Dr Antonio Colombo (EMO Centro Cuore Columbus, Milan, Italy)one of the most respected operators in the fieldwas 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%."
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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.
Shelley Wood
Shelley@theheart.org






