25 November 2019 Blog Post: You May Have Missed It: Implications from the ISCHEMIA Trial

25 November 2019 Blog Post: You May Have Missed It: Implications from the ISCHEMIA Trial

It’s understandable if you were otherwise occupied, as it seemed to be a busy news week, but last Saturday the American Heart Association met in Philadelphia where primary outcomes were presented from the much anticipated ISCHEMIA trial.

US taxpayers footed the $100 million bill and 10 years of research for “The International Study of Comparative Health Effectiveness With Medical and Invasive Approaches” the goal of which was to “establish whether a strategy of revascularization with percutaneous coronary intervention (PCI) or surgery, if feasible, results in fewer adverse cardiovascular events than optimal medical therapy alone in patients with stable moderate-to-severe ischemia.”

What did I pay for? In English please?
 
First, a couple of definitions:
1. PCI (percutaneous coronary intervention): a procedure used to open clogged heart arteries. A tiny balloon catheter is inserted in a blocked blood vessel to help widen it and improve blood flow to your heart.
2. Stent: made of metal or plastic, these are placed during PCI. Most stents used today are coated with a medication to help keep the artery open (drug eluting stents).
3. Statin: medications that can lower cholesterol. They work by lowering your body’s production of cholesterol.
4. Sham surgery: also termed placebo surgery and it is an intervention that omits the step thought to be therapeutically necessary.
 
Now lets move to some history. Way back in 1999, the AVERT study (Cardiologists seem to have a knack for acronyms in addition to their clinical talents – Atorvastatin VErsus Revascularization Treatment) was published in the New England Journal of Medicine by Dr Bertram Pitt and colleagues, with the hypothesis that “aggressive lipid lowering with atorvastatin appears to be as safe and as effective as angioplasty and usual care in reducing the incidence of ischemic events.” (Note: the brand name of atorvastatin is Lipitor and it is a statin / cholesterol lowering medication). Here were the first data suggesting that opening up a clogged heart artery in patients with stable symptoms may not improve future health outcomes. Critics bemoaned the small sample size (341 patients) and the fact that some participants had such minor disease burden that they didn’t even have symptoms. (We will ignore the fact that in 2004, 85% of all stenting procedures were performed in patient with stable coronary artery disease).
 
Fast forward to 2007 (still eons ago – I was a medical resident), Boden et al published the COURAGE study (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). In this study they found that placing a stent (the small mesh tube defined above) in a narrowed artery of the heart to help keep it open did not work better than medications. It was known at that point that stenting reduced the incidence of death and subsequent heart attacks in patients who presented with acute coronary syndrome (i.e. active heart attack symptoms) but similar benefit had not been shown in patients with stable coronary artery disease
 
However, the study led to massive criticism, and proper use of stents has since then become one of the most heated debates in medicine. Why? As eloquently stated by Carolyn Y. Johnson of the Washington Post, it is because so much is at stake. “Coronary heart disease affects 17.6 million Americans; companies that make stents are multibillion-dollar enterprises; the procedures are a major income stream to interventional cardiologists and hospitals; and many people who have stents credit their good health to the procedure.” (https://www.washingtonpost.com/…/embargoed-drugs-are…/)
 
One of my favorite studies in this field was published in 2017 by lead investigator Dr Rasha Al-Lamee (Imperial College London, UK) and colleagues. Called ORBITA (Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina), this UK based study sought to highlight the effect of stenting by adding a study group that had a ‘sham’ procedure. In other words, some patients underwent an apparent intervention but no stent was placed. Among patients with stable angina, even with severe coronary stenosis, exercise capacity and symptom relief were no better after PCI for single-vessel disease than a sham procedure. Dr. Robert Yeh seemed to echo the general reaction by saying, “To extrapolate that this means that elective PCI is not an indicated procedure is the furthest overreach that I can possibly imagine from a very small and I think hypothesis-generating trial with an interesting result.”
 
So last week’s ISCHEMIA results represent the “latest entry into a long and contentious argument over how to treat artery blockages, one that has pitted powerful factions of American heart specialists against each other” (Johnson; Washington Post). Check out #cardiotwitter for the debate in real time. But at its essence, not much has changed since 1999 as PCI and medical management are not mutually exclusive. Either can be employed in the correct patient context and, now, there is a better defined framework to discuss risks and benefits.
 
The best summary and contextualization that I could find on these findings, actually was from 2007 relating to the COURAGE trial. Dr. Eric Topol (a true thought leader in Cardiology and Medicine from Scripps Translational Science Institute, La Jolla, CA) reflected that these types of findings are neither new nor unexpected. “PCI has never been shown to reduce death or MI compared with medical therapy, COURAGE really does not present anything new but simply reinforces that the basis for revascularization is for control of ischemia. There is no surprise with this trial.”
 
No real surprise either with ISCHEMIA. But, no doubt, the debate will rage on.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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10 November 2019 Blog Post: A Post on Vaping and Vitamin E.

10 November 2019 Blog Post: A Post on Vaping and Vitamin E.

On September 5th, 2019 a short report from The New York State Department of Health announced findings from its ongoing investigation into the vaping-associated pulmonary (lung-related) illnesses. It showed very high levels of vitamin E acetate in nearly all cannabis-containing samples analyzed.

At that point in September, there had been 34 reports from New York State physicians of severe pulmonary illness among patients ranging from 15 to 46 years of age who were using at least one cannabis-containing vape product before they became ill. At least one vitamin E acetate containing vape product had been linked to each patient.

Yesterday – November 8th, 2019, the CDC announced that they detected Vitamin E acetate in every single sample from 29 patients with e-cigarette/vaping product use-associated lung injury (EVALI) . Vitamin E acetate is used as an additive in the production of e-cigarette, or vaping, products. During the press briefing, CDC’s Dr. James Pirkle described vitamin E acetate as “enormously sticky” when it goes into the lungs, and it “does hang around.”

Why in the world would Vitamin E be added to vape products? And isn’t Vitamin E just an innocuous Vitamin?

Vitamin E acetate is indeed a commonly available nutritional supplement that is not known to cause harm when ingested as a vitamin supplement or applied to the skin. However, is also used as an additive in the production of e-cigarette, or vaping, products, because it resembles THC oil. Vitamin E acetate is also used as a thickening ingredient in e-liquids. Of interest, Vitamin E acetate is not an approved additive for New York State Medical Marijuana Program-authorized vape products.

To add to the public health consequences of EVALI, a recent @jamanetwork article showed that more than 25% of high school students in the United States are vaping and 10% are doing so regularly. To date, there have been 2,051 cases of EVALI, reported in every state, except for Alaska, as of November 5. There have been at least 40 deaths.

As a result, vitamin E acetate is now a key focus of the CDC investigation of potential causes of vaping-associated pulmonary illnesses. They will continue investigate its health effects when inhaled because its oil-like properties could be associated with the observed symptoms.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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9 November 2019 Social Media Post: Effective treatment of midlife hypertension

9 November 2019 Social Media Post: Effective Treatment of Midlife Hypertension

Fascinating The Lancet Neurology article showing that effective treatment of midlife hypertension can reduce the risk of Alzheimer Disease by 16% and overall dementia by 12%.
 

Meta-Analysis: Hypertension Treatment Tied to Lower Risk for Dementia, Alzheimer's

By Amy Orciari Herman

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

 

Antihypertensive treatment is associated with lower risk for dementia in older adults with high blood pressure, a meta-analysis in the Lancet Neurology finds.

Researchers combined data from six prospective studies comprising over 30,000 adults aged 55 and older who were dementia-free at baseline. During a median follow-up of 7 to 22 years, roughly 3700 developed dementia, nearly half of whom developed Alzheimer disease.

Among participants with hypertension, those who used any antihypertensive agent had a 12% lower risk for dementia and a 16% lower risk for Alzheimer’s relative to those not using antihypertensives. No antihypertensive class emerged as superior to others.

Antihypertensive treatment was not associated with reduced dementia risk among participants with normal or pre-hypertensive blood pressure. This group probably included patients with well-controlled hypertension.

Commentators say that with these data, taken together with other analyses, “there is now persuasive evidence for a beneficial effect of blood pressure lowering on cognitive function from treatment initiated in midlife.”

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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7 November 2019 Appreciation Post

7 November 2019 Blog Post: Self Reflection on my Fall and Appreciation Post

I wanted to thank my patients (and staff!) for bearing with my abbreviated schedule the past two weeks. On Monday, October 28th, I fell off a ladder in an ill guided attempt to string garden hoses in the midst of the #gettyfire.

It has led me to some interesting (and literally painful reflective) research on the epidemiology of these falls. A 2014 study by Jorge Con and colleagues showed that ladder falls accounted for 1.3% of all trauma cases observed during their study period The average age of a ladder fall patient was 55 years (I’m far younger), with a male predominance of 89.3%. Average fall height was 9.8 ft. Although the mortality rate is relatively low, the health care costs and opportunity costs from such falls are significant, with one study finding an average hospital stay of 1 wk followed by 6 weeks of disability. However among patients >75 y, mortality could be as high as 3.3%.

My injury patterns are pretty consistent with the general profile observed in this study. Thoracic and spine injuries were the most common injuries sustained. The remaining injuries in order of decreasing frequency were head, lower-extremity fractures; upper-extremity fractures; pelvic fractures and intra-abdominal injuries.

I experienced the entire event in slow motion and not only was aware of my surroundings but experienced them in significant detail and depth. This slow motion effect is a well described phenomenon called “time dilation.” Charles Stetson of Cal Tech and colleagues studied participants in a 31 meter free fall (into a safety net!) to better describe this experience. Interestingly, a participant falling estimated their own fall to last 36% longer as compared to a standing outside observer of the same fall.

Their findings were fascinating and suggested that time-slowing is a function of recollection, not perception. What occurs a richer encoding of memory therefore making the fall to appear as though it lasted longer.
 
With my enhanced recollection and frequent painful reminders of this event, I found the attached OSHA summary on ladder safety. My error was the ladder angle – the proper angle for setting up a ladder is to place its base a quarter of the working length of the ladder from the wall or other vertical surface.
 
Although, at this point, I don’t ever plan on climbing one again which should eliminate my future risk entirely.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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6 November 2019 Blog Post: Blind Trust in Medical Algorithms

6 November 2019 Blog Post: Blind Trust in Medical Algorithms

I have used previous posts to show that a blind trust in medical algorithms can lead to adverse patient outcomes. In the case of the sepsis ‘bundle”, hospitals and the Centers for Medicare Services continue to mandate its use in spite of a lack of objective evidence that it is effective (see our August 20th 2019 post). It may even be harmful.

I’m somewhat surprised that there hasn’t been more press focus on an article published October 24th in Science showing that decision making software used in US Hospitals is systematically discriminatory. The results are shocking and emblematic of the erosion of humanistic values in Medicine for the sake of operational efficiency. Or perhaps this is expected when patient care decisions are made by those not at the patient’s bedside.

Any article published in the journal Science is one that has withstood the rigors of intensive peer review. For those unfamiliar with “impact factor” of scientific journals, only Nature (which wrote the accompanying summary article linked below) has a higher rated scientific prestige. Published since 1880, Science is considered one of the world’s top scientific journals. Published anywhere, this article is shocking – its appearance in Science amplifies its critical importance.

Unbeknownst to most patients, the U.S. health care system uses commercial algorithms to guide health decisions. Ziad Obermeyer and his team at UC Berkeley ran routine statistical checks on data they received from a large hospital, they were surprised to find that people who self-identified as African American were generally assigned lower risk scores than equally sick white people. Note the qualifying descriptor of these statistical checks: “routine.” The company that developed the algorithm, Optum of Eden Prairie, Minnesota, repeated these analyses and verified Obermeyer’s results.

This faulty computer program affected the health outcomes and resource allocations for millions of patients. By fixing the poorly written software, Obermeyer increased the percentage of African American patients receiving additional help from 17.7% to 46.5% (a multiple of 2.6 times). The authors noted that the bias arose because the algorithm predicts health care costs rather than illness.

Wait, what? The software predicts cost rather than illness? Why would it do that?

The answer is obvious. Optum is a for profit healthcare conglomerate. Described by Healthcare Finance magazine in 2018, “Optum is a behemoth in the healthcare industry, reaping profits for parent company UnitedHealth Group by having virtually every payer and over 5,000 hospitals in its portfolio.” Optum reported $101.3 billion in revenue for 2018, up by $10.1 billion from $91.2 billion reported in 2017. Optum’s CEO Andrew Witty made $21.2 million in 2018. By comparison, Obermeyer makes $102,827 annually as an acting associate professor (salary available publically as he is a California State employee). It shouldn’t be a surprise that healthcare software written by a company generating massive profits would consider cost first and patient care second.

Obermeyer and his team then collaborated with the company to find variables other than healthcare costs that could be used to calculate a person’s medical needs. He did this, by the way, as an unpaid consultant although Optum can clearly afford to pay him for his expertise. They then repeated the analysis and were able to reduce racial bias by 84%.

Even then, Optum could not be gracious and admit their errors. “We appreciate the researchers’ work,” Optum said in a statement. But the company added that it considered the researchers’ conclusion to be “misleading”. “The cost model is just one of many data elements intended to be used to select patients for clinical engagement programs, including, most importantly, the doctor’s expertise.”

Sorry, what? The doctor’s expertise? Where does that get plugged into the algorithm? It doesn’t. Like the sepsis bundle, we blindly hurdle forward in the wrong direction with increasingly ill patients who are not offered appropriate resources because clinical decisions are being made via poorly conceived programming code.
 
And who suffers? Patients.
Click Millions of black people affected by racial bias in health-care algorithmshere

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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