Table 2. Procedural and In-Hospital Outcomes.
| Outcomes | No./total No. (%) of patients | P value | ||
|---|---|---|---|---|
| Transseptal (n = 1326) | Transapical (n = 203) | Combined (N = 1529) | ||
| Procedural outcomes | ||||
| Implant volume per site, median (IQR) | 3 (1-6) | 1 (1-3) | 3 (1-7) | NA |
| MVARC technical successa | 1288/1326 (97.1) | 192/203 (94.6) | 1480/1529 (96.8) | .08 |
| SAPIEN 3 implanted | ||||
| 20-mm | 3/1326 (0.2) | 0/203 (0) | 3/1529 (0.2) | >.99 |
| 23-mm | 101/1326 (7.6) | 18/203 (8.9) | 119/1529 (7.8) | .54 |
| 26-mm | 553/1326 (41.7) | 80/203 (39.4) | 633/1529 (41.4) | .54 |
| 29-mm | 669/1326 (50.5) | 105/203 (51.7) | 774/1529 (50.6) | .74 |
| Procedural time, mean (SD), min | 125.8 (64.3) | 138.4 (73.9) | 127.4 (65.8) | .02 |
| Fluoroscopy time, mean (SD), min | 37 (25.7) | 18.2 (13.0) | 34.6 (25.2) | <.001 |
| Procedure aborted | 7/1326 (0.5) | 1/203 (0.5) | 8/1529 (0.5) | >.99 |
| Device embolization | 3/1326 (0.2) | 1/203 (0.5) | 4/1529 (0.3) | .43 |
| Cardiac perforation | 14/1326 (1.1) | 3/203 (1.5) | 17/1529 (1.1) | .48 |
| Conversion to open surgery | 9/1326 (0.7) | 5/203 (2.5) | 14/1529 (0.9) | .03 |
| Need for second valve | 0/1326 (0) | 0/203 (0) | 0/1529 (0) | NA |
| ASD closure | 101/1326 (7.6) | 0/203 (0) | 101/1529 (6.6) | NA |
| Anticoagulation at discharge | 1027/1255 (81.8) | 134/182 (73.6) | 1161/1437 (80.8) | .01 |
| In-hospital outcomes | ||||
| All-cause mortality | 48/1326 (3.6) | 13/203 (6.4) | 61/1529 (4.0) | .06 |
| Cardiovascular death | 24/1326 (1.8) | 9/203 (4.4) | 33/1529 (2.2) | .03 |
| Stroke | 9/1326 (0.7) | 1/203 (0.5) | 10/1529 (0.7) | >.99 |
| Mitral valve reintervention | 4/1326 (0.3) | 1/203 (0.5) | 5/1529 (0.3) | .51 |
| LVOT obstruction | 10/1326 (0.8) | 4/203 (2) | 14/1529 (0.9) | .10 |
| New pacemaker | 15/1326 (1.1) | 4/203 (2.0) | 19/1529 (1.2) | .30 |
| Periprocedural MI | 4/1326 (0.3) | 1/203 (0.5) | 5/1529 (0.3) | .51 |
| Device thrombosis | 2/1326 (0.2) | 1/203 (0.5) | 3/1529 (0.2) | .35 |
| Major vascular complications | 16/1326 (1.2) | 5/203 (2.5) | 21/1529 (1.4) | .18 |
| Length of stay, median (IQR) | 2 (1-5) | 6 (3-9) | 3.0 (2.0-6.0) | <.001 |
| Discharged home | 1094/1326 (82.5) | 120/203 (59.1) | 1214/1529 (79.4) | <.001 |
Abbreviations: ASD, atrial septal defect; IQR, interquartile range; LVOT, left ventricular outflow tract; MI, myocardial infarction; MVARC, mitral valve academic research consortium; NA, not applicable.
a
MVARC technical success was defined as at exit from the hybrid suite, patient is alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure.