Disruptive innovation in cardiac surgery.
Heart valve surgery has always been a special interest of mine. Dr. Albert Starr and Lowell Edwards, a retired engineer, developed the first mechanical mitral heart valve, which was implanted on August 25, 1960.(3) Previously, most patients were relegated to an early death from progressive heart failure. The Starr-Edwards valve was a true disruptive invention and what became a first step in my journey as a cardiac surgery trainee. These early valves solved the problem of either leakage or blockage of blood flow; however, they had intrinsic problems associated with the need for potent blood thinners (i.e., anticoagulants). With these valves either bleeding could occur or blood clots could form, causing strokes. Anticoagulant drug doses were difficult to balance for each patient. In Paris, Dr. Alain Carpentier (1968) developed and improved valves harvested from pigs by treating them with the chemical glutaraldehyde. This was a monumental breakthrough in heart valve science and is still used today. These early biologic valves did not require an anticoagulant but after about 10 years they became calcified and failed. Today, they are improved and provide much more durability. Both tissue and mechanical valves served an inaugural purpose by disrupting the field of heart valve disease. Despite intrinsic complications, at least there was some solution for either leaky or narrowed heart valves. Then, Carpentier discoved he could repair leaking mitral valves instead of replacing them. Although initial attempts were made in the United States, mitral valve repair came into vogue first in Europe. Carpentier's 1983 address brought the realization back to surgeons in the United States that one did not have to remove all mitral valves but could repair most--allowing patients to keep a near normal valve. (4) No anticoagulation was required and repairs usually lasted for the remainder of a patient's life. In 2007, Carpentier and Starr together received the Lasker Award for Clinical Medical Research (the U.S. equivalent of a Nobel Prize) for these contributions to heart valve therapy. To date, both mechanical and biologic valves have improved vastly and mitral valve repair is a standard of care.
These examples of innovation in cardiac surgery are impressive. However, the story does not stop here! In 2000, Dr. Delos Cosgrove, who was president of the American Association of Thoracic Surgery, delivered his presidential address entitled "The Innovation Imperative." (5) This was a clarion call for cardiac surgeons to think anew and develop new innovative technologies and techniques. By 2000, the time for disruptive innovation in cardiac surgery had arrived. Disruption was not a bad term as it meant that development of a new device or technique that could change the entire way we think about treating heart disease. We had to think anew!
This was the best time for an awakening as proven coronary bypass surgery was beginning to be underutilized compared with less durable angioplasty techniques, which were less invasive. By 2003, the number of angioplasties in the United States had passed coronary surgery by 22 percent. The development of intra-coronary stents provided improved patency and by 2007 coronary surgery had fallen to 40 percent less than percutaneous therapies. The influence of coronary artery bypass surgery was falling markedly despite better patient longevity. Cardiac surgeons had to tout their results and develop new ways of performing operations less invasively. This was the era when surgeons began to do coronary bypass surgery on the beating heart, not using the heart lung machine. This was less invasive and later was proven to be better for some patient subsets. Combined with the use of all arterial bypass grafts, instead of vein grafts, long-standing results became even better. Innovation had prevailed, and the results bespoke much progress!
To make progress as a specialty, cardiac surgeons and cardiologists had to develop what is called "lateral thinking." This means that we had to look to other medical specialties and disciplines to gather new information that could help spawn a new device or technique. Much of this information came from engineers, who understood material properties and mechanical devices, which could be applied to treat heart problems. As an example, Dr. Thomas Fogarty is the maven of cardiovascular surgical innovation and has been for 50 years. He is the archetypal "lateral thinker" who has worked with all types of engineers to develop more than 150 patents that spawned development of new cardiovascular surgical devices. More importantly, he is very approachable and energizes many younger surgeons through his Institute for Innovation to become lateral thinkers and innovate.
In 1994, Dr. Henning Andersen in Denmark filed a U. S. patent that changed the world of heart valve replacement forever. (6) He showed surgeons and cardiologists that an aortic valve potentially could be replaced --not through a large chest incision--but passed through a groin artery using a tiny catheter. This was technologic disruption at its best! Andersen's concept was not applied by him clinically. However, in April 2002, Dr. Alain Cribier in France performed the first percutaneous aortic valve replacement in a 57-year-old man who was in cardiogenic shock.7 This technology evolved rapidly so that these valves became more durable, and very small insertion catheters made them easier and safer to implant. This technologic evolutionary progress is reflected now in the widespread adoption of the trans-catheter aortic valve replacement, or TAVR. To date, more than 150,000 aortic valves have been replaced using TAVR methods, and it now has become a standard of care for treating elderly patients. No doubt that percutaneous heart valves in time may completely replace older surgical methods--even in younger patients. This type of innovation has led to closer working relations between cardiologists and cardiac surgeons, emanating in the cardiovascular specialist, who works both in the catheterization laboratory and hybrid operating room.
Another way cardiac surgeons have been able to minimize patient trauma is through the development of robotic surgical devices. At first it sounds like a robot is doing the heart operation, but it is just emulating the surgeon's hand motions. Miraculously, the device provides better ergonomics, when operating through tiny incisions, than could be produced by long, manual instruments and the surgeon's hands. After being impressed by a prototype of the surgical robot in 1997, I began to think of the ways that we could repair mitral valves through tiny port-like incisions. In 1999, we were fortunate to obtain the first commercial da Vinci[TM] robot in the U.S. Soon thereafter, our surgeons began to work in the laboratory to develop and perfect robotic repair operations. By 2000, we were prepared to begin the first FDA safety and efficacy clinical trial, which was premonitory to a multicenter trial that eventuated in approval to use the da Vinci[TM] surgical robot for mitral valve repair surgery. In 2008, we reported excellent results of our first 300 operations. (8) Learning from clinical trials, we were able to devise new robotic instruments to go with the 3-D magnifying, high definition camera. An entirely new vista had evolved from lateral thinking between surgeons and engineers. This was truly a great collaboration between industry and cardiac surgeons. To date, I have performed more than 1,000 cardiac operations robotically with excellent clinical outcomes. Additionally, many large reference centers now perform robotic mitral valve and arrhythmia surgery routinely.
These two examples of evolving technology typify how the cardiovascular specialist has the opportunity to see a clinical problem, develop a new innovative idea, design a device prototype, refine it, prove patient safety and efficacy, and then complete a clinical trial before distribution as a new standard of care. This really is a process of observation, imagination, innovation, engineering and application. There are many other examples in cardiac surgery that have followed this process--all benefiting patients. These include small cardiac assist devices and endovascular stent grafts to treat aortic aneurysms. Moreover, new imaging techniques are being applied in cardiac surgery to design and serve as a "blueprint guide" for aortic and mitral valve repair surgery. Some investigators are even able to make 3-D printed plastic models of a diseased aortic or mitral valve in preparation for an operation.
In the last twenty years, cardiac surgeons have "rekindled the flames of innovation" and, along with cardiologists, have merged to become the new cardiovascular specialist. This is the best way to deliver the optimal care to patients and to achieve the best outcomes--as each patient gets "tailor-made" knowledge and therapy. No one knows how that innovation will spawn new modalities of heart care in the next twenty years. However, my prediction is that all surgical operations will be minimally invasive, cell therapy may restore damaged heart muscle, gene therapy will help treat coronary artery disease, heart valves will be repaired or replaced using catheters or robotic devices, 3-D image guidance will plan and direct operations and there only will be cardiovascular specialists--not the traditional way of managing heart disease--but the best for the patient! For these hopes to come to fruition in a timely manner, we must have faster and more efficient government regulatory path-ways. It is only through well-planned and well-executed clinical trials that we can determine the comparative effectiveness of new cardiac devices and procedures. Innovation is truly the "initiator" but clinical trials have become the "finisher."
By W. Randolph Chitwood, Jr.
W. Randolph Chitwood Jr., M.D. FACS, FRCS, recently retired from the Brody School of Medicine at East Carolina University, also home to his Phi Kappa Phi chapter. In 2005, he was awarded the National Phi Kappa Phi Scholar Award. He is a graduate of Hampden-Sydney College, the University of Virginia Medical School, and the Duke University Surgical Training Program. He is a former chairman of the Department of Surgery at ECU and the founder of the East Carolina Heart Institute. Moreover, he started the cardiac surgery program at Vidant Medical Center, the ECU teaching hospital. Throughout his 30-year academic career he focused on clinical care, education, innovation and research, and during that time published more than 300 scientific articles and book chapters. As a very active cardiac surgeon and lead FDA investigator, he pioneered minimally invasive and robotic heart valve surgery, performing the first robotic complete heart valve repair in the United States. He has received many honors from his professional societies, as well as being awarded the Ellis Island Medal of Honor, the Bakulev Medal from the Russian Academy of Sciences, the National Mended Hearts National Harken Award, and the 0. Max Gardner Award from the University of North Carolina Board of Governors. His current interests relate to the development of innovative less-invasive heart valves and robotic surgical devices, as well as teaching surgeons new technology and the safe application in patient care. Email him at Chitwoodw@ecu.edu.
"Innovation is not the product of logical thought, although the result is tied to logical structure."
"We strive to create an [innovative] environmet where we can cost-effectively develop technology that directly benefits patients."
Thomas J. Fogarty, MD Surgical innovator and inventor
For works cited, go online to www.phikappapfli.org/forum/fall2015.
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|Author:||Chitwood, W. Randolph, Jr.|
|Publication:||Phi Kappa Phi Forum|
|Date:||Sep 22, 2015|
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