A retrospective study of HCM patients with implantable defibrillators conducted at eight centers worldwide has demonstrated that ICDs are not only lifesaving, the shocks they generate are not harmful to those in whom they are implanted.
The study looked at 486 patients with HCM with an ICD implanted for either primary or secondary cardiac arrest prevention. Of the 486 patients, 94 (19%) experienced at least one appropriate shock from their ICDs. 44 of those who had been shocked had experienced one or more shocks over the period of the study, including 6 patients who had at least 3 shocks over a 24 hour period. Inappropriate shocks occurred in 96 patients (20%).
Despite the shocks, appropriate or not, at the end of the follow-up period the ICD discharges did not appear to cause the patients to suffer from increased heart failure or sudden cardiac arrest. Furthermore, their general health and well-being were good: they did not suffer from significant degrees of anxiety and depression.
The U.S. Food and Drug Administration today issued a safety advisory regarding St. Jude Medical implantable cardiac devices used in conjunction with St. Jude’s proprietary Merlin @home Transmitter.
According to the advisory, these devices could potentially be vulnerable to hacking. However, only a highly skilled hacker would be sophisticated enough to exploit the vulnerability. Such unwarranted interference could conceivably cause premature battery depletion or unnecessary shocks.
A software patch has been developed for the Merlin @home monitor designed to address the issue and to reduce the risk of hacking. The update is now available and will be applied automatically to the Merlin monitor.
***Patients only need to make sure their Merlin@home Transmitter remains plugged in and connected in order to receive the software patch.***
Short-selling firm Muddy Waters first went public with this information in August, believing that it might cause a pending $25 billion acquisition of St. Jude Medical by Abbott Laboratories to fall apart. However, the deal closed last week despite the issue.
This article on Medscape
This article in the Minneapolis Star Tribune.
This article on Huffington Post.
This article on CNBC.