Edwards SAPIEN 3, Инструкция по эксплуатации, Страница: 22 / 46

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Six Minute Walk Test (6MWT)
The improvement in mean 6MWT distance was 38.5 ± 110.2 meters from baseline to 30 days for all
patients, 42.6 ± 107.8 meters for all TF patients, and 15.9 ± 121.2 meters for all TA/TAo patients.
Length of Stay (LoS)
The overall mean LoS was 6.8 ± 4.8 days, which included 3.0 ± 2.7 days in the ICU. The mean LoS was
6.1 ± 4.3 days (including 2.7 ± 2.3 days in the ICU) for the TF patients and 10.4 ± 5.4 days (including
4.8 ± 3.9 days in the ICU) for the TA/TAo patients.
Quality of Life (QoL)
QoL was measured using the visual analog scale (VAS) of the EuroQoL (EQ-5D) measure. 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. During the trial, the mean improvement in VAS scale from
baseline to 30 days was 14.6 ± 22.2 for all patients, 15.1 ± 21.5 for the TF patients, and 11.5 ± 25.7 for
the TA/TAo patients.
Additional QoL instruments
The mean overall Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score was 46.9 ± 22.6 at
baseline, and 67.5 ± 22.6 at 30 days for the entire VI population. Except for self-efficacy which showed a
small improvement, moderate to large improvements were observed in all other subscores at 30 days. In
general, improvements in the TF patients were slightly larger compared to those observed in the TA/TAo
patients.
Using the SF-36 norm based questionnaire, the physical component score for all patients improved from
32.0 ± 8.9 at baseline to 37.1 ± 9.7 at 30 days, and the mental component score improved from
46.9 ± 12.8 at baseline to 50.0 ± 12.5 at 30 days. In the TF patients, the physical component score
improved from 31.8 ± 8.7 at baseline to 37.3 ± 9.8 at 30 days, and the mental component score improved
from 46.8 ± 13.1 at baseline to 50.5 ± 12.2 at 30 days. In the TA/TAo patients, the physical component
score improved from 32.9 ± 10.0 at baseline to 35.9 ± 9.4 at 30 days, and the mental component scores
were 47.2 ± 11.1 at baseline and 47.2 ± 14.0 at 30 days.
SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION
Supplemental Clinical Study Design
Supplemental clinical data came from a study (referred to as “S3OUS” hereafter) conducted in Europe
and Canada.
The S3OUS study was a non-randomized, prospective, multi-center study in inoperable, high surgical
risk, and intermediate surgical risk patients who underwent implantation of the 23, 26, or 29 mm
SAPIEN 3 valve.
Except the intermediate surgical risk patients, the inclusion/exclusion criteria of the S3OUS trial were
largely similar to those of the PIIS3HR trial. The S3OUS study had a minimum age requirement
(≥ 75 years) and the upper limit for AVA was higher (< 1 cm
2
instead of ≤ 0.80 cm
2
). Additionally, the
S3OUS study included BAV within 30 days of the procedure (unless BAV was a bridge to procedure),
patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation, hemodynamic or
respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance
within 30 days of screening; and the need for emergency surgery for any reason. Furthermore, the
exclusion criteria in the S3OUS study excluded senile dementia and any neurologic disease which
severely affected the ability to walk or perform everyday activities, and shortened the time interval
regarding confirmed stroke or TIA (within 3 months instead of 6 month of the procedure). The follow-up
periods were discharge or 7 days, whichever comes first, 30 days, 1 year, and annually thereafter to a
minimum of 5 years post procedure.