The latest data from the National Database of the STS demonstrates that only 0.5% of the nearly 300,000 cases performed annually the US are done less invasively using the surgical robot. A conservative estimate is that around 40% of these cases could be done less invasively if referred to a center with the appropriate expertise. It is reasonable to ask why so many patients (39.5% ≈ 120,000/yr) would submit to a surgical procedure that was more invasive than they otherwise required. It may be that these patients, after being thoroughly briefed on all available options, made a deliberate choice of a more “time-tested” and proven conventional surgery. It could also be that patients and their families did not want the hassle of being referred out of town to the nearest regional center with the requisite expertise, sometimes hundreds of miles away. It is a basic human instinct to prefer to have medical care in one’s own neighborhood, close to home. Also, once a patient’s health status deteriorates, a tremendous amount of trust is placed into one’s healthcare providers. It is hard to question why open chest surgery was suggested instead of a more novel approach. Some just defer to the judgment of experts that have known them the longest.
It is important to acknowledge that most cases of symptomatic, severe coronary artery disease do not pose an emergency situation that needs to be dealt with immediately. Instead, the patient has time to consider viable options based on their personal priorities, often called a “preference sensitive” choice. Typically, the sequence of events starts with a surgical referral for evaluation for CABG, often times only a few days after this problem is diagnosed. During this initial meeting, the surgeon is obliged to discuss all available options with the patient and their family. Next, an elective operation is scheduled, usually within a timeframe ranging between 1-3 weeks. This pace of events provides a sufficient window for most patients to influence where their care is received and to obtain a second opinion about the surgical plan. Whether or not the patient has any desire to actually participate in this fashion isn’t the issue, the key is that there is an understanding that this option is available. Patients with this knowledge then start to understand that their own perspective on heart surgery (not just the surgeon’s) is important to consider.
I have personally performed over 1000 robotic cardiac surgical cases over the past 10 years – not a trivial portion of the total 0.5%. This experience has exposed me to patients that are not swayed by the allure of less invasiveness, freely defer to the judgment of their referring cardiologist (conservative or otherwise) and proceed with what’s available in their own backyard. For these patients, disclosure of a robotics option is unnecessary because it won’t change their decision and can cause confusion. There is another (in my opinion, much larger) group of patients that is indeed very interested in any option less invasive than splitting their sternum. Most heart surgeons (i.e. 99.5%) don’t share this enthusiasm for less invasiveness, perhaps because they don’t personally offer it, some because they don’t philosophically agree with it. This creates a disconnect between how surgeons and many of their referred patients define the key priorities for care. Surgeons often prioritize procedures that are proven to be superior in randomized clinical trials, without major consideration given to the required incision. Many patients on the other hand prefer the least invasive procedure as long as it hasn’t been proven to be inferior, giving it major consideration over a bigger incision. Sometimes, such as the case of coronary stenting, patients are even willing to sacrifice the superior efficacy (i.e. referral for bypass surgery) to acquire the less invasive benefits of stenting. When there are different views about “preference sensitive” choices, the final decision should reflect preferences of the patient rather than the surgeon.
Anytime two groups meet up that have different priorities, the risk of miscommunication is great. Many of the patients referred for heart surgery – certainly more than a negligible amount – would accept a second opinion to discuss less invasive options if it were offered. Few patients understand that they usually have to inquire about less invasive surgery for this possibility to be brought up in discussion. It is unusual for a surgeon that doesn’t offer this procedure to voluntarily refer the patient to a surgeon with experience in robotics just because the patient might be a great candidate. In the absence of an inquiry about robotic surgery, most surgeons view their duty for disclosure as analogous to the military’s rule on homosexuality, i.e. “If the patients don’t ask, we don’t tell.” Said differently, if you end up in that surgeon’s barbershop, you end up getting his version of a haircut.
Standard practice dictates that those in the referral channel – the patient’s primary doctor, cardiologist, surgeon and other providers – are responsible for providing information about alternatives such as less invasive, robotic surgery. Prior evidence suggests that these intermediaries have been either unwilling or unable to share information about less invasive surgery, even for a robotic program that is local and established. While the exact reasons for this are unclear, one possible contributor is that many of these providers are unable to provide confident advice about a novel procedure for which they had no personal experience.
In defense of withholding this information, issues surrounding surgical innovation make the ethics of informed consent more opaque. First and foremost are the unforeseen risks from a “learning curve”, a hazardous phase that all robotics programs must go through. Knowing that patients could be injured during this phase conflicts with the Hippocratic Oath to prevent unnecessary harm. In the name of progress and the desire to improve patient recovery in the long run, some motivated teams persist and develop into mature programs. Many more haven’t survived this phase and end up closing down in the end. No physician wants to see their patient become the casualty of a surgical team’s learning curve, particularly if their lessons end up being learned in vain because the program closed. It is uncomfortable, and could be criticized as unprofessional, for any doctor to speculate in front of a patient about bad outcomes at a new robotics program. In this context, the surgeon’s “don’t ask, don’t tell” approach is understandable, at least until a robotics program in the local area becomes more established. However, accurate information about a program’s progress is not widely shared among our profession, so it’s hard for the doctor to know when to discuss this option voluntarily.
Three experiences of mine corroborate that standard practice often fails to discuss alternatives and provide for second opinions about established robotic cardiac programs. First of all, when I was in Boston (2007-09), my hospital engaged an aggressive marketing firm to advertise robotic cardiac surgery using a variety of forms of mass media (newspaper, radio, TV, internet). We documented that over 100 patients sought a second opinion about robotics as a response to the ads, representing almost 8% of the potential market segment (http://theincidentaleconomist.com/wordpress/direct-to-consumer-advertising-dtca-for-robotic-cabc-r-cabg/). By comparison, typical ad campaigns in other healthcare fields prompt action in <2% of their target population. If these patients were referred for a second opinion by their providers, they would not have responded to an ad campaign. A plausible explanation for the strong response to our ads was that Boston patients were not sufficiently exposed to their preferred option through standard practice.
Second of all, my position as one of only 20 robotic heart surgeons in the US means that I’ve had the chance to perform hundreds of second opinions for patients initially referred with only the open sternum approach in mind. Some common themes have emerged from my conversations during these consultations. First and foremost is a sense of frustration with the initial surgeons that don’t volunteer information about the less invasive option. Patients understand that not every surgeon has expertise in something as complex as less invasive heart surgery. They can’t understand why it isn’t even discussed by a physician that should have their best interests in mind. In some cases, patients were shocked that only their persistence in questioning about robotics spared them from agreeing to a sternotomy that they didn’t need to have. Another of their concerns has been the misinformation provided about robotics – “you’re not a candidate” (when they obviously were), “he gets poor results” (which I easily refute with my STS publically reported data), “I get just as good of results with the open approach” (which no patient believes by this point), etc. Having listened to patients talk about this for the last 10 years, my list of bizarre and blatantly false statements that other surgeons have said about robotics could go on for pages.
Finally, I got a sense of what my peers thought after attending an ethical debate on this very topic at a recent surgical conference (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4489411/). A prominent cardiac surgeon, Dr Accola, provided persuasive reasons for the surgeon to discount the importance of disclosing the existence and availability of less invasive alternatives. The moderator was not swayed and asked Dr. Accola whether the patient is truly incapable of processing the available information himself. Is the surgeon’s skeptical interpretation of the data sufficient reason to withhold that information from the patient? To me the answer to both these questions is obviously “NO”. The surgeon at the podium and in those in the audience (other than me) seemed largely unmoved. Self-interest seems to be a powerful motivator.
The formal process that surgeons are ethically required to follow and provide truthful information to their patients about all alternatives is called informed consent. This process is a legal requirement in statutes and case law in all 50 states and clearly spells out the need to discuss all reasonable alternatives. Public policy dictates against imposing an unreasonable duty of disclosure upon professionals, so courts limit the type of disclosure they enforce. In the past, the legal standard for disclosure of alternatives used to be what a “reasonable surgeon” thought his patient should know. This is a paternalistic standard where the majority defines the practical, accepted and recognized alternatives that are necessary to discuss. Robotics goes unmentioned in this case.
More recently, paternalism has been replaced with the contemporary concepts of patient autonomy and shared decision-making. This shift, along with the rise of medical consumerism, had led courts to base informed consent on what a “reasonable patient” would want to know before agreeing to the proposed procedure. Under this standard, physicians must think from the perspective of the patient in front of them, starting with the assumption that everyone can cope with the facts. Nondisclosure is reserved for the unusual cases in which more harm will result from telling the truth than from not telling it. This approach understands that each party is an expert in their own area — the patient on his/her personal experience of symptoms, values, treatment preferences and life style choices and the surgeon on the technical issues of medical need and suitability of available treatment options. Input from both is needed to achieve consent that is truly informed.
Giving the sternotomy-only crowd the benefit of the doubt, a routine lack of disclosure about less invasive surgery amounts to making an assumption on behalf of unwitting patients that this information would have no interest to them and no influence on their decision. There has been a consistent, overwhelmingly positive response to less invasive options in every other surgical specialty. In fact, it has been patient demand that has driven the growth of these techniques. Since there is no basis to believe in a unique disinterest among those referred for cardiac surgery, the conservative heart surgeon’s assumption stands on very shaky legal ground. In fact, the statutory and common law obligations to provide this information exist in large part as a way to counter the lingering paternalistic tendencies of surgeons (and other physicians) to make these choices without patient input.
This doesn’t prevent the surgeon from giving their honest opinion. If the balance of benefits and harms associated with a robotic approach are unfavorable in a given case, then the traditional, open method is the appropriate recommendation. Unfortunately, understanding this balance is difficult for a surgeon who does not perform this procedure and is unaware of the types of outcomes that could be expected in a given case and/or given program.
It is worth clarifying the legal issues when all alternatives needed for informed consent are not discussed. A physician who performs any surgical procedure without obtaining consent appropriately can be exposed to civil liability for having committed a battery. In contrast to a claim of negligence, proving a battery case does not require that the plaintiff to have been injured as a result of the defendant’s conduct. The fact that a battery has occurred is sufficient to be compensated for all injuries caused by the mere performance of operation believed to have been unauthorized, whether the result of negligence or not. Battery requires a strong deterrent, so punitive damages are possible even where the actual damages are small. Expert testimony as to whether the physician breached his duty is not required in a battery action. In fact, judges have been more ready than in other areas of clinical negligence to go against expert medical evidence in deciding what amounts to “responsible” disclosure of information. A final point of practical significance is that as an intentional tort, battery is not within the scope of most physician’s malpractice liability coverage. That means that physicians have to pay for damages out of pocket.
If a physician misrepresents material facts and performs surgery under false pretenses, then the signed consent form becomes invalid. In the past 10 yrs, I’ve come across several patients that discovered after they underwent the open sternotomy incision that there was a robotic option that they would have qualified for. If any of these patients made a legal claim for battery, their surgeon would have to prove that a reasonable person would not have wanted that information. Legal precedents show this argument would be tough to make. The NJ state Supreme Court held that a physician must disclose all “medically reasonable” treatment options, including those he doesn’t recommend (Matthies v. Mastromonaco).
Our medical societies weigh in on the ethical issues by emphasizing the value of second opinions. In response to a patient inquiry, the best person to articulate where a new robotic team is with their learning curve is the surgeon performing the procedure. Both the AMA and the ACS have established strong ethical rules that prevent physicians from dissuading their patients from obtaining second opinions (AMA Opinion 8.041,https://www.facs.org/about-acs/statements/stonprin#top). Most medical boards also censure this type of behavior. Obtaining a second opinion from an expert provides the chance for all the information to be laid out before for patient in an open, unbiased, non-manipulative way. The burden of providing honest and complete information now shifts to the robotic surgeon. Battery has also been proven when doctors fail to disclose their lack of experience with a procedure (Johnson v. Kokemoor) or the availability of more-qualified physicians (Sell v. Bargar).
Realistically, most surgeons who do conventional, open surgery will never be motivated by legal risks or ethical arguments to disclose the idea of robotic surgery to patients. It is far more important to build and protect their practice by maintaining the trust and confidence of referral sources. This requires the surgeon to emphasize their own strengths to patients referred to them. Describing why another surgeon might have been better does not help a surgeon gain future referrals. Most patients know that heart surgery is big business, but don’t assume caveat emptor and give the benefit of the doubt to the integrity of information that is and isn’t provided. I’ve seen a subset of patients that are engaged enough to seek out information about robotics on their own. My experience is biased as someone who has been providing these type of second opinions for a decade to a small sliver of the overall population. But this sliver is predicted to grow. Perhaps more importantly, some patients that weren’t volunteered important information become disgruntled. It is bad business to ignore these types of customers because word of mouth spreads their opinion far more than a satisfied customer.
Robotics isn’t an idea driven by surgeons’ desire to play with a new toy, it has been driven by patient demand for less invasive surgery. Our whole profession suffers from the link between healthcare and politics that makes local needs of physicians trump the aims of patient–centered care. There is nothing more patient centered than accomplishing the same goals of invasive surgery with a less invasive approach. There are knowledge gaps among healthcare professionals about how well any given robotic surgery program is contributing to this goal. These gaps are addressed (and patients are empowered) when a referral is provided for a second opinion from someone with this expertise.
