Table 2.
Deficient retro-aortic rim (<5mm) |
Adequate retro-aortic rim (≥5mm) |
p | ||
---|---|---|---|---|
Defect treated | 96% (625) | 97% (887) | 0.09 | |
Technical failure | 6.7% (44) | 5.2% (47) | 0.19 | |
Device embolization | 2.2% (14) | 1.7% (15) | 0.48 | |
Malposition or thrombus with re-intervention | 0.3% (2) | 0.3% (3) | 0.94 | |
Residual shunt (≥3 mm) | 1.6% (10) | 1.4% (12) | 0.82 | |
Device deployed released and immediately retrieved | 2.9% (18) | 1.9% (17) | 0.23 | |
Adverse event* | 3.5% (23) | 4.5% (41) | 0.34 | |
Cardiac arrest | 0% (0) | 0.2% (2) | 0.23 | |
Embolic stroke | 0.3% (2) | 0% (0) | 0.10 | |
New arrhythmia | 1.5% (10) | 2.3% (21) | 0.28 | |
Repeat catheterization | 0.3% (2) | 0.9% (8) | 0.16 | |
Tamponade | 0% (0) | 0.2% (2) | 0.23 | |
Unplanned cardiac surgery | 1.1% (7) | 0.7% (6) | 0.38 | |
Unplanned other surgery | 0.2% (1) | 0.1% (1) | 0.82 | |
Vascular complication | 0.2% (1) | 0.3% (3) | 0.50 | |
Total case time (minutes) | 153.0±56.2 | 148.2±43.9 | 0.06 | |
Sheath time (minutes) | 77.5±44.0 | 77.0±35.9 | 0.81 | |
Fluoroscopy time (minutes) | 16.3±11.8 | 15.3±12.0 | 0.11 |
No cases with air embolus, new valve regurgitation, initiation of dialysis, initiation of mechanical circulatory support, or unplanned vascular surgery were recorded.