TCT live case demonstration ends tragically

Shelley Wood

September 28, 2004

Washington, DC - The first live case demonstration featured at the TCT 2004 meeting got off to a rocky start, forcing the live feed to cut away from complications following a percutaneous aortic valve replacement procedure.

Dr Antonio Colombo (EMO Centro Cuore Columbus, Milan, Italy)%mdash;one of the most respected operators in the field%mdash;was the operator for a patient who developed mitral regurgitation and nonfunctioning LV and went into shock, requiring defibrillation and CPR. In the halls of the TCT conference, the patient was widely rumored to have passed away after the live broadcast was terminated. Wednesday morning TCT organizers confirmed to heartwire the patient died hours after the procedure.

TCT course director and comoderator for the live case session, Dr Martin Leon (Columbia University, New York, NY), told heartwire that he was initially not comfortable discussing the patient until full details were disclosed by the Milan team. After receiving confirmation, Leon issued a statement saying, "We have had some 500 live cases at TCT for more than 16 years. This is the second tragic case fatality. That's less than 0.4%."

Colombo provides some details

Responding frankly to media questions in a morning press conference, Colombo explained that the percutaneous valve placement had actually been implanted successfully, but that the patienta 77-year-old man had died later of intractable heart failure.

"These patients are very brittle," Columbo commented, and have multiple comorbid conditions. "Unfortunately we have such good surgeons at our hospital, so that if the patients can't be treated he is really in a bad condition. So even if the procedure goes well technically, you have to be prepared that his heart won't tolerate it."

Colombo added that it is important for physicians and TCT attendees to understand that they should still be optimistic about the future of the cutting-edge procedure. Columbo himself did a successful percutaneous valve implantation one week ago, while Drs Eberhard Grube (Heart Center Siegberg, Germany) and Alain Cribier (University of Rouen Hospital, Charles-Nicolle, France) have done multiple cases over the past two years. Columbo himself says he has no qualms about doing another procedure, already slated for next week.

-SW

In a Wednesday afternoon press conference, Leon confirmed that an autopsy had been conducted on the patient, revealing perfect placement of the valve. Colombo personally attended the autopsy, Leon stated. The outcome from the case will be formally presented to TCT attendees later today in a session summarizing live case transmissions from the meeting.

Live case demonstrations are widely valued as an educational tool, but the events here have highlighted the pitfalls inherent in live case presentations at medical conferences [see the heartwire Feature for an in-depth look at this subject]. This meeting's percutaneous valve case has led many to comment that the device is still several years away from prime time.

The live case featured the Edwards Lifesciences percutaneous aortic valve. Barry Liden, a spokesperson for the company, emphasized that, of course, the company deeply regrets the death but is confident in the future of the device and the procedure. For now, however, even if the procedure itself is successful, Liden told heartwire , the company is obviously more concerned about the overall results.

A live case featuring competing product, CoreValve's ReValving device, had been slated for live presentation at the meeting, but according to a company representative, an appropriate patient had not been found in time.


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