Show and tell or just plain show? Experts ponder the risks and benefits of live case demonstrations

Shelley Wood

November 06, 2003

( Conceptis Technologies)

New York, NY - Dr Antonio Colombo (Centro Cuore Columbus, Milan, Italy) was nearing the end of a complex interventional procedure when things went abruptly wrong. For the audience, watching a larger-than-life Colombo transmitted live from his cath lab to the screens at the front of the presentation hall, the tension was no doubt electrifying. A familiar face behind the operator's mask during live case demonstrations at international meetings, Colombo is renowned for his calm confidence; legend has it he once picked up a guitar and sang a song for his remote audience to fill some downtime during a live broadcast.

Dr Antonio Colombo (Source: EMO Centro Cuore Columbus)

Not in this case. "This was a wire perforation that occurred during the last injection by having the guiding catheter placed too deeply into the artery," Colombo told heartwire . "We advanced the wire, which is a maneuver that is sometimes done to disengage the guide, and the distal tip of the wire perforated the artery."

This is a make-or-break moment for a live case demonstration. It is the occurrence that is both desired and dreaded. While no one would wish complications on a patient, there is at least an unspoken agreement that a procedure that goes smoothly during a live case will not be the most interesting to watch. The uncertainty is part of the pleasure.

Dr Steve Steinhubl

"I am one of those people who enjoy watching the live cases," Dr Steve Steinhubl (University of North Carolina, Chapel Hill) admitted to heartwire . "Clearly there is an entertainment aspect of it, people enjoy them for the same reasons that people go to car races. You like to see what somebody can get away with."

Dr Deepak Bhatt

"There's just no question that it makes any meeting more interesting to have live cases, and a meeting with live cases is more likely to draw a larger, more interested, and excited audience and more likely to leave a good impression, so that the audience leaves saying yes, this was a really a terrific meeting," Dr Deepak Bhatt (Cleveland Clinic, OH) agrees. And, of course, he adds, "It's fun to watch someone else sweating."

Seeing is believing

The father of angioplasty, the late Dr Andreas Gruntzig, is credited with inventing the first live demonstration case, organizing a television feed to run from one room to another during his early angioplasty cases. More than 25 years later, live case demonstrations, in which a case performed by an operator at a remote location is broadcast to an audience, usually at a major meeting, have become de rigueur. Once largely the domain of the localized specialty meetings with smaller audiences, live case demonstrations are now the sole focus of dedicated international meetings, and live cases are increasingly snagging program space at the larger, more general cardiology meetings that attract audiences numbering in the thousands. In recent years, the ACC has added them to its programsalthough not in 2003while the AHA, typically a more scientific meeting, is considering adding live cases in 2004.

It's fun to watch someone else sweating.

Dr Cindy Grines (Beaumont Hospital, Royal Oak, MI) thinks the general meetings are adding live sessions in the hopes of wooing back the interventional cardiology community, much of which flocks to the ISET, TCT, and EuroPCR meetings but appears in dwindling numbers at meetings like the AHA, ESC, and ACC.

Dr Cindy Grines

"We're very visual, we want to learn new techniques in addition to new data," Grines says. "When we go to the AHA meeting, for example, it's very boring for us interventional cardiologists because you hear one abstract presentation after another, and what does it really teach you with regards to how you're going to take care of your patients? Hardly anything. So that's why the ACC and AHA are adding these live demonstrations, because they want to get those interventional cardiologists to come back to their meetings."

But as the number of live cases proliferates and operators and program directors up the ante with the types of procedures being performed live, the clear benefits of these types of sessions inevitably clash with the increasing potential for problems. While no one disputes the educational value of seeing a case performed live, many point out that the border between education and entertainment is becoming increasingly blurred.

Edu-tainment?

"We should not look at these things as entertainment, these are educational events," Colombo insisted to heartwire . "You can have very sharp commentators who can build some entertainment into them, but the focus of these sessions is to make them entertaining just to the point that they keep attention at a certain level."

(Source: EuroPCR)

Bhatt points out that the two are linked. "The more challenging the case, the more likely it will be intellectually stimulating, but also entertaining, so I think the two go hand in hand. But part of the entertainment is entirely nonintellectual, it's just seeing someone else in the hot seat."

The operators performing the cases are invariably well-known names in the field of interventional cardiology and, as some physicians told heartwire , there are pros and cons to seeing the experts do battle with tough cases.

Dr Matthew Watkins (Source: University of Vermont, Burlington)

On one level, says Dr Matthew Watkins (University of Vermont, Burlington), part of what's enjoyable about a live case is seeing a big-name cardiologist doing more or less the same sort of work that members of the audience do on a day-to-day basis. "You learn that no matter what people's reputations are, they tend to put their pants on one leg at a time, and what they are doing is really not that different from what all of us do in interventional cardiology. They look just like you feel you look, and that's a good thing."

Dr Giles Montalescot

"It's narcissism," Dr Giles Montalescot (Hpital Pitie Salpetriere, Paris, France) told heartwire . "People like to see on the big screen what they do everyday.

Dr C Michael Gibson (Brigham and Women's Hospital, Boston, MA), however, notes that looks can be deceiving. "These are often world-class practitioners who are highly skilled, and often local practitioners view what is being done as the standard of care when in fact many of these cases are highly complex lesions and are a stretch, at least, from the standard of care, involving off-label use of drugs and devices. People should realize that this is not to be tried, necessarily, in their own cath lab."

To be fair, part of the reason interventional cardiology has made such "tremendous strides" in the past few decades is because interventionalists have been pushing the envelope, Gibson points out. "On the other hand, we need to make sure people understand when they're pushing the envelope and when they're working inside the envelope. And I think we let loose a lot of people from these meetings who think they're in the envelope when in fact they're pushing it."

You learn that no matter what people's reputations are, they tend to put their pants on one leg at a time.

Grines described the scene at Beaumont, where interventional cardiologists scheduled to perform a live case begin at least a month in advance to hone their techniques and "drum up" interesting cases. "They're not ordinary cases," she says. "If you were to come to our cath lab and look at what I do on a Monday, it's not at all the same thing that you would see in a live demonstration. For a live demonstration you're trying to use new toys that haven't been FDA approved or you're trying to do unusual cases so that people remember that you did something cool."

Trying this at home

Interventional cardiologists are divided over what should and should not be fodder for a live case demonstration. Bhatt, for one, thinks that it's fine for "just about anything" to be in a live case, as long as patient consent is obtained and the operator is completely comfortable performing the procedure on camera. Steinhubl, by contrast, thinks that live sessions should primarily feature approved devices, possibly with special satellite sessions for investigational devices that demonstrate novel technology. At the same time, he acknowledges, in the real world, devices are often used off-label or for an expanded patient population, so excluding such practice from live cases might not be reasonable.

Gibson points out that a live meeting is not the place for a device to make its debut. "If something has never been tried before, that might be something best not made a public spectacle of," he says. "Things should have their kinks worked out first."

Dr Gregg Stone

Dr Gregg Stone is codirector of the Transcatheter Cardiovascular Therapeutics (TCT) meeting, now in its 15th year, which bills itself as the largest international symposium in the field of interventional vascular therapy. He says that the issue of off-label use of drugs and devices during the sessions has been debated by TCT directors.

"That's something that we are actually concerned about and we are going to try to make even clearer in the futurewhen drugs and devices are being used in an off-label fashion. It's not that physicians can't use drugs or devices in an off-label fashion, but they should know when they're off label, and they should know whether there's a body of work that supports their application in that particular situation."

Stone also makes the point that there is no clear line distinguishing what should and should not be taken home by members of the audience. If a certain technique is deemed too difficult to try to emulate by the audience, then patient care does not move forward.

"For example, not everyone can do Antonio Colombo's techniques, but moderators do go out of their way to discuss the complexity and advisability of those techniques being generalized to the audience," Stone says. "Certainly there is a risk of people seeing great things that are done and going home and trying them on their patients and they don't work out as well. But usually what happens is unfortunately the opposite, and that is that there is a good technique that's shown, but it does require some persistence and learning, and an operator will appropriately go home and try to generalize that technique, they don't get success with it the first time, and then they never try it again."

-SW

Doing something cool

A peculiar dynamic inevitably arises between the operator, panelists, and audience. "I've been on live cases before and it does change the stress level of the procedure for sure, even for very experienced operators, and anyone who says otherwise is lying," Bhatt told heartwire .

(Source: EuroPCR)

Many of the interventional cardiologists interviewed by heartwire admitted that the level of care a patient receives as a result of the unusual circumstances is unorthodox at best, and in some cases imperfect, even catastrophic. At the same time, given the audience presence, operators are also striving to do their best work.

"My guess is that in many ways the people doing these procedures are being extremely careful because they are doing it live and they've got more people, and the best assistants, and everything in the room to help," Steinhubl commented. Likewise, Gibson points out that some of the top physicians in the field are doing the live procedures. "I'm sure all the people who are the operators in these courses provide great care whether they're part of a course or not."

Colombo told heartwire that along with the irrefutable learning opportunities these sessions provide, "there are some clear drawbacks for the patients as well as for the audience. The fact that these procedures are performed in a rather limited time imposes on the performance of the procedure to fit the schedule, and this fact may not always fully match the approach that would have been taken if this constraint were not present." As well, he notes, "there are sometimes problems in finding the most appropriate patient available for a specific live demonstration, and the risk of forcing a patient into a protocol is always present."

For the audience, time restrictions may mean that the audience misses out on seeing parts of the procedure that might not be as sexy to watch but that are nonetheless important from an educational point of view, Colombo notes.

As an operator, it is very annoying to have these moderators and panelists asking you questions when you're trying to deal with the patients.

Grines, too, worries about potential patient risks. "I heard a rumor that the cases at the live demonstration courses have a higher complication rate compared with the average case that would be done at a hospital," Grines said. "And is that because you are selecting very high-risk patients to show, or is it because you're being distracted? As an operator, it is very annoying to have these moderators and panelists asking you questions when you're trying to deal with the patients."

In fact, Dr Pascal Chatelain (University Hospital, Geneva, Switzerland) et al published a study in the Lancet in 1992 looking at this very questionpatient outcomes in live case demonstrations. The researchers were unidentified audience participants in 104 live cases of coronary angioplasty at 12 meetings in 1991 and took notes on everything from audience numbers to patient age, procedures, and outcomes. They reported that while no deaths or MIs occurred during the sessions, the observers tended to have a less favorable view of the outcome than the clinician doing the procedure and that the overall outcomes of the live procedures seemed "inferior to those reported in journals." Patient outcomes were not reported for six of the patients. They concluded, "Interventions done before an audience will be unusually stressful, but this will be outweighed by the fact that difficult cases with a low probability of success are rarely tackled during live courses."

Dr Bernhard Meier (University Hospital, Bern), a coauthor on the Chatelain paper, notes that live case demonstrations have changed radically over the past 10 years. "Now very difficult cases are tackled, but what has also changed is that they only show glimpses of these cases. What is no longer shown is the case from A to Z, with all the sweat and tears. Instead they have three or four labs working in parallel and the live transmissions jump from one room to another, like zapping between TV channels. And they only show the pearls; if something goes wrong, we don't see it."

The shape under the sheet

(Source: TCT meeting)

The issue of patient safety persists. "This has always been a controversial question," Bhatt told heartwire . "Is it helping or harming patient outcomes to be a live case demonstration? I think it really depends on the situation." He points out that patients sometimes obtain access to a life-saving technology long before it's on the market. As well, he has seen cases where an operator who appears unsure of the next step receives a suggestion from a panel member that dramatically improves the end result. "Likewise, I've also seen situations where a panel member will goad the operator into a series of steps that the operator may not have otherwise taken. Not in a malicious way, or bad way, but it's easy from a distance to critique something, your feelings may be different if you're actually there performing the procedure with your hands on the equipment. . . . I have seen some pretty wacky complications occur doing live cases that are very unusual and perhaps wouldn't have ever occurred in normal life, but by the same token, I've seen some patients get access to some pretty remarkable technology that they may not have, were they not part of a live course."

I've heard a lot of doctors say they would never want to be a patient in a live case.

That said, Bhatt admits, "I've heard a lot of doctors say they would never want to be a patient in a live case."

Meier has another take on modern-day live demonstrations. He believes the ability of the transmission to switch away from an operator in trouble to another procedure allows the operator to deal with the complication without the pressure of the audience, likely resulting in improved patient outcomes. "Once off the air, the doctor can revert to normal behavior and will take care of the real problems without being distracted." After all, he adds, "the spectacle of seeing doctors suffer under stress and patients suffer under complications is really not ethical."

"Anything I can do to help"

It is difficult to imagine that the patients are fully aware of the circumstances to come when they sign the consent form. "I've often wondered that myself," Steinhubl told heartwire , pointing out that patients rarely read though the entire length of their consent forms for clinical trials, and studies indicate that many patients do not fully understand the consent process.

Patients really trust their doctors, and if their doctor asks them to do something, they think it must be okay./span>

"Patients really trust their doctors, and if their doctor asks them to do something, they think it must be okay. I think the patients do understand what they're getting into with live case demonstrations, but probably only to the same extent that they understand what they're getting into with clinical trials, which is often not as complete as we'd like to think it is. If you tell a patient, 'we want to do this intervention, and your anatomy is perfect, so we want to show it live and it's going to help thousands of other doctors and help improve the care of patients,' then the patient is likely going to say, 'Sure, anything I can do to help.' You don't necessarily say that this isn't something that is commonly done and that's why we're doing it live."

Grines adds, "I'm not sure whether the patient is actually told, well, there's going to be a thousand people watching, although they do know that it's being taped and broadcast, and they have to sign a consent form." She adds that the patient's face is never shown, but that often the camera pans to the patient's monitor, where the patient's name appears, inadvertently jeopardizing patient confidentiality. "But the main thing from the patient perspective is that physicians will choose particularly challenging cases or do things that they wouldn't ordinarily do, just to have an effect, to show off," says Grines. "So that's my one concern, that they're taking risks."

(Source: TCT meeting)

While patient care in a live case demonstration may be somewhat unconventional, the risks and benefits may be little different from those of patients enrolled in clinical trials. There may be unanticipated harms, but patients might also gain access to an investigational drug or device that ultimately improves their quality of life. Moreover, as Meier points out. "Patients in live case demonstrations may pay a small price in terms of having a prolonged procedure, or a slightly less concentrated operator, but they serve medicine in general. Just as when patients participate in a clinical trial, they may not benefit, but they're helping medicine to develop and doing something good for mankind. They are paying a certain tribute to the advancement of medicine in general."

Patient outcomes a mystery

No one interviewed by heartwire had ever seen a patient die on screen during a live demonstration, but many pointed out that doesn't mean that patients don't occasionally die.

"Usually you don't see the people dying on the screen, but you don't get any information about the outcome of the patients, either," Montalescot points out. He notes that the convention of switching the transmission to another room leaves many cases open-ended for the audience. "When they move from one room to another, they don't come back to that previous patient who was having complications in the other room. The next morning, you don't know whether the patient is alive or not and they're not going to say whether anything happened, of course."

(Source: ISET meeting)

With some exceptions. During the on-screen complication that Colombo faced this year, he allowed the live feed to continue to broadcast the case to the remote meeting audience while he and his colleagues tried to place a coated stent, without success. "The patient was on GP IIb/IIIa inhibitors and the perforation could not be completely sealed, we could not place a covered stent, so we had to send the patient to surgery, and he died from complications."

Colombo is adamant that the live broadcast had no bearing on the patient's death and was completely forthcoming about the patient's outcome. In a later session on the same day of the live case, Colombo reported what happened in detail.

"Not every operator is keen to work on a complication with a larger audience watching them, so in those situations the feed is cut....For this case, we did not interrupt the transmission until the very end, so people had a very clear idea of what was happening." Colombo says. He thinks full disclosure of patient outcomes should be mandatory in live case demonstrations.

The next morning, you don't know whether the patient is alive or not and they're not going to say whether anything happened.

"I think follow-up information on what happens behind the curtains is absolutely important. Whether this happens depends on the ethics of the meeting's organizing people, but even if they don't show details, they can make a very brief, educational summary of what happened, and I think this should be provided in the evening, at the end of the day, or the next day. This can always be done and should be done."

Montalescot agrees. If education is indeed the primary purpose of these sessions, knowing patient outcomes is essential, he says. "I think we should receive the follow-up on all the cases, rather than just on the cases that are hand-picked."

Without a doubt, knowing that someone had died from a specific complication is valuable knowledge. "From an audience perspective, there's nothing more educational than seeing a complication in somebody else's hands," Bhatt agrees. "You don't feel the pain, but you do gain the knowledge."

Room for other improvements

Experts list other ways in which live sessions could be improved, including clarification of the relationship between panelists and operators to industry sponsors, and indeed of the sometimes-tortuous ties between device and drug manufacturers and the sessions more generally. Without a doubt, the panel members play an integral role in live sessions, helping to put the operator's choices in context for the audience and filling the "downtime" during the procedures themselves with discussion of different techniques and strategies. For these reasons, it is essential that the panelists be up front about their ties to particular companies, Gibson says.

"Live case demonstrations are a clever way to promote different drugs and devices. Just as in the movie industry, where Coca Cola will have its brand appear during a movie, often brands appear during these sessions," says Gibson. "There is always more than one device used and always more than one drug used, so it's very cumbersome, but necessary, to indicate all the potential conflicts of interest. And that could be done better. Efforts are being made, but we have a way to go."

It's a show, it's PR. . . . It's like a commercial on TV.

"Live cases today are much more a display of devices," Meier says. "It's a show, it's PR. If they show the glorious few minutes of a case using a new device, you don't see the somewhat intricate preparation beforehand and maybe the problems the operator can't get out of after half an hour. It's like a commercial on TV."

That said, he acknowledges, the execution of live cases has also become considerably more flashy and expensive, so the heightened presence of industry is "understandable. They pay for the sessions and they want to get the most bang for their buck."

Stone wouldn't name a number when asked about the average cost of producing a live case demonstration at the TCT meeting, pointing out that the price tag depends on a host of factors, ranging from the number of live feeds to the quality of the audiovisual equipment being used. He insists, however, that the sponsoring company has no influence over what is used in any given procedure. "At TCT, we do have support for transmissions, but it is totally unrestricted support. We actually never plan ahead of time as to what kinds of cases are being done with what devices," he says, "other than the fact that in general we think we should do a distal protection case or a long lesion or a bifurcation. We never tell sites that they should use Guidant products in this case, Cordis products in that case, etc. We never tell sites that because this session is being sponsored by Boston Scientific, you should use Boston Scientific products."

Grines points out that live case demonstrations depend more heavily on devices than drugs, although pharmaceutical companies will also sponsor a session if their agent is being used. In general, she thinks the device industry is more up front about conflict-of-interest issues than the pharmaceutical companies and in their use of intermediaries to present clinical data at educational meetings. "I think the disclosure is as good as it's going to get," she says.

And of course, promoting an investigational device in a live session can backfire, Bhatt notes. "If a company is touting its next big breakthrough and a patient in a live case demonstration with that new product has a bad outcome, then that could be some negative publicity."

Seeing is believing

The mixed admiration and misgivings that interventional cardiologists express when discussing live case demonstrations raise a question: if seeing cases performed is key to education, why can't videotaped material be substituted for "live" broadcasts? At the 2003 ACC meeting, featured taped cases took the place of live case demonstrations that had been on the program the previous year, and taped cases are planned for 2004. As of yet, ACC organizers had not decided what type of sessions they would be using in 2005. "The consensus of attendees from past surveys indicated that the taped cases provided a better learning tool," Diane Lee, senior specialist for education with the ACC, told heartwire .

"There are many reasons why I believe that there is a role, especially from the teaching point of view, for edited taped cases," Colombo says. "The edited taped cases may take away the drama of live transmission but may be more valuable from the educational point of view."

You could delete all the complications and make yourself look really good.

Bhatt agrees. "I'll be frank. I personally prefer taped cases in terms of what I think, overall, balances educational value with patient safety. You get essentially the same level of education, although probably not the same sense of excitement or vicarious thrill because it's not in real time. At the same time, you can enhance education because you don't have the 30 minutes while the operator is trying to wire an artery where it's not that exciting to watch."

Of course, he quips, "You could delete all the complications and make yourself look really good."

Not everyone agrees that tapes could supplant live case demonstrations. "As great as the internet is, and as great as media have become, there's always something about an event occurring live," Stone says. "There's a certain unknown quality and a certain immediacy that you can just never replace with something that's already happened."

Meier points to another hard reality. Physicians are busy, and mushrooming meeting options mean that they have to pick and choose among conferences. "The educational value of a taped case is probably greater, but people will not travel for a taped case, they'll say, send me the tape and I'll watch it at home. But if I go to Paris to the live course, I can see Toronto, and ten minutes later I can see Tokyo, then New York, then Los Angeles, and I will travel for that. These types of meetings get people to come together."

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