Variable | Base Case Value | Range | Distribution for probabilistic sensitivity analysis | Reference |
---|---|---|---|---|
Characteristics of patients’ population |  |  |  |  |
Age, years | 62 | 50–80 | Normal | [13] |
 |  |  | (SD =12) |  |
Male gender, % | 77 | 0–100 | Beta |  |
Proportion of patients with severe MR at baseline in both arms | 0.639 | 0.511–0.766 | Beta |  |
 |  |  | (α = 23; β = 13) |  |
Proportion of patients with severe MR between 1 and 5 months in PMVR arm | 0.35 | 0.28–0.42 | Beta |  |
 |  |  | (α = 12; β = 22) |  |
Proportion of patients with severe MR from 6 months and onwards in PMVR arm | 0.258 | 0.206–0.309 | Beta |  |
 |  |  | (α = 8; β = 23) |  |
Effectiveness data and transition probabilities | Â | Â | Â | Â |
Probability of peri-procedural mortality | 0.019 | 0.01–0.03 | Beta | [13] |
 |  |  | (α = 1; β = 52) |  |
Probability of myocardial infarction, which leads to PCI | 0.04 | 0.02–0.06 | Beta |  |
 |  |  | (α = 2; β = 51) |  |
Probability of vessel perforation | 0.02 | 0–0.03 | Beta |  |
 |  |  | (α = 1; β = 52) |  |
Probability of unsuccessful percutaneous annuloplasty | 0.32 | 0.05–0.40 | Beta |  |
 |  |  | (α = 17; β = 36) |  |
Probability of arrhythmia | 0.04 | 0.02–0.06 | Beta | Assumption |
 |  |  | (α = 2; β = 51) |  |
Six-month probability of excess mortality for NYHA class II | 0.04 | 0.02–0.06 | Beta | [22] |
 |  |  | (α = 4; β = 96) |  |
Six-month probability of excess mortality for NYHA class III | 0.07 | 0.035–0.105 | Beta |  |
 |  |  | (α = 7; β = 93) |  |
Six-month probability of excess mortality for NYHA class IV | 0.28 | 0.14–0.42 | Beta |  |
 |  |  | (α = 28; β = 72) |  |
Monthly probability of hospitalization for NYHA class I | 0.015 | 0.008–0.023 | Beta | [21] |
 |  |  | (α = 1.5; β = 98.5) |  |
Monthly probability of hospitalization for NYHA class II | 0.024 | 0.012–0.036 | Beta |  |
 |  |  | (α = 2.4; β = 97.6) |  |
Monthly probability of hospitalization for NYHA class III | 0.024 | 0.012–0.036 | Beta |  |
 |  |  | (α = 2.4; β = 97.6) |  |
Monthly probability of hospitalization for NYHA class IV | 0.154 | 0.077–0.231 | Beta |  |
 |  |  | (α = 15.4; β = 84.6) |  |
Relative risk for all-cause mortality with present severe MR | 1.5 | 1.1–1.9 | Log-normal (SElog = 0.26) | [23] |
Relative risk for hospitalization due to HF with present severe MR | 1.7 | 1.3–2.1 | Log-normal (SElog = 0.33) |  |
Resource utilization and cost data | Â | Â | Â | Â |
Cost of Carillon device, € | 18,000 | 12,600–23,400 | - | Cardiac Dimensions, Inc. |
Cost of PMVR placement procedure, € | 4844 | 3391–6297 | - | G-DRG code F19C |
Cost of treatment of vessel perforation after PMVR placement, € | 1998 | 1399–2597 | - |  |
Percentage of patients being hospitalized with stay in intensive care unit | 7.2Â % | - | Dirichlet | [27] |
Percentage of patients being hospitalized with stay in coronary care unit | 25.6Â % | - | Â | Â |
Percentage of patients being hospitalized with CABG performed | 0.3Â % | - | Â | Â |
Percentage of patients being hospitalized with PTCA performed | 0.2Â % | - | Â | Â |
Percentage of patients being hospitalized with heart transplantation performed | 2.6Â % | - | Â | Â |
Percentage of patients being hospitalized with no procedure performed | 62.3Â % | - | Â | Â |
Cost of hospitalization with stay in intensive care unit, € | 5004 | 3503–6506 | - | G-DRG code F62A 2013 |
Cost of hospitalization with stay in coronary care unit, € | 5004 | 3503–6506 | - | G-DRG code F62A 2013 |
Cost of hospitalization with CABG performed, € | 15,056 | 10,539–19,573 | - | G-DRG code F06E |
Cost of hospitalization with PTCA performed, € | 3793 | 2655–4931 | - | G-DRG code F56B plus ZE101 |
Cost of hospitalization with heart transplantation performed, € | 86,337 | 60,436–112,239 | - | G-DRG code A05B 2013 |
Cost of hospitalization with no procedure performed, € | 2740 | 1918–3562 | - | G-DRG code F62B 2013 |
Annual cost of routine management of heart failure in NYHA class I, € | 495 | 258–1031 | Gamma | [26] |
 |  |  | (α = 1;λ = 516) |  |
Annual cost of routine management of heart failure in NYHA class II, € | 874 | 455–1821 | Gamma |  |
 |  |  | (α = 1;λ = 910) |  |
Annual cost of routine management of heart failure in NYHA class III, € | 864 | 450–1800 | Gamma |  |
 |  |  | (α = 1;λ = 900) |  |
Annual cost of routine management of heart failure in NYHA class IV, € | 929 | 484–1935 | Gamma |  |
 |  |  | (α = 1;λ = 967) |  |
Utility data | Â | Â | Â | Â |
Utility for NYHA I class | 0.815 | 0.652–0.978 | Beta | [27] |
 |  |  | (α = 395; β = 90) |  |
Utility for NYHA II class | 0.720 | 0.576–0.864 | Beta |  |
 |  |  | (α = 662; β = 257) |  |
Utility for NYHA III class | 0.590 | 0.472–0.708 | Beta |  |
 |  |  | (α = 360; β = 250) |  |
Utility for NYHA IV class | 0.508 | 0.406–0.609 | Beta (α = 52; β = 50) |  |
Decrement for percutaneous annuloplasty procedure | 0.043 | 0.034–0.051 | Beta | [29] |
 |  |  | (α = 96; β = 2129) |  |