Table A3:
Inputs for Deterministic Sensitivity Analyses
| Variable | Mean | Source | Lower Bound Estimate | Upper Bound Estimate | Calculation of Lower and Upper Bounds |
|---|---|---|---|---|---|
| Clinical Event Rates and Treatment Costs | |||||
| Device embolization | 0.007 | PREVAIL, Holmes et al, 201420; PROTECT, AF, Reddy et al, 201440 | 0 | 0.014 | ± 50% of original estimate |
| Pericardial effusion | 0.037 | PREVAIL, Holmes et al, 201420; PROTECT, AF, Reddy et al, 201440 | 0 | 0.074 | ± 50% of original estimate |
| LAAC device implant unsuccessful | 0.075 | PREVAIL, Holmes et al, 201420; PROTECT, AF, Reddy et al, 201440 | 0 | 0.150 | ± 50% of original estimate |
| Baseline thromboembolic event rate (by CHA2DS2VASc score) | See Table 17 | Friberg et al, 201250 | Rate*0.5 | Rate*1.5 | ± 50% of original estimate |
| Baseline hemorrhagic stroke rate (by HAS-BLED score) | See Table 18 | Friberg et al, 201250 | Rate*0.5 | Rate*1.5 | ± 50% of original estimate |
| Baseline major bleed rate (by HAS-BLED score) | See Table 19 | Friberg et al, 201250 | Rate*0.5 | Rate*1.5 | ± 50% of original estimate |
| OR of ischemic stroke, LAAC device: warfarin | 1.56 | PREVAIL, Holmes et al, 201420; PROTECT, AF, Reddy et al, 201440 | 0.77 | 3.13 | Based on 95% CIs |
| OR of hemorrhagic stroke, LAAC device: warfarin | 0.21 | PREVAIL, Holmes et al, 201420; PROTECT, AF, Reddy et al, 201440 | 0.07 | 0.64 | Based on 95% CIs |
| OR of major bleed, LAAC device: warfarin | 0.95 | PREVAIL, Holmes et al, 201420; PROTECT, AF, Reddy et al, 201440 | 0.64 | 1.42 | Based on 95% CIs |
| Probability of fatal, major, moderate, and minor ischemic and hemorrhagic stroke | See Tables 17 and 18 | Goeree et al, 200554 | N/A | N/A | Assume all equally probable (0.25) |
| Utilities | |||||
| Myocardial infarction, first year | 0.87 | Tengs and Wallace 200063 | 0.5 | 1.00 | Range of MI utilities in Tengs and Wallace 200063 |
| Myocardial infarction, second year | 0.937 | Tengs and Wallace 200063 | 0.5 | 1.00 | Range of MI utilities in Tengs and Wallace 200063 |
| Myocardial infarction, third year | 0.95 | Tengs and Wallace 200063 | 0.5 | 1.00 | Range of MI utilities in Tengs and Wallace 200063 |
| Stroke | |||||
| Major (1 month) | 0.13 | Luengo-Fernandez et al, 201364 | 0.065 | 0.195 | ± 50% of original estimate |
| Major (post–1 month) | 0.41 | Luengo-Fernandez et al, 201364 | 0.205 | 0.615 | ± 50% of original estimate |
| Moderate (1 month) | 0.5 | Luengo-Fernandez et al, 201364 | 0.25 | 0.75 | ± 50% of original estimate |
| Moderate (post–1 month) | 0.65 | Luengo-Fernandez et al, 201364 | 0.325 | 0.975 | ± 50% of original estimate |
| Minor (1 month) | 0.73 | Luengo-Fernandez et al, 201364 | 0.365 | 1 | ± 50% of original estimate |
| Minor (post–1 month) | 0.74 | Luengo-Fernandez et al, 201364 | 0.37 | 1 | ± 50% of original estimate |
| Costs | |||||
| Cost of device | $10,000 | Manufacturer (Boston Scientific Corporation) | $5,000 | $15,000 | ± 50% of original estimate |
| Physician fees | $1,194 | Expert opinion | $597a | $2,031 | Expert opinion |
Abbreviations: CHADS2DS2VASc, Congestive heart failure, Hypertension, Age ≥ 75 years (2 points), Diabetes mellitus, Stroke or transient ischemic attack symptoms previously (2 points), Vascular disease, Age 65–74 years, Sex category; CI, confidence interval; HAS-BLED, Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratios (INRs), Elderly, Drugs or alcohol; LAAC device, left atrial appendage closure device with delivery system; OR, odds ratio.
a
Based on 50% of base case cost.