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Creating Value

Falk, Volkmar MD

Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery: January/February 2016 - Volume 11 - Issue 1 - p 3–6
doi: 10.1097/IMI.0000000000000234
Presidential Address

From the Deutsches Herzzentrum Berlin, Charite Berlin, Berlin, Germany.

Accepted for publication December 18, 2015.

Presidential Address presented at the Annual Scientific Meeting of the International Society for Minimally Invasive Cardiothoracic Surgery, June 3–6, 2015, in Berlin, Germany.

Disclosure: Volkmar Falk, MD, is a consultant to Philips, Hamburg, Germany; Heartware, Framingham, MA USA; Berlin Heart GmbH, Berlin, Germany; Aesculap, Tuttlingen, Germany; and Thoratec, Pleasanton, CA USA.

Address correspondence and reprint requests to Volkmar Falk, MD, Deutsches Herzzentrum Berlin, Charite Berlin, Augustenburger Platz 1, Berlin 13353, Germany. E-mail: falk@dhzb.de.

It is with great pleasure that I may address you today as president of the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS). Presidents come and go, and this position in most societies is regarded as a purely representative job that one gets for one’s long-term service within the organization. From the outside, it often looks as if the president has been selected through some sort of an “old boys” buddy network, and very often, this is actually the truth. What most people do not understand, however, is the fact that this network, which undoubtedly exists, is not a result of the exclusiveness of some back-door boardroom activists but because of the very limited number of individuals that engage themselves for something more than their own business, practice, patients, and family.

When ISMICS was founded, the idea was to establish an organization that would serve as a platform to promote the international scientific exchange on new ideas on minimally invasive surgery. Although established associations and societies such as the Society of Thoracic Surgeons (STS), the American Association of Thoracic Surgery (AATS), and the European Association of Cardiothoracic Surgery (EACTS) were struggling with their position toward some of the new technologies and minimally invasive access surgery, the ISMICS was designed to embrace and foster these developments.

A substantial number of enthusiastic researchers were frustrated at the time that their work on endoscopic and less invasive techniques, off-pump surgery, and hybrid techniques was not accepted for presentation and publication at major meetings. For ages, the dominant and very successful philosophy in the field was characterized by two attitudes, “the pump is your friend,” and “a sternotomy is the best (and only acceptable) access.” The cardiac surgical community was run by an established group of giants that had forgotten about their own pioneering efforts a few decades before and was by and large not ready for new adventures and the cost of change. As one former CEO of one of the medical device companies phrased it, cardiac surgeons “were the button salesmen in the age of zippers.” As a consequence, in May 1997 at the Second World Congress in Paris, France, the idea of a minimally invasive cardiac surgical society was born. A small group of inventors and early adopters presented the issue to the 600 member audience, and finally, the ISMICS became an official organization in January 1998.

At the same time, the large-scale use of percutaneous coronary intervention created a substantial threat that was largely ignored as long as a few coronary patients would still find their way into the surgeon’s office. The constant decline of coronary artery bypass surgery, the bread-and-butter business for most cardiac surgeons, did not trigger a major innovation of search for new strategy in most centers but was simply compensated by changing the age limit for valve operations and offering surgery to higher-risk populations. The demographic change came at the right time to secure the caseload and to support this adaptive behavior. For obvious reasons, this is not going to work again with the event of catheter-based valve interventions. By intention, the early randomized trials were designed to demonstrate noninferiority in the very high-risk population. With the proof of concept in our hands and equipoise between surgery and percutaneous treatment in the sickest and, more recently, in intermediate-risk patients, the target has now moved to younger and low-risk patients.

A number of new interventional meetings largely covering percutaneous valve therapies have evolved in only a few years, all of them outnumbering ISMICS by far. Transcatheter Cardiovascular Therapeutics, EuroPCR, and London Valve, to name a few, cover all aspects of structural valve disease. The occasional surgical visitor will note that the only accepted definition of minimally invasive at these meetings is percutaneous. Interventional cardiologists cannot be impressed by techniques discussed at surgical meetings such as ministernotomies, small thoracotomies, no-touch aorta, or endoaortic balloon clamping. In their thinking, cardiopulmonary bypass is a thing of the past, and a sternotomy is considered a defeat. With a few exceptions, all big players in the device industry more or less share this view and have cut down their research and development expenditure for their surgical product lines and invest preferably in catheter-based technology. In line with the growth of sales of percutaneous devices and the cutback on surgical device sales, the willingness to bring new surgical devices to the market is increasingly limited.

This comes at a time when venture capital flow into cardiovascular companies is already only half of what it used to be a few years ago. In 2013, device company investment represented only 7% of all venture investments, the lowest percentage since 2001.1 This reluctance of corporate venture to support early-stage device investment is shortsighted and will impede innovation. The decrease of funding will have a deep and lasting impact on our specialty because we were and are dependent on innovation coming mainly from industry.

The number of true innovators in this room is small. Most of us, including myself, at some point in their careers have benefitted from engineering ideas that were born in small start-up firms and brought to broad attention through a first-in-man trial or early feasibility study. In friendly competition, we have strived not only to perform first-in-man procedures to advance science but also to foster our own careers. Although I fully acknowledge the courage, the determination, the risk, and dedication that it takes to transition a device from bench to bedside, I also want to shine a light on the inventors of such ideas who are usually not visible at the podium during meetings such as this one. Because research happens where the money goes and money flow is being diverted away from cardiac surgery, it is very likely that we will see less major inventions happening in the field of our specialty.

The ISMICS has been leading the way of innovation and forward thinking. The acceptance of minimally invasive concepts into the mainstream of cardiac surgery was a clear validation of the early work performed by ISMICS members and is underscored by the fact that two of ISMICS former presidents, Michael Mack and Randolph Chitwood, later in their careers also served as presidents of the STS.

In 2015, the raison-d’etre for ISMICS, to be an incubator and think tank for new ideas in cardiac surgery, as Michael Mack once put it, is challenged in many ways. To fulfill its mission and sustain the test of time, the ISMICS has to provide added value to the community that goes beyond a meeting held once a year. Creating value is more than developing an instrument that facilitates minimally invasive surgery. It is more than minimizing an incision or doing something percutaneously that before required an incision. Creating value means providing new ways of health care delivery that have value for life.

Before we can discuss “value for life,” we have to discuss briefly the “value of life.” This is a complicated matter of moral and economic dimension that often leads to a decision dilemma and is best illustrated using a few examples, all more or less variations of the classic “trolley experiment.” A commercial airplane with 200 people on board is off route, approaching the downtown of a major city. You can give the order to shoot down the plane, killing 200 innocent people, or you can risk the life of thousands in case the plane crashes into the city. What would you do? In June 2005, a special US Army forces team was in a secret mission in Afghanistan in search of a terrorist leader. After they took position on a mountain ridge, two unarmed Afghan goatherds happened upon them. The choice the soldiers faced was to either let the goatherds go, at the risk that they would inform the terrorists of their presence, or take the two unarmed civilians hostage. The soldiers decided to release the goatherds. Shortly after, they found themselves surrounded by approximately 90 fighters. All but one soldier was killed, and a helicopter that sought to rescue them was shot down.

The moral dilemma that is underlying these situations is best described by the two competing moral principles. The first principle is a rule-based/Kantian approach. As the great philosopher Immanuel Kant stated in his Groundwork for the Metaphysics of Morals in 17852: “[E]verything has either price of dignity. Whatever has price can be replaced by something else which is equivalent; whatever, on the other hand, is above all price, and therefore admits of no equivalent, has a dignity.”

A more contemporary reflection of this moral principle can be seen in the MasterCard “Priceless” advertising campaign3: “There are some things that money can’t buy, for everything else, there’s MasterCard.”

According to this principle, it would be wrong to kill an innocent person, even for a good cause, or in other words, do not shoot down the plane or take the goatherds hostage. On the opposite side, we can take a utilitarian position, which has been defined by Bentham and Mill4,5 as maximizing welfare or “seek the greatest happiness for the greatest number.” Utilitarianism would demand us to save as many lives as possible; therefore, shooting down the plane and killing the goatherds is justifiable.

In medicine, like in any other profession, we are facing this moral dilemma every day. Often, we are forced to take a decision and explicitly or implicitly rely on utilitarian principles. In an ideal world with unbounded resources, everybody could get the best medical treatment. There would be no need to estimate a value of life because abundance of resources implies no tradeoff in resource allocation. In reality, resources are scarce, and allocation of resources implies tradeoffs. We have many resources to serve m people, but n > m people who would need a treatment (eg, a heart transplantation). A few numbers should demonstrate the true size of the matter. During the next 20 years, the prevalence of cardiovascular disease in the USA will increase by approximately 10% under status quo prevention and treatment trends. At the same time, between 2010 and 2030, the real (2008 dollars) total direct medical costs of cardiovascular disease are projected to triple, from $272.5 billion to $818.1 billion.6 Tradeoffs are therefore inevitable, and we need to compare costs and benefits as systematically as possible, even if this implies putting a price tag on human life. To perform such cost-benefit analyses, we have to determine what is the (societal) value of life?

Ashenfelter7 and Blomquist8 argue that the value of life is about the willingness of people to tradeoff wealth for changes in the probability of death. One way of evaluating the value of life is the so-called value of statistical life (VSL), a valuation of statistical mortality risks which is largely a tradeoff between wealth and profitability of death. It measures change in wealth due to action or change in behavior and relates it to the change in the probability of dying. This relation gives an intuitive estimate of how much people value life. To illustrate this equation, we may use an example that exploits a “natural experiment” to calculate the VSL implicit in US state traffic policy.9 In 1987, the US federal government permitted states to raise the speed limit from 55 to 65 mph on rural interstate highways (implemented by 40 states). In these states, the average speed increased by 2 mph, resulting in a fatality increase of 35%. At the same time, the benefits of higher speed were calculated to equal 125,000 hours saved per life lost. These hours can be transformed into wealth by multiplying their number by the average hourly wage, leading to an implicit VSL of $1.54 million (in 1997 values).

In 2010, the Food and Drug Administration set the value of a statistical life, at $7.9 million, an increase from the agency’s $5.0 million price tag of 2008. In the same year, the Environmental Protection Agency set the VSL at $9.1 million. The VSL differs not only for the various US agencies but also between countries, ranging from $1 million in South Korea to greater than $11 million in Japan.8

The issue is further complicated by the fact that this principle seems to be malleable by context and situation such as with the “identifiable victim effect”: people tend to help somebody identifiable oftentimes at all costs (rescuing victims from a burning house), whereas they refuse to give aid to a random nonidentifiable person (saving the life of an African child by donating $10). We also know this effect and show irrational behavior when we prolong therapies at all costs in patients that we have operated on or have some sort of relation to, despite an expected poor outcome.

In addition, we can observe the (ex-ante/ex-post) effect (series of action based on a forecast before an event vs measures actually taken after the event): if security standards for a certain event are increased, people often want their community not to spend the money (eg, for earthquake protection) but are willing to save lives afterward at all costs (eg, saving the life of people trapped in a collapsed house). This partly explains the reluctance to invest heavily in prevention but rather to spend money on expensive therapies. For these reasons, the VSL is not very useful to determine the value of life in the context of medical interventions.

A common currency in the medical field to assess the extent of the benefits gained from a therapy or an intervention is the quality-adjusted life-year (QALY). As opposed to the VSL, the QALY takes both the quantity and quality of life generated by health care interventions into account. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years and places a weighting on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0. It is important to notice that some health states are considered worse than death and therefore have negative scores. This is best understood and appreciated if you think about it during your next intensive care unit rounds.

When combined with the costs of providing the interventions, cost-utility ratios or incremental cost-effectiveness ratio can be calculated; these indicate the additional costs required to generate a year of perfect health (one QALY). Priorities and resource allocation decisions can and will be made in favor of interventions that are relatively inexpensive as indicated by low cost per QALY.

Most international standards and most private and government-run health insurance plans worldwide currently use a $50,000 value per year of quality life to determine whether to cover a new medical procedure. Currently, for most studies looking at high-risk but operable surgical patient cohorts, the evidence is insufficient to economically justify the use of transcatheter aortic valve implantation in preference to aortic valve replacement.10 It is therefore not surprising to see that at present, the use of transcatheter aortic valve implantation is dependent on national health care spending per capita, rather than indication. With decreasing device costs, however, this is likely to change sometime soon.

In summary, the amounts of venture capital available to support start-up medical device industries and research and development investments of established companies in cardiovascular surgical product lines are decreasing. At the same time, health care costs are constantly increasing. Despite these constraints, percutaneous techniques continue to improve and are starting to replace standard surgical techniques.

What are the implications of these developments for us surgeons and our mission to develop minimally invasive cardiac surgery?

First, we simply have to reinvent our profession. We have to leave our comfort zone, think outside the box, and become innovative again. We can no longer rely on others to advance the art and science of surgery. Make your own Hilbert’s list of the 10 biggest problems in your own practice and start looking for solutions. Cooperate with your local technical universities and start to engage engineers and IT specialists in life science. Get out of your silo, and walk across the street. Invite engineers into your operating room and show them a beating heart—it will motivate them for a lifetime, the same way it once motivated you to become a cardiac surgeon. In my own career, I have made this effort many times with researchers from German, French, American, and Swiss engineering schools. Besides meeting very bright and interesting individuals, I have had the most gratifying research experiences. Prof Wendelin Jan Stark from the Functional Materials Laboratory Institute for Chemical and Bioengineering of the ETH in Zürich, who will deliver the key note address tomorrow, is one great example.

Second, we have to do a much better job in generating outcomes data that prove the benefits of minimally invasive surgery. Even if you do not feel like you are an inventor, there is no reason that you cannot participate in a multicenter clinical trial or at least put your data into a registry. Cardiac surgery, including minimally invasive cardiac surgery, provides a huge benefit for individual lives and also for the society. Our products are long-lasting, durable, and safe. For myocardial revascularization and valve repair, surgery outperforms interventional approaches under most circumstances. Yet, if it were not for our cardiology challengers, we would still not have some of the trials that confirm these excellent outcomes.

Health care providers need data for decision making, and it is our task to provide them with the necessary evidence.

The ISMICS for some years has provided consensus documents to generate this evidence in the field of minimally invasive cardiac surgery. This program in the last few years has got less attention. We need to change that, and I therefore appeal to you to engage in ISMICS consensus groups and help provide the evidence for what we think is the right thing to do.

Third, we have to be cost-effective. Minimally invasive approaches should not only be effective, less painful, and cosmetically superior but also sustainable and should meet the socially accepted incremental cost-effectiveness ratio values to achieve and justify widespread application.

The mission of the ISMICS from the beginning was to promote minimally invasive cardiac surgery on a truly international level, including countries with limited financial power to support costly device therapy. The international outreach of the ISMICS has been documented over the years by holding successful Winter Workshops. If we take this mission seriously and our goal is to spread minimally invasive techniques outside affluent societies, we must develop additional tools to do so. In India, two thirds of the population live on less than $2 a day. Eighty-six percent of health care is paid by individuals and per-capita health spending is less than $60 a year. The question to answer is how can we help under these circumstances, to offer minimally invasive therapies to patients?

Fourth, we have to retrain and develop interventional skills. The next wave of percutaneous mitral interventions is coming. Some of these devices have been invented at least in part by our peers and ISMICS members. We should not just give birth to the next child and then wonder how it will grow under the care and breeding of our fellow cardiologists. We must take an active role and stay part of the family. In this regard, we must stay involved and remain the makers of our own destiny.

This projection translates into the need for the ISMICS as an organization to foster the vital developments of our profession, even more so than in the past. However, an organization like the ISMICS can only strive if its members are active. The question is therefore not what can the ISMICS do for you, but what can you do for the ISMICS?

I ask you to help ISMICS shape our professional future.

Thank you for your attention.

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REFERENCES

1. Norris J. Trends in Healthcare Investments and Exits 2014. Santa Clara, CA: Silicon Valley Bank Financial Group; 2014.
2. Kant I, Wood AW, Schneewind JB. Groundwork for the metaphysics of morals. New Haven: Yale University Press; 2002.
3. MasterCard Advertising Campaign.
4. Bentham J, Lafleur LJ. An introduction to the principles of morals and legislation. New York: Hafner Pub. Co.; 1948.
5. Mill JS, Piest O. Utilitarianism. Indianapolis: Bobbs-Merrill; 1957.
6. Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011; 123: 933–944.
7. Ashenfelter O. Measuring the value of a statistical life: problems and prospects. The Economic Journal. 2006; 116: C10–C23.
9. Ashenfelter O, Greenstone M. Using Mandated Speed Limits to Measure the Value of a Statistical Life. Journal of Political Economy. 2004; 112: 226–267.
10. Indraratna P, Ang SC, Gada H, et al. Systematic review of the cost-effectiveness of transcatheter aortic valve implantation. J Thorac Cardiovasc Surg. 2014; 148: 509–514.
©2016 by the International Society for Minimally Invasive Cardiothoracic Surgery