How likely is the sense-B-noise to affect patients with subcutaneous implantable cardioverter-defibrillators and can we solve that problem in every case?

Abstract

Background: Sense-B-noise is a newly reported possible cause of inappropriate shocks in patients with subcutaneous implantable cardioverter-defibrillators (S-ICDs). The nature of that noise is unknown, it is not related to mechanical failure of the S-ICD system. Reprogramming to the secondary sensing vector is suggested by the producer as a possible solution.

Methods: We analyzed the medical records of S-ICD recipients from two university clinical centers (Gdansk and Szczecin, Poland). Our aim was to determine the rate of sense-B-noise, and whether the secondary sensing vector would be available for reprogramming if such a problem occurred in our patients.

Results: The sense-B-noise issue affected three patients in our cohort (3%), which corresponds to the incidence of 0.012 events per patient-year of follow-up. The primary vector was permanently used in 47 patients (52%), secondary in 28 (31%), and alternate in 16 (17%), respectively. Therefore, the total number of patients potentially vulnerable to sense-B noise (with the primary or alternate vector programmed permanently) was 63 (69%). Among those 63 patients, 51 individuals (81%) had also the secondary vector available for permanent use.

Conclusion: The sense-B-noise affected 3% of patients in our cohort, with an incidence of 0.012 per patient-year of follow-up. Most patients potentially vulnerable to sense-B noise could be reprogrammed to the secondary sensing vector, if necessary. Further investigation of the sense-B-noise issue is needed.

Keywords: inappropriate sensing; inappropriate shock; oversensing; sense-B-noise; subcutaneous implantable cardioverter-defibrillator; sudden cardiac death.