September 10, 2009
View Full PaperAdherence to patient selection criteria in patients undergoing transcatheter aortic valve implantation with the 18F CoreValve ReValving System
Key Result
Off-label implantation of the 18F CoreValve ReValving System was common (67%) and had similar procedural success rates compared to on-label use (95% vs 91%, p=0.47).
Study Design
Type
Observational (n=63)
Structured PICO
Does off-label use of TAVI affect procedural success and short-term outcomes compared to on-label use in patients undergoing TAVI?
P
Population
63 patients undergoing transcatheter aortic valve implantation (TAVI) with the 18F CoreValve ReValving System (CRS)
I
Intervention
Off-label use of TAVI (defined as the presence of at least one exclusion criterion or non-acceptable criteria based on patient selection matrix)
C
Comparator
On-label use of TAVI
O
Outcome
Frequency of off-label use and procedural success rates
Off-label use of TAVI is common but appears to have similar procedural success and short-term mortality compared to on-label use.
Main Result
Absolute Event Rate: 95% vs 91%
p-value: p=0.47
Abstract
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-label 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 criterion 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-label 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-label" 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.