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

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Abstract

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%; I2 80%). Major bleeding was reported in 6.4% (95% CI 2.9–10.8%; I2 48%). All-cause mortality at 30 days was 10.4% (95% CI 7.1–14.2%; I2 20%). Stroke occurred in 2.2% (95% CI 0.9–3.9%; I2 0%). A permanent pacemaker was required in 10.7% (95% CI 7.3–14.6%; I2 23%). At 30 days after TAVR, ≥ moderate AR post-interventional was observed in 11.5% (95% CI 2.9–23.6%; I2 90%). In the “on-label”-group, success rate was 93.0% (95% CI 85.9–98.1%; I2 52%). 30-day-mortality was 9.1% (95% CI 3.7–16.0%; I2 36%). More than trace AR was present in 2.8% (95% CI 0.1–7.6%; I2 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.

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Data Availability

All data relevant for this study will be given by the authors upon specific request without restriction.

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Authors and Affiliations

  1. Department of Cardiology, Clinic of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria

    Bernhard Wernly, Michael Lichtenauer & Uta C. Hoppe

  2. Department of Internal Medicine, Hospital Oberndorf, Teaching Hospital of Paracelsus Medical University Salzburg, Oberndorf, Austria

    Sarah Eder & Christian Datz

  3. Interventional Cardiology and Cardiovascular Medicine Research, Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Falls Church, VA, USA

    Eliano P. Navarese

  4. SIRIO MEDICINE Network, Evidence-Based Section, Falls Church, VA, USA

    Eliano P. Navarese

  5. Cardiovascular Institute, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

    Eliano P. Navarese

  6. Department of Cardiology, Clinic of Internal Medicine I, Universitaetsherzzentrum Thüringen, Friedrich Schiller University Jena, Jena, Germany

    Daniel Kretzschmar, Marcus Franz & Paul Christian Schulze

  7. Department of Cardiology, University Heart Center Berlin and Charité University Medicine Berlin, Campus Benjamin-Franklin, Berlin, Germany

    Brunilda Alushi, Frederik Beckhoff, Ulf Landmesser & Alexander Lauten

  8. German Center for Cardiovascular Research (DZHK), Site Berlin, Berlin, Germany

    Brunilda Alushi, Frederik Beckhoff, Ulf Landmesser & Alexander Lauten

  9. Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Duesseldorf, Düsseldorf, Germany

    Christian Jung

  10. Berlin Institute of Health (BIH), Berlin, Germany

    Ulf Landmesser

  11. Department of Cardiovascular Surgery, Charite Berlin, Berlin, Germany

    Volkmar Falk

  12. Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany

    Volkmar Falk

  13. Department of Health Sciences and Technology, ETH Zürich, Zurich, Switzerland

    Volkmar Falk

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  1. Bernhard Wernly
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  2. Sarah Eder
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  8. Christian Jung
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  9. Michael Lichtenauer
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  10. Christian Datz
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  12. Ulf Landmesser
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  13. Uta C. Hoppe
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  14. Volkmar Falk
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  15. Alexander Lauten
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Correspondence to Alexander Lauten.

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Wernly, B., Eder, S., Navarese, E.P. et al. Transcatheter aortic valve replacement for pure aortic valve regurgitation: “on-label” versus “off-label” use of TAVR devices. Clin Res Cardiol 108, 921–930 (2019). https://doi.org/10.1007/s00392-019-01422-0

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