Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran

Reports from Ireland and New Zealand may herald new concerns about the Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa).

A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that  15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported that 20% of the patients had “clinically significant events.”

Quoted in an article in the Minneapolis Star Tribune. the chief of the Arrhythmia Service at Brigham and Women’s Hospital, Laurence Epstein, acknowledges the small size of the single-center study but states that “it could ultimately be a big issue… we’re just starting to scratch the tip of the iceberg of what the scope of the problem is.” Although the Riata leads were discontinued last year, more than 227,000 were sold worldwide.

In New Zealand, meanwhile, health authorities are struggling with a surge in bleeding complications following the government’s decision to fund dabigatran (Pradaxa). According to an article in the Star Times, the country’s drug monitoring agency “has received around 50 reports of people experiencing bleeding since the drug was introduced two months ago as a replacement” for warfarin.

The Star Times reports that about 56,000 people in New Zealand take warfarin and that thousands have been switched to dabigatran. The reports quotes an official of the country’s Haematology Society: “We do have concerns about the way it was rolled out. It was rolled out very rapidly without a lot of forethought and planning. In particular the fact that general practitioners could have widespread access to this drug from day one was a concern to us, when some of them did not know how to use it.”

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