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Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study

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An Erratum to this article was published on 04 July 2017

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Abstract

Background

Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting.

Objective

To report clinical and echocardiographic 3-year results from the ADVANCE study.

Methods

ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years.

Results

Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm2 from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration.

Conclusions

Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality.

Trial registration

ClinicalTrials.gov, NCT01074658.

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Change history

  • 04 July 2017

    An erratum to this article has been published.

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Acknowledgements

This study was funded by Medtronic. The authors thank Medtronic employees Francesca Barbieri, MD, PhD, Maarten Hollander, MSc, and Hanne Gonnissen, PhD, for study management responsibilities, Jia Guo, PhD, for statistical support, and Julie Linick, ELS, CMPP, and Jessica Dries-Devlin, PhD, for editorial assistance and preparation of figures and tables. In addition, they thank Sarah Verdoliva, MS, of NAMSA, for completion of statistical analyses.

Author information

Authors and Affiliations

  1. Clinic for Cardiovascular Surgery, Department of Cardiovascular Surgery, German Heart Center, Technical University Munich, Lazarettstr. 36, 80636, Munich, Germany

    Sabine Bleiziffer

  2. Cardiovascular Diseases Department, Antwerp University Hospital, Edegem, Belgium

    Johan Bosmans

  3. Cardiology Clinical Academic Group, St. George’s Hospital, London, UK

    Stephen Brecker

  4. Cardiology Department, Gemeinschaftskrankenhaus, Bonn, Germany

    Ulrich Gerckens

  5. Department of Cardiology, Bern University Hospital, Bern, Switzerland

    Peter Wenaweser

  6. Cardiology Unit, Ferrarotto Hospital, University of Catania, Catania, Italy

    Corrado Tamburino

  7. Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Leipzig, Germany

    Axel Linke

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  1. Sabine Bleiziffer
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For the ADVANCE Study Investigators

Corresponding author

Correspondence to Sabine Bleiziffer.

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Conflict of interest

Dr. Bleiziffer has served as a consultant and proctor for Medtronic, a proctor for JenaValve, a proctor for Boston Scientific, and has received travel expenses from Medtronic. Dr. Bosmans serves as a proctor for Medtronic. Dr. Brecker has received consultant fees from Medtronic and Boston Scientific. Dr. Gerckens has received consulting and lecture fees and study-related travel expenses from Medtronic and Edwards Lifesciences, and serves as a proctor for Medtronic and Boston Scientific. Dr. Wenaweser has received consulting fees from Medtronic and Edwards Lifesciences, and has received remuneration from Medtronic for study-related travel and for development of educational materials. Dr. Tamburino has no relevant relationships to disclose. Dr. Linke has received speaker honoraria or served as a consultant for the following companies: Medtronic, St. Jude Medical, Claret Medical Inc., Boston Scientific, Edwards Lifesciences, Symetis, and Bard, and holds stock options from Claret Medical Inc. In addition, he received grant support from Medtronic and Claret Medical Inc.

Additional information

The original version of this article was revised: The sentence in the Discussion describing the new pacemaker rate was incorrect. The correct version of the sentence is: The new pacemaker rate at 3 years of 31.4% is slightly higher than the 28% reported in the CoreValve US Pivotal High Risk Trial [8], and considerably higher than that reported with balloon-expanding devices [9,10].

In the Limitations, the sentence describing echocardiographic follow-up was incorrect. The correct sentence is: Echocardiographic compliance was 67%, as reported in the Results section.

An erratum to this article is available at https://doi.org/10.1007/s00392-017-1124-z.

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Bleiziffer, S., Bosmans, J., Brecker, S. et al. Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study. Clin Res Cardiol 106, 784–795 (2017). https://doi.org/10.1007/s00392-017-1120-3

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  • DOI: https://doi.org/10.1007/s00392-017-1120-3

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