The skeptical cardiologist shed his skepticism about marriage today and tied the knot with his Eternal Fiancee’.
This decision was not based on the findings of a recent meta-analysis of 34 studies with more than two million participants that found that that compared with married people, those who were unmarried ( never married, widowed or divorced) were 42 percent more likely to have some form of cardiovascular disease and 16 percent more likely to have coronary heart disease.
No, I was not influenced by these observational data which show a 43% increase risk of coronary heart disease death and a 55% increased risk of death from stroke.
Headlines like this from Time magazine:
How Marriage Can Actually Protect Your Heart Health
had no bearing on my decision.
This skeptical cardiologist found the perfect woman for his skeptical ways,
And observations that unmarried patients have longer delays in seeking medical help which influences the timing and benefit of invasive cardiac procedures that reduce mortality played no role in this decision.
Neither did the prospect that a spouse would encourage a more healthy lifestyle and better adherence to treatment nor the buffering hypothesis which suggests that informational or emotional resources from a spouse promote adaptive behaviour and may reduce excessive neuroendocrine response to acute or chronic stressor.
There is still no reason to take over the counter fish oil supplements.
In fact, a study published Saturday found that fish oil supplementation (1 g per day as a fish-oil capsule containing 840 mg of n−3 fatty acids, including 460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]
did not result in a lower incidence than placebo of the primary end points of major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type.
However, another study published Saturday (REDUCE-IT) and presented at the annual American Heart Association Scientific Sessions to great fanfare found that an ethyl-ester formulation (icosapent ethyl) of eicosapentanoic acid (EPA, one of the two main marine n-3 fish oils) reduced major cardiovascular events by 25% in comparison to placebo.
When I wrote about Icosapent ethyl (brand name Vascepa) in a previous blog post in 2015 there was no data supporting its use:
A fish oil preparation, VASCEPA, available only by prescription, was approved by the FDA in 2012.
Like the first prescription fish oil available in the US, Lovaza, VASCEPA is only approved by the FDA for treatment of very high triglycerides(>500 mg/dl).
This is a very small market compared to the millions of individuals taking fish oil thinking that it is preventing heart disease.
The company that makes Vascepa (Amrin;$AMRN)would also like to have physicians prescribe it to their patients who have mildly or moderatelyelevated triglycerides between 200 and 500 which some estimate as up to 1/3 of the population.
Given the huge numbers of patients with trigs slightly above normal, before approving an expensive new drug, the FDA thought, it would be nice to know that the drug is actually helping prevent heart attacks and strokes or prolonging life.
After all, we don’t really care about high triglycerides unless they are causing problems and we don’t care about lowering them unless we can show we are reducing the frequency of those problems.
Data do not exist to say that lowering triglycerides in the mild to moderate range by any drug lowers heart attack risk.
In the past if a company promoted their drug for off-label usage they could be fined by the FDA but Amarin went to court and obtained the right to promote Vascepa to physicians for triglycerides between 200 and 500.
Consequently, you may find your doctor prescribing this drug to you. If you do, I suggest you ask him if he recently had a free lunch or dinner provided by Amarin, has stock in the company (Vascepa is the sole drug made by Amarin and its stock price fluctuates wildly depending on sales and news about Vascepa) or gives talks for Amarin.
If he answers no to all of the above then, hopefully, your triglycerides are over 500.
And although elevated triglycerides confer an elevated CV risk nearly all prior trials evaluating different kinds of triglyceride-lowering therapies, including extended-release niacin, fibrates, cholesteryl ester transfer protein inhibitors, and omega-3 fatty acids have failed to show reductions in cardiovascular events
REDUCE-IT, Amarin trumpeted widely in September (before the actual data was published) now provides impressive proof that it prevents cardiovascular disease. Has the skeptical cardiologist changed his mind about fish oil?
Vascepa Is Not Natural Fish Oil
Although Amarin’s marking material states “VASCEPA is obtained naturally from wild deep-water Pacific Ocean fish” the active ingredient is an ethyl ester form of eicosapentoic acid (EPA) which has been industrially processed and distilled and separated out from the other main omega-3 fatty acid in fish oil (DHA or docosohexanoieic acid).
Natural fish oil contains a balance of EPA and DHA combined with triacylglycerols (TAGS).
So even if the REDUCE-IT trial results can be believed they do not support the routine consumption of over the counter fish oil supplements for prevention of cardiovascular disease.
Does REDUCE-IT Prove The Benefit of Purified High Dose EPA?
REDUCE-IT was a large (8179 patients) randomized, double-blind placebo controlled trial
Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter and had been receiving a stable dose of a statin for at least 4 weeks. In 2013 the protocol was changed and required a triglyceride level>200 mg/dl.
Participants were randomized to icosapent ethyl (2 g twice daily with food [total daily dose, 4 g]) or a placebo that contained mineral oil to mimic the color and consistency of icosapent ethyl and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group.
More importantly, the hard end-points of CV death, nonfatal stroke and heart attack were also significantly lower in the Vascepa arm compared to the “placebo” arm.
These results are almost unbelievably good and they are far better than one would have predicted given only a 17% reduction in triglycerides.
This makes me strongly consider prescribing Vascepa (something I heretofore have never done) to my higher risk patients with triglycerides over 200 after we’ve addressed lifestyle and dietary contributors.
Perhaps the high dose of EPA (4 grams versus the 1 gram utilized in most trials) is beneficial in stabilizing cell membranes, reducing inflammation and thrombotic events as experimental data has suggested.
Lingering Concerns About The Study
Despite these great results I have some concerns:
The placebo contained mineral oil which may not have been neutral in its effects. In fact, the placebo arm had a significant rise in the LDL cholesterol.
Enrolled patients were predominantly male and white. No benefit was seen in women.
Higher rates of serious bleeding were noted in patients taking Vascepa
Atrial fibrillation developed significantly more often in Vascepa patients (3.1%) versus the mineral oil patients (2.1%)
Finally, the trial was sponsored by Amarin Pharma. This is an aggressive company that I don’t trust. The steering committee consisted of academic physicians (see the Supplementary Appendix), and representatives of the sponsor developed the protocol, and were responsible for the conduct and oversight of the study, as well as the interpretation of the data. The sponsor was responsible for the collection and management of the data. All the data analyses were performed by the sponsor,
After i wrote my negative piece on Vascepa in 2015 a number of Amarin investors attacked me because Vascepa is the only product Amarin has and any news on the drug dramatically influences its stock price. Here is the price of Amarin stock in the last year.
The dramatic uptick in September corresponds to the company’s announcement of the topline results of REDUCE-IT. Since the actual results have been published and analyzed the stock has dropped 20%.
High Dose Purified and Esterified EPA-Yay or Nay?
I would love to see another trial of high dose EPA that wasn’t totally under the control of Amarin and such trials are in the pipeline.
Until then, I’ll consider prescribing Amarin’s pills to appropriate patients* who can afford it and who appear to have significant residual risk after statin therapy*.
But, I will continue to tell my patients to stop paying money for useless OTC fish oil supplements.
N.B.* Appropriate patients will fit the entry criteria for REDUCE-IT described below.
Patients could be enrolled if they were 45 years of age or older and had established cardiovascular disease or were 50 years of age or older and had diabetes mellitus and at least one additional risk factor. Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter (1.69 to 5.63 mmol per liter) and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter) and had been receiving a stable dose of a statin for at least 4 weeks;
So either secondary prevention (prior heart attack or stroke) or primary prevention in patients with diabetes and another risk factor.
The skeptical cardiologist has been utilizing coronary artery calcium (CAC) scans to help decide which patients are at high risk for heart attacks, and sudden cardiac death for the last decade. As I first described in 2014, (see here) those with higher than expected calcium scores warrant more aggressive treatment and those with lower scores less aggrressive treatment.
Although , as I have discussed previously, CAC is not the “mammography of the heart” it is incredibly helpful in sorting out personalized cardiovascular risk. We use standard risk factors like lipids, smoking, age, gender and diabetes to stratify individuals according to their 10 year risk of atherosclerotic cardiovascular disease (ASCVD) but many apparent low risk individuals (often due to inherited familial risk) drop dead from ASCVD and many apparent high risk individuals don’t need statin therapy.
Previously, major guidelines from organizations like the AHA and the ACC did not recommend CAC testing to guide decision-making in this area. Consequently, CMS and major insurers have not covered CAC testing. When my patients get a CAC scan they pay 125$ out of their pocket.. For the affluent and pro-active this is not an obstacle, however those struggling financially often balk at the cost.
I was, therefore, very pleased to read that the newly updated AHA/ACC lipid guidelines (full PDF available here) emphasize the use of CAC for decision-making in intermediate risk patients.
For those patients aged 40-75 without known ASCVD whose 10 year risk of stroke and heart attack is between 7.5% and 20% (intermediate, see here on using risk estimator) the guidelines recommend “consider measuring CAC”.
If the score is zero, for most consider no statin. If score >100 and/or >75th percentile, statin therapy should be started.
I don’t agree totally with this use of CAC but it is a step forward. For example, how I approach a patient with CAC of 1-99 depends very much on what percentile the patient is at. A score of 10 in a 40 year old indicates marked premature build up of atherosclerotic plaque but in a 70 year old man it indicates they are at much lower risk than predicted by standard risk factors. The first individual we would likely recommend statin therapy and very aggressive lifestyle changes whereas the second man we could discuss taking off statins.
Neil Stone, MD, one of the authors of the guidelines was quoted as saying that the imaging technique is “the best tiebreaker we have now” when the risk-benefit balance is uncertain.
“Most should get a statin, but there are people who say, ‘I’ve got to know more, I want to personalize this decision to the point of knowing whether I really, really need it.’ … There are a number of people who want to be certain about where they stand on the risk continuum and that’s how we want to use it,”
Indeed, I’ve written quite a bit about my approach to helping patients “get off the fence” on whether or not to take a statin drug.
Full title of these new guidelines includes an alphabet soup of organization acronyms
2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol
N.B. For your reading pleasure I’ve copied the section in the new guidelines that discusses in detail coronary artery calcium.
Two interesting sentences which I’ll need to discuss some other time
-When the CAC score is zero, some investigators favor remeasurement of CAC after 5 to 10 years
–CAC scans should be ordered by a clinician who is fully versed in the pros and cons of diagnostic radiology.
–In MESA (Multi-Ethnic Study of Atherosclerosis), CAC scanning delivered 0.74 to l.27 mSv of radiation, which is similar to the dose of a clinical mammogram
-188.8.131.52. Coronary Artery Calcium
Substantial advances in estimation of risk with CAC scoring have been made in the past 5 years. One purpose of CAC scoring is to reclassify risk identification of patients who will potentially benefit from statin therapy. This is especially useful when the clinician and patient are uncertain whether to start a statin. Indeed, the most important recent observation has been the finding that a CAC score of zero indicates a low ASCVD risk for the subsequent 10 years (S184.108.40.206-1–S220.127.116.11-8). Thus, measurement of CAC potentially allows a clinician to withhold statin therapy in patients showing zero CAC. There are exceptions. For example, CAC scores of zero in persistent cigarette smokers, patients with diabetes mellitus, those with a strong family history of ASCVD, and possibly chronic inflammatory conditions such as HIV, may still be associated with substantial 10-year risk (S18.104.22.168-9–S22.214.171.124-12). Nevertheless, a sizable portion of middle-aged and older patients have zero CAC, which may allow withholding of statin therapy in those intermediate risk patients who would otherwise have a high enough risk according to the PCE to receive statin therapy (Figure 2). Most patients with CAC scores ≥100 Agatston units have a 10-year risk of ASCVD≥7.5%, a widely accepted threshold for initiation of statin therapy (S126.96.36.199-13). With increasing age, 10- year risk accompanying CAC scores of 1 to 99 rises, usually crossing the 7.5% threshold in later middle age (S188.8.131.52-13). When the CAC score is zero, some investigators favor remeasurement of CAC after 5 to 10 years (S184.108.40.206-14–S220.127.116.11-16). CAC measurement has no utility in patients already treated with statins. Statins are associated with slower progression of overall coronary atherosclerosis volume and reduction of high-risk plaque features, yet statins increase the CAC score (S18.104.22.168-17). A prospective randomized study of CAC scoring showed improved risk factor modification without an increase in downstream medical testing or cost (S22.214.171.124-18). In MESA (Multi-Ethnic Study of Atherosclerosis), CAC scanning delivered 0.74 to l.27 mSv of radiation, which is similar to the dose of a clinical mammogram (S126.96.36.199- 19). CAC scans should be ordered by a clinician who is fully versed in the pros and cons of diagnostic radiology.
Downloaded from http://ahajournals.org by on November 11, 2018
from Grundy SM, et al.
2018 Cholesterol Clinical Practice Guidelines
I swear by Apollo the Healer, by Asclepius, by Hygieia, by Panacea, and by all the gods and goddesses, making them my witnesses, that I will carry out, according to my ability and judgment, this oath and this indenture.
Much as I enjoy the ribald hi jinx of the gods and goddesses in Greek mythology and appreciate the back story behind words like panacea and hygiene* I just don’t feel it is appropriate to swear an oath to mythical super beings.
Let Food Be Thy Medicine-The Apocryphal Hippocratic Trope
Hippocrates is often cited these days in alternative medicine circles because he is alleged to have said “let food be thy medicine and medicine thy food.”
I’ve come across two articles that are well worth reading on the food=medicine trope which is often used by snake oil salesmen to justify their useless (presumably food-based) supplements.
Food is so much more than medicine. Food is intrinsically related to human social interactions and community. Food is culture, love, and joy. Turning food into medicine robs it of these positive attributes.
A healthy relationship with food is essential to a person’s well-being, but not because it has medicinal properties. Food is not just fuel and it is more than nutrients — and we don’t consume it just to reduce our disease risk.
Seeing food as a medicine can contribute to obsessing about macronutrientintake, to unfairly canonizing or demonizing certain foods, and to turning eating into a joyless and stressful process.
People tend to overvalue the immediate impact of what they eat, thinking that a “super food” can have instant benefits while undervaluing the long-term effects of what they consume over their lifetime.
Gorski notes that just because Hippocrates is considered by some to be the “father of medicine” and his ideas are ancient doesn’t make them correct:
one of the best examples out there of the logical fallacy known as the appeal to antiquity; in other words, the claim that if something is ancient and still around it must be correct (or at least there must be something to it worth considering).
Of course, just because an idea is old doesn’t mean it’s good, any more than just because Hippocrates said it means it must be true. Hippocrates was an important figure in the history of medicine because he was among the earliest to assert that diseases were caused by natural processes rather than the gods and because of his emphasis on the careful observation and documentation of patient history and physical findings, which led to the discovery of physical signs associated with diseases of specific organs. However, let’s not also forget that Hippocrates and his followers also believed in humoral theory, the idea that all disease results from an imbalance of the “four humors.” It’s also amusing to note that this quote by Hippocrates is thought to be a misquote, as it is nowhere to be found in the more than 60 texts known as The Hippocratic Corpus (Corpus Hippocraticum).
Gorski goes on to point out that:
this ancient idea that virtually all disease could be treated with diet, however much or little it was embraced by Hippocrates, has become an idée fixe in alternative medicine, so much so that it leads its proponents twist new science (like epigenetics) to try to fit it into a framework where diet rules all, often coupled with the idea that doctors don’t understand or care about nutrition and it’s big pharma that’s preventing the acceptance of dietary interventions. That thinking also permeates popular culture, fitting in very nicely with an equally ancient phenomenon, the moralization of food choices (discussed ably by Dr. Jones a month ago
We’ve learned a lot about medicine and nutrition in the last 3 thousand years. We can thank Hippocrates, perhaps, for the idea that diseases don’t come from the gods but little else.
It’s time to upgrade the physician pledge and jettison the antiquated Hippocratic Oath.
We now have real, effective medicines that have nothing to do with food for many diseases. It’s important to eat a healthy diet.
But the food=medicine trope is just too often a marker for pseudo and anti-science humbuggery and should also be left behind.
*From Wikipedia, an explanation of the Gods and Goddesses mentioned in the Hippocratic oath
Asclepius represents the healing aspect of the medical arts; his daughters are Hygieia(“Hygiene”, the goddess/personification of health, cleanliness, and sanitation), Iaso (the goddess of recuperation from illness), Aceso(the goddess of the healing process), Aglæa/Ægle (the goddess of the glow of good health), and Panacea (the goddess of universal remedy).
The Physician’s Pledge
Adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948
and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968
and the 35th World Medical Assembly, Venice, Italy, October 1983
and the 46th WMA General Assembly, Stockholm, Sweden, September 1994
and editorially revised by the 170th WMA Council Session, Divonne-les-Bains, France, May 2005
and the 173rd WMA Council Session, Divonne-les-Bains, France, May 2006
and the WMA General Assembly, Chicago, United States, October 2017
AS A MEMBER OF THE MEDICAL PROFESSION:
I SOLEMNLY PLEDGE to dedicate my life to the service of humanity;
THE HEALTH AND WELL-BEING OF MY PATIENT will be my first consideration;
I WILL RESPECT the autonomy and dignity of my patient;
I WILL MAINTAIN the utmost respect for human life;
I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing, or any other factor to intervene between my duty and my patient;
I WILL RESPECT the secrets that are confided in me, even after the patient has died;
I WILL PRACTISE my profession with conscience and dignity and in accordance with good medical practice;
I WILL FOSTER the honour and noble traditions of the medical profession;
I WILL GIVE to my teachers, colleagues, and students the respect and gratitude that is their due;
I WILL SHARE my medical knowledge for the benefit of the patient and the advancement of healthcare;
I WILL ATTEND TO my own health, well-being, and abilities in order to provide care of the highest standard;
I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even under threat;
I MAKE THESE PROMISES solemnly, freely, and upon my honour.
In the course of researching some (likely obscure) phenomenon the skeptical cardiologist encountered a reference to a book with the fascinating title of “Fritz Spiegl’s SICK NOTES: An Alphabetical Browsing-Book of Medical Derivations, Abbreviations, Mnemonics and Slang for the Amusement and Edification of Medics, Nurses, Patients and Hypochondriacs.”
The book is no longer in print but I was able to purchase a used version for less than 10$ via the wonders of the internet.
Published in 1996 with a forward by Lord Smith of Marlow, the President of the Royal College of Surgeons, the book is most enjoyable, quite suited to short bursts of reading.
From time to time I will share random selections, most likely on a Wednesday.
Without further ado I give you today’s tidbit- the pancreas.
The name of the digestive gland comes from the Greek pan, all + areas, flesh; or so all the dictionaries tell us. It is actually fish-shaped, and the all-flesh connection is puzzling, as surely all our soft giblets-human as well as animal-are ‘all flesh”.
Could there be a connection with Latin panis, bread, in view of the fact that the pancreas of lambs, calves, etc. when used in cooking, are called sweetbread(s)-although the pancreas is, of course, neither sweet nor bread?
Further etymological investigation seems called for. The pancreas also contain small groups of cells called ISLETS of LANGERHANS, which secret two hormones, INSULIN and glucagon, regulating blood-sugar levels: another connection with sweetness. See DIABETES.
I can’t reference the islets of Langerhans without thinking about the brilliant humor of Firesign Theatre
The skeptical cardiologist picked up an Apple Watch 4 at the Galleria Apple Store in St. Louis today. The Apple employee who retrieved it told me that ECG recording capabilities were expected in the fall. Of course fall began today and it is not at all clear when, if ever, Apple will provide the software update to its AW4 that will provide ECG capabilities.
Fortunately, consumers already have the capability of recording a medical grade single lead ECG with any Apple Watch 2 or 3-using the KardiaBand from AliveCor.
Apple has hubristically proclaimed the AW4 as the ultimate guardian of our health and while setting it up I was asked if I wanted the watch to notify me if my heart rate dropped below 40 bpm for 10 minutes. Sure! Let’s see how irritating this feature will be.
After setting up the new watch I immediately attached my KardiaBand and installed the Kardia Apple Watch app.
I was able to open the Kardia app and it performed its normal SmartRhythm monitoring but when I tried to record an ECG, alas, nothing happened.
It appears that the KardiaBand does not work with the new Apple Watch 4. Yet.
I was informed by Ira Bahr at AliveCor that their “testing on AW4 is not yet complete. So at present, the device is not supported.”
Now I face a difficult decision-Do I wear my new AW4 with a non KardiaBand wrist band (and no ECG capability) or wear my old Apple Watch with the KardiaBand (and outstanding ECG capability.)
On February 10, 2014 AliveCor, Inc. announced that its heavily validated personalmobile ECG monitor had received FDA over-the counter clearance. Previously the device, which allows recording of a single-lead ECG and, in conjunction with a free smart-phone app, can diagnose atrial fibrillation was only available by prescription.
Since 2013, I have been successfully using this device with my patients who have atrial fibrillation (and writing about it extensively)
I was shocked, therefore, to hear the COO of Apple, Jeff Williams, announce that Apple will be offering in its new Apple Watch 4 “the first ECG product offered over the counter directly to consumers.”
This seemed blatantly inaccurate as AliveCor’s device clearly preceded by 4 years Apple’s claim.
Furthermore, AliveCor’s Kardia Band which converts any Apple Watch into a single-lead ECG (which I’ve written about here and here) has been available and providing the Apple Watch-based ECGs since November 30, 2017.
AliveCor has an outstanding website which documents in detail all the research studies done on their products (there are dozens and dozens of linked papers) and all of their press releases dating back to 2012. It also explains in detail how the product works.
AliveCor shortly thereafter (December 12, 2017) announced Smart Rhythm , an Apple Watch app that monitors your rhythm and alerts you if it thinks you are in atrial fibrillation. I’ve discussed Smart Rhythm here.
The new Apple Watch’s rhythm monitoring app sounds a lot like Smart Rhythm but without any of the documentation AliveCor has provided.
So, within 10 months of Alivecor providing the world with the first ever wearable ECG (and proven its accuracy in afib) Apple seems to have come out with a remarkably similar product.
The major difference between Apple and AliveCor is the total lack of any reviewable data on the accuracy of the Apple device. Yes, that’s right Apple has provided no studies and no data and we have no idea how accurate its ECG device is (or its monitoring algorithm).
For all we know, it could diagnose sinus rhythm with frequent APCS or PVCs consistently as atrial fibrillation, sending thousands of Watch 4 wearers into a panic and overloading the health care system with meaningless alerts.
Apple’s website claims
Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram. It’s a momentous achievement for a wearable device that can provide critical real-time data for doctors and peace of mind for you.
Apple’s “momentous achievement” was actually achieved 10 months earlier by AliveCor and if its monitoring algorithm and ECG system are significantly worse than the proven AliveCor system they will be destroying the peace of mind of users.
After describing the Apple Watch’s new health features, Jeff Williams introduced Ivor Benjamin, MD, the President of the American Heart Association. Benjamin proceeded to describe the new Apple Watch cardiac features as “game-changing”, noting that the AHA is committed to helping patients be “proactive.”
Does Benjamin have access to the accuracy of the Apple Watch ECG sensor? If so, he and the AHA should immediately share it with the scientific community. If not, by endorsing this feature of the Watch he should be ashamed. Users need to know if he or the AHA was paid any money for this appearance. Also, we should demand to know if (as the prominent AHA logo suggested and news reports implied) the AHA is somehow endorsing the Apple Watch.
Frequent readers know I’m a huge Apple fan but this Apple Watch business makes me think something is rotten in the state of Apple.
As I described here, the Kardia Band (KB) is an FDA-approved Apple Watch accessory available to the general public without a prescription which records a high quality single-lead ECG.
I’ve been using mine now for a while and can confirm the ease and accuracy of the ECG recordings it makes. I find recordings made with my Apple Watch/Kardia Band are reliably high quality with minimal artifact (unless I’m running on a treadmill.)
Once the 30 second recording is completed, the Kardia app on the Apple Watch takes about 5 seconds to process the information using an AI algorithm and then makes a determination of normal sinus rhythm (NSR), atrial fibrillation or unclassified.
In the JACC study, investigators from the Cleveland Clinic studied 100 consecutive patients presenting for cardioversion from AF with recordings made before and after the procedure. KB interpretations were compared to 12 lead ECGS read by electrophysiologists.
KB interpretations identified AF with 93% sensitivity and 84% specificity. Of the total 169 recordings, 34% were unclassified due to short recordings, low-amplitude p waves, and baseline artifacts.
The authors concluded that the KB algorithm for AF detection, when it is supported by a physician review can reliably differentiate AF from NSR.
(Of note the lead author on this study is on the advisory board of Alivecor the maker of the KB and AliveCor (AliveCor, Mountain View, CA) provided the Kardia Band monitors which were connected to an Apple Watch and paired via Bluetooth to a smartphone device for utilization in the study. AliveCor was not involved in the design, implementation, data analysis, or manuscript preparation of the study.)
My Updated Kardia Experience
I have found the standard Kardia device to be immensely helpful in the management of my afib patients before and after cardioversions (see my prior description here). The paper mentions that 8% of these pre-cardioversion patients showed up for the procedure in normal sinus rhythm, noting that
For each of these patients, the automated KB algorithm did not erroneously identify AF, and the physician interpretation of the KB recording correctly confirmed SR in each case.
Needless to say, it is better to find out a cardioversion is not needed before the patient shows up for the procedure. I would estimate this happens about 5-10% of the time in my practice.
The Kardia device or the KB is also really helpful post cardioversion. If the patient makes daily recordings (which I can review on Kardia Pro online) h/she and I know exactly how long sinus rhythm persisted before reverting back to AF.
This is important information which impacts future management decisions.
Kardia Band Versus Standard Kardia Device
None of my patients have purchased the Kardia Band most likely due to the cost and the fact that they don’t have an Apple Watch. If you have an Apple Watch and want to monitor your heart rhythm I think the KB is a good choice. Otherwise, the original AliveCor mobile ECG device continues to do a fantastic job (in conjunction with Kardia Pro, see here).
The combination of Kardia and Kardia Pro has substantially reduced my use of expensive and annoying long term monitors in my AF population.
In my next update on the KB I will share a reader’s real world description of the pros and cons of the KB (with Smart Rhythm monitoring) in a patient post cardioversion for AF.
The eye of the skeptical cardiologist was caught by an FDA alert issued recently:
FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease
According to the alert:
reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients. These reports are unusual because DCM is occurring in breeds not typically genetically prone to the disease.
What Is Dilated Cardiomyopathy?
Dilated cardiomyopathy refers to a disease of the heart muscle characterized by enlargement and global weakness of the main pumping chambers, the ventricles.
The image below is from the echocardiogram of a human with a severe dilated cardiomyopathy.
Humans with DCM experience weakness, shortness of breath and swelling in the legs due to heart failure. Severe cases of DCM are at risk for dying suddenly.
Cardiomyopathy Used To Be A Disease of Large Dogs
According to Lisa Freeman a veterinarian at the Cummings Veterinary Center at Tufts University
Heart disease is common in our companion animals, affecting 10-15% of all dogs and cats, with even higher rates in Cavalier King Charles Spaniels, Doberman Pinschers, and Boxer dogs.
Dilated Cardiomypathy in dogs
typically occurs in large- and giant-breeds, such as Doberman pinschers, Boxers, Irish Wolfhounds, and Great Danes, where it is thought to have a genetic component.
The FDA alert indicates that DCM
is less common in small and medium breed dogs, except American and English Cocker Spaniels. However, the cases that have been reported to the FDA have included Golden and Labrador Retrievers, Whippets, a Shih Tzu, a Bulldog and Miniature Schnauzers, as well as mixed breeds
“In the last few years I’ve seen more cases of nutritional deficiencies due to people feeding unconventional diets, such as unbalanced home-prepared diets, raw diets, vegetarian diets, and boutique commercial pet foods. The pet food industry is a competitive one, with more and more companies joining the market every year. Marketing is a powerful tool for selling pet foods and has initiated and expanded fads, that are unsupported by nutritional science, including grain-free and exotic ingredient diets. All this makes it difficult for pet owners to know what is truly the best food for their pet (as opposed to the one with the loudest or most attractive marketing). Because of the thousands of diet choices, the creative and persuasive advertising, and the vocal opinions on the internet, pet owners aren’t able to know if the diets they’re feeding have nutritional deficiencies or toxicities – or could potentially even cause heart disease.
Apparently, it has become trendy in the pet world (just like the human world) to vilify grains as in this article highlighting potential signs of doggy grain allergy at the dogbaker.com.
Freeman notes that grains are not felt to significantly contribute to pet diseases:
Many pet owners have, unfortunately, also bought into the grain-free myth. The fact is that food allergies are very uncommon, so there’s no benefit of feeding pet foods containing exotic ingredients. And while grains have been accused on the internet of causing nearly every disease known to dogs, grains do not contribute to any health problems and are used in pet food as a nutritious source of protein, vitamins, and minerals.
The FDA alert notes that in 4 cases of doggy DCM (3 of which were golden retrievers) taurine levels were low and with a change back to a normal diet and taurine supplementation the cardiomyopathy resolved. However, some reported cases had normal taurine levels.
Reconsider Your Dog’s Diet
To avoid doggy DCM, Dr. Freeman recommends
Reconsider your dog’s diet. If you’re feeding a boutique, grain-free, or exotic ingredient diets, I would reassess whether you could change to a diet with more typical ingredients made by a company with a long track record of producing good quality diets. And do yourself a favor – stop reading the ingredient list! Although this is the most common way owners select their pets’ food, it is the least reliable way to do so. And be careful about currently available pet food rating websites that rank pet foods either on opinion or on based on myths and subjective information. It’s important to use more objective criteria (e.g., research, nutritional expertise, quality control in judging a pet food). The best way to select what is really the best food for your pet is to ensure the manufacturer has excellent nutritional expertise and rigorous quality control standards (see our “Questions you should be asking about your pet’s food” post).
If you’re feeding your dog a boutique, grain-free, or exotic ingredient diet, watch for early signs of heart disease – weakness, slowing down, less able to exercise, short of breath, coughing, or fainting. Your veterinarian will listen for a heart murmur or abnormal heart rhythm and may do additional tests (or send you to see a veterinary cardiologist), such as x-rays, blood tests, electrocardiogram, or ultrasound of the heart (echocardiogram).
With the recent recall of valsartan due to carcinogenic Chinese contaminants the issue of where one’s generic medication is manufactured has become more important.
I take two generics: ramipril for my hypertension and rosuvastatin for my cholesterol/atherosclerosis and I had no idea where they came from when I discussed the rise of generics manufactured in China recently.
Where Is My Ramipril Made?
I called my St. Lukes pharmacist, Robert, and asked him if he could give me information on the origin of these pills.
Robert told me that my 10 mg ramipril capsule was distributed by a company called West-Ward located in New Jersey. West-Ward was an independent Columbus, Ohio company but was purchased in 2016 by a very large pharmaceutical company , Hikma, based in Aaman, Jordan. Now the Hikma web site indicates West-Ward is no more and is simply called Hikma in the US.
Hikma Pharmaceuticals Plc projects it will end 2017 with about $2 billion revenue, about $600 million of which is from generic drugs made by its U.S. subsidiary West-Ward. In the spring, the company had projected $800 million in generics sales.
Customer service at Hikma informs me that my ramipril was made in their Columbus, Ohio plant.
Where Is My Rosuvastatin Made?
My rosuvastatin (generic of Crestor) was made by Glenmark Pharmaceuticals which, per wikipedia
Glenmark received FDA approval to market their generic rosuvastatin in the US in July, 2016. and at that time had 115 products authorized for distribution in the US market and 61 drugs pending approval with the US FDA.
My rosuvastatin according to Robert was made in India although the Glenmark product catalog does not reveal this information.
Generic versus Brand Name
I’ve talked about Crestor/rosuvastatin a few times on this blog and the development of a generic version has been very helpful for many of my patients. Looking online today I see that generic rosuvastatin goes for about 10$ per month compared to 260$ for Crestor.
Is it worth paying an extra 250$ per month to get brand name Crestor if, let’s say it was manufactured in the US? For most people it isn’t. For one thing, there is no guarantee of where your brand name drug is manufactured.
Crestor used to be made in a factory in Bristol, UK but this was shut down in 2017 and now I can’t tell where Astra-Zeneca makes the stuff. Frankly, I’m surprised that they are selling any of the drug which used to account for 5 billion dollars of their annual sales.
So my cholesterol drug is made in India by an Indian company and my blood pressure drug is made in Columbus, Ohio by a Jordanian company.
I never realized how globalized the pharmaceutical industry has become. Hopefully, the FDA is doing a good job of monitoring the safety and quality of products we rely on for our wellbeing which are manufactured all over the globe.
Addendum: I have an updated post which includes more generic ARB recalls here