Full article reprinted from "The Gray Sheet" - October 27, 2008
Prominent interventional cardiologists plan to create guidelines for live case demonstrations that are broadcast at professional meetings in the face of intensifying scrutiny on the practice.
Guidelines Proposed For Live-Case Demonstrations
Full article reprinted from "The Gray Sheet" - October 27, 2008
A sign of FDA's discomfort with live case screenings was on display earlier this month at the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C.
A valve replacement procedure using the closely watched Edwards Lifesciences' Sapien transcatheter aortic valve was one of many live video feeds scheduled during TCT, which ran from Oct. 12-17. But shortly before the start of the conference, FDA informed TCT directors that it would not permit the presentation, says Ziyad Hijazi, M.D., Rush University, president of the Society for Cardiovascular Angiography and Interventions (SCAI).
Sapien is on the market in Europe, but it is in the pivotal trial stage in the U.S. While FDA must approve any case demonstrations of investigational devices performed domestically, the agency routinely grants these requests, so the decision to stop the planned Sapien case was a surprise, Hijazi said in an interview.
FDA cited the risk of the operator being distracted by interaction with the audience as a reason for nixing the planned case, he explained.
Live Demos Vital To Education - Interventionalists
To avoid surprises like this one, interventional cardiologists are coming together to create more standards for live demonstrations, which Hijazi says are vital to how he and his colleagues learn.
"Live cases are the heart and soul" of conferences like TCT, he affirmed.
SCAI is working with Martin Leon, M.D., director of the Cardiovascular Research Foundation and course director of TCT, and other luminaries in the field to form a writing group that will create a report on the role of live case demonstrations in educating interventionalists, Hijazi said.
Leon, also an interventional cardiologist at Columbia University Medical Center, explained that live case demonstrations have been critical to the development of interventional cardiology since Andreas Gruentzig pioneered angioplasty in Switzerland in the late 1970s.
No other form of education can replace it, he insisted during an Oct. 16 presentation at TCT. "We need to defend and preserve live case transmissions because didactic processes are insufficient to train interventional operators on vital elements of technique and critical decision making."
In addition to patient safety questions, live demonstrations have attracted criticism for the potential to serve as inappropriate marketing by device manufacturers. TCT organizers, including Leon, have been scrutinized by the press and by Congress for financial relationships with industry and how those relationships might impact the agenda of the annual meeting (1"The Gray Sheet" Oct. 20, 2008, In Brief).
Leon's presentation was part of a broad TCT panel discussion on conflicts of interest between industry and interventional cardiology professionals. He expressed hope that adoption of strict safety and ethics guidelines for live case presentations will resolve some concerns.
The guidelines would insist that all cases broadcast live have two experienced operators - one to speak to the audience and the other to perform the procedure, Leon explained.
The document would discourage allowing a broadcast to cause procedure delays or deviations that can increase the risk of the intervention. It would also state that all serious complications should be managed off-screen without input from the moderators or participants at the audience site. "This is not watching a warrior cope with a desperate situation. It's always patient first and there are no undue influences by moderators or discussants," Leon said.
"We focus on educational content," he added. "This starts with careful case planning, close communication with the sites, and qualified moderators who are empowered to stress educational aspects of the case." The case broadcast should also not feature any "commercial references" such as company logos or otherwise be influenced by device manufacturers, Leon said.
Live Cases On FDA's Radar, Zuckerman Confirms
FDA's Cardiovascular Devices Director Bram Zuckerman spoke at the TCT conference following Leon's presentation. He did not address the Sapien case in particular, but acknowledged FDA is scrutinizing live case demonstrations in general for potential safety and conflict of interest problems.
"We need to consider the patient first and look at risks to patients versus overall benefits to the interventional community and society with this live case format," Zuckerman said. FDA recently listed live case presentations involving products in investigational device exemption trials as one topic it is considering for guidance development in 2009 (2"The Gray Sheet" Oct. 6, 2008, p. 15).
Leon said that the conduct of live case demonstrations is "more controversial than I thought it would be or should be."
He cited a recent joint position paper from the American Association for Thoracic Surgery and the Society for Thoracic Surgeons, published in the Annals of Thoracic Surgery, in which the surgeons call for a prohibition of live demonstrations at large professional meetings and discourage the practice for meetings of any size. The American College of Obstetricians and Gynecologists and the American College of Surgeons have already banned the practice from some or all of their meetings.
But the risk-benefit ratio of live demonstrations is higher in surgery compared to coronary intervention, Leon asserted.
He also pointed out that the angiographic images that guide coronary intervention are more easily shown to a broadcast audience compared to surgery, which is difficult to capture adequately on camera. Also, the presence of a film crew at a surgery creates a higher risk of patient infection compared to intervention, he said.
"We are nothing like surgery," Leon said. "To be lumped in with the surgeons for the live surgical broadcast discussion is offensive."
- Reed Miller
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