Table 1. Baseline patient demographics.
| Overall (n=189) | Sapien XT (n=94) | Sapien 3 (n=95) | p value | |||
|---|---|---|---|---|---|---|
| Male | 93 (49.2) | 47 (50.0) | 46 (48.4) | 0.828 | ||
| Age (years) | 78.1±7.4 | 77.6±7.4 | 78.5±7.5 | 0.380 | ||
| Follow-up duration (days) | 438 | 444 | 357 | <0.001 | ||
| BMI (kg/m2) | 23.8±3.5 | 24.0±3.6 | 23.6±3.5 | 0.453 | ||
| Diabetes mellitus | 63 (33.3) | 35 (37.2) | 28 (29.5) | 0.258 | ||
| Hypertension | 146 (77.2) | 73 (77.7) | 73 (76.8) | 0.893 | ||
| Chronic lung disease | 44 (23.3) | 14 (14.9) | 30 (31.6) | 0.007 | ||
| CCr (mL/min) | 47.49±21.52 | 49.26±23.34 | 45.71±19.47 | 0.259 | ||
| CKD>stage 3 | 38 (20.1) | 21 (22.3) | 17 (17.9) | 0.446 | ||
| Dialysis | 9 (4.8) | 5 (5.3) | 4 (4.2) | 0.747 | ||
| PAOD | 41 (21.7) | 19 (20.2) | 22 (23.2) | 0.623 | ||
| Extent of CAD* | 0.082 | |||||
| Not significant | 104 (55.0) | 52 (57.1) | 52 (55.3) | |||
| 1 vessel | 41 (21.7) | 26 (28.6) | 15 (16.0) | |||
| 2 vessels | 18 (9.5) | 7 (7.7) | 11 (11.7) | |||
| 3 vessels | 22 (11.6) | 6 (6.6) | 16 (17.0) | |||
| Atrial fibrillation | 26 (13.8) | 9 (9.6) | 17 (17.9) | 0.097 | ||
| RBBB | 15 (7.9) | 9 (9.6) | 6 (6.3) | 0.407 | ||
| LBBB | 3 (1.6) | 1 (1.1) | 2 (2.1) | 1.000 | ||
| Previous stroke or TIA | 20 (10.6) | 11 (11.7) | 9 (9.5) | 0.619 | ||
| Previous MI | 18 (9.5) | 9 (9.6) | 9 (9.5) | 0.981 | ||
| Previous procedure/surgery | ||||||
| PCI | 42 (22.2) | 24 (25.5) | 18 (18.9) | 0.276 | ||
| CABG | 10 (5.3) | 6 (6.4) | 4 (4.2) | 0.536 | ||
| SAVR | 2 (1.1) | 1 (1.1) | 1 (1.1) | 1.000 | ||
| TAVR | 3 (1.6) | 3 (3.2) | 0 (0.0) | 0.121 | ||
| PPM or ICD | 4 (2.1) | 3 (3.2) | 1 (1.1) | 0.368 | ||
| PPM | 3 (1.6) | 3 (3.2) | - | |||
| ICD | 1 (0.5) | - | 1 (1.1) | |||
| NYHA | 0.067 | |||||
| 1 | 2 (1.1) | 2 (2.1) | 0 (0.0) | |||
| 2 | 45 (23.8) | 21 (22.3) | 24 (25.3) | |||
| 3 | 99 (52.4) | 58 (61.7) | 41 (43.2) | |||
| 4 | 43 (22.8) | 13 (13.8) | 30 (31.6) | |||
| Syncope | 10 (5.3) | 10 (10.6) | 0 (0.0) | 0.001 | ||
| CCS | 0.001 | |||||
| None | 64 (33.9) | 44 (46.8) | 20 (21.1) | |||
| 1 | 32 (16.9) | 10 (10.6) | 22 (23.2) | |||
| 2 | 45 (23.8) | 22 (23.4) | 23 (24.2) | |||
| 3 | 34 (18.0) | 16 (17.0) | 18 (18.9) | |||
| 4 | 14 (7.4) | 2 (2.1) | 12 (12.6) | |||
| STS-PROM (%) | 7.88±6.82 | 7.25±5.96 | 8.51±7.55 | 0.204 | ||
| Low, STS<4 | 61 (32.3) | 31 (33.0) | 30 (31.6) | |||
| Intermediate | 51 (27.0) | 31 (33.0) | 20 (21.1) | |||
| High, STS≥8 | 77 (40.7) | 32 (34.0) | 45 (47.4) | |||
| Inoperable conditions | 28 (14.8) | 20 (21.3) | 8 (8.4) | 0.013 | ||
| Severe COPD | 17 (9.0) | 14 (14.9) | 3 (3.2) | 0.005 | ||
| Porcelain aorta | 3 (1.6) | 3 (3.2) | 0 (0.0) | 0.121 | ||
| Previous CABG, LIMA under the sternum | 5 (2.6) | 2 (2.1) | 3 (3.2) | 1.000 | ||
| Severe frailty | 4 (2.1) | 2 (2.1) | 2 (2.1) | 1.000 | ||
| Bicuspid | 10 (5.3) | 6 (6.4) | 4 (4.2) | 0.536 | ||
| Mean pressure gradient (mmHg) | 50.0±18.6 | 51.4±19.5 | 48.7±17.6 | 0.321 | ||
| Peak velocity (m/s) | 4.45±0.75 | 4.49±0.74 | 4.41±0.75 | 0.472 | ||
| EOA (cm2) | 0.74±0.20 | 0.74±0.18 | 0.73±0.21 | 0.758 | ||
| EOAI (cm2/m2) | 0.47±0.12 | 0.46±0.11 | 0.47±0.13 | 0.816 | ||
| Ejection fraction (%) | 55.8±11.7 | 56.8±11.9 | 54.8±11.5 | 0.237 | ||
| Annular diameter (mm) | 22.1±2.9 | 22.0±3.4 | 22.3±2.3 | 0.594 | ||
| Aortic regurgitation>mild | 49 (25.9) | 21 (22.3) | 28 (29.5) | 0.263 | ||
| Mitral regurgitation>mild | 34 (18.0) | 11 (11.7) | 23 (24.2) | 0.025 | ||
Follow-up duration is presented as median value. Other values are presented as number of patients (%) or mean±standard deviation.
BMI = body mass index; CABG = coronary artery bypass grafting; CAD = coronary artery disease; CCr = creatinine clearance; CCS = Canadian Cardiovascular Society grading of angina pectoris; CKD = chronic kidney disease; COPD = chronic obstructive pulmonary disease; EOA = effective orifice area; EOAI = effective orifice area index; ICD = implantable cardioverter defibrillator; LBBB = left bundle branch block; LIMA = left internal mammary artery; MI = myocardial infarction; NYHA = New York Heart Association; PAOD = peripheral arterial occlusive disease; PCI = percutaneous coronary intervention; PPM = permanent pacemaker; RBBB = right bundle branch block; SAVR = surgical aortic valve replacement; STS = Society of Thoracic Surgeons; STS-PROM = Society of Thoracic Surgeons-Predicted Risk Of Mortality; TAVR = transcatheter aortic valve replacement; TIA = transient ischemic attack.
*Left main coronary artery disease was considered 2-vessel disease.