Table 3. Summary table of primary outcomes.
| Outcomes | No. of participants (studies), follow up | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with RDV | Risk difference with outcomes for SURD | ||||
| Overall mortality | 2,836 (7 observational studies) | ⨁⨁◯◯ low | OR 0.91 (0.51 to 1.63) | 23 per 1,000 | 2 fewer per 1,000 (11 fewer to 14 more) |
| Stroke | 3,670 (6 observational studies) | ⨁⨁◯◯ low | OR 1.04 (0.55 to 1.98) | 26 per 1,000 | 1 more per 1,000 (11 fewer to 24 more) |
| Paravalvular leak: mild | 2,331 (5 observational studies) | ⨁◯◯◯ very lowa | OR 2.51 (1.35 to 4.68) | 34 per 1,000 | 47 more per 1,000 (11 more to 106 more) |
| Paravalvular leak: moderate + | 3,400 (7 observational studies) | ⨁◯◯◯ very lowa | OR 0.90 (0.33 to 2.47) | 13 per 1,000 | 1 fewer per 1,000 (9 fewer to 19 more) |
| Pacemaker implantation | 3,626 (7 observational studies) | ⨁◯◯◯ very lowb | OR 1.39 (0.98 to 1.97) | 67 per 1,000 | 24 more per 1,000 (1 fewer to 57 more) |
| Mean post-op gradient | 4,076 (7 observational studies) | ⨁⨁◯◯ low | – | The mean mean post-op gradient was 10.8 mmHg | MD 2.46 mmHg higher (1.18 higher to 3.75 higher) |
| Cross-clamp time | 4,076 (7 observational studies) | ⨁⨁◯◯ lowc | – | The mean cross-clamp time was 63.6 minutes | MD 11.33 minutes lower (16.32 lower to 6.33 lower) |
| CPB time | 4,076 (7 observational studies) | ⨁⨁◯◯ lowc | – | The mean CPB time was 93.4 minutes | MD 16.18 minutes lower (22.88 lower to 9.48 lower) |
The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). GRADE Working Group grades of evidence—high certainty: we are very confident that the true effect lies close to that of the estimate of the effect; moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different; low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect; very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. a, surgical experience with these new prostheses is known to affect decisions in sizing. This has a direct impact on post-operative trans-valvular mean gradients. There is limited data available to assess learning curve effects and surgical experience; b, known significant learning curve that has a direct impact on pacemaker implantation rates. Limited data present on individual surgeon experience; c, learning curve may affect operative duration times. Limited data on operator experience. SURD, sutureless rapid deployment valve; RDV, rapid deployment valve; CI, confidence interval; OR, odds ratio; MD, mean difference; CPB, cardiopulmonary bypass.