Author + information
- Received July 24, 2017
- Revision received September 26, 2017
- Accepted September 28, 2017
- Published online January 1, 2018.
- Alaide Chieffo, MDa,
- Anna Sonia Petronio, MDb,
- Julinda Mehilli, MDc,
- Jaya Chandrasekhar, MBBS, MSd,
- Samantha Sartori, PhDd,
- Thierry Lefèvre, MDe,
- Patrizia Presbitero, MDf,
- Piera Capranzano, MDg,
- Didier Tchetche, MDh,
- Alessandro Iadanza, MDi,
- Gennaro Sardella, MDj,
- Nicolas M. Van Mieghem, MD, PhDk,
- Emanuele Meliga, MDl,
- Nicholas Dumonteil, MDm,
- Chiara Fraccaro, MD, PhDn,
- Daniela Trabattoni, MDo,
- Ghada Mikhail, MDp,
- Samin Sharma, MDq,
- Maria Cruz Ferrer, MDr,
- Christoph Naber, MDs,
- Peter Kievit, MDt,
- Usman Baber, MD, MSd,
- Clayton Snyder, BScd,
- Madhav Sharma, MBBSd,
- Marie Claude Morice, MDe,
- Roxana Mehran, MDd,∗ (, )
- on behalf of the WIN-TAVI Investigators
- aDepartment of Cardiology, San Raffaele Scientific Institute, Milan, Italy
- bDepartment of Cardiology, AOUP Cisanello, University Hospital, Pisa, Italy
- cDepartment of Cardiology, Ludwig-Maximilians-University of Munich, Munich, Germany
- dThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- eDepartment of Cardiology, Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France
- fDepartment of Cardiology, Istituto Clinico Humanitas, Milan, Italy
- gDepartment of Cardiology, University of Catania, Catania, Italy
- hDepartment of Cardiology, Clinique Pasteur, Toulouse, France
- iDepartment of Cardiology, Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte, Siena, Italy
- jDepartment of Cardiology, Policlinico “Umberto I,” Sapienza University of Rome, Rome, Italy
- kDepartment of Cardiology, Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
- lDepartment of Cardiology, Mauriziano Hospital, Turin, Italy
- mDepartment of Cardiology, Rangueil University Hospital, Toulouse, France
- nDepartment of Cardiology, University of Padova, Padova, Italy
- oDepartment of Cardiology, Centro Cardiologico Monzino, Milan, Italy
- pDepartment of Cardiology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom
- qDepartment of Cardiology, Mount Sinai Hospital, New York, New York
- rDepartment of Cardiology, Hospital Universitario Miguel Servet, Zaragoza, Spain
- sDepartment of Cardiology, Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen, Germany
- tDepartment of Cardiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands
- ↵∗Address for correspondence:
Dr. Roxana Mehran, Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, New York 10029-6574.
Objectives This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex–specific characteristics on composite 1-year clinical outcomes.
Background Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex.
Methods The WIN-TAVI (Women’s INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods.
Results A total of 1,019 intermediate to high-risk women, with mean age 82.5 ± 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I 17.8 ± 11.7% and mean Society of Thoracic Surgeons score 8.3 ± 7.4% were enrolled. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. The primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients. Prior coronary revascularization (hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.52; p = 0.006) and EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.027) were independent predictors of the VARC-2 efficacy endpoint. Similarly, EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.013), baseline atrial fibrillation (HR: 1.58; 95% CI: 1.07 to 2.33; p = 0.022), and prior percutaneous coronary intervention (HR: 1.50; 95% CI: 1.03 to 2.19; p = 0.035) were independent predictors of 1-year death or stroke. After adjustment, no significant association was observed between history of pregnancy or any sex-specific factors and 1-year TAVR outcomes.
Conclusions Intermediate to high-risk women enrolled in this first ever all-women contemporary TAVR registry experienced a 1-year VARC-2 composite efficacy endpoint of 16.5%, with a low incidence of 1-year mortality and stroke. Prior revascularization and EuroSCORE I were independent predictors of the VARC-2 efficacy endpoint, whereas EuroSCORE I, baseline atrial fibrillation, and prior percutaneous coronary intervention were independent predictors of the 1-year death or stroke.
- female-specific characteristics
- first female registry
- transcatheter aortic valve replacement
- 1-year outcomes
Dr. Petronio has served as a consultant for Boston Scientific, Medtronic, and Abbott Vascular. Dr. Mehilli has received lecture fees from Edwards Lifesciences, Abbott Vascular, Biotronik, Lilly/Daiichi-Sankyo, Terumo, and Bristol-Myers Squibb; and institutional research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Lefèvre has served as a proctor for Edwards Lifesciences. Dr. Sardella has received proctor fees for Edwards Lifesciences; and speaker fees from Direct Flow. Dr. Van Mieghem has received research grant support from Boston Scientific, Edwards Lifesciences, Medtronic, St. Jude Medical, Abbott Vascular, and Claret Medical. Dr. Dumonteil has received proctor fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular. Dr. Mikhail is the director of the Imperial Valve and Cardiovascular Course. Dr. S. Sharma has served on the Speakers Bureau for Boston Scientific, Abbott Vascular, Cardiovascular Systems Inc., and TriReme. Dr. Naber has received speaker fees from Edwards Lifesciences, Direct Flow Medical, Medtronic, and Claret; is a minor shareholder with Claret; and has served as an advisor for Direct Flow Medical. Dr. Mehran has received institutional research grant support from Eli Lilly/Daiichi-Sankyo Inc., AstraZeneca, The Medicines Company, Bristol-Myers Squibb, OrbusNeich, Beth Israel Deaconess, and Bayer; has served as a consultant for Boston Scientific, Cardiovascular Systems Inc., Medscape, and Shanghai BraccoSine Pharmaceutical; has received institutional advisory board funding from Bristol-Myers Squibb; has received institutional funding from Claret Medical; owns equity in Claret Medical and Elixir Medical; has served on the executive committee for Janssen Pharmaceuticals and Osprey Medical; has served on the data safety monitoring board for Watermark Research Partners; and has a spouse who has served as a consultant for Abiomed and the Medicines Company. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 24, 2017.
- Revision received September 26, 2017.
- Accepted September 28, 2017.