New CERENOVUS study demonstrates cost-savings associated with First-Pass Effect in mechanical thrombectomy for treating acute ischemic stroke in the US and Europe

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New CERENOVUS study demonstrates cost-savings associated with First-Pass Effect in mechanical thrombectomy for treating acute ischemic stroke in the US and Europe

Findings show that the first pass effect yields economic benefits for the healthcare system in addition to improved patient outcomes.

IRVINE, CA – January 11, 2021 Data published in the Journal of NeuroInterventional Surgery (JNIS) demonstrates that mechanical thrombectomy (MT) significantly reduces health care spending within the first year after ischemic stroke when complete or near complete reperfusion is achieved at the first pass (attempt)1,than when achieved with more than one pass. The study authors conclude that first-line treatment for ischemic stroke should ideally involve a MT technique that provides the best chance of success in the first pass.1

First pass effect (FPE) should be the procedural goal in the endovascular treatment of acute ischemic stroke and demonstrates the most favorable patient outcomes.2 FPE reduces the risk of endothelial vessel injury and irritation, lowers the rate of complication, and shortens procedure time. Repeated thrombectomy passes may be associated with an increased risk of vessel injury and a potential impact on clinical outcomes.3

Globally, there are 13.7 million new strokes a year,4 and stroke events are set to rise by an average of 34% by 2035,5 increasing the already significant burden on healthcare systems. The annual direct and indirect economic burden of stroke in the U.S. was $105 billion in 2012 and is expected to increase to $241 billion by 2030.7 In the European Union (EU) alone, the total cost of stroke was estimated at €45 billion in 2015,5 with direct healthcare costs of €20 billion, three-quarters of which relates to in-hospital care.5 This study demonstrates that patients achieving FPE have reduced length of inpatient stay and therefore has the potential to generate significant cost savings, with no negative impact on patient outcomes.

“Despite MT being recommended by both the European Stroke Association and the American Heart Association for the treatment of Acute Ischemic Stroke, access to MT remains limited and not all MT delivers the same outcomes,” said Professor Tommy Andersson**, MD, PhD, Karolinska University Hospital, Stockholm, Sweden and AZ Groeninge, Kortrijk, Belgium, and senior author of the report. “ Providing treatments that give patients the best chance of having a better quality of life, while reducing health care spending is increasingly vital, obviously for the individual stroke patient but also for society, not least regarding younger patients that otherwise may be living with a reduced quality of life for longer.”

The report, Health Economic Impact of First Pass Success Among Patients with Acute Ischemic Stroke Treated with Mechanical Thrombectomy – A United States and European Perspective, published in JNIS, is based on a post-hoc analysis of data from ARISE II6, paired with cost data from the US and six European studies and is the first analysis demonstrating the economic impact of improved clinical outcomes provided by first pass recanalization.

Patients achieving FPE were discharged significantly earlier, with length of stay reduced from 9.48 days to 6.10 days. In every country studied, achieving FPE resulted in potential per-patient cost savings during the acute care phase in hospital1, from $6,575 in the US to $1,833 (€1,560) in France. Also, beyond hospitalization, additional cost savings are projected in the first year after stroke varying from $4,116 in the US to $957 (€823) in Italy.1

“There is a wealth of data to show that achieving the first pass effect in mechanical thrombectomy gives patients the best chance of recovery from the devastating effect of ischemic stroke,” said Osama Zaidat**, Professor of Neurology, Neurosurgery, and Radiology, and Director of the Neurointerventional Program at the Medical College of Wisconsin, Milwaukee and lead author of the report. “This further analysis proves that the clinical benefit of achieving first pass has a positive impact on healthcare spending. As such, the goal of achieving first pass effect during mechanical thrombectomy should also be supported by administrators and payers by providing access to the best available treatment options.”

ARISE II2, a prospective single-arm international multi-center clinical trial with the use of EMBOTRAP® Revascularization Device, showed that achieving reperfusion in a single pass – the first pass effect (FPE) – is an independent predictor of good functional outcome after stroke.1 Clinical outcomes were derived from data on 227 treated patients and cost data analysis was done from the perspective of healthcare systems in the US, France, Germany, Italy, Spain, Sweden and the United Kingdom.

“Stroke is not only devastating for patients and their loved ones but places a huge burden on health systems across the world,” said Mark Dickinson***, Worldwide President, CERENOVUS. “For the first time, this study makes clear that focusing on patient outcomes also brings benefits in terms of reducing hospitalization costs and lower costs in the first year after stroke. First pass effect gives patients, healthcare systems and healthcare professionals the best possible chance of overcoming the huge challenges presented by stroke.”

Full report can be accessed here: https://jnis.bmj.com/content/early/2020/12/20/neurintsurg-2020-016930

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About CERENOVUS
CERENOVUS, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. For more information, visit www.cerenovus.com and connect on LinkedIn and Twitter.

About Johnson & Johnson Medical Devices Companies 
As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopedics, vision and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.

* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, vision and interventional solutions businesses. CERENOVUS is part of the Johnson & Johnson Medical Devices Companies.
** Dr. Tommy Andersson and Dr. Osama Zaidat are paid consultants to CERENOVUS
***Mark Dickinson is an employee of Biosense Webster, Inc.

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Media Contact:
Rebecca Ratcliffe
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References

  1.  Zaidat OO, Ribo M, Matte HP, et al. Health Economic Impact of First Pass Success Among Patients with Acute Ischemic Stroke Treated with Mechanical Thrombectomy – A United States and European Perspective. Journal of NeuroInterventional Surgery. https://jnis.bmj.com/content/early/2020/12/20/neurintsurg-2020-016930 (accessed January 2021)
  2. Zaidat OO, Castonguay AC, Lifante I, et al. First Pass Effect. A New Measure for Stroke Thrombectomy Devices. Stroke. 2018;49:660-666.
  3. Nikoubashman O, Dekeyzer S, Riabikin , et al. True First-Pass Effect. First-Pass Complete Reperfusion Improves Clinical Outcome in Thrmbectomy Stroke Patients. Stroke. 2019;50:2149-2146.
  4. World Stroke Organization. Learn about stroke. Available at: https://www.world-stroke.org/world-stroke-day-campaign/why-stroke-matters/learn-about-stroke (accessed 17 November 2020).
  5. King’s College London for the Stroke Alliance for Europe (SAFE). The Burden of Stroke in Europe Report. Available at: http://www.strokeeurope.eu/downloads/TheBurdenOfStrokeInEuropeReport.pdf (accessed 17 November 2020).
  6. Zaidat OO, Bozorgchami H, Ribo M, et al. Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischaemic Stroke with EmboTrap). Stroke. 2018;48:1107-1115.
  7. Stunz M, Busko K, Irshad S, et al. Nationwide trends of clinical characteristics and economic burden of emergency department visits due to acute ischemic stroke. Open Access Emergency Medicine. 2017:9 89-96.