Edwards SAPIEN Versus Medtronic Aortic Bioprosthesis in Women Undergoing Transcatheter Aortic Valve Implantation (from the Win-TAVI Registry): American Journal of Cardiology

C. Giannini, A.S. Petronio, J. Mehilli, S. Sartori, J. Chandrasekhar, M. Faggioni, T. Lefèvre, P. Presbitero, P. Capranzano, D. Tchetche, A. Iadanza, G. Sardella, N.M. Van Mieghem, E. Meliga, N. Dumonteil, C. Fraccaro, D. Trabattoni, G.W. Mikhail, M.C. Ferrer, C. NaberP. Kievit, S. Sorrentino, M.C. Morice, A. Chieffo, R. Mehran, WIN-TAVI Investigators

Research output: Contribution to journalArticlepeer-review


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. © 2019 Elsevier Inc.
Original languageEnglish
Pages (from-to)441-448
Number of pages8
JournalAm. J. Cardiol.
Issue number3
Publication statusPublished - 2020


  • 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


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