[Evaluation of nonpharmacologic invasive treatment in cardiology: the example of implantable automatic defibrillators].
Substantial therapeutic advances have been achieved in cardiology in the last fifteen years. They are due to the progress of cardiovascular pharmacology and interventional cardiology. Many devices are now competing with drugs. In France, the evaluation procedures of these two types of treatment are highly different. The benefit/risk ratio is not evaluated sufficiently before the marketing authorization of the devices. The procedures leading to reimbursement by Social Security are completely different for the drugs and the devices, and harmonization of these procedures is essential. It could allow the avoidance of paradoxical situations such as that of the automatic implantable defibrillator whose efficacy is now validated by controlled studies; but payment for which is not reimbursed by Social Security. The consequence is a serious dearth of this item, the implantation ratio per million residents in France being lower than that of all neighbouring countries.
Service de Cardiologie A, Hôpital Broussais, Paris, France.
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JY
Le Heuzey
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Guize
D017147:Defibrillators, Implantable / Q000191:economics; D004554:Electric Countershock / Q000191:economics / Q000295:instrumentation; D005069:Evaluation Studies as Topic; D005602:France; D006801:Humans; D012051:Reimbursement Mechanisms; D018570:Risk Assessment
L'évaluation des traitements invasifs non pharmacologiques en cardiologie: l'exemple du défibrillateur automatique implantable.