17
PARTNER II Cohort B Clinical Data
Table 6:
Cohort B (Inoperable) Baseline Characteristics of the Patients and Echocardiographic Findings
(AT Population)*
Characteristic
SAPIEN XT Valve
SAPIEN Valve
(N = 282)
(N = 271)
Age - yr
84.0 ± 8.68
84.5 ± 8.65
Male sex — no./total no. (%)
140/282 (49.6%)
138/271 (50.9%)
STS score†
10.3 ± 5.40
11.0 ± 5.72
Logistic EuroSCORE
‡
18.8 ± 14.66
21.0 ± 16.78
NYHA class
I/II — no./total no. (%)
9/282 (3.2%)
11/271 (4.1%)
III/IV — no./total no. (%)
273/282 (96.8%)
260/271 (95.9%)
Coronary artery disease — no./total no. (%)
184/282 (65.2%)
183/271 (67.5%)
Previous myocardial infarction — no./total no. (%)
55/282 (19.5%)
57/271 (21.0%)
Previous intervention
CABG — no./total no. (%)
76/282 (27.0%)
72/271 (26.6%)
PCI — no./total no. (%)
89/282 (31.6%)
98/271 (36.2%)
Balloon aortic valvuloplasty — no./total no. (%)
51/282 (18.1%)
53/271 (19.6%)
Cerebral vascular disease — no./total no. (%)
31/282 (11.0%)
35/271 (12.9%)
Peripheral vascular disease — no./total no. (%)
88/282 (31.2%)
73/271 (26.9%)
COPD
Any — no./total no. (%)
83/282 (29.4%)
71/271 (26.2%)
Oxygen-dependent — no./total no. (%)
38/282 (13.5%)
43/271 (15.9%)
Creatinine > 2 mg/dL (177 μmol/liter) — no./total no. (%)
31/282 (11.0%)
30/271 (11.1%)
Atrial fibrillation — no./total no. (%)
102/282 (36.2%)
108/271 (39.9%)
Permanent pacemaker — no./total no. (%)
57/282 (20.2%)
47/271 (17.3%)
Pulmonary hypertension — no./total no. (%)
72/282 (25.5%)
56/271 (20.7%)
Frailty
§
— no./total no. (%)
168/282 (59.6%)
162/271 (59.8%)
Extensively calcified aorta — no./total no. (%)
19/282 (6.7%)
11/271 (4.1%)
Chest-wall deformity — no./total no. (%)
10/282 (3.5%)
10/271 (3.7%)
Liver disease — no./total no. (%)
12/282 (4.3%)
13/271 (4.8%)
Echocardiographic findings
Aortic-valve area — cm
2
0.6 ± 0.18
0.6 ± 0.17
Mean aortic-valve gradient — mmHg
45.1 ± 13.67
45.2 ± 14.36
Mean LVEF — %
52.5 ± 13.39
52.9 ± 13.61
Moderate or severe mitral regurgitation
**
— no./total no. (%)
71/264 (26.9%)
77/251 (30.7%)
* Plus–minus values are means ± SD. To convert the value for creatinine to micromoles per liter, multiply by 88.4.
AT denotes as treated 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.