Original Title: Efectividad y coste-efectividad de los desfibriladores automáticos implantables en Espańa

Authors' objectives: • To review the scientific literature about ICD effectiveness and costeffectiveness compared to the best medical antiarrhythmic treatment for primary and secondary prevention of SCD. • To assess ICD cost-effectiveness and cost-utility compared to the best medical antiarrhythmic treatment for secondary prevention of SCD from the Spanish National Health Service perspective using a decision analytic model.

Authors' results and conclusions: RESULTS: On the one hand, the systematic review identified 13 randomized clinical trials (4 about secondary prevention and 9 about primary prevention). Conclusions show that ICD reduces mortality in patients with cardiac arrest due to ventricular arrhythmias, sustained ventricular tachycardia with syncope or sustained ventricular tachycardia with symptoms of hemodynamic comprise and depressed ventricular function (secondary prevention). Conclusions also show that prophylactic ICD also reduces mortality in patients with prior myocardial infarction, left ventricular ejection fraction ≤ 0.35; documented episode of asymptomatic nonsustained ventricular tachycardia; and inducible ventricular tachyarrhythmia at electrophysiological testing that was not suppressed by procainamide; and in patients with prior myocardial infarction and left ventricular ejection fraction ≤ 0.30. Health related quality of life studies show that increasing ICD shocks imply worst quality of life. On the other hand, 21 economic evaluations were identified. Neither of them was focused on Spain. There was a wide variation between studies but, in general, they agreed that ICD is a costeffectiveness alternative in high risk patients. However, it was not clear how that risk could be stratified. Results from our model suggest that ICD is a cost-effectiveness alternative for secondary prevention of SCD in Spain from the National Health Service perspective. Therefore, implantation should be enhanced in patients who had suffered cardiac arrest due to ventricular tachycardia or ventricular fibrillation. CONCLUSIONS: • ICD reduces mortality in patients with cardiac arrest due to ventricular arrhythmias, sustained ventricular tachycardia with syncope or sustained ventricular tachycardia with symptoms of hemodynamic comprise and depressed ventricular function (secondary prevention). • Prophylactic ICD also reduces mortality in patients with prior myocardial infarction, left ventricular ejection fraction ≤ 0.35; documented episode of asymptomatic nonsustained ventricular tachycardia; and inducible ventricular tachyarrhythmia at electrophysiological testing that was not suppressed by procainamide; and in patients with prior myocardial infarction and left ventricular ejection fraction ≤ 0.30. • Health related quality of life studies focused on secondary prevention show that increasing ICD shocks imply worst quality of life. • 21 economic evaluations were identified. Neither of them was focused on Spain. There was a wide variation between studies but, in general, they agreed that ICD is a cost-effectiveness alternative in high risk patients. However, it was not clear how that risk could be stratified. • Results from our model suggest that ICD is a cost-effectiveness alternative for secondary prevention of SCD in Spain from the National Health Service perspective. Therefore, implantation should be enhanced in patients who had suffered cardiac arrest due to ventricular tachycardia or ventricular fibrillation.

Authors' methods: We carried out a systematic review about ICD efficacy (based on randomized clinical trials) and ICD effectiveness (based on economic evaluations). We applied two search strategies in MEDLINE and MEDLINE in process using PubMed, EMBASE, Cochrane Central Register of Controlled Trials, CRD (DARE, HTA, NHS EED), Índice Médico Español (IME), LILACS and EconLit. Selection, data extraction and quality assessment were carried out through standardized procedures. A complete economic evaluation was developed to compare costs and health benefits of ICD vs amiodarone for secondary prevention of SCD using a decision Markov model. Cost-effectiveness and cost-utility analysis were performed. Main efficacy outcomes measures were death from any cause and arrhythmic death. We performed both deterministic and probabilistic sensitivity analyses to assess robustness and uncertainty around the parameters and results.

Project Status: Completed

Year Published: 2011

URL for published report: https://sescs.es/efectividad-y-coste-efectividad-de-los-desfibriladores-automaticos-implantables-en-espana/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es