Tag Archives: American College of Cardiology

In Historic Moment, Transcatheter Aortic Valve Replacement Proven Superior to Surgical AVR

Three years ago after hearing two amazing presentations at the ACC meeting the skeptical cardiologist opined:

These studies suggest to me for the first time that TAVR may ultimately replace SAVR for all patients with severe aortic stenosis, low to high in their risk for surgery.

Clearly, we need ongoing follow up of these patients and more long term data, but as these devices improve and the operators gain more experience it is likely that results will only get better.

This represents a huge paradigm shift in our approach to valvular heart disease.

This morning I watched two more amazing study presentations at the ACC meeting in New Orleans which unequivocally establish the minimally invasive TAVR procedure (which my cardiology colleagues perform here at St. Luke’s) as the treatment of choice for patients who have symptoms related to severe narrowing of their aortic valve (aortic stenosis).

I just published a piece on the presentations for the physician social media site, SERMO which follows:

Since 2015 it’s been clear to me that catheter-based procedures (TAVR) were a better option than open-heart surgical aortic valve replacement for most of my patients with severe symptomatic aortic stenosis who were at high (>8% STS )  and intermediate (>4% STS) risk for surgery.  

Based on continued durability of TAVR results and outstanding results in my own institution, I’ve been advising my low risk patients with severe aortic stenosis that it was only a matter of time before TAVR would become the best option for them.

At the American College of Cardiology Meetings in New Orleans this morning two back to back presentations have confirmed that TAVR should be considered the treatment of choice rather than surgical aortic valve replacement ( SAVR) for most low risk patients with severe symptomatic AS.

This is such a dramatic paradigm shift in the treatment of AS that the Eugene Braunwald (now 90 years old) the first discussant of the presentations after reviewing the history of the treatment of AS, described it as an “historic moment” , one that we will tell our grandchildren that we were present at.

Furthermore, in a display I’ve never seen at an ACC session, the audience spontaneously stood and gave the presenters a standing ovation. 

Both studies were published yesterday in the NEJM (something the presenters indicated was an error) and disappointingly I read the results described in a New York Times article prior to watching the live presentation.

The first presentation was from Martin Leon on the Partner 3 trial which utilizes the Edwards Sapien 3, third generation baloon-expandable valve. The study randomized 1,000 patients to either TAVR  or standard SAVR with a bioprosthetic valve. The primary endpoint was the composite of death from any cause, stroke or re-hospitalization at one year after the procedure. At one year, the primary endpoint occurred in 8.5 percent of the TAVR group compared with 15.1 percent of the surgery group, meeting the requirements for both noninferiority (p<0.001) and superiority of TAVR vs. surgery (p<0.001).

The Kaplan-Meir analysis of the primary endpoint components with TAVR vs. surgery found mortality rates of 1.0 percent vs. 2.5 percent, stroke rates of 1.2 percent vs. 3.1 percent, and rehospitalization rates of 7.3 percent vs. 11.0 percent, respectively. The length of hospital stay was reduced from seven to three days with TAVR.

A cardiac surgeon, Michael Reardon (who I described as cocky and folksy in my 2015 post on TAVR), presented the results of the  EVOLUT  trial which randomized 1,468 patients to TAVR with a self-expanding bioprosthesis compared with surgical replacement. The primary endpoint was the composite of death from any cause or disabling stroke at 24 months. At 24 months, death or disabling stroke occurred in 5.3 percent of the TAVR group compared with 6.7 percent of the surgery group,

At 30 days, TAVR was statistically superior to surgery for the secondary combined endpoint of all-cause mortality or disabling stroke (0.8 vs. 2.6 percent). Patients receiving TAVR had significantly better quality of life and hemodynamics at 30 days.

I concur that these studies represent tremendous data that will drive a paradigm shift in the treatment of AS and anticipate that we will rapidly receive approval to use these two TAVR devices in all patients who meet the entry criteria (note that bicuspid AV was an exclusion but a subsequent presentation at ACC19 suggests that outcomes are similar in bicuspid valve patients to tricuspid valve patients).

Transfemorally Yours,

-ACP

Apple Heart Study: Despite The Ballyhoo, No Benefits Demonstrated, Harms Not Measured

The results of the Apple Heart Study, were presented this morning at the American College of Cardiology Scientific Sessions amid intense media scrutiny. The AHS is a “prospective, single arm pragmatic study” which had the primary objective of measuring the proportion of participants with an irregular pulse detected by the Apple Watch who turn out to have atrial fibrillation on subsequent ambulatory ECG patch monitoring.

 

I and over 400,000 other Apple Watch owners participated in the AH study by downloading the Apple Heart Study app and self-verifying our eligibility. 

My assessment is that we have learned little to nothing from the AHS that we didn’t already know. I’m also concerned that many patients suffered anxiety or unnecessary testing after being referred to urgent care centers, emergency departments, cardiologists or primary care providers and the results of these inappropriate referrals may never be determined.

Here is the study in a nutshell:

  1. Participants enrolled by submitting  information using the iPhone Heart Study app and none of their isubmitted nformation was verified.
  2. An irregular pulse notification was issued to 0.5% of participants who were then  contacted and asked to participate in a Telehealth visit with a doctor (who we will call Dr. Appleseed)
  3. Only 945 of the 2161 who received a pulse notification participated in the first study visit.
  4. Interestingly, Dr. Appleseed was empowered to send participants to the ER if they had symptoms (chest pain, shortness of breath, fainting/losing consciousness) It is not clear how many were sent to the ER and what their outcomes were but this flow diagram shows that 20 were excluded from further testing due to “emergent symptoms.”

  5. Another 174 participants were excluded after finding out at the first visit that they had a history of afib or aflutter and 90 due to current anticoagulant use (both of these factors were exclusion criteria which gives us an idea of how accurate the information was at the time of participant entry.)
  6. After all these exclusions only 658 ECG monitor patches were shipped to the participants of which only 450 were returned and analyzed.
  7. This means of the original 2161 participants who were notified of pulse irregularity, the study only reports data on 450 or 21%. Such a low rate of participation makes any conclusions from the study suspect.
  8. Of the 450 ECG patches analyzed only 34% were classified as having afib. Only 25% of this afib lasted longer than 24 hours.
  9. After the patch data was analyzed, patients had a second Telehealth visit with Dr. Appleseed who reviewed the findings with the patient. Per the initial published description of the methods of the AHS (see here) Dr. Appleseed  would tell the participant to head to the ER if certain abnormalities were found on the ECG.

Per the study description (apple heart study), Dr. Appleseed recommended a visit to the PCP for “AF or any other arrhythmia” detected by the patch:”

“If AF or any other arrhythmias have been detected in reviewing the ambulatory ECG monitor data, or if there are other non-urgent symptom identified by the study physician during the video visit that may need further clinical evaluation, the Study Telehealth Provider directs the participant to his or her primary health care provider”

At this point it seems likely that a lot of participants were instructed to go see their PCPs. Because as someone who looks at a lot of 2 week ambulatory ECG recordings I know that is the rare recording that does not show “other arrhythmias.”

Even more distressing is the call that participants would have received based on “the initial technical read:” I’m presuming this “technical read” was by a technician and not by a cardiologist. In my experience, many initial reads from long term monitors are inaccurate.

“If the initial technical read identifies abnormalities that require urgent attention (ventricular tachycardia or ventricular fibrillation, high-degree heart block, long pauses, or sustained and very rapid ventricular rates), then the participant is contacted immediately and directed to local emergency care or advised how to seek local emergency care.”

I wonder how many  ERs had AHS participants show up saying they had been told they had a life-threatening arrhythmia? How much down stream testing with possible invasive, life-threatening procedures such as cardiac catheterization were performed in response to these notifications?

Overall, these findings add nothing to previous studies using wearable PPG technology and they certainly don’t leave me with any confidence that the  Apple Watch is accurately automatically detecting atrial fibrillation.

Was more harm than good done by the Apple Heart Study?

We will never know. The strength of this study, the large number of easily recruited participants is also its Achilles heel. We don’t know that any information about the participants is correct and we don’t have any validated follow up of the outcomes. In particular, I’m concerned that we don’t know what happened to all of these individuals who were sent to various health care providers thinking there might be something seriously wrong. 

Perhaps Apple and Stanford need to review the first dictum of medicine: Primum Non Nocere, First Do No Harm.

Tachogramophobically Yours,

-ACP

Marketing Medicine, Changing Practice, And Groping Watchmen at the American College of Cardiology Meetings

In March, the skeptical cardiologist attended the annual Scientific Sessions of his professional organization, the American College of Cardiology. This year’s meeting was held in Orlando, a city which, for me, holds little allure beyond milder March temperatures than St. Louis.

The meetings are termed Scientific Sessions because lots of science is presented and discussed. The results of the latest, most important and “practice-changing” studies on cardiovascular drugs, devices, and diseases are released to much ballyhoo.

They take place in massive soul and leg muscle-sucking convention centers, where one typically has to hike several thousand meters to get from one presentation to another.

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The Orange County Convention Center-the second largest in the U.S., offering 7,000,000 sq. ft. of space, wifi everywhere, and the opportunity to garner 10,000 steps going from one room to another.

Medical science is best when not adulterated by commercial interest, but the ACC meeting is blanketed by advertisements for the latest (consequentially most expensive) and greatest (hopefully) life-saving drugs and devices.

A feature of these meetings is the draping of the escalators with drug marketing material. Look! Repatha now approved for a new indication!

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I used an app provided by the ACC to find sessions I was interested in, plan my itinerary and to interact with presenters. Quite irritatingly, every time I opened the app, I was presented with a commercial for, you guessed it, Repatha, one of two new (and really expensive) PCSK9 inhibitors.img_1022

I was so irritated by this advertising intrusion into my app use that I totally failed to find out what the new indication for Repatha was. (It was to prevent heart attacks and strokes, something the FDA decided in December, 2017, after reviewing the outcomes data from the FOURIER trial presented at the ACC last year (I listed this as #3 of my top cardiology stories of 2017).

Booth 1807 was in the sprawling “Expo” area of the conference, where drugmakers and device makers compete for the attention of cardiologists by offering espresso-based beverages, free nitrogen ice cream, made to order cannolis (the definite favorite of the Eternal Fiancee’, herself working the Expo for Scimage) and occasional kitsch, like rubber bouncy balls that light up when they hit a hard surface.

Typically, I avoid the cannoli and cappuccino but seek out the oddest opportunity to be seduced by the dark side.

One day I ventured into the Expo area to explore how companies were promoting their products in 2018 and before I knew it I was inside a heart,  grasping a left atrial appendage occluder.

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The skeptical cardiologist standing on the interventricular septum while occluding the left atrial appendage. This is how I ACC!

The Watchman device I was grasping has been approved for preventing stroke in patients with atrial fibrillation who are at high risk and can’t, or won’t, take blood thinners. Boston Scientific has been flying cardiologists to various cities for the last year to wine and dine them and fill them full of reasons to send their patients for the device. Thus far I have avoided going on such a boondoggle. (Read John Mandrola’s skeptical take on Watchman here).

If you didn’t get the message about Repatha from the app or the escalators, there were frequent presentations from investigators at various sites in the Expo floor.

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A lipid expert explaining why cardiologists should be prescribing cholesterol lowering PCSK9 inhibitors. Note the towering graphic “High LDL. Prior CV Event? Time to Act!”

The presenters are typically experts in the field, but are handsomely compensated for their time. Consequently, one cannot rely on this being unbiased information, so I avoid these like the plague. To the ACC’s credit, such presentations do not qualify for CME credit, and are labeled as industry-sponsored.

Despite my irritation with constant marketing and advertisements, and the bias these things introduce into cardiology practice, I get a lot out of attending the ACC sessions.

Full participation allows me to accumulate 34 hours of continuing medical education (CME), hours which I need to maintain certification in the various fields I specialize in, such as echocardiography, nuclear cardiology, vascular imaging, and coronary CT angiography.

I usually find several presentations which advance my knowledge base or change my viewpoint, and how I practice cardiology. This is ultimately good for my patients. I wrote about three of these for Medpage Today here. Consider reading the article, if only to experience the wonder that is the new and large photo of the skeptical cardiologist.

I’ll share some other thoughts from the meetings as time allows. Until then I remain

Skeptically Yours,

-ACP

 

 

 

Why Is The American College of Cardiology Distorting The 2015 Dietary Guidelines for Americans?

The 2015-2020 Dietary Guidelines for Americans (DGA) have finally been released and I’m sure that most of you could care less what they say. You may think that they can’t be trusted because you believe the original science-based recommendations have been altered by political, food and agribusiness forces.  Perhaps you don’t trust science to guide us in food choices. Perhaps, like the skeptical cardiologist, you realize that the DGA has created, in the past, more problems than they have corrected.

This time, the skeptical cardiologist believes they have made a few strides forward, but suffer from an ongoing need to continue to vilify all saturated fats.

As such, the DGA no longer lists a recommended limit on daily cholesterol consumption (step forward) but persists in a recommendation to switch from full fat to non fat or low fat dairy products, which is totally unsubstantiated by science, (see my multiple posts on this topic here).

By now you should have gotten the message that a healthy diet consists of lots of fruits, vegetables, nuts, legumes, fish, olive oil and whole grains. The DGA emphasizes this.

There is general consensus that processed foods and added sugar should be limited.

Most of the controversy is about what to limit and how much to limit foods that are considered unhealthy.

Red meat and processed meat remain in the crosshairs of the DGA (although not stated explicitly), but eggs and cholesterol have gotten a pass, something which represents a significant change for the DGA and which I have strongly advocated (here and here).

But hold on, my professional organization, the American College of Cardiology says otherwise.

Misleading Information From the American College of Cardiology

The American College of Cardiology sent me an email and posted on their website the following horribly misleading title:

“2015 Dietary Guidelines Recommend Limited Cholesterol Intake”

The first paragraph of the ACC post reads as follows:

“Physiological and structural functions of the body do not require additional intake of dietary cholesterol according to the 2015 Dietary Guidelines released on Jan. 7 by the U.S. Departments of Health and Human Services (HHS) and of Agriculture (USDA). As such, people should practice healthy eating patterns consuming as little dietary cholesterol as possible. – ”

While technically these statements can be found in the document (by digging way down) the executive summary (infographic below) says nothing about limiting cholesterol.

healthy eating pattern includes

The “Key Recommendations” list eggs as included under a “healthy eating pattern” along with other protein foods.

 

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In addition, there is no mention of cholesterol under what a healthy pattern limits.

 

 

In the same section on cholesterol that the ACC inexplicably has chosen to emphasize, is this sentence:

“More research is needed regarding the dose-response relationship between dietary cholesterol and blood cholesterol levels. Adequate evidence is not available for a quantitative limit for dietary cholesterol specific to the Dietary Guidelines.”

So the DGA recommends no specific limit on dietary cholesterol.

This is consistent with what the DG advisory committee recommended when they wrote “dietary cholesterol is no longer a nutrient of concern.”

The DGA goes on to state:

“A few foods, notably egg yolks and some shellfish, are higher in dietary cholesterol but not saturated fats. Eggs and shellfish can be consumed along with a variety of other choices within and across the subgroup recommendations of the protein foods group.”

The Vegan Agenda

I have a theory on why the ACC went so wildly astray in reporting this information: they are led by a vegan.

The current president of the ACC, Kim Williams, is an evangelical vegan, unrepentant, as this NY times article points out. Apparently, he tries to convert all his patients to the “plant-based diet.”

He is quoted extensively in the ACC blurb on the DGA and is clearly attempting to put a bizarre vegan spin on the new guidelines, ignoring the evidence and the progressive shift from the 2010 guidelines.

Can any information from the ACC be trusted if such basic and important science reporting was so heavily distorted by its President?

No wonder Americans tune out dietary advice: it can so easily be manipulated by those with an agenda.

-May the forks and knives be with you

-ACP

 

 

 

 

Healthy Skepticism and Bias in Cardiology : Let’s Eliminate Drug Ads from Scientific Publications

The skeptical cardiologist has been asked by a number of his patients  “Why are you the skeptical cardiologist?”  In essence, I think they are either asking what does “skeptical” mean or what makes you skeptical and why should I care?

In the About section of this blog I wrote “All of these experiences have taught me to cultivate a healthy skepticism for information that has potential bias.”

Whereas skepticism initially was an approach that doubted the veracity of everything and questioned our ability to know anything, healthy skepticism accepts the veracity of information only after it has been evaluated by a scientific or evidence-based approach.

John Byrne, MD, has a wonderful website, skeptical medicine, which describes in detail the skeptical doctors approach.

The modern skeptic is a scientific skeptic. We use proper science and basic ethics to inform our decisions. We withhold acceptance of claims until proper evidence is presented. We use axioms such as ‘Occam’s Razor’, ‘Extraordinary Claims Require Extraordinary Evidence ‘, and ‘Correlation is Not Necessarily Causation’ to evaluate claims. The skeptic recognizes that humans are prone to biases. We recognize that people defend their biases with logical fallacies. Skeptics understand that we are all prone to such biases and fallacies, even skeptics.  To overcome these tendencies, we must learn about biases and fallacies in order to spot and correct them, especially in our own thinking.

Thus, as a skeptical cardiologist, I am doing my best to use scientific approaches to evaluate recommendations for lifestyle, testing and treatment in the world of cardiology. I do not accept recommendations in these areas from cardiology authorities (American Heart Association, American College of Cardiology guidelines, scientific conferences), media, or the government, without carefully examining the scientific studies supporting them. I seek to eliminate biases that can undermine such studies and recommendations.

The Influence of Drug Money on Doctors

Identifying bias in medical recommendations is essential. Just as our politicians are heavily influenced by campaign contributions from special interests, physicians can also be heavily influenced by special interest spending.

I have tried to eliminate any possibility of pharmaceutical company marketing from influencing my medical decisions. I used to believe that I could accept meals and honoraria from drug companies and not be biased by them. However, several years ago, I realized that any time I spent listening to a heavily biased pharmaceutical representative promoting their product was replacing and/or competing in my brain with information about medications and diseases from unbiased sources. In subtle ways, even to the most ethical doctors, this has been shown to effect prescribing practice. If it didn’t, these companies would not be spending billions promoting their drugs directly to doctors.

The American College of Cardiology and Drug Advertisements

The major professional organization for cardiologists is the ACC or American College of Cardiologists. I get lots of emails from the ACC offering educational opportunities and information on the activities of the college. The ACC also mails me, weekly, the Journal of the American College of Cardiology, the major publication for scientific studies on cardiology in the wIMG_3297orld. Once a week or so, they send me “Cardiology World News,” which is a summary of relevant articles and developments in cardiology. All of these sources of information from the ACC are riddled with advertisements for drugs. The newer and more expensive the drug, and (it appears) the less the benefit, the larger the advertisements. Accompanying the latest Cardiology World News this last week was the large multipage pamphlet pictured below, touting the fact that Brilinta is “preferred over clopidogrel” for NSTEMI in the updated AHA/ACC guidelines. The skeptical approach is to question the validity of these guideline recommendations by reviewing the studies that they were based on, as well as the possible conflicts of interest of the authors (how many are paid honoraria or have research funded by Astra-Zeneca, the company promoting Brilinta)?

IMG_3299Within the pages of Cardiology World News were several multipage advertisements for drugs, especially for newer oral anticoagulant drugs, such as Xarelto. Even the prestigious Journal of the ACC is stuffed with these annoying advertisements. The emails I get from the ACC often contain banner ads for similar over-priced and over-marketed brand name drugs; the websites of ACC and Medscape are littered with banner ads for drugs. Since I am the skeptical cardiologist, I’ve reviewed the studies that resulted in these drugs being approved, and then make my own conclusions about how to prescribe them to my patients.  Such ads are not useful in my decision making.

When I read journals, studies, editorials or reviews of cardiology information,  I simply want unbiased information. I don’t want my mind cluttered by biased presentations from drug companies.

Why is my professional organization helping to promote these biases?  Obviously, it is for the money.

To the American College of Cardiology I say: “let’s eliminate drug ads from your publications.” With that simple step, we can help reduce the control that pharmaceutical companies have over physicians and move toward ensuring that all of our drug and device recommendations to patients are in their best interest.