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Valvular heart disease
Adherence to patient selection criteria in patients undergoing transcatheter aortic valve implantation with the 18F CoreValve ReValving System
  1. N Piazza1,
  2. A Otten1,
  3. C Schultz1,
  4. Y Onuma1,
  5. H M Garcia-Garcia1,
  6. E Boersma2,
  7. P de Jaegere1,
  8. P W Serruys1
  1. 1
    Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands
  2. 2
    Department of Biostatistics and Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands
  1. Correspondence to Professor Patrick W Serruys, Department of Cardiology, Erasmus Medical Center, Thoraxcenter, Ba 583, Erasmus MC, ‘s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands; p.w.j.c.serruys{at}erasmusmc.nl

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.

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Footnotes

  • Competing interests None declared.

  • Provenance and Peer review Not commissioned; externally peer reviewed.

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