Two reasonable assumptions gave birth to the field of robotic heart surgery. First, patients don’t want their incisions to be any larger than is necessary for a surgical procedure to be performed safely. Second, a surgical robot makes it feasible to perform a technically demanding procedure like heart surgery through small incisions. Propelled by these self-evident ideas, around 20 heart surgeons across the US persisted long enough to ultimate master the robotic technique. Their collective experience is now documented in two large clinical studies that analyzed the STS National Cardiac Database (STS-NCD) and the National Inpatient Sample (NIS). In each study, thousands of robotic and open cardiac surgical cases over the past decade were compared. The results of robotic heart surgery cases were not just better than the open method, they were dramatically better. Both databases showed robotic cases had virtually no mortality, strokes, or deep wound infections – a major difference from open surgery. Because the risk of complications and transfusions was reduced by nearly 50%, the robotic cases showed a reduction in hospital costs. These findings corroborate the studies looking into the use of less invasive techniques in abdominal operations – less invasiveness generates superior patient results.
I had these results in mind when listening to a video presentation about the future of heart surgery by Dr. Michael Mack. He is one of the forerunners in less invasive heart bypass, so I was expecting a victory lap that touted the recent results of robotics since they vindicate his past efforts. Instead, he predicted that robotic coronary bypass was not part of the future of heart surgery. Great outcomes of a few robotic loyalists (including his own center) and the obvious patient demand for less invasiveness were not relevant. His stark conclusion was based on how impossible robotic adoption has been among the vast majority of cardiac surgical programs that have tried. There is irrefutable evidence that this has been a major problem for robotics, starting with the initial FDA sponsored multicenter trial of the robot in cardiac surgery in the early 2000’s. Out of the 18 prestigious centers hand-picked to participate – a third didn’t complete training, 2/3 never enrolled any patients, and only 1 continued robotics after the trial. Over the next decade, the results were no better: 95% of programs that obtained training and credentialing never performed more than a handful cases before abandoning the idea altogether. This extreme rate of failure has been confirmed by separate analyses of the STS, NIS, Intuitive Surgical marketing databases and an independent survey obtained by Dr. Francis Robischek.
Certain high risk ventures – new restaurants, start-up companies, major change initiatives at work – are recognized to fail up to 70% of the time. However, a distinct outlier like 95% is likely to have an equally distinct explanation. The most common explanation is that robotic or less invasive heart surgery is inherently unsafe. Success with a surgery that is unsafe by design would be as futile as finding a black cat in a dark room that has no cat. My academic career has been blessed by close interactions with highly influential and articulate surgeons that played a role in creating our current version of conventional wisdom. At the risk of misquoting these esteemed colleagues, I would expect their account to go something like this…open chest heart surgery as it exists today presents extremely tough competition to any new idea. Anything new could never be more elegant or well-honed. Millions of patients world-wide owe their lives to the reproducibility of its well established techniques. The surgical incision – a full sternotomy – has been integral to this success by providing the safety of full visualization and access to the entire thoracic cavity. Several hundred cardiac surgeons tried to implement robotics and other versions of less invasive operations into their ORs. Their failure reintroduces a basic lesson taught by the Hopkins legend Dr. Halstead 100 years ago. Poor access and visualization makes for poor surgery, in part by hindering the response to unexpected hazards that usually occur. This lesson further inculcates the value of the sternotomy and inherent gamble of robotics.
Halsteadian theories were confirmed by the first introduction of robotics to our field. Minimally invasive surgery started to blossom in other surgical specialties in the late 90’s, creating the spectacle of wide-spread publicity about the heart being operated on by a robot. The frenzy was welcomed by some programs looking to raise awareness but this also created pressure on many surgeons to adopt sooner than preferred. An article about minimally invasive surgery in the Wall Street Journal in 1999 quoted the renowned heart transplant surgeon Denton Cooley saying “I have never felt pressure quite that strong”. Dr. Cooley’s quote illustrates how pervasive the pressure was at the time. I’m not a marketing expert, but I could have predicted that a senior surgeon who was in his 80’s that built the specialty of open chest, high risk heart surgery in his image was not the ideal target demographic for robotics. Another well-known surgeon that was later responsible for my own involvement in robotic surgery, Dr. Bartley Griffith, was quoted in that article that the field was “not ready for prime time”.
Programs that failed over the next 15 years served as vivid “cautionary tales”, leaving an indelible impression on the collective mind of the cardiac surgical profession. Capital equipment and staff training were sunk costs that went to waste. Careers were tarnished for having fallen for the hype of the robotic bandwagon. Patients died and lawyers prospered. This branded robotic heart surgery with the “unsafe” label as an intrinsic and permanent feature of the idea itself. Programs purported to have achieved success were written off as imposters. Any period of good outcomes were said to be transient, random episodes (i.e. type I statistical error) that eventually will regress towards the mean (i.e. yet another failure).
After being presented with collective wisdom, it is often helpful to be reminded of the Mark Twain quote, ‘whenever you find yourself on the side of the majority, it is time to pause and reflect.’ The track record of robotics over the past decade is no paragon of safety. In a past blog, I criticized poorly designed training programs that unnecessarily prolonged the learning curve. Suggesting that programs well past their learning curve are still at risk for some kind of latent safety hazard is an irrational overreach. This view cannot be reconciled with the proven logic that any procedure is going to mature and improve if given the benefit of 15 years of trial and error. Robotics is now safe and streamlined at those few busy cardiac programs that have mastered it. Many of the cardiac surgeons that led robotic surgical teams towards high volumes and good outcomes (Dr. Balkhey, Srivastiva, Bonatti, myself) later moved to a different institution and repeated the same feat. These findings fit the well-established concept that performance (and therefore safety) improvements that occur in this context will be sustained.
Collective wisdom forms largely from information visible to the outside world. In the early days of robotic cardiac surgery, teams that would persevere to become established programs didn’t look much different than those that didn’t. Both had similar problems with learning curve, poor morale and high costs that overshadowed their good outcomes. There is a human tendency to judge the risk of an event by the ease with which vivid examples spring to mind, so collective wisdom eventually accepted the rumor that something about robotics was innately wrong. Cardiac surgery is a particularly hierarchical field. Negative views from higher status members like Dr. Cooley and Dr. Griffith caused a subtle pressure on others to go against robotics or risk the disapproval of a tight knit profession. An initial trickle of negative views then created a flood as the herd mentality locked in a collective viewpoint that was eventually unable to respond to new information. Rumors of successful robotic programs that claimed to have cracked the safety code of the sternotomy were brushed aside as one-off events. They were given as much credit as an urban legend, like the jackalope, cow-tipping or the story about the tourist who was ambushed, anesthetized and woke up minus a kidney.
Humans are hardwired to follow the herd. It is often an effective shortcut to keep us on track. In this case, the herd’s opinion that success with robotics was an urban myth was a distraction from the fact that it was actually a black swan. A single prosperous program contradicts the idea that “robotic cardiac surgery is inherently unsafe” the same way that seeing one black swan changes the belief that “all swans are white”. Once we accept this truth, we then ask why are some but not other robotic programs able to achieve sustainable success? In 2001, Harvard business professor Amy Edmundson took on this question by interviewing cardiac programs that succeeded with less invasive surgery and those that did not. Her widely cited paper (Harvard Business Review, Oct. 2001) described factors related to leadership (e.g. change management, teamwork and communication) as far more influential than technical skill on the chances for a program’s sustainable success. Fran Sutter, the most prolific robotic heart surgeon in the world, is fond of saying “we became heart surgeons because we like to focus on technical tasks, not because we like to communicate”. Safety concerns remain because robotics adds to the burden of communication relative to open surgery and these types of skills are uncommon in the lead surgeons. More importantly, the mystery of success is slowly being resolved and path is emerging for a safer future. It’s like the leper who once though his sins were being punished by God but then was told that he has a M. leprae infection and will respond to appropriate antibiotics. Uncovering the true mechanism of a problem transforms everything.
From a marketing perspective, a new procedure becomes a success when it is a new standard of care. This requires an entire ecosystem of support – administration, industry, referral sources, hospital staff and others – that emerges only when there is buy-in from at least 30- 50% market share. By definition, it is the majority of heart surgeons (those not doing robotics) that hold the key to that market. The long list of ideas for how to proceed – robotic facilitated or totally robotic, laparoscopic, hand-held instruments placed through a minithoracotomy, with or without endoballoon or any other of a number of facilitating technologies – is the signal that this field still doesn’t meet Dr. Griffith’s idea of “prime time”. When deciding among these dizzying array of options, it is important to ask the question “What’s the worst that could happen if I make the wrong choice?” In the case of a high risk activity like heart surgery, the answer is always scary. Erwin Rommel, one of the most daring generals of WWII was fond of saying: “When there is no clear option, it’s better to do nothing.” The safest default for the surgeon: open the chest.
On one hand, a small number of pioneers have a wealth of knowledge and could serve as invaluable guides to break the stalemate. On the other hand, those in the mainstream find it hard to trust a group of pioneers who’s risk tolerance and overall mindset is so different from themselves. The most unique psychological attribute of these innovators is what Malcolm Gladwell calls “disagreeableness”. This allows them to forge ahead based on a vision about the future, despite what others might think and often without the benefit of rigorously designed clinical trials or advice from other surgeons. Some interpret this as grit, but others see this as a lack of respect for safety and willingness to take gambles. This label causes critical damage to the credibility of robotic surgeons among the mainstream (ethos). The logic of maximizing safety (logos) is so compelling and the emotional pull of the vulnerable patient (pathos) so strong that no rebuttal can hope to be persuasive without the benefit of ethos.
Problems with trust run both ways. Visionaries of all fields have learned to mistrust the intentions of their mainstream constituents. Over half a millennium ago Machiavelli said “the innovator has for enemies all those who have done well under the old conditions, and lukewarm defenders in those who may do well under the new.” Supporters are often like marriage-averse bachelors. They may nod in all the right places and say all the right things, but they don’t show up when the wedding bells chime. In stark contrast, the enemies are fierce and always show up. I have found that this topic creates an existential dilemma in some surgeons and they will use any means of attack to defend against its consequences.
Heart surgeons that refuse the idea of less invasive surgery know, in their heart of hearts, they are pursuing a losing strategy. It violates basic rules of economics to ignore your customers and they clearly want access to a procedure that gives both better clinical results and is less invasive. Patient demand drove the adoption of robotics in other surgical fields. In the long run, this demand will do the same in heart surgery. The short term question is how to resolve our impasse. The few successful pioneers are the only ones that still have the confidence that robotic heart surgery is the goldmine that no one else sees. They see the story of robotic heart surgery ending like the transistor radio, electric car, and Steve Job’s career – all once declared to have no value and later rediscovered to achieve mainstream success. They also see the mainstream as far too optimistic about the status quo. It is fair to critique version 1.0 of robotic heart surgery as a failure, but that doesn’t mean that the sternotomy approach cannot/should not be improved or that more competitive robotic options are not possible from versions 2.0, 3.0…etc. The “catch 22” is that those best able and motivated to resolve the impasse have a knack for alienating those that will need to be influenced.
Some of this is not the pioneer’s fault. Robotic heart surgery over the past decade was set up for failure. It was touted for use in too many cardiac surgical procedures and too many programs/surgeons. I remember seeing presentations at national meetings at that time that showed robotics being used for multiarterial bypass grafting with 3 and 4 grafts. The improved vision and dexterity provided by robotics was touted as being able to make a surgeon good at mitral valve repair that might have had little prior experience in that procedure. Live videos showed the robot removing cardiac tumors, repairing cardiac defects, replacing valves, ablating atrial fibrillation – all without the supportive technology that is available now, no legitimate training, no benchmarking of performance, no continuous quality improvement, no defined prerequisites for who should do these cases. There essentially was no system put in place to help this idea succeed. Instead, the whole process seemed to be hijacked by the marketing team of Intuitive Surgical who wanted to impress administrators about the broad revenue streams possible from robotics in order to accept its sizable price tag.
Navigating Machiavelli’s treacherous waters of change requires a far more effective and disciplined course to be charted than just outlined. There is extensive evidence that shows that marketing high tech products starts out best by focusing on a highly targeted niche. Marketing of the device used to implant aortic valves without surgery (TAVI) followed this disciplined approach. The manufacturer (Edwards) worked only with teams that met a uniquely high level of prerequisites and selected cases that their proctors thought were appropriate to take on during the learning curve period. They literally would not sell it to hospitals that didn’t follow this game plan and only a small proportion of the overall market that desperately wanted access to this device met these criteria. This took discipline for a company that wants to recoup extensive R&D costs encumbered by first version of the TAVI device. But it established a beachhead of mainstream customers that have succeeded with this program. These programs provide references and helpful advice to the others that might have been scared off rumors of the challenging learning curve.
Restarting a robotic revolution should be modeled after TAVI. This will not require the majority but a highly engaged minority. There are surgeons in the mainstream that want to pursue new ideas but prefer those that are evidence based or supported by the guidelines of professional societies. The latest guidelines from our preeminent medical society (ACC-AHA) recommend robotic/less invasive CABG for patients with suitable anatomy (class IIa) or high risk for complications with open chest CABG (class IIb). The same guidelines also recommend referral of patients in need of complex mitral valve repair to reference centers (class I). Since robotics has been demonstrated to increase the rate of mitral repairs over replacement, a robotic mitral valve program is also consistent with the guidelines. As suggested by the AATS-STS task force, only surgeons and teams that are proficient in off-pump CABG and mitral valve repair meet the prerequisites required to understand the training requirements for robotic surgery. Most importantly, programs should be trained on improving perioperative communication. A variety of tools are available – heart team meetings, pre-case briefings, post-case debriefings, multidisciplinary team meetings and efforts to improve handoffs. Their unifying goal is to get past the traditional one-sided communication (i.e. surgeon tells staff what to do) into a new two-way approach that taps into the insights and wisdom of others in the room. The lead surgeon creates an environment where everyone feels comfortable speaking out. This is more difficult than it might appear. It has been helpful to follow the model of military debriefings where military ranks are temporarily ignored to allow each member to become an equal witness for the duration of the debriefing. Pragmatic surgeons that worry about the added demands on communication for a robotic case will be reassured that this effort is being taken to address that fear.
This more pragmatic approach to innovation is both good medicine and good marketing. Choosing a tightly bound group of surgeons to focus on improves the efficiency of the marketing process, making it easier to create and introduce messages. Having goals for robotic cardiac surgery that are more realistic will grow a base of references from surgeons that are in the mainstream, which increases the chance of messages traveling to others in the mainstream by word of mouth. Industry partners have known there has been a gap between the promise of robotics and its ability to deliver on that promise. A variety of additional products and services are needed to turn robotics into a complete solution that lives up to its value proposition. The necessary financial support to create that solution is far more viable when the efforts are focused on a single group.
It was fair for Dr. Mack to speculate about the death of robotic cardiac surgery. This view comes from an accepted practice to predict a procedure’s (near term) future by its volume growth over the recent past. That simplifies the topic of robotic cardiac surgery to the following: (the number of programs doing it haven’t expanded) + (programs without it don’t refer to those that do) = no future. The problem with this equation, and with many reductionists’ accounts of complicated topics, is not that it is incorrect, but that it is incomplete. It ignores the potential for a new brand of leadership – the pragmatic visionary – to mitigate the influence of the past and chart a future for less invasive surgery that extends well beyond the 5% of existing programs. Even a realist accepts there will someday be a new method that improves upon the sternal saw. It is self-evident that this will improve healthcare – and who is against that?