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Transcatheter aortic valve replacement for pure aortic valve regurgitation: “on-label” versus “off-label” use of TAVR devices

Clinical research in cardiology, 2019-08, Vol.108 (8), p.921-930 [Peer Reviewed Journal]

Springer-Verlag GmbH Germany, part of Springer Nature 2019 ;Clinical Research in Cardiology is a copyright of Springer, (2019). All Rights Reserved. ;ISSN: 1861-0684 ;EISSN: 1861-0692 ;DOI: 10.1007/s00392-019-01422-0 ;PMID: 30737532

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  • Title:
    Transcatheter aortic valve replacement for pure aortic valve regurgitation: “on-label” versus “off-label” use of TAVR devices
  • Author: Wernly, Bernhard ; Eder, Sarah ; Navarese, Eliano P. ; Kretzschmar, Daniel ; Franz, Marcus ; Alushi, Brunilda ; Beckhoff, Frederik ; Jung, Christian ; Lichtenauer, Michael ; Datz, Christian ; Schulze, Paul Christian ; Landmesser, Ulf ; Hoppe, Uta C. ; Falk, Volkmar ; Lauten, Alexander
  • Subjects: Aorta ; Aortic stenosis ; Aortic valve ; Aortic Valve - surgery ; Aortic Valve Insufficiency - surgery ; Bleeding ; Cardiology ; Devices ; Electrocardiography ; Equipment Design ; Humans ; Medicine ; Medicine & Public Health ; Mortality ; Original Paper ; Patients ; Regurgitation ; Risk assessment ; Stenosis ; Success ; Surgery ; Transcatheter Aortic Valve Replacement - instrumentation
  • Is Part Of: Clinical research in cardiology, 2019-08, Vol.108 (8), p.921-930
  • Description: Introduction Transcatheter aortic valve replacement (TAVR) has become the mainstay of treatment for aortic stenosis in patients with high surgical risk. Pure aortic regurgitation (PAR) is considered a relative contraindication for TAVR; however, TAVR is increasingly performed in PAR patients with unfavorable risk profile. Herein, we aim to summarize available data on TAVR for PAR with special emphasis on “on-label” versus “off-label” TAVR devices. Methods and results Pubmed was searched for studies of patients undergoing TAVR for PAR. Primary outcome was 30 day-mortality. Pooled estimated event rates were calculated. Twelve studies including a total of 640 patients were identified until December 2017. Among these, 208 (33%) patients were treated with devices with CE-mark approval for PAR (“on-label”; JenaValve and J valve). Overall, the procedural success rate was 89.9% (95% CI 81.1–96.1%; I 2 80%). Major bleeding was reported in 6.4% (95% CI 2.9–10.8%; I 2 48%). All-cause mortality at 30 days was 10.4% (95% CI 7.1–14.2%; I 2 20%). Stroke occurred in 2.2% (95% CI 0.9–3.9%; I 2 0%). A permanent pacemaker was required in 10.7% (95% CI 7.3–14.6%; I 2 23%). At 30 days after TAVR, ≥ moderate AR post-interventional was observed in 11.5% (95% CI 2.9–23.6%; I 2 90%). In the “on-label”-group, success rate was 93.0% (95% CI 85.9–98.1%; I 2 52%). 30-day-mortality was 9.1% (95% CI 3.7–16.0%; I 2 36%). More than trace AR was present in 2.8% (95% CI 0.1–7.6%; I 2 0%). Compared to first-generation devices, second-generation devices were associated with significantly lower 30-day-mortality ( r  = − 0.10; p  = 0.02), and significantly higher procedural success rates ( r  = 0.28; p  < 0.001). Compared to other second-generation devices, the use of J valve or JenaValve was not associated with altered mortality ( r  = 0.04; p  = 0.50), rates of > trace residual AR ( r  = − 0.05; p  = 0.65) but with a significantly higher procedural success ( r  = 0.15; p  = 0.042). Conclusion Based on this summary of available observational data TAVR for PAR is feasible and safe in patients deemed inoperable. First-generation TAVR devices are associated with inferior outcome and should be avoided. The “on-label” use of PAR-certified TAVR devices is associated with a significantly higher procedural success rate and might be favorable compared to other second-generation devices.
  • Publisher: Berlin/Heidelberg: Springer Berlin Heidelberg
  • Language: English
  • Identifier: ISSN: 1861-0684
    EISSN: 1861-0692
    DOI: 10.1007/s00392-019-01422-0
    PMID: 30737532
  • Source: MEDLINE
    ProQuest Central
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