Bradycardia patients unsure about whether they want a permanent pacemaker can try before they buy, a small study found.
Investigators used a permanent pacemaker but sewed it to the outside of the skin and attached it to the heart via leads through the neck, reported , of the University of Iowa, and colleagues, at the conference in Milan.
After trying this "temporary permanent" pacemaker for 2 to 3 weeks, all six patients in the study opted for permanent pacemaker implantation, the investigators said.
"You use a permanent pacemaker and a permanent pacing lead, but the device is just on the outside of the body. In symptomatic patients with slow heart rates it's hard to know for sure that the reason these people feel poorly is because their heart is slow. This was a nice way to test the hypothesis that your slow heart is causing your problem without committing them to a surgery and a permanent pacemaker," Giudici said in a press release.
Study participants were age 40 to 82 with diagnoses of bradycardia. The procedures were done in an electrophysiology lab. A needle was inserted directly into the subclavian vein and permanent pacing leads were passed percutaneously and attached in the atrium, ventricle, or in both locations.
The leads were fixed to the skin and attached to a nonsterile permanent pacemaker which was sewn to the skin and covered with a waterproof dressing. The pacemaker was programmed to a rate-response mode at an appropriate heart rate for each patient and removed after 2 to 3 weeks.
There were no complications associated with the initial implantation procedure, the trial period, or device removal, the investigators said.
"The pacemaker is placed outside the chest and there is no incision but it is the same device used for implants, so patients experience the real impact. They tell us their exercise tolerance, quality of life, and in some people even their alertness has improved as a result of pacing. They've commented, 'wow, I didn't realize how terrible I felt. This is great. When can we schedule my pacemaker?'" Giudici said.
"The test drive enables patients to go into their procedure much more confident that the pacemaker is going to do them some good. It also allows the patient to make the choice, which ultimately makes them much happier than if the doctor just tells them they need it," Giudici said.
In addition to patients with bradycardia, those with irregular heart rhythms might also benefit from test driving a pacemaker, Giudici said.
The technique was first used in patients who already had a permanently implanted pacemaker but needed to have it removed temporarily because of infection, Giudici said.
, a cardiologist at the Virginia Commonwealth University Medical Center and spokesperson for the American Heart Association, said that his group has also been using this procedure for a number of years and finds it beneficial.
"This is definitely a nice idea and something we have done off and on for at least several years," Ellenbogen said in an interview with .
"We tend to do this in patients who are younger [when] we are not completely convinced that they would benefit from a pacemaker. This is a novel way to test it," he said.
"The disadvantage is that it is costly to use a completely functional pacemaker externally," Ellenbogen added. "If they decide they want or need a pacemaker then we have to use a brand new pacemaker to implant under the skin. It's an expensive little experiment."
From the American Heart Association:
Disclosures
No funding sources were reported for this study.
No researchers reported financial relationships with industry.
Kenneth Ellenbogen reported no financial relationships with industry.
Primary Source
EHRA-EUROPACE-CARDIOSTIM
Source Reference: Guidici M, et al "Undecided about getting a pacemaker? Take one for a test drive" EHRA EUROPACE-CARDIOSTIM 2015; Abstract P874.