Debris was captured in essentially all patients (99%) and with every TAVR device. On automated histomorphometry, the Lotus device had significantly higher median particle counts relative to the Evolut R (P = .004), the Sapien S3 (P less than .001), and the Sapien XT (P = .02) devices. When stratified by particle size, the Evolut R generated significantly more particles greater than 500 mcm than either the Sapien S3 or the Sapien XT (both P less than .05).
For particle sizes greater than 1 mm, there were significantly higher counts for both the Lotus and Evolut R (both P less than .05) relative to the Sapien S3, but Dr. Schmidt emphasized all devices generated at least some debris this size and that particles greater than 1 mm were retrieved from 53% of all patients. Similarly, when median total particle area was calculated by histomorphometry, the Lotus (P = .0007) and Evolut R (P = .0009) devices were more likely to have particles greater than 1 mm than the Sapien devices, but again, debris with a large total particle area was retrieved from at least some patients in all device groups.
There were significant differences in patient demographics and procedural characteristics by device. For example, patients receiving an Evolut R were significantly more likely than those receiving the Lotus or Sapien S3 valves to have undergone dilation prior to TAVR. Patients receiving the Sapien XT were significantly older than patients receiving any of the other valve types.
In an effort to control for these differences, “multivariate analysis was performed to text for interaction with the amount of debris captured,” Dr. Schmidt explained. “This analysis showed that transcatheter valve type was the only significant predictor for the morphometric findings.”