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Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry

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Abstract

Background

Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year.

Methods and results

Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75–80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010).

Conclusions

In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI.

Clinicaltrial.gov number

NCT02698956.

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Abbreviations

BAV:

Balloon aortic valvuloplasty

COPD:

Chronic obstructive pulmonary disease

CABG:

Coronary artery bypass graft

EACTS:

European Association for Cardio-Thoracic Surgery

ESC:

European Society of Cardiology

KM:

Kaplan–Meier

NYHA:

New York Heart Association functional class

SOURCE 3:

SAPIEN 3 Aortic Bioprosthesis European Outcome

STS:

Society of Thoracic Surgeons

SAVR:

Surgical aortic valve replacement

TAVI:

Transcatheter aortic valve implantation

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Acknowledgements

The authors would like to acknowledge the patients, the CEC members and SOURCE 3 investigators. Frédérique Maneval, MS, Edwards Lifesciences provided manuscript drafting services. Tracey Fine, MS, ELS of Edwards Lifesciences provided manuscript editing services.

Funding

The SOURCE 3 Registry is funded by Edwards Lifesciences, LLC (Irvine, CA, USA).

Author information

Authors and Affiliations

  1. Department of Internal Medicine III (Cardiology, Angiology, and Critical Care), University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str. 3, Building 6, 24105, Kiel, Germany

    Derk Frank & Christian Kuhn

  2. Cardiology Department, Heart Center, Leipzig, Germany

    Mohamed Abdel-Wahab

  3. Public Hospital La Cavale Blanche, Brest, France

    Martine Gilard

  4. Centre Cardiologique du Nord, Saint-Denis, France

    Franck Digne

  5. Public Hospital Clermont-Ferrand, Clermont-Ferrand, France

    Geraud Souteyrand

  6. Institut Mutualiste Montsouris, Paris, France

    Christophe Caussin

  7. Public Hospital La Timone, Marseille, France

    Frédéric Collart

  8. Institut du thorax, Public Hospital Nantes, Nantes, France

    Vincent Letocart

  9. Department of Internal Medicine II, University Hospital of Ulm, Ulm, Germany

    Jochen Wöhrle

  10. Statistics, Edwards Lifesciences, Prague, Czech Republic

    Tomas Hovorka

  11. Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany

    Helmut Baumgartner

  12. DZHK (German Centre for Cardiovascular Research), Partner Site Kiel/Hamburg/Lübeck, Kiel, Germany

    Derk Frank & Christian Kuhn

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  1. Derk Frank
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Corresponding author

Correspondence to Derk Frank.

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Conflict of interest

All authors have received fees from Edwards Lifesciences as Investigators of the SOURCE 3 Registry. In addition, Christophe Caussin is a proctor for Edwards Lifesciences and has received speaker fees and travel support from Edwards Lifesciences. Derk Frank and Helmut Baumgartner are consultants and proctors for Edwards Lifesciences and have received speaker fees and travel support from Edwards Lifesciences.

Responsibility for the scientific content

The first and last author wrote the first draft of the manuscript, which was revised and approved by all co-authors. This manuscript was prepared using a clinical extract of completed and adjudicated 1-year follow-up results from the SOURCE 3 Registry. The Registry is in active follow-up and interim analyses were completed for this report.

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Frank, D., Abdel-Wahab, M., Gilard, M. et al. Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry. Clin Res Cardiol 108, 763–771 (2019). https://doi.org/10.1007/s00392-018-1404-2

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