Submitted:
03 January 2023
Posted:
06 January 2023
Read the latest preprint version here
Abstract
Keywords:
1. Introduction
2. Methods
Study and location
Comparators
Statistical analysis
Selection, measurement and valuation of resources and costs
| Study | Year | Currency | QALY benefit | ICER * | Complication cost * | Complication risk |
|---|---|---|---|---|---|---|
| Abraham et al. | 2011 | USD | 0,30 | €15.801,09 | - | 1,39% |
| Sandhu et al. | 2016 | USD | 0,28 | €77.484,34 | - | - |
| Martinson et al. | 2016 | USD | 0,40 | €20.075,32 | €6.256,26 | - |
| Schmier et al. | 2017 | USD | 0,58 | €47.925,24 | - | - |
| Cowie et al. | 2017 | EUR | 0,57 | €26.398,57 | €2.438,02 | 2,72% |
| Alcaraz et al. | 2021 | ARS | 0,37 | €18.913,27 | €1.087,79 | - |
| Mean: | 0,42 | €34.432,97 | €3.260,69 | 2,06% | ||
| Median: | 0,39 | €23.236,95 | €2.438,02 | 2,06% |
| Parameter | Cost | Source(s) | ||
|---|---|---|---|---|
| CardioMems HF device (each) | 11.440 € | Own | ||
| Pillow (each) | 1.210 € | Own | ||
| Implant procedure | 1.528 € | [15] | ||
| Outpatient costs | ||||
| Monitoring by the nurse (30’ daily, five days a week) | 16,31 € | [20] | ||
| Regular visits with the nurse (Every 4 months) | 80 € | [15] | ||
| Regular visits with the cardiologist (Every 6 months) | 80 € | [15] | ||
| Hospitalisation (per day) | 674 € | [15] | ||
Currency, price date, and conversion
3. Results
Study population
| CardioMEMS (n=35) | Matched cohort (n=58) | P-value* | |
|---|---|---|---|
| Age (years) | 76.1±7.5 | 75.4±8.5 | 0.66 |
| Male | 16 (45.7) | 26 (44.8) | 0.93 |
| BMI (Kg/m2) | 29.3±5.5 | 27.6±5.4 | 0.14 |
| LVEF (%) | 46±15 | 51±14 | 0.11 |
| NYHA class II III |
12 (34.3) 23 (65.7) |
20 (34.5) 38 (65.5) |
0.98 0.98 |
| Ischemic aetiology | 8 (22.8) | 28 (48.3) | 0.015 |
| Hypertension | 29 (82.9) | 40 (69.0) | 0.14 |
| Dyslipidaemia | 26 (74.3) | 24 (41.4) | 0.002 |
| Diabetes mellitus | 12 (34.3) | 19 (32.8) | 0.88 |
| Atrial fibrillation | 23 (65.7) | 21 (36.2) | 0.006 |
| COPD | 7 (20.0) | 11 (19.0) | 0.90 |
| Anaemia# | 18 (51.4) | 35 (60.3) | 0.40 |
| Serum creatinine (mg/dl) | 1.29±0.49 | 1.32±0.44 | 0.80 |
| Baseline HF medication Loop diuretic ACEI/ARB/ARNI Beta-blocker Digitalis Hydralazine MRA |
34 (97.1) 26 (74.3) 24 (68.6) 7 (20.0) 8 (22.9) 26 (74.3) |
51 (87.9) 46 (79.3) 26 (44.8) 19 (33.2) 6 (10.3) 10 (17.2) |
0.12 0.57 0.026 0.18 0.10 <0.001 |
| NT-proBNP (pg/ml) | 1806 [976-2825] | 1595 [717-3047] | 0.92 |
| ICD | 7 (20.0) | 2 (3.4) | 0.009 |
| CRT | 7 (20.0) | 1 (1.7) | 0.006 |
Clinical impact
Costs and benefits for the first year
| With CardioMEMS | % | Without CardioMEMS | % | |||
|---|---|---|---|---|---|---|
| CardioMEMS | Device | 11.440 € | 70,9% | 0 € | 0% | |
| Pillow | 1.210 € | 8% | 0 € | 0% | ||
| Implant procedure | 1.528 € | 9% | 0 € | 0% | ||
| Total device cost | 14.178 € | 87,9% | 0 € | 0% | ||
| Outpatient costs | Monitoring | 69 € | 0,43% | 0 € | 0,00% | |
| Nurse | 240 € | 1,49% | 240 € | 2,11% | ||
| Cardiologist | 160 € | 0,99% | 160 € | 1,41% | ||
| Total outpatient cost | 469 € | 2,87% | 400 € | 3,52% | ||
| Hospitalisation | 1.483 € | 9,19% | 10.955 € | 96,48% | ||
| Total costs | 16.129 € | 100,00% | 11.355 € | 100,00% | ||
| QALY (0,3) | 7.500 € | 100,00% | 0 € | 0,00% | ||
| Total benefits | 7.500 € | 100,00% | 0 € | 0,00% | ||
| Net monetary value per patient | 8.629 € | 11.355 € | ||||
Comparison of accumulated costs over 5 years


Sensitivity analysis
| Base (0,3) QALY benefit | Median (0,4) QALY benefit | High (0,5) QALY benefit | |
| -50% hospitalisation costs | 34.154,98 € | 25.616,24 € | 20.492,99 € |
| Base hospitalisation costs | 15.896,32 € | 11.922,24 € | 9.537,79 € |
| +50% hospitalisation costs | -2.362,34 € | -1.771,75 € | -1.417,40 € |
| 0 QALY benefit | Base (0,3) QALY benefit | Median (0,4) QALY benefit | |
| -50% hospitalisation costs | 2,74 | 1,47 | 1,04 |
| Base hospitalisation costs | 1,42 | 0,76 | 0,54 |
| +50% hospitalisation costs | 0,96 | 0,51 | 0,36 |
| -25% device costs | Base device costs | +25% device costs | |
| -50% hospitalisation costs | 22.339,98 € | 34.154,98 € | 45.969,98 € |
| Base hospitalisation costs | 4.081,32 € | 15.896,32 € | 27.711,32 € |
| +50% hospitalisation costs | -14.177,34 € | -2.362,34 € | 9.452,66 € |
4. Discussion
Limitations
Implications moving forward
5. Conclusions
Conflicts of Interest
References
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