Table 2.
Overview of cost data
| Variable | Mean | Uncertainty | Source |
| TAVI (high-risk operable patients) | |||
| TF | €40 917 | Normal (mean: 40 917; SD mean 1204) | Gov. Health Ins. Database* |
| TA | €49 799 | Normal (mean: 49 799; SD mean 1994) | Gov. Health Ins. Database* |
| All | €43 571† | ||
| TAVI (inoperable patients) | €40 057‡ | ||
| Standard therapy | €3170§ | ||
| AVR | €23 749¶ | Normal (mean: 23 749; SD mean 191) | Gov. Health Ins. Database** |
| Balloon aortic valvuloplasty | €489†† | Fixed fee | Belgian Nomenclature code |
| Repeat hospitalisation | €5983 | Gamma (mean: 5983; P5: 1339; P95: 15 596) | TCT, APR-DRG 194 (Heart failure) |
| Stroke | TCT, APR-DRG 045 (CVA with stroke) | ||
| Minor | €4679‡‡ | Gamma (mean: 3292; P5: 932; P95: 6842) | Minor |
| Gamma (mean: 6066; P5: 1574; P95: 17 285) | Moderate | ||
| Major | €12 493‡‡ | Gamma (mean: 9593; P5: 1630; P95: 27 526) | Major |
| Gamma (mean: 15 392; P5: 2631; P95: 40 079) | Extreme | ||
| TIA | €3946 | Gamma (mean: 3946; P5: 974; P95: 9942) | TCT, APR-DRG 047 (TIA) |
| Follow-up fees | €43.2/month§§ | Uniform (±50%) | Expert opinion |
| Follow-up drugs | €20.5/month¶¶ | Uniform (±50%) | Gov. Health Ins. Database* |
IMA data.
The weighted average of TF and TA TAVI cost. The weight is determined by the number of TF and TA patients in the PARTNER trial, being 244 and 104, respectively.
In the PARTNER trial, of the 179 patients assigned to TAVI, six (3.4%) did not receive a transcatheter heart valve: two patients died before the scheduled implantation, transfemoral access was unsuccessful in two patients and the intraprocedural annulus measurement was too large in two patients.1 Similarly, in our model, the complete TAVI procedure cost was assigned to 96.6% (173/179) of patients, 1.1% were assigned no costs because they died before the procedure and 2.2% was assigned the procedure cost without the TAVI device cost of €18 000. This results in an average cost of €40 057.
In the PARTNER trial, 12 of the patients who were assigned to standard therapy (6.7%) underwent aortic-valve replacement, five (2.8%) underwent placement of a conduit from the left ventricular apex to the descending aorta plus aortic valve replacement (AVR) and four (2.2%) underwent TAVI at a non-participating site outside the USA.1 Therefore, the cost of AVR is assigned to 9.5% (6.7% + 2.8%) of the patients and the TAVI cost to 2.2%. This results in an additional cost of €3170 in the standard therapy group.
The cost was calculated for patients (N=4811) older than 70 and an SOI index of 3 or 4. If this was restricted to patients (N=1506) older than 80 with an SOI index of 3 or 4, the cost remained the same (€23 772).
TCT data. Year of pricing: 2006–2010 for TAVI and standard therapy; 2008 for all TCT-based APR-DRG prices; 2004–2007 for AVR. Due to the incremental character of the analysis, price adjustments would have no substantial influence on results. Furthermore, the analysis in high-risk operable patients showed that the result is determined by the (lack of) incremental effect of TAVI versus AVR.
The fee is included explicitly in the control group. If this procedure would include a hospitalisation, then these costs are already included in the model as ‘repeat hospitalisation’. In the TAVI group, to avoid double counting, this cost is not included separately since it is part of the TAVI procedure, and thus, the cost is already included in the analysis.
For stroke, the TCT makes a distinction between four categories (minor, moderate, major and extreme). The former two categories were reclassified as minor stroke and the latter two as major stroke.
The follow-up costs included the following: four consultations cardiologist (€34.5/unit), four ECG (€17.18/unit); one echo, full transthoracal ultrasound bilan of the heart (€67.16/unit); three echo, repetition within the calendar year of full transthoracal ultrasound bilan of the heart (€67.16/unit) or limited transthoracal ultrasound bilan of the heart (€38.75); one full transoesophageal ultrasound bilan of the heart (€113.01/unit) or limited transoesophageal ultrasound bilan of the heart (€58.12/unit).
The selected drugs were the following: acenocoumarol, aspirin, clopidogrel, dalteparin, danaparoid, enoxaparin, fenprocoumon, heparin, nadroparine, ticlopidine, tirofiban and warfarin. The real-world expenditures in the Belgian Edwards TF TAVI group was €246 per year or €20.5 per month. For more details, we refer to the full HTA report.6
APR-DRG, All Patient Refined Diagnosis Related Groups; AVR, aortic valve replacement; Gov. Health Ins. Database, Governmental Health Insurance Database; IMA, Intermutualistic Agency; SOI, severity of illness; TAVI, transcatheter aortic valve implantation; TCT, Belgian Technical Cell; TIA, transient ischaemic attack.