All posts by Dr. AnthonyP

Cardiologist, blogger, musician

A Change In Practice

Dwight Enys is a fictional doctor during the American War of Independence who plays a prominent role in the BBC Series “Poldark”. Like all 18th century doctors, he has little beyond blood letting and snake oil to offer his patients. In particular, patients with “putrid throat” (diphtheria) die at an alarming rate under his care.

Enys changed his practice from Virginia in 1781 and moved to Cornwall to study lung disease in miners who worked in Ross Poldark’s mines.

Like Dr. Enys, I am changing practice location.

The following letter was sent to all my patients this week announcing that I was leaving my practice at St. Luke’s Hospital:

I am sorry to tell you that I am leaving my practice at CSSL and my last day will be August 7, 2020. I treasure the experience that I have had at St. Luke’s primarily because of the opportunity you have given me to share in your lives and provide your cardiac care. For me, these relationships with my patients and this service is what makes, and will continue to make, being a physician a fulfilling and satisfying profession.

These are difficult, stressful  and rapidly changing times and, I sincerely regret If this announcement adds to your stress.

I hope to have the opportunity to have a visit with most of you before I depart St. Luke’s. If you are not already scheduled and would like to schedule a visit to review your situation prior to my departure please let Coleen know at 3145427694. I have expanded my office hours to accommodate this and after 6/20 we can do these both by telemedicine or in office visits.

My life has been immeasurably improved by my interactions with you by learning, sharing and teaching and I thank you from the bottom of my skeptical cardiologist’s heart.

I hope you all prosper and persevere through these difficult times and go on to be happy with long, healthful lives.

I’m not retiring and will be working as a clinical cardiologist in a different practice in St. Louis beginning September 1, 2020. Unlike Dr. Enys, I’ll not be researching miner’s lungs (or hearts), and I will have many effective remedies in my pharmacologic armamentarium.

When a physician leaves a medical practice he/she is generally obligated to notify patients of the change and provide mechanisms for their ongoing care. Details on how this should be done vary by state, and Missouri has no laws in this area. The letter that went out to my patients emphasizes that the remaining physicians in my group will be available to take over my patients’ care.

My patients have the option of staying with my practice group or transferring their care to another practice.

Feel free to share any experiences you have had dealing with practice-changing doctors and their practices.

Skeptically Yours,

-ACP

N.B. Consumer Reports has an article on changes that patients should be aware of when their doctor joins a new practice here and the Washington Post has an interesting article on some of the issues that doctors and patients face when a doctor moves from one group to another here.

As always I can be reached at DRP@theskepticalcardiologist.com with any questions.

Can We Learn From History? The Tulsa Race Massacre, The Deadly Philadelphia Parade, and Covid-19

The skeptical cardiologist is in Broken Arrow, Oklahoma this Father’s Day weekend visiting Pops Pearson after a 2 week quarantine and a 6 hour drive. As fate would have it, we are not too far from the BOK Center in nearby Tulsa, where MAGA supporters have been queuing up since Thursday night in anticipation of President Trump’s campaign rally there today.

Tulsa’s local news has become national news as yesterday there were peaceful gatherings celebrating Juneteenth in the Tulsa Greenwood area and today it becomes the epicenter of Trump’s reelection campaign, and perhaps the epicenter of COVID-19 resurgence.

The Tulsa Race Massacre

Despite growing up in nearby Bartlesville and visiting Tulsa frequently over the years, until recently I was unaware of the horrible atrocities committed in the Greenwood area in 1921.

The New York Times yesterday published an article entitled “The Burning of Black Wall Street, Revisited” which provides details on what is now also termed the Tulsa Race Massacre.

” in the prosperous black district of Greenwood, white vigilantes systematically torched nearly 40 square blocks. Gone in the blink of an eye were more than 1,000 homes, a dozen churches, five hotels, 31 restaurants, four drugstores and eight doctors’ offices, as well as a public library and a hospital. As many as 9,000 black Tulsans were left homeless. Photographs from the period depict shellshocked survivors being marched at gunpoint to temporary concentration camps.

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The Rally

For unclear reasons, Donald Trump has decided to have a campaign rally today about a mile from Greenwood, and in a state and city facing an uptick in COVID-19 cases.

Below is the most recent graph of cases from Tulsa County’s health department:

covid tulsa

As USA Today noted, the Governor of Oklahoma seems unaware of the recent rise in cases and is confident that Oklahoma has safely reopened.

Oklahoma cases of COVID-19 rose by 450 on Thursday, blowing past the record 259 daily cases reported on Wednesday, as the surge of infections continued ahead of a massive rally for President Donald Trump and demonstrations set for this weekend in Tulsa.The Oklahoma State Health Department’s daily update showed Oklahoma City added 80 cases and Tulsa added 82, as the state’s total rose to 9,354. There were two additional deaths, raising the total to 366. The figures were released not long after Gov. Kevin Stitt participated at a roundtable at the White House and told Trump that Oklahoma was “one of the first states that has safely and measurably reopened.” “Oklahoma is ready for your visit,” the governor said. “It’s going to be safe and everyone’s really really excited.”

An opinion piece in the Tulsa World suggests “No matter how you feel about it, Saturday’s rally in Tulsa matters to us all:”

“Trump’s rally has turned Tulsa into a giant medical experiment with tremendous political implications. At issue is whether 19,000 people can be packed into an arena for hours on end while thousands more mingle in streets and parks outside without spreading COVID-19 and multiplying the deaths and debilitating aftereffects.

If they can, the lid almost certainly will come off. Concerts and sports events — and political rallies — will be back in business, no matter what public health officials say.

But if they can’t, the lid is likely to come down hard.

For Trump, the rally could be a wash, just another event among many.

Or, if things go well — if the crowds are large and adoring, if the incalculables go in his favor, if there is no associated COVID-19 spike — it could launch him toward a second term.

But if things don’t go well — if an acceleration of COVID-19 is traced to the rally, if even two or three people who contract it die, if there is violence that adheres to the president — it could be a turning point in the other direction.”

The Deadliest Parade in American History

My wife has been reading John Barry’s “The Great Influenza: The Story of the Deadliest Pandemic in History” and has pointed out to me several times the significance of a parade that took place in Philadelphia in accelerating the transmission of the Spanish Flu.

Per Wikipedia the “Philadelphia Liberty Loans Parade” was a parade in Philadelphia, Pennsylvania, on September 28, 1918, organized to promote government bonds that helped pay for the needs of Allied troops in World War I. More than 200,000 Philadelphians attended the parade, which led to one of the largest outbreaks of the Spanish Flu in the United States. It has since been declared the “deadliest parade in American history.”

At the height of World War I, history’s most lethal influenza virus erupted in an army camp in Kansas, moved east with American troops, then exploded, killing as many as 100 million people worldwide. It killed more people in twenty-four months than AIDS killed in twenty-four years, more in a year than the Black Death killed in a century

Barry concludes, “The final lesson of 1918, a simple one yet one most difficult to execute, is that…those in authority must retain the public’s trust. The way to do that is to distort nothing, to put the best face on nothing, to try to manipulate no one. Lincoln said that first, and best. A leader must make whatever horror exists concrete. Only then will people be able to break it apart.”

Skeptically Yours,

-ACP

N.B. More history we should be aware of:

Per Wikipedia, “Broken Arrow’s name comes from an old Creek community in Alabama. Members of that community were expelled from Alabama by the United States government, along the Trail of Tears in the 1830s. The Creek founded a new community in the Indian Territory and named it after their old settlement in Alabama. The town’s Creek name was Rekackv (pronounced thlee-Kawtch-kuh), meaning broken arrow. The new Creek settlement was located several miles south of present-day downtown Broken Arrow.”

….and something that Trump’s Tulsa visit has brought to the forefront:

“Juneteeth commemorates the end of slavery in the United States, when Union troops at the end of the Civil War reached Galveston, Texas, on June 19, 1865, to inform African-Americans there of the Emancipation Proclamation, which had been issued two years before.”

 

Saturated Fats and Health: Reassessment and Proposal for Food-based Recommendations

The skeptical cardiologist has been pointing out for some time that dietary advice to universally restrict consumption of saturated fats is not scientifically based.

Different foods present different types of saturated fats in different matrices and it is not reasonable to assume the overall effect of these foods can be predicted by measuring only saturated fat content.

In particular, there is not a scintilla of evidence that proves dairy fat which contains significant amounts of saturated fat has any harmful cardiovascular consequences. Thus, attempts to advise Americans to consume low fat or non-fat dairy are horribly misguided.

As I wrote in my letter to the FDA and in a recent critique of the AHA  “the suggestion to restrict or eliminate full-fat dairy from the diet is not a proven strategy for reducing the risk of cardiovascular disease, obesity or diabetes and should be eliminated from current dietary guidelines.”

Yesterday, a “State of the Art Review” (Saturated Fats and Health: A Reassessment and Proposal for Food-based Recommendations: JACC State-of -the-Art Reviewwas published in the Journal of the American College of Cardiology by a group of prominent nutritionists which provides substantial backing for my conclusions.

I encourage a full reading of the article but here is the abstract:

“across the board recommendation to limit dietary saturated fatty acid (SFA) intake has persisted despite mounting evidence to the contrary. Most recent meta-analyses of randomized trials and observational studies found no beneficial effects of reducing SFA intake on cardiovascular disease (CVD) and total mortality, and instead found protective effects against stroke. Although SFAs increase low-density lipoprotein (LDL)-cholesterol, in most individuals, this is not due to increasing levels of small, dense LDL particles, but rather larger LDL which are much less strongly related to CVD risk. It is also apparent that the health effects of foods cannot be predicted by their content in any nutrient group, without considering the overall macronutrient distribution. Whole-fat dairy, unprocessed meat, eggs and dark chocolate are SFA-rich foods with a complex matrix that are not associated with increased risk of CVD. The totality of available evidence does not support further limiting the intake of such foods.

Hopefully, the Committee discussing the next version of the Dietary Guidelines for Americans are objectively examining the extensive scientific literature that led to these conclusions.

Skeptically Yours,

-ACP

N.B. As I wrote in a previous post on the cardiometabolic health benefits of full fat yogurt

It is important to look at industry influence on research and publications (along with other biases)  but it is hard to find an expert in these areas who hasn’t had some industry ties. Part of these ties develop because researchers who have concluded a particular food is healthy based on their independent review of the literature will be sought after as a speaker at conferences organized by the support groups for that food.

Fortunately, my evaluations remain unsullied by any food industry ties and, like Dr. Astrup,(lead author on the JACC review) I am not an advocate or activist for specific diets and I am not not strongly committed to any specific diet.

Are Trump’s Problems with Walking, Drinking Water Due to Hydroxychloroquine? 

Chuck Dinerstein at the American Council on Science and Health has an intriguing hypothesis:

“This past weekend at West Point, President Trump had trouble drinking a glass of water and he displayed an unsteady gait when descending a ramp. It is possible these problems indicate some type of neuropathy. And while it’s unlikely, one potential cause is hydroxychloroquine.”

After describing Trump’s recent apparent physical problems he writes:

So now, we have issues with two sets of muscles: the legs and arms. It would be odd to have an injury that involved two areas not be reported, especially involving the president. The same holds for structural problems, and that moves neuropathy up the differential list. What could be the source of a new-onset neuropathy? I know little of the president’s medical status. That is, except for one, perhaps salient fact: he said he has been taking hydroxychloroquine.

Physicians have rightly been concerned about the cardiac effects of this medication on the heart’s rhythm. But hydroxychloroquine has some other, less frequently cited adverse effects. If you read the FDA required package insert under adverse effects, here is what you will find:

“Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.” [Emphasis added]

Proximal muscles are those closest to our body, like the muscles of the upper arm that raise the arm and hand. Or the muscles of the thigh that are actively involved in all phases of walking. It is not an overly common adverse side effect. It is probably relatively rare, but a quick search uncovered a review of 10 cases of hydroxychloroquine associated neuromyopathy.

I’ve been focusing on the cardiac side effects of HCQ but there are others including retinal toxicity which are more frequent and which could contribute to uncertain gait or hand-eye incoordination.

Of course, this is complete speculation but it contributes to understanding and recognition of how known and unknown side effects of unproven medications (or supplements) can tip the benefit/risk ratio toward increased risk.

I particularly like Dinerstein’s last sentence:

Again, let me emphasize that I am not attempting to diagnose an illness without performing both a careful history or physical examination. I am trying to point out a fallacy in the therapeutic use of medications. as there is always a tradeoff between benefits and risk. Always. In reporting on the president’s decision to treat himself with hydroxychloroquine on May 18, the New York Times reported, “Mr. Trump continued, explaining that his decision to try the drug was based on one of his favorite refrains: ‘What do you have to lose?’”

What indeed? It would be ironic that the drug President Trump described as a “game-changer” might instead turn out to be a “gait-changer.”

Skeptically Yours,

-ACP

FDA Withdraws Emergency Use Authorization for Hydoxychloroquine

A month ago the skeptical cardiologist detailed the potential for lethal cardiotoxicity of the antimalarial drug hydroxychloroquine  (HCQ) concluding:

  1. HCQ and chloroquine (CQ)  have associated and well-documented, albeit rare cases of potentially lethal cardiotoxicity.
  2. The benefit of these drugs in the treatment of coronavirus infection is currently unproven.
  3. Data from high-quality randomized trials of HCQ treatment in patients with coronavirus is needed before we can assess whether the drug benefits outweigh its risk in COVID-19 patients.

The drugs had been approved by the FDA for emergency use authorization (EUA),  many physicians and hospitals were using them for patients with COVID-19. Even more disturbing,, President Trump was enthusiastically promoting HCQ and revealed that he was taking it as a prophylaxis against COVID-19.

Intense demand for HCQ  led to a shortage for patients who needed it  for proven indications such as systemic lupus erythematosus.

Since I highlighted the drug’s cardiotoxicity a series of papers have either shown a lack of benefit or potential worsening of outcomes with these drugs. Recognizing this the FDA withdrew its EUA for HCQ and CQ yesterday.

On June 15, 2020, based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met.  Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19.

Fortunately, as more data became available over the last month hospitals which were previously routinely giving HCQ (and often azithromycin) dropped these drugs from their treatment protocols.

Hopefully, now we can get back to deliberately and scientifically validating the safety and efficacy of drugs for COVID-19. We still need more data from the dozens of ongoing randomized controlled trials (RCTs) on treatment.

Two large randomized controlled trials will be particularly helpful in determining the best treatment for SARS-CoV2 infection.

One of them, theRandomised Evaluation of COVid-19 thERapY (RECOVERY) Trial   published preliminary findings on 5 June 2020 showing a lack of benefit of HCQ.

In addition to HCQ, RECOVERY is analyzing treatment effects of the antivirals lopinavir-ritonavir, low-dose steroid therapy and interferon.

SOLIDARITY is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.

 

The Solidarity Trial will compare four treatment options against the standard of care, to assess their relative effectiveness against COVID-19.

Until we get results from high-quality RCTs like these, the antimalarials  HCQ and CQ should not be utilized for either prevention of or treatment of COVID-19.

Skeptically Yours,

-ACP

Father’s Day Visits and Flying During Covid-19: What Activities Are Safe To Resume?

Since COVID-19 struck America, most of us have stopped lots of heretofore normal activities in an effort to limit the spread of SARS-CoV-2. The curve has been flattened in most states and now the burning questions relate to when we can get back to normality.

Health care facilities have made the decision to resume most elective diagnostic procedures and are gradually moving from telemedicine to real in-person office visits. Hair stylists have gone back to cutting and colorizing hair.

For most activities, however, the decision to resume normality remains intensely personal and complicated.

For example, the skeptical cardiologist really wants to visit his 94-year-old father on Father’s Day weekend.

Pops Pearson lives in Tulsa, Oklahoma some 400 miles away, and I haven’t seen him (excluding Facetime sightings) since Christmas of last year.

 

How do I balance the risk of giving him COVID-19 versus the benefit of us spending time together? Would the risk/benefit change in 3 to 12 months? In a year or two?

There is no CDC or state or WHO guidance on whether I should make this trip.  However, the NY Times published a piece today which sampled the opinion of 511 “epidemiologists,” which offers some perspective on when it is right to resume certain activities.

The majority of the 511 epidemiologists who responded to the survey felt comfortable currently bringing in the mail and getting a haircut.

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My wife (the ex-eternal fiancée) and I still put the mail in quarantine and treat all packages as potentially contaminated. The epidemiologists were split on visiting hair salons or barber shops with 41% comfortable now and 39% in 3 to 12 months.

We have acquired hair cutting equipment for her to use on me and home hair colorizing stuff (not for me) and neither of us has seen a barber for 3  months. We plan to continue that for the foreseeable future.

It is interesting that 60% of epidemiologists are comfortable seeing a doctor for a non-urgent appointment. My patients also seem comfortable now coming into the office. We take a lot of precautions, but ultimately exposure risk for both patients and physicians is higher than if they had both stayed at home.

Resuming Activities in 3 to 12 Months

The majority of epidemiologists felt comfortable resuming ten activities in 3 to 12 months although a substantial minority were OK with doing them now.

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Two of the activities above are relevant to my “Pops Pearson visitation” decision.

Only 20% of the respondents felt comfortable visiting an “elderly relative or friend in their home” now, but this increased to 41 % by 3 to 12 months. This surprised me and suggests that most Americans may not be going into their relatives’ homes and/or spending significant time with their elderly parents.

Similarly, only 20% of respondents would travel by airplane now, but 44% would in 3 to 12 months.

A substantial minority of the respondents felt they would not be comfortable visiting relatives in the home (39%) or flying (37%) until over a year from now.

Of the other activities on the above list, I am uncomfortable right now with all except a “hike or picnic outdoors with friends.”  We have had close friends over to our house for outdoor socially distanced gatherings, two at a time. We have gone for bike rides with friends outdoors.

I’m not sure when I will feel comfortable attending an indoor dinner party, exercising at a gym, or eating at a dine-in restaurant.

To Visit Or Not To Visit?

After much discussion with family and rumination,  I have decided to drive to Tulsa and stay with Pops Pearson for Father’s Day.

The decision to drive was an easy one. Although we usually choose the one-hour SouthWest Airlines flight from St. Louis to Tulsa we still consider flying a  COVID-19 a high-risk activity. The airlines have made considerable strides in reducing the possibility of transmission in flight, but we still hear that it is not mandatory for fliers to wear masks.

The CDC website confirms that flying increases the risk of contracting COVID-19:

” Air travel requires spending time in security lines and airport terminals, which can bring you in close contact with other people and frequently touched surfaces. Most viruses and other germs do not spread easily on flights because of how air circulates and is filtered on airplanes. However, social distancing is difficult on crowded flights, and you may have to sit near others (within 6 feet), sometimes for hours. This may increase your risk for exposure to the virus that causes COVID-19.”

For those of you with more distant relatives, the decision to fly or drive is more complicated. I know that when we visit my wife’s relatives in Wilmington, NC in August  (which will be a 14 hour drive) we are still planning on driving.

To minimize the risk of me transmitting coronavirus to my dad, I have put myself in a modified quarantine. I will be conducting office visits by telemedicine and one of my partners has kindly offered to cover my hospital patients during this time. In the two weeks leading up to the visit, I and my wife have agreed to avoid any activities which might increase our risk of exposure to SARS-CoV-2.

Resuming Activities in > 1 year

When will it be safe to attend a large wedding or funeral service, go to church or attend a baseball game? Definitely not now.

Of note, the majority of epidemiologists did not respond to this survey and were uncomfortable making such predictions:

About 6,000 epidemiologists were invited to participate in the survey, which was circulated to the membership of the Society for Epidemiologic Research and to individual scientists. Some said they were uncomfortable making predictions based on time because they didn’t want to guess the timing of certain treatments or infection data. “Our concern is that your multiple choice options are based only on calendar time,” 301 epidemiologists wrote in a letter. “This limits our ability to provide our expert opinions about when we will feel safe enough to stop social distancing ourselves.”

I, too, am uncomfortable making predictions and doling out advice on behaviour during COVID-19. There is much uncertainty as evidenced by the reluctance of 90% of scientists to answer this survey.  The pace at which important data emerges is dizzying. For many personal decisions like mine, we must make critical decisions based on imperfect guidance.

Epidemiologically Yours,

-ACP

Enlightened Medical Management of Atrial Fibrillation, Part III: Flecainide for Chronic Suppression

As a practitioner of enlightened medical management of atrial fibrillation the skeptical cardiologist utilizes predominantly two antiarrhythmic drugs: amiodarone and flecainide.

As I outlined in Part I of this series, amiodarone is our most efficacious drug for maintenance of normal sinus rhythm (NSR) but requires close monitoring for long term side effects. It is also the safest antiarrhythmic drug (AAD) for patients with AF who have structural heart  disease.

The AAD I use in AF patients with normal hearts is flecainide.

Flecainide is a class IC AAD  which produces a potent and selective blockade of the cardiac fast inward sodium (Na+) current resulting in conduction slowing.

We don’t utilize flecainide (or any Type IC AAD) in patients with significant coronary artery disease or significantly depressed function of the left ventricle because of concerns about it increasing risk of more dangerous heart rhythms in such patients.

In patients with normal hearts, however, flecainide is very safe, extremely well-tolerated, and reasonably effective at maintaining NSR when combined with significant lifestyle modification.

I have scores of patients who have been maintained in NSR for years to decades with flecainide, therefore I think patients with normal hearts should undergo an adequate trial of this AAD before moving on to ablation.

Chronic Suppression of Atrial Fibrillation

A reader with atrial fibrillation recently submitted his case history which describes a typical scenario for a patient who would be a great candidate for long term flecainide therapy:

I am a 62 year old active male. I play (mostly) non-checking ice hockey 3 times a week and bicycle on off days and have a daily yoga practice. I suffer from Hashimoto’s disease and hypertension. Both are adequately managed with medication. I have been in persistent Afib for about a year, not sure about prior to that, but expect it was paroxysmal for awhile prior to diagnosis. There is no obvious cause. I was immediately put on Diltiazem and Eliquis. A month later I received a successful Cardioversion but at my follow-up a week later it was noted that the Afib had returned and is again persistent. I also had an echocardiogram that did not reveal any valve or muscle abnormalities. The advice at the time was to continue on the Dilt unless symptoms worsened. I was taken off the Eliquis due a risk factor of 1 and my desire to resume hockey. After about three months I noticed more fatigue, occasional dizziness, regular palpitations, etc. so got an appointment for another echo and to see an Electrophysiologist. The results of the echo indicate some structural changes since the last echo. Thus the EP recommended 3 choices: 1. continue with just the Dilt, 2. get a stress test and if OK then go back on Eliquis and add Flecainide for rhythm control and get another Cardioversion, or 3. get back on Eliquis and get an ablation and a Cardioversion. I’m not sure which option to choose. The difference in the two echos didn’t seem too extreme – how long can I go with option 1? Option 2 seems less risky but also less effective. Option 3 has the best results but is more risky. What will be the future of my hockey playing? With options 2 and 3 I;ll take a break while on Eliquis but once I turn 65 my risk will be 2 and I’ll probably be on Eliquis from then on. Can I chance option 1 for 3 years? I check my BP daily and use a KardiaMobile 6L to self-monitor.

The reader’s case history is similar to many of my patients.

He started with brief paroxysms of AF that were self-limiting (paroxysmal AF) but at some point, an episode began that was not self-limiting (persistent AF.)

At this point there are two major decisions for patient and physician: 1) Should a blood thinner be started to reduce the risk of stroke? and 2) Should the patient be left in AF (which generally means AF will be present lifelong , thus permanent- aka longstanding persistent AF) or should we attempt to restore and maintain SR?

I’ve reviewed the decision-making process for anticoagulation here.

The second decision is more complicated, controversial, and requires a good and unbiased conversation between physician and patient about options for maintenance of NSR.

In my post entitled “Why I Favor the Early Restoration and Maintenance of Sinus rhythm For Most Patients with Atrial Fibrillation” I laid out my rationale for trying to restore and maintain SR for most patients. In this 62 year old otherwise very healthy and active individual I would strongly favor a very aggressive approach to maintaining SR.

Enlightened Use of Flecainide To Suppress Atrial Fibrillation


Let’s take the example of Ralph,  a 63-year-old man who I saw first 5 years ago.  At that time he was admitted to the hospital with a prolonged episodes of weakness and rapid heartbeat.  Atrial fibrillation with a high heart rate (rapid ventricular response) was the cause and after starting a blood thinner and slowing his heart rate with intravenous diltiazem we proceeded to electrical cardioversion (ECV).

The cardioversion was successful in converting him back to normal sinus rhythm and he was discharged on oral diltiazem and a blood thinner.

Diltiazem is not an anti-arrhythmic drug and has not been proven to lower the risk of recurrent atrial fibrillation but is used in this situation to slow the patient’s heart rate should atrial fibrillation recur. I tell patients that after a first ECV without adding an AAD it is highly likely that AF will recur but we can’t predict if that will be in 5 days or 5 years. Given this possibility of no recurrent AF for years I generally don’t start an AAD with first ECV.

I highly recommend to all my AF patients the acquisition and use of a mobile Kardia ECG device to monitor their heart rhythm. The Kardia (or Apple Watch if the patient has one) is particularly useful pre and post ECV to alert us to the development of AF.

Ralph noted his heart rate had increased about 7 days after the ECV and his newly acquired Kardia ECG device confirmed AF as the cause.

At this point, we had another patient-physician discussion about the value of maintaining NSR and the therapeutic options. Given the early recurrence of the AF,  just repeating the ECV makes little sense. If he had maintained NSR for 5 years just repeating the ECV would be a reasonable option.

To increase our chances of maintaining NSR I started flecainide 50 mg twice daily. Flecainide can be started as an outpatient (as opposed to sotalol or dofetilide which require 72 hours of monitoring in hospital) and it often converts the patient’s rhythm back to NSR without the need for an ECV.  In addition, flecainide as a generic is cheap and at low dosages extremely well-tolerated without significant side effects.

The starting dosage of 50 mg is low but one of my guiding principles for Enlightened Medical Management of AF (EMMOAF) is to use the lowest effective dosage of AAD possible in order to minimize adverse effects.

After 5 days on flecainide, an ECG showed normal  QRS and QT intervals but AF persisted and we performed another ECV. After this ECV, the patient remained in NSR for 2 weeks but again noted high heart rates and AF had recurred.  Following another discussion I had him increase the flecainide to 100 mg twice daily.

Some patients, again, will convert to NSR upon an increase of the flecainide from 50 to 100 mg twice daily, but Ralph remained in AF and we performed a third ECV.

By this time he had acquired a Kardia device and was able to monitor his rhythm. The higher dosage of flecainide was the dosage that worked for him as he maintained NSR after the ECV and has maintained NSR for 5 years since.

I have scores of patients who have a similar path to Ralphs’s with successful maintenance of NSR on flecainide for many years. Some of them converted without an ECV and some, like Ralph, required 3 ECVs.

If AF recurs after a prolonged period of maintenance of NSR with flecainide, the choices are

  • -Leave in AF and control the rate
  • -Leave flecainide at current dosage and repeat ECV
  • -Increase the dosage of flecainide (which may or may not convert rhythm on its own) and repeat ECV at higher dosage.

Enlightened management of these patients who are maintaining NSR on flecainide over many years requires periodic visits (I recommend every 6 months) with an enlightened cardiologist to assess for

  •  any signs or symptoms of structural heart disease
  •  any evidence of proarrhythmia or electrical conduction abnormalities
  •  significant QRS prolongation, ischemia or arrhythmias during exercise stress
  • proper concomitant use of dromotropic (rate-slowing) drugs such as beta-blockers or diltiazem.
  • appropriate use of blood thinners to reduce the risk of stroke or systemic embolism.

When utilized in the manner I’ve described, flecainide usage results in prolonged maintenance of NSR at an extremely low risk of adverse effects in most patients who have structurally normal hearts.

Its effectiveness is greatly increased by patient attention to the eight lifestyle factors that increase the risk of AF and I emphasize these factors to all my patients on a regular basis.

Flecainidingly Yours,

-ACP

N.B. I’ve answered my readers question as to which option I would recommend if he were my patient but not some of his other good questions. Those will be discussed in Part IV of this series. And later I’ll discuss the pros and cons of other AADs for AF.

N.B.2.  For more detailed information on flecainide I recommend this 2015 review in the World Journal of Cardiology

If you are prescribing or taking flecainide it is important to be aware of the CAST trial

(Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991;324:781–788. [PubMed] [])

 

a seminal study which showed that Type I C AADs are dangerous in patients who have had a myocardial infarction and reduced heart function.

“The publication of the Cardiac Arrhythmia Suppression Trial (CAST) study in 1989, which was designed to investigate the efficacy of class I antiarrhythmic agents moricizine, encainide or flecainide in patients after myocardial infarction with reduced ejection fraction and frequent ventricular ectopic beats, resulted in a major revision of the role of these antiarrhythmic drugs. Thus, while flecainide suppressed ventricular ectopy in those patients, a threefold increase of arrhythmic death was recorded compared to placebo[]. Based on CAST results, flecainide nowadays is not recommended for patients with structural heart disease and coronary artery disease. However, it is recommended as one of the first line therapies for pharmacological conversion as well as maintenance of sinus rhythm in patients with atrial fibrillation and/or supraventricular tachycardias without structural heart disease”

 

AstraZeneca’s COVID-19 Vaccine Enters Phase 2/3 Clinical Trial |

From the Website FierceBiotech comes some good news in the battle against COVID-19


Researchers at the University of Oxford have begun enrolling subjects in a phase 2/3 clinical trial of AstraZeneca-partnered COVID-19 vaccine AZD1222. The next stage of the program, which follows a 1,000-subject phase 1, is set to enroll 10,260 people in the U.K. to generate results to support the first shipments to customers in September.AZD1222, the recombinant adenovirus vaccine that originated in Oxford, entered the clinic shortly after Moderna’s candidate. The initiation of the phase 1 trial marked the start of a large, significantly truncated development program plotted out by researchers at the University of Oxford, who have talked up the prospect of making the vaccine available in September.Work toward that goal is advancing apace on multiple fronts. On the R&D side, the University of Oxford said Friday that it has begun enrolling participants in the phase 2 portion of the program.The phase 2 will relax the exclusion criteria used in the phase 1, notably by enrolling a small number of children aged 5 to 12 years and adults aged 56 years and older. One cohort will enroll adults aged over 70 years, a demographic that is particularly at risk from the coronavirus. By expanding the age range, the researchers aim to understand how immune response varies across demographics.Once the vaccine moves into phase 3, the researchers will limit enrollment to people age 18 years and older. Adult participants in the phase 2 and 3 trials will be randomized to receive one or two doses of AZD1222 or a vaccine against meningococcal bacteria that will serve as the control. The use of an active vaccine as a control is intended to ensure participants are unable to tell whether they received AZD1222 based on side effects such as soreness at the injection site. In the absence of such effects across both groups, participants could determine whether they had received the vaccine and make behavioral changes that skew the results of the study. Investigators plan to administer the vaccines to participants in the next stage of the study across May and June. Subjects will then attend follow-up visits to provide blood samples that will show whether their immune system has responded to the virus. The researchers will also ask some participants to log any symptoms they feel in the week after vaccination.Those measures will provide an early look at the safety and immunogenicity of the vaccine, but it will take longer to gauge whether the shot can prevent people from becoming infected with the coronavirus. The researchers are trying to accelerate that process by enrolling healthcare workers and other people who are more likely to be exposed to the virus. Depending on the extent to which SARS-CoV-2 is present in the U.K., it is expected to take two to six months for enough infections to happen to show whether the vaccine is working.Neither the university nor AstraZeneca are hanging around to see if that is the case before preparing for widespread use of the vaccine. The phase 2/3 trial is getting underway despite the university being yet to share phase 1 data, and AstraZeneca is already racing to equip itself to ship 1 billion doses.

Source: AstraZeneca’s COVID-19 vaccine enters phase 2/3 clinical trial | FierceBiotech

I’ve got my fingers crossed that it will be effective and safe and we could potentially have a vaccine by September.

Skeptically (but occasionally optimistically) Yours

-ACP

Subclinical Atrial Fibrillation-Seek And Ye Shall Find, But What Then?

For those of us over age 55 years there is a lifetime risk of developing atrial fibrillation (AF) of 37%. and with AF comes a 5 fold risk of stroke which can be reduced by oral anticoagulant therapy.

Because up to 25% of AF is asymptomatic investigators have recognized a need to screen for AF in high risk individuals with the goal of reducing stroke. When AF is found in individuals without symptoms by screening or from monitoring a patient’s pacemaker it is termed subclinical atrial fibrillation (SCAF.)

Surprisingly, there is no consensus on 1)  whether we should screen for SCAF 2) if we should screen for SCAF, how should we do it 3) whether individuals with SCAF  found  by screening should be treated with oral anticoagulants just as we treat clinical AF patients.

Two presentations at the 2018 American College of Cardiology Meeting in Orlando shed some light on the problem of SCAF.

The mHealth Screening To Prevent Strokes (mSTOPS) study took a novel  approach to identifying and enrolling patients. Working with Aetna, invitations were sent by email or snail mail to over a 100,000 Aetna members who did not have a diagnosis of AF and who were over age 74 year or younger but with CHADS2 risk factors.

The members were directed to a website for information on the the trial and were guided through an enrollment process for informed consent. Half were randomized to early monitoring and half delayed monitoring at 4 months.

Immediate monitoring involved the patient being mailed a 14 day patch type monitor (Zio Patch, iRhythm Technologies Inc.) within 2 weeks of consenting to the trial. Patients in the delayed monitoring group received the patch 4 months after consent.

The primary endpoint was a new diagnosis of AF at 4 months,  defined as greater than 30 seconds of AF by ECG or a new diagnosis listed on Aetna claims data.

Patients in the immediate or early monitoring group were 9 times more likely to have AF diagnosed than those in the delayed group (prior to them wearing the Zio)).

Diagnosis of AF in these participants were then compared to 5,310 observational controls matched for age, sex and CHADS-VASc score who did not undergo screening.

At the end of one year 6.3% of the monitored group had been diagnosed with AF versus 2.8% in the observational controls, a highly significant 3 fold increase in AF detection.

More patients in the monitoring group were started on therapy and had more testing done (at the discretion of their physicians who were informed of the results at the patient’s discretion).

There was no difference in stroke, MI or systemic thromboembolism at one year between the two groups but clearly this study was underpowered and nonrandomized so differences would have been unlikely and if present hard to interpret.

Does Manner of Detection of AF Matter

AF detected by screening and AF detected only by implanted devices share many similarities. For both, if we seek them we shall find them (one study showed in patients with no history of AF undergoing new pacemaker implantation during a mean follow-up period of 596 ± 344 days, 77 (29%) patients had at least one AF episode lasting ≥ 5 min.

At another session at ACC18 two EP doctors debated whether  a high stroke risk individual with 9 minutes of an atrial high rate episode (AHRE) of presumed AF detected by pacemaker should receive anticoagulation.

I ended up agreeing with the CON side of this debate for most patients because

-device detected AF has a lower stroke risk (precisely how much unclear and related to CHADSVAS score (but I’m going with 1/3) than clinically detected AF

-The ASSERT study only showed increased risk for >24 hours duration of device detected AF (DDAF)

-Unlike clinical AF we have no randomized controlled trial data supporting treatment with oral anticoagulants for DDAF.

(Of note, funding for many studies in this area comes from either makers of monitor devices like the Zio patch (iRhythm) used in mStops or the Medtronic loop recorder used in LOOP which detect SCAF or makers of the blood thinners doctors would be prescribing if SCAF is detected (like Janssen the maker of Xarelto.))

I haven’t learned the answer to the 3 key questions I posed at the beginning of this post since 2018 but more information continues to emerge.

For example, the ongoing Danish LOOP (Atrial Fibrillation Detected by Continuous ECG Monitoring) study is a randomized, controlled trial, randomizing subjects who are ≥70 years of age and have ≥1 of the following stroke risk factors: hypertension (HTN), diabetes, heart failure, or previous stroke, in a 1:3 ratio to receive an implanted loop recorder (ILR) (Reveal LINQ; Medtronic, Dublin, Ireland) with continuous electrocardiographic monitoring via the CareLink Network, or to standard of care.

The early results published late last year are fascinating and worthy of more detailed discussion. Briefly, 35% of participants had SCAF lasting>6 minutes. However, the AF burden was low, and progression was limited. In addition, symptoms were scarce, and the heart rate was only modestly elevated during SCAF.

This graph shows the time course of AF (blue bars) before and after a first AF episode >24 hours. Contrary to the idea that AF gets progressively more frequent with longer episodes, the natural history of AF in these patients varied wildly. Many had no prolonged episodes for  months before or after the first prolonged AF episode.

The final results of this study will tell us if seeking SCAF is worthwhile in reducing cardiovascular morbidity and mortality.

I see patients daily with brief episodes of AF detected by their pacemaker of which they are completely unaware. Currently, after a discussion with the patient about the risks and benefits of anticoagulation in this situation I will offer the option of anticoagulation if episodes >24 hours are noted, recognizing the lack of scientific studies to guide us.

Ideally, patients with <24 hours of DDAF will be enrolled in ongoing randomized trials which will give us the correct answer to these difficult questions. Similarly, we desperately need randomized studies on the effects of screening for AF on long term outcomes.

Skeptically Yours,

-ACP

 

Telemedicine Visits: Are They Right For You During and Beyond COVID-19?

The skeptical cardiologist, like most physicians in America, began converting scheduled in-person office visits to “telemedicine” visits in late March when it became clear that  COVID-19 was spreading rapidly.

It made no sense at that time to bring patients into our office for regular visits who were vulnerable and high risk, exposing them to physicians and staff who might have asymptomatic COVID-19 and vice versa.

Telemedicine made a lot of sense. As eloquently expressed by Dr. Russel Libby:

With the evolving COVID-19 pandemic and its impact on access to medical care, there is no better time to help physicians navigate and implement telemedicine into their practices and enhance their ability to care for patients. Through telemedicine, we can triage patients and help avoid unnecessary visits to health care settings, thereby reducing exposure to the COVID-19 virus and helping to keep our front lines safe, ensuring they have the resources needed to take on this immense challenge. The tools and guidelines being created now are already helping many to use telemedicine and will continue to help define its role at this moment, and shape the future of physician practice.” 

I wrote a post on March 20 (but didn’t publish it for some reason) explaining this change to patients:

Because the virus can be spread from infected individuals before they have symptoms there is a risk that patients can be infected anytime they are out in public.
Infected patients can visit the doctor’s office without any symptoms and transmit the virus to health care workers and other patients.
The perfectly healthy person sitting near you  in the doctor’s waiting room could be infected.This means you should reserve  seeing in person a doctor for when it is absolutely necessary that you be examined.

Due to the above concerns, beginning yesterday I personally began contacting all patients on my office schedule for the day.  After having a conversation with them, if  they were doing well and could delay their visit, the appointment was canceled. I encourage all physicians and patients to do everything they can to minimize unnecessary health care visits. Stop elective surgeries and screening procedures. Stop routine check-up visits.


The Rise of Telemedicine

Fortunately, due to COVID-19 CMS changed its coverage policies for telemedicine and has been reimbursing visits done utilizing video connections as if these were office visits.

For those individuals who do not have the ability to connect via video means (including Face time, WebEx, Zoom,and  Doximity) we have been utilizing telephone only visits. CMS has also ramped up reimbursement for these interactions.

In addition, I can see new patients as a telemedicine visit since CMS announced waivers on old restrictions.

CMS also announced that “the requirement for physicians to hold a license in the state in which services are rendered is waived.”

Rules, coding, and reimbursement for billing are in flux right now but I have found CodingIntel.com to be a reliable source and this summary PDF from Woodcock and Associates to be unusually clear:

I’ve been trying to get my employers to utilize telehealth services for several years unsuccessfully. I think they make good sense for many patient situations, especially when combined with the kinds of remote patient monitoring (like Kardia Pro) have implemented with my patients.

Hopefully, now that telehealth has been expanded it will become the norm after COVID-19.

 


Telemedicine Visits Work For Many Patients

It’s been two months since we began utilizing telemedicine visits and we have successfully flattened the curve of the epidemic.

For the most part, I think the telemedicine visits have been successful in allowing me to check on the status of my patients and manage their cardiac conditions. We are typically able to get the patient to record a home blood pressure and heart rate. Many of my patients have home ECG devices (mostly Kardia) which allow us to monitor their cardiac rhythm

The video allows a rudimentary physical exam. I can tell how the patient is breathing, speaking, and answering questions. I can see any gross abnormalities of their head, neck, ears, and eyes.

One significant limitation is that  I cannot listen to their heart and lungs. In cases where patients are having difficulties that would best be assessed by a full physical exam or by an ECG  we have brought them into the office.


Reopening

On May 18 St. Louis City and County officials announced the reopening of certain businesses. Of note, hospitals and doctor’s offices weren’t mentioned in these announcements.

The CMS document on “Opening Up America Again” states:

Therefore, if states or regions have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I. The Guidelines for Opening Up America Again can be found at the following link: https://www.whitehouse.gov/openingamerica/#criteria

Maximum use of all telehealth modalities is strongly encouraged.

In conversations with patients these last 2 months I have found that they have almost without exception been sheltering at home and practicing social distancing and have been very happy to conduct the visits using telemedicine.

Of course, some have elected to reschedule follow-up visits to a future time with the hope that COVID-19 will be less of an issue and these are the patients I’m not having conversations with.

In the next few weeks I will be personally contacting patients on my schedule and assessing their need and desire for an in-person office visit.

The guidance I have from CMS and from the leadership of my medical group is to continue primarily favoring telemedicine visits. However, if my patient has a strong preference for an in-person office visit or if I perceive that a physical examination, vital sign check, or ECG is essential for their proper care we will keep the in-person office visit.

I’d appreciate hearing all reader’s and patient’s thoughts on this topic so feel free to leave comments or email me at DRP@theskepticalcardiologist.com

Virtually Yours,

-ACP

Feature Image

LDN 1471: A Windblown Star Cavity
Image Credit: Hubble, NASA, ESA; Processing & License: Judy Schmidt