Original Investigation
Sex Differences in Transfemoral Transcatheter Aortic Valve Replacement

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Abstract

Background

Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes.

Objectives

This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade.

Methods

The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex.

Results

We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m2 but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time.

Conclusions

In this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women.

Key Words

sex differences
outcome differences over time
predictors of 30-day mortality
transfemoral aortic valve implantation

Abbreviations and Acronyms

BMI
body mass index
CI
confidence interval
EuroSCORE
European System for Cardiac Operative Risk Evaluation
GFR
glomerular filtration rate
OR
odds ratio
RR
risk ratio
STS
Society of Thoracic Surgeons
TAVR
transcatheter aortic valve replacement
VARC
Valve Academic Research Consortium

Cited by (0)

This study was supported by the Netherlands CardioVascular Research Initiative: the Dutch Heart Foundation (CVON 2018-28 and 2012-06 Heart Brain Connection), Dutch Federation of University Medical Centres, the Netherlands Organisation for Health Research and Development, and the Royal Netherlands Academy of Sciences. Dr. de Brito Jr. has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Barbanti has served as a consultant for Edwards Lifesciences; has received speaker honoraria from Medtronic and Biotronik; and has served on the advisory board for Biotronik. Dr. Latib has served as a consultant for Medtronic; has received honoraria from Abbott Vascular; and has served on the advisory board for Medtronic and Abbott Vascular. Dr. Baan has received an unrestricted research grant from Edwards Lifesciences. Dr. Moreno has received lecture fees from Edwards Lifesciences, Boston Scientific, and Abbott; has served as a proctor for Boston Scientific and New Vascular Therapy; has received consulting fees from Abbott; and has served as a consultant for Boston Scientific. Dr. Nicolas has served as a proctor for and received consulting fees from Abbott Vascular, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr. Dangas is a clinical trial investigator and has common stock interest (entirely divested) in Medtronic; he and his spouse have served on the advisory board for Boston Scientific; and his spouse is a medical consultant and holds equity interest (entirely divested) in Claret Medical. Dr. Mehran has served as a consultant (with fees paid to her institution) for Abbott Laboratories and Spectranetics/Philips Volcano Corp.; has served as a speaker for Abbott Laboratories and Medtelligence (Janssen); has received institutional research grant support from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb, Chiesi USA, CSL Behring, Eli Lilly/DSI, Medtronic, Novartis, OrbusNeich, and PLC/Renal Guard; has served as a consultant for Boston Scientific, Bracco Group, Medscape/WebMD, Siemens Medical Solutions, Roivant Sciences, Sanofi, and Janssen Pharmaceuticals; has served on the scientific advisory board for and received advisory board fees from PLx Opco/dba PLx Pharma; has served as a consultant (no fee) for Regeneron Pharmaceuticals; has served on the advisory board for Medtelligence (Janssen); has received advisory board funding to her institution from Bristol-Myers Squibb; and has served on the data safety monitoring board (with fees paid to the institution) for Watermark Research Partners; and has a spouse who has served as a consultant for Abiomed and The Medicines Company. Dr. Piek has served as a consultant for Philips/Volcano; and has received advisory board fees and travel honoraria from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.

© 2019 Published by Elsevier on behalf of the American College of Cardiology Foundation