Live Case Demonstrations of Interventional Procedures Pose No Greater Risks 

By TCT Daily Staff

Patients treated during live case demonstrations of interventional procedures are at no higher risk for complications than those treated in the more tightly controlled setting of a major clinical trial, according to the results of a study presented here.

Jennifer Franke, MD, of the CardioVascular Center in Frankfurt, Germany, and colleagues created a registry to record acute in-hospital results of carotid artery stenting procedures performed during live transmissions. Their objective was to scientifically address the contention by some that the environment created by live transmission of procedures may put patients at greater risk.

Franke and colleagues’ review of 123 live interventions transmitted to 17 interventional conferences indicates that this perception of reduced safety is not substantiated and that the patients selected for live demonstrations "represent the real-world scenario in these centers."

Results

The investigators found carotid interventions performed in a live demonstration to be successful in 122 of 123 cases (99.2%). They defined success as the ability to implant a carotid stent with an adjunctive embolic protection device. The primary endpoint was a composite of death, major stroke, minor stroke, or myocardial infarction.

No patients died or suffered an MI while in the hospital. One patient suffered a major hemorrhagic stroke during recovery of the tip of a broken filter device. In total, there were 12 acute in-hospital complications including major stroke (two patients), minor stroke (three patients), transient ischemic attack (six patients), and amaurosis of the ipsilateral eye due to an occluded retinal artery (one patient).

Franke said the patients, outcomes, and complications are in line with what can be expected in a typical hospital setting and that the live transmission of the cases does not impact the outcomes.

"The patients and procedures selected for live transmissions are chosen from day-to-day practice in these centers," Franke said. "No selection is made to make these demonstrated procedures look easy. The ‘live transmission’ situation does not lead to a higher risk of peri-interventional complications in these patients."

Importance in education

Not only are they safe, but live transmissions of carotid stenting and other interventions are an essential component in teaching courses, Franke said.

"Teaching courses focusing on live demonstrations of carotid interventions are the key educational facility for physicians interested in learning state-of-the-art interventional techniques," she said.

Franke noted that a study is currently underway that will report on live transmission data from three centers that routinely perform live demonstrations of carotid interventions.

Origins of the debate

According to Franke, the debate over safety and live case transmissions dates back to the first live demonstrations of interventional procedures. Those who contend that live transmissions are less safe have cited the potential distraction of the operator by panel or audience discussions, timing issues, the desire to use investigational devices, and the general stress associated with a live audience.

She pointed to a study published in 1992 in The Lancet, in which Pascal Chatelain, MD, and colleagues concluded that live demonstrations produce results inferior to those reported in the literature and that the audience could be stressful.

"We were curious to find out how the situation is today, more than 15 years later. In some ways, the results are surprising [in that] complications during live transmissions are not higher anymore," Franke said in an interview.

Disclosures:

• Dr. Franke reports having ownership interest in Lumen Biomedical, and serving as a consultant for or on the advisory board of Kensey Nash, Lumen Biomedical, EndoTex, ev3, Gore, and Invatec.