Table 2 Procedural features at unadjusted analysis.

From: Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

Feature

Acurate

Evolut

Lotus

Portico

Sapien3

P

Patients

234

703

151

347

541

Local anesthesia

202 (86.3%)

594 (84.5%)

134 (88.7%)

313 (90.2%)

420 (77.6%)

<0.001

Transephageal guidance

76 (32.5%)

10 (1.4%)

47 (31.1%)

128 (36.9%)

51 (9.4%)

<0.001

Femoral access

216 (92.3%)

612 (87.1%)

141 (93.4%)

303 (87.3%)

510 (94.3%)

<0.001

Percutaneous approach

208 (88.9%)

616 (87.6%)

130 (86.1%)

305 (87.9%)

464 (85.8%)

0.732

Sheathless procedure

5 (2.1%)

160 (22.8%)

4 (2.7%)

6 (1.7%)

26 (4.8%)

<0.001

Sheath size (French)

18.4 ± 2.1

15.1 ± 1.7

18.4 ± 1.8

18.4 ± 0.7

14.5 ± 1.7

<0.001

Embolic protection device

     

<0.001

   None

232 (99.2%)

702 (99.9%)

150 (99.3%)

345 (99.4%)

519 (95.9%)

 

   Claret

1 (0.4%)

1 (0.1%)

1 (0.7%)

2 (0.6%)

20 (3.7%)

 

   Shimon

1 (0.4%)

0

0

0

2 (0.4%)

 

Right ventricular pacing

118 (50.4%)

422 (60.0%)

60 (39.7%)

192 (55.3%)

452 (83.6%)

<0.001

Predilation

     

<0.001

   None

82 (35.0%)

272 (38.7%)

93 (61.6%)

117 (33.7%)

92 (17.0%)

 

   One balloon

149 (63.7%)

417 (59.3%)

58 (38.4%)

225 (64.8%)

449 (83.0%)

 

   Two balloons

3 (1.3%)

14 (2.0%)

0

5 (1.4%)

0

 

Balloon diameter (mm)

21.8 ± 2.9

20.4 ± 2.0

20.3 ± 1.9

20.7 ± 1.6

21.6 ± 2.0

<0.001

Balloon type

     

<0.001

   Cristal

52 (34.2%)

19 (4.4%)

0

25 (10.9%)

7 (1.6%)

 

   Nucleus

3 (2.0%)

37 (8.5%)

7 (12.1%)

0

4 (0.9%)

 

   Z.Med

24 (15.8%)

72 (16.6%)

23 (39.7%)

1 (0.4%)

4 (0.9%)

 

   Other

73 (48.0%)

307 (70.6%)

28 (48.3%)

204 (88.7%)

434 (96.7%)

 

Prosthesis

     

0.029

   One

230 (98.3%)

681 (96.9%)

150 (99.3%)

340 (98.0%)

537 (99.3%)

 

   Two

4 (1.7%)

22 (3.1%)

1 (0.7%)

7 (2.0%)

4 (0.7%)

 

Heterogenous device

1 (0.4%)

0

0

0

0

0.114

Device size (French)

25.0 ± 2.1

28.1 ± 3.1

24.9 ± 2.0

26.4 ± 2.2

25.0 ± 2.4

<0.001

Pacing during implant

71 (30.3%)

152 (21.6%)

16 (10.6%)

18 (5.2%)

501 (92.6%)

<0.001

Pacing rate (bpm)

181 ± 25

158 ± 36

145 ± 59

163 ± 24

182 ± 12

<0.001

Postdilation

111 (47.4%)

202 (28.7%)

2 (1.3%)

165 (47.6%)

27 (5.0%)

<0.001

Balloon diameter (mm)

23.2 ± 1.9

24.1 ± 2.6

20 ± 0

23.9 ± 2.0

22.4 ± 2.1

<0.001

Balloon length (mm)

42.1 ± 4.7

40.8 ± 2.4

40.0 ± 0

41.1 ± 2.9

40.9 ± 7.4

0.415

Fluoroscopy time (seconds)

22.7 ± 13.5

26.3 ± 16.3

30.0 ± 11.0

26.4 ± 14.1

21.5 ± 14.8

<0.001

Procedural time (minutes)

120.5 ± 50.8

113.0 ± 51.5

104.5 ± 39.6

87.4 ± 43.1

113.1 ± 46.6

<0.001

Device success

232 (99.2%)

693 (98.6%)

148 (98.0%)

343 (98.9%)

533 (98.5%)

0.899

Procedural success

232 (99.2%)

693 (98.6%)

148 (99.4%)

345 (99.4%)

533 (98.5%)

0.627

Complications

   Death

1 (0.4%)

2 (0.3%)

3 (2.0%)

1 (0.3%)

6 (1.1%)

0.085

   Valve migration

5 (2.1%)

7 (1.0%)

0

0

1 (0.2%)

0.007

   Anulus rupture

0

0

0

0

2 (0.4%)

0.257

   Surgical conversion

0

1 (0.1%)

1 (0.7%)

2 (0.6%)

2 (0.4%)

0.576

   Coronary occlusion

0

1 (0.1%)

0

0

2 (0.4%)

0.590

   Myocardial infarction

0

1 (0.1%)

0

0

1 (0.2%)

0.873

   Pericardial tamponade

1 (0.4%)

2 (0.3%)

3 (2.0%)

2 (0.6%)

8 (1.5%)

0.069

   Aortic dissection

0

3 (0.4%)

0

3 (0.9%)

2 (0.4%)

0.492

   Major vascular complication

7 (3.0%)

25 (3.6%)

5 (3.3%)

11 (3.2%)

21 (3.9%)

0.969

   Major bleeding

8 (3.4%)

39 (5.6%)

5 (3.3%)

8 (2.3%)

43 (8.0%)

0.002