HRS: Patients not swayed from ICD generator change because of cost, device advisory
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Concerns that patients might decide against an implantable cardioverter-defibrillator (ICD) generator change when the elective replacement indicator or end of life is reached may be unfounded. Patients will consent to a generator exchange even if a small percentage has negative views of the device or is concerned about out-of-pocket costs, according to a May 10 poster presentation at the 33rd annual scientific sessions of the Heart Rhythm Society.

Caroline M. Brown and colleagues from Monmouth Cardiology Associates in Ocean, N.J., conducted a consecutive preoperative survey of patients at the time of a generator change to determine whether economics, or other factors, affected their attitudes toward the procedure or their device in general.

A total of 41 patients responded to the survey between September 2010 and August 2011. Sixty-nine percent of patients had primary ICD implants, and this was the first generator change for most of those involved in the study.

When asked about their view of their ICD implant, 83 percent of patients felt their device improved their lives, while 15 percent felt it was not helpful. Among those who had a favorable view of the device, the most common reason given was that it provided peace of mind.

“Within this study, regardless of whether the patients had inappropriate or appropriate shocks, those patients still had positive views of their device,” explained Brown.

Patients who had a negative view of their device were 2.6 times more likely to be part of a lead or device advisory, though all patients surveyed, even those with negative views, still elected to continue with the generator change.

“Patients understand it’s a manufactured product and it can have defects,” said Brown. “As long as the FDA and companies are proactively following these devices, I think patients are safe. That’s how we educate our patients. If you purchase a car, you know it could have a recall. If you purchase a device, it could have a recall. We try to be matter-of-fact and informative, but relaxed. If you make patients anxious, they will be.”

Potential out-of-pocket costs could impact a decision to undergo a generator change, but the authors noted that patients are remotely detached from the true costs of the procedure. They speculated that cost concerns would be much higher if true costs were shifted to patients.

While all patients surveyed eventually proceeded with the generator change, 15 percent contemplated not undergoing the procedure. Despite the hesitation among this group of patients, no physicians ever raised the possibility of not undergoing the generator change, and the authors cited anecdotal evidence that physicians may fear litigation or alienating their patients if they suggest denying an ICD implant.

Brown said the researchers are looking to further the study to examine the effect of patients’ socioeconomic backgrounds, as well as various cost factors.