Pacemaker 'Test Drive' May Guide Patients Undecided About Permanent Implants, Says Study

Deborah Brauser

June 24, 2015

MILAN, ITALY — An unpresuming poster presentation about pacemakers temporarily affixed to the outside of the body, instead of in a subcutaneous pocket, drew a big crowd of photo-snapping clinicians here at the European Heart Rhythm Association (EHRA) EUROPACE-CARDIOSTIM 2015 meeting[1].

The small proof-of-concept study included only six outpatients with sinus bradycardia and atrial fibrillation (AF), who wore a pulse generator outside their bodies for 2 to 3 weeks, with pacing leads positioned transvenously, after they expressed serious reservations about being permanently implanted with a device. Ultimately, all six reported being comfortable with the process and subsequently chose to get a permanent implant. In addition, there were no complications from the novel "preprocedure," including during device removal.

"This process lets patients experience the clinical impact of pacing therapy and has been very popular so far. I think we should do it a lot more," lead author Dr Michael C Giudici (University of Iowa Hospitals and Clinics, Iowa City) told heartwire from Medscape.

"Instead of putting this device under their skin, we're just putting in over their skin, programing it the normal way, and then sending patients home," said Giudici. "We tell them to take it for a test run."

Fighting Ambivalence

Dr Michael C Giudici

Giudici noted that bradycardia from sinus or atrioventricular (AV) nodal disease often progresses over several years, with symptoms commonly downplayed or even written off because of the patient's age. Because of this, "some patients and even clinicians are ambivalent about implanting a pacemaker, especially if there's not clear evidence of benefit," he said.

"Some people who have a heart rate of 50 feel great while others are tired and miserable. So it can sometimes be hard to sort out if a pacemaker will really do a lot of good," added Giudici. "Giving someone an implant of a device that might last for 10 years when you really don't know if it's going to make that big a difference is a problem."

He reported that his center had already been using this type of pacing in some patients who had their devices removed due to infection or around the time of a transcatheter aortic-valve replacement (TAVR) "when you think conduction is going to return."

Because of this, Giudici said they wanted to investigate the feasibility of giving patients a so-called temporary-permanent pacemaker. "It's telling a patient who is undecided: let's do this very simple outpatient procedure. You wear it under your clothes for 2 to 3 weeks and we'll see whether or not you derive enough difference that you want to proceed with a permanent pacemaker," he explained.

In addition to sinus bradycardia and slow conduction of AF, the three men and three women who participated in the study also had second-degree AV block.

In this test-drive approach, pacing leads were placed using "a subclavian approach into the right atrium, right ventricular septum, or both." They were attached to a used pacemaker that was sewn to the outside of the skin. Air-and waterproof dressing was then applied over the pacemaker, which was programmed to an individualized rate-response mode.

When asked about cost, Giudici said that permanent and temporary pacing leads have similar prices in the US. "And the used pacemakers, which came from other procedures, cost virtually nothing," he said. "You also need to compare this with going through a whole process of putting in a permanent device that doesn't help."

Other ways his hospital is continuing to use these temporary-permanent devices is "around the time of TAVRs to try to move people along in the hospital more quickly, which saves money. Many of these people just don't need a permanent pacemaker," he said.

Giudici noted that he now plans on doing a bigger study assessing the effectiveness of the procedure in these different types of patients, as well as to collect quality of life data.

Opens Up New Options?

Temporary external pacemaker

"I found this to be very interesting," said Dr Franz Gurtner (Braunau General Hospital, Austria) after hearing the presentation. "I've seen similar procedures on other patients with serious infection who could not get a permanent pacemaker. And now I'm convinced that I'm doing right in my thinking."

Gurtner, who was not involved with the research, added that he found the results encouraging and plans to look into it more for his center.

Dr Dragos Cozma (Institute of Cardiovascular Disease, Timisoara, Romania) agreed. "I have a lot of undecided patients who wonder if they will really feel okay with a pacemaker. This would be a nice idea," he said. "It crossed my mind before, but I feared some legal issues in Romania. But after talking with the author, I think it would be interesting to try it."

Cozma noted that sometimes a decision needs to be made quickly or a pacemaker only needs to be used once in a while. "We have a lot of sinus bradycardia patients, and I'm not convinced that a permanent device is the answer just to try to improve quality of life. This new procedure opens up some options," he said.

Giudici reports no relevant financial relationships.

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