At Thursday's HRS session the importance of lead safety seemed to be everywhere. Interest in the early morning session Riata ICD Lead Safety Alert Update had physicians standing in the hallway outside the presentation room to hear what presenters had to say about the Riata, Riata ST, and Durata leads. Evidence was presented demonstrating that the Durata lead is competitive with alternative leads available on the market today; however, some physicians questioned whether the Durata would stand the test of time. Regardless of the transvenous lead used, I think all physicians would agree that every lead has an inherent level of risk of failure associated with it.
On the other end of the spectrum is Cameron Health and the company's subcutaneous implantable cardioverter-defibrillator (ICD) system. At the Late-Breaking Abstract session results were presented on the safety and efficacy of the subcutaneous system from a single-arm, prospective study. The study reached both its primary efficacy and safety endpoints. These positive results aside, what I found interesting was the informal debate that arose during the question and answer session regarding the value of removing transvenous leads from the picture entirely with the subcutaneous system. One audience member questioned how many patients the subcutaneous system would be appropriate for, and felt that there are other ways to get around the problem with transvenous leads, such as improved training. In response, the presenter commented he doubted the problem with the Riata leads is due to training. Regardless of what manufacturer's lead is being scrutinized, every lead has a failure rate, and historically lead failure has been a problem in this industry. One thing that is clear from Thursday's sessions, however, is that despite the differing opinions around Cameron Health's subcutaneous ICD, its lack of transvenous leads will be a strong selling point for some physicians, and its future adoption in the US upon anticipated Food and Drug Administration approval will be closely followed by physicians and industry alike.