Volume 97, Issue 5 pp. 876-884
VALVULAR AND STRUCTURAL HEART DISEASES

Four-year mortality in women and men after transfemoral transcatheter aortic valve implantation using the SAPIEN 3

Giuseppe Tarantini MD, PhD, FESC

Corresponding Author

Giuseppe Tarantini MD, PhD, FESC

Department of Cardiac, Thoracic and Vascular Science, University of Padova, Padova, Italy

Correspondence

Prof. Giuseppe Tarantini, Department of Cardiac, Thoracic, and Vascular Science, Padova University Hospital, Via Giustiniani 2, 35128 Padova, Italy.

Email: [email protected]

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Helmut Baumgartner MD, FESC

Helmut Baumgartner MD, FESC

Department of Cardiology III, University-Hospital Münster, Münster, Germany

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Derk Frank MD

Derk Frank MD

University Hospital Schleswig-Holstein, Kiel, Germany and DZHK (German Centre for Cardiovascular Research), Kiel, Germany

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Oliver Husser MD, PhD

Oliver Husser MD, PhD

Department of Cardiology, Klinik für Innere Medizin, St.-Johannes-Hospital, Dortmund, Germany

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Sabine Bleiziffer MD, PhD

Sabine Bleiziffer MD, PhD

Klinik für Thorax- und Kardiovaskularchirurgie, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany

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Tanja Rudolph MD, PhD

Tanja Rudolph MD, PhD

Klinik für Thorax- und Kardiovaskularchirurgie, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany

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Raban Jeger MD

Raban Jeger MD

University Hospital Basel, University of Basel, Basel, Switzerland

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Chiara Fraccaro MD, PhD

Chiara Fraccaro MD, PhD

Department of Cardiac, Thoracic and Vascular Science, University of Padova, Padova, Italy

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Tomas Hovorka MSc

Tomas Hovorka MSc

Statistics Department, Edwards Lifesciences, Prague, Czech Republic

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Olaf Wendler MD, PhD

Olaf Wendler MD, PhD

Department of Cardiothoracic Surgery, King's College Hospital, London, UK

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First published: 04 September 2020
Citations: 7

Funding information: Edwards Lifesciences

Abstract

Objectives

To investigate 4-year, post-transcatheter aortic valve implantation (TAVI) survival and predictors of survival by sex, in a real-world cohort that underwent transfemoral TAVI with SAPIEN 3 transcatheter heart valve.

Background

Previous TAVI investigations of first-generation devices demonstrated an early- to mid-term survival advantage in women compared with men.

Methods

SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) is a post-approval, multicentre, observational registry. Patients (N = 1,694, 49.2% women, age 81.7 ± 6.7 years) with severe aortic stenosis and high surgical risk (logistic EuroSCORE 17.8%) underwent TAVI between 2014 and 2015. Kaplan–Meier event estimates were used to determine mortality by sex. Predictors of overall mortality were identified using a cox multivariate proportional hazard model.

Results

At 4 years, women had lower all-cause mortality than men (36.0 vs 39.7%; p = .0911; HR: 0.87 [95% CI: 0.75–1.02]). No difference was observed for cardiac mortality between women 24.2% and men 24.7% (p = .76; HR: 0.97 [95% CI: 0.79–1.19]). When adjusted for baseline characteristics (age, height, weight, NYHA functional class, renal insufficiency, EuroScore, and tricuspid regurgitation), sex had no impact on mortality.

Conclusions

In this large, real-world cohort, all-cause mortality trended lower in women than men at 4 years post TAVI; however, several baseline factors, but not sex, were predictors of mortality. No difference between sexes was observed for cardiovascular mortality.

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