Back in January we reported here on the so-called “Riata Summit”, which took place in Minneapolis and at which a group of cardiologists, associated specialists and staff from St Jude Medical, manufacturer of the Riata and Riata ST leads were present.
Lest we forget, the meeting was called with the intention of reviewing the state of play, following high profile problems with the insulation around the leads in these implantable defibrillator systems, leading to “externalisation” of electrical wiring, with the risk of non delivery or inappropriate delivery of electrical impulse.
The meeting was reportedly quite a feisty affair with data from several sources providing much reason for debate and conjecture about the actual risk and the proposed course of action, although all agreed that data collected thus far from the significant patient group was inadequate to on which to base firm conclusions.
The consensus was that patients would be monitored rather than reoperated to remove and replace the lead, prophylactic removal being an undesirable course of action when balancing the probability of malfunctioning leads with the risk associated with a difficult procedure.
It’s taken a while, but the fallout from the meeting has now reached the public domain with the appearance of an article in Minneapolis’s Star Tribune, here.
Bringing the human side to the story, the article talks about patient Dan Meyer, who did indeed have his device replaced in early March. Furthermore it raises the question of how to manage the anxiety likely to be felt by patients as expressed by Minneapolis cardiologist Dr Robert Hauser, who reportedly said; “We are ill-prepared to counsel our patients because we do not have the clinical evidence to support any recommendations.”
Source: Star Tribune, medlatest staff
published: March 12, 2012 in: Alerts/Adverse Events, Cardio, St Jude