"In the largest, most robust study of its kind, population hemodynamic trends show excellent durability of the SAPIEN transcatheter heart valve over five years, with virtually no structural valve deterioration," said Pamela Douglas, M.D., Ursula Geller professor of research in cardiovascular disease at Duke University and director of the Imaging Program at Duke Clinical Research Institute, who presented the data. "Similarly, large adverse hemodynamic echo findings in individual patients are rare in this protocol-driven database. Together, these data demonstrate excellent mid-term durability of THV, suggesting that the low 5-year survival observed in this cohort is not due to adverse hemodynamics."
Using three standard echocardiographic parameters, the study assessed hemodynamics (at 7 days, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-implant) and related the findings to clinical events of death and aortic valve re-intervention.
"We are very pleased with the scientifically rigorous 5-year outcomes data presented at TCT," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "While this research is meaningful and important information for both clinicians and patients, we see this as the starting point for further evaluations, and our intention is to use the PARTNER and PARTNER II Trial data to generate additional longer-term evidence on durability for the SAPIEN family of heart valves."
The PARTNER Trial was the world's first prospective, randomized and controlled trial for transcatheter heart valves.