Background: Anecdotal evidence suggests that transcatheter aortic valve implantation (TAVI) is being used beyond pre-market label indications.
Methods: To assess the frequency and outcomes associated with “off-label” use of TAVI, we conducted a retrospective study, examining adherence to patient selection criteria in 63 patients undergoing implantation with the 18F CoreValve ReValving™ System (CRS). Label status (on- vs. off-label) was determined by following 1) inclusion/exclusion criteria indicated in the 18F CRS safety and efficacy trial and 2) a patient selection matrix indicating anatomical boundaries to guide patient selection. Off-label use was defined as the presence of at least one exclusion criteria or “non-acceptable” criteria based on the patient selection matrix.
Results: Off-label implantation was identified in 42 patients (67%) - 40% had one, 19% had two, and 8% had three or more off-label criteria. Baseline demographics were similar between the groups except for a higher logistic EuroSCORE in the on-label group (19.8±11.2 vs. 14.5±7.3, p=0.029). There was no significant difference in the procedural success rates between the on- and off-label groups (91 vs. 95%, respectively, p=0.47). The frequency of angiographic moderate-severe aortic regurgitation, post-implant dilatation or implantation of a second valve was also similar between the groups. At 30 days, the cumulative death rate was 10%; there were four deaths in the “on-” and three deaths in the off-label group.
Conclusion: In this study we found that “off-label” implantation of the CRS was common. Further studies are needed to evaluate the consequences of “label status” for patients undergoing TAVI.
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