Safety concerns of Piezoelectric Units in Implantable Cardioverter Defibrillator.

PURPOSE: Evidence-based research appears to conflict on the potential risk of electromagnetic interference (EMI) between piezoelectric units (Pzs) and implantable cardioverters and defibrillators (ICDs). The purpose of this study was to observe whether the EMI produced by Pzs is hazardous for ICDs.

MATERIALS AND

METHODS

A cross-sectional study of 6 Pzs was conducted in vitro for EMI using an ICD system. To simulate the human body's electrical resistance, electrographic recordings were made of the ICD and lead that were immersed in a bath of saline solution. The variables investigated were the presence of EMI, the distance between the ICD and the Pz, and signal intensity, damage, and type of damage to the ICD and lead. Each series of tests was repeated 3 times, beginning with a 15-second baseline recording (control), until all recording conditions had been covered. Each Pz was recorded under the following conditions: less than 2 cm from the tip of the ICD lead; less than 2 cm from the ICD; less than 2 cm from the lead body and coils; and 15 cm from the lead or the ICD (R4).

RESULTS

In the positive control (direct contact between the lead or the ICD with the Pz switched on), the ICD detected electrical activity as false heart activity. However, after covering all test conditions, no EMI was produced by the Pzs.

CONCLUSION

No EMI or permanent changes in the functioning of the ICD were detected in vitro.