Transcatheter Aortic Valve Implantation with ACURATE neo: Results from the PROGRESS PVL Registry
Table 1
Procedural outcomes.
Variable
ITT population (N = 500)
Total time from first puncture to time of transfemoral access site closure (min)
56.7 ± 26.8 (499)
Total time from insertion of delivery system to removal of delivery system (min)
10.2 ± 11.6 (491)
Valve size implanted
S
19.6% (98)
M
38.8% (194)
L
41.6% (208)
Balloon predilatation
91.4% (457)
Postdilatation
45.2% (226)
Correct positioning of a single valve in the proper location
98.6% (493)
Procedural mortality†
0.2% (1)
Periprocedural myocardial infarction (≤72 h)‡
0.8% (4)
Major vascular complications
2.8% (14)
Life-threatening/disabling bleeding
0.8% (4)
Valve-in-valve implant^
0.8% (4/500)
Surgical aortic valve replacement
0.0% (0/500)
Unplanned use of cardiopulmonary bypass
0.0% (0/500)
Coronary obstruction requiring intervention
0.0% (0/500)
Ventricular septal perforation
0.0% (0/500)
Cardiac tamponade
0.0% (0/500)
Endocarditis
0.0% (0/500)
Valve embolization
0.2% (1/500)
Valve thrombosis
0.0% (0/500)
Data are % (n) or mean ± standard deviation (n). Two patients from the ITT population were not implanted with ACURATE neo. † ACURATE neo valve lost contact with the annulus; patient was treated valve-in-valve with a nonstudy valve, experienced cardiogenic shock, and died the same day as the index procedure. ‡Intra-procedural myocardial infarction, n = 2 (STEMI, n = 1; NSTEMI, n = 1).
