Table 1.
Clinical Inputs Derived From Meta‐Analyses and Pivotal Trials
| Variable | Value | Range | Distribution | Source |
|---|---|---|---|---|
| LAAC: clinical trial‐based procedural events | ||||
| Implantation success | 92.50% | 85.00%–100.00% | β | 15 |
| Procedural risk of ischemic stroke | 0.82% | 0.66%–0.98% | β | 15 |
| Procedural risk of major bleeding | 0.55% | 0.44%–0.66% | β | 15 |
| Procedural risk of pericardial effusion requiring intervention | 3.69% | 2.95%–4.43% | β | 15 |
| Procedural risk of device embolization | 0.68% | 0.54%–0.82% | β | 15 |
| LAAC: post‐FDA, real‐world procedural events | ||||
| Implantation success | 95.60% | 85.00%–100.00% | β | 11 |
| Procedural risk of ischemic stroke | 0.05% | 0.04%–0.06% | β | 11 |
| Procedural risk of hemorrhagic stroke | 0.03% | 0.02%–0.03% | β | 11 |
| Procedural risk of major bleedinga | 0.55% | 0.44%–0.66% | β | 15 |
| Procedural risk of pericardial effusion | 1.02% | 0.82%–1.22% | β | 11 |
| Procedural risk of device embolization | 0.24% | 0.19%–0.29% | β | 11 |
| Procedural risk of death | 0.10% | 0.08%–0.13% | β | 11 |
| LAAC: postprocedural events | ||||
| Relative risk of postprocedure ischemic stroke (relative to warfarin) | 1.29 | 1.03–1.54 | Lognormal | 10 |
| Relative risk of hemorrhagic stroke (relative to warfarin) | 0.16 | 0.12–0.19 | Lognormal | 10 |
| Relative risk of postprocedure major bleeding (relative to warfarin) | 0.60 | 0.48–0.72 | Lognormal | 10 |
| Annual risk of systemic embolism | 0.10% | 0.08%–0.12% | β | 10 |
| Relative risk of myocardial infarction (relative to warfarin) | 0.50 | 0.40–0.60 | Lognormal | 8 |
| Risk of minor bleeding | Based on concomitant drug therapy | |||
| Warfarin | ||||
| Relative risk of ischemic stroke (relative to no therapy) | 0.33 | 0.23–0.46 | Lognormal | 20 |
| Relative risk of major bleeding (relative to HAS‐BLED) | 1.00 | 0.80–1.20 | Lognormal | 21 |
| Percentage of major bleeding that is hemorrhagic stroke | 41.80% | 33.40%–50.20% | β | 22 |
| Annual risk of systemic embolism | 0.11% | 0.90%–0.11% | β | 4, 6 |
| Annual risk of myocardial infarction | 1.47% | 0.53%–1.47% | β | 22 |
| Annual risk of minor bleeding | 7.70% | 0.80%–16.40% | β | 20, 21 |
| Nonclinical discontinuation rate | 4.33% | 3.46%–5.19% | Uniform | 16, 17, 18, 19 |
| NOACs | ||||
| Relative risk of ischemic stroke (relative to warfarin) | 0.92 | 0.83–1.02 | Lognormal | 22 |
| Relative risk of hemorrhagic stroke (relative to warfarin) | 0.48 | 0.39–0.59 | Lognormal | 22 |
| Relative risk of extracranial hemorrhage (relative to warfarin) | 1.25 | 1.01–1.55 | Lognormal | 22 |
| Relative risk of systemic embolism | 0.92 | 0.83–1.02 | Lognormal | 22 |
| Relative risk of myocardial infarction (relative to warfarin) | 0.97 | 0.78–1.20 | Lognormal | 22 |
| Annual risk of minor bleeding | 8.70% | 7.00%–10.40% | β | 20, 21 |
| Nonclinical discontinuation rate | 4.18% | 3.34%–5.01% | Uniform | 4, 6 |
| All treatment arms | ||||
| Discount rate | 3.00% | 2.00%–4.00% | β | 39 |
FDA indicates US Food and Drug Administration; LAAC, left atrial appendage closure; NOAC, nonwarfarin oral anticoagulant; HAS‐BLED, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drugs/alcohol.
a
Major bleeding was not an end point in the post‐FDA real‐world data study, so we have used the trial‐based event rate for this input.