Surgical Innovation: Lessons From the Pragmatic Philosophical School

Surgical Innovation: Lessons From the Pragmatic Philosophical School

THE THOMAS B. FERGUSON EDUCATION LECTURE Surgical Innovation: Lessons From the Pragmatic Philosophical School Pedro J. del Nido, MD Harvard Medical S...

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THE THOMAS B. FERGUSON EDUCATION LECTURE

Surgical Innovation: Lessons From the Pragmatic Philosophical School Pedro J. del Nido, MD Harvard Medical School and Department of Cardiac Surgery, Boston Children’s Hospital, Boston, Massachusetts

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t is indeed a great honor for me to give this year’s Thomas B. Ferguson Lecture, and I would like to extend my gratitude, in particular to Dr David Fullerton, president of The Society of Thoracic Surgeons, for affording me this opportunity. Dr Thomas Ferguson in many ways epitomized the principles of our major professional associations, The Society of Thoracic Surgeons and the American Association for Thoracic Surgery, having been president of both. Indeed, he epitomized the principles and philosophy of our profession of cardiothoracic surgery. Dr Ferguson achieved many accomplishments during his career and was recognized for this when he received the Lifetime Achievement Award from the American Association for Thoracic Surgery in 2009. Perhaps one of his most significant achievements was to reinvigorate the American Board of Thoracic Surgery. In his Presidential address in 1977 entitled “Guilds, Boards, and Hobgoblins,” Dr Ferguson addressed what he felt were badly needed reforms of the Board of Thoracic Surgery when he detailed a number of lessons from history to be heeded by those in our specialty who are in positions of influence, and who focus blindly on a particular principle. Dr Ferguson warned against this trait, quoting Emerson: “a foolish consistency is the hobgoblin of little minds” [1]. By this, he meant that we should not let one concept or one ordained principle blind us to the real solutions for the challenges we face. Dr Ferguson’s focus during his time on the American Board of Thoracic Surgery was driven by the recognition that cardiothoracic surgery was a relatively new subspecialty of surgery. Thus, he resolved to bring much-needed reforms to the Board, reforms that persist to this day. He applied this results-oriented pragmatic approach to other areas relevant to the practice of our subspecialty, such as public policy, a topic that was covered by the inaugural Ferguson Lecturer, the Honorable Bill Frist. Ferguson and Frist both recognized that although we in cardiothoracic surgery had little if any inclination or interest in public policy matters, it was imperative that we engage policy makers in debate over matters that affect our patients and our ability to practice our profession. Our professional societies heeded that call, and a concrete example of this Presented at the Fifty-first Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 24–28, 2015. Address correspondence to Dr del Nido, Harvard Medical School, Department of Cardiac Surgery, Boston Children’s Hospital, 300 Longwood Ave, Boston, MA 02115; e-mail: [email protected]. edu.

Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier

is the creation of The Society of Thoracic Surgeons National Database, which has aided us in addressing critical public policy issues. This practical, or pragmatic, approach to accomplishing an important goal is characteristic of the early pioneers of our profession and is the topic of my presentation to you today. And, like Ferguson in his address to this Society in 1977, I would like to invoke some important lessons from our history to make my points and to help us chart our future. As I have looked at the long list of distinguished speakers at the Ferguson Lectures, I have noted that these lectures have been used as an opportunity for reflection and an analysis of the major challenges that are facing our profession at the time. Each of the speakers has chosen a topic that has less to do with the technical aspects of the practice of our profession, and more to do with the philosophy and methods of actions of our profession in response to the needs of our patients, and to our needs. The topic that I have chosen also has more to do with our approach and mindset, but I will argue that it is also directly relevant to the technical aspects of our specialty. I will explore how the concept of pragmatism as described by the pragmatist philosophical school has served us and how it has enabled our development of innovative and, at times, radically new solutions and treatments for cardiothoracic diseases. Pragmatism originates from the Greek word pragma, or action, from which the terms practice and practical come. In the dictionary, the term is defined to mean “a straightforward practical way of thinking about things or dealing with problems, concerned with results rather than with theories and principles.” In philosophical terms, it is defined as “a method for evaluating theories, a philosophical view that a theory or concept should be evaluated in terms of how it works and its consequences as the standard for action and thought.” Pragmatism is an approach that assesses the truth and meaning of theories or beliefs in terms of the success of their practical application. The pragmatist philosophical school was a uniquely American school that originated at the end of the 19th century with the writings of Charles Sanders Pierce, and was further refined by William James and John Dewey. Perhaps its greatest and most original thinker was William James (Fig 1), whose younger brother, the great novelist Henry James, you are probably more familiar with. William James trained as a physician, having graduated from Harvard Medical School. James not only developed much of the philosophy of pragmatism but also publicized the movement through his many lectures and influential publications. Ann Thorac Surg 2015;-:-–-  0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.03.125

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Fig 1. William James, MD (1842–1910). Photo courtesy of Houghton Library, Harvard University, Boston, Massachusetts, MS Am 1092 (1185) #62.

The end of the 19th century and the beginning of the 20th was ripe for the pragmatist philosophy in America. This philosophy rejected the idea that the mind is the basis of knowledge and that reason and rational principles lead to all new knowledge, which was the prevailing philosophy up to that time. For pragmatists, it is practical activity and results from an action that generate new knowledge. William James stated in his essay entitled “Pragmatism” that the evaluation of an idea or a new concept should be approached with the question as to “what definite difference it will make to you and me, at definite instances of our life, if this world-formula or that world-formula be the true one.” The pragmatist school proposed that the only measure by which to judge a piece of knowledge is whether that knowledge is useful for a given interest. James stated: “A pragmatist turns his back resolutely.from abstraction and insufficiency, from verbal solutions, from bad a priori reasons, from fixed principles, closed systems, and pretended absolutes.,“it [pragmatism] does not stand for any special results. It is a method only.” At the end of the 19th and the beginning of the 20th centuries, America was in the middle of a great transition from an agricultural society to a manufacturing one, and the pragmatist philosophy was embraced by the great industrialists of the time, such as Henry Ford and John D. Rockefeller. In medicine, the concept was slower to be accepted, except in the rapidly evolving field of surgery. From the early days of “modern” surgery, the pioneers had a sense that outcomes and results were the metric by which to judge new procedures and to advance the field. Although the philosophical school of pragmatism is credited to American philosophers, in medicine, the fundamental tenets of pragmatism were being applied in Europe.

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Theodor Billroth (1829–1894) of Austria (Fig 2), considered the father of abdominal surgery, is known not only for introducing many new radical procedures such as esophagectomy (1871) and the first successful gastrectomy for cancer (1881), but also for introducing the concept of surgeons tracking their techniques and reporting their results, good or bad. He proposed that an honest discussion of morbidity and mortality was the best method for advancing our knowledge of surgery. Thus, he advanced the concept that new techniques should be evaluated on the basis of results and that a detailed analysis of results leads to further advances. Billroth was a significant influence on William Halstead’s thinking, as well. After visiting Billroth and observing his methods, Halstead embraced the pragmatic philosophy. Halstead went on to apply the pragmatist’s methods in his work, developing the aseptic technique, local anesthetics, and radical surgical procedures, and, in his work, developing the principles of a surgical residency program. In the embryonic fields of thoracic and cardiac surgery, a similar pragmatist spirit was emerging, with new techniques for known diseases being developed. An example of this was the first ligation of the arterial duct. The importance of a patent arterial duct was well known in the early 20th century, both for the risk of endocarditis and for the increased work imposed on the heart. Indeed, anatomists had already shown that the arterial duct could be dissected and had shown how to ligate it in a cadaver. But there was also strong opposition to the concept of ductus ligation. Maude Abbott, the greatest

Fig 2. Theodor Billroth (1829–1894). Photo courtesy of the National Library of Medicine, Bethesda, Maryland.

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authority on congenital heart disease at that time, and William Ladd, surgeon-in-chief at the Children’s Hospital of Boston, both believed that the arterial duct served to decompress the pulmonary circulation and should not be ligated. Robert Gross, after much work in the animal laboratory, was convinced otherwise, however, and proceeded to ligate the vessel in a 7-year-old girl. Gross stated, in his publication describing the procedure, that he performed the operation “in the hope of preventing subsequent bacterial endocarditis and with the immediate purpose of reducing the work of the heart caused by the shunt between the aorta and the pulmonary artery.” [2]. Unlike most of the children with heart failure due to a large patent arterial duct, that young girl is still alive today. The hemodynamic consequences of the duct ligation were noted immediately at the time of the surgery. Evidence that endocarditis could be prevented by ductal ligation, however, came a few years later. Of note, Gross performed this operation as a chief resident and waited until Ladd was away to proceed, for which Ladd never forgave him. Ladd himself was a pioneer in thoracic surgery of children, however, and was the first to successfully repair esophageal atresia in a young child. This vignette of surgical history also serves to underscore the fragility of the pragmatist philosophy, which can easily be lost when the individual is influenced by “fixed principles.or pretended absolutes,” and even personal emotions. The field of cardiac surgery continued on a relentless advance, fueled primarily by experimentation, which typically was developed first in the animal laboratory and then quickly moved into the clinic to address real-world problems that, up to that time, had no solutions. The “blue baby” operation was another example of the pragmatist spirit. Here, the observations of the effects of duct ligation on decreasing pulmonary flow led to the idea of increasing pulmonary blood flow for cyanotic children by the creation of a ductlike connection between the aorta and pulmonary artery. This concept was proposed by Helen Taussig, who then persuaded Alfred Blalock to work on the idea in the laboratory. Vivian Thomas, working in the laboratory, developed the procedure, which was then performed by Blalock in a human. Of importance is that Taussig first proposed the idea to Robert Gross who had the most experience with aortic and blood vessel surgery. Gross discarded the idea, however, and it was then pursued by Blalock, successfully. This historical vignette provides another example where an individual capable of very pragmatic thinking in one instance is unwilling or unable to apply it to another, and underscores the fragility of the pragmatist concept. Up to this point, blood vessel surgery meant endarterectomy and vessel ligation or resection with direct anastomosis. Clarence Crafoord was the first to perform a coarctectomy after he realized during a bleeding episode for repair of a patent ductus that the aorta could remain clamped for at least 26 minutes without major sequelae. This observation gave him the idea that a strictured

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segment of the aorta could be removed as long as it could be completed within the safe time period. Here again, the pragmatist concept that it is practical activity and results from an action that generates new knowledge was clearly at work. By this time, an explosion of activity and new developments was occurring in cardiothoracic surgery, driven by the new challenges faced whenever a new procedure was developed and applied more broadly. The first use of a human artery to replace a deformed vessel in another human (cadaver donor), was performed by Gross to treat long segment coarctation of the aorta. That was based on laboratory work done by Hufnagel and Gross in Boston, and opened up many new possibilities for the repair of blood vessels. Surgeons could now tackle the resection of long segments of the aorta without having to worry that if they removed too much, they would be unable to reconnect the two ends. More important, the availability of these allografts meant that, now, acquired diseases of the aorta such as aneurysms, which were much more common than congenital defects, could be treated directly. Procedures such as the wiring of abdominal aneurysms and abdominal aortic ligation could be abandoned and relegated to the history books. During World War II, these techniques were rapidly applied and further refined. But the rapid growth of vascular surgery uncovered another problem: the availability of allografts. The pragmatist philosophy then combined with an entrepreneurial approach to address this problem, and the first tissue banks were created. A headline from The New York Times in May 1950 describes a “blood vessel bank” that was established, “opening new opportunities for surgical attack on cancer and degenerative ailments..” In spite of the rapid growth of these new charitable enterprises, there was still a limited supply of usable cadaver vessels. The main limitation to the widespread availability of blood vessel replacement surgery was the limited supply of blood vessels from tissue banks around the country. Once again, the pragmatist spirit came to the rescue of the cardiothoracic surgical specialty. And, once again, it was a surgeon who had the idea, developed the concept, and acted on this concept to radically change the way that we practice. In 1954, Michael DeBakey fashioned a tube made out of Dacron, a type of polyester, and used it to replace a segment of the aorta. He reportedly used his wife’s sewing machine to create the tube graft (Fig 3), which was then sterilized and implanted in a patient. He wanted to use Nylon, which was the more commonly used synthetic material at that time, but was unable to obtain it, so he instead used Dacron. That was apparently fortuitous, as Nylon forms a very aggressive neointimal layer, more so than Dacron, and also has a tendency to fracture late after implantation, which Dacron does not. The widespread availability of this synthetic material led to another leap forward in vascular surgery, extending to more peripheral blood vessels and smaller visceral grafts. Suddenly, many ailments could be treated surgically, and consequently, many new procedures were

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Fig 3. Michael DeBakey sitting at his wife’s sewing machine fashioning the first artificial blood vessel made of Dacron. Photo courtesy of Michael E. DeBakey Library and Museum, Houston, Texas.

While effective for enabling the repair performed, the potential “200% mortality,” as some critics characterized the cross-circulation technique, prevented its widespread application. Instead, a race to “bypass” was under way, with many centers working feverishly on a completely artificial bypass solution. Many new devices were developed, evaluated, and either discarded or proposed for use on humans, in the classic pragmatist’s method. Development of the oxygenator alone is a complete story of just such a series of trials and ingenious solutions. Even rhesus monkey lungs were incorporated into bypass circuits in the belief that they could be used as a substitute for the patient’s native lungs for the brief period required to complete the intracardiac repairs. Finally, in 1953, and after much work in the laboratory, John Gibbon successfully performed a corrective procedure using the “heart-lung machine” (Fig 4). Unfortunately, few procedures were performed with this new

rapidly developed. But the impact of this development was felt not only in the clinical world: a whole new industry was created through the invention of the synthetic blood vessel. New materials were developed, tested, and either discarded or moved into clinical evaluation at a rapid pace over the subsequent 2 decades. Indeed, a whole new crop of device manufacturers came into being during this period, driven by the growing demand for implantable devices such as blood vessel grafts. At the same time, another field was developing in parallel: intracardiac surgery. Knowledge of the anatomy and much of the pathophysiology of cardiac disease was available. The fear and reverence for the heart that was present in the minds of surgeons at the time was rapidly eroding as experience with blood vessel surgery was gained. What was missing was a method for safely working inside the heart. Many ingenious techniques were being evaluated both in the laboratory and in the operating theater, such as the use of a plastic well to enable the surgeon to directly suture inside the heart while it was still beating and supporting circulation. Robert Gross was the first to describe a clinical series of “interauricular septal defects” using this well technique [3]. This experience was reproduced at other centers, opening up the new field of intracardiac surgery. When the limitations of this technique became apparent early on, surgeons began working on techniques for supporting the circulation while working inside the heart, to permit the correction of more complex defects and to allow entry into less accessible areas of the heart. At about the same time that Gross was performing procedures using the plastic well technique, another surgeon in Minnesota was exploring a radically different approach. C. Walton Lillehei was another in a long line of pragmatic thinkers who applied the pragmatist methods to complex surgical problems. In 1954, he connected the femoral artery of an adult parent to the carotid of their infant child and the jugular vein of the infant to the femoral vein of the parent to perform the first cross-circulation–supported intracardiac surgical repair.

Fig 4. John H. Gibbon and Mary H. Gibbon and the heart-lung machine. Photo courtesy of Thomas Jefferson University, Archives and Special Collections, Philadelphia, Pennsylvania.

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machine because many new challenges were uncovered, such as the requirement for large blood transfusions, as the application of this technology was expanded to address many different heart defects. Fortunately, the pragmatist spirit was not abandoned by the surgical community at the time; rather, even more work was done, often in partnership with engineers, physicists, chemists, and even industry. The first batteryoperated pacemaker was developed by Earl Bakken of Medtronic, a small start-up company that repaired medical equipment, in response to a request from a local surgeon, Dr Walton Lillehei. Up to that point, pacemakers required a wall plug for power. The problem the surgeon had was that with power outages, the patients who were being kept alive by wall-plug–supported pacemakers were at risk of dying if the power stopped. Numerous similar stories exist, but few are as dramatic in outcome as this one. These adjunct developments enabled surgeons to continue to create new procedures to treat old problems. In parallel, constant incremental improvements in the devices and equipment resulted in improved clinical outcomes and, more important, the rapid growth of the field. Cardiac surgery was starting to become commonplace and ubiquitous. As rapidly as surgeons were being trained, more centers with surgeons performing open heart procedures were opening, with clinical results that were comparable to those in the large academic centers. Coronary artery bypass surgery is a good example of a new operation for an old problem, atherosclerotic disease of the coronary blood vessels. Surgeons in the 1950s had recognized that the focal nature of coronary artery disease could be addressed by a simple bypass around the vessel blockage. What was needed was a “graft” suitable for this purpose. The internal mammary artery had been used to bring blood flow into the area of myocardium affected by the obstructed coronary vessel. Arthur Vineberg performed the first such intramyocardial mammary implantation in 1950. But in 1958, F. Mason Sones, Jr, performed the first direct coronary angiography, leading the way to direct revascularization by arterial anastomosis. Robert Goetz performed the first mammary artery to coronary artery bypass operation in 1960 by connecting the two vessels over a metal tube. In 1964, Vasilii Kolesov in Russia reported the first suture anastomosis, the first occurrence of the technique still used today. David Sabiston in 1962 and Rene Favaloro in 1967 described the use of a saphenous vein segment to achieve bypass of an obstructed coronary artery, and a reproducible technique for achieving coronary revascularization. In the subsequent 2 decades, coronary artery bypass grafting became one of the most frequently performed cardiac operations, overtaking surgery, for valvular heart disease. But the innovative and pragmatic spirit was present not only within the cardiothoracic surgical community. The challenge of treating atherosclerotic vessel disease was taken up by other clinicians working in parallel. Charles Dotter was an interventional radiologist who had a strong interest in angiocardiography. Throughout his career, he manufactured his own catheters and worked to

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develop ways to open blocked arteries using these catheters. At a radiology conference in 1963, Dotter met a selfemployed manufacturer of angiography catheters named Bill Cook. At their first meeting, Cook showed Dotter a new material, called Teflon, for making catheters. Dotter used Cook’s blowtorch in his hotel room that night and made 10 new catheters, which Cook sold the next day. The two partnered to create an interventional catheter with a tapered tip that could push open atherosclerotic plaques when passed over a guidewire. Although this technique was effective in opening the vessel, distal embolization and a limited ability to dilate the vessel remained problems. Dotter went on to develop many other techniques and Cook went on to become sole proprietor of one of the world’s largest manufacturers of angiographic supplies. This story is reminiscent of the relationship between Lillehei and Earl Bakken of Medtronic, except that this time it was not a cardiothoracic surgeon who developed the idea. Creating wider openings into a plaque-filled artery was solved by the use of a balloon catheter, which applied radial forces to the plaque, compressing it against the arterial wall to widen the lumen. Andreas Gruentzig first applied the catheter to a coronary obstruction in 1976, using what he called a “kitchen-built” catheter. It is important to note that the first such procedure was actually performed by Gruentzig in an operating theater during a bypass operation at the invitation of Richard Myler, a cardiothoracic surgeon in San Francisco. Thus, cardiothoracic surgeons had a chance to incorporate this technique into their armamentarium, but the opportunity quickly passed, as Gruentzig went on to perform this procedure during coronary angiography on 4 patients in 1977. Both coronary artery bypass and percutaneous coronary intervention procedures continued to grow in use over the subsequent 2 decades, but percutaneous coronary intervention grew at such a faster rate that, by 1998, there were more catheter-based coronary procedures than surgical bypass operations. The growth trend for percutaneous coronary intervention peaked in the first decade of the 21st century, along with a continuously steady decline in coronary artery bypass graft surgery. Interestingly, during this same period, mortality related to cardiovascular disease also declined in a relentless and dramatic fashion. This trend implies that there are innovations impacting the mortality of cardiovascular disease that may have little to do with current procedures. Our field is now confronting a whole new set of clinical challenges. However, many of the innovations being developed to address these challenges are not being developed by cardiothoracic surgeons. Structural heart disease is at a crossroads in so far as who will further develop solutions for it. The question we must all ask ourselves is can we, as cardiothoracic surgeons, afford to let this opportunity pass us by? We must answer this question for ourselves. But I urge you to remember the pragmatist philosophy, which has served us so well. To quote William James: “A pragmatist turns his back resolutely.from bad a priori reasons, from fixed

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principles, closed systems, and pretended absolutes..” Instead, a pragmatist asks “what definite difference it will make to you and me, at definite instants of our life, if this world-formula or that world-formula be the true one.” The pragmatist philosophy has been embraced by our specialty from its very inception. We have always looked at a problem and sought solutions that had a concrete and immediate impact. We must continue to apply the pragmatic method not only to our everyday practice but also to our discovery of new and often radical solutions to address the challenges of our field. This is a call to action. The action will need to be by individuals and by collectives of dedicated individuals working in concert. Finally, on a lighter note, I will leave you with a quote from Pablo Picasso that, in my view, captures the

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challenge we face. Picasso said, “It took me four years to paint like Raphael, but a lifetime to paint like a child.” It is always much easier for us to learn to copy our masters, but much harder to think with the freedom and imagination necessary to develop a path of our own. Thank you.

References 1. Ferguson TB. Guilds, boards, and hobgoblins. Ann Thorac Surg 1977;24:6–18. 2. Gross RE, Hubbard JP. Surgical ligation of a patent ductus arteriosus: a report of first successful case. JAMA 1939;112: 729–31. 3. Gross RE, Pomerantz AA, Watkins E, et al. Surgical closure of defects of the interauricular septum by use of an atrial well. N Engl J Med 1952;247:455.