Table 1

Edwards Sapien Transcatheter Heart Valve Registries

CharacteristicREVIVE, REVIVAL, PARTNER EU (N=222)SOURCE Registry (TF) (N=920)France Registry (N=1,137)Belgium Registry (N=303)Canada Registry (TF) (N=162)
Demographics
Age (y)8382838383
Female (%)5556494644
EuroSCORE (mean, %)2624232926
NYHA functional class III/IV (%)8976758093
Aortic valve area (cm2)0.590.700.670.600.63
Mean gradient (mm Hg)4549484748
Prior CABG (%)2615192030
Ejection fraction (%)5152535055
Outcomes
30-day mortality (%)10.47.57.889.5
1-y mortality (%)2418.9NRNRNR
Stroke (%)3.33.53.55.03.0
Major vascular complications (%)27.911.311.3NR13.1
Permanent pacemaker (%)1.86.78.54.03.6

Data are derived from the Edwards Lifesciences briefing document for the U.S. Food and Drug Administration (FDA) Circulatory Devices Advisory Panel meeting on TAVR on July 21, 2011 (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm240575.htm).

CABG indicates coronary artery bypass graft; NR, not reported; NYHA, New York Heart Association; and TF, transfemoral.