CT images for another 132 valves came from a Cedar’s-Sinai registry and a second, independent registry maintained in Denmark. CT images showed that 17 (13%) of the replaced aortic valves showed a leaflet-motion abnormality, including two valves placed using SAVR. Half the registry patients had undergone CT imaging within 88 days of valve replacement. The only signal of a clinical outcome linked with reduced-motion leaflets was a small increase in the incidence of transient ischemic attacks, but Dr. Makkar cautioned that transient ischemic attacks “are hard to adjudicate.”
Dr. Makkar’s report was “a small but important study, one of the first reports of this phenomenon. You don’t want to lose sight of all the evidence of patient benefit” from aortic valve replacement, stressed Dr. Kodali at the meeting, sponsored by the Cardiovascular Research Foundation. “This needs to be investigated further, probably by a Food and Drug Administration–mandated trial with CT imaging.”
“Aortic valves are lifesaving devices. The last thing that should happen is patients not getting their aortic valves replaced” when their condition demands it, Dr. Makkar said.
The PORTICO IDE study and RESOLVE registry were funded by St. Jude. Dr. Makkar has received honoraria and research support from St. Jude, lecture fees from Edwards Lifesciences, research grants from Edwards and Medtronic, and has an equity interest in Entourage. Dr. Kodali has been a consultant to Edwards Lifesciences and Claret Medical and has an equity interest in Thubrikar Aortic Valve. Dr. Leon has been a consultant to Edwards. Dr. Popma has been a consultant to Abbott Laboratories, Boston Scientific, and St. Jude, and he has been a speaker for and received grants from Medtronic, Dr. Leipsic has been a consultant to Edwards and Heartflow and received grants from Edwards, Neovasc, and Tendyne.
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