Incidence and Sequelae of Prosthesis-Patient Mismatch in Transcatheter Versus Surgical Valve Replacement in High-Risk Patients With Severe Aortic StenosisA PARTNER Trial Cohort-A Analysis
Table 1
Baseline Clinical and Doppler Echocardiographic Characteristics of Patients in the TAVR and SAVR Arms of the PARTNER Trial Cohort A According to Presence or Absence of PPM
| SAVR-RCT (n = 270) | TAVR-RCT (n = 304) | TAVR-NRCA (n = 1,637) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| No PPM (n = 108) (40%) | PPM (n = 162) (60%) | p Value | No PPM (n = 163) (53.6%) | PPM (n = 141) (46.4%) | p Value | No PPM (n = 920) (56.2%) | PPM (n = 717) (43.8%) | p Value | |
| Demographic and clinical data | |||||||||
| Age, yrs | 84 ± 7 | 85 ± 6 | 0.55 | 85 ± 6 | 83 ± 8 | 0.02 | 86 ± 6 | 84 ± 7 | <0.0001 |
| Female | 44.4 (48) | 40.7 (66) | 0.55 | 39.9 (65) | 44.0 (62) | 0.47 | 48.2 (443) | 48.3 (346) | 0.97 |
| BSA, m2 | 1.79 ± 0.23 | 1.85 ± 0.22 | 0.04 | 1.77 ± 0.23 | 1.90 ± 0.26 | <0.001 | 1.75 ± 0.24 | 1.85 ± 0.25 | <0.0001 |
| BMI, kg/m2 | 26.6 ± 5.6 | 27.0 ± 5.7 | 0.44 | 25.7 ± 4.8 | 29.7 ± 8.5 | <0.001 | 25.5 ± 5.5 | 27.8 ± 6.4 | <0.0001 |
| Obesity, BMI ≥30 kg/m2 | 23.0 (25) | 25.9 (42) | 0.67 | 16.2 (26) | 38.0 (54) | <0.001 | 14.9 (137) | 30.7 (220) | <0.001 |
| STS score | 11 (10–13) | 11 (10–13) | 0.45 | 11 (10–13) | 11 (10–13) | 0.92 | 11 (9–13) | 11 (10–13) | 0.32 |
| Logistic euroSCORE | 26 (16–37) | 27 (19–42) | 0.12 | 26 (17–38) | 26 (15–39) | 0.85 | 23 (15–34) | 23 (14–35) | 0.81 |
| Diabetes | 40.7 (44) | 42.0 (68) | 0.84 | 40.5 (66) | 46.8 (66) | 0.27 | 32.6 (300) | 42.8 (307) | <0.0001 |
| Hyperlipidemia | 80.6 (87) | 87.0 (141) | 0.15 | 79.1 (129) | 80.1 (113) | 0.83 | 85.1 (783) | 87.0 (624) | 0.27 |
| Smoking | 48.1 (52) | 48.8 (79) | 0.92 | 48.5 (79) | 53.2 (75) | 0.41 | 47.1 (433) | 50.2 (360) | 0.21 |
| Hypertension | 96.3 (104) | 93.8 (152) | 0.37 | 85.3 (139) | 93.6 (132) | 0.02 | 94.2 (867) | 93.6 (671) | 0.58 |
| NYHA functional class IV | 55.6 (60) | 48.1 (78) | 0.23 | 53.4 (87) | 49.6 (70) | 0.52 | 43.9 (403) | 48.6 (348) | 0.056 |
| Angina | 21.3 (23) | 19.1 (31) | 0.66 | 23.9 (39) | 27.0 (38) | 0.55 | 19.0 (175) | 19.2 (138) | 0.91 |
| Coronary artery disease | 74.1 (80) | 79.0 (128) | 0.34 | 70.6 (115) | 79.4 (112) | 0.08 | 78.3 (720) | 82.1 (589) | 0.056 |
| Prior MI | 25.9 (28) | 30.6 (49) | 0.40 | 27.0 (44) | 27.0 (38) | 0.99 | 25.0 (229) | 28.9 (206) | 0.07 |
| Prior PCI | 29.6 (32) | 33.5 (54) | 0.50 | 29.4 (48) | 35.0 (49) | 0.30 | 44.8 (412) | 39.5 (283) | 0.03 |
| Prior CABG | 39.8 (43) | 50.0 (81) | 0.10 | 39.9 (65) | 48.2 (68) | 0.15 | 42.3 (389) | 48.1 (345) | 0.02 |
| Stroke or TIA (last 6–12 months) | 31.4 (32) | 25.7 (38) | 0.32 | 27.8 (42) | 32.8 (44) | 0.36 | 25.5 (232) | 25.9 (183) | 0.84 |
| Carotid disease | 28.7 (29) | 23.9 (34) | 0.40 | 28.7 (43) | 31.8 (42) | 0.56 | 24.7 (223) | 28.2 (197) | 0.11 |
| Peripheral vascular disease | 49.5 (53) | 39.9 (63) | 0.12 | 38.9 (63) | 42.4 (59) | 0.53 | 47.2 (431) | 45.5 (320) | 0.48 |
| Porcelain aorta | 0.9 (1) | 0.0 (0) | 0.40 | 1.2 (2) | 0.0 (0) | 0.50 | 1.5 (14) | 0.6 (4) | 0.06 |
| Pulmonary hypertension | 48.1 (52) | 50.6 (82) | 0.69 | 50.9 (83) | 51.1 (72) | 0.98 | 37.2 (337) | 38.7 (276) | 0.54 |
| Major arrhythmia | 50.9 (55) | 53.4 (86) | 0.69 | 45.4 (74) | 47.5 (67) | 0.71 | 47.9 (440) | 56.2 (403) | 0.0008 |
| Permanent pacemaker | 22.2 (24) | 24.1 (39) | 0.72 | 22.7 (37) | 17.7 (25) | 0.28 | 20.4 (188) | 23.9 (171) | 0.09 |
| Renal disease (creatinine ≥2) | 13.0 (14) | 25.3 (41) | 0.01 | 17.3 (28) | 17.7 (25) | 0.92 | 15.8 (145) | 16.2 (116) | 0.81 |
| Liver disease | 4.6 (5) | 1.2 (2) | 0.12 | 1.8 (3) | 2.8 (4) | 0.71 | 2.4 (22) | 2.0 (14) | 0.55 |
| COPD | 45.4 (49) | 43.8 (71) | 0.80 | 39.9 (65) | 48.9 (69) | 0.11 | 39.8 (366) | 46.2 (331) | 0.01 |
| Oxygen dependent | 5.6 (13) | 8.0 (19) | 0.44 | 8.6 (14) | 9.2 (13) | 0.85 | 6.3 (58) | 10.2 (73) | 0.004 |
| Baseline Doppler-echocardiographic data | |||||||||
| Aortic annulus diameter, mm | 20.3 ± 2.3 | 19.8 ± 2.2 | 0.12 | 19.8 ± 2.4 | 20.4 ± 2.4 | 0.18 | 18.9 ± 2.8 | 18.8 ± 2.6 | 0.61 |
| LV ejection fraction, % | 56 ± 13 | 53 ± 13 | 0.12 | 53 ± 15 | 50 ± 13 | 0.09 | 54 ± 12 | 51 ± 13 | 0.0001 |
| AV mean gradient, mm Hg | 45 ± 14 | 42 ± 15 | 0.053 | 44 ± 15 | 43 ± 14 | 0.39 | 45 ± 15 | 44 ± 14 | 0.22 |
| Moderate/severe AR | 10.8 (11) | 15.1 (24) | 0.48 | 10.0 (16) | 4.4 (6) | 0.12 | 10.3 (93) | 8.8 (61) | 0.40 |
| Moderate/severe MR | 13.7 (14) | 22.8 (36) | 0.16 | 22.4 (36) | 18.8 (25) | 0.46 | 22.5 (196) | 22.9 (157) | 0.46 |
Values are mean ± SD, % (n), or median (interquartile range). Continuous variables are reported as mean ± SD and compared with the Student t test, except the STS score and logistic euroSCORE, which are reported as median and (interquartile range) and compared with the Wilcoxon rank-sum test. Values in parentheses indicate the number of patients.
AR = aortic regurgitation; AV = aortic valve; BMI = body mass index; BSA = body surface area; CABG = coronary artery bypass graft surgery; COPD = chronic obstructive pulmonary disease; euroSCORE = European System for Cardiac Operative Risk Evaluation; LV = left ventricular; MI = myocardial infarction; MR = mitral regurgitation; NRCA = nonrandomized continued access; NYHA = New York Heart Association; PCI = percutaneous coronary intervention; PPM = prosthesis-patient mismatch; RCT = randomized clinical trial; SAVR = surgical aortic valve replacement; STS = Society of Thoracic Surgeons; TAVR = transcatheter aortic valve replacement; TIA = transient ischemic attack.