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Taking Blood Pressure Medication At Bedtime Lowers Risk Of Death, Stroke And Heart Attack

When should you take your once daily BP meds?

Increasingly, the skeptical cardiologist has been recommending to patients that they take BP meds at bedtime as evidence has mounted  that this does a better job of normalizing asleep blood pressure and minimizing daytime side effects.

Now a study published in European Heart Journal in October has demonstrated that routine ingestion of BP meds at bedtime as opposed to waking results in improved 24 hour BP control with enhanced decrease in asleep BP and increased sleep-time relative BP decline (known as BP dipping.)

More importantly, bedtime BP med ingestion in this randomized trial of over 19 thousand hypertensive Spaniards resulted in highly significant reductions in cardiovascular events including death, heart attack, heart failure and stroke over a 6 year median follow-up

The so-called Hygia Chronotherapy Trial was extremely well done and the results are powerful and should modify clinical practice immediately.

This figure demonstrates the dramatic and highly significant 45% reduction in all types of cardiovascular events measured. Note that stroke rate was halved!

Screen Shot 2019-11-05 at 7.56.12 AM

Here are the Kaplan-Meier curves showing early and progressive separation of the treatment curves.

Screen Shot 2019-11-05 at 7.50.10 AM

There was no difference side effects or compliance between the two groups.

The remarkable aspect of this intervention is that it costs nothing, introduces no new medications and has no increased side effects.

This study is practice-changing for me. We will be advising all hypertensive patients to take their once daily BP meds at bedtime.

Chronotherapically Yours,

-ACP

h/t Reader Lee Sacry for bringing this study to my attention

 

 

The Skeptical Cardiologist’s 2019 Guide to Self-Monitoring Hypertension (High Blood Pressure)

Because uncontrolled high blood pressure (hypertension) is a well documented risk factor for stroke, heart attack and heart failure I discuss it a lot on this site and with my patients.

I just updated my page on hypertension which summarizes my thoughts and recommendations on home BP self-monitoring along with the latest on the optimal BP goal.

What To Monitor and How To Measure

I primarily makes decisions on blood pressure treatment these days based on patient self-monitoring. I discuss this in detail in a post entitled  (Why I Encourage Self-Monitoring Of Blood Pressure In My Patients With High Blood Pressure.)

I have found self-monitoring of patient’s BP to substantially enhance patient engagement in the process. Self-monitoring patients are more empowered to understand the lifestyle factors which influence their BP and make positive changes.

Blood pressures are amazingly dynamic and as patient’s gain understanding of what influences their BP they are going to be able to take control of it.

If high readings are obtained in the office I instruct patients to use an automatic BP cuff at home and make a measurement when they first get up and again 12 hours later. After two weeks they report the values to me (preferably through the electronic patient portal or by Kardia Pro.)

I discuss in detail the recommended technique for BP measurementin my 2018 post entitled  “Optimal Home Blood Pressure Monitoring: Must The Legs Be Uncrossed and The Feet Flat?

The 2018 ACC/AHA guidelines on hypertension  specify in detail how to optimally make home BP measurements as follows:

• Remain still:

• Avoid smoking, caffeinated beverages, or exercise within 30 min before BP measurements.

• Ensure ≥5 min of quiet rest before BP measurements.

• Sit with back straight and supported (on a straight-backed dining chair, for example, rather than a sofa).

• Sit with feet flat on the floor and legs uncrossed.

• Keep arm supported on a flat surface (such as a table), with the upper arm at heart level.

• Bottom of the cuff should be placed directly above the antecubital fossa (bend of the elbow).

• Take at least 2 readings 1 min apart in morning before taking medications and in evening before supper. Optimally, measure and record BP daily. Ideally, obtain weekly BP readings beginning 2 weeks after a change in the treatment regimen and during the week before a clinic visit.

• Record all readings accurately:

• Monitors with built-in memory should be brought to all clinic appointments.

And, spoiler alert, it does matter if you cross or uncross your legs.

What Should The BP Goal Be?

For many patients with hypertension, SPRINT trial data published in 2015 suggest that a systolic blood pressure target of <120 mm Hg (intensive therapy) is preferable to a target of <140 mm Hg.

The SPRINT trial found that cardiovascular events like stroke and heart attack and death from these cardiovascular causes was lower by 25% in those patients treated intensively.  Overall death was lower by 27%

Read my post on SPRINT here and have a discussion with your physician about whether these more stringent BP goals are right for you. Keep in mind that the technique used in SPRINT likely gives us lower BP than home self-monitoring.

I discuss recent European and American BP guidelines which came to different BP goals after SPRINT in a post entitled “Becoming Enlightened About More Stringent Blood Pressure Goals: Sapere Aude”.

“As a 64 year old who has emerged from his nonage with hypertension, I have carefully examined the latest American hypertension guidelines especially in light of the SPRINT study and elected to add a third anti-hypertensive agent to get my average BP below 130/80. It’s worked for me with minimal  side effects but I carefully monitor my BP.

If I notice any symptoms (light-headed, fatigued) suggesting hypotension associated with systolic BP <120 mm Hg I tweak my medical regimen to allow a higher BP.

Like all of my patients I would prefer to be on less medications, not more but when it comes to enlightenment about the effects of hypertension, it is now clear that lower is better for most of us in our sixties down to at least 130/80*

Home Blood Pressure Monitoring Devices

You can get a good validated automatic BP monitor at Walgreens or CVS for around 35-40$.

But if you want to spend a little more you can get  BP devices which have added features such as style, portability, BlueTooth communication with smartphone apps and perhaps most importantly connection through the cloud with your physician.

My favorite BP cuff used to be the QardioArm (QardioArm: Stylish, Accurate and Portable. Is It the iPhone of Home Blood Pressure Monitors?)

I still love the QardioArm but lately I’ve been recommending the Omron Evolv for my patients who need monitoring as their recordings can be connected with me through Omron/Alivecor’s smartphone app:

The Omron Evolv One-Piece Blood Pressure Monitor: Accurate, Quick And Connected

For my patients using Omron Bluetooth BP monitors plus Alivecor’s Kardia Mobile ECG and the KardiaPro cloud connection I can view their rhythm and blood pressure at any time and analyze summary data via my patient dashboard as below.Finally, be aware that scam methods of BP measurement are being promoted to the public.

I wrote about one such  smartphone app called “Instant blood pressure”

Sphygmomanometrically Yours,

-ACP

Should You Choose The High-Dose Flu Vaccine?

Between patients last week the skeptical cardiologist skipped over to the employee health office at St. Luke’s and requested he be given a flu shot.

To my surprise, I was given a choice between a “high dose” flu shot which was “recommended for individuals 65 and older” and the regular quadrivalent flu vaccine.

I hadn’t been aware of this “high dose” flu shot previously thus had not had a chance to research it.  My time was limited and I decided to go with the high dose flu vaccine hoping that high dose did not also mean more chance for side effects.

Fortunately, I had no side effects and thus far have not contracted the flu.

Influenza More Deadly In Elderly But Vaccine Less Effective

Influenza, of course, is a huge killer which causes around 36,000 deaths per year in the United States. We adults 65 and older particularly vulnerable to complications of influenza and we are the ones that account for most of the more than 200,000 hospitalizations per year from the disease.

Hospital cardiology consultations typically spike during flu season as a bad case can worsen heart failure or trigger heart attacks and arrhythmias.

Although vaccination is the most effective intervention against influenza and associated complications, older individuals mount a lower antibody response to the vaccine compared to younger individuals.

Fluzone HD: High Dose Antigen Which Increases Antibody Reponse

To improve protect strategies to improve antibody responses to influenza vaccine in the older population, such as increasing the amount of antigen in the vaccine have been developed.

The vaccine I received is called Fluzone HD and is manufactured by the French pharmaceutical company Sanofi. It is a high-dose, trivalent, inactivated influenza vaccine (IIV3-HD) and contains four times as much hemagglutinin (HA) as is contained in standard-dose vaccines.

AFter studies demonstrating an acceptable safety profile and superior immunogenicity as compared with a standard-dose vaccine, IIV3-HD was licensed for use in the United States in December 2009,

Studies Show Improved Relative Efficacy Of Fluzone Compared to Standard Dose Flu Vaccine

A study published NEJM in 2014 proved the clinical superiority of Fluzone. It has a relative efficacy compared to standard vaccines of around 24%.

The CDC summarizes it as follows

Fluzone High-Dose (HD-IIV3) met prespecified criteria for superior efficacy against laboratory-confirmed influenza to that of SD-IIV3 in a randomized trial conducted over two seasons among 31,989 persons aged ≥65 years, and might provide better protection than SD-IIV3 for this age group . For the primary outcome (prevention of laboratory-confirmed influenza caused by any viral type or subtype and associated with protocol-defined ILI), relative efficacy of HD-IIV3 compared with SD-IIV3 was 24.2% (95% CI = 9.7–36.5%).

Subsequent studies have provided further support for the improved efficacy of Fluzone according to the CDC:

These findings are further supported by results from retrospective studies of Centers for Medicare and Medicaid Services (CMS) and Veterans Administration data, as well as a cluster-randomized trial of HD-IIV3 versus SD-IIV among older adults in nursing homes  A meta-analysis reported that HD-IIV3 provided better protection than SD-IIV3 against ILI (relative VE = 19.5%; 95% CI = 8.6–29.0%); all-cause hospitalizations (relative VE = 9.1%; 95% CI = 2.4–15.3); and hospitalizations due to influenza (relative VE = 17.8%; 95% CI = 8.1–26.5), pneumonia (relative VE = 24.3%; 95% CI = 13.9–33.4), and cardiorespiratory events (relative VE = 18.2%; 95% CI = 6.8–28.1)

Should You Choose Fluzone?

Most likely, now that I have had a chance to look in detail at the studies supporting Fluzone HD for the elderly and review the CDC recommendations, I would choose it for myself for  vaccination this year.

This is not a slam dunk decision and the CDC is actually quite wishy washy in its recommendations basically saying any formulation of vaccine is OK with them

For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV4 are acceptable options.

As the CDC points out, we need more studies comparing these different flu vaccines to help guide decision-making.

Skeptically Yours,

-ACP

Addendum. Dr. Chelsea Pearson, the prominent St. Louis internist,tells me she recommends Fluzone or Flublok to her patients 65 or older.

Flublok is a quadrivalent recombinant vaccine of standard dosage.

A head to head comparison of these two vaccines would be nice to help patients and physicians decide which to take.

Cost was not an issue in my decision but a year ago Canadian health officials felt the five-fold greater cost of flu zone HD was not warranted (see here.)

N.B. Be aware there is a quadrivalent flu vaccine from Sanofi also called fluzone.  From the FDA:

Tradename: Fluzone, Fluzone High-Dose and Fluzone Intradermal
Manufacturer: Sanofi Pasteur, Inc (for Fluzone High-Dose and Fluzone Intradermal only)
Indication:

  • Fluzone is indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
  • Fluzone High-Dose is indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
  • Fluzone Intradermal indicated for active immunization for use in adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

 

Very Cool Cartoon On Side Effects Of Proton Pump Inhibitors (PPI) For GERD

The skeptical cardiologist not uncommonly recommends OTC Prilosec (omeprazole), a proton pump inhibitor for cardiac patients with chest pain that is from acid reflux (GERD).

Lately, however, some studies have raised concerns about the long term side effects of taking PPIs.

I came across a very cool cartoon which reviews one patient’s history with respect to PPIs in today’s Annals of Internal Medicine.

I’ve been meaning to delve more deeply into the literature on PPI side effects but until then I think this cartoon does a great job of summarizing what patient’s should be considering.

You can view the entire cartoon for free on the Annals website here

Here is the first panel which describes a patient who has been taking the PPI pantoprazole for decades:

And this is the last panel

It’s ironic that at one point in this patient’s treatment he is put on Zantac (ranitidine). In recent weeks the FDA has issued warnings about a possible carcinogen in generic ranitidine and CVS and Walgreens have pulled it from their shelves.

Antirefluxively Yours,

-ACP

Behold The Korg Triton and Marilyn Monroe’s Posthumous Starring Role

The skeptical cardiologist has started taking Tuesdays off more or less. Whereas I used to spend this day deep in the bowels of the hospital in a darkened room viewing all manner of echocardiograms and EKGS and occasionally venturing into the special procedure room to perform cardioversions and transesophageal echocardiograms, I now “work” from my home.

Cutting back my work hours enables two things:1) It makes for a sustainable work situation-one where I can enjoy patient care and interaction more (the most fulfilling part of the job) and interact with computer screens less thus  allowing me to keep working for another 10 years and 2) It allows me to do all the other things I love doing but which I never seem to find enough time for. These other things are mostly music creation, research and writing for this blog, reading, and taking care of my health.

In the realm of music creation I’ve been doing a lot more straight improvisation on my acoustic grand. I just sit at the keys and start playing whatever my brain tells my hands to do. It’s quit exhilarating but I fear that too much of it may drive the wife formerly known as the eternal fiancee’ bananas.

In order to avoid a bananas wife and to allow playing of the grand piano at any time of the night or day, I have ordered a Yamaha CP4 digital piano. This, according to all reports, plays very much like an acoustic grand and has sounds which are hard to tell from a Steinway.  In anticipation of its arrival I dug up from the basement my old synthesizer workstation a Korg Triton Studio. It was upon this 76 key electronic marvel that yours truly did most of the music production for my first album “Atherosclerosis Is My Psychosis” under the pseudonym Dr. P And The Atherosclerotics.

Emboldened by the interest readers displayed in my Neil Young tickets, I am hereby offering up for sale my beloved Korg Triton Studio 76 to readers of my blog who will provide a nurturing home for the instrument.  The wife just put this up plus its Korg gig bag on something called “Facebook MarketPlace” for $800 but I am willing to sell it for much less to any reader who says nice things about my blog.

What, you may ask, does all this have to do with Marilyn Monroe? Well, quite a bit (not much actually, its just clickbait.)  Using my extra time off this morning I ran 2 miles in the neighborhood and while listening on my airpods the following (reasonably obscure) Monty Python sketch (cowritten by Graham Chapman and Douglas Adams)  from   The Album of the Soundtrack of the Trailer of the Film of Monty Python and the Holy Grail   came up.

In it Michael Palin interviews film director Carl French (Graham Chapman) who has just released his latest movie which features the deceased and cremated  Marilyn Monroe in every scene.

Fans of MP will enjoy but those who are easily offended by nasty words or off-kilter humour should avoid.

 

Pythonically Yours,

-ACP

Which Ambulatory ECG Monitor For Which Patient?

The skeptical cardiologist still feels that KardiaPro has  eliminated  use of long term monitoring devices for most of his afib patients

However not all my afib patients are willing and able to self-monitor their atrial fibrillation using the Alivecor Mobile ECG device. For the Kardia unwilling and  many patients who don’t have afib we are still utilizing lots of long term monitors.

The ambulatory ECG monitoring world is very confusing and ever-changing but I recently came across a nice review of the area in the Cleveland Clinic Journal of Medicine which can be read in its entirety for free here.

This Table summarizes the various options available. I particularly like that they included relative cost. .

The traditional ambulatory ECG device is the “Holter” monitor which is named after its inventor and is relatively inexpensive and worn for 24 to 48 hours.

The variety of available devices are depicted in this nice graphic:

For the last few years we have predominantly been using the two week “patch” type devices in most of our patients who warrant a long term monitor. The Zio is the prototype for this but we are also using the BioTelemetry patch increasingly.

The more expensive mobile cardiac outpatient telemetry (MCOT) devices like the one below from BioTel look a lot like the patches now. The major difference to the patient is that the monitor has to be taken out and recharged every 5 days. In addition, as BioTel techs are reviewing the signal from the device they can notify the patient if the ECG from the patch is inadequate and have them switch to an included lanyard/electrode set-up.

The advantage of the patch monitors is that they are ultraportable, relatively unobtrusive and they monitor continuously with full disclosure.

The patch is applied to the left chest and usually stays there for two weeks (and yes, patients do get to shower during that time) at which time it is mailed back to the company for analysis.

Continuously Monitoring,

-ACP

A Patient’s Confusing Journey Into The Quagmire Of Cardiac Imaging: A Cautionary Tale

Mary-Ann, a reader from the north,  provides today’s post. Her story illustrates how easily medical care can veer off the rails while it is simultaneously railroading patients.  It is a cautionary tale with wisdom that can help most patients.

In this post I’ll just present Mary-Ann’s perspective and solicit responses.  Down the line I’ll provide some perspective on the processes, the problems and the solutions.


It started innocently enough. I showed up for a regular visit with my cardiac provider, a mid-level professional. She noted I was flushed and had a high pulse — about 100. 

Starbucks, I explained, and I flush easily — always have. She looked skeptical.

That is how I went from a half-caf Americano to a 48-hour holter monitor.

I went back for results — the usual ectopic beats but nothing scary or new. But again, she noted I had a fast heart rate and I was flushed.

And once again I explained: Starbucks — it is right down the street and okay, I might have a problem.

That is the short — but highly accurate — version of how I wound up getting a stress echo. 

I showed up for the results of the echo and that is where the runaway train started down the tracks.

“…possible inferoapical wall hypokinesis with lack of augmentation of systolic function, which are abnormal findings and may be indicative of ischemia due to underlying coronary artery disease. EF was 56% at rest and 40-50% at stress.” 

Wait — what?!

I was marched down the hall and scheduled for a cardiac angiography — and told not to run any marathons in the intervening two days. 

Marathon?! I was terrified I was going to drop dead at any moment. I contemplated just sitting the waiting room for 48 hours — just to be safe.

Then I started reading the professional literature and things were not adding up. An EF at stress of 40 – 50% is not good — in fact, it can be heading into heart failure land.

But I was active and fine — it did not make any sense.

I called the office; my provider was not available. I explained that I was worried there was a mistake. Oh no, I was assured, they are very careful to not make mistakes.

I wrote my will. I cried a lot. 

And when the person called to remind me of the procedure (like I could forget!?) I once again explained that I was worried there had been a mistake, and once again — reassurance. No mistake.

Nevertheless, she (aka me) persisted!

I sat on the hospital bed in nothing but a gown and handed the nurse my two-page letter; it started like this:

“I am reminded that what is normal and ordinary for a professional is never that for a patient. I am terrified.

First, I want to be really sure that there is not any chance of a mix-up in the stress echo test results. This is not simple denial or wishful thinking…” 

And that nurse paid attention, which is how I wound up not having a cardiac angiography. 

The cardiologist scheduled to do the procedure — we shall call him Doc #2 — wrote: 

“She has some concerns regarding the results of the stress echo study … I reviewed the most recent stress echo and it appears to me that the results for the resting versus the stress echo ejection fractions have been transposed…”

Translation: A Typo.

I was elated! Jubilant! We went to Starbucks to celebrate.

The giddy joy quickly turned to something along the lines of WTH just happened here? I read the original echo report written by Doc #1 — that lit the tinder. There were two different values for EF at stress documented in the report, and another sentence that was repeated. 

The professorial side of me was deeply affronted — in a subsequent meeting with hospital administrators I confess to saying that someone who is making hundreds of thousands of dollars a year doesn’t get to write such a sloppy ass report — and about someone’s heart, no less! 

But the best part of that meeting was learning that Doc #1 denied there was a typo — he stood by his findings. 

Oh dear.

And Doc #2 stood by his findings as well. And Doc #3 got involved somewhere along the way and he agreed with Doc #2. And the mid-level Provider also agreed with Doc #2.

The majority rule seems like an odd way to make health care decisions — wouldn’t you think all those smart people could talk among themselves and agree?

Apparently not.

That first meeting with the hospital folks included all manner of solicitous apologies and an attitude of collaboration. Of course, they said, we can send the echo to an outside cardiologist — at our expense — and get an answer.

And then I made the unthinkable mistake — and I blame the Skeptical Cardiologist for this — of asking informed questions.

“Are the cardiologists involved in reading my echo Level III echo specialists?”

“I understand that there can be variance in estimated EF between cardiologists — what level of variance is considered acceptable?”

The hospital team responded to my questions by calling a meeting — and the tone had changed considerably (Thanks a lot, Corporate Legal).

The offer to pay for an outside opinion was off the table — after all, they said, you would not have a patient-provider relationship with the cardiologist reading the echo. Ahem, I noted — I have zero relationship with the first cardiologist who read the echo and would not know him if I bumped into him at Starbucks. And you all did offer to pay for that outside opinion…

Oh never mind those minor details. No outside opinion on their dime. They would do a Lexiscan at their expense as a tie breaker. Final Offer.

Tiebreaker — really?! Is this a soccer game?

And seriously — should I have to have an invasive test to settle THEIR disagreement?! [Note: If it involves needles, it is invasive.]

Because there were not enough cardiologists involved already, I saw yet another one — from a different practice. He offered that the EF at stress looked more like 55%, placing his bet smack in the middle, and recommending a CT Angiography Coronary Arteries with Contrast as the tiebreaker.

Tiebreaker. That word implies both sides are equivalent or equal. However, my heart is not actually a game and the two teams cannot both be right — there is no equivalency in play here. What we are really trying to do involves accuracy — not breaking a tie score.

But I digress.

It doesn’t seem like you should have to make a chart to keep track of what cardiologists say about the same echo but in this case, it seemed necessary.

 And in the meantime, yet another cardiologist weighed in that the quality of the echo was poor — and no wonder they could not agree.

Deep breaths.

And so, for the past four months I have tried to navigate all this, and to understand what this actually means about cardiology and medicine and so many things. My confidence and my mind have been blown. Resources – and time – have been wasted. 

Ectopic heartbeats are typically benign in a structurally normal heart — I thought I was safe. But I have not felt safe since that day when I learned that Doc #1 and Docs #2, 3, and so on had decided to have a stand-off at the OK Corral that is my heart.

Except, I do not know if it is okay. And that is the problem. 


Unfortunately, Mary-Anne’s tale is not uncommon. It touches on many of the areas that patient’s should be aware of including

-Undergoing diagnostic imaging testing when you are free of symptoms

-Inadequate quality control in diagnostic imaging and how that leads to false positive results

-Variance in imaging performance and interpretation-how the same test can be read as normal by one doctor and markedly abnormal by another.

-The tendency of some cardiologists to recommend invasive testing when it is inappropriate and likely to cause more harm than good

-The importance of second opinions, especially if invasive testing is recommended

-The importance of patient’s doing their own research and asking good questions based on that research.

Transparently Yours,

-ACP

AliveCor’s KardiaBand Will No Longer Be Sold And Smart Rhythm Is No More

The skeptical cardiologist was quite enthusiastic about AliveCor’s Kardia Band for Apple Watch upon its release late in 2017.

I was able to easily make high fidelity, medical grade ECG recordings with it and its AI  algorithm was highly accurate at identifying atrial fibrillation  (see here). This accuracy was subsequently confirmed by research.

Many skepcard readers spent $200 dollars for the Kardia Band and had found it to be very helpful in the management of their atrial fibrillation.

However, in December of 2018 Apple added ECG recording to its Apple Watch 4, essentially building into the AW4  the features that Kardia Band had offered as an add on to earlier Apple Watch versions.

In my evaluation of the Apple Watch I found it to be “an amazingly easy, convenient and straightforward method for recording a single channel ECG” but its algorithm in comparison to AliveCor’s yielded more uncertain diagnoses.

Given it size, prominence and vast resources, Apple’s very publicized move into this area seemed likely to threaten the viability of AliveCor’s Kardia Band.

But then-interim CEO (and current COO)  Ira Bahr later told MobiHealthNews that his company’s broader business wasn’t threatened by its new direct competitor.

“We’re not convinced that Apple’s excellent, engaging product is a competitor yet,” he said in February. “We believe that from a price perspective, this product is least accessible to the people who need it most. If you’re not an Apple user, you’ve got to buy an Apple Watch, you’ve got to buy an iPhone to make the system work. So their technology is excellent, but we think the platform is both complicated and expensive and certainly not, from a marketing perspective, targeting the patient populations we target.”

Indeed, AliveCor’s Mobile ECG device and its recently released 6 lead ECG are doing very well but the threat to the viability of KardiaBand was real and MobiHealth News announced Aug. 19 that AliveCor had officially ended sales of the Kardia Band.

An AliveCor representative told MobiHealthNews that the company “plans to continue supporting KardiaBand indefinitely” for those who have already purchased the device. The company’s decision was first highlighted by former MobiHealthNews Editor Brian Dolan in an Exits and Outcomes report.

Mr. Bahr has confirmed to me that AliveCor does plan to continue supporting KardiaBand indefinitely. This includes replacement of KardiaBand parts.

Did Apple Kill Smart Rhythm?

The informed reader who notified me of AliveCor’s decision also notes:

The official reason is that they could not keep up with the Apple Watch updates and therefore the Smart Rhythm feature did not work properly.

I think many of us knew from the beginning that smart rhythm was not very accurate But in spite of that the Kardia band provided a valuable convenience over their other products.

It does appear that Smart Rhythm is no more.

AliveCor’s website was updated 6 days ago to state that Smart Rhythm was discontinued:

” due to changes beyond our control in the Apple Watch operating system, which caused SmartRhythm to perform below our quality standards”

Likely, as my reader was told, the frequent  AW4 updates plus the lack of a large KardiaBand user base made it unprofitable for AliveCor to continue to support Smart Rhythm.

Smart Rhythm, of course was AliveCor’s method for watch-based detection of atrial fibrillation. It clearly had limitations, including false positives but given AliveCor’s track record of dedication to high quality and accuracy I assumed it would improve over time..

Apple, on December 6, 2018  with the release of its watchOS 5.1.2 for AW4 announced its own version of Smart Rhythm at the same time it activated the ECG capability of AW4.

Apple called this feature “the irregular rhythm notification feature” and cited support for its accuracy from the widely ballyhooed Apple Heart Study (which I critiqued here.)

The irregular rhythm notification feature (TIRNF)was recently studied in the Apple Heart Study. With over 400,000 participants, the Apple Heart Study was the largest screening study on atrial fibrillation ever conducted, also making it one of the largest cardiovascular trials to date. A subset of the data from the Apple Heart Study was submitted to the FDA to support clearance of the irregular rhythm notification feature. In that sub-study, of the participants that received an irregular rhythm notification on their Apple Watch while simultaneously wearing an ECG patch, 80 percent showed AFib on the ECG patch and 98 percent showed AFib or other clinically relevant arrhythmias.

Despite widely publicized reports of lives being saved by TIRNF we still don’t know whether its benefits outweigh its harms. It is not clear what its sensitivity is for detecting atrial fibrillation and I have reported one patient who was in atrial fibrillation for 3 hours without her AW4 alerting her to its presence.

For AW4 users, absence of an alert should not provide reassurance that your rhythm is normal.

Thus is does appear that the Goliath Apple hath smote the David AliveCor in the watch-based afib battle. This does not bode well for consumers and patients as I think as competition in this area would make for better products and more accountability.

Philorhythmically Yours,

-ACP

N.B.

Per AliveCor the KardiaBand currently works with all all Apple Watches except the original one.

The Apple TIRNF per Apple:

is available for Apple Watch Series 1 and later and requires iPhone 5s or later on iOS 12.1.1 in the US, Puerto Rico, Guam and US Virgin Islands. The irregular rhythm notification feature does not detect a heart attack, blood clots, a stroke or other heart-related conditions including high blood pressure, congestive heart failure, high cholesterol or other forms of arrhythmia.

What Is A Cardiologist?

The skeptical cardiologist recently received a cease and desist letter from a lawyer representing Dr. Steven Gundry who felt I was defaming the goop doctor and supplement peddler by saying he was not a cardiologist.

The lawyer’s letter reminded me that many patients do not understand exactly what a cardiologist is and mistake us for cardiothoracic surgeons.

Here’s how the American College of Cardiology defines a cardiologist:

A cardiologist is a doctor with special training and skill in finding, treating and preventing diseases of the heart and blood vessels.

And here is part of my response to the lawyer which further clarifies the differences:

I understand your confusion with respect to the terminology of cardiologist versus cardiac or cardiothoracic surgeon. A surprising number of patients and readers think that I as a cardiologist perform “heart surgery.” Of course, actual surgery on the heart requiring “cracking open the chest” (which is what most laypeople consider “open heart surgery”) is always done by a cardiac surgeon not a cardiologist.

Like all other board-certified cardiologists I have gone through accredited training programs in internal medicine followed by a formal cardiology training program. There is no evidence that Dr. Gundry has done this.

Cardiologists, being extremely bright, entrepreneurial  and energetic, have expanded the toolkit they have for diagnosing and treating heart disease without having to engage in surgery. Thus,
cardiologists can insert  stents to open blocked coronary arteries, implant pacemakers and even replace valves all by accessing the cardiovascular system via its arteries and veins.

We don’t call this surgery because we aren’t surgeons and didn’t go through surgical training. We call these procedures. These are invasive procedures, to be fair, as we have invaded the vasculature and the interior of the heart and from these arterial and venous incursions complications may ensue.

A typical invasive procedure that cardiologists do looks like this:

This is a cardiologist  gaining access to the arterial system by inserting a catheter into the radial artery.

 

 

A typical open heart surgery performed by a cardiothoracic surgeon requires large incisions with direct visualization of the heart and looks like this:

 

 

 

 

 

Cardiologists And Cardiac Surgeons Undergo Totally Different Training

I began my response to Gundry’s lawyer by indicating my surprise that the lawyer felt Gundry was a cardiologist:

This comes as quite a surprise to me as my detailed research into Dr. Gundry’s background, training and credentials revealed absolutely no evidence that he is or ever was a cardiologist as we in the medical community define cardiologist. In fact, as you can see in his listing on CTSnet (which is a network of cardiothoracic surgeons) his post medical school training consisted of the following

University of Michigan Hospitals Surgery Internship (1977-78)
National Institutes of Health, Clinical Associate in Cardiac Surgery (1978-80)
University of Michigan Hospitals Surgery Residency (1980-83)
University of Michigan Hospitals Cardiothoracic Surgery Residency (1983-85)

He is trained as a cardiothoracic surgeon. Cardiothoracic surgeons go through surgical training programs which are completely different from the medical training programs that cardiologists like myself go through.

My description of him in this regards reads as follows:

“He is also widely described as a cardiologist but he is not, He is (or was) a cardiac surgeon (like, strangely enough, the celebrity prince of quackery, Dr. Oz)”

As you can see, my statement is perfectly accurate.

As far as him being a being elected a “Fellow of the American College of Cardiology” I can find no documentation of this and he is not currently listed as a member of the American College of Cardiology. But even if he was this does not make him a cardiologist because many cardiothoracic surgeons are members of the ACC.

Might I suggest you ask Dr. Gundry if he thinks he is a cardiologist. I’m pretty sure he would answer no.

What Is A Quack?

The lawyer then went on to accuse me of suggesting that Gundry is a quack because:

A “quack” is defined in common parlance as a lay person pretending to be a licensed physician. In other words, a fake doctor. The term “quack” connotes dishonesty, deception, fraudulent behavior, etc. Dr. Gundry has been a licensed physician and surgeon since at least 1989 (see Exhibit B attached), performed thousands of heart surgeries, and developed patented, life- saving medical technology. Your statements are not only factually incorrect, but are also irresponsible and intentionally misleading, resulting in harm to Dr. Gundry’s reputation and income.

To which I responded:

There seems to be an attempt here to suggest that by saying he is not a cardiologist I am calling him a quack. But as my previous information should have convinced you he is not a cardiologist but a cardiothoracic surgeon. He has done very good work as a cardiothoracic surgeon and I am happy to attest to that. I will be happy to add that information to his description in my up and coming posts on him.

At no point do I call him a quack in my posts. Clearly if I’m calling him a cardiothoracic surgeon I am acknowledging that he is a licensed physician and not, clearly, a fake doctor.

I have to admit my definition of quack has not been the common dictionary definition of “fake medical doctor.”  I have always considered those who engage in quackery to be quacks.

Quackery is defined at Quackwatch (the definitive website on the topic) as the promotion of unsubstantiated methods that lack a scientifically plausible rationale. 

And one can have a perfectly legitimate training as a medical doctor and engage in what most would consider quackery.

Even board-certified cardiologists like myself can engage in quackery.

Clearly there is a disconnect between the common definition of quack and that of quackery and in a  subsequent post I will delve further into the miasma of quackery, quacks and quacking,

Anatinely Yours,

-ACP

N.B. While researching this post I came across a fantastic article on Gwyneth Paltrow’s goop Doctors from David Gorski at Science-Based medicine. I highly recommend reading the entire piece (gwyneth-paltrow-and-goop-another-triumph-of-celebrity-pseudoscience-and-quackery) for your edification and pleasure.

Gorski’s paragraph on Gundry begins

  • Dr. Steven Gundry, a cardiothoracic surgeon very much like Dr. Mehmet Oz who, as he took incredible pains to lecture Dr. Gunter in his section of Goop’s hit piece on her, who once was a very respectable academic surgeon and, even better than Dr. Oz, served as Chairman of Cardiothoracic Surgery at Loma Linda University for a number of years, before leaving academia to undertake his private practice. (No wonder he and Dr. Oz seem to have an affinity for each other!) These days, he devotes his time to his practice, writing books, giving talks, and selling expensive supplements like Vital Reds (a bargain at $69.95 for per jar, discounted to $377.73 if you buy six jars) and Lectin Shield (a slightly more expensive bargain at $79.95 a jar, $419.70 for six), while bragging (as he did in his response to Dr. Gunter) about how so very, very hard he works and even—gasp!—accepts Medicare and Medicaid patients. His most recent book is The Plant Paradox: The Hidden Dangers in “Healthy Foods” That Cause Disease and Weight Gain. (Spoiler: That “hidden danger” is lectins.)

 

Featured image Photo by Ravi Singh on Unsplash

Does One Need A Doctorate To Analyse Science? And Does Bias Smell?

The skeptical cardiologist reserves the exclusive and unimpeachable right to censor reader comments he deems inappropriate, nasty or unhelpful.

There’s a good chance if you attack me personally, I won’t post your comment. On the other hand,  if I find your attack particularly amusing there is a good chance I’ll include it in a blog post.

Here’s an ad hominem attack I really enjoyed:

You may be an MD, but you are no doctor. That requires a doctorate, which I have, and I can smell the bias from the other side of the Earth. Your “skepticism” is a front for your cynicism, and you yourself are the very thing you hate when denigrating people like Esselstyn as “evangelists”. Get a doctorate degree and learn science before attempting to analyse it.

There is so much to unpack and ponder in this paragraph! I love it.

The reader says that I am “no doctor.” This, it appears, requires a doctorate (which, coincidentally my reader has). The reader advises me to “get a doctorate degree” before attempting to analyse science.

The Cambridge English dictionary defines doctorate as “the highest degree from a university” whereas Merriam-Webster defines it as “the degree, title, or rank of a doctor”

If we assume the reader is going by the Cambridge English definition, and my title of doctor of medicine doesn’t count as a doctorate, let’s see what does.

Wikipedia lists a ton of different types of doctorates. My reader didn’t specify what kind. Would a Doctor of Music qualify me to analyse science? If so, sign me up for the coursework.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

My newly-minted mother-in-law has a doctorate in English, is she more qualified than me to analyse science?

The reader left his comment on my post about the death of Robert Atkins, so I’m not even sure what bias I am accused of, but I love this sentence:

“I can smell the bias from the other side of the earth”.

In my defense it should be pointed out that the entire Robert Atkins post is a precise  analysis of his medical history and doesn’t really touch on science. Perhaps the bias my reader smells from so far away is my bias to seek the truth.

Finally, I have to say the killer sentence in my reader’s comment  is the most brilliant ad hominem attack I have ever encountered:

Your “skepticism” is a front for your cynicism, and you yourself are the very thing you hate when denigrating people like Esselstyn as “evangelists”.

It is so deep and piercing that I am incapable of defense and I can only say “mea culpa” and I yield to your doctoral brilliance.

By the way, this whole PhD versus MD debate brings up the burning question of who one should be referring to as doctor. Should I address my mother-in-law as Dr. Perkins since she has a Ph. D. in English Literature?  And, by the way, although she is my go-to person for questions about D.H. Lawrence, Hemingway and Shakespeare, I don’t think her scientific analytic skills are up to mine even with her doctorate.

Doctorally Yours,

-ACP

Photo by Adrien Converse on Unsplash

N.B. I have deduced my reader is from Australia based on his use of analyse and his smelling my bias on the other side of the earth.

(Also, his email address ends in au)

frequency of usage of analyse versus analyze in England
frequency of usage of analyse versus analyze in England .
frequency of analyse versus analyze in America