26
Table 10:
Cohort B (29 mm / Transfemoral / Inoperable)
Baseline Characteristics of the Patients and Echocardiographic Findings
(Intent to Treat Population)
Characteristic
SAPIEN XT Valve
(N= 61)
Age - yr
83.3 ± 7.89
Male sex — no. (%)
61 (100.0%)
STS score†
8.3 ± 4.39
Logistic EuroSCORE
‡
11.3 ± 13.75
NYHA class — no. (%)
I/II
6 (9.8%)
III/IV
55 (90.2%)
Coronary artery disease — no. (%)
48 (78.7%)
Previous myocardial infarction — no./total no. (%)
14/61 (23.0%)
Previous intervention — no./total no. (%)
CABG
34/61 (55.7%)
PCI
19/61 (31.1%)
Balloon aortic valvuloplasty
20/61 (32.8%)
Cerebral vascular disease — no./total no. (%)
10/61 (16.4%)
Peripheral vascular disease — no./total no. (%)
16/61 (26.2%)
COPD — no. (%)
Any
19 (31.1%)
Oxygen-dependent
6 (9.8%)
Creatinine > 2 mg/dL (177 μmol/liter) — no./total no. (%)
8/61 (13.1%)
Atrial fibrillation — no./total no. (%)
30/61 (49.2%)
Permanent pacemaker — no./total no. (%)
18/61 (29.5%)
Pulmonary hypertension — no./total no. (%)
13/61 (21.3%)
Frailty
§
— no./total no. (%)
30/61 (49.2%)
Extensively calcified aorta — no. (%)
3 (4.9%)
Chest-wall deformity — no. (%)
5 (8.2%)
Liver disease — no./total no. (%)
2/61 (3.3%)
Echocardiographic findings
Aortic-valve area — cm
2
0.8 ± 0.16
Mean aortic-valve gradient — mmHg
40.3 ± 11.67
Mean LVEF — %
46.1 ± 14.52
Moderate or severe mitral regurgitation
**
— no./total no. (%)
15/56 (26.8%)
Note: Plus–minus values are means ± SD. To convert the value for creatinine to micromoles per liter, multiply by
88.4. ITT denotes intent to treat population, CABG denotes coronary-artery bypass grafting, COPD chronic
obstructive pulmonary disease, LVEF left ventricular ejection fraction, NYHA New York Heart Association, PCI
percutaneous coronary intervention, and TAVR transcatheter aortic-valve implantation.
† The Society of Thoracic Surgeons (STS) score measures patient risk at the time of cardiovascular surgery on a
scale that ranges from 0% to 100%, with higher numbers indicating greater risk. An STS score higher than 10%
indicates very high surgical risk.
‡ The logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), which measures patient risk
at the time of cardiovascular surgery, is calculated with the use of a logistic-regression equation. Scores range
from 0% to 100%, with higher scores indicating greater risk. A logistic EuroSCORE higher than 20% indicates
very high surgical risk.
§ Frailty was determined by the surgeons according to prespecified criteria.
** Moderate or severe mitral regurgitation was defined as regurgitation of grade 3+ or higher.