Counterintuitive Advice About Staying Alive After A Heart Attack 1

An interventional cardiologist– the cardiologists who put in stents and usually treat heart attack patients in the first few hours– asked an electrophysiologist– the cardiologists who treat arrhythmias– whether wearable defibrillators should be used post-MI. Here’s what that electrophysiologist, Edward J. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, replied. It is a good example of how sometimes a procedure or a therapy that seems, intuitively, to be worthwhile and beneficial, may actually not be beneficial at all. Here’s his response, which he originally posted on Twitter:

Click here to read the full post on Forbes.

 

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MADIT-CRT Long-Term Follow-Up Shows Survival Benefit with CRT-D Reply

MADIT-CRT was an influential trial that showed a reduction in heart failure complications — but not mortality — when cardiac resynchronization therapy (CRT) was added to an implantable defibrillator in patients with mild heart failure who also had left bundle-branch block (LBBB). Patients in the trial were followed for 2.4 years, raising questions about the long-term effects of CRT. Now, a second look at 854 patients who participated in a follow-up study, presented at the American College of Cardiology and published in the New England Journal of Medicine, suggests that over the long term, CRT may save lives in this population. MADIT-CRT was sponsored by Boston Scientific.

Click here to read the full post on Forbes.

 

 

 

MADIT-CRT Long-Term Follow-Up Shows Survival Benefit with CRT-D

Could Terrorists Have Hacked Dick Cheney’s ICD? 3

It happened in Homeland. Could it happen in real life?

In a 60 Minutes segment scheduled for broadcast tomorrow, Dick Cheney says that his doctors turned off the wireless function of his implanted cardiac defibrillator (ICD) “in case a terrorist tried to send his heart a fatal shock,” according to the Associated Press.

Years later, Cheney watched an episode of the Showtime series “Homeland” in which such a scenario was part of the plot.

“I found it credible,” Cheney tells “60 Minutes” in a segment to be aired Sunday. “I know from the experience we had, and the necessity for adjusting my own device, that it was an accurate portrayal of what was possible.”

I asked three experienced electrophysiologists– the cardiologists who devote a good part of their professional life implanting ICDs– whether this was a realistic concern…

Click here to read the full story on Forbes.

 

Richard Lehman On ICDs In Clinical Practice And Serelaxin For HF Reply

This week in CardioExchange Richard Lehman is not quite as funny as most weeks (perhaps he’s still recovering from New Years’ celebrations?), but he has some interesting and useful comments on a JAMA study comparing real world patients garcinia cambogia plant uses in registries to patients in clinical trials and an impressive Lancet study testing the role of the novel agent serelaxin in acute heart failure.

“So after much hard work and statistical legerdemain, the study shows that the mortality of real-life heart failure patients after ICD implantation for primary prevention is the same as that in the trials, and less than that of the control patients in the trials. Which I guess is a useful thing to know.”

….

 “I don’t think that by itself it changes practice in any way, but it does show that recombinant human relaxin 2, serelaxin, is an interesting new treatment that deserves further study in heart failure.”

Subcutaneous ICD Gains FDA Approval Reply

The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) system from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and  therefore  does not need to be guided with x-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage and breast bone.

The S-ICD System has been approved only for patients who do not also require a pacemaker or pacing therapy. The FDA will require Cameron Health to perform a 5-year postmarketing study with 1,616 patients to measure the long-term safety and efficacy of the device and to test whether the device is equally effective in men and women.

“The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine ICD placement procedure is not ideal,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, in a press release. “Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device.”

In April, the FDA’s Circulatory System Devices panel voted 7-1 that the benefits of the S-ICD outweigh the risks in appropriately selected patients. Approval was based on the pivotal 321-patient study in which 304 patients successfully received the S-ICD. During the six month followup period the device detected 78 arrhythmias in 21 patients. According to the FDA analysis, all the arrhythmias were terminated by the device or resolved spontaneously. Common complications of the device include inappropriate shocks, discomfort, system infection, and electrode movement.

Earlier this year Boston Scientific acquired Cameron Health for an initial payment of $150 million. Depending on future performance, the price may reach as much as $1.2 billion.

Rick Lange, who served on the FDA’s Circulatory System Devices advisory panel that reviewed the S-ICD, provided the following comment:

This will be a niche device…..it will have a limited role because it’s not suitable for patients who also need or would benefit from pacing therapy.  However, it may be particularly suitable for primary prevention of SCD in children or young adults (i.e. those with HOCM, long QT, RV dysplasia, Brugada syndrome, family history of SCD, etc) where intravascular lead placement is not attractive because of continued growth of the child or concerns about long term lead complications. The FDA panel was insistent that a post marketing study be performed to ensure that the device appropriately sensed and treated lethal arrhythmias. Early versions of the sensing algorithm needed tweaking.
Click here to read the press releases from the FDA and Boston Scientific…