Appendix Table 2.
Parameter Distributions for Probabilistic Sensitivity Analysis
| Variable | Mean (95% CI) | Type | Defining Parameters | References |
|---|---|---|---|---|
| Device implantation | ||||
| CRT-D procedural failure (%) | 6.0 (5.5–6.5) | Beta | α=502.4, β=7871.6 | 13 |
| CRT-D implant complication (%) | 5.0 (4.6–5.4) | Beta | α=480.6, β=9131.4 | 24 |
| ICD implant complication (%) | 3.0 (2.4–3.7) | Beta | α=83.9, β=2714.1 | 24 |
| CRT-D procedural death (%) | 0.30(0.15–0.50) | Beta | α=11.6, β=3863.4 | 24 |
| ICD procedural death (%) | 0.20(0.07–0.40) | Beta | α=6.0, β=3010.0 | 24 |
| Efficacy | ||||
| Mortality (risk ratio, CRT-D vs ICD) | 0.80(0.67–0.96) | Log normal | μ=-0.228, SE=0.102 | 13 |
| Hospitalization (risk ratio, CRT-D vs ICD) | 0.69(0.59–0.80) | Log normal | μ=-0.374, SE=0.081 | 12, 13 |
| Device complications | ||||
| CRT-D lead failure* | 0.0022 (0.0020–0.0024) | Beta | α=411.9, β=186818.8 | 25 |
| ICD lead failure* | 0.0015(0.0014–0.0017) | Beta | α=421.3, β=280424.7 | 25 |
| Lead infection* | 0.0007 (0.006–0.008) | Beta | α=184.3, β=263099.7 | 25–28 |
| Death from lead failure* | 0.013(0.009–0.018) | Beta | α=34.2, β=2593.8 | 29 |
| Death from lead infection* | 0.05 (0.03–0.08) | Beta | α=11.4, β=216.6 | 27, 30 |
| Length of lead failure hospitalization (days) | 2.0 (0.0–5.9) | Log normal | μ=0.347, SE=0.833 | Expert opinion |
| Length of lead infection hospitalization (days) | 5.0 (4.8–5.2) | Log normal | μ=1.609, SE=0.020 | CMS |
| CRT-D battery life (years) | 4.0 (1.9–5.9) | Log normal | μ=1.326, SE=0.263 | 31 |
| ICD battery life (years) | 5.0 (2.2–8.0) | Log normal | μ=1.588, SE=0.287 | 31 |
| Heart failure events | ||||
| Baseline hospitalization* | 0.008(0.004–0.013) | Beta | α=11.7, β=1449.3 | 11, 12 |
| Subsequent hospitalization* | 0.060 (0.055–0.065) | Beta | α=609.1,0=9541.9 | 23 |
| Death following heart failure hospitalization* | 0.050(0.046–0.054) | Beta | α=507.6, β=9643.5 | 23 |
| Length of heart failure hospitalization (days) | 5 (5–5) | Log normal | μ=1.609, SE=0 | CMS |
| Device costs, $ | ||||
| CRT-D implantation without complication | 40 892 (38 936–42 848) | Normal | SE=997.76 | CMS |
| ICD implantation without complication | 33 323(31 729–34 917) | Normal | SE=813.08 | CMS |
| CRT-D implantation with complication | 49 418(47 161–51 675) | Normal | SE=1151.44 | CMS |
| ICD implantation with complication | 41 850(39 939–43 761) | Normal | SE=975.11 | CMS |
| Failed CRT-D implantation | 33 892 (32 271–35 513) | Normal | SE=827.00 | CMS |
| CRT-D lead failure | 16 425(15 163–17 686) | Normal | SE=643.62 | CMS |
| ICD lead failure | 16 361 (15 104–17 618) | Normal | SE=641.13 | CMS |
| CRT-D lead infection | 49 149(47 685–50 613) | Normal | SE=747.06 | CMS |
| ICD lead infection | 40 812 (39 596–42 027) | Normal | SE=620.34 | CMS |
| CRT-D generator change | 34 902 (31 872–37 932) | Normal | SE=1546.16 | CMS |
| ICD generator change | 27 884(25 463–30 305) | Normal | SE=1235.26 | CMS |
| Heart failure costs | ||||
| Heart failure hospitalization | 6227 (6041–6413) | Normal | SE=94.80 | CMS |
| Heart failure background costs | 1298/month (1256–1340) | Normal | SE=21.68 | CMS, 32, 33 |
| Utilities | ||||
| CRT-D baseline utility | 0.884 (0.860–0.906) | Beta | α=661.2 β=86.8 | 15 |
| ICD baseline utility | 0.874(0.844–0.902) | Beta | α=439.6, β=63.4 | 15 |
| Decrement prior to heart failure hospitalization | 0.828 (0.809–0.846) | Beta | α=1347.7 β=280.3 | 35 |
| Duration of decrement prior to heart failure hospitalization | 7 days (0–21) | Log normal | μ=1.599, SE=0.832 | Expert opinion |
CMS = Centers for Medicare & Medicaid Services; CRT-D = cardiac resynchronization therapy combined with an ICD; ICD = implantable cardioverter-defibrillator.
*
Indicates unit in monthly probability terms.