Early Real-World Experience with CoreValve Evolut PRO and R Systems for Transcatheter Aortic Valve Replacement

Table 5

Clinical outcomes and safety endpoints.

	Evolut PRO (N = 60)	Evolut R (N = 56)	value
Mortality
Prior to discharge	0	0	—
30 days	0	0	—
Myocardial infarction	0	0	—
Stroke
Ischemic	1 (1.7)	1 (1.8)	0.96
Hemorrhagic	1 (1.7)	0	0.33
Vascular complications
Major	3 (5.0)	3 (5.4)	0.93
Minor	3 (5.0)	7 (12.5)	0.15
Percutaneous closure—device failure	0 (3.3)	0	0.17
Bleeding
Life-threatening	2 (3.3)	0	0.17
Major	1 (1.7)	2 (3.6)	0.52
Acute kidney injury
Stage 1	3 (5.0)	8 (14.3)	0.09
Stage 2	0	2 (3.6)	0.14
Stage 3	1 (1.7)	1 (1.8)	0.96
Embolization/migration	0	0	—
Endocarditis	0	0	—
Valve thrombosis	0	0	—
Coronary artery obstruction	0	0	—
Early safety at 30 days	56 (93.3)	53 (94.6)	0.76
New LBBB	21/57 (36.8)	23/52 (44.2)	0.43
New PPM requirement	13/47 (27.7)	15/48 (31.3)	0.70

Values are n or n/N (%). The group of patients with pre-existing LBBB or PPM was excluded for comparison.