Table 2. Procedural characteristics, immediate results, and clinical outcomes of the study patients.
| Parameters | Early-generation CoreValve (N=15) | Newer-generation valves (N=10) | P value |
|---|---|---|---|
| Transfemoral access, n [%] | 15 [100] | 7 [70] | 0.05 |
| THV valve type, n [%] | |||
| CoreValve | 10 [67] | 0 | <0.01* |
| CoreValve-in-CoreValve | 6 [40] | 0 | <0.01* |
| Sapien-in-CoreValve | 2 [13] | 0 | 0.50 |
| Evolut R | 0 | 7 [70] | <0.01* |
| J-valve | 0 | 3 [30] | 0.05 |
| Perimeter-derived aortic annulus (mm) | 25.0±1.2 | 24.9±1.6 | 0.43 |
| THV valve size (mm) | 30.3±1.4 | 30.0±2.9 | 0.34 |
| 26, n [%] | 1 [7] | 1 [10] | >0.99 |
| 27, n [%] | 0 | 1 [10] | 0.40 |
| 29, n [%] | 3 [20] | 5 [50] | 0.19 |
| 31, n [%] | 11 [73] | 0 | <0.01* |
| 34, n [%] | 0 | 3 [30] | 0.05 |
| Oversizing (%) | 17.5±0.6 | 17.0±0.8 | 0.50 |
| Implantation depth below annulus (mm) | 14.1±5.5 | 8.5±3.2 | <0.01* |
| Device success, n [%] | 5 [33] | 10 [100] | <0.01* |
| Causes of device failure, n [%] | |||
| Aortic regurgitation ≥ moderate | 2 [13] | 0 | 0.50 |
| Need for second valve implantation | 8 [53] | 0 | <0.01* |
| Post-TAVR trans-valvular PG >20 mmHg | 0 | 0 | 1.00 |
| Procedure time (min) | 64.9±26.4 | 37.1±14.1 | <0.01* |
| Fluoroscopy time (min) | 41.5±13.3 | 19.3±4.7 | <0.01* |
| Contrast agent (mL) | 165.1±69.3 | 88.1±52.0 | <0.01* |
| Procedural success, n [%] | 15 [100] | 10 [100] | 1.00 |
| Conversion to SAVR, n [%] | 0 | 0 | 1.00 |
| Coronary obstruction, n [%] | 0 | 0 | 1.00 |
| Annulus rupture, n [%] | 0 | 0 | 1.00 |
| Left ventricular rupture, n [%] | 0 | 0 | 1.00 |
| Emergency CPB/ECMO, n [%] | 0 | 0 | 1.00 |
| Major bleeding, n [%] | 1 [7] | 0 | >0.99 |
| Major vascular complications, n [%] | 1 [7] | 0 | >0.99 |
| New permanent pacemaker implantation, n [%] | 3 [23] | 3 [25] | >0.99 |
| Intensive care unit stay (day) | 3.0±2.5 | 2.2±1.3 | 0.55 |
| MACCE, n [%] | 12 [80] | 5 [50] | 0.19 |
| Total mortality | 2 [13] | 2 [20] | >0.99 |
| Non-fatal myocardial infarction | 0 | 0 | 1.00 |
| Non-fatal stroke | 1 [7] | 0 | >0.99 |
| Readmission for heart failure | 9 [60] | 3 [30] | 0.23 |
Continuous variables are expressed as mean ± standard deviation. *, significance level, P<0.05. THV, transcatheter heart valve; TAVR, transcatheter aortic valve replacement; PG, pressure gradient; SAVR, surgical aortic valve replacement; CPB, cardio-pulmonary bypass; ECMO, extracorporeal membranous oxygenation; MACCE, major adverse cardiac cerebral events.