Table 3. Thirty-Day and 1-Year Outcomesa.
| Outcome | No./total No. (%) of patients | P value | ||
|---|---|---|---|---|
| Transseptal (n = 1326) | Transapical (n = 203) | Combined (N = 1529) | ||
| 30-d Outcomes | ||||
| All-cause mortality | 62 (5.0) | 16 (8.1) | 78 (5.4) | .07 |
| Cardiovascular death | 26 (2.1) | 10 (5.1) | 36 (2.5) | .01 |
| Observed:expected ratio | 0.45 | 0.69 | 0.49 | NA |
| Stroke | 14 (1.1) | 2 (1) | 16 (1.1) | .91 |
| Mitral valve reintervention | 5 (0.4) | 1 (0.5) | 6 (0.4) | .82 |
| New dialysis requirement | 18 (1.5) | 6 (3.1) | 24 (1.7) | .10 |
| New pacemaker | 17 (1.4) | 4 (2.0) | 21 (1.4) | .44 |
| Device thrombosis | 3 (0.2) | 1 (0.5) | 4 (0.3) | .49 |
| LV ejection fraction, mean (SD), % | 54.2 (11.73) | 52.7 (12.55) | 54.0 (11.84) | .17 |
| Mean MVG, mean (SD), mm Hg | 7.4 (2.74) | 7.2 (2.69) | 7.3 (2.73) | .50 |
| 30-d KCCQ improvement, mean (SD) | 35.3 (27.13) | 37.4 (25.17) | 35.5 (26.90) | .47 |
| 30-d NYHA class | ||||
| I | 385/863 (44.6) | 58/131 (44.3) | 443/994 (44.6) | .94 |
| II | 356/863 (41.3) | 55/131 (42.0) | 411/994 (41.3) | .87 |
| III | 106/863 (12.3) | 13/131 (9.9) | 119/994 (12.0) | .44 |
| IV | 16/863 (1.9) | 5/131 (3.8) | 21/994 (2.1) | .18 |
| 1-y Outcomes | ||||
| All-cause mortality | 138 (15.8) | 37 (21.7) | 175 (16.7) | .03 |
| All-cause mortality No. at risk | 438 | 97 | 535 | NA |
| Cardiovascular death | 36 (3.7) | 11 (5.7) | 47 (3.9) | .07 |
| Stroke | 27 (3.3) | 5 (3.5) | 32 (3.3) | .95 |
| Mitral valve reintervention | 8 (0.8) | 1 (0.5) | 9 (0.8) | .78 |
| New dialysis requirement | 19 (1.6) | 6 (3.1) | 25 (1.8) | .13 |
| New pacemaker | 21 (2.0) | 5 (2.8) | 26 (2.1) | .44 |
| Device thrombosis | 4 (0.3) | 2 (1.2) | 6 (0.5) | .17 |
| LV ejection fraction, mean (SD), % | 53.3 (11.52) | 52.8 (13.11) | 53.2 (11.76) | .77 |
| Mean MVG, mean (SD), mm Hg | 7.0 (2.94) | 7.0 (2.61) | 7.0 (2.89) | .99 |
| 1-y KCCQ Improvement, mean (SD) | 40.2 (27.26) | 35.3 (26.37) | 39.4 (27.14) | .27 |
| 1-y NYHA class | ||||
| I | 143/290 (49.3) | 30/62 (48.4) | 173/352 (49.1) | .89 |
| II | 119/290 (41.0) | 26/62 (41.9) | 145/352 (41.2) | .90 |
| III | 23/290 (7.9) | 5/62 (8.1) | 28/352 (8.0) | >.99 |
| IV | 5/290 (1.7) | 1/62 (1.6) | 6/352 (1.7) | >.99 |
Abbreviations: LV, left ventricular; KCCQ, Kansas City Cardiomyopathy Questionnaire; MVG, mitral valve gradient; NYHA, New York Heart Association.
a
Event rates were calculated by Kaplan-Meier methods.