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AUTOSET CS - 29 juin 2010 (2413) avis - AUTOSET CS (2413) English version

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Laboratory / Manufacturer RESMED SAS FRANCE Posted on Jul 06 2010 Adaptive servo-ventilation machines Posted on Jul 06 2010

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Published 29 June 2010
Reads 25
Language English
     
 
 
The legally binding text is the original French version
NATIONAL COMMITTEE FOR THE EVALUATION OF MEDICAL DEVICES AND HEALTH TECHNOLOGIES (CNEDiMTS)  OPINION  29 June 2010
Name: Models and references: Manufacturer: 
Applicant: 
Claimed indications:
Available data:
Actual Benefit (AB) :
CONCLUSIONS 
AUTOSET CS, adaptive servo-ventilation machines AUTOSET CS and AUTOSET CS2 RESMED Ltd RESMED SAS FRANCE Adaptive servo-ventilation for the symptomatic treatment of patients with heart failure associated with Cheyne-Stokes breathing or suffering from central sleep apnoea, with or without upper airway obstruction. Seven comparative prospective studies and three non-comparative prospective studies which assessed adaptive servo-ventilation in the treatment of sleep apnoea in heart failure patients were submitted by the applicant. These mostly single-centre studies were conducted in small numbers of patients (between 11 and 51) and usually over short follow-up periods (between 1 night and 12 months). Two studies assessed the efficacy of adaptive servo-ventilation over a period of just 1 night. The main endpoints assessed in these studies related to sleep disorders (apnoea/hypopnoea index, nocturnal oxygen saturation, arousal index, etc.), heart failure parameters (left ventricular ejection fraction, plasma concentration of B-type natriuretic peptide, urinary catecholamine excretion, 6-minute walk test, etc.), quality of life and daytime sleepiness. These studies demonstrate that sleep disorders are corrected by the use of adaptive servo-ventilation. The changes in the heart failure parameters (e.g. left ventricular ejection fraction and plasma concentration of B-type natriuretic peptide) were of little clinical significance, and no improvement in the prognosis of heart failure was demonstrated. The results relating to quality of life and daytime sleepiness are conflicting and cannot serve as a basis for drawing conclusions. Insufficient  The clinical data submitted are insufficient to establish the benefit of the AUTOSET CS range of adaptive servo-ventilation machines in respect of the morbidity and mortality of patients with heart failure associated with Cheyne-Stokes breathing or central sleep apnoea. The results of the international multi-centre SERVE-HF study, currently under way, should provide a basis for assessing the impact of sleep disorder correction with adaptive servo-ventilation on the course of heart failure. Definitive opinion 2
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