Table 1.
GRADE evidence profile on risk estimates summarizing findings from observational studies of surgical aortic valve replacement in patients with severe aortic stenosis
| No of studies | Quality assessment | Effect | Quality | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | No of events | No of individuals | Estimate (95% CI) | ||||
| Survival (follow-up median 4.7 years; assessed with Kaplan-Meier) | ||||||||||||
| 85 | Observational studies | Not serious | Serious* | Not serious | Not serious | None | 14 053 | 45 347 | Survival at 5 years ≤65 83.7%; 65-75, 81.4%; 75-85 67.4%; and >85, 52.2% | Moderate | ||
| Stroke (follow-up median 5.1 years; assessed with incidence rate per 100 patient years) | ||||||||||||
| 8 | Observational studies | Not serious | Not serious | Not serious | Serious† | None | 64 | 6702 | Event rate 0.26 per 100 person years (0.06 to 0.54) | Moderate | ||
| Atrial fibrillation (follow-up mean 4.1 years; assessed with incidence rate per 100 patient years) | ||||||||||||
| 2 | Observational studies | Serious | Not serious | Not serious | Serious† | None | 21 | 177 | Event rate 2.90 per 100 person years (1.78 to 4.79) | Low | ||
| Structural valve deterioration (follow-up median 6.4 years; assessed with Kaplan-Meier) | ||||||||||||
| 12 | Observational studies | Not serious | Not serious | Not serious | Not serious | None | 418 | 7703 | 6.0% , 19.3%, and 48% by 10, 15, and 20 years, respectively | High | ||
| Length of hospital stay (assessed with mean; scale 0 to 100) | ||||||||||||
| 7 | Observational studies | Not serious | Not serious | Not serious | Not serious | None | - | 6405 | Mean 12 (9 to 15) | High | ||
*Wide variety of individual Kaplan-Meier curves around overall mega Kaplan-meier curve.
†Wide confidence interval around the point estimate of incidence rate.