37
Table 22: CEC-Adjudicated Adverse Events through 1 Year
(EP Population)
Events
SAPIEN 3 Valve
PIIA-SAVR
Overall TF Only Non-TF Only
Minor (non-disabling) stroke 18/1074 (1.7%) 17/948 (1.8%) 1/126 (0.8%) 16/938 (1.7%)
Myocardial infarction 3/1074 (0.3%) 3/948 (0.3%) 0/126 (0.0%) 17/938 (1.8%)
Major vascular complication 65/1074 (6.1%) 60/948 (6.3%) 5/126 (4.0%) 50/938 (5.3%)
Life threatening (disabling) or
major bleeding
159/1074 (14.8%)
112/948 (11.8%)
47/126 (37.3%)
733/938 (78.1%)
Aortic valve re-intervention 1/1074 (0.1%) 1/948 (0.1%) 0/126 (0.0%) 0/938 (0.0%)
Any endocarditis 2/1074 (0.2%) 2/948 (0.2%) 0/126 (0.0%) 0/938 (0.0%)
Rhythm disturbance requiring
permanent pacemaker
108/1074 (10.1%)
99/948 (10.4%) 9/126 (7.1%)
68/938 (7.2%)
1 Year
Death 79/1074 (7.4%) 61/948 (6.4%) 18/126 (14.3%) 117/938 (12.5%)
Cardiac death 47/1074 (4.4%) 37/948 (3.9%) 10/126 (7.9%) 70/938 (7.5%)
Non-cardiac death 32/1074 (3.0%) 24/948 (2.5%) 8/126 (6.3%) 47/938 (5.0%)
Stroke 49/1074 (4.6%) 40/948 (4.2%) 9/126 (7.1%) 74/938 (7.9%)
Major (disabling) stroke 24/1074 (2.2%) 16/948 (1.7%) 8/126 (6.3%) 53/938 (5.7%)
Minor (non-disabling) stroke 25/1074 (2.3%) 24/948 (2.5%) 1/126 (0.8%) 22/938 (2.3%)
Aortic valve re-intervention 6/1074 (0.6%) 6/948 (0.6%) 0/126 (0.0%) 4/938 (0.4%)
Any endocarditis 8/1074 (0.7%) 7/948 (0.7%) 1/126 (0.8%) 6/938 (0.6%)
Categorical measures - n. / total no. (%).
In addition, site-reported new-onset atrial fibrillation was 5.9% in the PIIS3i EP population and 29.2% in
the PIIA-SAVR EP population.
Bleeding Rate
The bleeding rates utilizing the number of units transfused are presented in Table 23.
Table 23:
Bleeding Rate Using Site-Reported Units Transfused (EP Population)
SAPIEN 3 Valve
(N = 1074)
PIIA-SAVR
(N = 938)
Transfusion units ≥ 2 and < 4 47/1074 (4.4%) 184/938 (19.6%)
Transfusion units ≥ 4 18/1074 (1.7%) 218/938 (23.2%)
Site-reported Transfusion at Day 0 or Day 1; Categorical measures - n. / total no. (%)
Other Results
Procedural Information
In the PIIS3i EP population the mean duration in the catheterization laboratory was 187.3 ± 53.2 minutes,
the mean total procedure time was 84.2 ± 40.7 minutes, and the mean total anesthesia time was
186.9 ± 61.1 minutes, all of which were slightly shorter in the TF group. General anesthesia was used in
the vast majority of cases; 18.9% of the TF patients had conscious sedation. Correct positioning of the
valve was achieved in 99.3% of the patients. Four patients (0.4%, all TF patients) were implanted with a
second valve. One patient (0.1%) experienced valve embolization and 2 patients (0.2%) experienced
annular rupture.
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