Your Path to Program Success: Expert Advice

We Need Increased Access to Mechanical Thrombectomy for Large-Vessel Occlusion Strokes in the U.S.

Michelle Luffey, Senior Consultant, Corazon, Inc.

Michelle Luffey, Senior Consultant, Corazon, Inc.

Large-vessel occlusions account for up to 46% of acute ischemic strokes, which place large areas of the brain at risk for irreparable damage if not treated appropriately within a designated recommended timeframe. Furthermore, this type of stroke causes disproportionately high rates of post-stroke death and disability (95% and 62%, respectively) when compared to other types of ischemic stroke.1

Over the past few years, study data have demonstrated the efficacy of endovascular thrombectomy for improving clinical outcomes in patients with large-vessel occlusions (LVOs), which has significantly impacted the treatment recommendations for the large and growing patient population that suffers from LVOs. In response to the study data and results, in October of 2019, the American Heart Association/American Stroke Association published the 2019 Updates to the Guidelines for the Early Management of Acute Ischemic Stroke, in which the window for mechanical thrombectomy expanded from the prior six-hour recommendation to up to 24 hours for LVO patients. However, even with the longer potential timeframe for mechanical thrombectomy, nearly two years later, many patients who could benefit from this therapy are still not receiving it. The question is, why?

Corazon believes the number-one reason is a lack of access. In many areas across the U.S., there are simply not enough established thrombectomy-capable centers to ensure availability to this life-saving, life-altering treatment.

Unlike the significant proliferation of percutaneous coronary intervention (PCI) centers that emerged across the country over the last 30 years, there has been a much slower rate of implementation for neurointervention. There are, of course, significant differences in the overall volume of patients who need PCI versus those who may need mechanical thrombectomy, though the similarities in these two procedures are many.

In 2018, there were approximately 965,000 PCI procedures performed in the U.S.;2 therefore, the approximately 2,600 PCI centers across the country make mathematical sense. When looking at potential volume for mechanical thrombectomy, the numbers are significantly smaller. There are roughly 800,000 strokes per year in the U.S., with 87% classified as ischemic in nature. This equates to about 696,000 ischemic-type strokes, and with the LVO incidence ranging from 24% up to 46%, the overall potential for mechanical thrombectomy is somewhere in the range of 167,000 to 320,000 patients annually who could benefit from receiving interventional treatment.3

However, annual U.S. thrombectomy volumes are not even close to 167,000 in number, the lowest end of the range for potential candidates. In 2016, there were only 13,010 thrombectomies completed, yet the stroke rate was not significantly less than that of today.4 The shorter six-hour window certainly played a part in the smaller volume, but even a shorter time window could not fully account for the low case volume performed. According to Mission Thrombectomy 2020+, a global non-profit committee of the Society of Vascular and Interventional Neurology (SVIN), the total number of thrombectomy procedures performed was estimated to be just under 40,000 in 2019.5 The numbers tell the story: we still have a long way to go in order to provide this beneficial and recommended treatment to all patients in need.

It is difficult to calculate the actual number of comprehensive stroke centers or thrombectomy-capable stroke centers, as there is not a nationally maintained list. A recently published study6 from the UT McGovern Medical School indicated that of the 1941 stroke centers in 2017, only 713 were able to perform mechanical thrombectomy, and only 19.8% of the U.S. population had direct access within 15 minutes to endovascular therapy or mechanical thrombectomy. Of those who had access within 30 minutes, there was just an incremental increase to 30.9% of the U.S. population.

In alignment with the researchers at UT McGovern and the Mechanical Thrombectomy 2020+ committee, Corazon strongly believes that there are two necessary, critical paths to increase access to treatment: (1) Implementing state-mandated bypass laws that direct EMS providers to take patients with suspected large-vessel occlusion strokes directly to a thrombectomy-capable stroke center, and (2) Increasing stroke program expansion in order to include thrombectomy services where community need, geography, or other factors indicate.

Get Ahead of Stroke, an organization founded by the Society of Neurointerventional Surgery (SNIS), is working to drive state legislative changes aimed at ensuring patients who screen positive for LVO in the field are transported to stroke centers with mechanical thrombectomy capability, even if that means bypassing a primary stroke center.

We repeatedly hear the phrase “Time is Brain,” and best-practice hospitals without thrombectomy services DO attempt timely patient transfer, but despite these efforts, studies have shown that patients transferred before thrombectomy have worse outcomes than those taken directly to a thrombectomy-capable center. In fact, a study from just last year concluded that patients with a suspected LVO should be redirected to a comprehensive stroke center if the additional delay to receiving an IV thrombolytic (tPA) is <30 minutes in an urban area and <50 minutes in a rural area.7

However, program expansion is still necessary across the country. In order for bypass laws to be effective for optimal treatment, there is still the need to implement more thrombectomy-capable centers. The UT McGovern researchers indicated that flipping 10% of the high-volume, non-thrombectomy stroke centers to thrombectomy-capable could result in an additional 23 million Americans having access within 15 minutes to this lifesaving treatment. That’s raising the total access from 19.8% to 27% of the population, a major improvement from today, though still not enough. Should we not be working towards providing this access to a very high majority, if not all, Americans?

We know from the many studies conducted that thrombectomy is the superior treatment for LVOs and is now considered the gold standard despite the still very limited availability. The outcomes speak for themselves: for every 100 patients treated with thrombectomy, approximately 40 patients will have a less disabled outcome than with intravenous thrombolysis (tPA), and nearly 23 patients more will achieve an independent outcome as a result of treatment.8

We should no longer sit back and view this lack of access as acceptable. As healthcare professionals, we need to advocate for what’s best for patients, therefore hospitals across the country need to be looking at the clinical, operational, and financial feasibility of implementing thrombectomy services. Programs that offer coronary intervention are already well-positioned to consider neuro-intervention. In fact, many sites have capitalized on the similarities between heart attack (myocardial infarction, MI) and brain attack (stroke), and have found ways to operationalize shared interventional space. This strategy is not without its challenges, but given the need to advance stroke care within the neuroscience service line, building from a foundation of excellence in cardiovascular intervention or surgery is a prime place to start.The country does not need as many neuro-interventional sites as cardiovascular, but even doubling the number of programs currently in place would not cover the current need; adequate access would still be lacking.

A degree of assessment is necessary to determine whether or not it is appropriate for a facility to implement thrombectomy services, as evaluation of the current stroke treatment infrastructure, the potential thrombectomy volume, the distance to other thrombectomy-capable centers and the ability to recruit the required manpower are essential to the process. Understanding the current market dynamics and the potential for case volume and future growth will set the stage for a successful interventional service. As certain coronary interventional cases move to the outpatient setting, some hospital-based labs could have capacity; backfilling with thrombectomy cases is one option to consider for optimized operational efficiency.

These next 10+ years will likely result in a large increase in stroke burden on hospitals, as most strokes afflict patients over the age of 65. Hospitals should start NOW to consider neuro expansion. As the Baby Boomer generation crosses the 65-year age threshold, the population of those at highest risk for stroke is only going to increase, with all of the members of that generation reaching this age bracket by 2030.

All of the industry statistics, clinical study results, and anecdotal and reported program data suggest that a future increase in the need for thrombectomy services is imminent. Hospitals that work now to consider this offering will be best positioned to handle the fast-emerging needs of their community. 

Michelle Luffey is a Sernior Consultant at Corazon, Inc., offering strategic program development for the heart, vascular, neuro, and orthopedic specialties. Corazon provides a full continuum of consulting, software solution, recruitment, and interim management services for hospitals, health systems and practices of all sizes across the country and in Canada.

To learn more, visit www.corazoninc.com or call (412) 364-8200. To reach the author, email mluffey@corazoninc.com

References
  1. Malhotra K, Gornbein J, Saver JL. Ischemic strokes due to large-vessel occlusions contribute disproportionately to stroke-related dependence and death: a review. Front Neurol. 2017 Nov 30; 8: 651. doi: 10.3389/fneur.2017.00651
  2. iData Research. Over 965,000 angioplasties (PCIs) are performed each year in the United States. Accessed May 21, 2021. Available online at https://idataresearch.com/over-965000-angioplasties-are-performed-each-year-in-the-united-states/
  3. Rennert RC, Wali AR, Steinberg JA, et al. Epidemiology, natural history, and clinical presentation of large vessel ischemic stroke. Neurosurgery. 2019 Jul 1; 85(suppl_1): S4-S8. doi: 10.1093/neuros/nyz042
  4. MacKenzie IER, Moeini-Naghani I, Sigounas D. Trends in endovascular mechanical thrombectomy in treatment of acute ischemic stroke in the United States. World Neurosurg. 2020 Jun; 138: e839-e846. doi: 10.1016/j.wneu.2020.03.105
  5. Hoffman M. The global push for mechanical thrombectomy in stroke care. NeurologyLive. December 31, 2020. Accessed May 24, 2021. Available online at https://www.neurologylive.com/view/the-global-push-for-mechanical-thrombectomy-in-stroke-care
  6. Sarraj A, Savitz S, Pujara D, et al. Endovascular thrombectomy for acute ischemic strokes: current US access paradigms and optimization methodology. Stroke. 2020 Apr; 51(4): 1207-1217. doi: 10.1161/STROKEAHA.120.028850
  7. Schlemm L, Endres M, Nolte CH. Bypassing the closest stroke center for thrombectomy candidates: what additional delay to thrombolysis is acceptable? Stroke. 2020 Mar; 51(3): 867-875. doi: 10.1161/STROKEAHA.119.027512
  8. Chen SY, Zhang XR, Chen J, et al. An overview of meta-analyses of endovascular bridging therapies for acute ischemic stroke. Biomed Res Int. 2018 Mar 7; 2018: 9831210. doi: 10.1155/2018/9831210