Preprocedural anemia in females undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI registry
Abstract
Objectives
To assess the impact of anemia on clinical outcomes in female patients enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry.
Background
Anemia is highly prevalent among females who constitute half of TAVI candidates, yet, its clinical significance remains poorly investigated.
Methods
Patients were divided into three groups according to preprocedural hemoglobin (Hb) level: (1) no anemia (Hb ≥12 g/dl), (2) mild-to-moderate anemia (10 ≤ Hb <12 g/dl), and (3) severe anemia (Hb <10 g/dl). The primary outcome was the occurrence of Valve Academic Research Consortium (VARC)-2 efficacy endpoint, a composite of mortality, stroke, myocardial infarction (MI), hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up.
Results
Hemoglobin level was available in 877 (86.1%) patients: 412 (47.0%) had no anemia, 363 (41.4%) had mild-to-moderate anemia, and 102 (11.6%) had severe anemia. The latter group had a higher prevalence of cardiovascular risk factors. Compared with patients without anemia, severe anemia was associated with a greater risk of VARC-2 efficacy endpoint (adjHR 1.71, 95% CI: 1.02–2.87, p = .04), all-cause death (adjHR 2.36, 95% CI: 1.31–4.26, p = .004) and a composite of death, MI or stroke (adjHR 1.88, 95% CI: 1.10–3.22, p = .02) at 1 year. Moreover, an increased risk of late mortality (adjHR 1.15, 95% CI: 1.02–1.30, p = .03) was observed with every 1 g/dl decrease in hemoglobin level.
Conclusion
Severe anemia in females undergoing TAVI was independently associated with increased rates of VARC-2 efficacy endpoint and mortality at 1 year.
CONFLICT OF INTEREST
Dr. Baber received institutional research grant from AstraZeneca; personal fees from Amgen, AstraZeneca, and Boston Scientific. Dr. Petronio received consultancy fees from Medtronic, Abbott, Boston, and funds by Boston and Abbott. Dr. Mehilli received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol-Myers Squibb, Boston Scientific and Edwards Lifescience. Dr. Lefèvre proctors for Edwards, Boston and Abbott. Dr. Sardella received sponsorships from Medtronic in terms of technical training courses and congress assistance. Dr. Van Mieghem received research grant support and advisory fees from Abbott, Boston Scientific, and Medtronic and research grant support from Edwards Lifesciences. Dr. Dumonteil received proctoring and consultancy fees from Abbott Vascular, BostonScientific, Edwards LifeSciences, Medtronic. Dr. Mikhail is the Director of Imperial Valve and Cardiovascular Course (IVCC) which is supported by a number of device and pharmaceutical companies; has received educational grant from Abbott for an Interventional Fellowship. Dr. Ferrer-Gracia received sponsorships from Medtronic and Edwards companies in terms of: Technical training courses and congress assistance. Dr. Sharma served on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular Systems, Inc. Dr. Morice is CEO and shareholder of CERC, a CRO based in Massy that had no role in WINTAVI. Dr. Dangas received consulting fees from GE HealthCare, Janssen Pharmaceuticals, Inc., and Medtronic, Inc.; <1% equity with Claret Medical and Elixir Medical; delivered industry sponsored lectures for The Medicines Company; and is on Scientific Advisory Board of AstraZeneca. Dr. Chieffo received speaker/consultant fees from Abiomed, Abbott vascular, Biosensor, Cardinal Health, GADA, Magenta Medical. Dr. Mehran reports institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich; consultant fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, Siemens Medical Solutions; consultant fees paid to the institution from Abbott Laboratories, Bristol-Myers Squibb; advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; consultant (spouse) from Abiomed, The Medicines Company, Merck; Equity <1% from Claret Medical, Elixir Medical; DSMB Membership fees paid to the institution from Watermark Research Partners; consulting (no fee) from Idorsia Pharmaceuticals Ltd., Regeneron Pharmaceuticals. Associate Editor for ACC, AMA.
