番茄社区

For all the technological advances in implantable cardioverter-defibrillator (ICD) technology, patients have lost out in their ability to convert the device to pacing only. It's time to change that, one group argued.

"In the past, ICD systems could be downgraded to only provide pacing by replacing the ICD generator with a pacemaker generator attached to the existing leads. Unfortunately, changes in ICD lead technology have made this impossible, specifically because there is no adaptor available to facilitate this simple, cost-effective, and patient-centered procedure," wrote Daniel Kramer, MD, MPH, and colleagues at Beth Israel Deaconess Medical Center in Boston.

Millions of people currently live with the devices that use DF4 ICD leads, a design approved by the FDA in 2009 because it allowed for smaller ICD generators and made operator connection errors less likely.

"However, they cannot be connected to pacemakers, because the pace-sense conductor cannot be separated from the combined pin," Kramer's group highlighted in their viewpoint article published online in .

"In practice, this means that each patient who would be eligible for conversion to pacing therapy must instead receive a new ICD, which in many cases would presumably be immediately deactivated."

Their fix: An adaptor to make DF4 ICD leads compatible with pacemaker generators.

"I'm in complete agreement with the authors. Universal compatibility amongst ICD and pacemaker pulse generators is feasible and would benefit patients by avoiding the need for ," commented Robert Hauser, MD, of the Minneapolis Heart Institute.

Kramer's group urged cardiologists and others to put pressure on manufacturers and regulators in advocating for a universal adaptor for patients with ICDs.

Given that putting one on the market would require substantial investment and be financially self-defeating for manufacturers (given the price difference between ICDs and pacemakers), payers such as Medicare could force the issue and "reimburse facilities only for the cost of a pacemaker in cases in which a downgrade was planned but not possible, with manufacturers then required to rebate the difference," they suggested.

The FDA could do its part by helping to guide adaptor development and testing through the most efficient pathway, reducing time spent under regulatory review, the group added.

An FDA representative told 番茄社区 that the agency had no comment.

Kramer's team estimated that 1,000 U.S. patients per month would get a pacemaker in lieu of a replacement ICD because of the rising risks associated with age and conditions like chronic kidney or lung disease.

However, that may be quite a large overestimation, according to Sean Pokorney, MD, of the Duke Clinical Research Institute in Durham, North Carolina.

It's really just two groups who would switch from an ICD to a pacemaker, he noted: patients who have a shorter life expectancy, and those who have a cardiac resynchronization therapy defibrillator system in place and have had an improvement in their ejection fraction.

"Even if an adapter was available, I believe that a minority of patients would change their ICD to a pacemaker at the time of generator change-out," he said. Nevertheless, "this would be an important minority for which to be able to provide that option," according to Pokorney.

Providers shouldn't assume that just because their patients , they will continue to want another one in the future, he emphasized.

"I believe strongly that the patient should be offered the options of an ICD generator change-out versus a change to a pacemaker (assuming that they have a pacing need), and the patient should be engaged in the decision-making. I also believe that these conversations and patient engagement are likely not happening enough at the time of generator change-out," Pokorney said.

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