Complication | AngioSeal Treated Patients | Mechanical Compression Treated Patients | |||||||
---|---|---|---|---|---|---|---|---|---|
95% CI | 95% CI | ||||||||
Patients | Events (%) | Lower | Upper | Patients | Events (%) | Lower | Upper | Sources | |
Bleeding | 480 | 8 (1.67%) | 0.52% | 2.81% | 561 | 43 (3.00%)* | 2.00% | 5.46% | 7,9,10 |
Hematoma | 463 | 22 (4.75%) | 2.81% | 6.69% | 549 | 31 (5.65%) | 3.72% | 7.58% | 8,9,10 |
Arterio-venous fistula | 1,471 | 3 (0.20%) | 0.00% | 0.43% | 8,642 | 72 (0.83%) | 0.64% | 1.02% | 3,4,14,15 |
Pseudoaneurysm | 627 | 6 (0.96%) | 0.19% | 1.72% | 699 | 12 (1.72%) | 0.75% | 2.68% | 6-11 |
Retroperitoneal hemorrhage | 627 | 2 (0.32%) | 0.00% | 0.76% | 699 | 1 (0.14%) | 0.00% | 0.42% | 6-11 |
Acute limb ischemia | 1,471 | 2 (0.14%) | 0.00% | 0.32% | 8,642 | 8 (0.09%) | 0.03% | 0.16% | 3,4,14,15 |
Access site infection | 306 | 1 (0.33%) | 0.01% | 0.97% | 306 | 0 (0.05%)† | 0.015 | 0.29% | 9 |
Complication | Total Events | Representative Cases | Median Cost (case) | Median Cost (control) | Attributable Cost | 95% CI | |
---|---|---|---|---|---|---|---|
Lower | Upper | ||||||
Bleeding | 71 | 6 | $17,167 | $11,727 | $5,440 | $2,250 | 10,226 |
Hematoma | 35 | 24 | $14,347 | $12,948 | $1,399 | $700 | 6,959 |
Arterio-venous fistula | 5 | 2 | $15,521 | $14,106 | $1,415 | $700 | 4,409 |
Pseudoaneurysm | 5 | 5 | $19,602 | $13,245 | $6,357 | $4,900 | 10,408 |
Retroperitoneal hemorrhage | 25 | 20 | $18,688 | $11,990 | $6,698 | $3,038 | 12,751 |
Acute limb ischemia | 3 | 2 | $23,238 | $17,704 | $5,534 | $5,200 | 14,000 |
Access site Infection* | 1 | 1 | n/a | n/a | $5,127 | ||
Compression | $2,400 | $1,500 | 3,300 | ||||
Angioseal | $4,200 | $3,000 | 6,000 |
Model Input | Base Case Value | Sensitivity Analysis | Threshold value* | |
---|---|---|---|---|
Lower bound | Upper bound | |||
Complication Rates | ||||
Access site bleeding | ||||
Angioseal | 1.67% | 0.52% | 2.81% | >2.49% |
Compression | 3.00% | 2.00% | 5.46% | <2.19% |
Pseudoaneurysm | ||||
Angioseal | 0.96% | 0.19% | 1.72% | >1.66% |
Compression | 1.72% | 0.75% | 2.68% | <1.02% |
Cost inputs | ||||
Access site bleeding | $5,440 | $2,250 | $10,226 | (<$2,105)† |
Compression cost | $110 | 0 | $150 | <$66 |
Angioseal cost | $190 | $100 | $300 | >$234 |