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Tag: cardiology

Reviewing the all-in-pod heart health segment

BY ANISH KOKA

The All-in podcast is a fairly popular show that features successful silicon valley investors commenting about everything worth commenting on from politics to health. The group has good chemistry and interesting insights that breaks the mold of the usual tribal politics that controls legacy media analysis of current events.

Last week, the podcast touched on a topic I spend a fair amount of time on: Cardiology.

Brad Gerstner, who is actually a guest host for this particular episode starts off by referencing something called Heartflow to evaluate the heart that has been recommended by one of the other hosts: Chamath Palihapitiya. Brad apparently asked his primary care physician about Heartflow and was instead directed to get a calcium scan.

Heartflow is a proprietary technology that purports to evaluate the presence of significant narrowing in the coronary arteries just by doing a heart CT scan. A calcium score is a low-dose CT scan used to identify the presence of calcium in coronary vessels.

The segment ends with a recommendation for everyone over the age of 40 to get some type of heart scan, so I thought it would be worth reviewing some of the main claims.

Question 1. Does Brad need a calcium scan?

Brad notes that his primary care physician told him he was young, fit, and had a low bad cholesterol (LDL) and needed a calcium scan rather than a heart flow scan. The answer to this question and the questions to follow depend on what outcome Brad is looking for. If the goal is to feel happier knowing if he has coronary calcium than the resounding answer is to get the calcium scan. But if the goal is to live longer and healthier, there is nothing to suggest a calcium scan will help. Most cardiologists believe that the lower the LDL, the better cardiovascular outcomes are. So if a calcium scan convinces Brad to NOT lower his LDL further either naturally or with medications, a calcium scan may be detrimental.

We have zero evidence to suggest patients who get calcium scans lower their risk of future mortality.

Question 2. Does Brad need a Heartflow scan?

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Vaccine Myocarditis Update

BY ANISH KOKA

The European Medicines Agency decided on July 19, 2021 that myocarditis and pericarditis be added to the list of adverse effects of both messenger RNA (mRNA) based vaccines (BNT162b2 [Pfizer-BioNTech] and mrna-1273 [Moderna]) against COVID-19. This advice was based on numerous reports of myocarditis that followed a clinical pattern that strongly suggested a causal link between these particular vaccines and myocarditis/pericarditis. The adverse events that appeared to be predominantly in young men typically occurred within a week after injection, and were clustered after the second dose of the vaccine series. A recent national database from France sheds some light on the approximate rates of mrna vaccine related myocarditis.

Between May 12, 2021 and October 31, 2021 within a population of 32 million persons aged 12-50 years, 21 million first doses of the BNT162b2 (Pfizer) vaccine and 2.86 million first doses of the mrna-1273 (Moderna) vaccine. In the same period, 1612 cases of myocarditis and 1613 cases of pericarditis with myocarditis were recorded in France. Compared to matched control subjects, the risk of myocarditis was markedly increased after 1st and 2nd doses of the vaccine. For the Pfizer vaccine, the odds of myocarditis were 1.8 times the expected background rate for the 1st dose and 8 times the expected background rate for the 2nd dose. The Moderna vaccine, which delivers about three times the dose of the Pfizer vaccine has an even higher risk of myocarditis — a stunning 30 times the expected background rate after the second dose. A prior history of myocarditis was associated with an odds-ratio of 160.

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The Paradigm Shift That Wasn’t: The ISCHEMIA Trial

By ANISH KOKA

A recent email that arrived in my in-box a few weeks ago from an academic hailed the latest “paradigm shift” in cardiology as it relates to the management of stable angina.  (Stable angina refers to chronic,non-accelerating chest pain with a moderate level of exertion).  The points made in the email were as follows (the order of the points made are preserved):

  1. The financial burden of stress testing was significant (11 billion dollars per annum in the USA!)
  2. For stable CAD, medical treatment is critical.  We now have better medical treatments than all prior trials including ischemia. these include PCKS9 Inhibitor, SGLT2-i, GLP1 agonists Vascepa and others
  3. CTA coronaries is by far the most important single test for evaluation of these patients
  4. ” the paradigm of ischemia testing may have come to an end”
  5. For stable angina (not ACS!) in most cases, the decision on revascularization should be based only on symptoms alleviation (as no survival benefit).

The general public should find it interesting, and not a random coincidence that the first point immediately gets to the financial burden of stress testing in a communication that is supposed to assess the level of evidence for the management of coronary artery disease. Imagine a cardiologist enters your exam room to talk about the chest pain you get every time you run up a flight of steps, and starts off the conversation with how much the societal cost of stress tests are.  The cost of care is certainly a relevant concern, especially if it’s to be borne directly by the patient, but it would seem that the decision of whether a therapy is effective or not should be divorced from how much some bean counter decides to price the therapy to generate a certain return on investment.  As such, the discussion that follows will omit any consideration of cost when evaluating the new ‘paradigm shift’ in management of coronary disease that is apparently upon us.

This particular debate boils down to the relevance of diagnostic testing for coronary artery disease.  The traditional approach to testing is a functional test that utilizes the uptake of radioactive isotope injected into a patient during stress and rest conditions to identify mismatches in blood flow in the two states to identify myocardial ischemia.  The amount of ischemia can be quantified as percent of total myocardium, and has been well correlated with prognosis.  Having lots of ischemia typically means a much shorter lifeline than having little or no ischemia.  The accepted paradigm in Cardiology has been to use traditional stress testing to triage patients to ‘conservative’ medical therapy or an invasive approach to bypass or open arteries via stents or coronary bypass surgery. 

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Rationale for Testing Anticoagulants Against COVID-19

By ETHAN WEISS, MD

We have seen and heard about the classic symptoms of COVID-19 at UCSF Medical Center, where I work as a cardiologist. Patients keep coming in with pulmonary distress, pneumonia, and ultimately, Acute Respiratory Distress Syndrome (ARDS) – the life-and-death situation that requires ventilators.

However, I’m beginning to learn about other symptoms that some doctors are noticing. There are numerous reports of other complications, especially in advanced disease.

One of the most interesting involves disruption of the blood’s coagulation system. New anecdotal reports have described clotting in test tubes and lines, derangements of clinical clotting assays, pulmonary embolilarge clots in the heart, as well as microvascular thrombosis.

Elevation in D-Dimer, (a biomarker of coagulation system activation) has been associated with dramatically increased risk of death from COVID-19. This has led some to speculate that empiric treatment with anticoagulants might improve outcomes in these critically ill patients. Indeed, there was this recent publication of a retrospective analysis of anticoagulation with heparin or low molecular weight heparin showing an association with improved outcomes in COVID-19 patients in China.

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Low Value Testing and Unmet Cascades

By ANISH KOKA, MD

Mr. Smith has a problem. 

He can’t see. 

Even this cardiologist knows why.  The not so subtle evidence lies in the cloudy lens in front of his pupils.  He is afflicted with cataracts that obstruct his vision to the point he can’t really do his job refurbishing antique furniture safely.  His other problem is that he hates doctors. He hasn’t had reason to see one for more than a decade.  He’s 68, takes no medications, smokes a pack of cigarettes a day, and is a master of one word answers. He’s in my office because he needs a medical evaluation prior to his cataract procedure. Someone needs to attest to medical safety. I’m it.

He just wants to get out of here.

His annoyance of being in the office is justified.  Cataract surgery is very low risk.  Unless he’s having an acute medical problem, there is little to do.  The problem is that in an age of high volume, super specialized care, the eye doctor can’t attest to this, and the anesthesiologists have little interest in finding out the morning of his procedure that Mr. Smith has been having more frequent episodes of chest pain over the last two weeks.  Perhaps the chest pain is just acid reflux, or maybe it’s because of a pulmonary embolism related to the tobacco induced lung malignancy no one knows about. It’s possible, and highly likely, Mr. Smith will survive his cataract surgery even if he has a pulmonary embolism.  Cataract surgery really is pretty low risk.

But the doctor’s ethos has never been to ‘clear a patient for a cataract’, it is to commit to the health of the patient.  Mr. Smith deserves the opportunity to receive good medical care that isn’t made threadbare just because of the cataract surgery on the horizon.

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Coronary Stent Price Control in India: Two Years and Counting

By SOMALARAM VENKATESH MD

With a stated intent of bringing social justice and financial relief to hundreds of thousands of patients undergoing coronary angioplasty in the country every year, the Government of India capped the sale price of coronary stents in Feb 2017. Stent prices fell by as much as 80% with this populist move, seen as anti-trade within the industry circles. It is tempting for a practising interventional cardiologist to look at two years of this government control on medical device prices in a market economy.

Before price-capping, angioplasty patients were indeed getting a raw deal. There was no uniformity in price among stents of similar class/generation made by different manufacturers. The cost of the only bioabsorbable stent then available in India, to the patient, was 200,000 Indian Rupees (a little under USD 3000), whereas the US or European-manufactured (“Imported”) drug eluting stents (DES) would cost anywhere between INR 85,000 to 160,000. Stents manufactured within India (“Indigenous”) were cheaper. The real cost of manufacture or import was hidden from public view. It was left to the eventual vendor, with alleged involvement of the user hospitals, to determine the Maximum Retail Price (MRP). It was speculated that a huge margin was worked into it, and the profit was split between manufacturers, distributors, and hospitals. Allegedly, some unscrupulous physicians received kickbacks for implanting these devices. Even in government-run hospitals, foul play was suspected.

By a single stroke of the pen, Prime Minister Narendra Modi government slashed stent prices substantially. The bioabsorbable stent cost, to the patient, was capped at INR 60,000 (< USD 1000). Bare metal stents (BMS) and Drug-eluting stents (DES) were capped at INR 7500 and 30,000, respectively. The government seemed to have done its homework: these figures were arrived at from industry-supplied figures on manufacturing or import costs. The cosy network of coronary stent food chain was set on fire with this move: with sudden diminution of profit margins, it was feared that multinational companies would cut Indian workforce; stent distributors & vendors (especially small vendors) were expected to be wiped out or cut in size; doctors worried that with low profitability, multinational stent manufacturers would exit the country or at least, stop importing newer technologies; and hospitals feared revenue loss.

Following this, Industry and Hospital-chain representatives are said to have had series of discussions with the government. Rumours were that the Central Government was arm-twisting traders and that it would relent and raise price limits after these ‘talks.’ The National Pharmaceutical Pricing Authority (NPPA) promised a price revision, one year after the price cap. Meanwhile, some multinationals informed the government that they would withdraw some of their ‘top-end products’ from the Indian market, citing financial nonviability, obviously to put pressure on the government. The Bioresorbable Scaffold from Abbott actually disappeared from Cath lab shelves.

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Do Kaiser Cardiologists Need More Pharmacist Consults to Keep Their Patients Alive?

A study by a team consisting mostly of Kaiser clinical pharmacists published in Pharmacotherapy[1] finds that a very inexpensive pharmacist consult for cardiac patients reduces the cardiac death rate by more than 80% and — even though it’s a cardiac-specific drug regimen consult — also reduces the non-cardiac death rate by more than 95% vs. what Kaiser’s doctors achieved with usual care.  Plus, even though it increases drug use, it earns a 56:1 ROI while reducing drug costs.

The implication: Kaiser’s doctors need Kaiser’s pharmacists to prevent their cardiac patients from dying, in general, but especially from non-cardiac causes…and that Kaiser is losing huge amounts of money if they don’t do this.

However, the study’s conclusions violate every “rule of plausibility” and are invalid. This study, unless its invalidity becomes more widely recognized, could also be used to justify expanded reimbursements for clinical pharmacist consults.   Clinical pharmacists may or may not deserve expanded reimbursement, but justification for that reimbursement cannot be made based on studies like this one.

Quite a number of findings deserve mention. First, not getting the $1/patient-day of clinical pharmacist support given to the study group had apparently cost 30% of the retrospective control group patients their lives, vs. 3% of the intervention group.

 

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Orbiting ORBITA

I’m sitting amidst a number of cardiologists to go over the most recent trials presented at the interventional cardiology conference in Denver.  The cardiology fellow presenting goes quickly through the hors de oeuvres until finally getting to the main course – ORBITA.

ORBITA sought to test the very foundations interventional cardiology was built on – the simple idea that opening a stenosed coronary artery was good for patients.  The trial was a double blind randomized control trial of patients with tightly stenosed arteries who either had a stent placed or had a sham procedure.  Before the results are presented, the lay media headlines from cardiobrief, the New York Times, and the Atlantic are presented to guffaws from the audience.  The indignant smirks are audible as the accompanying editorial remarks from Rita Redberg and David Brown are displayed :

”The results of ORBITA show unequivocally that there are no benefits for PCI compared with medical therapy for stable angina, even when angina is refractory to medical therapy.”

The trial results follow – no statistically significant difference in the primary outcome of exercise time increment between sham and stent, and no difference in angina between the two groups.  The meat of the presentation involves the limitations of the trial that make the trial inapplicable – 200 patients total, 6 week follow up, the underlying heterogeneity of the patient angiograms that were randomized, and the wide confidence intervals of the primary outcome that swallowed the actual effect size.  Two different angiograms were shown to the audience from the ORBITA appendix.

The images demonstrate two ‘blockages’.  To the eye, at least, one appears tighter than the other.  The audience was polled on each image – everyone voted to stent the tighter blockage and medically manage the lesser of the blockages.  It could be all perception but I could feel the relief in the room as ORBITA was being made irrelevant.  The implication clearly was that some angiograms used to show the lack of benefit from stents would not have needed stenting in the first place.

There was no real challenge to the presenter save for one:

“One of the authors – Rita Redberg – is very sharp – why do you think she wrote that editorial?”

There was no good answer – the presenter shrugged and muttered something about an anti-interventional cardiology bias.

It was at that moment that I realized why cardiologists were having such trouble with  ORBITA – we were arguing like puritans.   Everyone in the room already ‘knew’ stents worked.  This was an exercise in bias confirmation when what was needed was an examination of the source of bias.  Faced with the ultimate epistemological challenge we were resorting to authority to dismiss findings we didn’t like.  Now I think cardiologists have authority with good reason, and certainly ORBITA may have limitations inherent in any small randomized control trial that’s performed, but we can do a better job answering the fundamental question raised here that relates to the primary evidence opening a narrowed artery actually can relieve angina.

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Death and Readmissions

Eugene’s wife is on the phone.  She has been taking care of Eugene for 41 years.  I supposedly take care of his heart, weakened by two prior heart attacks.  I say supposedly because his wife does all the heavy lifting.  She makes sure he takes his medications when he should.  She watches his weight every day and occasionally administers an extra dose of diuretic when his weight climbs more than a few pounds in a day.  And perhaps most importantly, she calls me when Eugene’s in the hospital and things seem wrong to her.  This is one of those phone calls.  They were in the ER, Eugene hadn’t been responding to his diuretic as he normally does, and his breathing seemed more labored to her.  The ER physician wanted to send them home – she was hoping I would weigh in.  Not surprisingly, she was right, Eugene needed to come into the hospital.  I used to be surprised when the ER wouldn’t call me for complex cardiac patient having an acute cardiac problem.  Not any more.

There is a clear culture shift that is obvious to those who have spent any time in the ER over the past ten years.  Low risk patients used to be managed and discharged from the ER, and higher risk patients were quickly admitted to the hospital for management by specialists.  This used to be a source of tremendous friction with the ER in my younger years, as I would try to explain to ER physicians that every single chest pain in a patient with known coronary disease did not deserve admission.  I seldom have this conversation with the ER anymore.  What changed?

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How Mayo Clinic Is Using iPads to Empower Patients

Throughout the world, companies are embracing mobile devices to set customer expectations, enlist them in satisfying their own needs, and get workers to adhere to best practices. An effort under way at the Mayo Clinic shows how such technology can be used to improve outcomes and lower costs in health care.

Defining the care a patient can expect to receive and what the road to recovery will look like is crucial. When care expectations are not well defined or communicated, the process of care may drift, leading to unwarranted variation, reduced predictability, longer hospital stays, higher costs, poorer outcomes, and patient and provider dissatisfaction.

With all this in mind, a group at the Mayo Clinic led by the four of us developed and implemented a standardized practice model over a three-year period (2010-2012) that significantly reduced variation and improved predictability of care in adult cardiac surgery.

One of the developments that germinated in that effort was the interactive Mayo myCare program, which uses an iPad to provide patients with detailed descriptions of their treatment plans and clinical milestones, educational materials, and a daily “To Do” list, and to report their progress and identify problems to their providers.

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