New Technology in Treating Hemorrhagic Stroke: Could Training Lead Toward a New Gold Standard?

New Technology in Treating Hemorrhagic Stroke

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To date, a total of 18 peer-reviewed papers and abstracts that included 221 cases have been published on the clinical experiences and outcomes when using the BrainPath Approach for access and evacuation of ICH. This evidence, and the support of major academic healthcare centers like Sutter Eden, Emory University, Johns Hopkins, Cleveland Clinic, Cedars-Sinai, and Indiana University currently participating in the ENRICH trial, gives a high level of confidence that the standardized approach and technologies are in prime position to help ICH patients who have no proven surgical option for treatment and may eventually provide a new gold standard of care in ICH.

Dr. Larry Dickerson, Neurosurgeon, Sutter Eden Medical Center, Castro Valley, CA

Could Training Lead Toward a New Gold Standard?

by Larry Dickinson, MD, Neurosurgeon, Sutter Eden Medical Center, Castro Valley, CA

There is an unmet need in the United States and abroad for the treatment of hemorrhagic stroke. But now, this deadliest, costliest and most debilitating form of stroke with no surgical standard is experiencing a paradigm shift. New and growing peer-reviewed published evidence showing improved morbidity and mortality with early intervention of hemorrhagic stroke is gaining wide attention by neurosurgeons from across the U.S. and Europe, where technologies used in a new ICH surgical approach just gained CE Mark.

Training and education opportunities on this new minimally disruptive surgical approach occur at various healthcare institutions across the country, as well as during the annual course and meeting of the Subcortical Surgery Group (SSG). I believe that educational opportunities like these will will go a long way in solidifying the approach as a possible new gold standard in treating patients with hemorrhagic stroke.

 

Hemorrhagic stroke has always been “the other stroke” with no proven surgical answer. It carries early mortality rates ranging from 35%-52%1 and an estimated associated cost of care and productivity losses at approximately $12.7 billion annually2-4. While hemorrhagic stroke accounts for only 20% of all strokes in the U.S., its affects are devastating with only 10%-25% of patients returning to functional independence.2,3

NICO Brain Path Technology

Evidence from the more common ischemic stroke that makes up the other 80% of stroke occurrences has taught practitioners that “time is brain” and early invention has a direct impact on patients’ functional and cognitive recovery. Although less recognized, the same principle applies to ICH, where different mechanisms of secondary brain damage also occur in the first few hours after incident onset.4 Despite clinical evidence from early clinical trials with MISTIE and STICH supporting the role of early hematoma evacuation, surgical intervention for supratentorial ICH remains unproven and is rarely performed or performed only after the patient is in decline.5 Consequently, approximately 95+% of ICH-based care involves medically managing symptoms.

The new technologies that answer these unmet needs include the BrainPath and Myriad, both FDA-cleared devices. BrainPath is a navigation-compatible, port-based technology already used in more than 5,000 procedures. It provides minimally disruptive access to deep regions of the brain and is the first and only device that creates a path to the target by using a parafascicular, trans-sulcal surgical approach versus cutting through critical brain fiber tracts6. The Myriad is an automated multi-functional resection tool that has been used in more than 11,000 surgery procedures. It is used through the BrainPath sheath for safe and maximum clot evacuation. These technologies improve the applicability and evidence that early surgical ICH evacuation can potentially lead to improved functional recovery.7

What these technologies provide is a surgical approach that establishes a standardized methodology to treating ICHs, as evidenced in a published paper highlighting a two-year, multi-center pilot study of 39 patients with clot evacuation by 15 neurosurgeons uniformly trained on the technologies and approach. The authors reported no new deficits, no surgical deaths, and over 90% clot removal, resulting in a statistically significant GCS improvement.8 The results were replicated by Cleveland Clinic in a prospective study of 18 patients where 65% of patients had an active bleed successfully managed – providing an ultra-early treatment option without the need for clot stability prior to surgery.9 Total hospital length of stay also compared favorably to other recent studies, suggesting a meaningful cost benefit exists.

For ICH, two key goals emerge once non-disruptive access is achieved: Gain maximum clot evacuation and don’t create additional bleeding.7 Gaining maximal clot evacuation while not disrupting the brain or causing additional bleeding that leads to post-operative “re-bleeding” is achieved using the Myriad versus using a traditional sucker. The device, unlike a sucker, is capable of removing both fibrous and liquefied clots because it combines and automates two important tools – scissors and suction. The surgeon is able to toggle between gently sucking near delicate structures and controlled cutting or scissors when the clot is cross-linked (view surgical procedure videos HERE using these technologies). This capability is what achieved unprecedented 95% clot evacuation with no new surgical deficits in published literature.9

Typically, the earlier the clot is accessed, the better for the patient. But it is also the typical time when the clot is cross-linked and more difficult to remove, often leading to further bleeding and less than satisfactory clinical outcomes. The multi-functional capabilities of the Myriad enhance the efficiency of clot evacuation, decreases operative time, and enables safe and maximum clot evacuation.

Despite the positive results of the initial case series, retrospective and prospective studies, and the widely accepted benefit of this new surgical approach for subcortical lesions, Level I evidence supporting the use of these techniques in ICH is needed for the approach to become supported by standard of care guidelines. This information, coupled with the successes of past trials, led to the development of a larger multi-center, randomized, adaptive clinical trial called ENRICH (Early Minimally-invasive Removal of IntraCerebral Hemorrhage). ENRICH includes 25 major academic and community centers that will compare standard medical management to early surgical hematoma evacuation using minimally invasive parafascicular surgery in the treatment of acute spontaneous supratentorial intracerebral hemorrhage. The trial is led by Emory University School of Medicine and Grady Memorial Hospital in Atlanta.

To date, a total of 18 peer-reviewed papers and abstracts that included 221 cases have been published on the clinical experiences and outcomes when using the BrainPath Approach for access and evacuation of ICH. This evidence, and the support of major academic healthcare centers like Sutter Eden, Emory University, Johns Hopkins, Cleveland Clinic, Cedars-Sinai, and Indiana University currently participating in the ENRICH trial, gives a high level of confidence that the standardized approach and technologies are in prime position to help ICH patients who have no proven surgical option for treatment and may eventually provide a new gold standard of care in ICH.

References:

1Macellari F, Paciaroni M, Agnelli G, Caso V. Neuroimaging in intracerebral hemorrhage. Stroke. 2014;45:903-8.

2Adeoye O, Broderick JP. Advances in the management of intracerebral hemorrhage. Nat Rev Neurol. 2010; 6:593-601.

3Andersen KK, Olsen TS, Dehlendorff C, Kammersgaard LP. Hemorrhagic and ischemic strokes compared: Stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068-72.

4Sahni R, Weinberger J. Management of intracerebral hemorrhage. Vascular Health and Risk Management. 2007;3(5):701-709.

5Zammar SG, Zimmerman RS, Tiano MM, Bendok BR. Time is brain and so is less blood: The hyperacute period after intracerebral hemorrhage. Neurosurgery: Science Times. 2015; 76(6): N12.

6Kassam AB, Labib MA, Bafaquh M, et al. Part I: The challenge of functional preservation: An integrated systems approach using diffusion-weighted, image-guided, exoscopic-assisted, transulcal radial corridors. Innovative Neurosurgery. 2015;3:5-23.

7Ritsma B, Kassam AB, Dowlatshahi D, Nguyen T, Stotts G. Minimally invasive subcortical parafascicular transsulcal access for clot evacuation (Mi SPACE) for intracerebral hemorrhage. Case Rep Neurol Med. 2014;2014(102307): 4 pages.

8Labib MA, Shah M, Kassam AB, et al. The Safety and Feasibility of Image-Guided BrainPath-Mediated Transsulcul Hematoma Evacuation: A Multicenter Study. Neurosurgery. 2016.

9Bauer AM, Rasmussen PA, Bain MD. Initial Single-Center Technical Experience With the BrainPath System for Acute Intracerebral Hemorrhage Evacuation. Operative Neurosurgery. 2016.