Table 2.
Effect of LLTS on AF burden and cytokine levels
| Active | Control | Outcome (3 and 6 months combined) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Outcome | Baseline (N=26) | 3 months (N=25) | 6 months (N=24) | Baseline (N=27) | 3 months (N=26) | 6 months (N=23) | Ratio of medians (Active vs. sham) | 95% CI | p-value |
| AF burden | |||||||||
| AF burden (%) | 4.5 (0.2 – 31) | 2.0 (0 – 21) | 2.0 (0 – 11) | 1.0 (0 – 15) | 3.0 (0.1 – 11) | 8.5 (0 – 42) | 0.25 | 0.08 – 0.77 | 0.016 |
| Total AF duration (hours) | 12.0 (0.1 – 77) | 6.5 (0 – 62) | 7.0 (0 – 37) | 2.0 (0 – 43) | 4.0 (0.2 – 37) | 19.8 (0 – 77) | 0.27 | 0.07 – 1.08 | 0.064 |
| Longest daily AF duration (hours) | 6.0 (0 – 21) | 6.5 (0 – 24) | 6.0 (0 – 19) | 2.0 (0 – 13) | 3.5 (0 – 16) | 10.3 (0 – 23) | 0.51 | 0.13 – 1.97 | 0.33 |
| Cytokines | |||||||||
| TNF-α (pg/ml) | 6.9 (4.6 – 9.3) | 5.2 (3.8 – 9.2) | 5.5 (3.9 – 8.3) | 5.4 (4.3 – 9.1) | 6.5 (4.5 – 9.4) | 5.4 (4.4 – 8.3) | 0.77 | 0.63 – 0.94 | 0.0093 |
| IL-6 (pg/ml) | 1.6 (0.5 – 3.7) | 1.6 (0.5 – 2.7) | 1.5 (0.7 – 3.2) | 2.0 (0.9 – 3.7) | 2.2 (1.2 – 4.3) | 2.3 (1.0 – 4.4) | 0.99 | 0.64 – 1.51 | 0.94 |
| IL-1β (pg/ml) | 0.9 (0.4 – 15) | 0.7 (0.5 – 12) | 0.8 (0.5 – 11) | 1.0 (0.4 – 13) | 0.8 (0.3 – 12) | 0.7 (0.3 – 12) | 1.13 | 0.97 – 1.30 | 0.11 |
| IL-10 (pg/ml) | 6.2 (1.3 – 10.4) | 4.4 (2.1 – 9.6) | 5.0 (2.0 – 7.3) | 11.7 (3.5 – 19.5) | 10.0 (4.1 – 21.2) | 9.0 (3.7 – 15.3) | 1.02 | 0.79 – 1.31 | 0.88 |
| IL-17 (pg/ml) | 5.2 (2.2 – 9.6) | 4.7 (2.8 – 10.0) | 4.6 (2.7 – 9.3) | 5.6 (2.9 – 9.5) | 5.1 (2.3 – 11.6) | 3.8 (2.2 – 6.4) | 1.11 | 0.90 – 1.38 | 0.34 |
Data are presented as median (interquartile range). The p-value is based on a comparison of median levels at the 3-month and 6-month time points combined, after adjusting for baseline measures using Generalized Estimating Equations methodology to fit linear regression models.