Health state/outcome (timeframe) | Study design (n=participants) | Estimate of effect, mean (SD) unless otherwise stated | Certainty of evidence | Interpretation of finding |
Mortality (30 days) | Adaptive swing weighting (109*) | Maximum acceptable increase in risk in exchange from SAVR to TAVI =3.7% (3.0)†. | Very low§¶** | The risk willingness of trading a reduction in mortality risk (30 days) for a less invasive procedure was uncertain and highly variable. |
Mortality and aortic stenosis-related symptoms and concerns (lifetime) | Standard gamble (429) | Median risk willingness=25% (IQR 25%–50%). No risk (0%)=104 (23%). Low risk (0%–8%)=26 (6%). High risk (>8%–50%)=224 (51%). Prohibitive risk (>50%–95%)=68 (15%). 95%–100%=17 (4%). | Low§¶ | The risk willingness of trading a reduction in mortality risk for full health with the procedure is highly variable among participants and across risk groups. |
Disabling non-fatal stroke (30 days) | Adaptive swing weighting (110*) | Maximum acceptable increase in risk in exchange from SAVR to TAVI=6.7% (5.7)†. | Very low§¶** | The risk willingness of trading a reduction in risk of disabling stroke for a less invasive procedure was uncertain and highly variable. |
Independence (30 days) | Adaptive swing weighting (131*) | Maximum acceptable reduction in benefit in exchange from SAVR to TAVI=13.9% (11.8)†. | Very low§¶** | The risk willingness of trading an increase of independence for a less invasive procedure was uncertain and highly variable. |
Requirement for dialysis (1 year) | Adaptive swing weighting (132*) | Maximum acceptable increase in risk in exchange from SAVR to TAVI=6.2% (5.6)†. | Very low§¶** | The risk willingness of trading a reduction in the requirement for dialysis at 1 year for a less invasive procedure was uncertain and highly variable. |
New permanent pacemaker (1 year) | Adaptive swing weighting (131*) | Maximum acceptable increase in risk in exchange from SAVR to TAVI=7.0% (5.7)‡. | Very low§¶** | The risk willingness of trading a reduction in permanent pacemaker insertion for a less invasive procedure was uncertain and highly variable. |
Time over which the procedure has been proven to work | Adaptive swing weighting (131*) | Maximum acceptable decrease in duration that the procedure is known to work in exchange from SAVR to TAVI=17.4 years (16.9)‡. | Very low§¶** | The risk willingness of trading the expected duration or a new valve for a less invasive procedure was uncertain and highly variable. |
*The total sample size was 219 participants, but they were not presented with all outcomes.
†Minimum acceptable reduction in benefit in exchange for reducing procedure invasiveness from ‘invasive’ to ‘minimally invasive’.
‡Maximum acceptable increase in risk in exchange for reducing procedure invasiveness from ‘invasive’ to ‘minimally invasive’.
§Serious risk of bias.
¶Serious imprecision.
**Serious indirectness.
GRADE, Grading of Recommendations Assessment, Development and Evaluation; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve insertion.