In the United States, a person suffers a stroke every 40 seconds while someone dies of a stroke every 4 minutes.1 As one of the leading causes of disability in the country, stroke is an evergreen field for research into the care and treatment of this patient population.
According to researchers in a recent CERENOVUS study, the first-pass effect is an independent predictor of good functional results in the endovascular treatment of acute ischemic stroke. The results also showed that mechanical thrombectomy significantly reduced health care expenses in the first year after an ischemic stroke when complete or near complete reperfusion is achieved on the first pass, compared to reperfusion after more than one attempt
With Dr. Tom Yao, a Neurosurgeon with Norton Health and a consultant at Johnson & Johnson Pharmaceuticals, spoke to discuss the future and challenges of stroke research, the first pass effect and the results of the latest CERENOVUS study.
How do you see the future of stroke research in the next 5 years?
There are many aspects of stroke research that have the potential to improve patient outcomes; However, mechanical thrombectomy (MT) – a minimally invasive procedure – is an important part of stroke care that could have an immediate impact on good patient outcomes. The goal of stroke treatment is to prevent brain cells from dying because once brain cells die, they do not regenerate – resulting in disability and death.
Stroke is still a leading cause of disability and death in the world [US].1 However, over the past decade, advances in MT have improved the safety, success, and efficacy of MT, reducing the total number of stroke deaths and disabilities. 3 Recent randomized clinical trials have even put MT in the first category transforms transformed line of stroke treatment. In short, the faster the blockage is cleared from the brain during a stroke, the more brain cells can be saved, leading to a better clinical outcome.
We can influence the quality of life of patients and families by limiting neural death. We can do this by affecting the time it takes for blood flow to fully restore, which can be done in many ways. Stroke research should focus on device and catheter access device innovation.
The improvement in the speed, success and effectiveness of revascularization in the shortest possible time leads to a significantly improved patient outcome (both quality of life and quality of life) .4 Each generation of devices has led to the result known as the first pass effect (FPE.)). Despite the success of MT in the stroke world, patient outcomes can always be better.
Together with MT we need increased community awareness and better education. These aspects are often overlooked [favor of] Increase the speed of treatment and access to comprehensive stroke care. Improved symptom recognition for patients would directly result in a shorter time to final treatment. Knowing that there are specialized hospital systems that are Comprehensive Stroke Center (CSC) certified would reduce the need for patient transfers from centers that do not offer the full range of services offered by the CSC, as these transfers directly delay the ultimate care of many stroke patients.
Further optimizing the process from field assessment to the right hospital will improve clinical outcomes because time is the brain – and the earlier a stroke is detected and treated, the better the clinical outcome. By focusing on and investing in research with this multi-pronged approach, we can help prevent deaths, improve overall outcomes for patients with stroke, and improve the quality of life for survivors.
Can you explain the importance of the First Pass Effect (FPE) and the results of the current CERENOVUS study? What are the clinical implications of these findings?[FPE] describes patients who underwent MT who had improved single pass results in restoring blood flow to the brain compared to those who required multiple pass attempts.
Repeated rounds of thrombectomy can be associated with an increased risk of vascular injury and a longer time to restore blood flow, which can potentially affect clinical outcomes. For this reason, FPE should be the procedural objective in the endovascular treatment of acute ischemic stroke because it provides the most beneficial patient outcomes and has a positive impact on healthcare spending. Therefore, increased research into the effectiveness and availability of devices would help us achieve FPE more frequently.
The CERENOVUS study, recently published in the Journal of NeuroInterventional Surgery, highlights the patient benefits and economic benefits of FPE during mechanical thrombectomy.5 Specific findings include:
- Reduced risk of vascular injuries and irritation, lower complication rate and reduced procedure time
- Much earlier discharge from hospital, length of stay shortened from 9.48 days to 6.10 days
- Potential cost savings of up to $ 6,575 per patient during the acute care phase in the hospital
Beyond hospitalization, additional cost savings of approximately $ 4,116 are projected for the first year after a stroke.
Which areas of stroke research still need attention? Why is continuous innovation important in these areas?
Ongoing research and innovation into the devices used and how they are delivered, educating patients and communities, and healthcare infrastructure are critical to helping patients and improving outcomes. Streamlining and developing improvements in these areas will lead directly to new technologies and procedures that practitioners can use in the office to help our stroke patients.
The effectiveness, safety and availability of devices should continue to be a focus of stroke research. This will allow us to improve the time to full restoration of blood flow without causing unwanted injury. For example, ongoing innovation and research into FPE will help us better understand FPE predictors and how we can use this marker more effectively for stroke treatment success.
The other aspect of stroke that requires ongoing support is getting the patient to the hospital earlier. This includes community awareness as well as community infrastructure. Our communities need to understand that there are only specific hospitals or comprehensive stroke centers certified for all aspects of stroke care and the complexities of neurovascular care.
Many people outside of the healthcare sector are unaware that not all hospitals offer a full range of stroke care professionals. CSCs are centers that offer:
- Availability of advanced imaging modalities including MRI / MRA, CTA, DSA and TCD
- Availability of personnel trained in vascular neurology, neurosurgery, and endovascular procedures
- 24/7 availability of staff, imaging, operating room and endovascular facilities
- ICU / Neuroscience ICU facilities and capacities
- Experience and expertise in the treatment of patients with major ischemic stroke, intracerebral haemorrhage and subarachnoid haemorrhage including research
What challenges were there in this research area and how were they met?
Stroke treatment has improved exponentially over the past 10 to 15 years. In fact, 10 years ago we were still trying to find out which devices were safe for use in the brain. We spent hours opening a ship and 50% of the time we were unsuccessful.
Today it’s far from when we first performed MT. We always said, “If we could open the ship.” As catheters and devices have improved, we can now say “when we open the vessel”.
Research must now focus on:
- How we can get the patient to the right hospital (CSC) faster (community awareness of both the disease process and the hospitals that can be treated)
- How surgeons can perform the operation faster, more effectively and safely (improvements in catheters, access and devices).
How has the COVID-19 pandemic impacted this direction in research?
COVID-19 has caught the world’s attention and affected the progress of other health initiatives. For example, many laboratory values and tests have been restricted because insufficient materials were available to perform them, and these bottlenecks often have a direct impact on patient care. In addition, several research studies had to be stopped or slowed down as we cannot enroll in studies due to the limitations of face-to-face meetings.
Now that we have a better understanding of this virus and a major vaccination effort has been made, we need to move forward with other initiatives and focus again on areas like stroke care.
Anything else you want to add regarding R&D therapy, stroke research direction, or its impact in the face of the ongoing pandemic?
As an industry, we must continue to strive to do what is best for the patient. If we continue to advocate patient care, the necessary research and development improvements will have a positive impact on their treatments.
1. “Stroke facts”. The Centers for Disease Control and Prevention. March 2021. www.cdc.gov/stroke/facts.htm
2. Zaidat OO, Ribo M, Mattle HP, et al. Health economic implications of first-pass success in acute ischemic stroke patients treated with mechanical thrombectomy: a US and European perspective. J Neurointerv Surg. Published online December 21, 2020. doi: 10.1136 / neurintsurg-2020-016930
3. McCarthy, David J. et al. Long-term results of mechanical thrombectomy for stroke: a meta-analysis. ScientificWorldJournal. Published online on May 2, 2019. doi: www.ncbi.nlm.nih.gov/pmc/articles/PMC6521543/
4. Zaidat OO, Castonguay AC, Lifante I, et al. First pass effect. a new measure for stroke thrombectomy machines. Stroke. 2018; 49 (3): 660-666. doi: 10.1161 / STROKEAHA.117.020315
5. New CERENOVUS Study Demonstrates Cost Savings Associated with the First Pass Effect in Mechanical Thrombectomy for the Treatment of Acute Ischemic Stroke in the US and Europe. Irvine, California: Johnson & Johnson. January 11, 2021. Accessed May 13, 2021.