Patients have many concerns before choosing a permanent implant, such as body image issues. The test drive enables patients to opt for the procedure with confidence.
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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.
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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.
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