Edwards SAPIEN 3

44
Additional QoL instruments
QoL was also measured using the visual analog scale (VAS) of the EuroQoL (EQ-5D) measure
and the SF-36 Health Status Questionnaire. The VAS is a self-assessment in which patients rate
their well-being on a scale from 0 to 100 where 0 is the worst state they can imagine and 100 is
the best state. SF-36 uses 36 questions to measure functional health and well-being from the
patient’s point of view and is generally reported in two summary scores on a scale from 0 to 100
which evaluate physical (the Physical Summary Score) and mental (the Mental Summary Score)
health, with higher scores representing better functional health and well-being. The results of the
VAS and SF-36 measures are presented in Tables 26 and 27, respectively.
Table 26: EQ-5D Visual Analog Scale (EP Population)
EQ-5D Visual Analog Scale
SAPIEN 3 Valve
PIIA-SAVR
All
TF
Non-TF
Baseline
60.3 ± 20.0
61.0 ± 19.8
55.1 ± 20.7
59.5 ± 20.5
30 days
74.0 ± 16.6
74.8 ± 16.6
68.5 ± 16.2
67.2 ± 19.5
1 year
74.4 ± 17.2
74.7 ± 17.1
71.8 ± 17.8
74.3 ± 16.7
Plus–minus values are means ± SD.
Table 27: SF-36 Health Status Questionnaire Score (EP Population)
SF-36 Health Status
Questionnaire Score
SAPIEN 3 Valve
PIIA-SAVR
All
TF
Non-TF
Physical Component Score
Baseline
34.7±9.1
35.0±9.1
33.1±8.5
34.3±9.0
30 days
39.7±9.8
40.3±9.7
34.8±9.2
34.5±8.4
1 year
40.0±10.3
40.4±10.2
37.0±10.8
39.5±10.4
Mental Component Score
Baseline
48.0±11.8
48.1±11.8
47.0±12.3
48.0±12.3
30 days
51.8±10.6
52.3±10.4
47.8±11.3
45.5±13.3
1 year
52.5±10.7
52.7±10.8
50.7±10.1
52.0±11.3
Plus–minus values are means ± SD.
REFERENCES
[1]
Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for
transcatheter aortic valve implantation: the Valve Academic Research Consortium-2
consensus document (VARC-2). Eur J Cardiothorac Surg 2012;42:S45-60.
[2]
Imbens G. W. (2004) Nonparametric Estimation of Average Treatment Effects under
Exogeneity: A Review. The Review of Economics and Statistics, February 2004,
86(1): 4–29.
These products are manufactured and sold under one or more of the following US patent(s): US Patent
No. 6,214,054; 6,547,827; 6,908,481; 7,214,344; 7,530,253; 7,585,321; 7,780,723; 7,846,203; 7,895,876;
7,993,394; 8,057,540; 8,382,826; 8,591,575; 8,690,936; 8,790,387; 9,301,840 and 9,301,841 and
corresponding foreign patents. Additional patents are pending.