Table 2. Procedural Characteristics and In-Hospital Outcomes.
| Total/No. (%) of Patients With Aortic Valve Stenosis | Absolute Difference (95% CI), % | P Value | ||
|---|---|---|---|---|
| Bicuspid (n = 2691) | Tricuspid (n = 2691) | |||
| Procedural Characteristics | ||||
| Procedure statusa | ||||
| Electiveb | 2431/2689 (90.4) | 2423/2689 (90.1) | 0.3 (−1.3 to 1.9) | .51 |
| Urgentc | 248/2689 (9.2) | 259/2689 (9.6) | 0.4 (−2.0 to 1.2) | |
| Emergentd | 8/2689 (0.3) | 7/2689 (0.3) | 0 (−0.3 to 0.4) | |
| Salvagee | 2/2689 (0.1) | 0/2689 (0) | 0.1 (−0.1 to 0.2) | |
| Cardiopulmonary bypass | 38/2687 (1.4) | 26/2686 (1.0) | 0.4 (−0.2 to 1.1) | .13 |
| Access sitea | ||||
| Transfemoral | 2518/2690 (93.6) | 2526/2690 (93.9) | 0.3 (−1.6 to 1.0) | .74 |
| Subclavianf | 75/2690 (2.8) | 65/2690 (2.4) | 0.1 (−0.6 to 0.9) | |
| Transapicalg | 45/2690 (1.7) | 36/2690 (1.3) | 0.3 (−0.4 to 1.0) | |
| Transaortich | 27/2690 (1.0) | 37/2690 (1.4) | 0.4 (−1.0 to 0.2) | |
| Prosthesis size, mma | ||||
| 20 | 72/2691 (2.7) | 84/2691 (3.1) | 0.4 (−1.4 to 0.5) | <.001 |
| 23 | 620/2691 (23.0) | 767/2691 (28.5) | 5.5 (3.1 to 7.8) | |
| 26 | 1052/2691 (39.1) | 1129/2691 (42.0) | 2.9 (0.2 to 5.5) | |
| 29 | 947/2691 (35.2) | 711/2691 (26.4) | 8.8 (6.3 to 11.3) | |
| Secondary outcomes | ||||
| Implant successi | 2663/2689 (99.0) | 2662/2688 (99.0) | 0 (−0.6 to 0.6) | >.99 |
| Device successj | 2577/2671 (96.5) | 2586/2678 (96.6) | 0.1 (−1.1 to 0.9) | .87 |
| Conversion to open heart surgery | 24/2689 (0.9) | 11/2683 (0.4) | 0.5 (0 to 0.9) | .03 |
| Annulus rupture | 7/2689 (0.3) | 0/2683 (0) | 0.3 (0 to 0.5) | .02 |
| Ventricular rupture | 2/2689 (0.1) | 1/2683 (<0.1) | 0 (−0.1 to 0.2) | >.99 |
| Device embolization to left ventricle | 3/2689 (0.1) | 2/2683 (0.1) | 0 (−0.2 to 0.2) | >.99 |
| Coronary occlusion | 3/2689 (0.1) | 4/2683 (0.1) | 0 (−0.3 to 0.2) | .73 |
| Other | 9/2689 (0.3) | 4/2683 (0.1) | 0.2 (−0.1 to 0.5) | .17 |
| Procedure complications | ||||
| Annular dissection | 9 (0.3) | 3 (0.1) | 0.2 (−0.1 to 0.5) | .08 |
| Aortic dissection | 7 (0.3) | 3 (0.1) | 0.1 (−0.1 to 0.4) | .34 |
| Coronary compression or obstruction | 11 (0.4) | 7 (0.3) | 0.1 (−0.2 to 0.5) | .34 |
| Device embolization to aorta | 0 | 3 (0.1) | 0.1 (−0.3 to 0.1) | .25 |
| Device embolization to left ventricle | 3 (0.1) | 1 (<0.1) | 0.1 (−0.1 to 0.3) | .62 |
| Perforation with or without tamponadek | 25 (0.9) | 15 (0.6) | 0.4 (−0.1 to 0.9) | .11 |
| Need for second valve | 12 (0.4) | 6 (0.2) | 0.2 (−0.1 to 0.6) | .16 |
| In-Hospital Event | ||||
| Death | 45 (1.7) | 42 (1.6) | 0.1 (−0.6 to 0.8) | .75 |
| Stroke | 56 (2.1) | 32 (1.2) | 0.9 (0.2 to 1.6) | .01 |
| Death or stroke | 92 (3.4) | 70 (2.6) | 0.8 (−0.1 to 1.8) | .08 |
| Myocardial infarction | 8 (0.3) | 7 (0.3) | 0 (−0.3 to 0.4) | .80 |
| Life-threatening bleeding | 0 | 0 | >.99 | |
| Major vascular complication | 23 (0.9) | 24 (0.9) | 0 (−0.6 to 0.5) | .88 |
| New requirement for dialysis | 12 (0.4) | 14 (0.5) | 0.1 (−0.5 to 0.3) | .69 |
| New permanent pacemaker | 196 (7.3) | 160 (5.9) | 1.3 (−0.0 to 2.7) | .05 |
| New-onset atrial fibrillation | 45 (1.7) | 48 (1.8) | 0.1 (−0.8 to 0.6) | .75 |
P values were calculated with χ2 test for an overall test of the 4 categories.
Cardiac function stable days or weeks before the operation; procedure could be deferred without increased risk of cardiac compromise.
Procedure required during same hospitalization to minimize further clinical deterioration .
Ongoing, refractory unrelenting cardiac compromise, with or without hemodynamic instability, and not responsive to any therapy but cardiac intervention and should not be delayed.
Cardiopulmonary resuscitation en route to the procedure, before anesthesia, or ongoing extracorporeal membrane oxygenation to maintain life.
Performed from subclavian/axillary artery when femoral access is prohibitive.
Procedure performed from left ventricle apex with the anterolateral minithoracotomy when femoral access is prohibitive.
Procedure performed from ascending aorta with ministernotomy or right thoracotomy when femoral access is prohibitive.
Correct positioning of a single prosthetic heart valve.
Composite end point (successful vascular access, delivery, and deployment of the device and successful retrieval of the delivery system; correct position of the device in the proper anatomical location; intended performance of the prosthetic heart valve (aortic valve area >1.2 cm2 and mean aortic valve gradient <20 mm Hg or peak velocity <3 m per second, without moderate or severe prosthetic valve aortic regurgitation); only 1 valve implanted in the proper anatomical location.
Perforation of the myocardium, aortic annulus, or aorta, with or without tamponade associated with the perforation.