From innovation to guideline implementation: a long way

Abstract

In Cardiology, with evidence-based medicine, a new therapy has a long and difficult journey before being recommended with a high class of recommendation by the scientific societies. Usually strong evidence from large clinical randomized using mortality and morbidity endpoints are needed. This is not the case in other medical specialties where new therapies, usually very expensive, with a limited benefit in terms of decreased mortality are widely used with a high cost for the society. Are we right in Cardiology? Do not we slow down too much innovations? Cardiac contractility modulation (CCM) is an electrical treatment which may be proposed to patients with severe heart failure, reduced left ventricular ejection fraction (LVEF), QRS <130 ms and optimal medical treatment. This technique is not really new, starting almost 20 years ago. By contrast to cardiac resynchronization therapy which started in 1994 and was implemented in the guidelines for heart failure in 2005 with a class I recommendation, CCM is not yet implemented in the guidelines even if this technique got the Food and Drug Administration (FDA) approval and the CE mark.1,2 CCM is just suggested for consideration by the European Society of Cardiology guidelines in patients with symptomatic heart failure on optimal medical treatment and with normal or mildly prolonged QRS duration and reduced LVEF. The main reason is probably the lack of data and evidence from large randomized trials with hard endpoints such as mortality and morbidity. The concept of CCM is attractive and induces biological and molecular changes: CCM is applied usually 5 to 7 h/day at relatively high voltage (7.5 V), long duration (20 ms), and biphasic electric signals to the right ventricular septal wall during the absolute myocardial refractory period. CCM signals do not induce ventricular contraction but influence the biology of the failing