A script for the show: Live cases in cardiology get a code of conduct

Shelley Wood

October 06, 2010

Washington, DC - Not long after one of the world's most skilled interventionalists had coaxed a 26F sheath through the apex of a beating heart, a freelance photographer shooting the TCT 2010 meeting—thousands of miles from the valve procedure itself—burst out of the main auditorium as if from a burning barn. Eyes agog, he accosted the first person he recognized: a journalist.

A live case demonstration at the TCT meeting [Source: CRF]

"Do you see what they're doing in there?" he asked. "That's a real person in there, on screen, getting that operation. Live!"

The reaction by the photographer—more accustomed to filming politicians and sporting events—stood in sharp contrast to that of other TCT attendees watching the live procedure, inured as they've become to the sheer technological, logistical, and medical wizardry of live case transmissions. Thirty years after the late Dr Andreas Gruntzig used a television feed between rooms during his early angioplasty cases, real-time broadcasts of procedures performed in a different city or country are now commonplace at interventional cardiology and electrophysiology meetings. Part education, part performance art, live cases have become an international telecommunications phenomenon. Case in point: when TCT first migrated to high definition several years ago, organizers were told that the sheer number and complexity of HD transmissions they pulled off was second only to that of the Olympic Games.

Sober second thoughts

The reaction of a nonmedical layperson to a larger-than-life, real-time, on-screen operation could serve as a reminder to physicians that the live demonstrations they now take for granted are both extraordinary and deserving of sober second thoughts. In recent years, the American College of Surgeons (ACS) has banned live cases from its meetings, and the American Heart Association (AHA), which told heartwire in 2003 it was considering adding live cases, never did and has no current plans to do so. In 2008, the American Association for Thoracic Surgery (AATS) and the Society of Thoracic Surgeons (STS) issued a statement prohibiting live case broadcasts to the general public and discouraging the use of live demonstrations to audiences of any kind when taped cases could be used instead [1].

Now, in an announcement issued at TCT 2010, cardiology societies have collaborated on their own "Statement on the use of live case demonstrations at cardiology meetings," including a code of conduct [2]. The statement was simultaneously published in the journals of other signatories.

Dr Gregory J Dehmer

According to Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple), who chaired the writing group, the document has been in the works since 2008, when the FDA asked to meet with representatives of the Society for Cardiovascular Angiography and Interventions (SCAI) and the American College of C ardiology (ACC) at their joint i2 Summit that year and "floated the idea" of writing a guidance document for live case demonstrations.

The FDA, says Dehmer, was concerned about the use or promotion of unapproved devices and off-label usage, both of which were more common outside of the US but being transmitted via live broadcasts to American meetings. Other concerns raised by the FDA included patient safety and a lack of research supporting the actual educational benefits of live cases.

Dr Gregg Stone

"Live cases have had their critics," Dehmer acknowledged. "There needed to be a document that kind of brought us back to certain core principles. Number one: the purpose of live cases is for the education of physicians and other paramedical personnel, first and foremost. Anything that starts to deviate too far from that is probably something that needs to be scrutinized very carefully."

Dr Gregg Stone (Columbia University, New York), one of the course directors for TCT, the premier cardiology meeting for live cases, says that discussions about the value and risks of live transmissions "got promoted to the forefront when the surgical societies came out with their position statements.

"We have always felt that there is such a tremendous inherent value of education through live cases," Stone told heart wire , "that it was frankly kind of a wake-up call that another society didn't see this the same way."

All in favor say aye

Both ACC and SCAI are signatories on the document, along with the Heart Rhythm Society (HRS), the European Society of Cardiology (ESC), the Latin A merican Society of Interventional Cardiology (SOLACI), and the Asian Pacific Society of Interventional Cardiology (APSIC).

"We just could not reach out to every single organization, but we are hopeful that the standards we propose and the code of conduct here will be adopted by many organizations that choose to put on live cases," Dehmer said. Absent is the AHA, which Dehmer points out doesn't have live case demonstrations at its meeting. "While they were very appreciative of the offer to join this effort, in the end they respectfully declined."

Two of the biggest cardiology meetings that rely heavily on live cases are TCT and EuroPCR. While neither of the official organizers of these two meetings (the Cardiovascular Rese arch Foundation [CRF] and the European Association of PCI [EAPCI]) is listed on the statement, the CRF recently announced it would be partnering with the ACC on future meetings, while EAPCI is a "subcommunity" of the ESC.

-SW

Lead author on the AATS/STS position paper, Dr Robert Sade (Medical University of South Carolina, Charleston), spoke with heart wire about the newly released cardiology live case statement and "code," saying he thinks there are actually more similarities than differences between the cardiology statement and that of the cardiothoracic surgery societies.

Dr Robert Sade [Source: Medical University of South Carolina]

But tellingly, the surgery societies concluded that surgeons should not participate in live surgery broadcasts to the general public, via any medium—an edict not addressed in the interventional document. Moreover, the surgeons concluded, "National and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings" and "Live surgery broadcasts to professional audiences of any size become progressively less acceptable with more rigid scheduling constraints, increasing complexity of the operation, decreasing educational value of the procedure, greater intensity of the surgeon's interaction with the audience, and less familiarity of the surgeon with the operating-room environment." And the kicker: "Violation of these guidelines may lead to disciplinary action by the Society of Thoracic Surgeons."

By contrast, the cardiology document merely proposes unspecified "monitoring [of] operator and course behavior." To heart wire , Dehmer elaborated, "We kind of propose that there be not so much a separate organization that actually polices all this, but a way to actually start collecting information about live cases that are performed so that we have a little bit more data on which to base future decisions."

A paucity of proof

In fact, a point stressed in Dehmer et al's document is the sheer dearth of information on two of three questions that anyone wanting to offer live broadcasts should be addressing: what is the educational value, and what are the risks/benefits to patients?

A live case operator takes questions from the panel [Source: SCAI]

In a detailed, point-by-point fashion, the authors on the statement point out that while there are theoretical educational benefits to live cases, these have never been measured empirically. And while there are also potential benefits to patients, there are also substantial risks. These include increased infection risks, disruptions within the operating theater, delays or haste to accommodate broadcast schedules, a distracted or pressured operator, and changes to the course of treatment for "educational" purposes.

"The important question is, does doing this as a live case add any as-yet-unmeasured or unknown risks to the patient? Ideally, the answer to that question is no," Dehmer says. "In reality, that's one of those things that is very hard to perform research on, and we don't know for sure. At this point, there is precious little information in the literature actually looking at the results of live cases vs other cases not performed in a live venue."

The live case statement cites only two such papers—one from 1992, suggesting results of coronary angioplasty in live-case patients were slightly inferior to that reported in journals [3]], and one from 2009, suggesting that procedural and 30-day outcomes in patients undergoing carotid stenting during live case demonstrations were similar to results in the contemporary literature [4].

Documenting deaths

More striking, perhaps, are the stats on outcomes from TCT over 20 years of live case demonstrations. According to Dehmer et al's paper, TCT has broadcast 928 live cases from sites around the world and has seen just two procedure-related deaths (one in a complex coronary disease procedure, the other during an aortic-valve procedure—reported at the time by heartwire), yielding a mortality rate of 0.21%, "well within acceptable standards for such procedures," the document reads.

In fact, says Stone, "that's below the expected range, from the complexity of the cases that are done. It's really an extraordinary track record."

Even Dr Josep Rodés-Cabau (Quebec Heart and Lung Institute, QC), who has been an operator for a number of live cases, including during last month's TCT meeting, says he was "very struck" by just how low that mortality rate is. "When you go to these live case meetings, people always remember the one terrible case and forget what happened in all the other cases," he observed wryly.

Dr Josep Rodés-Cabau

One of the ideas put forward by Dehmer et al in their statement is the creation of national and international registries for live case outcomes, something Stone called an "excellent" idea.

"We believe that, done appropriately, patients do extremely well in live cases," he said. "There's an incredible preparation that goes on at most sites for a live case; obviously most operators have an extra motivation to not have anything go wrong during a live case, so they are very, very well prepared; and in addition, we do believe, while we can't prove it, that there are advantages to having a dozen of the world's top operators sitting on a panel, with the adrenalin levels low, being able to make comments on new ideas when difficult situations arise. I've seen that at least a dozen times help a patient, although that's not science and I can't prove it."

A requirement stipulated in the surgeon's statement—but not in the cardiology statement—is that 24-hour and 30-day outcomes from patients treated in live cases be made available to audience members. "You always see what happens in the OR, but god only knows what happens the next day," Sade observes.

Celebrity medicine?

One of the things the new guidelines hope to help live cases steer clear of are scenarios where the focus is on the albeit-masterful skills of an internationally renowned physician, and not as much on the procedure.

Dr Antonio Colombo

"That certainly is to be discouraged," Dehmer says. "There's no doubt that the operators that do these cases are some of the finest and most experienced operators on the planet, but they are also very charismatic individuals, and I think the purpose of the article is to keep everybody reminded that the primary goal is education."

One of the most recognizable faces from live cases both in the US and Europe is Dr Antonio Colombo (Columbus Hospital, Milan, Italy). He points out that, charisma aside, choosing the right operator requires meeting criteria beyond just skills. "It is essential for the operator transmitting the live case to be very confident with the procedure that is going to be shown—this fact allows optimal interaction with good safety on the side of the patient," he says. Moreover, "the operator should be very confident in the strategy to be utilized and to accept suggestions from the moderators with a high level of critical expertise. In no way [should] the operator perform maneuvers just to please the suggestions of the panel or of the audience."

What about the alternative?

The third and final question that the cardiology statement sets out is whether there are reasonable alternatives to live case demonstrations. The surgeons seem to think so: the "STS University," a stand-alone course that runs immediately following the STS annual meeting, replaced live cases with taped sessions at this year's conference, and, according to Sade, organizers who originally resisted the idea said this "worked out significantly better" than live cases in previous years.

This is like NASCAR. And the reason you go to NASCAR races is to see if there is a crash!

The cardiology document, which points out the scheduling/predicted-duration/pause-and-discuss advantages of taped cases, also notes potential disadvantages, including the possibility that editing would make procedures look easier, more "scripted" than reality. Advocates also argue that the interaction with the panelists sitting on stage at the meetings, watching the broadcasts, is an integral part of the real-time learning, as is hearing and seeing how an operator deals with the unexpected.

And therein lies the central, unavoidable truth underpinning the popularity of live cases—procedures that go entirely according to plan are the least interesting to watch and, arguably, less of a learning experience for the audience.

"The objection of some of the people in our writing group was that this is like NASCAR," Sade told heart wire . "And the reason you go to NASCAR races is to see if there is a crash! It gets very exciting and this is what they called spectacle—that's why people are attracted to it, and they are very popular."

"You never want this," says Rodés-Cabau, "you never want any complications. But it has to be said that even when you have some minor problems, this is very helpful in terms of education. You see how to manage it, how difficult it can be or not. I'm not even talking about major things: I'm taking about maybe doing a coronary patient, and the wires are crossing, and then what exactly do you do?"

Stone echoes this, stressing that contrary to what people like to think, procedures selected for live cases at TCT are complex but common, and he rejects the suggestion that audience members are hoping for surprises. "I don't think people have ever been hoping that things go wrong, but part of the educational aspect of a live case is that [audience members] are sitting there and putting themselves in the position of the operator and asking themselves on a minute-by-minute basis, what would I do now? How would I solve this situation? And then they see not infrequently that the operator does something different from what they would have done, and it either works or it doesn't."

At TCT, Stone stresses, when a major complication arises, "that's a situation where absolutely the patient comes first and we have a very, very low threshold for cutting the transmission so that the operators can just help the patient without any other distractions."

As for the question of taped vs live cases, Colombo sees a role for both: "I would like to stress the educational value of taped cases, which for some specific needs are very valuable and sometimes may fulfill the goal in a better way than live cases."

Better by two

One of the recommendations in the cardiology code of conduct is that all live cases should include two operators: one doing the procedure, the other interacting with the far-flung panel members and explaining the steps of the procedure. Most of the bigger meetings that feature live cases, including TCT, have already been doing this for years, Stone noted.

It has to be said that even when you have some minor problems, this is very helpful in terms of education.

In fact, Rodés-Cabau told heart wire that what struck him most about the cardiology live case statement and code of conduct is just how closely it resembles the type of information and instruction he received from TCT prior to his live case demonstration. TCT codirector Dr Martin Leon (Columbia University, New York) was on the writing group for the statement.

According to Stone, "we've really been following these principles for years, and I think the FDA has acknowledged publicly that they are in general very pleased with the quality and preparedness of the live cases at TCT and that they kind of wish most centers would use that as a template."

The FDA, which pushed for the live case document, has also published a companion article outlining the agency's role in live case demonstrations—for example, specific approval is required when a US site plans to demo an investigational device [5]. The FDA paper also emphasizes the need for research into patient safety and educational value and notes that it is considering developing further guidance related to live demonstrations of devices being used in clinical trials.

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