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Original article
DOI: 10.1016/j.rec.2021.02.013
Available online 18 May 2021
Cost-effectiveness analysis of the SAPIEN 3 transcatheter aortic valve implant in patients with symptomatic severe aortic stenosis
Análisis coste-efectividad del implante percutáneo de válvula aórtica SAPIEN 3 en pacientes con estenosis aórtica grave sintomática
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Eduardo Pinara,
Corresponding author
epbhva@yahoo.es

Corresponding author: Sección de Hemodinámica-Cardiología Intervencionista, Hospital Universitario Virgen de la Arrixaca, Ctra. Cartagena s/n, 30120 El Palmar, Murcia, Spain.
, Juan García de Laraa, José Hurtadoa, Miguel Roblesb, Gunnar Leitholda, Belén Martí-Sánchezc, Jesús Cuervod, Domingo A. Pascuala, Anabel Estévez-Carrillod, Carlos Crespod,e
a Servicio de Cardiología, Hospital Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain
b Servicio de Contabilidad de Ingresos y Gastos, Servicio Murciano de Salud, Murcia, Spain
c Edwards Lifesciences, Valencia, Spain
d Axentiva Solutions, Santa Cruz de Tenerife, Spain
e Departamento de Genética, Microbiología y Estadística, Universidad de Barcelona, Barcelona, Spain
Received 19 September 2020. Accepted 15 February 2021
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Figures (2)
Tables (7)
Table 1. Clinical results stratified by surgical risk profile and intervention option
Table 2. Costs included in the model: procedures and complications
Table 3. Preprocedure and hospitalization resource use
Table 4. Clinical treatment costs during follow-up over a 15-year projected time horizon
Table 5. Utilities in each risk profile assessed during follow-up
Table 6. Economic assessment of TAVI with SAPIEN 3: base case results from the Spanish collective perspective
Table 7. Economic assessment of TAVI with SAPIEN 3: sensitivity analysis from the perspective of Hospital Clínico Universitario Virgen de la Arrixaca (a center with a high volume of percutaneous implants)
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Abstract
Introduction and objectives

Transcatheter aortic valve implant has become a widely accepted treatment for inoperable patients with aortic stenosis and patients at high surgical risk. Its indications have recently been expanded to include patients at intermediate and low surgical risk. Our aim was to evaluate the efficiency of SAPIEN 3 vs conservative medical treatment (CMT) or surgical aortic valve replacement (SAVR) in symptomatic inoperable patients at high or intermediate risk.

Methods

We conducted a cost-effectiveness analysis of SAPIEN 3 vs SAVR/CMT, using a Markov model (monthly cycles) with 8 states defined by the New York Heart Association and a time horizon of 15 years, including major complications and management after hospital discharge, from the perspective of the National Health System. Effectiveness parameters were based on the PARTNER trials. Costs related to the procedure, hospitalization, complications, and follow-up were included (euros in 2019). An annual discount rate of 3% was applied to both costs and benefits. Deterministic and probabilistic sensitivity analyses (Monte Carlo) were performed.

Results

Compared with SAVR (high and intermediate risk) and CMT (inoperable), SAPIEN 3 showed better clinical results in the 3 populations and lower hospital stay. Incremental cost-utility ratios (€/quality-adjusted life years gained) were 5471 (high risk), 8119 (intermediate risk) and 9948 (inoperable), respectively. In the probabilistic analysis, SAPIEN 3 was cost-effective in more than 75% of the simulations in the 3 profiles.

Conclusions

In our health system, SAPIEN 3 facilitates efficient management of severe aortic stenosis in inoperable and high- and intermediate-risk patients.

Keywords:
Aortic valve stenosis
Transcatheter implant
Cost-effectiveness analysis
Abbreviations:
CMT
HRP
IP
IRP
SAVR
TAVI
Resumen
Introducción y objetivos

El implante percutáneo de la válvula aórtica se ha consolidado como tratamiento de la estenosis aórtica grave inoperable o de alto riesgo quirúrgico. Recientemente las indicaciones se han ampliado a riesgo intermedio y bajo. Nuestro objetivo es evaluar la eficiencia de SAPIEN 3 frente al tratamiento médico conservador (TMC) o el reemplazo quirúrgico de válvula aórtica (RVA) en pacientes sintomáticos inoperables con riesgo alto e intermedio.

Métodos

Análisis de coste-efectividad de SAPIEN 3 frente a RVA/TMC mediante un modelo de Markov (ciclos mensuales) adaptado con 8 estados definidos por la New York Hearth Association y resultados a 15 años, incluidos las complicaciones mayores y el tratamiento tras el alta hospitalaria, desde la perspectiva del Sistema Nacional de Salud. Los parámetros de efectividad se basan en los estudios PARTNER. Se incluyeron costes sanitarios (en euros de 2019) derivados del procedimiento, hospitalización, complicaciones clínicas y seguimiento. Se aplicó una tasa de descuento anual del 3% en costes y beneficios. El análisis de sensibilidad fue determinístico y probabilístico (Monte Carlo).

Resultados

En comparación con el RVA (riesgo alto e intermedio) y el TMC (inoperables), el SAPIEN 3 implicó mejores resultados en las 3 poblaciones y menor estancia. Las tasas de coste-utilidad incremental fueron 5.471 (riesgo alto), 8.119 (riesgo intermedio) y 9.948 (inoperables) euros/años de vida ajustados por calidad ganados. En el análisis probabilístico, el SAPIEN 3 resultó coste-efectivo por encima del 75% de las simulaciones en los 3 perfiles.

Conclusiones

En nuestro medio, el SAPIEN 3 permite un tratamiento eficiente de la estenosis aórtica grave tanto en pacientes inoperables como en riesgo alto e intermedio.

Palabras clave:
Estenosis valvular aórtica
Implante percutáneo
Análisis de coste-efectividad

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