COMMENTARY

The Growth of TAVR and the Capitalist Creed

Jaya Mallidi, MD, MHS

Disclosures

January 22, 2021

Jaya Mallidi, MD, MHS

Wearing our masks, we sat at one of the metallic picnic tables on the patio of our newly constructed medical office building. The corporate business vibe made me uneasy.

I wore my baggy blue scrubs, having just come from the cath lab after performing a transcatheter aortic valve replacement (TAVR). The product manager for a TAVR valve, whom I will call Mike*, was in his dark blue suit with matching tie.

I agreed to the meeting because I was eager to better understand the business aspect of TAVR procedures. Given their high cost, the profit margin is low for each procedure from the hospital perspective. To run a financially sustainable TAVR program, the hospital administrative team and the physicians work closely to reduce the length of stay by adopting a minimally invasive approach without use of general anesthesia, and to reduce the overall complication rates. Thankfully, these cost-saving measures also enhance patient outcomes and satisfaction. A win-win for all, it appears.

Mike, with his flair for the sales pitch, described the excellent patient outcomes with his product and how our hospital, as part of a bigger hospital chain system, contracted with his company to buy the valves in bulk at a cheaper price. He urged me to preferably consider using his company's valve and subtly informed me that in the near future, the hospital chain will essentially force me to use a specific valve anyway. Suddenly, I felt the intrusion of the medical- industrial complex into my clinical decision- making like never before.

TAVR on the Rise

The story of TAVR is a remarkable example of the successful translation of research and technology into everyday medical practice, made possible by multidisciplinary collaboration between clinicians, scientists, engineers, and industry. It is also an example of the concept of the " capitalist creed" described by Yuval Noah Harari in his book Sapiens: A Brief History of Humankind. Harari writes about the "trust in future " — that is, the belief that the common pie will grow larger — as the foundation for the modern capitalist economy. That trust paid off for the TAVR device industry. The pie grew and continues to grow at an exponential rate.

TAVR volumes have increased every year and exceeded surgical aortic valve replacement volumes in 2019. An analysis from the TVT Registry attributes this growth to the benefits for patients coupled with the reduced burden of complications from TAVR. Assuming a high adoption rate, it is estimated that by 2028, the annual rate of TAVR procedures in the United States and Europe will be 631,000, valued at 13 billion US dollars. This explosion is possible only because of a profit-driven industry in the capitalist world we live in. The burgeoning profits are reinvested to improve innovation, conduct randomized trials, increase production, and generate more profits.

The Perfect Marriage vs Capitalist Hell

Edwards Lifesciences Corporation and Medtronic share the majority of the worldwide market in TAVR devices. Both have invested in excellent training of clinical specialists who are closely involved in case planning and strategy. Attending an industry-sponsored training program is mandatory for initial privileging at most US institutions. The companies are closely involved when hospitals start a new TAVR program and even help with marketing strategies. Looking at the adoption of TAVR through the lens of capitalism, I am reminded of the saying of the economist John Maynard Keynes: "Capitalism is the astounding belief that the most wickedest of men will do the most wickedest of things, for the greatest good of everyone." The truth is that the wide adoption of TAVR is more a testament to the ingrained capitalistic culture of our society than to its benefits for patients.

Ostensibly, this relationship between industry and medicine in the TAVR world is akin to a perfect marriage. However, as Harari points out, where there is the "capitalist creed," there is also a "capitalist hell" in some shape or form. When markets have free rein and capitalists establish monopolies or duopolies, growth and profit become the main objective above all else. He states , "When growth becomes a supreme good, unrestricted by any other ethical considerations, it can easily lead to catastrophe." We see this in the tech industry. A handful of gigantic powerful tech companies monopolize their space and use unscrupulous business practices to curtail growth and competition from smaller companies. They are now so powerful that they have the lobbying power to affect public policies unrelated to their core business.

It's not immediately obvious what "capitalist hell" scenario could be lurking in the structural heart disease world. Unlike other cardiovascular devices, such as Impella or Watchman, TAVR has unequivocal patient benefits established via multiple large randomized trials. In my experience, even raising the possibility of any imperfections in this perfect marriage is anathema to those in the field.

However, if we consider the TAVR world forest (not just a few trees), through the lens of capitalism, the "capitalist hell" phenomenon comes into view. With their market dominance, there is little incentive for either company to reduce prices, and so there is limited use of TAVR in countries with scarce health care resources. Even in the United States, there is significant geographical variation in the availability of TAVR programs, and the growth is driven less by community need than by disparities in access to care.

Relationship With Industry Pros and Cons

From an everyday practical standpoint, the interaction with clinical specialists from industry is invaluable for case planning and troubleshooting during the procedure. The industry- sponsored training sessions and webinars are excellent learning tools for the technical aspects of the procedure. However, I constantly find myself guarding against any unconscious bias when listening to speakers who are paid by industry advocate one valve over another. In the TAVR world, it is extremely hard to find a webinar or educational content that is not industry- sponsored. Although a head-to-head comparison of the two valves did not show any significant difference in the primary valve-related efficacy endpoint, one valve may be preferable to the other in specific patient- related anatomical scenarios.

I am also acutely aware of the pressure for indication creep. Given the low profit margin for the hospital on each procedure, to maintain the financial sustainability, the overall volume needs to be high. Unlike the relatively undifferentiated coronary stent market, which has multiple manufacturers with similar delivery systems and largely equivalent patient outcomes, the TAVR industry is dominated by two companies, whose products have very different delivery systems, implantation techniques, and procedural complications. It is too early in the game for hospitals to enter into bulk purchasing agreements with one company. It is also important for professional organizations, medical societies, and regulatory bodies to ensure that public policies regarding expansion of new structural heart programs are based on community needs and free from the lobbying power of rising monopolies in the industry. The capitalist creed is beneficial only when the capitalist hell is consciously and constantly kept under control.

I ended my meeting with Mike with the usual pleasantries, pondering just that.

*Some details have been changed.

Jaya Mallidi, MD, MHS, is an interventional cardiologist in Santa Rosa, California. An ardent patient advocate, she writes opinion pieces using patient stories as context to highlight problems in the practice of modern day medicine. In addition, she enjoys digital sketching and playing tennis.

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