COMMENTARY

Jan 8, 2021 This Week in Cardiology Podcast

John M. Mandrola, MD

Disclosures

January 08, 2021

Please note that the text below is not a full transcript and has not been copyedited. For more insight and commentary on these stories, subscribe to the This Week in Cardiology podcast.

In This Week’s Podcast

For the week ending January 8, 2021, John Mandrola, MD comments on the following news and features stories.

First, America

For months on end, the pandemic has rightfully distracted us from almost everything medical. Before Wednesday, it would have been hard to believe that anything else could have been bigger news than the third wave of this pandemic. I feel sad for this nation.

What I hope for is that perhaps this is a spark; perhaps leaders can come together, reach out, and get back to the business of trying to help this nation heal. The Democrats are in charge now. Let’s see if they can do it. If they can’t, there are other elections. In eighth grade history, we learn that America has come through many nadirs. I will remain hopeful and optimistic.

COVID Surge, Vaccines

Just before Christmas, there was a nationwide decrease in COVID cases. Then, boom, in the last two weeks, cases are back up, way up, and certain areas are struggling mightily. Colleagues in Los Angeles and Texas tell of severe stress in their hospital from cases. More than 4000 people died from COVID in one day this week.

The good news is that we now have millions of doses of highly effective vaccines going out. While the rollout in the United States has been less than perfect, the optimistic case of vaccines ending the pandemic looks more and more realistic. I am also mildly reassured that millions have received the vaccine and I haven’t seen any trends in serious adverse events.

A great debate on vaccines has emerged: that is the one-shot vs two-shot vaccine rollout. In the Pfizer and Moderna trials, efficacy was > 90% with a two-shot regimen. So if we were treat vaccine intervention as we do ICDs (implantable cardioverter-defibrillator), TAVI (transcatheter aortic valve implantation), or anticoagulants, we would strictly adhere to trials.

But modeling has shown that delaying the second shot in an effort to get a single shot to more people—especially the vulnerable—might save lives. Proponents of this one-shot strategy delve deep into the trials for post-hoc kinds of analyses showing that efficacy after one shot is good enough.

The utilitarian (or benefit the most) take favors one-shot. But then you have virologists like Florian Krammer warning that one-shot strategies may encourage selection pressure towards more resistant strains of virus.

Valve Guidelines

In mid-December, the American College of Cardiology and American Heart Association released a new guideline document for treating patients with valvular heart disease. The main document is 156 pages. Here are some highlights.

Highlight Number 1: The authors highlight the history and physical exam and say that these should be correlated with non-invasive tests. I know what you may be thinking: Come on Mandrola, that is anodyne. But no, it is not. In the real-world of clinical practice, I can’t emphasize enough how important it is to do a good history and exam. Why? Because valve disease isn’t an ST-segment elevation myocardial infarction (STEMI).

Uncommon is the low-risk patient with isolated severe aortic stenosis or the acute leaflet tear. Most often, treating patients with valve disease requires a clinician who sees the whole person: Did they come with a walker, how much dementia do they have, what are their goals. Who is helping them at home? Do they shop for themselves? Kudos to the authors for highlighting the need for doctors to use doctoring skills.

Highlight Number 2 is the strong mention of the MDT (multidisciplinary team). The authors give it a Level 1 recommendation based on expert opinion, basically no evidence, but I would suggest you don’t need a colored coated box or evidence to understand the importance of discussing a patient’s case with clinicians with different points of view.

Here are some of my worries about MDT’s: Patients aren’t usually there to advocate for themselves. Depending on the circumstances, does one point of view dominate? Are the surgeons driving decisions, or is it the interventionalists? Is there really robust critical appraisal of the transcatheter aortic valve replacement (TAVR) vs surgical AVR (SAVR) data? Is there a palliative care or geriatrics clinician there to help clinicians see past the color dopplers?

In addition, underlying the American MDT is the conflict of interest born from our productivity-based compensation. In many if not most hospitals these days, power and status comes from being a high-producer.

Highlight Number 3: Guideline authors give great leeway for the choice of TAVR in patients for whom a bioprosthetic valve is appropriate. What is strange to me is their choice to define categories based on age—they give 1A recommendations for symptomatic patients between ages 65-80 years to have either TAVR or SAVR after shared decision-making. That is strange because the trials (PARTNER 2A, PARTNER 3) underpinning these recommendations were not based on age; the trials were based on surgical risk.

In the text (page e30), the authors justify their choice to use age-based TAVR recommendation based on a 2019 meta-analysis by Siontis and colleagues. The problem with that meta-analysis is that it lumps in trials that should not be lumped together. A significant driver of the barely significant hazard ratio was mortality benefit in elderly high-risk patients. Another issue was the inclusion of 1–2-year data from the low-risk trials, of which only a small number had completed follow-up.

It seems obvious to me that the TAVR vs SAVR decision in 70-year-old with low to intermediate risk ought to be determined only by the longest-term data from patients in that category. In my opinion, the longer-term issues with TAVR relative to SAVR, including higher rates of aortic insufficiency, more pacemakers, and unknown valve durability, should have received a lot more attention.

Highlight Number 4: Functional mitral regurgitation (MR). The authors give percutaneous edge-to-edge repair with MitraClip a 2A recommendation based on the results of the COAPT trial. Obviously, most listeners of the podcast know that while the industry-funded COAPT trial found MitraClip to be hugely beneficial in terms of reduced heart failure hospitalization and death, the government-funded French MITRA-FR study showed no difference.

Guideline authors explain the differences based on enrolled patients and medical therapy: COAPT enrolled patients with smaller left ventricles (LV), more MR, and who had more rigorous medical management.

Milton Packer and colleagues wrote a compelling paper in JACC-Imaging in which they explained the disparate results of the two functional MR RCTs using the concept of proportionate and disproportionate MR. Their theory is that the positive COAPT enrolled patients with disproportionate MR, thus the benefit from MC. Disproportionate MR is more regurg than you would expect based on the LV size. You have one trial that shows MC is as good as clean drinking water and antibiotics and the other shows no benefit. And you want to hang this difference on a few millimeter measurements of orifice area and LV measurements?

I don’t deny that there are patients who might benefit from this procedure, but I suspect they are small in number and must be highly selected. That’s why I would have given this a 2b recommendation.

Physician Harassment on Social Media

JAMA-IM published a research letter on the prevalence of online harassment. The group of authors from Chicago designed a survey and put it out on their respective social media feeds. Of 1100 views, 464 clinicians responded. About one in four reported personal attacks. And 16% of women respondents reported sexual harassment.

As many of you know I was an early adopter and have been an advocate for social media. I see far more benefits than harms for being present in the online space. Two big reasons: If you choose not to participate, your online presence is made for you: by those silly doctor-grading sites. Google John Mandrola and you find my blog, my Twitter feed and my publications. I have defined who I am. I highly recommend you do the same.

The second reason to be online is to keep up with prevailing trends in medical education. I am a far more informed doctor b/c of the things I learn online. From statistics, to trial appraisal, to pharmacology, to economics, and even philosophy.

But being active online comes with downsides. I wish it were not so, but the openness of social media can bring vitriol. I agree strongly with what Dr. Esther Choo said in the Medscape News piece: “harassment is part of the deal.” Choo said she barely even notices the negative aspects of the social media environment anymore. To me (and granted, as a white male, I do not have to put up with sexual harassment), dealing with vitriol is easy on Twitter: you just mute people who don’t engage in good faith, and you report and block accounts that are threatening.

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