Copyright
©The Author(s) 2016.
World J Cardiol. Dec 26, 2016; 8(12): 735-745
Published online Dec 26, 2016. doi: 10.4330/wjc.v8.i12.735
Published online Dec 26, 2016. doi: 10.4330/wjc.v8.i12.735
Table 1 Baseline characteristics
| Variable | S3-THV (n = 283) | XT-THV (n = 507) | P value |
| Age | 82.8 ± 7.1 | 83.5 ± 7.0 | 0.14 |
| Female sex | 137 (48.4) | 275 (54.3) | 0.12 |
| STS-PROM, % | 5.3 ± 3.5 | 6.4 ± 4.0 | < 0.0001 |
| Logistic EuroSCORE, % | 15.7 ± 10.8 | 18.8 ± 11.5 | < 0.0001 |
| NYHA class 3 or 4 | 162 (59.1) | 383 (75.8) | < 0.0001 |
| History of syncope | 1 (0.5) | 10 (2.1) | 0.19 |
| Atrial arrhythmia (flutter or fibrillation) | 80 (29.5) | 135 (27.8) | 0.67 |
| Diabetes | 71 (25.1) | 124 (24.5) | 0.86 |
| Hypertension | 161 (71.6) | 344 (68.8) | 0.49 |
| Dyslipidemia | 99 (44.0) | 263 (52.6) | 0.04 |
| Active smoker | 4 (1.4) | 18 (3.6) | 0.11 |
| Previous PPM | 35 (12.4) | 60 (11.8) | 0.91 |
| Previous PCI | 81 (29.3) | 114 (22.9) | 0.06 |
| Previous CABG | 25 (9.0) | 51 (10.3) | 0.62 |
| Previous SAVR | 2 (0.7) | 7 (1.4) | 0.5 |
| Previous stroke | 25 (8.8) | 39 (7.7) | 0.59 |
| Peripheral vascular disease | 56 (19.8) | 143 (28.4) | 0.01 |
| eGFR, mL/min per 1.73 m2 | 62.8 ± 24.6 | 61.4 ± 22.6 | 0.42 |
| eGFR < 40 mL/min per 1.73 m2 | 82 (16.2) | 41 (14.5) | 0.61 |
| Dialysis | 4 (1.5) | 13 (2.6) | 0.44 |
| Chronic obstructive pulmonary disease | 33 (11.7) | 110 (21.9) | < 0.0001 |
| Body mass index, kg/m2 | 26.5 ± 5.1 | 26.3 ± 4.9 | 0.61 |
| LVEF, % | 54.9 ± 14.8 | 53.6 ± 14.2 | 0.24 |
| LVEF < 30% | 55 (11.1) | 31 (11.4) | 0.91 |
| Mean aortic gradient, mmHg | 46.7 ± 15.3 | 46.9 ± 15.3 | 0.92 |
| AVA, cm2 | 0.67 ± 0.17 | 0.65 ± 0.14 | 0.31 |
| Pulmonary artery systolic pressure, mmHg | 44.5 ± 13.0 | 46.5 ± 12.9 | 0.06 |
| Pulmonary artery systolic pressure > 50 mmHg | 64 (28.3) | 123 (28.5) | 1 |
Table 2 Procedural characteristics
| Procedural characteristic | S3-THV (n = 283) | XT-THV (n = 507) | P value |
| Transfemoral approach | 232 (82.6) | 273 (53.8) | < 0.0001 |
| Local anesthesia | 232 (82.6) | 271 (54.2) | < 0.0001 |
| Predilatation | 50 (17.7) | 440 (86.8) | < 0.0001 |
| Postdilatation | 45 (15.9) | 61 (12.0) | 0.13 |
| Implanted device size | < 0.0001 | ||
| 23 mm | 111 (39.8) | 127 (25.1) | |
| 26 mm | 101 (36.2) | 270 (53.4) | |
| 29 mm | 67 (24.0) | 109 (21.5) | |
| Valve area oversizing, % | 11.5 ± 9.8 | 22.9 ± 11.2 | < 0.0001 |
| Device diameter/annulus diameter (area-derived) | 1.05 ± 0.05 | 1.11 ± 0.05 | < 0.0001 |
| Need for seconde valve implantation | 7 (2.5) | 8 (1.6) | 0.42 |
| Annulus rupture | 0 (0) | 13 (2.6) | 0.01 |
| Conversion to SAVR | 2 (0.7) | 14 (2.8) | 0.06 |
| Contrast use (mL) | 108.2 ± 42.7 | 131.6 ± 60.9 | < 0.0001 |
| Fluoroscopy time (min) | 17.4 ± 9.9 | 16.5 ± 9.8 | 0.28 |
Table 3 Thirty-day and 1-year outcomes
| 30-d outcomes | S3-THV (n =283) | XT-THV (n = 507) | Odds ratio (95%CI) | P value | Adjusted odds ratio (95%CI) | Adjusted P value |
| Death | 8 (3.5) | 42 (8.7) | 0.36 (0.16-0.81) | 0.01 | 0.44 (0.12-1.56) | 0.21 |
| Stroke | 4 (1.4) | 13 (2.8) | 0.51 (0.16-1.58) | 0.24 | 0.59 (0.08-4.33) | 0.6 |
| Myocardial infarction | 0 (0) | 2 (0.4) | 0 (0-∞) | 1 | ||
| New pacemaker implantation1 | 43 (17.3) | 44 (9.8) | 1.88 (1.19-2.97) | 0.007 | 1.68 (1.05-2.69) | 0.03 |
| Major vascular complication | 8 (2.8) | 50 (9.9) | 0.27 (0.13-0.57) | 0.001 | 0.20 (0.09-0.44) | < 0.0001 |
| Paravalvular regurgitation > mild | 6 (2.4) | 47 (9.7) | 0.23 (0.10-0.55) | 0.001 | 0.20 (0.08-0.47) | < 0.0001 |
| Acute kidney injury | 3 (1.1) | 69 (13.6) | 0.07 (0.02-0.22) | < 0.0001 | 0.12 (0.04-0.39) | < 0.0001 |
| Mean gradient > 20 mmHg | 7 (2.8) | 6 (1.3) | 2.48 (0.78-7.89) | 0.13 | ||
| Mean gradient, mmHg | 11.8 ± 5.8 | 10.0 ± 5.0 | < 0.0001 | |||
| Total hospital length of stay, d [median (IQR)] | 8 [5-13] | 9 [7-14] | < 0.0001 | |||
| 1-yr outcomes | P value | Adjusted hazard ratio (95%CI) | Adjusted P value | |||
| Death | 20 (25.7) | 87 (20.1) | 0.24 | 0.86 (0.52-1.42) | 0.55 |
Table 4 Causes of death at 1 year in the SAPIEN 3 transcatheter heart valve group
| Patient | Days to death | Cause of death |
| 1 | 0 | Dissection of ascending aorta |
| 2 | 2 | Left main compression/cardiogenic shock |
| 3 | 3 | Iliac rupture |
| 4 | 5 | Sudden cardiac death |
| 5 | 10 | Cardiogenic shock |
| 6 | 22 | Heart failure |
| 7 | 24 | Subdural hematoma |
| 8 | 25 | Unknown |
| 9 | 31 | Stroke |
| 10 | 36 | Acute renal failure |
| 11 | 62 | Unknown |
| 12 | 87 | Heart failure |
| 13 | 96 | Heart failure |
| 14 | 133 | Unknown |
| 15 | 200 | Sudden cardiac death |
| 16 | 202 | Cancer |
| 17 | 247 | Myocardial infarction |
| 18 | 268 | Septic shock |
| 19 | 305 | Chronic obstructive pulmonary disease acute exacerbation |
| 20 | 326 | Major stroke |
Table 5 Electrocardiographic and angiographic characteristics according to new permanent pacemaker requirement in the SAPIEN 3 transcatheter heart valve group
| Variable | New PPM (n = 43) | No PPM (n = 201) | P value |
| Complete RBBB | 12 (32.4) | 17 (9.5) | 0.001 |
| Complete LBBB | 0 (0) | 14 (7.8) | 0.14 |
| Fascicular block | 12 (32.4) | 33 (18.4) | 0.07 |
| QRS duration, ms | 108 ± 26 | 101 ± 23 | 0.1 |
| PR duration, ms | 196 ± 37 | 183 ± 30 | 0.04 |
| Implant depth (septal), mm | 5.3 ± 2.4 | 5.0 ± 2.6 | 0.67 |
| Implant depth (non-septal), mm | 4.9 ± 2.4 | 5.2 ± 1.9 | 0.64 |
| Device lack of coaxiality during deployment, mm | 4.0 ± 3.6 | 2.9 ± 2.5 | 0.06 |
Table 6 Predictors of new pacemaker implantation in the S3 group
| Parameter | Univariate analysis | Multivariate analysis | |||
| OR | P value | OR | 95%CI | P value | |
| Complete RBBB | 4.6 | < 0.001 | 4.9 | 1.88-12.95 | 0.001 |
| Complete LBBB | 1 | 1 | - | - | - |
| Fascicular block | 2.12 | 0.06 | 1.88 | 0.71-5.00 | 0.2 |
| QRS duration (per 10 ms increment) | 1.12 | 0.1 | 0.87 | 0.65-2.72 | 0.345 |
| PR duration (per 10 ms increment) | 1.14 | 0.05 | 1.14 | 1.00-1.29 | 0.05 |
| Implant depth (septal, per 1 mm increment) | 1.05 | 0.66 | - | - | - |
| Implant depth (non-septal, per 1 mm increment) | 0.94 | 0.63 | - | - | - |
| Device lack of coaxiality during implant (per 1 mm increment) | 1.13 | 0.07 | 1.13 | 1.00-1.29 | 0.049 |
Table 7 Summary of studies comparing the rate of permanent pacemaker between the S3 and XT device
| PPM | S3 | XT | P value | Predictor/comments |
| Binder et al[40] 2015 Circulation interventions | 17% | 13% | 0.01 | Predictors: Depth, RBBB |
| Binder et al[14] 2013 JACC interventions | 13.30% | Excluded patient with LBBB, PR > 200 ms No predictors studied | ||
| Husser et al[25] 2015 JACC interventions | 15.20% | Predictors not studied | ||
| Binder et al[40] 2015 EuroIntervention | 20.70% | Predictor > 8 mm depth of implants | ||
| Nijhoff et al[17] 2015 Circulation interventions | 9.80% | 8.80% | 0.94 | High implants: 80/20 in aorta as mentioned by authors |
- Citation: Sawaya FJ, Spaziano M, Lefèvre T, Roy A, Garot P, Hovasse T, Neylon A, Benamer H, Romano M, Unterseeh T, Morice MC, Chevalier B. Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves: A single-center experience. World J Cardiol 2016; 8(12): 735-745
- URL: https://www.wjgnet.com/1949-8462/full/v8/i12/735.htm
- DOI: https://dx.doi.org/10.4330/wjc.v8.i12.735