Author + information
- Received August 26, 2019
- Revision received September 12, 2019
- Accepted September 13, 2019
- Published online November 25, 2019.
- Wieneke Vlastra, MD, PhDa,
- Jaya Chandrasekhar, MBBS, MSa,b,
- Bruno García Del Blanco, MD, PhDc,
- Didier Tchétché, MDd,
- Fabio S. de Brito Jr., MD, PhDe,
- Marco Barbanti, MDf,
- Ran Kornowski, MDg,
- Azeem Latib, MDh,
- Augusto D’Onofrio, MD, PhDi,
- Flavio Ribichini, MD, PhDj,
- Jan Baan, MD, PhDa,
- Jan G.P. Tijssen, PhDa,
- Raul Moreno, MD, PhDk,l,m,
- Nicolas Dumonteil, MDd,
- Flavio Tarasoutchi, MD, PhDe,
- Samantha Sartori, PhDb,
- Paola D’Errigo, MScn,
- Giuseppe Tarantini, MD, PhDi,
- Mattia Lunardi, MDj,
- Katia Orvin, MDg,
- Matteo Pagnesi, MDh,
- Alberto Berenguer, MDo,
- Thomas Modine, MDp,
- George Dangas, MD, PhDb,
- Roxana Mehran, MDb,
- Jan J. Piek, MD, PhDa and
- Ronak Delewi, MD, PhDa,∗ (, )@amsterdamumc
- aHeart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands
- bZena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- cDepartment of Cardiology, Vall d’Hebron University Hospital, Barcelona, Spain
- dClinique Pasteur, Toulouse, France
- eHeart Institute, University of São Paulo Medical School, São Paulo, Brazil
- fDivision of Cardiology, Policlinico-Vittorio Emanuele Hospital, University of Catania, Catania, Italy
- gCardiology Department, Rabin Medical Center, Petah Tikva, Israel
- hDivision of Cardiology, Montefiore Medical Center, New York, New York
- iDivision of Cardiac Surgery, University of Padova, Padua, Italy
- jDivision of Cardiology, Department of Medicine, University of Verona, Verona, Italy
- kUniversity Hospital La Paz, Madrid, Spain
- lInstituto de Investigación Hospital La Paz (IDIPAZ), Madrid, Spain
- mCentro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain
- nNational Centre for Global Health, Istituto Superiore di Sanità, Rome, Italy
- oCardiology Department, Hospital General de Valencia, Valencia, Spain
- pCentre Hospitalier Universitaire, Lille, France
- ↵∗Address for correspondence:
Dr. Ronak Delewi, Heart Center, Department of Cardiology, University of Amsterdam, Amsterdam University Medical Center, Meibergdreef 9, 1105AZ Amsterdam, the Netherlands.
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.
- sex differences
- outcome differences over time
- predictors of 30-day mortality
- transfemoral aortic valve implantation
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.
- Received August 26, 2019.
- Revision received September 12, 2019.
- Accepted September 13, 2019.
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