First encouraging results for an extravascular implantable defibrillator
A new type of defibrillator has been developed, by Medtronic, the extravascular implantable defibrillator, whose lead is placed under the sternum and not above, and closer to the heart.
This defibrillator would be an alternative to transvenous defibrillators which have a good efficiency and are the standard for the prevention of sudden cardiac death, but the placement of the leads is "the main responsible for complications (vascular lesions, pneumothorax, cardiac perforation)" and in the long term "venous obstructions", as well as failures requiring extraction.
This extravascular defibrillator has shown satisfactory efficacy, but with a high rate of inappropriate shocks that needs to be improved, in a non-randomized trial that included 299 patients implanted in 17 countries including France. The results were presented for the first time at the European Society of Cardiology (ESC) congress in Barcelona on Sunday and are published online by the New England Journal of Medicine.
Efficacy in terms of 30-day defibrillation capability was achieved in 98.7% of patients, which was at least 88% above target.
The primary safety endpoint was the absence of adverse events related to the implantation procedure or system function at 6 months, and this was achieved in 92.6% of patients, again exceeding the prespecified goal of 79%.