Budget impact analysis of a bovine pericardial aortic bioprosthesis versus mechanical aortic valve replacement in adult patients with aortic stenosis in Romania

Figures & data

Figure 1. Model structure.

Table 1. Patient population and clinical outcomes (Base Case Parameters).

Variables	Period	BPAP	Mech. Valve	Sources
Start Age (mean, years)
Start Age	-	65	65	Vahanian 2022
Thromboembolic Events (TE)
Hazard Ratio (BPAP vs. Mech)	30-day	0.78	–	Kytö 2019
Hazard Ratio (BPAP vs. Mech)	1 Year	0.78	–	Kytö 2019
Disabling Stroke
Proportion of TE	30-day	18.5%	18.5%	Bourguignon 2015
Proportion of TE	1 Year	18.5%	18.5%	Bourguignon 2015
Reoperation
Event Rate	30-day	0.15%	0.06%	Bourguignon 2015, Brennan 2013.
Event Rate	1 Year	0.821%	0.244%	Bourguignon 2015, Brennan 2013.
Major Bleeding
Event Rate	30-day	0.33%	0.58%	Bourguignon 2015, Brennan 2013.
Event Rate	1 Year	0.404%	0.826%	Bourguignon 2015, Glaser 2016
Endocarditis
Event Rate	30-day	0.11%	0.11%	Habib 2015
Event Rate	1 Year	0.75%	0.75%	Habib 2015
Anticoagulation Complications
Re-admission Event Rate^1	6 week	0%	1.83%	Lopez-Marco 2021
Monitoring Event Rate^2	6 week	0%	7.30%	Habib 2015, Glaser 2016

Abbreviations. Mech, Mechanical valve; 30-day, initial 30-day period; 1 Year, annual event rate. 1. Re-admission to treat subtherapeutic INR. 2. INR check and anticoagulation dosage adjustment.

Table 2. Costs (in EUR) (Base Case Parameters).

State	Frequency/Setting	BPAP	Mechanical Valve	Sources
In-Hospital Procedure
Procedure
Procedure Cost	Per Procedure	2872.20	1787.20	Institutional Mean
Postprocedure
ICU	Per Procedure	315.00	315.00	Institutional Mean
General Ward	Per Procedure	210.00	210.00	Institutional Mean
Length of Stay (Days)	Intensive Care Unit	2.50	2.50	Institutional Mean/Median
Length of Stay (Days)	General Ward	8.50	11.50	Institutional Mean/Median
Outpatient Complications
Major Bleeding	Per Event	7966.00	7966.00	Institutional Mean
Endocarditis	Per Event	8883.00	8883.00	Institutional Mean
Thromboembolic event	Per Event	3400.00	3400.00	Institutional Mean
Disabling stroke (initial cost)	Per Event	3150.00	3150.00	Institutional Mean
Disabling stroke (future cost)	Per Month	448.99	448.99	PPP

Abbreviations. EUR, Euros; ICU, Intensive care unit; PPP, Purchasing power parity.

Table 3. Budget impact results (in 2022 EUR) by year.

	Year 1	Year 2	Year 3	Year 4	Year 5
Overall Budget Impact Results
Eligible population	1002	1998	2988	3972	4950
Population to receive a BPAP	51	110	176	249	328
Population to be on follow up care with a BPAP	0	51	161	337	586
Total cost of treatment pathway without a BPAP	7,423,013	8,585,934	9,580,466	10,501,266	11,348,789
Total cost of treatment pathway with a BPAP	7,441,222	8,603,108	9,596,261	10,515,368	11,360,852
Net budget impact	18,209	17,174	15,796	14,102	12,064
Disaggregated Budget Impact: BPAP vs. Mechanical Valves
Cost of initial procedure	23,654	26,947	30,201	33,414	36,583
Reoperation	1557	3186	4913	6724	8604
Other background medical costs	37	84	148	232	332
Endocarditis	0	0	0	0	0
Additional monitoring costs	0	0	0	0	0
Anticoagulation complications	−971	−1107	−1240	−1372	−1502
Disabling Strokes	−161	−423	−782	−1229	−1756
Minor thromboembolic event	−465	−892	−1332	−1796	−2285
Major Bleeding	−2477	−4395	−6423	−8546	−10,809
Acenocumarol	−2966	−6226	−9689	−13,325	−17,102
Net budget impact	18,209	17,174	15,796	14,102	12,064
Cost per Initial Procedure per Patient
BPAP Valve
Procedure	2872	2872	2872	2872	2872
Postprocedure	2593	2593	2593	2593	2593
Mechanical Valves
Procedure	1787	1787	1787	1787	1787
Postprocedure	3219	3219	3219	3219	3219
Net budget impact	460	460	460	460	460

Figure 2. Tornado diagram – BPAB vs. MV (costs and probabilities).