Edwards SAPIEN 3 - Page 30

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Figure 18:
NYHA Class by Visit
(S3OUS AT Population)
PARTNER II SAPIEN 3 INTERMEDIATE RISK COHORT
Accountability
Table 16 presents patient accountability in the PIIS3i and PIIA-SAVR cohorts. Of the 1,074 eligible
patients (Eligible Patient or EP Population) in PIIS3i, 1,069 were successfully implanted with a SAPIEN 3
valve and constitute the PIIS3i Valve Implant (VI) population. Among the VI population, 943 patients were
implanted via the transfemoral (TF) access route, and 126 patients via a non-transfemoral (non-TF;
mainly transapical and transaortic) access route. Of the 938 eligible patients in the PIIA-SAVR cohort,
936 were successfully implanted with a surgical valve and constitute the PIIA-SAVR VI population.
Table 16: Patient Accountability
All Enrolled
Patients
Eligible Patient (EP)
Population
†
Valve Implant
(VI)Population
‡
SAPIEN 3 Cohort 1078 1074 1069
TF 952 948 943
Non-TF 126 126 126
PIIA SAVR 1021 938 936
†. Eligible Patient (EP) Population consists of all enrolled patients who were determined eligible after
screening, entered into the catheterization laboratory and remained eligible to receive the assigned implant.
‡. Valve Implant (VI) Population is a subset of the EP Population who received
the assigned valve, and retained the valve upon leaving the catheterization laboratory.
1 2 3
4
Percent
0
20
40
60
80
100
All Patients
Transapical/Transaortic Transfemoral
Baseline 30 Day 1 Year Baseline
30 Day 1 Year Baseline 30 Day 1 Year
11%
78%
11%
46%
47%
6%
33%
58%
8%
11%
73%
16%
34%
54%
9%
25%
64%
7%
11%
82%
7%
54%
43%
38%
54%
8%