Transcatheter Aortic Valve Implantation with ACURATE neo: Results from the PROGRESS PVL Registry
Table 2
Clinical safety outcomes.
Variable
30 days
12 months
VARC-2 composite early safety
9.2% (46)
—
All-cause mortality
2.2% (11)
11.3% (54)
Cardiovascular death
2.0% (10)
7.1% (34)
Noncardiovascular death
0.2% (1)
4.2% (20)
Stroke
2.6% (13)
3.6% (17)
Disabling Stroke
2.4% (12)
3.1% (15)
Nondisabling Stroke
0.2% (1)
0.4% (2)
Major vascular complications
3.6% (18)
4.0% (19)
Bleeding, life-threatening or disabling
1.4% (7)
3.4% (16)
Myocardial infarction (>72 h postprocedure)
0.0% (0)
1.0% (5)
Acute kidney injury (AKI stage 2/3)
0.8% (4)
1.0% (5)
New permanent pacemaker implantation
All patients
10.2% (51)
12.2% (58)
Pacemaker-naive patients (n = 443)
11.6% (51)
13.4% (57)
New onset of atrial fibrillation/flutter
5.2% (26)
7.5% (36)
Valve malpositioning†
1.4% (7)
1.5% (7)
Coronary obstruction requiring intervention
0.0% (0)
0.0% (0)
Ventricular septal perforation
0.0% (0)
0.0% (0)
Cardiac tamponade
0.0% (0)
0.0% (0)
Repeat procedure for valve-related dysfunction
1.2% (6)
1.7% (8)‡
Prosthetic valve endocarditis
0.0% (0)
0.8% (4)
Prosthetic valve thrombosis
0.0% (0)
0.2% (1)
Data are % (n), reported for the ITT population (N = 500). Component of VARC-2 composite endpoint for early safety at 30 days. † Includes valve migration, valve embolization, ectopic valve deployment; ‡Two patients were treated with a repeat procedure after 30 days. In one patient, the 30-day follow-up TEE revealed reduced LVEF with persistent moderate PVL; balloon valvuloplasty was performed but did not improve aortic valve insufficiency, and patient underwent SAVR. One patient experienced endocarditis and associated dissection of the ascending aorta on day 89 post-TAVI; SAVR was performed to replace the ACURATE neo valve.
