@article{ed58373912ed4c6e9ec0ceea1299843d,
title = "Edwards SAPIEN Versus Medtronic Aortic Bioprosthesis in Women Undergoing Transcatheter Aortic Valve Implantation (from the Win-TAVI Registry): American Journal of Cardiology",
abstract = "We sought to analyze outcomes of women receiving balloon-expandable valves (BEV) or self-expanding valves (SEV) in contemporary transcatheter aortic valve implantation (TAVI). WIN TAVI (Women's INternational Transcatheter Aortic Valve Implantation) is the first all-female TAVI registry to study the safety and performance of TAVI in women. We compared women treated with BEV (n = 408, 46.9%) versus those treated with SEV (n = 461, 53.1%). The primary efficacy end point was the Valve Academic Research Consortium-2 (VARC-2) composite of 1-year all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction. Women receiving SEV had higher surgical risk scores, higher rate of previous stroke and pulmonary hypertension whereas women receiving BEV were more frequently denied surgical valve replacement due to frailty. BEV patients were less likely to require post-dilation and had significantly lower rates of residual aortic regurgitation grade ≥2 (9.8% vs 4.7%, p = 0.007). At 1 year, the crude incidence and adjusted risk of the primary VARC-2 efficacy end point was similar between groups (17.1% with SEV and 14.3% with BEV, p = 0.25; hazards ratio 1.09, 95% confidence interval 0.68 to 1.75). Conversely the crude rate and adjusted risk of new pacemaker implantation was higher with SEV than BEV (15% vs 8.6%, p = 0.001; hazards ratio 1.97, 95% confidence interval 1.13 to 3.43). A subanalysis on new generation valves showed no difference in the need for pacemaker implantation between the 2 devices (10.1% vs 8.0%, p = 0.56). In conclusion, in contemporary TAVI, SEV are used more frequently in women with greater co-morbidities. While there were no differences in unadjusted and adjusted risk of 1-year primary efficacy end point between the valve types, there was a greater need for permanent pacemakers after SEV implantation. {\textcopyright} 2019 Elsevier Inc.",
keywords = "aged, aortic regurgitation, Article, cause of death, cerebrovascular accident, comorbidity, controlled study, female, frailty, heart failure, heart infarction, hospitalization, human, major clinical study, pacemaker implantation, priority journal, pulmonary hypertension, scoring system, surgical risk, transcatheter aortic valve implantation, very elderly, aortic valve, aortic valve stenosis, bioprosthesis, clinical trial, diagnostic imaging, Europe, incidence, multicenter study, multidetector computed tomography, postoperative complication, procedures, prosthesis design, register, risk factor, survival rate, treatment outcome, United States, Aged, 80 and over, Aortic Valve, Aortic Valve Stenosis, Bioprosthesis, Cause of Death, Female, Humans, Incidence, Multidetector Computed Tomography, Postoperative Complications, Prosthesis Design, Registries, Risk Factors, Survival Rate, Transcatheter Aortic Valve Replacement, Treatment Outcome",
author = "C. Giannini and A.S. Petronio and J. Mehilli and S. Sartori and J. Chandrasekhar and M. Faggioni and T. Lef{\`e}vre and P. Presbitero and P. Capranzano and D. Tchetche and A. Iadanza and G. Sardella and {Van Mieghem}, N.M. and E. Meliga and N. Dumonteil and C. Fraccaro and D. Trabattoni and G.W. Mikhail and M.C. Ferrer and C. Naber and P. Kievit and S. Sorrentino and M.C. Morice and A. Chieffo and R. Mehran and WIN-TAVI Investigators",
note = "Export Date: 11 March 2021 CODEN: AJCDA Correspondence Address: Mehran, R.; The Zena and Michael A. Wiener Cardiovascular Institute, United States; email: roxana.mehran@mountsinai.org Tradenames: Evolut R, Medtronic, United States; SAPIEN 3, Edwards Lifesciences, United States Manufacturers: Edwards Lifesciences, United States; Medtronic, United States Funding details: Bristol-Myers Squibb, BMS Funding details: Bayer Funding details: AstraZeneca Funding details: Medicines Company Funding details: Boston Scientific Corporation, BSC Funding details: Claret Medical Funding details: Abbott Vascular Funding details: St. Jude Medical, SJM Funding text 1: Dr. Petronio has served as a consultant for Boston Scientific, Medtronic, and Abbott Vascular. Dr. Mehilli has received lecture fees from Edwards Lifesciences, Boston Scientific, Medtronic and Bristol-Myers Squibb; and institutional research grant support from Boston Scientific. Dr. Lef{\`e}vre has served as a proctor for Edwards Lifesciences. Dr. Sardella has served as a consultant for Medtronic,Biosensors, BSC, NVT. 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 which is supported by a number of device companies. 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. There was no funding received for this analysis or for the conduct of the WIN-TAVI registry.",
year = "2020",
doi = "10.1016/j.amjcard.2019.10.056",
language = "English",
volume = "125",
pages = "441--448",
journal = "Am. J. Cardiol.",
issn = "0002-9149",
publisher = "Elsevier Inc.",
number = "3",
}