Unfortunately, Conflicts of Interest Abound

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I had a transcatheter aortic valve replacement (TAVR) with an Edwards Lifesciences valve for symptomatic aortic valve stenosis. I had had severe aortic stenosis by echocardiography for at least two years, but I was asymptomatic and capable of riding my bike up to 75 miles in the western Connecticut hills with no symptoms. But when symptoms appeared, I got the valve fixed as detailed in 500 Rules of Cardiology. (1)

My last blog stated:

“It is especially important now for clinicians to continue to critically evaluate common medical wisdom because so many studies of new drugs and devices are designed and funded by the manufacturers, and then published in journals supported by the same companies. I say that despite being a clinician who is eternally grateful to industry for the wonderful drugs and devices they have invented. It’s just that sometimes the enthusiasm exceeds the evidence.

I don’t like criticizing industry because they have given us so many great drugs and devices to help our patients, but within a week of my blog, an article in Medpage reignited my concern that we clinicians are being manipulated to do what pharmaceutical and device companies want, and not always what’s best for patients.

The Medpage article on Jun 26, 2026, entitled “Aortic Stenosis Patients Still Tripped Up by Diagnosis Issues on the Path to AVR” stated that according to a national registry: “U.S. patients flagged with moderate or severe AS, based on an initial echocardiogram, ended up getting all their confirmatory diagnostic assessments within 30 days in 61.4% of cases in 2024, up from 54.2% in 2023 (P=0.001), per the American Heart Association’s Target: Aortic Stenosis registry. Among those with a class I indication for aortic valve replacement (AVR), the goal of timely treatment was achieved by 84.7% in 2024, no significant change from 82.2% the year before. This meant that nearly one in six eligible individuals did not get AVR within 90 days….”

This delay was described as a “gap in care”. These data were presented at the New York Valves conference and simultaneously published in Circulation. The MedPage article also stated that “There’s been a small but ‘alarming’ bump in aortic stenosis (AS) deaths among people ages 45 to 74 in recent years, according to nationwide trends” and that “… prior studies have suggested increased wait-time mortality during periods of rapid adoption of TAVR, which has been thought to explain the overall uptick in AS deaths in recent years.”

Wow. That is scary. We clinicians are allowing a gap in care, and an “increase in mortality” and an “uptick in AS deaths”. We better start hustling these patients to surgery or TAVR faster. But when you check the article on wait-time, it refers to patients with symptomatic severe aortic stenosis.(2) Symptomatic severe aortic stenosis is a different animal than asymptomatic severe aortic stenosis. And when you look up articles on the uptick in AS deaths, the change is extremely small and not significant. The increase in one study was 1.75%. The cause is unclear.(3) It is unusual to see an increase with the appearance of a new, effective, non-surgical treatment such as TAVR. (3) It’s possible (but not discussed) that the increase could be related to more frequent and earlier use of TAVR procedures in asymptomatic AS patients because the procedure is so much less invasive than surgical repair.

But who has the time to look up the reference articles? Clinicians should be able to trust what is written in medical journals and in lay literature for clinicians. The MedPage article is not wrong, just…slanted. I looked up the references because I delayed my TAVR until I had symptoms. I also try to delay interventions in my truly asymptomatic patients because if I can delay the procedure several years, it might just be enough to enable them to be “one and done” and not require a redo. So, that is my bias. But I think that many of these articles push clinicians to earlier, and more, interventions. Who wants to be wrong? Doing something is better than doing nothing, or is it? Early may be the right approach but many times the justifying data are absent. For example, those studies showing clinical benefit from TAVR in asymptomatic patients obtained their clinical benefit primarily by reducing heart failure admissions and not by reducing deaths, strokes, or the stuff we really care about.

The Circulation manuscript does not list who funds the AHA’s registry but Google AI says that Edwards Lifesciences funds it. Hmmm.

And then there are the physician financial incentives.

I have a relative with Parkinson’s who developed atrial fibrillation. He was referred to a cardiologist who refused (yes, refused) to treat him with a novel anticoagulant because of the Parkinson’s, and told him that without an atrial occlusion device he would have a stroke. My relative was scheduled for the device, a procedure which the cardiologist just happened to perform. My relative was so frightened by the cardiologist’s refusal to discuss other options, that he called me. My relative has never fallen and does non-contact, Parkinson’s boxing therapy weekly. Neither I nor my electrophysiologist colleagues thought my relative had an absolute contraindication to a novel oral anticoagulant. My relative changed cardiologists.

So, the Rule is: Surround yourself by expert clinicians whose opinion and recommendations you can trust. I feel fortunate to have my cardiology colleagues at Hartford Healthcare because our clinicians are largely salaried, and the culture is to do what is right for the patient.

None of us can know everything so we have to depend on others. But pay enough attention to the medical literature so that you can make some evaluation on your own and recognize when others may be slanting their opinion. Just another example of “Trust but Verify”.

1. https://pauldthompsonmd.substack.com/p/biking-75-miles-to-my-tavr

2. Albasam O, et. al. Increasing Wait-Time Mortality for Severe Aortic Stenosis: A Population-Level Study of the Transition in Practice From Surgical Aortic Valve Replacement to Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2020 Nov;13(11) PMID: 33167700

3. https://www.tctmd.com/news/concerning-trends-seen-aortic-stenosis-related-mortality-cdc-wonder

#medicalcare; #TAVR; #EdwardsLifesciences; #aorticstenois; #heartvalve; #atrialocclusion; #atrialfibrillation; #conflictofinterest