Blood clot facts relevant to the 2016 Presidential campaign

There is one issue which has not yet received much scrutiny during the primary season which is sure to gain focus during the general election–the physical fitness of each candidate.  If elected, Trump would become our oldest President while Clinton would become the first Commander-in-Chief on long-term anticoagulation to prevent the recurrence of venous blood clots. While there was a time when the health of a candidate was considered too personal to broach, in this election season where the most personal of attacks are the norm, pre-existing conditions will certainly be on the table for discussion.

Clinton has the largest elephant in the room with three documented clotting events—in 1998, 2009 and 2012; according to the statement of health issued by her personal physician.(REF 1)  I’ve read much mis-information about these events…most people don’t appreciate the nuances between various types of blood clots (arterial, venous), their location (leg, lung, brain, etc), the various treatment options, risk factors for recurrence, etc. And when we inevitably hear the clotting history brought up again during the general campaign, we are sure to hear even more mis-information.  So I’m going to lay out some facts about these types of blood clots now and connect it to what is known about Clinton’s clotting experience.

Blood clots defined

For greater understanding, let’s get a few basics out of the way first.   Arteries are the blood vessels that carry blood away from the heart to the extremities.  Veins are the blood vessels which carry blood back to the heart from the extremities.

Clots in arteries and veins are different.  Blood clots which form in arteries lead to stroke, TIA (mini-stroke), heart attack (myocardial infarction), and peripheral arterial clots.  Blood clots which form in veins lead to venous thromboembolism (VTE) (2). VTE is the broad term which encompasses clots which form in a deep vein of the body and they may go by several names, depending on the location of the clot:  deep vein thrombosis (DVT), pulmonary embolism (PE), sinus vein thrombosis (SVT), cerebral vein thrombosis(CVT), portal vein thrombosis (PVT), mesenteric vein thrombosis (MVT).  Clots in arteries and clots in veins have different risk factors, treatments and risks for recurrence.

  • Note that each of Clinton’s clots have been in a vein:  2 DVT and 1 SVT.   Importantly, contrary to some misinterpretations, not all clots in the brain are stroke.  A SVT (sinus vein thrombosis) is NOT the same as stroke (stroke is an arterial clot) nor does it occur in the sinuses!  The ‘sinus vein’ is a deep vein in the brain.(15)SVT is therefore a venous clot (VTE).

Around 900,000 Americans a year are diagnosed with VTE, according to the CDC.(2)  VTE is the third leading cause of death, with an estimated 300,000 deaths annually.(16) VTE can happen to anyone—from young athletes and pregnant women to cancer patients and the elderly. There are identifiable risk factors for VTE such as recent hospitalization, cancer, pregnancy, hormone replacement therapy, long-distance travel, clotting disorders, past history of clot. More information and statistics can be found at the end of this article, but for now let’s simply establish that VTE is a serious, sudden, potentially life-threatening condition with long-term health and psychological implications.(3)

Risk of recurrence

The statistics are unnerving—around 30% of patients die within the first 3 months following diagnosis of VTE, most deaths are immediate with no warning.(4) Once you have a VTE, you are at increased risk for another.  Repeat clotting episodes are not unusual—nearly half of VTE survivors will experience another clot within ten years.(5)  Clinton’s history of 3 clots within 13 years exemplifies this increased threat rather well.

HRC lovenoxThe release of Clinton’s emails earlier this year provided some detail on how she has previously managed her clot risk.  A December 22, 2011 email from aide Huma Abedin to Clinton while she was traveling in Prague reminders her to take Lovenox.(17) Lovenox is the brand name for a low-molecular weight herparin which goes by the generic name enoxaparin, an injectible anticoagulant (blood thinner). Taking an anticoagulant during higher clot risk situations (like long-distance travel) as a prophylaxis is not unusual for persons with a previous VTE history.

Post-thrombotic limitations

Around half of deep vein thrombosis survivors will experience some level of post-thrombotic complication due to blood vessel damage caused by the clot, such as chronic pain, swelling and reduced mobility.(5)  For most patients, these long-term effects mainly pose mild to moderate quality of life effects. However, for around 10% of patients, complications can be severe and disabling.(6) It is unknown if Clinton experiences any post-thrombotic issues; none have been mentioned.

Almost 80% of patients with sinus or cerebral vein thrombosis fully recover (Ref 14) while around 50% of deep vein thrombosis patients recover without chronic issues (Ref 15).

Treatment risks

While effective strategies exist to treat and prevent clots, none are fully benign and without risk. Clinton takes an anticoagulant medication (sometimes referred to as a ‘blood thinner’) to prevent a clot recurrence.  While these medications are truly life-saving, they also come with their own worrisome issues, namely an increased risk of bleeding.  Anticoagulants increase the time it takes for the blood to form a clot; which is a desirable thing if the goal is to prevent a VTE from forming. Yet, there are situations when we need our blood to clot quickly, such as with injury.

All anticoagulants increase the risk for bleeding, but the level of this risk varies depending on the specific drug.  Clinton’s physician says she currently takes warfarin (Coumadin) which has a bleeding frequency of 15-20% per year and a life-threatening bleeding rate of 1-3% per year.(7) Managing anticoagulation well is crucial to avoid such complications.  Unfortunately, warfarin is notoriously difficult to manage because its blood thinning effect is highly influenced by diet, medications and lifestyle factors. For this reason, frequent blood testing and dosage changes are necessary to ensure just the right balance of drug.  Too little drug metabolized puts one at increased risk of clotting while with too much, one is at higher risk of bleeding.(8)

There are four additional oral anticoagulants which have been FDA approved in recent years as alternatives to warfarin to treat and prevent VTE.(9) While they are easier to manage than warfarin, these too come with their own unique risks, namely that for 3 of the 4, no FDA approved reversal agent currently exists in the event of a major, life-threatening bleed.  So the choice of treatment for patients like Clinton is not an easy one—an established, but  finicky drug that is difficult to manage or an easy-to-manage drug which is so new that it has no reversal agent.   And with all choices, a risk of bleeding and clotting remains.  No drug is a 100% sure fire bet.

Psychological impact

High levels of anxiety, depression and psychological stress have been reported among patients with VTE.(3)   Numerous studies have found that the psychological consequences of experiencing VTE are considerable and it is no wonder given the many fears associated with diagnosis, cause, recurrence, bleeding, impact on family, coupled with any chronic complications or clotting disorders.(10)  I have published work in this area, writing for the medical journal Circulation that “it is normal to feel shock, anxiety and fear following the diagnosis of a blood clot.”(11)  How an individual responds to their VTE event and treatment regime is as variable as the type of persons who experience VTE.  For some patients, VTE is perceived as ‘no big deal’; for others, it is a life-altering event. What is Clinton’s patient perspective? We don’t know, she has not publicly talked about her clot experience.

Inaccuracy of medical statement

HRC health letter snipMuch of what we know about Clinton’s clot history comes from her physicians medical statement, released by the Clinton campaign in July 2015.  It should be noted that one detail in thepublic letter  is inaccurate.  In detailing the 2012 episode, Dr. Lisa Bardack says

“Mrs. Clinton was found to have a transverse sinus venous thrombosis and began anticoagulation therapy to dissolve the clot.

The problem with this statement is that anticoagulants DO NOT dissolve blood clots. Anticoagulants prevent existing clots from growing larger and new clots from forming. It is the body itself which, over time, naturally breaks down blood clot material. Put differently…As I wrote in the peer-reviewed medical journal Circulation:

Anticoagulants  “increase the time it takes for blood to clot. They prevent new clots from forming and existing clots from growing larger. Anticoagulants do not dissolve a clot. The body naturally dissolves a clot over time, sometimes completely, sometimes only partially.” (11)

Clot-dissolving drugs do exist, called thrombolytics. For venous clots,  a fibrinolytic drug is given via an intravenous line. (14)  There is nothing in Dr. Bardack’s statement referencing such fibrinolytic drugs, only anticoagulants. This is not surprising because fibrinolytic drugs are typically not used in cerebral or sinus vein thrombosis (the type of clot which Mrs Clinton had in 2012) due to the risk of bleeding in sensitive brain tissue.(15)

As I have written, once again in the peer-reviewed medical journal Circulation, on this very topic of treatment of sinus vein thrombosis: “Clot busting drugs (known as fibrinolytic drugs) are typically not given, because they may increase the risk of bleeding into the brain. Radiological or surgical procedures with catheters to break up and extract the clot (called thrombectomy and endovascular therapy) are done only in severe cases and in patients who get worse despite adequate blood thinning therapy.”) (15)

Therefore the statement that “Mrs. Clinton was found to have a transverse sinus venous thrombosis and began anticoagulation therapy to dissolve the clot” is inaccurate.

Policy implications

If Clinton were President, would this have an impact on funding for blood clot education and research?  Let’s look at the past as a guide.

The Surgeon General in a 2008 Call to Action identified VTE as “a major health problem, exacting a significant human and economic toll on the Nation“. (4) The report said few problems are as serious as VTE, yet there was low public awareness and clinician adherence to effective prevention and treatment strategies.  The report laid out a blueprint for change to serve as a catalyst for future VTE policy activity.

Unfortunately, little happened after the Surgeon General’s report was released, especially in the priority area of federal funding.  President Obama’s Fiscal Year 2017 budget proposal includes no named funding at all to address VTE.(12) By comparison, a more publicly aware condition such as HIV/AIDs gets a $3.3 billion allocation yet there is not a single budgetary mention of VTE which kills more Americans annually than AIDs, breast cancer and car crashes COMBINED.(13)

Could Clinton play a key role in changing that funding inequality?  Perhaps, but we’ve not witnessed this during past opportunities. Clinton’s first clot occurred in when she was First Lady.  Her second episode occurred the year she transitioned from the US Senate to the State Department.  Her third VTE episode happened while she was Secretary of State.  All of Clinton’s clots occurred while she held positions of great public influence.  It could be argued that if at any of those junctures, she had stepped up to share her clotting experience in a public way, perhaps even become a VTE advocate and encouraged Congress or the President to increase funding, millions of lives could have potentially been positively impacted or saved. Whether she might advocate differently as President is unknown.

The mere presence of a Commander-in-Chief on anticoagulation with a clotting history may help change federal viewpoints related to military members with similar clotting concerns. Hypercoagulable states which require chronic anticoagulation are grounds for service members to be classified nondeployable, thus impacting their ability to remain on active duty status.(29) If Clinton’s example increases awareness of blood clots, there is the potential to educate and change individual perceptions of what is considered acceptable risk for anticoagulated persons.

It is also unlikely that Former President Bill Clinton would take advantage of renewed public spotlight to advocate for VTE as he has intentionally avoided the topic when given past good opportunities with speeches and foundation work.

Conclusion: Past Presidents & Vice-presidents with Clots

PresidentsClotHistoryI hope this has provided some fact based perspective to a topic which I suspect will be given more attention prior to the general election.  As a VTE survivor on long-term anticoagulation myself, it is of course difficult for me to be objective–it’s something I live with daily.  I personally would very much like to see Clinton speak up about her clot experience and advocate for patients, help bring about a VTE funding line-item in the federal budget, and push for more coordinated federal efforts…but realistically, I just don’t think that’s going to happen.

Interesting side note: Clinton is not the first politician with a VTE history–Richard Nixon (1965 & 1974) and Dick Cheney (2007) are two with a DVT history that immediately come to mind, Dan Quayle had a pulmonary embolism (1994) and Teddy Roosevelt died of a pulmonary embolism (1919).  Nor would Clinton be the first anticoagulated President–Eisenhower was treated with warfarin in1955 following a heart attack (arterial clot) andGeorge HW Bush was placed on warfarinto manage atrial fibrillation in 1991 (to prevent stroke/arterial clot). Clinton would however be the first (to my knowledge) President with a SVT history on long-term anticoagulation.

 


Facts about VTE

VTE is a leading cause of death and disability:

  • Over 900,000 Americans have a VTE event each year and it causes more deaths than breast cancer, AIDS and car crashes combined.(18, 19)
  • VTE is the third leading cause of death, but is not widely known because VTE is excluded from CDC Vital Statistic reports which reflect only 113 select causes of death.(20)
  • Upwards of a third of VTE patients die within one month of diagnosis.(21)
  • Even with optimal medical care, half of VTE patients will have long-term complications and one-third will have a recurrent clot within 10 years.(22)
  • VTE is the leading cause of preventable hospital deaths in the United States. ~60% of VTE are associated with hospitalization.(23)
  • VTE is the leading cause of maternal death in the United States.(24)
  • An estimated $7-12 billion in medical costs in the US each year can be attributed to DVT and PE.(25)
  • High levels of anxiety, depression and psychological stress have been reported among patients with VTE.(26)

By comparison to other better known conditions:

  • AIDS funding = $31.7 billion[11], CDC portion of AIDS funding = $927.8 million(27)
  • Breast & cervical cancer funding (in 1 combined line-item), CDC = $169 million

References 

  1. Clinton physician letterJuly 28, 2015
  2. CDC statisticshttp://www.cdc.gov/ncbddd/dvt/data.html
  3. Simon Noble “Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study” BMJ Open http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987719/
  4. 2008 Surgeon General Call to Action reporthttp://www.ncbi.nlm.nih.gov/books/NBK44178/pdf/Bookshelf_NBK44178.pdf
  5.  Beckman MG, Hooper WC, Critchley SE, Ortel TL. Venous thromboembolism: a public health concern.Am J Prev Med. 2010 Apr;38(4 Suppl):S495-501. http://www.ncbi.nlm.nih.gov/pubmed/20331949
  6. Clive Kearon, Natural history of VTE, Circulation http://circ.ahajournals.org/content/107/23_suppl_1/I-22.full
  7. US National Action Plan for Adverse Drug Events, page 50-51, http://www.health.gov/hcq/pdfs/ADE-Action-Plan-Anticoagulants.pdf
  8.  Munir Pirmohamed,  Warfarin:  almost 60 years old and still causing problems. Br J Clin Pharmacol.http://circ.ahajournals.org/content/107/23_suppl_1/I-22.full
  9. Calvin Yeh Evolving use of new oral anticoagulants for treatment of venous thromboembolism Blood Journalhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4133479/
  10. Waldron, Psycological impact of VTE,UNC,Clot Connecthttp://professionalsblog.clotconnect.org/2012/02/28/psychological-impact-of-dvt-and-pe/
  11. Beth Waldron, Stephan Moll  A patients guide to recovery after deep vein thrombosis or pulmonary embolism Circulation 2014; 129: e477-e479
  12. http://www.whitehouse.gov/omb/budget
  13. http://www.cdc.gov/fmo/topic/Budget%20Information/appropriations_budget_form_pdf/FY2016_CDC_CJ_FINAL.pdf
  14. Radha Krishna Popuri, Suresh Vedantham “  The Role of Thrombolysis in the Clinical Management of Deep Vein Thrombosis ”  Arteriosclerosis, Thrombosis, and Vascular Biology.
    2011; 31: 479-484
  15. Stephan Moll, Beth Waldron “Cerebral and sinus vein thrombosis” Circulation,  2014;130:e68-e70
  16. Selective statistics diminish VTE burden https://bethwaldron.com/selective-statistics-diminish-vte-burden/
  17. Email December 22, 2011 https://wikileaks.org/clinton-emails/emailid/24804
  18. CDC Statistics on DVT/PE (VTE) http://www.cdc.gov/ncbddd/dvt/data.html
  19. 2008 Surgeon General Call to Action reporthttp://www.ncbi.nlm.nih.gov/books/NBK44178/pdf/Bookshelf_NBK44178.pdf
  20. Selective statistics diminish VTE burden https://bethwaldron.com/selective-statistics-diminish-vte-burden/
  21. CDC Data and Statistics, DVT/PE, 12/4/2015 http://www.cdc.gov/ncbddd/dvt/data.html
  22. Beckman MG, Hooper WC, Critchley SE, Ortel TL. Venous thromboembolism: a public health concern.Am J Prev Med. 2010 Apr;38(4 Suppl):S495-501.  http://www.ncbi.nlm.nih.gov/pubmed/20331949
  23. AHRQ, Preventing Hospital Associated Vhttp://cpol.army.mil/library/mobil/docs/CEW-Guide-Attach-IX-C.pdfenous Thromboembolism: A Guide for Effective Quality Improvement, October 2015, Publication: 16-0001-EF  http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/vtguide/index.html and Greg Maynard, Venous Thromboembolism (VTE) Prevention in the Hospital (Text Descript: Slide Presentation. June 2010. Agency for Healthcare Research and Quality, Rockville, MD.http://archive.ahrq.gov/professionals/quality-patient-safety/quality-resources/value/vtepresentation/maynardtxt.html
  24.  Berg CJ, Atrash HK, Koonin LM, Tucker M. “Pregnancy-related mortality in the United States 1987-1990”. Obstet Gynecol 1996;88(2):161-7 Also see Marik. P.E. and Plante, L.A. “Venous Thromboembolic Disease and Pregnancy”. New England Journal of Medicine, volume 359, number 19, November 6, 2008, pages 2025-2033
  25. Gross, Scott et al The economic burden of incident venous thromboembolism in the United States: A review of estimated attributable healthcare costs, Thrombosis Research, November 24, 2015,  http://www.thrombosisresearch.com/article/S0049-3848(15)30209-7/abstract
  26. Simon Noble “Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study” BMJ Open http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987719/
  27. CDC FY 2016 budgethttp://www.cdc.gov/fmo/topic/Budget%20Information/appropriations_budget_form_pdf/FY2016_CDC_CJ_FINAL.pdf CDC FY 2017 Request http://www.cdc.gov/budget/fy2017/congressional-justification.htm
  28. Kaiser Family Foundation U.S. Federal Funding for HIV/AIDS: The President’s FY 2016 Budget RequestApr 13, 2015 http://kff.org/global-health-policy/fact-sheet/u-s-federal-funding-for-hivaids-the-presidents-fy-2016-budget-request/#footnote-148589-1
  29. Army policy: http://cpol.army.mil/library/mobil/docs/CEW-Guide-Attach-IX-C.pdf

 

 

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