Five-year TAVR data reassure on durability

Five-year data from a clinical trial of early transcatheter aortic valve replacements showed good durability, allaying concerns raised by a study last month in which more than a third of the valves deteriorated significantly over that span. Results from the Partner clinical trial, presented last week at the Transcatheter Valve Therapies conference in Chicago, showed a much lower mean gradient (the change in pressure across the valve) than were found in a smaller study presented in May at the annual EuroPCR meeting in Paris. The researchers behind that study predicted that as many as half of all 1st-generation TAVR devices, like the Edwards Lifesciences (NYSE:EW) Sapien valve, would show signs of deterioration within 8 years. But 5-year data from the Partner I trial of the 1st-generation Sapien showed that the mean gradient was both in-line with its surgical device replacement comparator and well below the threshold set by the earlier trial. Sapien patients in Partner I showed mean gradients of 10.7mmHG, compared with 10.6mmHg for the surgical arm and about half of the 20mmHG or more mark set by lead author Dr. Danny Dvir, of Vancouver’s St. Paul’s Hospital. The 5-year Partner I data show “valve durability as evidenced by stable valve areas and gradients out to 5 years,” Columbia University’s Dr. Rebecca Hahn said in presenting the findings at TVT last week. Further study of late valve deterioration and early valve thrombosis – an issue that prom...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news