Is broadcasting heart procedures at meetings safe?
NEW YORK (Reuters Health) - Broadcasting heart procedures live to doctors at medical meetings may not present a risk to the patient on the table, a new study suggests.
It's already common practice for major medical meetings to feature "live case demonstrations" -- where doctors can watch a real-time transmission of a procedure being done at a large medical center anywhere in the world.
The goal is to help doctors learn from experienced colleagues and see new technology in action. But there's been little research into whether there's any special risk to the patient having the procedure.
In theory, there could be. Not only are there distractions -- like cameras -- in the operating room, but there's a live discussion as well. The surgeons talk about what they are doing, and in many cases they take comments from an expert panel at the meeting as they operate.
To study the question, doctors at Rambam Medical Center in Haifa, Israel, reviewed records for 101 patients who had their heart procedure transmitted live to a medical meeting between 1998 and 2010.
They found that the procedures were a "technical success" 95 percent of the time.
One patient had a minor stroke because of a heart-rhythm disturbance during the procedure. And another had a rise in blood levels of a protein called troponin -- which can signal a heart attack or other damage to the heart muscle.
But that complication rate was no different from that of 66 patients who underwent the same procedures by the same doctors -- only not fed live to an audience.
EXPERIENCE, CAREFUL SELECTION
The findings, reported in the Journal of the American College of Cardiology: Cardiovascular Interventions, are not the final word.
One of the biggest limitations is that they are based on procedures at just one hospital.
"Our paper calls for future studies which will include immediate results, as well as follow-up outcomes of procedures performed live during large meetings," Dr. Ariel Roguin, one of the researchers on the work, told Reuters Health in an email.
But for now, he and his colleagues write, the findings suggest that live demonstrations may be safe when experienced doctors operate on "carefully selected" patients.
That, Roguin said, includes picking patients who are good candidates for the procedure, and not at elevated risk for complications.
The state of live demonstrations in cardiology is still under debate. Some professional societies -- including the American Association for Thoracic Surgery and the Society of Thoracic Surgeons -- have suggested that major meetings consider banning live surgery broadcasts.
At the same time, Roguin said, the demos offer educational opportunities to a large number of doctors. And since the point is to educate, the demonstrations are done by "very, very experienced" surgical teams.
The study does offer some reassurance that these demonstrations are safe, but there's still more to be learned, according to Dr. Andrew Farb, a medical officer at the U.S. Food and Drug Administration (FDA) who co-wrote an editorial published with the findings.
"Live case demonstrations have really proliferated in the field of cardiology," Farb told Reuters Health, "and it would be best if we had more assurance on the risks, to increase our comfort level."
When it comes to regulation, the FDA's main authority is in demonstrations that involve a device that is still under study and not yet approved for wide use.
Those demonstrations have to first be approved by the FDA, Farb said. The agency also requires a report on patients' outcomes afterward.
The main goal is to increase awareness of a clinical trial, and possibly get more doctors to enroll patients in it.
That, Farb said, is part of the FDA's "mission" to help get clinical trials done in a timely manner -- and, hopefully, get effective treatments into practice.
But the demo should clearly state that the procedure involves an "investigational device," Farb said, and the operators cannot try to commercially promote the device.
As for the patients themselves, the FDA says they must be fully informed of what their procedure will entail. And that includes being told that they should expect "no additional clinical benefit" from being the subject of a live demo.
As for demonstrations that use approved devices, the FDA has less authority.
But the agency can take action if the demo is used essentially as an advertisement for a device -- even for its approved use.
SOURCE: bit.ly/x1Xr8B Journal of the American College of Cardiology: Cardiovascular Interventions, February 2012.