Table A2:
Quality of Studies Given Full-Text Review
| Objective: To Assess the Cost-Effectiveness of the LAAC Device | ||||
|---|---|---|---|---|
| Author, Year | Does the model structure adequately reflect the nature of the health condition under evaluation? | Is the time horizon sufficiently long to reflect all important differences in costs and outcomes? (e.g., if the rate of mortality differs between interventions, does the model take a lifetime horizon?) | Are all important and relevant health outcomes included? | Are the estimates of relative treatment effects obtained from the best available sources (in terms of the LAAC device)? |
| Patients Without Contraindications to OACs | ||||
| Amorosi et al, 201539 | Yes | No (10-year) | No (MI) | No (didn't use relative; rates of IS off) |
| Freeman et al, 201634 | Yes | Yes (lifetime) | Yes | No (didn't use relative; rates off for PREVAIL, major hemorrhage, bleed) |
| Lee et al, 201635 | Yes | Yes (lifetime) | Yes | No (didn't use relative; rates of IS off) |
| Micieli et al, 201637 | Yes | Yes (lifetime) | Most (SE, HS by severity) | No (no PREVAIL; underestimates IS; overestimates MB, HS) |
| Reddy et al, 201533 | Yes | Yes (lifetime) | Yes | No (no PREVAIL; underestimate IS; underestimates HS; overestimates MB) |
| Singh et al, 201338 | Yes | Yes (lifetime) | Most (SE, HS by severity) | No (no PREVAIL; underestimates IS; overestimates MB, HS) |
| Patients With Contraindications to OACs | ||||
| Reddy et al, 201632 | Yes | Yes (lifetime [20-year]) | Yes | Yes |
| Saw et al, 201636 | Yes | Yes (lifetime) | Yes (HS by severity) | Yes |
| Author, Year | Do the estimates of relative treatment effect match the estimates contained in the clinical report? | Are all important and relevant (direct) costs included in the analysis? | Are the estimates of resource use obtained from the best available sources? | Are the unit costs of resources obtained from the best available resources? | Is an appropriate incremental analysis presented, or can it be calculated from the reported data? |
|---|---|---|---|---|---|
| Patients Without Contraindications to OACs | |||||
| Amorosi et al, 201539 | N/A | No (cost of device unclear) | Unclear | Unclear | Yes |
| Freeman et al, 201634 | N/A | Yes | Yes | Yes | Yes |
| Lee et al, 201635 | N/A | Yes | Yes | Yes | Yes |
| Micieli et al, 201637 | N/A | No (only hospital costs for events) | Yes | Yes | Yes |
| Reddy et al, 201533 | N/A | Yes | Yes (U.S.) | Yes | Yes |
| Singh et al, 201338 | N/A | No (only hospital costs for events) | Yes | Yes | Yes |
| Patients With Contraindications to OACs | |||||
| Reddy et al, 201632 | Yes | Yes | Yes | Yes | Yes |
| Saw et al, 201636 | N/A | No (only hospital costs for events) | Yes | Yes | Yes |
| Author, Year | Are all important and uncertain parameters subjected to appropriate sensitivity analysis? | Is there a potential conflict of interest? | Overall assessment (minor limitations/potentially serious limitations/very serious limitations) |
|---|---|---|---|
| Patients Without Contraindications to OACs | |||
| Amorosi et al, 201539 | No | Yes | Very serious limitations |
| Freeman et al, 201634 | Yes | Yes | Very serious limitations |
| Lee et al, 201635 | Yes | Yes | Very serious limitations |
| Micieli et al, 201637 | Yes | No | Potentially serious limitations |
| Reddy et al, 201533 | Yes | Yes | Potentially serious limitations |
| Singh et al, 201338 | Yes | No | Potentially serious limitations |
| Patients With Contraindications to OACs | |||
| Reddy et al, 201632 | Yes | Yes | Minor limitations |
| Saw et al, 201636 | Yes | No | Minor limitations |
Abbreviations: HS, hemorrhagic stroke; IS, ischemic stroke; LAAC device, left atrial appendage closure device with delivery system; MB, major bleed; MI, myocardial infarction; N/A, not applicable; OAC, oral anticoagulant; SE, systemic embolism.