised 1:1 to receive either high- or low-intensity ONS (100% and 30% stimulation, respectively). A 10-day run-in period with a stimulation intensity set to 10% was followed by a 24-week double-blind period—with stepwise increases in stimulation intensity—and 24 weeks of open-label, optimal treatment. A total of 130 patients (mean age=44 years, 36% women) were implanted with a stimulation device. One patient was lost from each of the two groups prior to follow-up, leading to 64 patients being available for analysis at 24 weeks. The speaker noted that there were no major differences between the two groups in terms of baseline characteristics.
“After the study, we adapted our implantation technique based on new anatomical insights, leading to a section of those who were originally non-responders also becoming responders. We are continuing to look for solutions for the non-responders and, in the meantime, we have long-term data (six years) that will be submitted soon showing a strong, ongoing effect after an even longer period of time.” Huygen also noted that—according to Ferrari, who is a headache neurologist and was his co-lead on the project—no other therapy has been launched for cluster headache patients over the past few decades that boasts an effect that is as convincing as the one seen with ONS.
WiN provides a platform to share ideas, discuss challenges in the field, and come together in solidarity despite where they are in their career trajectory. The first woman being elected to the North American Neuromodulation Society (NANS) board of directors occurred in 2015. At this time, the board of directors comprised of 32% women, including two women serving as officers. Since 2015, the WiN reception has been a highlighted social event at NANS annual meeting; and, this year’s International Women in Neuromodulation (iWIN) event in Barcelona, Spain was the most robust in the committee’s history. The scientific programme committee at NANS and the International Neuromodulation Society (INS) have increasingly ensured speaker diversity with 20–30% of women speakers in recent years. Since its inception in 2015, WiN’s efforts have been amplified locally by women physicians and industry partners. Work to be done Despite pioneering efforts, there is still work to do. Although data illustrate more women entering the neuromodulation field, many leave during and after residency. Further, as faculty, 23.5% of females, compared to 3.55% of males, were not satisfied with their career progression or prospects of receiving similar leadership opportunities in academic medicine. Exposure to role models is but one aspect. Mentorship from an early age in STEM is essential. Further, female medical students should be encouraged to pursue careers traditionally deemed male. Educational exposure must be combined with diverse mentors, including those in leadership roles.
Comment & Analysis effortsFocusedon mentoring and sponsoring women during early career stages is essential, as this is where the greatest amount of attrition occurs and dissatisfactionwherewith career progression is found.”
Women are absent on the editorial boards of top journals too. Their absence from the literature impacts a journal’s ability to benefit from women’s intellect and expert contributions. Stated another way, by Kirsti Malterud in a 1993 publication in Health Care for Women International, “knowledge is constructed by voice, yet women’s voices are often silent in the factory where medical knowledge is produced”. Noting this disparity, Catherine DeAngelis was appointed senior editorial consultant for Neuromodulation and ten women at the top of their respective fields in neuromodulation were added to the journal’s editorial board in 2014. Prior to this amendment, only two of the journal’s editorial board members were women.Progress continues to be made with each decade as women in neuromodulation come together to shift the narrative of a male-dominated field. Indeed, three authors of this paper have made great strides serving in leadership roles within their respective fields and within national organisations, such as WiN, NANS, and INS, among others.
To aid in fostering diversity, WiN was formed in 2015. The goals at that time were to provide more opportunities for women to realise their professional and personal goals, and to foster a continuation of mentorship opportunities for women throughout their careers.
Progress update on Women in Neuromodulation: andAchievementsobstacles
References: References for this article are available online and can be viewed at neuromodulation-achievements-obstacles.neuronewsinternational.com/women-in-
Kiran Patel is the director of Neurological Pain at Lenox Hill Hospital in New York, USA, and secretary of the NANS board of directors.
for professional development, unfair salary differences, and problems encountered with departmental leadership. Women who manage to advance in male-dominated areas of academia also represent a rarity, which may perpetuate unfair scrutiny and professional isolation. To combat these omissions, both NANS and INS established mentorship programmes, and for the past five years, at least one-third of NANS mentor/ mentee pairings have coordinated with NANS-WiN. While mentorship and leadership positions among women in neuromodulation have since increased, continued momentum requires sponsorship for women to expand networking opportunities and advocate for the advancement of women to leadership positions. Sponsors can be men or women, and are people that have the authority to advocate successfully for others. Sponsors also stake their own reputations in this role. Sponsorship and the WiN committees have afforded professional networking opportunities along with forums that provide experiences outside of conferences, given that conferences can present an additional challenge for women.
For women who balance job and caregiver roles, reluctance to attend conferences is often related to longdistance travel, requiring longer than feasible absence from the home. To successfully perform both of these roles, women are less likely to attend conferences when compared to men. In some instances, these barriers have been addressed. The National Institutes of Health and Society for Neuroscience, in particular, has arranged or subsidised childcare at meetings to ensure participation. The American Society of Anesthesiology annual conference provides mother’s room resources, and permits babywearing and strollers on the exhibit hall floor, but not in educational sessions. However, these concessions must also be offered at neuromodulation society meetings. Further, children of appropriate age and majority should be permitted to attend conferences with their parent, regardless of gender.
authorship. In particular, an increased likelihood of the first author being a woman when the last author was also a woman should be investigated.
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Anne Fennimore is the director of Marketing and Communications in the Charles E Schmidt College of Medicine at Florida Atlantic University in Boca Raton, USA.
DISCLOSURES: Julie Pilitsis is a consultant for Boston Scientific, Nevro, Medtronic, Saluda and Abbott, and receives grant support from Medtronic, Boston Scientific, Abbott, Nevro, Saluda, National Institutes of Health (NIH) 2R01CA166379-06 and NIH U44NS115111. She is the medical advisor for Aim Medical Robotics and has stock equity.
Women in the literature While the proportion of women as first authors in high-impact neurosurgery journals increased from 2002 to 2019, senior authorship has lagged— indicating continued disparity in academic advancement for women in neurosurgery. Further, as compared with male authors, female authors have published fewer articles as first authors (518 women compared to 2,729 men) and senior authors (352 women compared to 2,884 men) in neurosurgery journals. And, the proportion of women as last authors tends to coincide with the percentage of board-certified women neurosurgeons i.e. 5.4% in 2010 and 6.8% in 2019. Women also represent a lower proportion of invited papers than men. In addition to addressing women’s presence in editorials, better clarity is needed for defining women’s career rank as it relates to first and last, or senior,
In light of recent progress made in alleviating gender disparities within the neuromodulation field, Magdalena Anitescu (Chicago, USA), Anne Fennimore (Boca Raton, USA), Kiran Patel (New York, USA) and Julie Pilitsis (Boca Raton, USA) of the Women in Neuromodulation (WiN) group—pictured left to right—discuss this progress, as well as outlining remaining challenges.
However, focused efforts on mentoring and sponsoring women during early career stages is essential, as this is where the greatest amount of attrition occurs and where dissatisfaction with career progression is found. Increasing leadership opportunities for women neuromodulators and neurosurgeons in academic medicine will provide diverse perspectives on medical education delivery, and offer future generations of women practitioners and researchers with role models who look like them.
Julie Pilitsis is the dean of the Charles E Schmidt College of Medicine at Florida Atlantic University in Boca Raton, USA, and president-elect of the NANS board of directors.
Magdalena Anitescu is a professor of Anesthesia and Pain Medicine at the University of Chicago in Chicago, USA, and a director-at-large of the NANS board of directors.
Among the most cited reasons for women leaving the workforce in neuromodulation are unequal chances
T he presence of women in the field of neuromodulation worldwide is currently predicted to be approximately 10%, with even fewer women practising as interventional pain management specialists. Similarly, women represent only 4% of full professors in neurosurgery, and the number decreases further for female neuromodulators and neurosurgeons in leadership roles within academic medicine. For instance, the first and only female neurosurgeon to also serve as dean of a US medical school in 2022 is Julie Pilitsis.
Self-administered tDCS reduces knee osteoarthritis pain in older adult patients
Enrolled patients were assigned to receive 15 daily sessions of 2mA tDCS for 20 minutes (n=60) or sham tDCS (n=60) over the course of three weeks, with remote supervision being provided via telehealth. Clinical pain intensity was measured by the Numeric Rating Scale (NRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), while data on tDCS experiences were also collected via a questionnaire, the authors note. Active tDCS significantly reduced pain intensity compared to sham tDCS after completion of the 15 daily sessions in the study. NRS changes from baseline to three weeks were found to be significantly different between the two groups, with an average decrease of 24.07 seen in the active group compared to just 1.08 in the sham group. In addition, the average NRS decrease from baseline at three months was 14.27 in the active group versus 0.43 in the sham group. However, while WOMAC scores decreased from baseline at both three weeks and three months, these decreases did not represent a statistically significant difference.
were obtained without serious adverse effects, by evaluating the feasibility and efficacy of at-home, selfadministered tDCS for knee osteoarthritis pain.
SALUDA MEDICAL HAS announced that Steven Falowski (Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, USA) recently presented latebreaking 24-month data from the company’s EVOKE study at the 2022 American Society of Pain and Neuroscience (ASPN) annual meeting (14–17 July, Miami Beach, USA).
Three professional societies that are part of a larger consortium— Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), Institute of Neuromodulation (IoN), and International Neuromodulation Society (INS)—recently published recommendations suggesting patient outcomes should be evaluated as a composite measure beyond just pain relief, and include functional ability, sleep, quality of life and mood, for a more complete assessment of an individual’s response to SCS.
According to Saluda, the evidence presented at ASPN 2022 marks the first time a company has published data from a pivotal randomised controlled trial (RCT) capturing pain relief as well as quality of life, functional status, sleep, and mood improvements. Together with pain relief, these outcome measures constitute “holistic outcomes”, a Saluda press release adds. Historically, patients prescribed spinal cord stimulation (SCS) have been evaluated primarily on pain reduction or responder rate (>50% pain relief)—but, chronic pain is complex and can affect virtually all parts of a patient’s life, the release continues.
Responders in the study were defined as those patients who had at least a 30% reduction in NRS scores from baseline to three weeks. There were 36 responders and 24 non-responders in the active tDCS group, and 14 responders and 46 non-responders in the sham tDCS group. And, according to Ahn and colleagues, home-based tDCS was “well-received” and patients showed high levels of satisfaction with their experience. Overall, they found that the device was easy to use and felt confident using it, and appreciated receiving guidance remotely via video-conference. All participants tolerated tDCS well without experiencing any serious adverse effects, the authors add.
Two-year EVOKE data provide insight on holistic response to ‘smart’ spinal cord stimulation
The authors also outline the wider relevance of their study, citing the fact home-based implementation of tDCS is “very meaningful” for a population with reduced mobility, while reducing the reliance on pharmacological treatment is “a considerable advantage, especially in an older population”.
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Ahn and colleagues conducted a Phase 2, doubleblind RCT with two parallel groups (sham and active tDCS). A total of 120 patients aged 50–85 years (mean age=66 years, 68.3% female) were randomly assigned across these two groups, and randomisation balanced the allocation of patients to each arm with respect to distributions of age, race and sex.
Despite the variability of self-administered tDCS therapy potentially limiting their results, Ahn and colleagues state that the results offer promise regarding the long-term efficacy of this approach, and “set the stage” for further research involving larger samples and effectiveness assessments. “Future trials need to explore optimal dosage for knee osteoarthritis pain relief on two aspects: the magnitude of the effect, and the duration and maintenance of benefits,” they add.
In January 2022, Saluda first announced longterm results from its double-blinded EVOKE RCT, which have been published in JAMA Neurology and demonstrate superior, sustained pain relief with the company’s Evoke closed-loop SCS technology as compared to open-loop systems.“Inmy view, the EVOKE study has demonstrated through rigorous clinical evidence that Evoke ECAP [evoked compound action potential]controlled closed-loop SCS is poised to provide chronic pain patients with a remarkable opportunity to improve their total health and live a pain-free life,” said Nagy Mekhail (Cleveland Clinic, Cleveland, USA), lead author and medical monitor for the EVOKE study. “These unprecedented outcomes have the potential to set new clinical standards for chronic pain treatment, and I believe the results are due to the Evoke system’s novel technology, which is designed to instantaneously measure the spinal cord’s response to stimulation and automatically adjust to maintain consistent therapy in and out of the Thisclinic.”followed the publication of 12-month results from EVOKE in The Lancet Neurology in late-2019—and follow-up is planned out to 36 months in the study.
Home-based, self-administered transcranial direct current stimulation (tDCS) has demonstrated feasibility, acceptability and significant reductions in clinical pain intensity in older adults with knee osteoarthritis, as per a randomised controlled trial (RCT) published in the journal Brain Stimulation.
To our knowledge, this is the first RCT evaluating the efficacy of home-based, self-administered tDCS for patients with osteoarthritis pain.”
“It is well understood that chronic pain is dynamic and often multidimensional,” said Robert Levy (Marcus Neuroscience Institute, Boca Raton, USA), immediate pastpresident of the INS and author on IMMPACT recommendations published in the journal Pain “Clinicians have relied on relatively subjective measures, such as a patient’s verbal pain rating, and we recognise the need for more objective assessments that give a more complete picture of patient outcomes. The consortium’s recommendation is to assess SCS trial outcomes on a more holistic manner that is more reflective of the chronic pain experience.” Saluda claims that its Evoke system is the first and only smart spinal cord stimulator that can sense and measure the spinal cord’s response to stimulation. Powered by SmartLoop technology, Evoke can automatically adjust therapy more than four million times per day to deliver consistent neural activation based on the patient’s unique neural signature. Long-term evidence presented at ASPN 2022 demonstrated that 100% of patients treated with Evoke smart stimulation were clinically significant responders in at least one outcome measure of pain relief, function, sleep, quality of life, or mood. Additionally, nearly one in two Evoke smart stimulation patients displayed a holistic outcome response that included clinically significant improvements in all five domains, according to Saluda.
LevyRobert
“To our knowledge, this is the first RCT evaluating the efficacy of home-based, self-administered tDCS for patients with osteoarthritis pain,” Ahn and colleagues conclude. “We found that home-based tDCS with real-time remote supervision was associated with significant improvement in clinical pain intensity up to three months after a three-week treatment. These Phase 2 results corroborate our previous preliminary findings on the feasible and acceptable application of a two-week treatment with tDCS in the home setting for older adults with osteoarthritis—and extend these by providing evidence of efficacy in the longer term.”
T he study’s authors, Hyochol Ahn (Florida State University College of Nursing, Tallahassee, USA) and colleagues, note that this approach holds the potential to increase the accessibility of tDCS therapy—but future studies, including multicentre RCTs, are needed to validate their findings.
As the authors note at the outset, arthritis is the leading cause of work disability in the USA, and osteoarthritis is the most frequent form of arthritis, with knee osteoarthritis showing the highest incidence. They also detail that the current standard of care for clinical treatment comprises mainly of prescribed analgesic medications—but this approach has limited efficacy for knee osteoarthritis pain and can lead to significant adverse effects, especially in older adults. With this in mind, they set out to assess “one of the more promising non-pharmacological interventions” for these patients: non-invasive brain stimulation therapy. Specifically, they built on a recent pilot RCT, carried out in the clinical setting, in which pain benefits
University of Connecticut Neuroengineering & Pain Research Lab—synchronised pulse and sinusoidal stimulation of sacral dorsal root ganglia and nerve roots to relieve chronic visceral pain in the lower abdominal organs by selectively blocking C-fibre neural transmission.
Roberto De Icco
Data from a randomised controlled trial (RCT), which have been published in Frontiers in Neurology, support the use of neuromodulation with transcranial direct current stimulation (tDCS) as an add-on to neurorehabilitation in the treatment of Parkinson’s disease patients affected by Pisa syndrome.
BIOS Health—data-driven stimulations of the vagus nerve using neural biomarkers to modulate cardiac function and minimise side-effects on offtarget organs.
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Randomised data support use of tDCS in Parkinson’s patients with Pisa syndrome
THE NATIONAL INSTITUTES OF HEALTH (NIH) Common Fund has named eight winners of the first phase of the Neuromod Prize—a US$9.8 million competition to accelerate the development of targeted neuromodulation therapies that adjust nerve activity to improve organ function.
University of Louisville Research Foundation neuromodulation of the lumbosacral spinal cord to automatically regulate cardiovascular, respiratory and urinary systems after spinal cord injury.
The Neuromod Prize is part of the NIH Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) programme, which has attempted to make critical progress to help accelerate the development of neuromodulation therapies, close fundamental knowledge gaps, and offer tools that enable open science and innovation, through the SPARC portal.
At baseline, end of rehabilitation, and six months, patients were evaluated with both trunk kinematic analysis and clinical scales—including Unified Parkinson’s Disease Rating Scale (UPDRS-III), functional independence measure (FIM), and Numerical Pain Rating Scale (NPRS) for lumbar pain.
The first phase called on scientists, engineers and clinicians to compete for a share of the initial US$800,000 prize pool by submitting novel concepts and plans for precisely stimulating the peripheral nervous system to treat disease, and improve human health. With this competition, the NIH is using open innovation to foster approaches that are capable of precisely adjusting nerve activity to restore healthy organ function, while limiting side-effects and improving patient quality of life. Phase one of the Neuromod Prize received 45 submissions from independent teams, small companies, universities, and medical centres. The eight winners were selected by a federal judging panel and each team was awarded US$100,000 as well as an exclusive invitation to conduct proof-of-concept studies in the second phase of the competition, which is expected to begin later this year. “The winning teams have proposed exciting and innovative approaches to treating a variety of conditions, such as diabetes, incontinence, sexual disorders and obesity,” said Elizabeth Wilder, director of the Office of Strategic Coordination, which oversees the NIH Common Fund. “We await the progress of these teams as they begin to test their solutions through proof-of-concept studies and identify new ways to use neuromodulation to improve human health.”
The competition will aid winning teams from phase one in accelerating and developing their solutions in phase two. Up to four phase two winners may be selected to advance to phase three and further develop their solutions for translation to clinical use. Phase two will have a total prize pool of up to US$4 million and—subject to availability of funds—phase three will have a total prize pool of up to US$5 million.
Neuromod Prize phase one winners:
Detailing their results, De Icco and colleagues report that, compared to the sham group, the tDCS group achieved a more pronounced improvement in the following variables: Overall trunk posture (p=0.014) during upright standing position Lateral trunk inclination (p=0.013) during upright standing position Total active range of motion (ROM) of the trunk (p=0.012) FIM (p=0.048)score Lumbar groupachieved“Theintensitypain(p=0.017)improvementinourtDCSisconsistentwith
Warren Grill and Duke Biomedical Engineering collaborators—electrical recording and stimulation of the sacral nerve with closed-loop bioelectronic control to restore bladder and bowel function.
The winning teams have proposed exciting and innovative approaches to treating a variety of conditions, such as disordersincontinence,diabetes,sexualandobesity.”
General Electric Research—a single, imageguided ultrasound treatment to induce a response in the gut-brain sensory pathway, providing sustained remission in Type 2 diabetes and obesity.
RBI Medical—ultraprecise, selective pelvic neuromodulation therapy for stress urinary incontinence, overactive bladder and faecal incontinence using a minimally invasive microimplant.
University of Pittsburgh Department of Urology—a multichannel implantable device for sacral-pudendal neuromodulation to address bladder, bowel and sexual disorders.
previous data reporting a reduction between 30 and 50% of lateral trunk inclination, and a comparable increase of ROM of trunk bending at the end of a rehabilitation programme,” the authors write.
“The new and inspiring aspect of our present findings is that the addition of tDCS to neurorehabilitation induced a more persistent improvement in trunk posture. This result has a great clinical significance, because the persistence of the improvement is one of the critical issues in the management of Pisa syndrome in Parkinson’s disease. In this frame, it is tempting to hypothesise that the observed benefit may possibly be further extended over time when considering the possibility of repeating tDCS stimulation in the ambulatory setting in association with a tailored physical exercise programme at home.”
treatment and randomisation to receive either tDCS (n=13) for five daily sessions with bi-hemispheric stimulation over the primary motor cortex, or sham stimulation (n=15) with the same duration and cadence.
Anthony DiMarco—high-frequency spinal cord stimulation to reduce respiratory tract infections and improve bowel management in people with neurological impairment.
Detailing limitations of their study, they add that the small sample size involved “does not allow us to infer definitive conclusions” and claim that, despite adopting a bihemispheric approach, they cannot exclude the possibility that other stimulation paradigms might induce comparable or even better results—for instance, a longer duration of tDCS therapy within the hospital“Despitesetting.these limitations, this study warrants further trials on larger cohorts, in order to confirm our findings,” they conclude.
BASED ON THESE FINDINGS, the study’s authors—Roberto De Icco (University of Pavia, Pavia, Italy) and colleagues—conclude that tDCS “may represent a therapeutic alternative” in this patient population, owing to the fact it is a non-invasive, well-tolerated, easily repeatable, and low-cost, technique.Theauthors begin by noting that Pisa syndrome, a pathological lateral flexion of the trunk, is a frequent postural complication of Parkinson’s disease that responds poorly to antiparkinsonian drugs, and improvements achieved with neurorehabilitation tend to fade in six months or less. They also state that tDCS has shown promising results in improving specific symptoms in different movement disorders. De Icco and colleagues further note that several previous case series suggest deep brain stimulation (DBS) may exert positive effects over Pisa syndrome—but the invasiveness of this therapeutic approach, and a lack of specifically designed and well-powered trials, have limited its application in clinical practice. As such, they conducted an RCT aimed at evaluating the role of bihemispheric tDCS as an add-on to a standardised hospital rehabilitation programme for Pisa syndrome management. According to a central pathophysiological hypothesis, an imbalance in the dopaminergic outflow between basal ganglia of the two hemispheres may play a crucial role in the development of Pisa syndrome. The authors state that a bi-hemispheric tDCS approach was designed with the aim of re-equilibrating the imbalance between left and right basal ganglia. Their study included 28 patients with Parkinson’s disease and Pisa syndrome. Twenty-one of these patients were men, and the average age across the cohort was 72.9 years. Each underwent a four-week intensive neurorehabilitation
Phase one winners announced in US$9.8 million Neuromod Prize competition
One of the added benefits of certain Abbott DBS systems is that they can be used with NeuroSphere Virtual Clinic—a first-of-its-kind connected care technology that recently gained licensing from Health Canada. NeuroSphere allows people to communicate with, and receive care and therapy adjustments from, their doctors remotely, and from the comfort of their own home.
The published data showed treatment with 10kHz therapy resulted in significant pain relief and multiple significantly improved metrics of health-related quality of life, according to a Nevro press release. Results included significantly less pain interference with sleep, mood and daily activities.And,at 12 months, 10kHz SCS treatment resulted in improvement in overall health-related quality of life that was 2.5- to 4.5-fold higher than the minimally clinically important difference. Furthermore, more than 70% of clinicians and patients reported overall improvement as better or a great deal better than the pre-SCS baseline. These outcomes were durable over 12 months and support 10kHz SCS treatment in patients with refractory PDN, the release adds. In addition, approximately 92% of participants were satisfied or very satisfied with 10kHz therapy.
Flow Neuroscience gains US FDA nod to launch “largest clinical trial to date” for tDCS depression treatment Flow Neuroscience has received full US Food and Drug Administration (FDA) investigational device exemption (IDE) to launch a US pivotal trial using its self-managed transcranial direct current stimulation (tDCS) headset in the treatment of major depressive disorder.
In the largest trial to date with a portable device using tDCS for depression—according to Flow—the results could see this non-pharmacological depression treatment be readily accessible for US populations and pave the way for healthcare system inclusion in the UK.
Abbott has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to investigate the use of its deep brain stimulation (DBS) system in treatment-resistant depression (TRD).Asper a company press release, Abbott’s DBS system is a personalised, adjustable therapy that involves implanting thin wires—or leads—into targeted areas of the brain. A pulse generator implanted under the skin in the chest is connected to the leads and produces electrical impulses that can modulate abnormal brain activity. While Abbott’s DBS system has traditionally been used to help control symptoms for people with movement disorders, such as Parkinson’s disease and essential tremor, evidence suggests that implanting electrodes in the part of the brain that regulates mood could help reduce symptoms of TRD, the release continues.
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Abbott is working with the FDA to develop a plan for evaluating its DBS system’s safety and effectiveness for this purpose. The release also notes that Abbott DBS therapy for TRD is currently limited to investigational use only.
Nevro Corporation has announced that the complete 12-month results from the SENZA-PDN randomised controlled trial (RCT), including health-related quality of life outcomes in patients with painful diabetic neuropathy (PDN) treated with high-frequency 10kHz spinal cord stimulation (SCS), have been published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes
The clinical trial will include 270 participants across two research centres, and will be led by Sudhakar Selvaraj (University of Texas, Houston, USA) and head principal investigator Cynthia Fu (University of East London, London, UK) with co-researcher Allan Young (King’s College London, London, UK).
Abbott
“This is a key trial for gathering more clinical evidence for tDCS delivered through a portable device,” said Selvaraj. “As a promising non-pharmaceutical treatment for depression, these results would mean that we can work towards offering an alternative for patients and reach the 27 million US adults who remain untreated.”Thisfollows a Flow announcement from April 2022, which detailed that Erin Sivyer—formerly of Babylon Health, Uber and Google—had been appointed as the company’s new CEO. deviceLenire in use
Neuromod publishes new data showing improvement of tinnitus symptoms with bimodal neuromodulation Neuromod Devices has published the results of the company’s TENT-A2 (Treatment evaluation of neuromodulation for tinnitus—stage A2) clinical trial in Scientific Reports. The TENT-A2 trial, which included 191 participants, is Neuromod’s second large-scale clinical trial, and sought to replicate and further enhance the results demonstrated in the TENT-A1 trial—a study that evaluated the safety and efficacy of the company’s non-invasive bimodal neuromodulation device, Lenire, in 326 participants.
Flow headset
Neuro MODULATION NEWS
The study was conducted at the Wellcome Trust-HRB Clinical Research Facility at St James’s Hospital, Dublin, Ireland with no treatment-related serious adverse events reported and a high treatment compliance. Out of 191 enrolled participants, 83.8% used the device at or above the minimum compliance level over the 12-week treatment period. When treatment was completed, participants returned their devices and were assessed at three follow-up appointments up to 12 months. Some 70.3% of the 172 participants who filled out the exit survey said they had benefitted from using the treatment and 87.8% said they would recommend other people with tinnitus to try the treatment.
The more recent study investigated if changing treatment stimuli after six weeks of treatment would result in greater improvement in tinnitus symptoms than that observed in the TENT-A1 study, during which participants were treated with the same stimuli for the entire 12-week treatment period.Inthe TENT-A1 study, treatmentcompliant participants demonstrated a mean improvement that was more than twice the published clinically important improvement. In the TENT-A2 study, 95% of treatment-compliant participants achieved a greater average improvement in symptoms compared to TENT-A1 and almost three times the published clinically important improvement. And, according to a Neuromod press release, 91% of treatment-compliant participants achieved an improvement that sustained 12 months after treatment concluded.
MicroTransponder raises US$53 million and appoints new CEO MicroTransponder has closed an oversubscribed US$53 million Series E funding round led by US Venture Partners (USVP), a multistage investment firm. GPG Ventures and Exceller Hunt Ventures return as existing investors alongside new venture investors that include Osage University Partners, Action Potential Venture Capital and The Vertical Group, as per a MicroTransponder pressTherelease.company plans to use the funds to commercialise its Vivistim paired vagus nerve stimulation (VNS) system and establish it as the recommended rehabilitation intervention for stroke survivors working to improve their quality of life through improved hand and arm mobility.
TENT-A2 is the second large-scale clinical trial validating the safety of bimodal neuromodulation as a treatment for tinnitus, with high patient satisfaction and tolerability, while also demonstrating greater efficacy in reducing tinnitus symptoms through optimised treatment regimens compared to the first large-scale trial, the release Similarlyadds.toTENT-A1, participants in the TENT-A2 trial were instructed to use Lenire for 60 minutes each day for 12 weeks. However, after an initial six weeks of treatment, the timing and delivery of the audio and tongue stimuli delivered by the device were changed for participants of the TENT-A2 trial for their remaining six weeks of treatment. In TENT-A1, the stimulation setting remained the same for the full 12 weeks of treatment. This change in treatment regimen resulted in a greater average reduction in tinnitus symptom severity being achieved by treatmentcompliant participants.
severeDBSdesignationBreakthroughreceivesDevicetoexploreinmanagingdepression
In May, MicroTransponder also announced the first commercial use of Vivistim at Keck Medicine in Los Angeles, USA. In addition, the company has announced medical device executive Richard Foust as its new CEO and director. Foust has more than 25 years of strategic leadership in global medical device development and commercialisation, the release notes. He has held executive roles that spanned research and development, marketing, sales and general management at Velano Vascular, Analyte Health, Abbott Vascular, Guidant Corporation, and Perclose. As part of the investment, Casey Tansey of USVP and Bill Harrington of Osage University Partners will join the MicroTransponder board of directors too. Nevro frequencylifein“substantialannouncesimprovement”health-relatedqualityofoutcomeswithhigh-SCS
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Enrolling up to 90 patients across 10 centres in Australia, this prospective, multicentre, randomised, investigational feasibility study will evaluate the long-term performance of the closed-loop algorithm and overall patient experience with the study device, Medtronic states. Following device implantation and optimisation, subjects will be randomised to a sequence of ‘closed-loop on’ and ‘closed-loop off’ for in-clinic testing. They will then continue being followed for a total study duration of up to 24 months.Thenext-generation, closed-loop neurostimulator is investigational in Australia, and has not been approved for sale or distribution, the release details. Medtronic also notes that this study is independent of its submission to the US Food and Drug Administration (FDA) for approval of its closed-loop neurostimulator—arechargeabledevicethat is not approved or cleared in the USA for commercial use.
To facilitate the sale of assets and the financing described above, Stimwave has filed for voluntary Chapter 11 bankruptcy protection in the US Bankruptcy Court for the District of Delaware. In a statement on 15 June, the company said it expected the sale to close within the next 90–120 days.
Medtronic recently announced the first patient implant in a clinical study of its investigative, closed-loop, implantable neurostimulator. The study is being conducted in Australia, and its objective is to characterise the efficacy of the company’s rechargeable neurostimulator for the treatment of overall pain in back and limb pain subjects.Medtronic’s closed-loop feature uses the spinal cord’s physiological response to stimulation, known as an evoked compound action potential (ECAP), to automatically deliver a consistent therapeutic dose at the precise moment it is needed, according to a press release. ECAPs are signals generated by the spinal cord in response to an electrical stimulus, offering a direct measure of how many nerve fibres are activated in the spinal cord and provide a metric that can be used to inform real-time, patient-specific control of SCS“Astherapy.SCSpatients go about their daily lives, their dosage needs vary,” said Vahid Mohabbati (Sydney Pain Research Centre, Sydney, Australia), the first physician to implant a patient with the investigational device for the study. “Maintaining the right intensity of stimulation is essential for treating patients with SCS. It is our hope that the closed-loop feature will enable more personalised and real-time stimulation adjustments that reduce pain while minimising variances that fall outside of the optimal therapeutic dose.”
Medtronic announces first implant in study evaluating investigational, neurostimulatorclosed-loop
In addition, Stimwave announced that it has received a commitment from Kennedy Lewis for up to US$40 million in debtor-in-possession financing. These new funds will enable the company to operate its business uninterrupted, and to continue to grow while providing the highest level of service to physicians and the patients they serve, the release adds.
Stimwave announces sale of business and secures US$40 million in financing Stimwave Technologies recently announced that it has agreed to sell substantially all of its assets to Kennedy Lewis Management LP. Since 2020, the company has successfully restructured its entire team and business operations— according to a press release—and is now ready for “the next chapter in its continued growth” as it looks to establish a new standard of care in the field of peripheral nerve stimulation (PNS) for chronic pain patients.
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Neuspera announces second phase of SANS-UUI clinical trial with Nuvella system Neuspera Medical recently announced it will begin enrolment in its pivotal clinical trial, SANS-UUI—a singlearm investigational device exemption (IDE) study that will enrol 145 patients at 25 sites globally. The study will evaluate the safety and efficacy of Neuspera’s Nuvella system, which is designed to treat overactive bladder (OAB) for patients with urinary urgency incontinence (UUI) symptoms. The system is the first sacral neuromodulation (SNM) device that offers a minimally invasive option, which may allow for a better patient experience and greater procedural versatility, according to a Neuspera press release. The feasibility-phase results of SANS-UUI were presented previously, the release adds. In 34 patients implanted with the Nuvella system, 90% of subjects demonstrated a 50% improvement in UUI symptoms at six and 12 months with two hours of daily stimulation, while 52% were completely dry at the 12-month visit. These results are “very promising”, according to the company, with Nuvella demonstrating safety consistent with other commercially available devices—in addition to these clinical benefits.
The ROADSTER 3 study will fulfil the US Food and Drug Administration’s (FDA) condition of approval for the recent expansion of labelling for Silk Road’s Enroute transcarotid stent system, which now includes patients at high and standard risk of complications from carotid endarterectomy (CEA) as of May 2022. This prospective, multicentre, single-arm study is designed to assess the real-world treatment of standard surgical risk patients with carotid artery disease using TCAR, targeting a maximum enrolment of 400 patients across approximately 50 sites. Primary endpoints include a composite of major adverse events (death, stroke or myocardial infarction) through 30 days post-procedure, plus ipsilateral stroke from day 31 to 365 post-procedure.
“The introduction of large-bore guide catheters that can track further in the brain has been a game-changer for the treatment of ischaemic stroke,” said Milburn. “These results further support that intracranial access is directly associated with improved reperfusion, or as evidenced by this study, final TICI 2C or better reperfusion rate.”
TCAR Clinical News
“Results are encouraging and give reason to continue assessing the Monopoint platform as a potential tool for improved patient outcomes in stroke.”
“This study is providing physicians with the unique opportunity to participate in a first-ever prospective study to demonstrate the safety and efficacy of TCAR among the standard surgical risk patient population,” said co-national principal investigator Jeffrey Jim (Allina Health Minneapolis Heart Institute, Minneapolis, USA). “I [...] eagerly await clinical results that will help expand a less invasive treatment option for carotid patients regardless of their surgical risk.”
CereVasc announces US FDA approval for second IDE study of eShunt system
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Siemens study to assess intracranial haemorrhage detection with flat-detector versus multi-slice CT Siemens Healthineers has announced that a new prospective, multicentre study (SPINNERS) has been set up
to evaluate the diagnostic accuracy of non-contrast flat-detector computed tomography (CT) compared to multislice CT for detecting intracranial haemorrhage in stroke patients. This investigator-initiated clinical trial will be performed at multiple sites in Switzerland, Austria and the USA. If its outcome shows non-inferiority of flat-detector CT, this will support a one-stop management (or ‘angioonly’) approach—which may improve diagnosis, door-to-needle time and, subsequently, outcomes for acute ischaemic stroke patients, according to the company. In this workflow, imaging for the diagnosis of a large vessel occlusion (LVO) and the subsequent thrombectomy procedure are both carried out with the help of flat-detector CT inside the angiography room.
Vena announces first global thrombectomy procedures with Balloon Distal Access Catheter
“Twelve out of 10 navigability. The BDAC is not even comparable to the competitors,” said Sachin Pandey, who completed the first procedure alongside Michael Mayich (both LHSC University Hospital, London, Canada).
Silk Road to evaluate TCAR in standard surgical risk patients with ROADSTER 3 study Silk Road Medical has announced a post-market study to evaluate the transcarotid artery revascularisation (TCAR) system in the treatment of standard surgical risk patients with carotid artery disease.
“I easily pulled back the stentriever and clot all the way through the lumen of the BDAC with zero resistance. You cannot do this with the current devices on the market.” The procedure was performed via a tiny incision over the right hip and took less than 10 minutes, reconstituting blood flow to a large part of the brain, and restoring the patient’s movement and speech almost immediately. teamLHSC
CereVasc announced recently that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt system in patients who develop communicating hydrocephalus post-aneurysmal subarachnoid haemorrhage topatientsofresults“Considering(paSAH).theencouragingfromourfirst-in-humanstudytheeShuntsysteminArgentinainwithhydrocephalussecondarysubarachnoidhaemorrhage,we are eager to study the same patient population in the USA,” said Adel Malek (Tufts Medical Center, Boston, USA). The study is enrolling in parallel with CereVasc’s first IDE study in patients with normal-pressure hydrocephalus (NPH) and will allow the company to further examine the safety and efficacy of its eShunt system in a second aetiology of hydrocephalus.
NeuroVasc announces treatment of first patients in clinical trial evaluating novel stent retriever NeuroVasc Technologies has announced that the first patient has been treated in its US investigational device exemption (IDE) clinical study, the ENVI randomised controlled trial (RCT). The ENVI RCT will evaluate the safety and efficacy of the company’s ENVI-SR stent retriever, which is intended for the treatment of acute ischaemic stroke caused by large vessel occlusion (LVO). “By enrolling the first patient in this trial, we are taking an important step toward building evidence to
support the clinical use of this novel, next-generation stroke device,” said Vitor Pereira (St Michael’s Hospital, Toronto, Canada), who is a co-principal investigator along with Raul Nogueira (University of Pittsburgh, Pittsburgh, USA).The study is a global, prospective, parallel group-controlled, blinded non-inferiority trial designed to examine and compare clinical outcomes of patients being treated for acute ischaemic stroke as measured by modified Rankin Scale (mRS) score at 90 days post-treatment, and related performance characteristics of the NeuroVasc ENVI-SR, against concurrent, parallel control devices currently cleared by the US Food and Drug Administration (FDA) for the sameTheindication.studywill compare the nextgeneration ENVI-SR stent retriever with the Solitaire (Medtronic) and Trevo (Stryker) product families, and its results will support an application to the FDA for clearance of the ENVI-SR device in the USA.
Findings from the study demonstrated that intracranial guide catheter placement in the petrous internal carotid artery (ICA) segment or further distal, versus placement in the cervical ICA segment or more proximal, was associated with a better rate of thrombolysis in cerebral infarction (TICI) ≥2C reperfusion and a better first-pass effect. Access time to final recanalisation was significantly shorter in patients with intracranial guide catheter placement compared to patients with proximal guide catheter placement too, according to Imperative.
Imperative announces positive real-world data associated with Zoom stroke solution at SNIS 2022 Imperative Care has announced that new data from studies evaluating the utility of its Zoom stroke solution were recently presented at the Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto,ResultsCanada).froman independent, single-centre experience evaluating the association between guide catheter position and final reperfusion in patients who received aspiration thrombectomy for ischaemic stroke were presented by James Milburn (Ochsner Health, New Orleans, USA).
Results from a retrospective review of 33 consecutive patients—conducted without input from Route 92—also demonstrated 100% success in reaching the intracranial occlusion with the company’s HiPoint 88 (0.088-inch inner diameter [ID]) super-bore catheter, a groin-to-recanalisation time of 20 minutes, mean groin-to-clot contact time of 14 minutes, and no serious adverse events or emboli in a new“Thisterritory.initial experience across three experienced, high-volume neurointerventional centres using the SLIC technique for treatment of acute ischaemic stroke due to large vessel occlusion shows high rates of complete clot ingestion resulting in excellent first-pass efficacy and reperfusion rates using the HiPoint 88 super-bore catheter,” said corresponding author Ajit Puri (University of Massachusetts Medical Center, Worcester, USA).
SPINNERS will be conducted at approximately 12 clinical sites in Europe and North America, and is designed to include 252 patients.
Route 92’s Monopoint operating platform shows 82% first-pass effect in independent study Route 92 Medical recently announced the publication of an investigatorinitiated, multicentre SLIC (Super large-bore ingestion of clot) study of its proprietary Monopoint operating platform in the Journal of NeuroInterventional Surgery, with the company claiming that an 82% rate of first-pass efficacy was shown.
Vena Medical has announced the successful treatment of the first five patients in the world using its Vena Balloon Distal Access Catheter (BDAC) at London Health Sciences Centre (LHSC) University Hospital (London, Canada) and The Ottawa Hospital (Ottawa, Canada). The Health Canada-approved Vena BDAC combines the balloon guide catheters and distal access catheters that are currently used in thrombectomy to remove clots from the brains of stroke patients—which the company claims allows clinicians to get the balloon much closer to the clot, potentially improving first-pass success rates and leading to better patient outcomes, while also reducing the number of devices to treat each patient and therefore the cost of the procedure.
“The MIVI team shares my passion for improving the lives of patients who suffer an acute ischaemic stroke,” said Brinjikji. “I am looking forward to representing MIVI in the neurointerventional community and contributing to the advancement of novel technologies that advance stroke treatment.”
NeuroOne Medical Technologies has announced the submission of a special 510(k) to the US Food and Drug Administration (FDA) for its stereoelectroencephalography (sEEG) electrode to extend the duration of use from less than 24 hours to less than 30 days. A special 510(k), according to FDA guidance, is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k). On 16 May 2022, NeuroOne issued a press release stating the FDA’s decision to uphold a ‘not substantially equivalent’ decision after the company had appealed the ruling. The FDA informed NeuroOne it could submit a new 510(k) with new evidence specifically as it relates to the subacute toxicity biocompatibility endpoint.
Vesalio also announced a new addition to its board of directors: Bobby Helmedag, the managing director of Orlando Health Ventures. In May, Vesalio announced the completion of patient enrolment for the CLEAR US FDA investigational device exemption (IDE) study—a prospective, open-label, multicentre, single-arm trial designed to assess safety, performance and efficacy when utilising its NeVa thrombectomy platform in the treatment of acute ischaemic stroke.
Rapid Medical gains US FDA clearance for “smallest and only” thrombectomyadjustabledevice
received US Food and Drug Administration (FDA) 510(k) clearance for Viz Subdural (SDH). The Viz SDH algorithm uses artificial intelligence (AI) to automatically detect subdural haemorrhage, with the intention of enabling physicians to triage patients effectively and deliver optimal care. According to the company, Viz SDH is the only subdural haematoma (SDH)specific, AI-powered detection and care coordination platform with the ability to identify acute and chronic subdural bleeds before quickly notifying the care team to mobilise in case an immediate intervention is necessary.
30 Market Watch August 2022 | Issue47
The unique adjustability of the Tigertriever portfolio comes from complex three-dimensional braiding borrowed from recent advances in aerospace engineering, according to Rapid. The company also claims that this adjustability gives Tigertriever 13 the lowest profile of any stent retriever—24% smaller than 3mm devices, providing easier navigation in challenging anatomies and the ability to tailor each procedure to drive new safety levels for higher-risk thrombectomies.ThisfollowsRapid’s
As per a company press release, Brinjikji is an internationally respected interventional neuroradiologist who is extensively involved in stroke and neuroendovascular research, with more than 500 peer-reviewed papers and multiple industry and National Institutes of Health (NIH) grants, including for a study on improving revascularisation techniques in stroke. Most recently, Brinjikji was chief
medical officer of Marblehead Medical. He trained at top North American institutions including the University of Toronto (Toronto, Canada) and the Mayo Clinic. As medical director, Brinjikji will provide MIVI with input and medical guidance across a wide spectrum of its activities, including original clinical research and studies, product design and development, and clinical and customer communications, at a time when the company is looking to advance its CE-marked Q aspiration catheter and its investigational Daise thrombectomy device.
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Viz.ai receives US FDA 510(k) clearance for subdural detectionhaemorrhageplatform Viz.ai recently announced it has
NeuroOne also recently announced it had entered into an amendment to its exclusive development and distribution agreement with Zimmer Biomet, which it claims will provide the company with a US$3.5 million accelerated payment relating to certain milestone payments.
NICO announces new distributor for neurosurgery markets in Australia and New Zealand NICO Corporation recently announced that it has partnered with Imedcare, an Australiabased supplier and distributor of devices, as its distributor for the neurosurgery markets in the medical sectors of Australia and New Zealand. As per a NICO press release, the company currently holds more than 250 issued or pending patents. Areas of focus here include safe and repeatable non-disruptive access through eloquent areas of the brain with NICO BrainPath; efficient removal of tumours and clots down a small corridor using the NICO Myriad; and collection and biological preservation of tumour tissue in the operating room with the Automated Preservation System.
Vesalio oversubscribedannouncesClass A financing round
A multicentre trial of more than 500 patients has demonstrated the high degree of accuracy achieved with Viz SDH, according to the company, with the AI achieving 94% sensitivity and 92% specificity. In addition, Viz.ai also announced at the Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada) that it is partnering with Hyperfine—creator of what it claims is the first FDA-cleared point-of-care magnetic resonance imaging (MRI) device, Swoop—to deliver “valuable insights to the clinician’s fingertips for timely decision-making”. MIVI names Waleed Brinjikji as new medical director MIVI Neuroscience has announced that Waleed Brinjikji (Mayo Clinic, Rochester, USA) has joined the company as its medical director.
Vesalio recently announced that it has oversubscribed a Class A financing round led by Solas BioVentures, with participation by new and existing investors, including the recent addition of Orlando Health Ventures. With an expanding customer base established in Europe, Vesalio says it will use this funding to enter the US market by executing US Food and Drug Administration (FDA) clearances, adding key personnel, developing support infrastructure, expanding its product portfolio, and completing its cardiology clinical study.
Tigertriever 13
RapidAI receives US FDA clearance for Rapid Hyperdensity RapidAI has announced receipt of US Food and Drug Administration (FDA) clearance for Rapid Hyperdensity—a tool that, according to the company, empowers physicians to quickly assess the severity of injury in patients with acute neuro conditions, such as traumatic brain injury and brain haemorrhages, allowing for better and faster patient care decisions.“Asaneurosurgeon who treats many patients with intracranial haemorrhage (ICH), I am very excited for the recently approved Rapid Hyperdensity product that builds on the well-established RapidAI stroke platform,” said Alejandro Spiotta (Medical University of South Carolina, Charleston, USA). “Detection of ICH via artificial intelligence (AI) can save lives by helping to speed up diagnosis and accelerate transfer to the best physician and hospital that can take care of the patient. With the addition Brinjikji
“Viz SDH allows us to detect both acute and chronic subdural haemorrhages to better identify early treatment pathways,” said Jason Davies (State University of New York [SUNY], Buffalo, USA). “Acute subdurals require urgent intervention. Therefore, prompt notification will allow us to improve outcomes in emergent cases. Chronic subdurals have a very different pathway and having an algorithm that identifies both can allow us to take better care of our patients. The Viz.ai algorithm ensures that patients are quickly identified and routed to the appropriate therapy.”
NeuroOne submits special 510(k) to US FDA for Evo sEEG electrode
“Enrolling the first patient in this landmark study is an important milestone for patients,” said Hannes Nordmeyer (Radprax Neurocenter, Solingen, Germany). “We know from large vessel ischaemic stroke that restoring blood flow to the brain as quickly as possible provides greatly improved outcomes. Now that we have the technology to reach distal strokes with Tigertriever 13, we must understand the patient benefit in quickly opening smaller blood vessels as well.”
In July, the company announced that the first clinical case using the Evo sEEG electrode had been performed by Robert Gross at Emory University in Atlanta, USA, noting that Gross selected the device for intraoperative brain mapping at the subsurface level of the brain.
June announcement that the first patient had been enrolled in its DISTALS study, which the company claims is the firstever US FDA investigational device exemption (IDE) trial to examine the safety and effectiveness of mechanical thrombectomy in distal stroke.
Rapid Medical announced at the Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada) that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Tigertriever 13 device to treat large vessel occlusions (LVOs). Tigertriever 13 is the smallest revascularisation device in the world to date, according to the company, and is designed to remove thrombus from delicate brain blood vessels during an ischaemic stroke. The company further claims that it is the only device that adjusts to the vasculature and clot—a more atraumatic approach than existing fielddevices.“Theneurovascularhasbeenwaiting for a thrombectomy device dedicated to small vessels,” said David Fiorella (Stony Brook University Medical Center, New York, USA). “Medical therapy is currently suboptimal for these patients, so there can be a huge benefit for devices that emergently restore blood flow while minimising the potential for harm.”
registration process with a fast and accurate procedure. And, the system provides precise navigation to the surgical target. It is also user-friendly and has many other benefits.”
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on
The head-supporting assembly can also be removed completely to suit specific patient or case needs, the company also claims, and the Prone Support can be simply placed underneath the mattress using the baseboard design, allowing for efficient setup and removal on most C-arm imaging tables.
Annual Meeting San
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16–19 November Society of Vascular and Interventional Neurology (SVIN) Annual Meeting Los Angeles, USA cfm?pageid=3581svin.org/i4a/pages/index.
As per a Brain Navi press release, NaoTrac’s technology—Surface Mapping Auto-Registration Technology (SMART)—merges machine vision, robotics and artificial intelligence (AI) to streamline surgical procedures with real-time imaging and minimally invasive outcomes. Avail partners with STAR network to aid remote physician collaboration Avail Medsystems recently announced that it has entered into a partnership with the Stroke Thrombectomy and Aneurysm Registry (STAR), which will attempt to leverage the company’s surgical telepresence platform and facilitate real-time, interactive collaboration among physicians during liveTheprocedures.partnership will facilitate implementation of the Avail platform across 94 participating institutions in the STAR network—several of which already have an Avail console on site—so that they can broadcast live procedures while communicating with remote viewers via a simple app available tablet devices and according to Avail.
27 November–1 December Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting Chicago, USA rsna.org/annual-meeting
of automatic hyperdense volume measurement, physicians can more easily track volume over time and help quickly identify which patients may require an intervention. This is an exciting time for those of us treating ICH.”Powered by AI, Rapid Hyperdensity uses non-contrast computed tomography (CT) scans to quickly assess the volume of hyperdense tissue in the brain to help physicians identify the extent of an ICH. RapidAI claims that, for hospitals and mobile stroke units on the front lines of patient assessment, this latest addition to its platform provides additional contextual data to help physicians make more informed triage and transfer decisions, getting patients to the right place more efficiently.Thecompany also states that key benefits of Rapid Hyperdensity include automated detection of intracranial hyperdensities (>1ml), quick identification of hyperdense volumes to improve haemorrhage management, and fast results that can be viewed via the Rapid mobile app, PACS/ Workstation or email.
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NaoTrac, a CEcertified neurosurgical navigation robot from Brain Navi Biotechnology, has achieved Taiwan Food and Drug Administration (TFDA) approval, with a submission for US FDA clearance by the end of 2022 now alsoNaoTracplanned.clinical trials were performed at the Hualien Tzu-Chi Medical Center in Hualien, Taiwan, with external ventricular drain (EVD) placement abstract results being published in Acta Neurochirurgica Tsung-Lang Chiu (Hualien Tzu-Chi Medical Center, Hualien, Taiwan) said: “NaoTrac has several advantages besides the high precision, like a non-invasive, non-contact patient
navigationneurosurgicalautonomousforapprovalFDA“firstrobot”
Brain Navi gains Taiwan
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Calendar of events 7–9 September Congress of the European Society of Minimally Invasive Neurological Therapy (ESMINT) Nice France esmint.eu/esmint-congress 15–18 September European Society of Neuroradiology (ESNR) Annual Meeting Lisbon, Portugal meetingesnr.org/en/45th-esnr-annual-
12–13 October Stroke Live Course (SLICE) Worldwide Virtual masterandfellow.com/slice/ww 25–28 October Iberolatinoamericana Society of Diagnostic and Therapeutic Neuroradiology (SILAN) Annual Congress Montevideo, Uruguay silan.org/en/congress
26–29 October World Stroke Congress (WSC) Singapore worldstrokecongress.org 11–13 November International Neuromodulation Society (INS) Interim Meeting Mumbai, India ins-im2020.com/index.php
Prone Support
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comfortably support and manage a patient in the prone position with the launch of its new Prone Support solution. The Prone Support is the “ideal solution” for supporting and managing a prone patient, providing comfortable patient positioning during C-arm image-guided procedures, according to Adept. The arm-supporting surface is cantilevered out from the imaging table, accommodating a variety of patient sizes and mobility ranges comfortably.Theelevated, cushioned face support provides additional comfort with clearance through the centre to reduce any anxiety experienced from being contained and providing space for nasal oxygen prongs.
Adept announces Prone productSupportlaunch Adept Medical says it has responded to the call forradiologistsinterventionalfromadeviceto
6–7 October British Society Neuroradiologistsof (BSNR) Annual Scientific Meeting Liverpool, UK bsnr.org.uk/annual-meeting 8–12 October Congress of Neurological Surgeons (CNS) Francisco, USA cns.org/annualmeeting
Potential Adverse Events Possible complications include, but are not limited to, the following: acute occlusion, air embolism, allergic reaction and anaphylaxis from contrast media, aneurysm rupture, arteriovenous fistula, coagulopathy, coil herniation into parent vessel, death, device malfunction, distal embolization, emboli, embolic stroke and other cerebral ischemic events, false aneurysm formation, hematoma or hemorrhage at access site of entry, incomplete aneurysm occlusion, infection, intima dissection, intracranial hemorrhage, ischemia, myocardial infarction, neurological deficits including stroke, parent artery occlusion, peripheral thromboembolic events, post-embolization syndrome, premature device detachment, recanalization, renal failure, respiratory failure, revascularization, thromboembolic episodes, vessel spasm, thrombosis, dissection, or perforation. POD System – Intended Use For POD Coils with nominal sizes ≤ 6 mm The POD System is intended for the embolization of: • Intracranial aneurysms. • Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. • Arterial and venous embolizations in the peripheral vasculature.
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. • Arterial and venous embolizations in the peripheral vasculature.
Penumbra Coil System – Intended Use The Penumbra Coil System is intended for the embolization of:
Hospital, Bristol, UK POD400 Distal Anchor Segment POD400 Proximal Softer Packing Segment PAC400 Designed to Seek Space for Dense Packing Available in lengths up to 60 cm Product availability varies by country. Renderings for illustrative purposes only. Individual results may vary depending on patient-specific attributes and other factors. Images used with permission. Consent on file at Penumbra, Inc. Please contact your local Penumbra representative for more information. Copyright ©2022 Penumbra, Inc. All rights reserved. The Penumbra P logo, POD, POD400, and PAC400 are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. 23130, Rev. A 02/22 EU
Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use.
• Intracranial aneurysms.
premature device detachment; recanalization; renal failure; respiratory failure; revascularization; thromboembolic episodes; vessel spasm, thrombosis, dissection, or perforation. www.penumbrainc.com Designed for Efficient, Dense Packing One POD400 and one PAC400, 4 mm vessel Photographs taken by and on file at Penumbra, Inc. Bench test results may not be indicative of clinical performance. Image used with permission. Consent on file at Penumbra, Inc. Individual results may vary depending on a variety of patient-specific attributes and other factors. POD400™ & PAC400™ dAVF Coiling
Potential Adverse Events Possible complications include, but are not limited to, the following: acute occlusion; air embolism; allergic reaction and anaphylaxis from contrast media; aneurysm rupture; arteriovenous fistula; coagulopathy; coil herniation into parent vessel; death; device malfunction; distal embolization; emboli; embolic stroke and other cerebral ischemic events; false aneurysm formation; hematoma or hemorrhage at access site of entry; incomplete aneurysm occlusion; infection; intima dissection; intracranial hemorrhage; ischemia; myocardial infarction; neurological deficits including stroke; parent artery occlusion; peripheral thromboembolic events; post-embolization syndrome; Dr. Alex Mortimer Southmead
