Valvular & structural heart disease
Optimal Oversizing With the New-Generation Evolut (PRO/PRO+/FX) Self-Expanding Valves: A Multicenter Study
Main finding · Presence of PVL (mild/moderate-severe), by echocardiographyResult — go to the resultOdds ratio 0.95 CI 0.92–0.99Authors' conclusion
In transcatheter aortic valve replacement with recent Evolut valve iterations (PRO/PRO+/FX), a higher oversizing degree was associated with a lower frequency of PVL without increasing the risk of other complications (including permanent pacemaker). These data suggest that a low degree of valve oversizing should probably be avoided when using Evolut valves, particularly in borderline cases.
Study context
- Population
- Patients undergoing transcatheter aortic valve replacement with the Evolut PRO/PRO+/FX valvespatients included (Evolut PRO/PRO+/FX, 55.5%/34.8%/9.7%)
- Participants
- 762 patients
- Exposure
- Low (≤20%) vs high (>20%) valve oversizing, estimated from multidetector computed tomography aortic annulus perimeter
- Low valve oversizingn = 381
- High valve oversizingn = 381
- Outcome
- Presence of PVL (mild/moderate-severe), by echocardiography
- Follow-up
- Hospital discharge
Main finding
As reported in the abstract
Odds ratio
0.95
CI 0.92–0.99
P = 0.006
By group
Each 1% increase in oversizing, as printed
- PVL, all patients
- 35.6%
- Mild PVL
- 32.6%
- Moderate-severe PVL
- 3.0%
Observational data: associations, not effects.
Secondary outcomes
- Median valve oversizing
- 20 (17-25)%
- No differences in baseline characteristics between low and high valve oversizing recipients
Safety
Permanent pacemaker · similar
P = 0.21
In-hospital mortality and stroke
- In-hospital mortality
- 2.4%
- Stroke
- 4.3%
- No oversizing-related differences in clinical outcomes
Original publication
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