Background
Methods
Study characteristics
Data extraction
Statistical analysis
Results
Baseline patient details
N | TAVI with BAV N = 339 | TAVI without BAV N = 355 | P-value | |
---|---|---|---|---|
Patient characteristics | ||||
Age (years) | 694 | 82 (79–86) | 81 (78–86) | 0.057 |
Female (%) | 694 | 49.9 | 45.4 | 0.254 |
Height (cm) | 694 | 166 (160–172) | 168 (160–175) | 0.052 |
Weight (kg) | 694 | 72 (63–82) | 75 (63–87) | 0.027 |
Body surface area (cm2)a | 694 | 1.81 (1.68–1.94) | 1.84 (1.68–2.01) | 0.032 |
BMI (kg/m2) | 692 | 26 (23–29) | 26 (24–30) | 0.207 |
Hypertension (%) | 678 | 85.2 | 88.4 | 0.255 |
Diabetes (%) | 676 | 31.0 | 32.9 | 0.621 |
Stroke, TIA (%) | 678 | 13.5 | 16 | 0.387 |
Peripheral artery disease (%) | 679 | 43.4 | 23.9 | < 0.001 |
Pulmonary hypertension (%) | 527 | 33.0 | 38.6 | 0.202 |
Creatinine > 2 mg/dL (%) | 694 | 5.9 | 6.2 | 0.875 |
Dialysis (%) | 361 | 6.4 | 2.7 | 0.108 |
Coronary artery disease (%) | 694 | 61.9 | 64.8 | 0.478 |
Prior myocardial infarction (%) | 557 | 29.8 | 24.4 | 0.182 |
Prior CV intervention (%) | 694 | 36.3 | 44.8 | 0.025 |
Prior pacemaker / ICD implant (%) | 501 | 17.6 | 12.7 | 0.152 |
EuroSCORE II | 588 | 4 (2–8) | 5 (3–10) | 0.005 |
STS Risk Score | 616 | 5.3 (3.2–10.0) | 4.6 (3.0–8.0) | 0.002 |
Disease characteristics | ||||
Echo AV peak PG (mmHg) | 533 | 70 (57–82) | 69 (55–81) | 0.275 |
Echo AV mean PG (mmHg) | 649 | 43 (35–54) | 41 (33–50) | 0.111 |
Echo Vmax (m/s) | 435 | 4.0 (3.7–4.4) | 4.1 (3.6–4.5) | 0.965 |
Echo ejection fraction (%) | 653 | 55 (47–60) | 55 (45–60) | 0.324 |
Effective orifice area | 534 | 0.70 (0.57–0.80) | 0.70 (0.60–0.80) | 0.043 |
Indexed effective orifice areab | 533 | 0.38 (0.31–0.46) | 0.39 (0.32–0.46) | 0.348 |
NYHA Class III or IV | 685 | 79.8 | 75.9 | 0.232 |
CCS grading of angina pectoris Class III or IV | 645 | 16.8 | 17.0 | 1.000 |
Dizziness or syncope | 694 | 30.1 | 30.1 | 1.000 |
Periprocedural details
TAVI with BAV | TAVI without BAV | P-value | |||
---|---|---|---|---|---|
N | Value | N | Value | ||
Valve size | 339 | 355 | < 0.001 | ||
20–23 mm | 28.9 | 31.0 | |||
26 mm | 45.1 | 41.1 | |||
29 mm | 26.0 | 27.9 | |||
Post-delivery balloon dilation (%) | 339 | 22.4 | 355 | 15.5 | 0.020 |
Quantity contrast agent used (mL) | 303 | 100 (73–131) | 349 | 95 (70–126) | 0.343 |
Access complications (%) | 339 | 0.9 | 355 | 2.3 | 0.224 |
Hemodynamic instability (%) | 117 | 5.1 | 277 | 2.5 | 0.219 |
Catecholamine use (inotropes) (%) | 117 | 17.9 | 277 | 9.0 | 0.016 |
Effective orifice area post-surgery | 119 | 1.89 (1.59/2.30) | 114 | 1.80 (1.50/2.20) | 0.378 |
Indexed effective orifice area | 282 | 0.38 (0.31/0.46) | 251 | 0.39 (0.31/0.46) | 0.348 |
AV mean PG post-surgery | 286 | 9.0 (6.0/12.0) | 252 | 9.0 (6.0/12.8) | 0.862 |
Paravalvular regurgitation | 339 | 351 | < 0.001 | ||
None/trace | 78.5 | 84.3 | |||
Mild | 18.9 | 15.1 | |||
Moderate | 2.4 | 0.6 | |||
Severe | 0.3 | 0.0 | |||
Device success (%) | 339 | 97.9 | 355 | 99.2 | 0.214 |
Second valve needed (%) | 339 | 1.2 | 355 | 0.8 | 0.719 |
Conversion to surgery (%) | 141 | 3.5 | 280 | 2.1 | 0.518 |
Coronary artery obstruction requiring intervention (%) | 213 | 0.9 | 71 | 0.0 | 1.000 |
Device malfunction (%) | 339 | 0.6 | 355 | 0.3 | 0.616 |
Atrioventricular block (%) | 339 | 4.1 | 355 | 1.4 | 0.035 |
Aortic root rupture (%) | 339 | 0.3 | 355 | 0.0 | 0.488 |
Correct positioning of a single prosthetic valve into the proper anatomical location | 339 | 99.1 | 355 | 99.7 | 0.363 |
Intended performance of the prosthetic valve | 287 | 97.9 | 217 | 98.6 | 0.738 |
TAVI with BAV | TAVI without BAV | OR (95% CI) | Adjusted ORa (95% CI) | |
---|---|---|---|---|
Post-delivery balloon dilation (%) | 22.4 | 15.5 | 0.63 (0.43–0.93) | 0.67 (0.41–1.06) |
Catecholamine use (Use of inotropes) (%) | 17.9 | 9.0 | 0.45 (0.24–0.85) | 0.56 (0.24–1.38) |
Atrioventricular block (%) | 4.1 | 1.4 | 0.33 (0.11–0.88) | 0.44 (0.12–1.38) |
Correct positioning of a single prosthetic valve into the proper location (%) | 99.1 | 99.7 | 3.16 (0.4–64.07) | 2.13 (0.24–45.99) |
Intended performance of the prosthetic valve (%) | 97.9 | 98.6 | 2.11 (0.55–10.08) | 1.06 (0.22–5.69) |
Procedural efficacy
30-day outcomes
TAVI with BAV | TAVI without BAV | OR (95% CI) | ||||
---|---|---|---|---|---|---|
N | % | N | % | Not-adjusted | Adjusteda | |
Death (%) | 327 | 1.8 | 343 | 1.5 | 0.79 (0.23–2.65) | 0.4 (0.06–1.86) |
Stroke (%) | 327 | 0.9 | 341 | 0.3 | 0.32 (0.02–2.5) | 0.79 (0.02–27.7) |
Non-fatal MI (%) | 336 | 0.6 | 349 | 0.9 | 1.45 (0.24–11.05) | 1.29 (0.12–13.1) |
New-onset dialysis (%) | 332 | 3.9 | 348 | 3.7 | 0.95 (0.43–2.1) | 0.97 (0.4–2.32) |
Creatinine increase (%) | 268 | 1.5 | 210 | 1.4 | 0.96 (0.19–4.38) | 0.42 (0.02–3.22) |
Permanent pacemaker implantation (%) | 337 | 10.1 | 350 | 8.6 | 0.84 (0.5–1.4) | 1.17 (0.62–2.2) |
Life-threatening bleeding (%) | 333 | 3.0 | 345 | 1.4 | 0.48 (0.15–1.35) | 0.42 (0.09–1.48) |
Major vascular complications (%) | 333 | 4.5 | 345 | 3.5 | 0.76 (0.35–1.66) | 0.63 (0.21–1.65) |
Hospitalization (%) | 333 | 2.7 | 344 | 1.2 | 0.42 (0.11–1.31) | 0.48 (0.09–1.9) |
Valve dysfunction (%) | 322 | 0.9 | 337 | 0.0 | – | – |
NYHA Class III or IV (%) | 336 | 54.5 | 346 | 17.6 | 0.18 (0.13–0.25) | 0.18 (0.12–0.27) |
CCS grading of angina pectoris Class III or IV (%) | 308 | 1.6 | 296 | 1.0 | 0.62 (0.13–2.55) | 0.98 (0.18–4.8) |
Outcomes by access route
TF access | TA access | TAo access | ||||
Xw/Xwo | p-value | Xw/Xwo | p-value | Xw/Xwo | p-value | |
Valve size | 0.038 | 0.005 | 0.001 | |||
20–23 mm | 37.5 / 31.4 | 29.5 / 30.7 | 26.6 / 30.8 | |||
26 mm | 23.2 / 39.3 | 49.2 / 40.9 | 49.5 / 44.9 | |||
29 mm | 39.3 / 29.3 | 21.3 / 28.5 | 23.9 / 24.4 | |||
Quantity contrast agent used (mL) | 131 / 120 | 0.240 | 85 / 80 | 0.681 | 94 / 80 | 0.008 |
Effective orifice area post-surgery | 1.40 / 1.65 | 0.203 | 2.10 / 2.00 | 0.222 | 1.80 / 1.82 | 0.809 |
Indexed effective orifice area | 0.71 / 0.87 | 0.175 | 1.17 / 1.04 | 0.137 | 1.04 / 1.00 | 0.857 |
AV mean PG post-surgery | 12 / 11 | 0.138 | 4 / 5 | 0.641 | 9 / 10 | 0.863 |
Paravalvular regurgitation | 0.001 | < 0.001 | < 0.001 | |||
None/trace | 85.7 / 86.0 | 78.7 / 84.7 | 76.6 / 80.8 | |||
Mild | 14.3 / 13.2 | 21.3 / 14.6 | 19.4 / 19.2 | |||
Moderate | 0 / 0.7 | 0 / 0.7 | 3.6 / 0 | |||
Severe | 0 / 0 | 0 / 0 | 0.5 / 0 | |||
TF access | TA access | TAo access | ||||
Xw/Xwo | OR (95% CI) | Xw/Xwo | OR (95% CI) | Xw/Xwo | OR (95%CI) | |
Post-delivery balloon dilation (%) | 30.4 / 15.7 | 0.43 (0.21–0.89) | 14.8 / 9.5 | 1.65 (0.65–4.07) | 22.5 / 25.6 | 0.84 (0.47–1.56) |
Access complications (%) | 0 / 5 | n.a. | 0 / 0.7 | n.a. | 1.4 / 0 | n.a. |
Hemodynamic instability (%) | 3.6 / 0.7 | 0.19 (0.01–2.07) | 6.6 / 4.4 | 0.65 (0.18–2.63) | n.c. | n.a. |
Catecholamine use (%) | 1.8 / 0.7 | 0.4 (0.02–10.12) | 32.8 / 17.5 | 0.44 (0.22–0.87) | n.c. | n.a. |
Device success (%) | 92.9 / 98.6 | 5.31 (1.01–39.12) | 100 / 100 | n.a. | 98.6 / 98.7 | 0.95 (0.05–7.53) |
Second valve needed (%) | 0 / 0.7 | n.a. | 0 / 0 | n.a. | 1.8 / 2.6 | 0.7 (0.13–5.1) |
Conversion to surgery (%) | 0 / 2.9 | n.a. | 0 / 1.5 | n.a. | 1.7 / 0 | n.a. |
Device malfunction (%) | 0 / 0 | n.a. | 0 / 0.7 | n.a. | 0.9 / 0 | n.a. |
Atrioventricular block (%) | 3.6 / 2.1 | 0.59 (0.1–4.58) | 1.6 / 1.5 | 0.89 (0.08–19.34) | 5 / 0 | n.a. |
Aortic root rupture (%) | 0 / 0 | n.a. | 0 / 0 | n.a. | 0.5 / 0.0 | n.a. |
Correct positioning of a single prosthetic valve into the proper anatomical location (%) | 100 / 100 | n.a. | 100 / 100 | n.a. | 98.6 / 98.7 | 1.05(0.13–21.5) |
Intended performance of the prosthetic valve (%) | 92.9 / 98.6 | 5.31 (1.01–39.1) | 100 / 100 | n.a. | 99.1 / 98.7 | 0.7 (0.07–15.2) |
TF access | TA access | TAo access | ||||
---|---|---|---|---|---|---|
Xw/Xwo | OR (95%CI) | Xw/Xwo | OR (95%CI) | Xw/Xwo | OR (95%CI) | |
Death (%) | 0 / 1.4 | n.a. | 0 / 0.8 | n.a. | 2.8 / 2.8 | 1 (0.14–4.46) |
Stroke (%) | 0 / 0 | n.a. | 0 / 0 | n.a. | 1.4 / 1.4 | 1 (0.05–7.95) |
Non-fatal MI (%) | 0 / 0.7 | n.a. | 1.6 / 0.7 | 0.44 (0.05–11.28) | 0.5 / 1.4 | 2.99 (0.12–76.16) |
New onset dialysis (%) | 0 / 0.7 | n.a. | 4.9 / 5.1 | 1.04 (0.25–4.96) | 9.2 / 10.3 | 1.13 (0.23–4.66) |
Creatinine increase (%) | 0 / 1.4 | n.a. | – | 1.9 / 1.4 | 0.74 (0.04–5.13) | |
PPI (%) | 8.9 / 7.2 | 0.79 (0.27–2.64) | 14.8 / 10.2 | 0.66 (0.27–1.67) | 9.1 / 8.1 | 0.88 (0.31–2.17) |
Life-threatening bleeding (%) | 1.8 / 1.4 | n.a. | 1.7 / 0.8 | 0.44 (0.02–11.13) | 3.7 / 2.7 | 0.73 (0.11–3.01) |
Major vascular complications (%) | 10.7 / 5.8 | 0.51 (0.17–1.61) | 1.7 / 1.5 | 0.88 (0.08–19.09) | 3.7 / 2.7 | 0.73 (0.11–3.01) |
Hospitalization (%) | 1.8 / 0.7 | 0.40 (0.02–10.27) | 1.7 / 0 | n.a. | 3.2 / 4.1 | 1.28 (0.27–4.74) |
Valve dysfunction (%) | 0 / 0 | n.a. | 0 / 0 | n.a. | 1.4 / 0 | n.a. |
NYHA Class III or IV (%) | 5.04 / 8.1 | 1.55 (0.46–7.08) | 1.7 / 2.3 | 1.33 (0.17–27.11) | 80.6 / 60.3 | 0.36 (0.21–0.64) |
CCS III or IV (%) | 0 / 0 | n.a. | 0 / 0 | n.a. | 2.5 / 6.4 | 2.62 (0.52–11.08) |