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How to Reverse Acute Ischemic Stroke

August 2018

By William Faloon

William Faloon
William Faloon

In 2018, the American Heart Association and the American Stroke Association released new guidelines that radically change the landscape of acute ischemic stroke treatment.1

The magnitude of this advance cannot be overstated.

Instead of suffering lifelong disability, one out of three stroke patients can now fully recover.2

We at Life Extension® applaud recognition of this game-changing technology. It will spare millions from permanent paralysis, nursing homes, and death.

Our issue with these “new” stroke-treatment guidelines is they could have been adopted sooner.

The technique announced this year involves threading a catheter into a blocked cerebral artery and mechanically removing the clot that is occluding blood flow. The medical term for this is:

Endovascular Thrombectomy

If this sounds familiar, it’s because we described it three years ago in this magazine and passionately argued for widespread use.3

The New England Journal of Medicine concurred with our position and criticized the lag in implementing this stroke-reversal treatment.4,5

My overriding concern is other effective therapies that people remain largely unaware of.

This means only scant fractions of the public gain access to lifesaving techniques.

The mission of Life Extension® is to keep our readers informed about novel approaches to disease prevention and treatment.

This article describes simple ways to reduce your risk of stroke and what to do if stroke symptoms manifest.

More than 2,000 Americans suffer a stroke on an average day.6

Some will recover with minor outward effects, while others endure paralysis and prolonged nursing-home confinement.

Most strokes happen when a blood clot blocks an artery that feeds a portion of the brain.7 As neurons die, the result can be paralysis, blindness, and cognitive dysfunction.8,9

Stroke is a leading cause of long-term disability in the United States. It’s the fifth leading cause of death.6

The tragedy is that many acute ischemic strokes can be reversed if thrombectomy intervention is delivered in a timely manner.10 This treatment should have become routine emergency room practice several years ago.

Evolving at a Snail’s Pace

The box on this page provides a succinct timeline of medical advances that enable doctors to dissolve or mechanically remove blood clots that occlude arteries in the heart and brain.

One of these involves a drug called tPA (tissue plasminogen activator) that can dissolve clots blocking arteries in the heart and brain.

The FDA approved tPA in 1987, but it could have been made available earlier.

Former talk-show host Larry King was saved from sudden death by tPA because he was fortunate to be taken to a hospital that was a clinical study center. After recovery, King asked why everyone was not given access to the tPA drug that saved his life.

When King learned the FDA was delaying approval of tPA, he launched a public relations campaign that, along with Life Extension, was harshly critical of the FDA holding back approval of this clot-dissolving drug.

Within six months, the FDA approved tPA to treat acute coronary artery occlusion.

It took another nine years before the FDA approved tPA to reverse cerebral artery blockage (ischemic stroke).

Stroke-Reversal Timeline
Stroke-Reversal Timeline
  • 1987 – Clot-dissolving drug (tPA) approved to reverse heart attack
  • 1996tPA approved to reverse acute ischemic stroke (three hours).
  • 1999Thrombectomy first shown to reverse acute stroke.
  • 2004FDA approves first thrombectomy device for stroke.
  • 2006Thrombectomy demonstrates partial safety and efficacy.
  • 2010 – Only 7% of acute stroke victims receiving tPA.
  • 2012tPA shown effective up to 4.5 hours after stroke onset.
  • 2015Thrombectomy effective up to six hours after stroke onset.
  • 2015New England Journal of Medicine advocates thrombectomy.
  • 2017 – Thrombectomy effective up to 24 hours after stroke onset.
  • 2018 – “New” guidelines urge thrombectomy up to 24 hours after.

Note the delay in incorporating tPA into standard practice whereby 14 years after FDA approval, less than 7% of stroke patients received this clot-dissolving drug in community hospitals. The safety and efficacy of thrombectomy was not fully demonstrated until 2015.11 Earlier studies with thrombectomy were not consistent, which is common with a medical device of this nature employed in emergency clinical settings.

Delay Extends Beyond FDA

I’ve authored numerous articles critical of FDA impediments that preclude timely introduction of lifesaving therapies.

The delay in bringing forth the clot-busting drug tPA and mechanical clot-retrieving thrombectomy, however, lies more with an apathetic (and overworked) medical establishment that is too slow in adopting better treatment methods.

Long after the FDA’s belated approval of tPA in 1996 to reverse ischemic stroke, less than 7% of potential stroke victims were administered the drug (as of year 2010).12

The lag time in implementing widespread use of mechanical clot retrieval (thrombectomy) is also troubling.

Despite inconsistent findings from initial thrombectomy trials using primitive techniques, by 2015 the evidence clearly demonstrated significant benefit over risk.11 Yet three years went by before conventional medicine formally adopted the procedure.

Every year, about 200,000 Americans are confined to nursing homes or rehabilitation facilities due to stroke-inflicted brain damage.13

A significant percentage of these miseries would have been avoided if tPA and thrombectomy had been instituted sooner by ER departments…long after the FDA’s belated approvals.

Huge Advance Announced in 2017

In findings presented at the European Stroke Organization Conference on May 16, 2017, researchers showed that thrombectomy (mechanical retrieval of cerebral blood clots) was effective up to 24 hours after stroke symptom onset.14-16

A scientist from the University of Pittsburgh Medical Center Stroke Center stated:

This is the largest treatment effect we have seen (in stroke).17

While this was hot news for the media, it was not to us at Life Extension.

That’s because we had made phone calls to Comprehensive Stroke Centers several years ago and were informed of successful acute stroke reversals long after conventional guidelines of six hours.

A list of comprehensive stroke centers and the names of hospitals offering these acute stroke reversal therapies may be found at: www.LifeExtension.com/stroke

A reason some stroke victims benefit from thrombectomy as long as 24 hours after acute arterial occlusion is a phenomenon known as “collateral circulation.” This enables a portion of the brain to be fed by multiple smaller blood vessels, even though a major cerebral artery is acutely blocked.

Research long ago demonstrated that brain cells survive far longer than what conventional medicine realizes, especially in the presence of lowered body temperature (hypothermia). But even warm ischemia research shows impressive findings.

American Stroke Victims Needlessly Confined to Nursing Homes
American Stroke Victims Needlessly Confined to Nursing Homes
  • An American experiences a stroke every 40 seconds.
  • Every four minutes an American dies of a stroke.
  • Stroke costs the United States $34 billion each year.
  • About 200,000 ischemic-stroke victims per year confined to nursing homes or rehabilitation facilities.

Three-year delay for the “new” stroke guidelines caused many Americans to suffer paralysis and nursing home confinement!


References:

Available at: https://www.cdc.gov/stroke/facts.htm. Accessed May 24, 2018.

Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb51.pdf. Accessed May 30, 2018

Victims of Delay

heart attack  

The new 2018 guidelines from the American Heart Association/American Stroke Association are welcome news to humanity and medical science.1

What they starkly reveal, however, is that large numbers of people have been permanently paralyzed (or have died) who could have been saved utilizing existing technologies (thrombectomy and/or tPA).

In other words, many stroke victims who were rushed to hospital emergency rooms were given up on too soon by medical personnel, who failed to realize the lifesaving advantages of aggressive use of tPA and/or thrombectomy.

For people in otherwise decent health, failure of hurried doctors to more aggressively attempt to remove (or dissolve) cerebral blood clots could result in years of paralysis in institutional confinement (or cemeteries).

A founding tenet of Life Extension is that humans in need are too often denied access to experimental and proven therapies. Our most powerful weapon to mitigate this crisis is to convey real-world solutions in the pages of this magazine.

Economic Consequences

Published studies have attempted to look at the cost effectiveness of administering tPA clot-dissolving drug therapy within 3 to 4.5 hours after stroke symptom onset.

Most of this data has been rendered obsolete by virtue of the expanded criteria for tPA efficacy and thrombectomy shown to be effective up to 24 hours after stroke symptom onset.18

One of these studies states that an estimated $74 billion was spent in year 2010 on stroke-related medical and disability costs. This same study points to the fact that tPA was approved in 1996, but is underutilized in the emergency room setting.19

In analyzing the clinically demonstrated benefits of tPA clot-dissolving therapy, the authors conclude that timely administration would result in more lives being saved, more quality-adjusted life years added, and some modest cost savings.

The burden to the healthcare system of crippling diseases caused by stroke is expected to increase over the coming decades due to the aging of the population and the underutilization of proven stroke-risk reduction factors (like keeping blood pressure in Life Extension’s recommended range).

As I and others have written, this nation has an unfunded liability for future sick-care costs that could render Medicare and other insurance programs financially insolvent.

When adding up the number of paralyzed stroke victims confined to nursing homes today, the savings per year should equal many $billions with widespread use of tPA/thrombectomy.

But there is an important caveat to potential cost savings that should be of particular interest to readers of this magazine.

Most severe strokes occur in elderly persons who suffer comorbidities and whose cardiovascular systems are already severely compromised. Attempting to calculate how many added healthy life years can be attained via increased use of tPA/thrombectomy is challenging because so many elderly stroke victims do not have long to live in the first place.

The bottom line for each of you is to proactively control your vascular risk factors by adhering as closely as possible to Life Extension’s optimal ranges for blood pressure, glucose, LDL, homocysteine, C-reactive protein, etc.20-22

As it relates to cost savings of enhanced tPA/thrombectomy treatments, data from healthier population groups (such as most readers of this magazine) are more compelling.23-25

Improved Standards for Acute Stroke Reversal

stroke  

About 300 hospitals around the country now use new automated brain imaging software (called RAPID) to identify patients who may be candidates for thrombectomy after their six-hour window has expired.2

The new RAPID software analyzes CT or MRI scan results to look at blood-flow levels in the brain. This allows doctors to determine if thrombectomy can help those who have blood-flow occlusion caused by acute clot.

The new guidelines recommend an increased treatment window for clot removal from six hours to 24 hours based on brain imaging in select patients. This enables expanded eligibility for clot-busting drugs and mechanical procedures like thrombectomy.

Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, commented on the new guidelines for expanding the window for thrombectomy use:

“I really cannot overstate the size of this effect. The study shows that one out of three patients are saved from the devastation of a stroke, and can walk out of the hospital, completely recovered… The results of the trial were astounding and will have an immediate impact in the clinic and will help us save many lives.”2
Succinct Review of New Guidelines
Succinct Review of New Guidelines

Medical practice has grown so sophisticated that the new American Heart Association stroke treatment guidelines stretch for 65 pages.

These kinds of complexities are why we try not to blame practicing physicians for their delays in implementing novel treatments.

What is needed is more doctors who highly specialize in single areas. As it relates to this topic, we need more specialists (vascular interventionists) capable of rescuing victims of acute ischemic stroke.

While the number of Comprehensive Stroke Centers has increased significantly over the past three years, there still are not enough masters of this emerging field of brain rescue.

Here is a succinct review of the new acute ischemic stroke guidelines:

Extending Time Window for Thrombectomy

The previous upper limit for thrombectomy intervention was only six hours, though more progressive stroke centers were going up to 12 hours based on what Life Extension’s investigators were told three years ago by practicing physicians.

The new (2018) guidelines increase the time from onset of acute ischemic stroke symptoms for mechanical thrombectomy from six hours to up to 24 hours.18

In the past, physicians recommended mechanical clot removal only for patients with large vessel strokes. This recommendation holds in 2018, but a team of experts that analyzed more than 400 published papers found that large vessel clots can be removed safely via mechanical thrombectomy for up to 16 hours after a stroke. In certain cases, this window of time extended up to 24 hours.28

According to William J. Power, M.D., who led a team of experts that authored these new guidelines:28

“The expanded time window for mechanical thrombectomy for appropriate patients will allow us to help more patients lower their risk of disability from stroke…That’s a big deal. That’s potentially a lot more people who could benefit, and it has completely changed the landscape of acute stroke treatment.”

Expanding Eligibility for tPA (clot-dissolving) Drug Therapy

The drug tissue plasminogen activator (tPA) was approved to treat acute ischemic stroke in 1996.29

Yet a study published in 2011 revealed that only 1%-3% of acute stroke patients were receiving tPA in community hospitals.30 (Slightly more stroke victims received tPA at major medical institutions.)

Previously, physicians avoided administering tPA to mild stroke patients. The 2018 guidelines reveal tPA to be helpful in a fraction of mild stroke victims, especially in reducing disability rates post-stroke.

The 2018 guidelines continue to recommend tPA for major stroke patients and suggest it also be administered to certain minor stroke patients within a three to 4.5-hour window of the stroke event.

According to Dr. Powers, these new tPA guidelines “potentially increase the number of people getting intravenousclot-busting treatment.”28

The 65 pages of new guidelines also advocate for better certification of stroke centers, something that Life Extension also advocated for years, but without a high degree of confidence due to the limited number of physicians trained in this (thrombectomy) procedure.31

Interestingly, the American Heart Association has allied with other conventional authorities to create a new level of hospital certification titled Thrombectomy-Capable Stroke Centers.

This takes the place of “Comprehensive Stroke Center” and seeks to identify hospitals that meet rigorous standards for performing mechanical endovascular thrombectomy.

We applaud this enhanced certification program.

What Took So Long?

What Took So Long?  

We at Life Extension cannot express enough gratitude to the scientific community for these life-sparing medical advances.

Our ongoing concern, however, is the sluggish pace at which innovation translates into clinical practice.

From what the medical establishment now acknowledges, over two million American lives could have been spared the disabling miseries of stroke-induced paralysis (and death) if tPA and enhanced-thrombectomy interventions had been advanced sooner.

These kinds of delays impacting the health and longevity of Americans today are not unique to stroke. I am currently investigating numerous interventions to delay if not reverse biological aging. Yet obstacles to moving discoveries into the clinical setting remain daunting.

The excuses I hear for foot dragging are eerily reminiscent of what caused so few ER physicians (less than 7% by year 2010) to utilize tPA, and even fewer to attempt thrombectomy. Recall the FDA approved tPA for acute stroke in 1996.

We acknowledge side-effect concerns with tPA such as excessive bleeding. But when a stroke patient lies in an emergency room, and the treating physician does nothing but watch the patient slowly undergo permanent paralysis, we think the risk-to-benefit ratio should be revised.

Stroke

In the United States, a person has a stroke every 40 seconds and 87% of them—roughly 700,000 cases per year—are ischemic, which refers to a blockage within an artery supplying blood to the brain.32

The remaining 13% of strokes occur when a blood vessel in the brain ruptures and blood accumulates in the brain.

One out of three ischemic strokes can be effectively treated with thrombectomy or tPA drug therapy.2

There are other endovascular procedures that can save victims of certain forms of hemorrhagic (bleeding) strokes.

Stroke Prevention Far More Effective

Stroke Prevention Far More Effective  

While treatment advances that have occurred since 1987 in reversing occlusive arterial disease are impressive, it is far more efficient to protect against it.

Ischemic strokes are caused by blood clots that form in an artery feeding the brain (thrombotic stroke) OR when a blood clot forms elsewhere in the body and travels to a cerebral artery (embolic stroke).26

Narrowing of arteries feeding the brain can create acute or chronic blockages of blood flow.

Atrial fibrillation is a common cause of embolic strokes, which is why powerful anticoagulant drugs are prescribed to people with certain heartbeat irregularities. These drugs have side effects, but the data show the antithrombotic benefits outweigh the increased bleeding risks.

When one realizes that formation of abnormal blood clots (thrombosis) in arteries and veins represents a major health threat, one can understand the importance of proactively maintaining healthy circulatory function.

On page 52, you can read a reprint from a front-page article on stroke reversal published this year in the Wall Street Journal. The first article in this month’s issue describes a new spearmint tea that has been shown to provide an immediate boost in mental focus, attention, and concentration.27

For longer life,

For Longer Life

William Faloon, Co-Founder

Life Extension Buyers Club

References

  1. Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018;49(3):e46-e110.
  2. Available at: https://www.nbcnews.com/health/aging/new-stroke-guidelines-extend-time-frame-life-saving-treatment-n840771. Accessed May 24, 2018.
  3. Available at: http://www.lifeextension.com/Magazine/2015/9/Reversing-Acute-Ischemic-Stroke/Page-01. Accessed May 24, 2018.
  4. Berkhemer OA, Fransen PS, Beumer D, et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):11-20.
  5. Hacke W. Interventional thrombectomy for major stroke--a step in the right direction. N Engl J Med. 2015;372(1):76-7.
  6. Available at: https://www.cdc.gov/stroke/facts.htm. Accessed May 24, 2018.
  7. Available at: https://www.cdc.gov/stroke/types_of_stroke.htm. Accessed May 24, 2018.
  8. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Post-Stroke-Rehabilitation-Fact-Sheet. Accessed May 24, 2018.
  9. Available at: https://www.nhlbi.nih.gov/health-topics/stroke#Signs,-Symptoms,-and-Complications. Accessed May 24, 2018.
  10. Available at: https://www.npr.org/sections/health-shots/2017/05/01/525896731/a-lazarus-patient-and-the-limits-of-a-lifesaving-stroke-procedure. Accessed May 24, 2018.
  11. Balasubramaian A, Mitchell P, Dowling R, et al. Evolution of Endovascular Therapy in Acute Stroke: Implications of Device Development. J Stroke. 2015;17(2):127-37.
  12. Johnson M, Bakas T. A review of barriers to thrombolytic therapy: implications for nursing care in the emergency department. J Neurosci Nurs. 2010;42(2):88-94.
  13. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb51.pdf. Accessed May 30, 2018.
  14. Caso V, van der Worp HB, Fischer U. European Stroke Organizational Report. Stroke. 2017;48(8):e195-e6.
  15. Available at: https://www.stroke.org.uk/news/highlights-day-one-european-stroke-organisation-conference. Accessed May 30, 2018.
  16. Available at: https://eso-stroke.org/eso/data-highlights-opening-plenary-esoc-2017/. Accessed May 30, 2018.
  17. Available at: https://www.wsj.com/articles/new-research-on-strokes-extends-window-for-treatment-1494928980. Accessed May 30, 2018.
  18. Available at: http://hartvision.com/latest-stroke-research/. Accessed May 24, 2018.
  19. Boudreau DM, Guzauskas GF, Chen E, et al. Cost-effectiveness of recombinant tissue-type plasminogen activator within 3 hours of acute ischemic stroke: current evidence. Stroke. 2014;45(10):3032-9.
  20. Available at: http://www.lifeextension.com/Magazine/2009/5/Heart-Attack-Risk-Factors/Page-01. Accessed May 24, 2018.
  21. Available at: http://www.lifeextension.com/Magazine/2011/1/Glucose-The-Silent-Killer/Page-01. Accessed May 24, 2018.
  22. Available at: http://www.lifeextension.com/Magazine/2018/3/As-We-See-It/Page-01. Accessed May 24, 2018.
  23. Villwock MR, Singla A, Padalino DJ, et al. Acute ischaemic stroke outcomes following mechanical thrombectomy in the elderly versus their younger counterpart: a retrospective cohort study. BMJ Open. 2014;4(3).
  24. Steen Carlsson K, Andsberg G, Petersson J, et al. Long-term cost-effectiveness of thrombectomy for acute ischaemic stroke in real life: An analysis based on data from the Swedish Stroke Register (Riksstroke). International Journal of Stroke. 2017;12(8):802-14.
  25. Baek JH, Yoo J, Song D, et al. Predictive value of thrombus volume for recanalization in stent retriever thrombectomy. Sci Rep. 2017;7(1):15938.
  26. Available at: http://www.mayoclinic.org/diseases-conditions/stroke/symptoms-causes/syc-20350113. Accessed May 23, 2018.
  27. Herrlinger KA, Nieman KM, Sanoshy KD, et al. Spearmint Extract Improves Working Memory in Men and Women with Age-Associated Memory Impairment. J Altern Complement Med. 2018;24(1):37-47.
  28. Available at: https://newsroom.heart.org/news/more-stroke-patients-may-receive-crucial-treatments-under-new-guideline. Accessed May 24, 2018.
  29. Zivin JA. Acute stroke therapy with tissue plasminogen activator (tPA) since it was approved by the U.S. Food and Drug Administration (FDA). Ann Neurol. 2009;66(1):6-10.
  30. Meurer WJ, Majersik JJ, Frederiksen SM, et al. Provider perceptions of barriers to the emergency use of tPA for acute ischemic stroke: a qualitative study. BMC Emerg Med. 2011;11:5.
  31. Gatto LAM, Koppe GL, Demartini ZJ, et al. Physicians are not well informed about the new guidelines for the treatment of acute stroke. Arq Neuropsiquiatr. 2017;75(10):718-21.
  32. Benjamin EJ, Virani SS, Callaway CW, et al. Heart Disease and Stroke Statistics—2018 Update: A Report From the American Heart Association. Circulation. 2018.
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