COMMENTARY

July 16, 2021 This Week in Cardiology Podcast

John M. Mandrola, MD

Disclosures

July 16, 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 on: Apple Podcasts, Spotify, or your preferred podcast provider.

In This Week’s Podcast

For the week ending July 16, 2021, John Mandrola, MD comments on the following news and features stories.

COVID-19

My gosh, this pandemic is exhausting.

Geographic hotspots of rising hospitalizations remain; most of the patients ill enough to be in the hospital are not vaccinated.

I’d estimate that 1 in 10 of my clinic patients don’t plan to be vaccinated. Most of these folks are not persuadable. Some are and I have had rare successes. It seems unrealistic to think all US patients will comply with the vaccine.

On the matter of persuasion: I see many of my colleagues online pushing hard for vaccines. I get that. I’ve been loud and clear that vaccine efficacy is truly amazing.

But I want to push back on one of the techniques being used to scare folks; it is use of relative percent increases of cases. It is misleading to promote a rise in cases of 300% when the number has gone from 5 per 100,000 to 15 per 100,000. In absolute terms it is a tiny and insignificant increase in risk.

On mandates: I remain concerned about vaccine mandates for young people. The signal of vaccine-induced myocarditis is real, it is causal, and rational people ought to be able to make their own vaccine decision without being denied employment or a college education.

I know plenty of you will disagree, and that is ok, but mandates are a different story. Because over time, we may learn that different vaccine strategies in young low-risk people are safer.

Also, have you wondered why, exactly, the mRNA causes cardiac inflammation and injury? It’s curious.

Yale Nephrologist and Medscape contributor F Perry Wilson has an excellent dissection of the recent “positive” Ivermectin meta-analysis. It’s good both on the specifics, and the methodology.

Three points: 1) the plausibility isn’t there because the doses needed to inhibit virus are mainly fold higher than one can achieve in vivo; 2) the studies driving the “positive” meta-analysis are high in bias, 3) Just yesterday we learned that the trial (a preprint paper) with the largest weight in the meta-analysis was retracted.

Dissolving Pacemaker

A group at Northwestern reports in Nature BioTechnology on a leadless, battery-free, fully implantable cardiac pacer that dissolves and is cleared by natural biological processes after a period of weeks

The electronic components rest between two encapsulation layers of PLGA to isolate the active materials from the surrounding biofluids during implantation, and connect to a pair of flexible extension electrodes that deliver the electrical stimuli to a contact pad sutured onto the heart. The entire system is about 0.05 mL in width, 16 mm in length, and weighs about 0.3 g.

The pacemaker receives power and control commands through a wireless inductive power transfer — the same technology used in implanted medical devices, smartphones, and RFID tags — between the receiver coil in the device and a wand-shaped, external transmission coil placed on top of or within a few inches of the heart.

Obviously the report, done in an animal model, in the epicardial space would be most useful for post cardiac surgery pacing, but the next step is to move to transvenous setting, which would be great for ICUs, and post TAVR for instance,

I mention this story because too often we doctors forget the huge contribution that bioengineers make to our field.

Clinician Well-being

Lead author Laxmi Mehta from Ohio State U along with 4 other colleagues from the US and Europe wrote a joint opinion article about clinician well-being. Four journals published the short article. Thanks Dr. Mehta for the brevity!

More than a decade ago, Donald Berwick and colleagues proposed the triple aim of healthcare systems: improve the patient experience and the health of populations, and lower healthcare costs. But others remarked that you can’t do that unless you care for the healthcare workforce.

Hence the quadruple aim adds the goal of improving the work life of clinicians and staff.

The stats for burnout in cardiology are impressive: they cited a survey of nearly 3000 cardiologists, more than one-quarter reported being burned out and almost 50% were stressed; only 1 in 4 reported that they were enjoying their work.

A paper from the AFP journal included these quotes from doctors:

  • “The joy of practicing medicine is gone.”

  • “I can’t tell you how defeated I feel...The feeling of being punished for delivering good care is nerve-racking.”

  • “I am no longer a physician but the data manager, data entry clerk and steno girl... I became a doctor to take care of patients. I have become the typist.”

There is also a Medscape news article on the under-reporting of bullying in academic medical centers.

These are tough topics to discuss.

I was lucky. I had mentors who were committed to teaching. They had time; they cared. They were not burdened by the RVU productivity model. Do modern-day mentors in teaching centers, have the same time and energy to teach?

My wife Staci, a doctor, put her career on hold for 10 years to raise our children. This allowed me to get established in a private practice setting. When I worked long hours, took night call, went to group meetings, one parent was there for the kids. But this wasn’t fair to Staci. If we can find ways to make dissolving pacemakers, we ought to be able to design pathways that allow women to advance in their careers.

I believe the root of suffering stems from attachment. I see colleagues suffering because they hate the paperwork, the data-entry, the loss of status in the healthcare organization. They are attached to the old model of doctoring.

One of the best moves I ever made was to shun the anachronistic notion that being a doctor was something special or revered. My friend Andrew Foy taught me that doctoring is a job. A good job, a well-paying job, an important job, but the doctor as hero or icon is deeply problematic for our own well-being.

After talking with colleagues across the globe, I have come to believe that every place has its downsides.

Another strategy that works for me is to remind myself that administrators are just struggling people too. They surely feel the pressure to keep the hospital and clinic afloat in a competitive environment. They too are employees who can be off-boarded. A few years ago, I was in leadership at the hospital, and I could not believe how hard the CEO and leadership worked. I tap out the shortest notes possible to minimize screen time, I make as much eye contact as possible in the clinic and try not to look at emails on the weekends or nights. And I almost never open the envelope that has my RVU scorecard.

Mehta and colleagues are 100% correct in putting pressure on professional societies to improve working conditions of their paying members. For instance, instead of partnering with organizations like ABIM to extract testing revenue from paying members, how about lobbying law-makers for better working conditions for female colleagues? Or, pressuring lawmakers to protect clinical teaching programs? Or making sure that employee mental health programs are both easily accessible and private.

Professional societies need to focus more on the needs of their paying members and less on lofty goals like population health, guideline documents and partnerships. Medicine would be far better with fewer guideline documents.

Final point is on the matter of bullying at academic medical centers. In training, it seemed that we were over-worked, and asked to do tons of jobs under our level of training, and we were criticized, especially in echo and ECG conference, but I don’t recall feeling bullied—perhaps because everyone was treated in the same way.

But my wife Staci reminds me that this could be because I am a man. I simply cannot experience how women or minority learners feel.

One thing that has been great in private practice compared to training: clinicians respect each other and mostly act in a collegial way. Bullies don’t do well in private practice.

Finerenone

Earlier this month, FDA approved the use of the novel nonsteroidal mineralocorticoid receptor antagonist finerenone for the prevention of CKD in patients with Type 2 DM.

This is now the third drug for prevention of kidney disease in DM, the other two are the renin-angiotensin blockers, and the sodium glucose co-transporter 2 inhibitors.

The trial underpinning the FDA decision on finerenone, FIDELIO-DKD, randomized about 5700 patients with DM and CKD to the drug or placebo and measured a three-part renal composite outcome. Finerenone was associated with a highly significant 18% lower risk of CKD progression. NEJM published the first study in late 2020. https://www.nejm.org/doi/full/10.1056/NEJMoa2025845

In the latest paper published in Circulation  finerenone reduced the risk of the composite cardiovascular outcome compared with placebo (hazard ratio, 0.86 [95% CI, 0.75-0.99]; P=0.034), with no significant interaction between patients with and without CVD https://pubmed.ncbi.nlm.nih.gov/33198491/

In FIDELIO-DKD, the incidence of hyperkalemia was 2.3% vs 0.8% in placebo –but the drug may have less of tendency to cause hyperkalemia than the generic spironolactone.

The big thing with finerenone is that is nonsteroidal and a totally different chemical than spironolactone or eplerenone. This may be the reason it has less hyperkalemia and of course it may have less issues with gynecomastia—which is something I see a lot of in HF clinic.

Caveats: we don’t know the incremental benefit of adding the drug in diabetes and CKD when patients are on SGLT2i and costs, of course.

Finally – the makers of Finerenone BAYER, announced in a press release the results of FIGARO-DKD which was a CV outcomes trial in patients with CKD and T2D. Finerenone significantly reduced the risk of the composite primary endpoint of cardiovascular death and non-fatal cardiovascular events versus placebo.

I suspect we are early but this class of MRA will soon be a new class of CV drugs.

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