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Transcatheter aortic valve implantation using Evolut R and Evolut PRO seemed to be associated with a lower need for permanent pacemaker implantations compared to CoreValve.
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More-than-mild paravalvular leakage seemed to occur less often with repositionable technology.
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Addition of a sealing wrap in Evolut PRO did not further reduce the risk for more-than-mild paravalvular leakage compared to Evolut R in this study.
Introduction
Methods
Patient selection
Primary and secondary outcomes
Data analysis
Results
CoreValve (n = 116) | Evolut R (n = 160) | Evolut PRO (n = 92) | p-value | |
---|---|---|---|---|
Baseline characteristics | ||||
Male gender | 68 (59%) | 86 (54%) | 42 (46%) | 0.17 |
Age (years) | 80 (75–84) | 79 (73–84) | 80 (74–85) | 0.32 |
STS score (%) | 4.3 (3.1–5.7) | 4.2 (2.7–6.4) | 4.3 (2.5–6.5) | 0.86 |
Creatinine at baseline (µmol/l) | 95 (75–128) | 98 (75–117) | 90 (74–117) | 0.56 |
Body mass index (kg/m2) | 27 ± 4 | 27 ± 5 | 27 ± 5 | 0.78 |
Ischaemic heart disease | 53 (46%) | 70 (44%) | 31 (34%) | 0.18 |
History of AVR/TAVI | 5 (4%) | 14 (9%) | 7 (8%) | 0.36 |
Diabetes mellitus | 38 (33%) | 44 (28%) | 29 (32%) | 0.66 |
Hypertension | 87 (75%) | 121 (76%) | 71 (77%) | 0.93 |
History of atrial fibrillation | 28 (24%) | 47 (29%) | 22 (24%) | 0.52 |
History of stroke | 21 (18%) | 18 (11%) | 14 (15%) | 0.27 |
Peripheral arterial disease | 43 (37%) | 80 (50%)c | 27 (29%)c | 0.003 |
NYHA class ≥3 | 84 (75%)a | 93 (58%)a | 62 (68%) | 0.035 |
Bicuspid valve (functional) | 9 (8%) | 10 (6%) | 7 (8%) | 0.92 |
Moderate or severe annulus calcification (Rosenhek) | 92 (79%) | 126 (79%) | 77 (84%) | 0.46 |
Moderate or severe LVOT calcification | 20 (17%) | 22 (14%) | 14 (15%) | 0.65 |
Baseline conduction disturbances (alone or in combination) | ||||
RBBB | 7 (6%) | 15 (10%) | 11 (12%) | 0.32 |
LBBB | 18 (16%) | 11 (7%) | 6 (7%) | 0.03 |
UIVD | 3 (3%) | 3 (2%) | 3 (3%) | 0.79 |
AV1B | 26 (22%) | 28 (18%) | 21 (23%) | 0.52 |
LAFB | 15 (13%) | 12 (8%) | 4 (4%) | 0.08 |
LPFB | 1 (1%) | 1 (1%) | 0 (0%) | 0.69 |
Procedural details | ||||
Femoral access | 97 (84%)b | 142 (89%) | 89 (97%)b | 0.01 |
Target access vessel diameter (mm) | 7.0 ± 1.6 | 6.7 ± 1.4c | 7.4 ± 1.3c | 0.002 |
Sheath to femoral artery ratio | 1.03 (0.87–1.23)a,b | 0.87 (0.75–0.97)a | 0.80 (0.72–0.93)b | <0.005 |
Valve sizes (mm) | – | |||
23 | 2 (2%) | 7 (4%) | 2 (2%) | |
26 | 27 (23%) | 49 (31%) | 30 (33%) | |
29 | 58 (50%) | 78 (49%) | 60 (65%) | |
31 | 29 (25%) | – | – | |
34 | – | 26 (16%) | – | |
Perimeter derived annular diameter (mm) | 25.0 (23.4–26.7)a,b | 23.9 (22.4–25.5)a | 23.8 (22.5–24.9)b | <0.005 |
Annular sizing ratio | 1.15 (1.10–1.20)a,b | 1.19 (1.15–1.23)a | 1.18 (1.14–1.21)b | <0.005 |
Depth of implantation (mm) | 7.0 ± 3.2 | 7.0 ± 3.3 | 7.2 ± 2.6 | 0.85 |
Pre-dilatation | 92 (79%)a,b | 12 (8%)a | 11 (12%)b | <0.005 |
Post-dilatation | 32 (28%)a | 67 (42%)a | 38 (41%) | 0.03 |
Repositioning used? | – | 56 (35%) | 17 (19%) | <0.005 |
One time | 35 | 6 | ||
Two times | 14 | 7 | ||
Three times | 4 | 2 | ||
Four times | 3 | 2 | ||
Valve in valve during procedure | 8 (7%) | 6 (4%) | 4 (4%) | 0.47 |
Number of valves implanted | 1, range 1–3 | 1, range 1–3 | 1, range 1–2 | 0.23 |
Clinical outcomes among the three generations of SEV
CoreValve (n = 116) | Evolut R (n = 160) | Evolut PRO (n = 92) | p-value | |
---|---|---|---|---|
Clinical outcomes | ||||
Permanent pacemaker post-TAVI owing to: | 31 (27%) | 26 (16%) | 17 (18%) | 0.091 |
AV3B | 20 (65%) | 23 (89%) | 14 (82%) | – |
AV2B (Mobitz II) | 3 (10%) | 1 (4%) | 3 (18%) | – |
AF with bradycardia | 3 (10%) | 0 (0%) | 0 (0%) | – |
Sick sinus syndrome | 3 (10%) | 0 (0%) | 0 (0%) | – |
Other | 2 (7%) | 2 (8%) | 0 (0%) | – |
Mortality at 30 days | 8 (7%) | 6 (4%) | 1 (1%) | 0.10 |
Moderate to severe paravalvular leakage | 15 (13%) | 12 (8%) | 5 (6%) | 0.11 |
Moderate | 11 (10%) | 12 (8%) | 5 (6%) | |
Severe | 4 (3%) | 0 (0%) | 0 (0%) | |
Minor vascular complication | 11 (10%) | 11 (7%) | 3 (3%) | 0.21 |
Major vascular complication | 12 (10%) | 19 (12%) | 4 (4%) | 0.14 |
Minor bleeding | 7 (6%) | 15 (9%) | 5 (5%) | 0.42 |
Major or life-threatening bleeding | 17 (15%)** | 23 (14%)*** | 4 (4%)**,*** | 0.034 |
Major | 8 (7%) | 14 (9%) | 3 (3%) | |
Life-threatening | 9 (8%) | 9 (6%) | 1 (1%) | |
Any stroke | 7 (6%) | 4 (3%) | 2 (2%) | 0.21 |
Disabling | 5 (4%) | 2 (1%) | 1 (1%) | |
New conduction disturbances | ||||
Procedural AV3B | 24 (21%) | 29 (18%) | 15 (17%) | 0.74 |
Procedural LBBB | 65 (56%) | 87 (55%) | 51 (55%) | 0.99 |
Procedural RBBB | 2 (2%) | 2 (1%) | 0 (0%) | 0.48 |
Temporary LBBB | 37 (32%) | 40 (25%) | 30 (33%) | 0.34 |
Permanent LBBB | 35 (30%) | 51 (32%) | 29 (32%) | 0.95 |
Temporary RBBB | 4 (4%) | 10 (6%) | 2 (2%) | 0.26 |
Permanent RBBB | 0 (0%)** | 1 (1%)*** | 6 (7%)**,*** | 0.001 |
Temporary AV2B/AV3B | 8 (7%) | 10 (6%) | 13 (14%) | 0.08 |
Permanent AV2B/AV3B | 20 (17%) | 20 (13%) | 11 (12%) | 0.46 |
AV1B | 22 (19%) | 29 (18%) | 15 (17%) | 0.88 |
AF | 16 (14%)*,** | 8 (5%)* | 3 (3%)** | 0.005 |
Pacemaker implantation OR (95% CI) | p-value | |
---|---|---|
Type of THV used | ||
Evolut R | 1.00 (reference) | – |
CoreValve | 2.79 (1.31–5.94) | 0.008 |
Evolut PRO | 1.18 (0.52–2.71) | 0.69 |
Male gender | 0.71 (0.36–1.42) | 0.33 |
RBBB at baseline | 14.44 (5.59–37.28) | <0.005 |
LAFB at baseline | 1.28 (0.46–3.61) | 0.64 |
AV1B at baseline | 3.36 (1.64–6.87) | 0.001 |
Mean depth of implantation (mm) | 1.21 (1.09–1.34) | <0.005 |
Annular sizing ratio | 0.17 (0.002–11.700) | 0.41 |
Peripheral artery disease | 1.70 (0.91–3.18) | 0.098 |
Moderate or severe PVL OR (95% CI) | p‑value | |
Type of THV used | ||
Evolut R | 1.00 (reference) | – |
CoreValve | 2.06 (0.79–5.39) | 0.14 |
Evolut PRO | 0.53 (0.16–1.77) | 0.30 |
Bicuspid valve (functional) | 1.51 (0.46–4.96) | 0.49 |
Annular sizing ratio | 0.02 (0.000–5.410) | 0.18 |
Post-dilatation | 5.56 (2.23–13.86) | <0.005 |