Dr John M

cardiac electrophysiologist, cyclist, learner

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The Nobel in Economics and Medicine?

October 11, 2017 By Dr John

Once again, the Nobel prize for economics–not science and medicine–has immense influence on the practice of medicine.

Every day, in fact.

This year, Richard Thaler, a behavioral economist at the University of Chicago, won for his work on human biases and temptations.

The famous writer Michael Lewis (Moneyball) has a nice essay on Thaler’s work here.

Along with Kahneman and Tvresky, the work of behavioral psychologists and economists directly relates to clinical medicine because it describes human decision making.

Thaler made lists of irrational decisions. For example, we often make choices that don’t result in long-term well-being. E.g. Eating sugary foods and obesity. This led him and colleague Cass Sunstein to the concept of choice architecture.

This concept, applied to employee savings programs, led to an increase in the savings rate of workers.

Thaler calls it a sort of libertarian paternalism.

That’s sort of what doctors do, isn’t it? We are experts in medical science; patients are expert in their goals, and the best medical decisions come when we help align care with a person’s goals.

Libertarian paternalism: freedom of choice with expert nudges.

What’s critical for doctors to understand–and I wrestle with this everyday in the office–is that humans are not maximizers, or logical, or even all that sensible. Doctors feel decisions. So do our patients.

Kahneman and Tversky described the notion that people respond differently when a choice was framed as a loss than when it was framed as a gain. As Lewis writes: “tell a person that he had a 95 percent chance of surviving some medical procedure and he was far more likely to submit to it than if you told him he had a 5 percent chance of dying.”

In my earlier years as a physician, I would emphasize the 95% chance things would go well. Now, as I have aged and seen more of what Nassim Taleb calls iatrogenics (medical harm), I find myself more often feeling the potential harm. (I’m reading Taleb’s book Antifragile. It’s really good.)

Then I am thinking to myself: how I feel about this decision determines the framing.  And that will surely influence the patient. Gosh. This behavioral psychology stuff is damn important.

If I am too pessimistic, patients might lose out on the gain. If I am too optimistic, patients can be exposed to needless harm.

Take the decision to implant an ICD for prevention of sudden cardiac death.

The accepted benefits in selected patients is an absolute risk reduction of about 7%. That’s pretty good. It corresponds to an NNT (number needed to treat) of about 14–meaning, you have to implant 14 ICDs to save one life. We can’t know who the 13 are who won’t need it, and who the one is who will have his life extended.

But all treatment comes with potential harms. A recent look at real-world data suggests complications of ICDs occur in about 7% of people.

How do I frame this? What if the day before this visit, I had a patient suffer a massive complication from an ICD? Or perhaps the day before, a person was saved from death with an appropriate shock.

 

Medical decisions are not so easy. Because, humans, as Thaler has found, are complicated. Thinking about how we humans think is one of the most interesting aspects of this job.

JMM

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Filed Under: AF ablation, Doctoring, General Cardiology, ICD/Pacemaker, Knowledge Tagged With: Behavioral economics

2017 European Heart Rhythm Meeting Update

June 24, 2017 By Dr John

I attended the European Heart Rhythm Association meeting last week in Vienna. Here is an update on the stories I found most interesting–the ones I wrote about on the heart.org | Medscape Cardiology.

Brain Lesions after AF ablation: 

Electrophysiologists do not talk much about the small brain lesions that appear after procedures in the left atrium. MRI brain scans done before and after procedures such as AF ablation reveal the presence of “white sports” in a not insignificant number of patients. These lesions usually do not cause symptoms and mostly resolve over time. The cause of the brain lesions is not known, but the most likely explanation is northward spread of debris from catheters and or the burns/freezes of the ablation.

Two studies presented at EHRA shed light on these lesions. One dealt with AF ablation; the other with left atrial appendage occlusion. My report is titled: EHRA 2017: Brain Imaging and the Trade-offs of AF Procedures

Should we screen for asymptomatic AF? 

People who feel their AF episodes have trouble believing that many patients with AF don’t know they have it. But it’s true: in about 1 in 3 cases, AF causes no symptoms.

Digital technology will surely increase the amount of asymptomatic AF that we find. In the old days, it took a formal ECG to find asymptomatic AF. Now, with the advent of fancy BP devices (the type that can signify an irregular rhythm), smart watches, iPhone ECGs, and long-term ECG monitors, it’s easier to find AF.

One thing I learned at EHRA is that asymptomatic AF may confer a higher risk of stroke. A study presented in Vienna found that the incidence of prior stroke was more than twofold higher in patients who do not feel their AF. And this finding aligns well with previous observational studies.

The importance is obvious: it provides a rationale for screening for AF.

But I am not convinced. Read why in my post titled: The Danger of AF Without Symptoms.

Ventricular Tachycardia (VT) Ablation:

Another nugget I learned at EHRA is that VT ablation procedures are increasing more than AF ablation procedures–in percentage terms.

I went to a session at EHRA called strong statements and controversies. The format was cool: a young doctor presented less than 10 slides in 5 minutes and purposefully came to a provocative conclusion. Then a panel of the world’s biggest names spent 15 minutes discussing their views.

One of these of provocative conclusions was VT ablation does not reduce mortality.

This is true. Many authors have published studies on VT ablation, and none of these papers have shown that the procedure extends life. VT ablation reduces the number of shocks patients get from their ICDs, improves quality of life and reduces the chance of being re-admitted to the hospital but it does not lower the death rate.

Are these outcomes enough to forge ahead with increasing numbers of VT ablation procedures? Read my thoughts here:  EHRA 2017: Should VT Ablation Be on the Rise Without Mortality Data?

Clots on left atrial appendage occluders? 

I have another post coming out early next week on the matter of clots forming on left atrial appendage occlusion devices, such as the Watchman. Clots on these devices, and the risks they pose were topics of two late-breaking clinical trials presented in Vienna. This is significant because organizers designate late-breaking trials as the most important to the field.

I found it notable that two of these featured studies came to cautionary messages concerning left atrial appendage closure–which I believe will be one of cardiology’s biggest mistakes.

JMM

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Filed Under: AF ablation, Atrial fibrillation, General Ablation, General Medicine, ICD/Pacemaker

A short take of the big stories in cardiology in 2015

December 20, 2015 By Dr John

Here is my most recent column on theHeart.org | Medscape Cardiology: Mandrola’s Top 10 Cardiology Stories 2015

What follows below is a short-writing summary of my ten picks. The hyperlinks go to earlier columns I wrote on the topic.

1. The FDA approved two new (injectable) cholesterol drugs. The problem with the PCSK9-inhibitors: the study to determine whether or not the $14,500-per-year drugs prevent heart attack or death finishes in 2017. I wished the FDA had waited.

2.  The Sprint Trial studied the effects of lowering BP to 120 versus 140 in high-risk adults. The lower-BP target won. The differences were small, and there were tradeoffs: more pills and more adverse events in the lower-BP group. The challenge will be applying these results to the real world–where patients aren’t as uniform or closely followed as they are during a trial.

3. In 2015 we relearned that coffee, fat and cholesterol are not baddies. Refined sugars are. This made my list because it was a huge reversal; not a single trial backed the 1970s-era advice to cut fat consumption. And, I love coffee.

4. Three discoveries dominated the news in atrial fibrillation. I listed them in the Medscape story.

5. When a researcher presented results of a study of a diabetes drug (one already approved, and in use), he received a round of applause. Why? It was the first time a drug for Type 2 diabetes had been shown to lower death rates. Of course, concerns arose; later in the year, FDA released warnings about adverse effects with this class of drugs.

6. One of the worries with the new oral anticoagulant drugs (NOACs) is a lack of reversal agent. That changed in 2015–at least for dabigatran (Pradaxa). Reversal agents for the other three drugs (Factor-Xa inhibitors) performed well in studies, and will likely be available in 2016.

7. I love pacemakers because they are so pure. Pacemakers don’t treat risk factors; they treat disease. 2015 brought a wireless revolution. Pacemakers without leads performed well in studies. This is the beginning of a new era.

8. Like heart attacks are, strokes are often caused by blood clots that abruptly occlude a blood vessel to the brain. Five studies this year showed that stroke patients did better if they were treated with rapid intervention to open the blocked artery in the brain. This is big because it will require revamping of EMS and hospital systems to treat stroke like heart attacks. E.g–faster.

9. Patients who take clot-preventing drugs (anticoagulants) often require procedures or surgeries. This means stopping the drug for a period of time before and after. In the past, doctors felt it was best to bridge them with IV or subQ anticoagulant drugs. Two big studies in 2015 showed that bridging made matters worse. There were caveats though. I listed them in the column.

10. When you board an airplane and look into the cockpit, you expect that the pilots have been well-trained. Great controversy erupted in 2015 on how best to train doctors. One non-profit organization had enjoyed a monopoly on the lucrative doctor-testing process. Powered by social media and a few vocal activists, a revolt among doctors occurred this year. The monopoly conceded a lot; the question as to how doctors certify in the future remains unknown.

A reminder that you need to register to read Medscape articles. This is free but it requires an email.

JMM

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Filed Under: AF ablation, Atrial fibrillation, Dabigatran/Rivaroxaban/Apixaban, Doctoring, Exercise, General Cardiology, Healthy Living, ICD/Pacemaker, Nutrition

Right Care Action Week — Be skeptical

October 21, 2015 By Dr John

Right Care seeks to be smart care.

In the first part of my career, I rarely looked critically at the evidence. I was too busy; and I was more trusting of the vertical hierarchy of medicine. Eminence-based medicine seemed normal. Listen to the experts, for they are experts, went my mindset.

Then something happened. When internal cardiac defibrillators (ICDs) came to be around the turn of the century, someone asked me to do a talk on ICDs. This forced me to study the actual data.

I’ve never forgotten what I learned–not merely about the studies, but also how device companies used key opinion leaders, free food, junkets, and selective reporting of favorable data to make their case. I watched, and lived through the irrational exuberance of ICDs. (That experience still stings the medical profession.)

That was the beginning of my skepticism. Although I am no statistician or methodologist, I now read past headlines and abstracts. I look for the “hidden stitch” in studies.

Here is a slide from the famous Stanford professor, John Ioannidis, in which he lists the biases that exist before a trial.  Who knew? IMG_4678

Then there is this picture showing how results from big data sets depend greatly on how one slices the data. (credit — Ioannidis)

IMG_4675

Pharma and device companies don’t stay in business unless they design trials and slice data in a way that favors their product.

But industry bias is not bad; it’s expected. Industry works in the healthcare system we have created. It’s our job to recognize that free samples, pens, burritos and CME aren’t at all free.

Dr Ioannidis explains more about bias and other problems with medical evidence in this famous paper…Why Most Published Research Findings Are False. Bias and flaws in methods do not only affect industry studies.

In the interpretation of medical evidence, Right Care practitioners look at Figures 1-2 or Tables 1-2 of major trials. These show the actual differences in events. The key word being actual–not relative. The actual difference is often tiny. A 30% relative reduction looks great but if the event rate goes from 1% to 0.7% the actual difference is not so much.

Right Care means skillfully communicating these numbers with patients. Dr. David Newman, an ER professor and methodologist, believes the best care happens when patients and doctors have the same data. He and colleagues have created a website called NNT.com. This website looks at actual data from clinical trials and calculates how many patients would need to be treated (or harmed (NNH) for one to get the result.

To be fair, others have criticized the use of NNT in explaining medical decisions. But I like the NNT and NNH because it helps me understand the magnitude of benefits and harms. And if I understand the actual data, I can better explain it to my patients.

Another example…The news yesterday was that the American Cancer Society decreased their support of mammography in younger women. Why? Because there is no evidence that screening mammography in this group saves lives. But there is data showing that it creates harm, in the form of overdiagnosis and overtreatment.

Right Care supporters knew the limits of screening mammography a long time ago. The delay in getting good information to women occurred because the dollar-infused pink forces swamped the voices of reason.

Right care stands against hype. Right care seeks to understand and recognize bias, to frame decisions based on evidence not eminence, and most of all, Right Care is candid about uncertainty.

There is a lot of uncertainty out there. In fact, the more I learn, the less certain I become.

JMM

Right Care needs more voices. Go visit the Right Care Alliance. And speak up.

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Filed Under: Doctoring, General Medicine, Health Care, Health Care Reform, ICD/Pacemaker, Knowledge Tagged With: Bias, Lown Institute, pharma, Right Care Action Week, RightCare

Right Care Action Week – Un-informed Consent

October 20, 2015 By Dr John

The current state of informed consent in the US is best described as un-informed consent.

A study this May reported that only 3% of patients with coronary artery disease received full informed consent before having an invasive procedure.

Findings like these, and there are many other similar studies, reflect the ill-health of the medical decision in US healthcare.

It’s hardly a stretch to say most patients falsely believe stenting blockages is a fix for heart disease. Too many patients who receive cardiac defibrillators misunderstand the gamble they made. And don’t get me started on the LifeVest.

Patient-centered care and shared decisions are not platitudes; in an ethical and just healthcare system, they are normal.

Let’s review the current state of informed consent:

A patient takes a day off from work. He shows up at the hospital with a family member or friend, who has also likely taken a day off. He then gets put in a medical gown and lies flat on a gurney. The doctor comes in and stands above him. Then he is shown a piece of paper written in a small font, the language: legalese.

This is not the setting for a good decision. Instead, it’s the setting for a one-sided doctor-centered decision.

When patients don’t understand or take part in the medical decision, it’s a blemish on us as caregivers.

It does not have to be this way. Other than heart attack, stroke, a burst appendix and other emergencies, most medical decisions have multiple paths. There is time to think.

The medical decision (or we could say the medical gamble) is simple: Each path has positives, negatives and possible expectations.

In the decision to ablate AF, patients can decide to live with the disease or they can take the risk of the procedure. How one experiences a disease, or thinks about risks, plays into that decision. My job is to use my experience and expertise to help people make the decision that is best for them.

A patient with risk factors for heart disease can decide to lower that risk by taking a statin, or he can decide the absolute risk reduction isn’t worth taking a pill or possibly experiencing the side effects.

The right answer in a medical decision is not what the doctor or guideline writer says, it’s what the informed patient feels is best for them. Doctors need to remember it is not they who swallow the chemical or have the catheter put in their heart.

The good news is that the broken informed consent of today represents a major opportunity to get closer to Right Care.

First, I think decision quality would make an excellent quality measure. A patient with an ICD should be able to answer a couple of simple questions as to why she received it and what the device does. We could measure decision quality after a procedure and pay doctors extra when patients understand the gamble they just made.

Another thing we could do is scrap the legalese in the informed consent and make it an accessible document (or video) that has legitimate comparisons of the multiple approaches. Imagine an informed consent before a stent in a patient with stable coronary artery disease that made it clear that the stent did not prevent heart attack or death, and, at three years, there would be no difference in chest pain.

(Don’t get mad. This is the evidence. And evidence belongs on the informed consent.)

Finally, informed consent should move to a different area and time. It’s not fair to sign people up on the day of the procedure when they lie flat in a hospital gown.

Right Care is when patients have the time and permission to ask their doctor the four basic questions.

I stand for better medical decisions. That is Right Care.

JMM

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Filed Under: AF ablation, Doctoring, General Medicine, Health Care, Health Care Reform, ICD/Pacemaker, Knowledge Tagged With: Lown Instutute, Right Care, Right Care Action Week, RightCare

Right Care Action Week — rational care

October 19, 2015 By Dr John

I wrote yesterday about how a broken healthcare system favors overuse of procedures.

Today I will discuss rational care. Remember the goals of the Lown Institute: We think healthcare should be affordable, effective, rational and available to all.

Rational means in accordance with reason or logic.

Hardly a day goes by that I don’t see irrational care. Why it happens is complicated. Patients may expect irrational care. Doctors and nurses can get pushed into delivering it. Then, insidiously, unreasonable and illogical care become normal; and rational care stands out as an outlier.

Some examples:

It’s not rational to perform (or offer) CPR to frail emaciated elders. CPR is an intervention–similar to surgery or chemotherapy. We don’t feel compelled to offer drugs or surgery that won’t help. If a patient would get no benefit from CPR, it’s not rational to do it.

It’s not rational to avoid asking patients about their end-of-life goals. As medical experts, we understand that death is normal. In taking the oath of Maimonides, we promised to look after the life and death of our patients.

The best way to help our patients avoid a bad death (death by ICU, death alone or death in pain) is to 1) ask patients what is important to them, and 2) be rational about how we frame the trade-offs. And there are always trade-offs.

We should stand against all who oppose recent the CMS’ proposal to reimburse end-of-life discussions. We let the death-panel trope squash rational reform in the past, let’s not let it happen again. Advance directives should be as normal as Time-Outs.

In general cardiology:

It’s not rational to routinely prescribe the new PCSk9 drugs. The FDA recently approved these drugs on the basis of their cholesterol-lowering properties. Costs will be huge, about $14,500 per year. That’s outlandish because there is not a shred of evidence that the drugs improve outcomes. The trials looking at this question will report in 2016-2017. Two facts to remember: 1) high cholesterol is not a disease. 2) Not all drugs that lower cholesterol reduce the risk of heart disease. Lilly just gave up on a potent cholesterol lowering drug, Evacetrapib.

Two examples in electrophysiology:

It’s not rational to offer primary-prevention defibrillators (ICDs) to patients with life-limiting illnesses, especially those on dialysis. The clinical trials demonstrating benefits from ICDs were performed in mostly young male patients with heart disease as their primary problem. Too often, the benefits of these expensive invasive devices are wrongly extended to those who do not stand to benefit.

It’s not rational to offer ablation of AF to patients who have not been tried on conservative measures. AF ablation is risky and expensive, and the disease AF is not immediately life-threatening. We learned in medical school that when AF occurred with high thyroid levels, we should treat the thyroid problem and the AF would resolve. Now we know most AF stems from typical lifestyle issues, such as obesity, sleep apnea, alcohol excess and high blood pressure. Hospitals and doctors make big money burning the heart for AF, but the rational thing to do is treat the problems that cause the disease first.

Then there is oncology: (I have personal experiences here.)

It’s irrational to offer chemotherapy and radiation to patients with late-stage disease who are debilitated. It defies logic to think people who can’t walk to the bathroom or eat a decent meal will tolerate and benefit from chemo. When my mom died a few years ago from rapidly progressive stage-4 GI cancer, a respected oncologist recommended chemo only 2 days before she died. A brave hospitalist helped my family understand the irrationality of “palliative” chemo. Oncology as a field has done amazing things, but this outside observer thinks it would benefit from a hefty dose of reason and logic.

Rational care needs a following. Many are the caregivers who want it to become normal. If you do, say so. Head over to Right Care Alliance and sign-up. Tweet, blog, write letters, make noise. Feel free to add other examples of irrational care in the comments.

JMM

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Filed Under: Cardiac Stem Cells, Cycling Stuff, General Cardiology, General Medicine, Health Care, Health Care Reform, ICD/Pacemaker, inflammation, Knowledge Tagged With: Lown Instutute, Right Care

The medical decision is sick but not hopeless…

August 23, 2015 By Dr John

What follows is my latest post on theHeart.org | Medscape Cardiology. It’s weird; the post is one of my favorites, but it’s not made the most read list–at all, not even fifth place. There are thoughtful comments but it’s simply not popular among doctors.

****

Imagine this scenario: A learned professor comes to your office as a patient. She brings information downloaded from PubMed and various other sources. What are your sensations? If, after getting care from you or your team, would this professor feel compelled to write an essay about paternalism and power imbalance in the healthcare decision?

In her 2013 essay in the Atlantic, Thinking About Pregnancy Like an Economist, Emily Oster, then an associate professor at the University of Chicago, objects to the state of pregnancy care. I am not an expert in obstetrics, but her point, and mine, applies to most medical decisions. Be sure, obstetrics is not the only area of healthcare mired in anachronism.

Prof Oster is an economist who read a lot about pregnancy. That information, taken together with her expertise in statistics, transformed her into a (very) informed patient. She is not a medical doctor, but she acquired much of the same information medical doctors had. That became a problem. And that it was a problem is the issue we should discuss.

To read the rest of the post, click on its title, Doctor Doesn’t Always Know Best.

JMM

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Filed Under: AF ablation, Atrial fibrillation, Doctoring, General Medicine, Health Care, ICD/Pacemaker, Knowledge Tagged With: Medical decision making

Avoiding a bad death requires preparation

July 31, 2015 By Dr John

If there was a hashtag for sub-specialty healthcare and ICU medicine in the United States it would be:

#WeCanButShouldWe

A recent study led by Dr. Harlan Krumholz (Yale University) showed that we have become more efficient at keeping elders alive. This is not surprising. And it’s good news in the sense that technology–if used wisely–can enhance both quality and quantity of life.

The key phrase above is…if used wisely.

The obvious fact remains: Human beings don’t live forever. The same medical technology that can extend life can also prolong death. Most cases we review each month in our peer-review meeting begin with an elderly or chronically ill person who suffered excessive care at the end of life. This happens because the default in hospitals is to do everything.

Life-prolonging care in 2015 is aggressive, often painful, and doctor-centric. Life-prolonging care steals autonomy and shuns dignity. Life-prolonging care is immense.

The key to avoiding a bad death is preparation. To prepare is to make something ready for consideration; create in advance; have a plan. Dr. Dan Matlock (University of Colorado) and I wrote that doctors, electrophysiologists particularly, should help their ICD patients make plans for turning off shocks when death is near. Dr. Jeffrey Burns (University of Pennsylvania) urged kidney doctors to help dialysis patients plan for the future–and avoid futile CPR. Dr. Atul Gawande educates the entire world with his best-selling book, Being Mortal.

Then there is ZDoggMD, who spreads common sense in his unique way:

To make ready. This is the key.

JMM

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Filed Under: Doctoring, General Cardiology, Hospice/Palliative Care, ICD/Pacemaker

Recap of 2015 European Heart Rhythm Association Meeting — Milan

June 28, 2015 By Dr John

I recently returned home from Milan, Italy. I was covering the 2015 European Heart Rhythm Association (EHRA) sessions.

Selfie at the MiCo convention site

Selfie at the MiCo convention site

My favorite part of the congress, as it always is with medical meetings, was connecting with old friends, and making new friends. I had coffee, lunch or dinner with colleagues from Australia, Netherlands, France, Italy, Belgium, Frankfurt, Hamburg, Leipzig, Milan and the US.

You learn a lot from colleagues. Even after 20 years, it never gets old listening to others explain how they do this or that. I hope the Internet and social media does not render medical meetings extinct. In real life is different–better.

Here are the topics I wrote about for theHeart.org on Medscape.

FIRM ablation for AF:

Focal Impulse and Rotor Modulation (FIRM) is a novel way to approach AF ablation. The idea is to find and burn the rotors (think eye of a hurricane) that cause AF. The doctor places a basket catheter in the atria during AF. This basket has many electrodes, which record the waves of electricity. These signals are fed into a computer, and voila, the computer tells the operator, “burn here.”

The European perspective on FIRM ablation is one of strong skepticism. More than half of the EHRA program dealt with AF, but there were only a handful of presentations on FIRM. No Euro doctor I spoke with used a Topera rotor-finding system, or were they looking into getting one. That’s quite different from the US.

Here is my post on the stark differences of opinion:

FIRM Ablation for Atrial Fibrillation on Unfirm Ground

The CARDIOFIT Trial:

The CARDIOFIT study, which was presented as a late-breaking clinical trial and simultaneously published in the Journal of the American College of Cardiology, was, by far, the most important study from EHRA.

In CARDIOFIT, the University of Adelaide research team studied whether fitness (or gains in fitness) would reduce AF burden or possibly add to the benefits of weight loss. More than 300 patients in their study group had before and after exercise stress tests–which are a fast and easy way to gauge fitness.

The results were remarkable (below are only a few highlights):

  • Two-thirds of patients with high baseline fitness remained free of AF without drugs or ablation, while only 12% of patients with low fitness remained free of AF.
  • With both weight loss and fitness gain, the odds of AF-free survival without drugs or ablation was 76%, vs only 13% in those with neither weight loss nor fitness gain.
  • With AF drugs or ablation, the weight-loss and fitness-gained group had a 94% chance of being free of AF, while only 34% of those who did not lose weight or gain fitness were free of AF.

I was not the only one excited about this data. Trial discussant, Dr. Claudia Siklody (Germany), called the results “spectacular.”

You can read my entire commentary here:

New Antiarrhythmic Drug for AF: No FDA Approval Required

Cryo v RF Ablation for AF:

Most every one agrees that electrical isolation of the muscle sleeves in and around the pulmonary veins is essential for AF ablation. The question is how best to accomplish this. The original way is to do point-to-point RF ablation. Another way to isolate the PVs is to use a cryoballoon. One freeze of a well-placed balloon makes a circular lesion around the veins.

Cryoballoon ablation began in Europe well before it did in the US. I can’t cite the statistics, but it seems cryo is more commonly done in Europe. All the European doctors I talked with did cryo. You see lots of cryo-related abstracts at EHRA–much more so than at American meetings, especially lately.

Right now, no one knows which technique is superior. All we have for evidence comparing the two strategies are single-center studies and non-randomized registries. The Fire and Ice trial is a multi-center randomized comparison of RF v Cryo. That study is finished recruiting patients and is currently in follow-up. It will be a biggie.

The young investigators award at EHRA went to an abstract that looked into how operator experience figures in the results of both cryo and RF ablation. The results were intriguing. The teaser is that operator experience plays a much more important role in one technique. From a patient perspective, the findings have important implications.

My full commentary is here:  Fire or Ice for AF Ablation? Operator Experience Counts

ICD generator change:

An implantable cardiac defibrillator (ICD) battery lasts between 5-8 years. These days, ICD generator change procedures nearly outnumber new implants. The reason for that trend is, in large part, good news. Good news because people with heart disease are living longer. The bad news is longevity often comes with age-related organ dysfunction and chronic diseases.

My favorite slide from the meeting -- Love Osler

My favorite slide from the meeting — Love Osler

Recall that when we implanted an ICD the first time, we gambled. We took the risk that future device benefits would outweigh harms. That gamble changes—often for the worse—at the time of generator change. ICDs only prevent death from arrhythmia. When we age, biology dictates that organ function declines. When organ function declines, chronic diseases develop. In medical speak, we call this law of nature, “competing causes of mortality,” which lessons the benefit of an ICD. What’s more, the surgery to change an ICD generator is as high (or higher) a risk as putting in a new one.

You see the problem: older patients, more diseases, and significant surgical risks. A number of studies on this topic were presented at EHRA.

Here is my coverage of this important and growing dilemma.

ICD Generator Change: No Easy Answers at EHRA

Deborah Brauser is a new journalist at theheart.org on Medscape. She was also in Milan and has filed some nice reports from EHRA. There is an especially cool study on test-driving a pacemaker before getting a permanent one.

JMM

P.S.: Finally, if you ever visit Milan, the B and B Hello Milano provided outstanding accommodations. Perhaps the best I have had in Europe. Note that I grew up with an Italian grandmother next door–so I consider myself highly qualified to make that statement. It was lovely. Thanks Lorenza and Mary!

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Filed Under: AF ablation, Atrial fibrillation, ICD/Pacemaker, inflammation Tagged With: Cardiostim, EHRA, European Heart Rhythm Association

Update: Baltimore, Safety in AF ablation, Podcasts, and some personal notes

May 4, 2015 By Dr John

On Baltimore:

Human beings rioting in the streets of an American city forced cancellation of an important cardiology meeting. This is a vivid example that doctors do not practice in a vacuum. We are connected to this world. Here in Louisville, just a few miles north, an HIV crisis runs amok because of IV drug use. Despair. Inequality. These are no small things. What bothers me most about our healthcare system is the waste. We burn money. If we stopped doing that, we would have more to do for the less fortunate. I make a call out to every day physicians to stop burning money. Medicine Can’t Ignore Baltimore and Ferguson.

On a failure of a safety method in AF ablation:

The most devastating complication of AF ablation is damage to the esophagus. Thermal lesions can lead to a connection (a fistula) between the esophagus and the left atrium. This–thankfully rare–event leads to death in the great majority of people. Most doctors take evasive action to protect the esophagus. One maneuver is to monitor temperature in the esophagus. The idea is that if a burn in the heart causes a rise in temp in the nearby esophagus, the operator stops burning and damage is avoided. Sounds good, right? Except a new study from Germany suggests the act of temperature monitoring associated with dramatic increases in thermal lesions. AF Ablation: Esophageal Monitoring Harmful or Helpful?

Podcast for May 1, 2015:

This 12-minute video podcast includes my comments on Baltimore, outcomes in LVADs, gene-therapy for heart failure, statins for all elders, and an FDA alert on hand sanitizers. May 1 Cardiology News Podcast

Podcast for April 24, 2015:

This 11-minute video podcast includes my comments on a consensus statement from AHA on the treatment of adults with congenital heart disease, safety of sports in youngsters with Long QT syndrome, the vital importance of treating sleep apnea in patients with AF, the cardiovascular risk of divorce, and the Dr. Oz controversy. April 24 Cardiology News Podcast

Mention in the Houston Chronicle:

Markian Hawryluk is an accomplished healthcare journalist who contacted me for my thoughts on the Watchman, a device used to occlude the left atrial appendage in patients with AF. It was a long slog through the FDA process but Watchman finally made it. I am worried about where this chapter in cardiology is headed. You can read my quotes here: New device effective in preventing blood clots, but experts fear overuse, high costs. I will surely have more to say about this focal solution for a systemic problem in the months to come. My stance has changed little since I wrote Eight Reasons to Remain Doubtful on Watchman in 2013.

Personal Note:

I am currently on a Mark Twain kick. My recent reads include, The Handmaid’s Tale (Margaret Atwood), Hitch-22, (Christopher Hitchens’ memoir), The Sun Also Rises (E Hemingway), The Human Stain (Philip Roth), Writing Tools and How to Write Short (Roy Peter Clark).

I am back to running and mountain biking. I like both–for lots of reason. One is that they keep my legs sufficiently tired so that I am less likely to succumb to criterium thoughts. It is that season. And crits are so beautiful.

JMM

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Filed Under: AF ablation, Atrial fibrillation, Cycling Stuff, Doctoring, Exercise, General Medicine, Health Care, Health Care Reform, ICD/Pacemaker, Reflection, Social Media/Writing/Blogging Tagged With: Statins

Update: Social justice of AF care, NOAC monitoring, population health and two new podcasts

April 20, 2015 By Dr John

Hi All,

Here is a short update of the past week.

The first thing to say is the Atrial Fibrillation Care: Put the Catheter (and Rx Pad) Down post has gotten a lot of attention. It stayed on the most popular list all week. It has over a 130 comments, and I have received many emails on it. It is a big moment in AF care.

Screen Shot 2015-04-16 at 2.29.45 PMI would also point you to an interview I did with Dr. Prash Sanders from Adelaide. Prash is the senior researcher on the LEGACY trial. His team’s work has been most responsible for the change in thinking of AF care. The title of the post: LEGACY PI Throws Down the Gauntlet to US Physicians

Is AF care fair?

One aspect of AF care that I discussed recently with one of my partners was the notion of social justice. An AF ablation costs $100,000; a redo ablation costs $100,000. That is a lot of money. And now we know that in most cases, lifestyle changes either eliminate the need for procedures or render them more likely to succeed.

So…how fair is to spend $200,000-plus to treat a patient with AF? Think of what could be accomplished if that much money was used to care for the needy in our community? Is it right or just to allocate that many resources to a disease that is most often due to life’s excesses?

Population Health?

This leads me to population health–a hot topic in the hospital these days. The thinking goes that hospitals will be charged with delivering health to the population it serves. That is funny. As if health comes from hospitals. My mantra on the matter of health in populations: #BuildParksNotCathLabs.

Monitoring of NOAC drugs:

My column last week delved into the issue of monitoring patients who take the new anticoagulant drugs dabigatran, rivaroxaban and apixaban. Conventional wisdom–powered by marketing–has it that these drugs are more convenient than warfarin because less monitoring is required. A new study suggests otherwise. Researchers from Stanford looked at 67 VA medical centers and found great variation in patient’s adherence to the drug (dabigatran). They also discovered a yet unappreciated benefit from pharmacists.

The title and the link of the post is here: Should NOACs Be Monitored Like Warfarin . . . and by Pharmacists?

Two new podcasts:

In This Week in Cardiology for April 17th, I discussed NOAC monitoring, news from the FDA, including a warning on two new diabetes drugs, the future of cardiac devices and physicians’ view of electronic health records.

In This Week in Cardiology for April 10th, I discussed cooling after cardiac arrest, sports-related cardiac arrest, young adults and statins (ouch), antidotes for Factor Xa anticoagulant drugs and Staci’s letter to cardiologists on palliative care.

Great read of the week:

The best medical writing of the week came from my colleague and fellow writer Dr. Melissa Walton-Shirley. Trust me. Read her stirring essay A Death Well Lived. 

JMM

P.S. I rode 80 miles Saturday. It felt great.

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Filed Under: AF ablation, Athletic heart, Atrial fibrillation, Doctoring, General Medicine, Health Care Reform, Hospice/Palliative Care, ICD/Pacemaker, Reflection

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John Mandrola, MD

Welcome, Enjoy, Interact. john-mandrola I am a cardiac electrophysiologist practicing in Louisville KY. I am also a husband to a palliative care doctor, a father, a bike racer, and a regular columnist at theHeart.org | Medscape

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For patients...Educational posts

  • 13 things to know about Atrial Fibrillation — 2014
  • A new cure of AF
  • Adding a new verb to doctoring: To deprescribe is to do a lot
  • AF ablation — 2015 A Cautionary Note
  • AF Ablation in 2012–An easier journey?
  • Atrial Flutter — 15 facts you may want to know.
  • Benign PVCs: A heart rhythm doctor’s approach.
  • Caution with early Cardioversion
  • Decisions of 2 low-risk cases of PAF
  • Defining success in AF ablation in 2014
  • Four commonly asked questions on AF ablation
  • Inflammation and AF — Get off the gas
  • Ten things to expect after AF ablation
  • The medical decsion as a gamble
  • The most important verb in our health crisis
  • Wellness Requires Ownership

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