Patients are trying out pacemaker outside the skin before committing to invasive procedure and having a permanent implant.
Professor Michael Giudici, director of arrhythmia services in the Department of Internal Medicine, University of Iowa Hospitals said that patients have numerous concerns, such as body image issues, so this allows them to see the before and after, which helps them make a much more informed decision.
Professor Giudici came up with the idea for a test drive after using the technique successfully in patients who were already dependent on a pacemaker but needed to have it removed temporarily because of a device infection. These patients had all their hardware removed and were required to take antibiotics to clear the infection before receiving a new permanent device.
The current study was conducted in patients with bradycardia (slow heart rate). Over a period of nearly four years, six patients aged 40 to 82 years were offered a two to three week test drive to allow them to assess the potential benefits of permanent pacemaker implantation.
Procedures were conducted in an electrophysiology lab. A needle was stuck directly into the subclavian or axillary vein and a permanent pacing lead (or leads) was passed percutaneously and attached in the atrium or ventricle (or both).
The leads were fixed to the skin and attached to a non-sterile 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 two to three weeks.
All six patients subsequently chose to have a permanent pacemaker implanted under the skin. There were no complications associated with the initial implantation procedure, the trial period, or device removal.