Table 3

Procedural variables and outcomes of TF-TAVI

Total
(n=196)
TAVI with BAV
(n=56)
TAVI without BAV
(n=140)
P value
n/N (%) or Median (IQR)n/N (%) or Median (IQR)n/N (%) or Median (IQR)
Anaesthesia0.101
 General anaesthesia149/196 (76.0)47/56 (83.9)102/140 (72.9)
 Conscious sedation47/196 (24.0)9/56 (16.1)38/140 (27.1)
Size of balloon used for predilationn.a.
 20 mm16/196 (8.2)16/56 (28.6)
 22/23 mm17/196 (8.7)17/56 (30.4)
 24 mm2/196 (1.0)2/56 (3.6)
 26 mm21/196 (10.7)21/56 (37.5)
Size of implanted THV0.316
 20 mm1/196 (0.5)1/56 (1.8)0/140 (0)
 23 mm64/196 (32.7)20/56 (35.7)44/140 (31.4)
 26 mm68/196 (34.7)13/56 (23.2)55/140 (39.3)
 29 mm63/196 (32.1)22/56 (39.3)41/140 (29.3)
Sizing vs native annulus0.779
 Undersized14/179 (7.8)3/55 (5.5)11/124 (8.9)
 Normal size121/179 (67.6)38/55 (69.1)83/124 (66.9)
 Oversized44/179 (24.6)14/55 (25.5)30/124 (24.2)
Requirement for balloon postdilation39/196 (19.9)17/56 (30.4)22/140 (15.7)0.029
Procedural duration (min)65 (47/104)90 (59/118)56 (40/87)0.001
Fluoroscopy time (min)10.5 (8.0/14.0)13.0 (10.0/16.0)10.0 (7.0/12.0)0.001
Contrast volume (ml)125 (100/175)131 (116/164)120 (98/190)0.240
Device success*†189/196 (96.4)52/56 (92.9)137/140 (97.9)0.104
 Absence of death196/196 (100)56/56 (100)140/140 (100)n.a.
 Correct positioning195/196 (99.5)56/56 (100)139/140 (99.3)1.000
 Post-TAVI mean AV gradient ≤20 mm Hg190/196 (96.9)52/56 (92.9)138/140 (98.6)0.057
Paravalvular leakage0.740
 Mild26/196 (13.3)8/56 (14.3)18/140 (12.9)
 Moderate/severe1/196 (0.5)0/56 (0)1/140 (0.7)
Mean AV gradient (mm Hg)11.8±4.712.9±5.311.4±4.50.058
Procedural complications
 Access complications‡7/196 (3.6)0/56 (0)7/140 (5.0)0.195
 Aortic root rupture0/196 (0)0/56 (0)0/140 (0)n.a.
 Haemodynamic instability3/196 (1.5)2/56 (3.6)1/140 (0.7)0.197
 Catecholamine use2/196 (1.0)1/56 (1.8)1/140 (0.7)0.491
 Complete AV block with PPI5/196 (2.6)2/56 (3.6)3/140 (2.1)0.625
 Conversion to open surgery0/196 (0)0/56 (0)0/140 (0)n.a.
 Device malfunction0/196 (0)0/56 (0)0/140 (0)n.a.
 Need for second valve1/196 (0.5)0/56 (0)1/140 (0.7)1.000
  • *Defined according to VARC-2 as the absence of death, correct positioning of a single prosthetic heart valve and its intended performance.14

  • †Multiple reasons may apply.

  • ‡Defined according to VARC-2 as dissection, aortic root rupture or uncontrolled bleeding.14

  • AV, aortic valve; BAV, balloon aortic valvuloplasty; n.a., not applicable; PPI, permanent pacemaker implantation; TAVI, transcatheter aortic valve implantation; THV, transcatheter heart valve; VARC-2, Valve Academic Research Consortium-2.