Category Archives: Hypertension

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

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

When it comes to self-monitoring of blood pressure the best device (assuming equivalent accuracy) is the one that patients are most likely to use.

The Omron Evolv has become that device for the skeptical cardiologist as it combines a unique one-piece design with built in read-out with a quicker, more comfortable  yet highly accurate BP measurement technique.

My previous favorite BP device, the QardioArm remains a close second.

Evolv Form and Function

The Evolv is sleek and stylish in appearance and has no external tubes, wires or connectors. It runs on 4 AAA batteries.

 

 

The  cuff is pre-formed and is incredibly easy to self-administer to the upper arm. Measurement is simple. Press the start button and it immediately starts inflating the cuff.

The results are displayed on an LCD screen on the cuff.

The Omron uses an oscillometric technique to measure the blood pressure as it is inflating. This “inflationary” technique has been shown to be as accurate as measuring during deflation but is much quicker. A study using the recently developed “Universal Standard Protocol” for evaluating the accuracy of BP devices showed that the Omron Evolv was highly accurate compared to gold standard sphygmomanometry.

Omron has come up with some slick marketing terms for the inflationary and pre-formed wrap aspects:

  • Intellisense Technology – Inflates the cuff to the ideal level for each use.
  • Intelli Wrap Cuff – For an easy and accurate reading

With the inflationary technique the cuff knows when to stop inflating, (hence “intellisense”) therefore, there is less tendency to go to higher pressures compared to the deflationary technique and less potential for discomfort from those higher pressures.

Evolv Communication-Sharing Results

The Evolv communicates via Bluetooth with the Omron Wellness (or Connect) smartphone app. Your BP  and heart rate measurements are easily transferred to this app and can be viewed over time.

My blood pressure and heart rate measurements over the last week.

If  one clicks on the little export icon at the upper right had corner of this summary screen you can “export CSV” which creates a file of BP measurements over a defined period that can then be emailed to yourself, your curious friends, or your doctor.

Another option is to export the summary report but this is a premium feature and requires payment.

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Monitoring Heart Rhythm and Blood Pressure-The Omron/Kardia Pro Connection

I’ve discussed in detail how management of my afib patients who have the Kardia mobile ECG device and connect to me via the internet using KardiaPro Remote has tremendously advanced their care.

AliveCor has partnered with Omron and the Omron Connect (or Wellness) app is essentially the Kardia app which my patients utilize to record their ECG recordings and share them with me.

With this app, therefore, patients who have the connection subscription service can utilize the Omron app to share both their ECG and BP recordings with me online. This is really quite an amazing development.

Below are recordings from one of my patients that I took from the patient screen which I view online.

The data can be viewed in various formats including this one which gives a good idea of daytime variation in BP as well as percentage recordings in goal range.

 

For me, this ability to rapidly view patient’s blood pressures over time in meaningful ways greatly facilitates management. If we could find a way to seamlessly import these data directly into our EMR it would an even bigger step forward.

Speaking To Your BP Cuff

I don’t use Alexa but Omron highlights how the Evolv works with Alexa:

 

 

Somehow, this doesn’t seem helpful to me but I tried asking Siri (with both my Apple Watch and iPhone) if she could give me info on my blood pressure and she failed miserably

 

 

 

 

 

 

 

Evolv-The Future of BP Management?

To summarize why I am so enthusiastic about this BP cuff

  • Portability and compactness. One piece design without tubes or wires.
  • Rigorously proven accuracy
  • Esthetically pleasing
  • Quicker and more comfortable than “deflationary” cuffs
  • Read-out on cuff-no separate unit or smartphone required
  • Communicates well with highly functional app for organizing or reporting BP measurements over time
  • Coordination of ECG measurements from Kardia and BP measurements on app through KardiaPro facilitates physician management of patient’s cardiovascular conditions.

Oscillometrically Yours,

-ACP

N.B. In the course of researching the Omron Evolv I looked at multiple home BP monitor review websites online. Almost without exception these were worthless.  I suspect many of these device review sites are funded by companies making the products. Others just aggregate information from company websites and regurgitate it without analysis. Websites with apparent consumer reviews are also suspect as I have found unscrupulous vendors are manipulating the whole review process.

Fortunately, your trusty skeptical cardiologist remains unsullied by any financial connections to corporate America. Or corporate Japan for that matter  (It appears Omron has its headquarters in Kyoto, Japan). However, Omron, if you are listening perhaps you can send me for my review one of your new Complete combined BP and EKG monitoring devices!

 

 

 

 

And one final detail. I checked just now and you can purchase the Evolv at Amazon for $69. Bundles that connect you to your doctor through the cloud and get you an Evolv plus or minus the Kardia ECG device at a reduced price are available through both the Kardia and Omron websites and apps.

 

Why I Encourage Self-Monitoring Of Blood Pressure In My Patients With High Blood Pressure

The skeptical cardiologist primarily makes decisions on blood pressure treatment these days based on patient self-monitoring. 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.

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

Although I’ve been recommending self-monitoring to my patients for decades it is only recently that guidelines have endorsed the approach and good scientific studies verified its superiority. I was pleased when the 2017 ACC/AHA guidelines for High Blood Pressure made home self-monitoring of BP a IA recommendation.

And last year a very good study, the TASMNH4 was published which demonstrated the superiority of self-monitoring compared to usual care.

TASMINH4 was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group).

The home BP goal was 135/85 mm Hg, 5 mm Hg lower than the office BP goal. At one year both home self-monitoring groups had significantly lower systolic blood pressure than the usual care group.

This trial was not powered to detect cardiovascular outcomes, but the differences between the interventions and control in systolic blood pressure would be expected to result in around a 20% reduction in stroke risk and 10% reduction in coronary heart disease risk. Although not significantly different from each other at 12 months, blood pressure in the group using telemonitoring for medication titration became lower more quickly (at 6 months) than those self-monitoring alone, an effect which is likely to further reduce cardiovascular events and might improve longer term control.

Advantages of Home Self-Monitored Blood Pressure-Limitations of Office BPs

I described why I switched to home BPs in a post about the landmark  SPRINT trial in 2015:

Every patient I see in my office gets a BP check. This is typically done by one of the office assistants who is “rooming” the patient using the classic method with , listening with stethoscope for Korotkov sounds. If the BP seems unexpectedly high or low I will recheck it myself.

Often the BP we record is significantly higher than what the patient has been getting at home or at other physician offices.

There are multiple factors that could be raising the office BP: mental stress from driving to the doctor or being hurried or physical stress from walking from the parking lot.

In addition, I feel that multiple assessments of out of office BP over the course of the day and different days are more likely representative of the BP that we are consistently exposed to rather than one reading in the doctor’s office.

Accuracy and technique in the doctor’s office is also an issue.

Interestingly, we have assumed that manual office BP measurement is superior to automatic but this recent paper found the opposite:

Automated office blood pressure readings, only when recorded properly with the patient sitting alone in a quiet place, are more accurate than office BP readings in routine clinical practice and are similar to awake ambulatory BP readings, with mean AOBP being devoid of any white coat effect.

A patient left a comment to that paper which is quite insightful:

I had a high blood pressure event several years ago. Since then I have monitored my BP at home, sitting with both feet flat on the floor, not eating or drinking, not speaking or moving around, on a chair with a back, and without clothes on the arm being used for the measure. My BP remains normal.

I have never had my BP taken correctly in a doctor’s office. They will do it while I am speaking with the doctor, sitting on an exam table with my legs swinging, with the monitor band over my heavy winter sweater, right after I have sat down. They do not ensure that my arm is supported or at the right height. If I recommend that I take off my sweater, or move to a chair with a back, they tell me that is not needed. I have decided to refuse such measurements. How can they possibly be monitoring my health this way?

This patient’s observations are not unique and I suspect the majority of office BPs have most if not all of the limitations she describes.

Self Monitoring Improves Patient Engagement In BP Control

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.

I take my BP almost daily and adjust my BP medications based on the readings. After prolonged work or exercise in heat, for example, BPs will decline to a point where I’m light headed or fatigued. Less BP med at this time is indicated. Conversely, if I’ve been overly stressed BPs increase and upward titration of medication is warranted.

With some of my most engaged and enlightened patients we perform similar titrations depending on their circumstances. Sometimes patients perform these titrations on their own and tell me about them at the next office visit.

What’s The Best Way To Communicate Home BPs?

Many of my patients provide me with a hand-written record of their BPs over two weeks.  Some mail them to me, others bring them in to the office. We scan these into the EMR. I look at these and make an estimate of the average systolic blood pressure, the variation over time and the variation during the day. It’s not feasible for me or my staff to enter the numbers or precisely obtain an average.

Some patients send us the numbers through the internet-based patient portal into the EMR. This is preferable as I can view these and respond quickly and directly back to the patient with recommendations.

More and more patients are utilizing their smart phones to record and aggregate their health data and will bring them in for me to look at during an office visit. I’ve described one stylish and slick BP cuff, the QardioArm which has neither tubes nor wires and works through a smartphone app. Omron , also has multiple cuffs which communicate via BlueTooth to store data in a smartphone app.

Ideally, we would have a way for me to view those digitally recorded BPs with nicely calculated averages online and within the EMR. Unfortunately, such connectivity is not routinely available.

However, for my patients who are already monitoring their heart rhythms with a Kardia mobile ECG and are connected with me online through KardiaPro Remote I can view their BP recordings online.

I’ll discuss in detail in a subsequent post the Omron Evolv home automatic BP cuff (my current favorite) which is wireless and tubeless and connects seamlessly to KardiaPro allowing me to view both BP and heart rhythm (and weight) recordings in my patients

To me, this empowerment of patients to record, monitor and respond to their own physiologic parameters is the future of medicine.

Sphygmomanometrically Yours,

-ACP

From the 2017 ACC/AHA BP guidelines

and the proper technique for office BP measurement

 

 

FDA Recalls More Generic Blood Pressure Meds: Where Are Your Medications Manufactured?

In July of 2018, the FDA made a series of voluntary recalls of several versions of the generic blood pressure medication valsartan which were made in China and were contaminated by the “possible carcinogen,”  N-nitrosodimethylamine (NDMA).

At the time I asked readers the question, “Is your BP med made in china and is it safe?” as it became clear that now in the US users of medications must be very aware of the source and quality of the products they put in their body.

Generic prescription medications and OTC products are highly likely to be manufactured out of the US and with minimal oversight.

Since then the FDA has announced multiple other recalls for companies producing angiotensin II receptor blockers (ARBs) in the same class as valsartan, including products containing losartan and irbesartan,. These drugs have been found to be contaminated contaminated with NDMA or another carcinogen  N-nitrosodiethylamine (NDEA).

The recall now includes irbesartan and losartan plus additional lots of valsartan. Thus, some patients who we switched from valsartan to losartan are now having to switch again.

Click the following links to review updated lists of irbesartan products under recall, losartan medications under recall, valsartan products under recall and valsartan products not under recall.

Here’s  the FDA’s valsartan alert notice from 1/2/19

FDA is alerting patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. Aurobindo is recalling amlodipine and HCTZ only in combination medications containing valsartan. Neither amlodipine nor HCTZ is currently under recall by itself.

Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million.

The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels.

FDA also updated the list of valsartan products under recall and the list of valsartan products not under recall.

FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. Some ARBs contain no NDMA or NDEA.

Fortunately, there are multiple generic  and brand nameARBs we can substitute for the recalled products.

perspective-1

Patients Discover How Hard It Is To Find Non-Chinese Medications

When I tried to find the source of my generic medications, the results were eye-opening:

 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 had not realized how globalized the pharmaceutical industry had become.

Many readers also researched the source of the pills they were taking and shared their experience through comments on my blog:

“Frustrated” wrote

My cardiologist changed my blood pressure med to irbesartan. Another generic ARB. I went to get it filled today at a local grocery store pharmacy. I asked where it was made and they showed me the bottle. Guess what? It was SOLCO/Prinston as distributor and Zhejiang Huahai Pharmaceuticals LTD – the same manufacturer as the tainted valsartan. Exactly the same. Despite the recent horrible FDA inspection report of that facility which is posted online here: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM621162.pdf

Also, the FDA has found another cancer causing chemical in the drug since I last wrote – now there are two. I checked at [MAJOR CHAIN] pharmacy – they use the SAME CHINESE MANUFACTURER. I checked at [MAJOR CHAIN 2] – yep, they use the SAME CHINESE MANUFACTURER. This is really starting to get scary. I’m trying hard to find a pharmacy that has the non-Chinese version (there are 16 other generic manufacturers of the drug). My insurance company only permits me to use the pharmacies I tried today. Funny how everyone is buying Chinese. Does that validate the claims made in the Epoch article. Is this really that Chinese are undercutting everyone else? I’m just disgusted. I will tell you that if I owned a pharmacy I would not purchase my generics from the same company that just caused one of the largest drug recalls in history. It must be really really cheap. Really really cheap.

Mitch writes:

I have been taking Losartan, but became really concerned with the latest news about carcinogens found in two more BP medications. I called EVERY local pharmacy, including big-box stores, grocery store pharmacies, independent pharmacies, and traditional pharmacies. Not a single one has US-made losartan. Every one of them has stock of meds made in either China or India. One pharmacists told me that he had no control of what he sells; it’s all decided on the corporate level. Another said that he would stock the cheapest generic he could find. Still another pharmacy tried to convince me that Citron, Torrent, and Solco are New Jersey companies selling US-made drugs. It takes only a few minutes of Internet research to prove them wrong. Apparently, there is no incentive to stock US-made drugs. I agree, the consumers have to take action and write to their representatives demanding answers from the FDA.

BIS wrote:

I have just had the same experience. My Indian made Valsartan (Camber) was recalled so my doctor switched me to Irbesartan 150 mg tablets which at my local CVS were also manufactured by Camber. I reluctantly took these while searching for US or European made alternatives. I just went to CVS to get my refill. When I got home instead of the Indian Irbesartan I received a bottle manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd.,(ZHP) Xunqiao, Linhal, Zhejiang China. I am a mechanical engineer not a chemistry major but I believe Irbesartan contains API which is what has been the problem from this company. Looking at the internet I see that the FDA has and import alert for this company. The import alert halts all ZHP-made API and finished drug products using the company’s API from legally entering the United States (https://www.pharmacist.com/article/fda-places-zhejiang-huahai-pharmaceuticals-import-alert). Let’s see- did the Chinese use good API in this batch….I called the CVS and asked for alternatives and was told “good luck”. My doctor said he will work with me if I can find non Chinese or Indian medication. I go out of my way to buy American made goods as I have worked in manufacturing my entire career and have made numerous trips to China and seen what goes on. My Chinese colleagues when they come to the US fill their bags with US made baby formula and vitamins (which probably contain Chinese ingredients). If anyone finds a US or European source of BP medication please post it.

What Can We Do?

One of my readers, Kate, made the following suggestion which made a lot sense:

write to the Senate committee that oversees the FDA. Demand more clarity in labeling of prescription bottles – the country of origin should be CLEAR and CONSPICUOUS – just like that little “Made in China” sticker on the photo above – but on the prescription label itself. Right now only the pharmacist’s supply bottle has the labeling. Write your congressman and to:

U.S. Senate Committee on Health, Education, Labor & Pensions

428 Senate Dirksen Office Building

Washington, DC 20510

I would encourage patients who are taking these recalled ARBS (which are really good blood pressure medications) to check their pill bottles and check with their pharmacists to determine if they have been recalled. If the pharmacist can’t replace your medication with an identical ARB that hasn’t been withdrawn, ask your physician for one of the alternatives listed above.

Find out what country you’re generic drugs in general are made in and let your congressional representatives know you want better FDA oversight of off-shore pharmacuetical manufacturing along with complete transparency with respect to country of origin.

Skeptically Yours,

-ACP

Becoming Enlightened About More Stringent Blood Pressure Goals: Sapere Aude!

The skeptical cardiologist and many of his patients with hypertension have a decision to make: what should our BP goal be?

Given that we have data now on over 1 million patients one might think that the answer would be clear and that there would be a consensus amongst all the experts.

Messerli and Bangalore, writing in a recent special hypertension issue of JACC, however, clearly articulate the “blood pressure landscape schism” that currently exists.

This figure from their paper (subtitled “Schism Among Guidelines, Confusion Among Physicians, and Anxiety Among Patients”) shows the marked difference in BP goal and treatment recommendations for the same patient in recent American and  European Cardiology and American Family Practice Guidelines.

The 2017 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines—which aide approximately 25,000 cardiologists in the United States—indicate that her BP should be <130/80 mm Hg (1). The 2018 European Society of Hypertension (ESH)/European Society of Cardiology (ESC) guidelines—which aide approximately 75,000 physicians—indicate that her BP should be <140/90 mm Hg (2). The 2017 American College of Physicians (ACP)/American Association of Family Physicians (AAFP) guidelines—which aide approximately 250,000 family practitioners and internists in the United States—indicate that her BP should be <150/90 mm Hg

 

 

 

 

 

 

 

 

 

 

 

Messerli and Bangalore use a second figure to graphically illustrate the potential consequences of the differing guidelines.

Stroke Mortality for Upper Limit of On-Treatment Systolic Target BP as per Various Guidelines Absolute risk of stroke mortality is 5% for the suggested on-treatment target BP of the ACC/AHA guidelines, 8% for target BP of the ESH/ESC guidelines, and 14% for target BP of the ACP/AAFP guidelines. Abbreviations as in

Cardiovascular death rates thus may vary three-fold depending on what BP goal we choose.

This marked variation in treatment recommendation highlights that they

are not only an evaluation and interpretation of evidence in question, but also a judgment weighted by personal, regulatory, and organizational preferences that can vary from physician to physician within a country and across geographical regions.

Physicians and patients (hopefully through shared decision making) are going to have to do some thinking on their own.

Messerli and Bangalore quote Immanuel Kant in this regard:

Enlightenment is man’s emergence from his self-imposed nonage. Nonage is the inability to use one’s own understanding without another’s guidance. This nonage is self-imposed if its cause lies not in lack of understanding but in indecision and lack of courage to use one’s own mind without another’s guidance. Dare to know! (Sapere aude.) “Have the courage to use your own understanding,” is therefore the motto of the enlightenment.

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*.

Sapere Audaciously Yours,

-ACP

*N.B. In the SPRINT study the BP was obtained using an automatic BP cuff after 5 minutes of rest with the patient unobserved and averaging 3 recordings one minute apart.

This “research grade BP” averages about 12 mm Hg less than a routine single clinic obtained BP (see here.)

The BP Schism

Optimal Home Blood Pressure Monitoring: Must The Legs Be Uncrossed and The Feet Flat?

The new ACC/AHA guidelines for High Blood Pressure were published late last year and they were in favor of using home blood pressure measurement to aid in the management of hypertension.

I was happy to hear this as I am constantly advising my hypertensive patients to buy a home BP cuff, measure their BP once when they get up and again 12 hours later and report the values to me after two weeks.

I have not spent a lot of time instructing them on  exactly how to make the measurement but the new guidelines do specify in detail how this should be done:

• 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.

I monitor my own BP at home and often wonder whether there is scientific evidence to support such a rigid protocol.  Being a contrarian and a skeptic, I typically violate 3/4 of the recommendations that are listed.

It seems like all of the instructions are guaranteed to give you the lowest BP you are likely to experience during the day. The vast majority of the time I am not sitting quietly with my legs uncrossed, my bladder empty and my back straight so following these directions will underestimate my average daily BP.

I’ve spent some time looking into all the instructions and they generally have some scientific studies to support them. For example, the position of the upper arm in relation to the heart does  heavily influence BP readings (more on that in subsequent posts.)

The Mandate To Uncross The Legs

The instruction that most intrigued me was this one:

Sit with feet flat on the floor and legs uncrossed.

A number of questions came to the skeptical hypertensive:

What if you are on an exam table and your feet don’t reach the ground?

Does it really make a difference if your feet are flat on the ground versus slightly crooked?

Does any degree of leg crossing influence BP? Legs crossed at the ankles? Legs crossed at the knee?

And once I began thinking of leg crossing I realized that I spend a lot of my time with my legs crossed. Was this raising my blood pressure and my cardiovascular risk? Did I cross my legs because I liked the feel of a higher blood pressure?

The ACC/AHA guidelines are not alone in this recommendation-take a look at the British Health Service recommendation:

3.5. Measurements should be taken in silence when the patient is relaxed, with both feet flat on the floor and their back and arm supported. Many patients automatically cross their legs, which raises their blood pressure, so it is particularly important to emphasise the need for the patient to uncross their legs when taking their blood pressure.

Apparently the Brits believe that any ambient sound will alter the blood pressure. Talking is right out!

But if talking, ambient sounds and crossing your legs raises your blood pressure shouldn’t we be advising patients to spend their days wearing ear plugs in silence with their legs uncrossed?

Scientific Studies On Leg Crossing

It turns out there are good studies showing that leg crossing raises your blood pressure.

The first was published in 1999 and involved  53 hypertensive and 50 normotensive subjects.

Participants were randomly assigned, using a cross over design to having seated blood pressures measured with their leg in three different postures

  1. Feet flat on the floor and legs uncrossed

    Here I am demonstrating method 2 with my lateral malleolus carefully placed on my suprapatellar bursa. I actually prefer method 1 which is depicted below.
  2. Legs crossed , method 1-popliteal fossa of the dominant leg over the suprapatellar bursa of the non-dominant leg.
  3. Legs crossed, method 2- lateral malleolus (which the article spells mallelous) of the dominant leg over the suprapatellar bursa of the non-dominant leg.

I love the efforts these Calgarian investigators went to in this study to ensure blinding (although spelling is clearly not their forte’). They state “blood pressures were measured by one investigator who was behind a screen and blinded to the leg position of the patient while a second investighator (sic)  ensured that the subject assumed the proper leg position.”

Systolic blood pressure in patients with hypertension increased by 8 mm Hg by method 1 leg crossing and 10 mm Hg by method 2.

Figure from Adiyaman, et al. demonstrating method 1 on the left.

Another study demonstrated that although crossing the legs at the knees influenced blood pressure, crossing them at the ankles had no effect.

A recent review identified 7 studies which support the influence of leg crossing on BP.

 An Inconvenient Truth
If leg crossing raises the systolic blood pressure  8 to 10 mm Hg why aren’t we doctors recommending patients sit with leg uncrossed the majority of the time. Personally, I had never heard there were any health complications to sitting with my legs crossed.
Apparently the myriad health information sources on the internet are near unanimous in their condemnation of leg crossing but the hypertensive effect of this maneuver is usually not cited.
My favorite title condemning the practice was “The surprising and inconvenient truth of crossing your legs.”
I must admit since doing this bit of research I have substantially reduced the amount of time I sit with my legs crossed. And I’ve pondered extensively whether sitting with legs crossed makes me feel any different and why I suddenly and seemingly randomly decide to cross my legs.
I’ve also started asking  friends and colleagues and medical residents how much of the day they spend with legs crossed.
On teaching rounds one morning recently we tested a volunteer resident’s blood pressure with legs crossed and uncrossed. Sure enough, the systolic BP was 10 mm Hg higher with legs crossed.
Chiasmically Yours,
-ACP

 

For those of you itching to read more about BP and leg crossing here are the references:

 

Pinar R, Ataalkin S, Watson R. The effect of crossing legs on blood pressure in hypertensive patients. J Clin Nurs 2010; 19:1284–1288. [PubMed]
Adiyaman A, Tosun N, Elving LD, Deinum J, Lenders JWM, Thien T. The effect of crossing legs on blood pressure. Blood Press Monit 2007; 12:189–193. [PubMed]
Pinar R, Sabuncu N, Oksay A. Effects of crossed leg on blood pressure. Blood Press 2004; 13:252–254. [PubMed]
Avvampato CS. Effect of one leg crossed over the other at the knee on blood pressure in hypertensive patients. Nephrol Nurs J 2001; 28:325–328. [PubMed]
Keele-Smith R, Price-Daniel C. Effects of crossing legs on blood pressure measurement. Clin Nurs Res 2001; 10:202–213. [PubMed]
Foster-Fitzpatrick L, Ortiz A, Sibilano H, Marcantonio R, Braun LT. The effects of crossed leg on blood pressure measurement. Nurs Res 1999; 48:105–108. [PubMed]
Peters GL, Binder SK, Campbell NR. The effect of crossing legs on blood pressure: a randomized single-blind cross-over study. Blood Press Monit 1999; 4:97–101. [PubMed]

Is There A Difference in Blood Pressure Between Your Right and Left Arms?

The skeptical cardiologist has a question for all patients who have elevated blood pressure: has your doctor ever taken your BP in both the right and left arms?

Have you ever noted a difference in the systolic BP between arms (interarm difference or IAD) when you do home recordings?

Although UK and USA national hypertension guidelines recommend measuring BP in both arms on  a first visit and most PCPs are aware of the recommendation, only 30% agree with it and few actually adhere to it. (2007) Hypertension guideline recommendations in general practice: awareness, agreement, adoption, and adherence. Br J Gen Pract 57(545):948952.

It’s important to measure the difference between right and left arm BP at least once because:

  1. An IAD >10 mm Hg often indicates peripheral artery disease (such as a blocked subclavian artery to the arm with the lower BP) and is associated with higher cardiovascular disease risk.(Clark, et al (2006) Prevalence and clinical implications of the inter-arm blood pressure difference: a systematic review. J Hum Hypertens 20(12):923931)
  2. A blocked subclavian artery can cause neurological symptoms, dizziness or loss of
    Graphic depiction of blockage of left subclavian artery indicating that the collateral flow is stolen from the brain via reversed flow down the vertebral artery. Thus subclavian steal syndrome.

    consciousness (termed subclavian steal syndrome and typically occurring after using the arm with the blocked artery.)

  3. A consistently  lower BP in the left arm compared to the right arm  can be a sign of a serious and correctable congenital heart disease called coarctation of the aorta.
  4. The true BP (i.e. the one we should be treating) is the higher of the two. Thus, if you do have a consistent IAD, you should only measure the higher one for monitoring BP.

In 2009, Parker and Glasziou noted that whereas 13 of 15 national hypertension guidelines recommend measuring BP in both arms:

“only seven guidelines gave some justification, with only one quantifying the prevalence of substantial arm differences and only one providing a reference to the evidence. No guideline provided a description of appropriate techniques for reliably measuring blood pressure in both arms. “

they speculated that if PCPs were given better justification and precise details on how to reliably measured the IAD they would be more likely to do it.

I’ve mentioned the “why” for measuring IAD above.

The “why” is so compelling that if you have hypertension or pre-hypertension (SBP 120-140) and you’ve never had the BP compared in both arms you should do it yourself.

The “how” of IAD is more complicated.

In a subsequent post I will give my recommendations on how to reliably measure IAD and I will tell the story of a 75 year old competitive ice hockey player with a totally blocked subclavian artery to his right arm.

Dextrosinistrally Yours,

-ACP

 

 

 

 

 

 

 

QardioArm: Stylish, Accurate and Portable. Is It the iPhone of Home Blood Pressure Monitors?

The skeptical cardiologist frequently has his hypertensive patients check their BPs at home and report the values to him.

An easy, accurate and efficient way to record BPs at home, and transmit to the doctor, is my Holy Grail for management of hypertension; QardioArm offers to improve on this process compared to more conventional home BP cuffs.

I recently bought a QardioArm for my father and tested one myself over the last month, and herein are my findings. I compared it closely to my prior “go to”  BP device, the Omron 10 (which I recommended as a Christmas gift here).

Appearance

The QardioArm looks like and is packaged like an Apple product. The box containing the device is esthetically pleasing, and can serve as an excellent storage and transportation mechanism. The case closes magnetically and has a pocket, within which resides the manual.

 

Upon removing the QardioArm, one is struck by how compact, sleek and cool it looks. This is not your father’s BP cuff. There are no wires or tubes coming off it, and the cuff wraps around a red (white, blue or gold) plastic rectangular cuboid.

The cuff/cuboid is small enough to easily fit in a purse or satchel, facilitating portability.

Ease of Use

Once you understand how the device works it is a breeze to use.  However, if you are inclined, like me, to skip reading the instruction manual, you run the risk of being incredibly frustrated.

First, you must download the free Qardio App to your smartphone, create a user login, register and create your personal account. If you don’t have a smartphone or tablet or don’t use the internet, this cuff if not for you. For me, this was a simple, quick process.

After setting up the Qardio App, you pair the QardioArm with the App. This requires the QardioArm be on and Blue Tooth be enabled on your smartphone.

An example of the profoundly negative review individuals give the device when they have not figured out the on/off process. This one on Consumer Reports

You might think that turning on the QardioArm, and knowing it is on,
would be an incredibly easy and obvious process: it is not (unless you pay close attention to the instructions). If you read reviews of Qardioarm on Consumer Reports or Amazon, you will encounter many very unhappy users. This is primarily because some folks could not get it to turn on.


Here are my detailed instructions for turning it on:

  1. There is a small magnet inside the cuff.
  2. The device turns itself on when you unwrap the cuff and it turns off when you wrap the cuff back up. (I am not good at wrapping things up properly and ran into issues initially because of this). When you wrap the cuff up properly you can feel the magnet locking into place and thus turning the device off.
  3. When the device is on there is no light to indicate it is on. A green light flashes on the side when it turns on, but then goes out. Many user reviews indicate frustration with this and often they end up trying to change the batteries, believing that the device is dead. I went through this same thought process initially.
  4. The device turns off “after a few minutes” if not used. You won’t know if it is on or off. If it doesn’t respond when you trigger it from the App, you must carefully rewrap the cuff and then unwrap it. If you don’t trigger the device properly with the magnet, it won’t wake up.

The QardioArm encircling the beautiful arm of the eternal fiancee’ of the skeptical cardiologist. Note: when the cuff is wrapped around my unattractive arm, it fastens properly and does not hang down.

Now that you know how to turn the device on and have paired it with your Cardio App, put the cuff over your upper arm with the cuboid over the inner aspect of your arm,
hit the big green START button and sit back while the cuff is magically inflated and an oscillometric measurement of your blood pressure performed.

 

 

The blood pressure is displayed on the app instantaneously along with pulse. If the device detects irregularity of the pulse (a possible but not reliable sign of atrial fibrillation or other abnormal heart rhythms), it display an “irregular heart beat” warning.

You can have the QardioArm take 3 BPs, a variable amount of time apart, and average the readings.

BP and pulse data can be viewed in tabular or graphic formats and  can be synched with the Apple Health App:

 

Accuracy

I found the QardioArm BP measurements to be very accurate. My medical assistant, Jenny, recorded our patient’s BPs using the “gold-standard” manual technique, and with QardioArm (consecutively and in the same arm), and there was excellent agreement. In one man with a very large arm, she could not record a BP (QardioArm’s cuff fits the arm of most people, and is appropriate for use by adults with an upper arm size between 22 and 37 cm (8.7 and 14.6 inches).  If your upper arm is larger than that, this device is not for you.  In one patient who was in atrial fibrillation, the device properly recorded an “irregular heart beat.”

From the Qardio website:

QardioArm is a highly accurate blood pressure monitor and has undergone independent, formal clinical validation according to ANSI/AAMI/ISO 81060-1:2007, ANSI/AAMI/ISO 81060-2:2009, ANSI/AAMI/IEC 80601-2-30:2009, as well as British Standard EN 1060-4:2004.

QardioArm is a regulated medical device: FDA cleared, European CE marked and Canadian CE marked.

It measures blood pressure with a resolution of 1 mmHg and pulse with 1 beat/min.

The accuracy is +/- 3 mmHg or 2% of readout value for blood pressure, and +/- 5% of readout value for pulse.

Comparison To Omron 10

I spent time evaluating the accuracy of QardioArm because a few online reviewers suggest that it is highly inaccurate for them and Consumer Reports gives it a “poor” rating for accuracy.

Consumer Reports gave the QardioArm an astonishingly low score giving it lower marks than the Omron for Convenience, Accuracy and Comfort. It gave the QardioArm a Poor mark for accuracy. No details of their measurement data are available on the site.

I compared it to the Omron 10 (Consumer Reports highest-rated BP device), and found close agreement between the two.

Simultaneous BP using Omron (above) and QardioArm (left)


I took my own BP with the QardioArm on the left arm and the Omron 10 on the right arm. Multiple simultaneous measurements showed less than 3 mmHg difference in systolic blood pressure between the two.

Unlike Consumer Reports, I found QardioArm superior to the Omron 10 in several areas:

  1. QardioArm is faster. It took 30 seconds to complete a BP measurement, compared to 50 seconds for the Omron 10.
  2. BPs are immediately available on my iPhone with QardioArm, whereas a separate Bluetooth synching process is required for the Omron App. This process never works well for me, as the Omron fails to transmit measurements reliably.
  3. It is amazingly easy to transmit BPs via email to your doctor (or friends if so inclined).

Support

I found the QardioArm website to be very informative and helpful. The manual that comes with the device is very complete and you should definitely read it before using the device. I did not need telephone or email support services, so I can’t comment on those.

Overall Rating and a Caveat

Despite an initial frustration with QardioArm, I ended up really liking this device a lot. This sounds a little silly but the QardioArm improved the esthetic experience of home BP monitoring for me. Because it is compact, sleek and attractive, patients may be more likely to utilize it on a regular basis. In particular, I see it as something that you would be much more inclined to take with you for BP monitoring at work or on vacation.

I will be recommending  this to my tech-savvy, style-conscious patients who require home BP monitoring. Previously, this type of patient would bring in their smartphone and show me the accumulated data from their BP readings. With a QardioArm, they can easily email my office the data and we can have it scanned into their record.

My final caveat: the QardioArm I gave my father for his 91st birthday does not work on his arm. It works without a problem on the arms of his friends and relatives. I have no idea why, but fortunately QardioArm honored their 30 day 100% money-back no questions asked guarantee. I’ve asked him to give me his nonagenarian perspective on the QardioArm experience so I can share it in a future post.


Quriously Yours,

-ACP

Salt Talks Two

The skeptical cardiologist found himself reading a cookbook the other day, something he heretofore had avoided. Cookbooks somehow seem archaic and, I presumed, exclusively the domain of the women in my life.  My mother had loads of them, hiding their food-stained bindings behind a cabinet door in my childhood kitchen. Whereas I can stare longingly at all manner of books on  bookstore shelves, I scrupulously avoid the cooking section, finding nothing that intrigues or attracts me in their heavily illustrated contents.

The eternal fiancee’ of the skeptical cardiologist (EFOSC), I believe, had requested I find the recipes for several dishes we (more accurately, she) could prepare the next week and had headed off to Whole Foods or Nordstrom Rack or Pier 1 (all of which, strangely and conveniently sit side by side).

IMG_6880 copyAfter receiving directions on where these mysterious tomes resided, I grabbed the cookbook that looked the most interesting: Ruhlman’s TWENTY: 20 Techniques, 100 Recipes, A Cook’s Manifesto. Instead of searching for recipes I ended up being distracted by Chapter 2: Salt: Your Most Important Tool.

In Chapter 2, Ruhlman makes the bold statement that “if you don’t have a preexisting problem with high blood pressure and if you eat natural foods-foods that aren’t heavily processed-you can salt your food to whatever level tastes good to you without worrying about health concerns.”

As I’ve written previously, I agree with him, and a recent article published in The Lancet casts further doubt on recommendations for the general population to limit sodium consumption drastically.

In the Lancet article, the authors did a pooled analysis of four large prospective studies involving 133118 patients in 49 countries. They studied the relationship between salt consumption, measured by 24 hour urine excretion of sodium (because what goes in must come out) and the incidence of cardiovascular disease and death over about 4 years.

The findings:

  1. Patients without hypertension who excreted more than 7 grams/day of sodium were no more likely to have cardiovascular disease or death than those excreting  4-5 grams/day.
  2. In fact, in both normotensive and hypertensive groups, sodium excretion of < 3 g/day was associated with a significantly (26% higher in normotensives, 34% in hypertensives) increased risk of cardiovascular disease and death.
  3. The only group that would appear to benefit from lower sodium consumption was the hypertensive group which excreted 7 g/day of sodium and when compared to the hypertensive group that excreted 4-5 g/day of sodium had a 23% higher risk of CV death and disease.

If we have to worry about anything with salt consumption, this study (and others) suggests that it is consuming too little salt.

The only group that need worry about too much salt consumption is those who have hypertension and who consume a really large amount of salt.  Since the average American Average consumes 3.4 grams per day of salt, very few of us are consuming over 7 g/day.  Despite this, The American Heart Association continues to stick by its totally unjustified recommendation that sodium levels be no higher than 1,500 mg/day, and other organizations recommend sodium levels below 2,300 mg/day.

What Kind of Salt Should We Consume

Ruhlman recommends coarse kosher salt, preferably Diamond Crystal or, if that’s not available, Morton’s.

Why? Because “salt is best measured with your fingers and eyes, not with measuring spoons.”

“Coarse salt is easier to hold and easier to control than fine salt.”

He feels that salting is an inexact skill and one should always salt to taste.

“When  recipe includes a precise measure of salt, a teaspoon, say, this is only a general reference, or an order of magnitude–a teaspoon, not a tablespoon. You may need to add more. How do you know? Taste the food.”

IMG_6874
The skeptical cardiologist’s frittata.

These words were music to my ears as I am an advocate of serendipity, chaos and creativeness in the kitchen.  When I make a frittata, as I did this morning, I measure nothing precisely; not the butter and olive oil used to sauté, the bell peppers, onions and garlic; not the milk mixed with the eggs; not the cheese sprinkled on top; not the time spent in the oven or even the heat; and most assuredly, not the salt and pepper.

IMG_6876At the end of the frittata creation process I took a bite. It was delicious but it needed something: a touch more salt. I sprinkled some David’s kosher salt on top and tried again, Perfection!

Although I have hypertension, I know (see discussion here) that my salt consumption is way below 7 grams/day and, if anything, based on the most recent studies, I should be worrying about too little sodium in my diet.

saltatorily yours,

-ACP

PS>

As I outlined in one of my previous posts on salt, here is what I tell my patients:

  • Spend a day or two accurately tracking your consumption of salt to educate yourself. I found this app to be really helpful. I’ll expand on this in a future post.
  • Recognize that not everybody needs to follow a low salt diet. If your blood pressure is not elevated and you have no heart failure you don’t need to change your salt consumption.
  • If your blood pressure is on the low side and especially if you get periodic dizzy spells, often associated with standing quickly liberalize your salt intake, you will feel better.
  • If you have high blood pressure, you are the best judge of how salt effects your blood pressure. In the example I gave in a previous post, my patient realized that all the salt he was sprinkling on his tomatoes was the major factor causing his blood pressure to spike.
  • The kidneys do a great job of balancing sodium intake and sodium excretion if they are working normally. If you have kidney dysfunction you will  be more sensitive to the effects of salt consumption on your blood pressure and fluid retention.
  • If you are following a Mediterranean diet with plenty of fresh fruits and vegetables you are going to be in the ideal range for both potassium and sodium consumption.