Hematoma, Subdural

Society of NeuroInterventional Surgery says shift in treatment protocol represents major advance for the field FAIRFAX, Va., Feb. 12, 2024 /PRNewswire/ -- The Society of Neurolnterventional Surgery (SNIS) is acknowledging middle meningeal artery embolization (MMAE) as a beneficial adjunctive treatment for chronic subdural hematoma in light of new research. The minimally invasive MMAE procedure significantly reduced the failure rates of traditional surgical and non-surgical management strategies without an increased rate of serious neurological complications. Chronic subdural hematoma refers to the gradual accumulation of blood over the surface of the brain. This disorder primarily affects elderly patients, is associated with significant morbidity and mortality, and represents a tremendous health care resource burden. As the U.S. population continues to age, studies show that chronic subdural hematomas may be the most prevalent neurosurgical diagnosis that requires treatment within the next decade. The existing standard of care for treating chronic subdural hematomas involves either drilling holes into the skull to drain the blood (i.e., surgical management) or watchful waiting with various medical interventions (i.e., non-surgical management) for patients who do not require early surgical intervention and/or are poor surgical candidates. However, an average of 10% to 30% of patients experience recurrence of chronic subdural hematoma after surgery, often necessitating reoperation. Studies show these surgical failure rates are higher among elderly patients. Failure rates in patients initially managed non-surgically are reported to be even higher. According to three new prospective randomized controlled trials (EMBOLISE, MAGIC-MT and STEM), adjunctive MMAE significantly reduces the failure rates of standard management strategies. The technically straightforward and minimally invasive MMAE procedure is performed using small catheters inserted through blood vessels in the arm or leg. These small catheters are then navigated into the middle meningeal artery and liquid agents are injected into these blood vessels, solidifying within them (like a glue), blocking them off and stopping the chronic bleeding into the subdural space. This treatment represents a major shift in the management of this disease. The effect sizes of adjunctive MMAE in patients in the non-surgical arms of MAGIC-MT and STEM indicate that many patients may be able to avoid open surgery completely as MMAE substantially reduced the failure rates of non-surgical management. For patients who required surgical drainage, EMBOLISE showed that adjunctive MMAE significantly reduced reoperation rates. The surgical management arm of the STEM trial showed a similar robust trend with MMAE cutting surgical failure rates by about half, however, STEM did not show differences in the non-surgical and surgical subgroups separately, and as such, the surgical arm findings were not significant as a stand-alone subgroup. Adjunctive MMAE with liquid agents started in 2018 with two members of SNIS who went on to lead the pivotal STEM trial (sponsored by BALT USA) — former SNIS President Adam Arthur, MD, MPH and David Fiorella, MD, PhD. "The presented data indicate that this novel adjunctive procedure represents an important advance as it reduces the failure rates of standard management strategies with a high margin of procedural safety. Chronic subdural hematoma is an exceedingly common problem, and these findings will be relevant to a large population of patients. We look forward to the final published results of all three studies," said Dr. Fiorella, professor of neurosurgery at Stony Brook University. "In many ways these data are really just the beginning. There will be a tremendous amount of additional insight coming very soon. The MEMBRANE trial from Cerenovus just recently completed enrollment and a combined analysis of all four of these randomized controlled trials of MMAE is planned. It is important to acknowledge that EMBOLISE and STEM were performed under investigational device exemptions within the context of U.S. FDA regulated prospective clinical trials. No liquid embolic agent currently has U.S. FDA clearance for MMAE and regulatory review is pending." "It is incredible to see the fruits of our labor after six years of research," said Dr. Arthur, chair of neurosurgery at the University of Tennessee Health Sciences Center and Semmes-Murphey Clinic. "Together as neurointerventionalists and neurosurgeons, we are making a difference by providing evidenced-based, effective and patient-centric minimally invasive alternatives to traditional treatment strategies. My SNIS colleagues are continually producing remarkable work to advance the field and I am eager to witness what is to come." To receive a copy of this research or to speak with the study authors, please contact Camille Jewell at [email protected] or 202-248-5460 About the Society of NeuroInterventional Surgery The Society of NeuroInterventional Surgery (SNIS) is a scientific and educational association dedicated to advancing the specialty of neurointerventional surgery through research, standard-setting, and education and advocacy to provide the highest quality of patient care in diagnosing and treating diseases of the brain, spine, head and neck. Visit and follow us on X (@SNISinfo) and Facebook (@SNISOnline). CONTACT: Camille Jewell [email protected] or 202-248-5460 SOURCE The Society of NeuroInterventional Surgery (SNIS)

RapidAI’s three-in-one solution aims to help hospitals speed up assessing and treating traumatic brain injury and hemorrhagic stroke. RapidAI is showing no signs of slowing down after racking up a trio of FDA clearances since the start of the year. The latest of the agency nods was bestowed upon an artificial intelligence-powered module that’s designed to spot signs of possible subdural hematomas in non-contrast CT scans of the brain. The FDA clearance of Rapid SDH, announced by RapidAI on Thursday, makes the module available to hospitals in the U.S., where cases of subdural hematoma current carry a mortality rate between 40% and 60% and are expected to grow in prevalence by almost 80% within the next 20 years, according to the company. Rapid SDH’s AI was trained using hundreds of previous patient scans to spot potential indicators of both acute and chronic subdural hematomas, in which blood builds up between the surface of the brain and its protective cover. Studies of the module have proven it to have sensitivity of 93% and specificity of 99% in identifying possible brain bleeds, adding up to a positive predictive value of 99%, per RapidAI. According to its maker, the technology can scan a brain CT scan and return its results to doctors within one minute. Those results come through via the RapidAI mobile app, emails and a hospital’s existing picture archiving and communication system (PACS), allowing every member of a trauma team to view the scan, assess the findings themselves and begin remotely triaging the patient’s case if needed. Rapid SDH can be used alongside additional AI-powered modules from RapidAI trained to catch signs of intracranial hemorrhage and hyper-dense areas of the brain, dubbed Rapid ICH and Rapid Hyperdensity, respectively. RapidAI’s aim with the three-in-one solution is to help hospitals speed up the process of assessing potential cases of traumatic brain injury and hemorrhagic stroke and begin treating diagnosed patients as quickly as possible. “The FDA’s clearance of Rapid SDH significantly enhances our expanding range of hemorrhagic and trauma care solutions at this crucial time of rapidly growing patient numbers, clinician shortages and advancements in potential treatment options,” Amit Phadnis, the company’s technology chief, said in this week’s announcement. “Our goal is to continue to expand the capabilities and applications of our deep AI to deliver comprehensive clinical solutions that provide care teams with the crucial insights necessary to evaluate patients, streamline decision making and expedite care for this common and dangerous disease,” Phadnis continued.

The new solution is intended to facilitate the identification and care coordination of patients with MeVOs, along with posterior and anterior LVOs Aidoc's Full Brain Solution is intended to identify suspected posterior and anterior large and medium vessel occlusions apart from aneurysms and haemorrhages. (Credit: PRNewswire/Aidoc Medical LTD) Aidoc has introduced the artificial intelligence (AI)-based Full Brain Solution with an aim to significantly broaden the anatomy analysed by AI for the detection of suspected strokes. As per the health technology company, the new solution will facilitate the identification and care coordination of patients with medium vessel occlusions (MeVOs), along with posterior and anterior large vessel occlusions (LVOs). Aidoc stated that the Full Brain Solution marks significant progress in medical technology by supporting patient care as the first and only AI technology capable of identifying suspected posterior and anterior LVOs as well as MeVOs. Aidoc CEO Elad Walach said: “AI continues to drive significant gains and contributions in addressing the challenges health systems are facing. “Our groundbreaking Full Brain Solution is propelling AI into new and needed territories and proving impact to facilities by cutting the time to treatment nearly in half for twice as many patients. “Our vision is to continue pushing boundaries, transforming the lives of a significantly larger patient population, elevating the standard of care, and driving remarkable improvements in patient outcomes.” Aidoc claimed that the Full Brain Solution goes beyond acute ischemic stroke. It harnesses various AI technologies, including image-based identification and natural language processing. The company said that the solution effectively identifies and coordinates care for patients with intracerebral haemorrhage, brain aneurysms, and subdural haemorrhage, which makes it the most comprehensive neurovascular AI solution available. The Full Brain Solution is delivered through Aidoc’s proprietary operating system called aiOS. The OS is said to empower organisations to implement AI solutions at scale and overcome challenges associated with legacy IT systems and separate physician workflows. Seamlessly integrating with existing IT infrastructure, aiOS is said to enable the full potential of AI in healthcare to be realised. Furthermore, it is the only platform integrated into electronic health records (EHR), said the health technology company. Aidoc is showcasing the Full Brain Solution at the ongoing Society of NeuroInterventional Surgery (SNIS) annual meeting in San Diego, California.